Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | ★ Recommendation | Older clinical validation; older protocol; multiple clinical validations |
BP | BIHS (UK and IRL) | ABPM | Published evidence |
BP | ESH (Europe) | ABPM | Published evidence |
BP | Stride BP | ABPM for adults (Preferred) | Published evidence |
Legend: P Stride Equivalence
Ragazzo F, Saladini F, Palatini P. Validation of the Microlife WatchBP O3 device for clinic, home, and ambulatory blood pressure measurement, according to the International Protocol. Blood Press Monit. 2010 Feb;15(1):59-62. doi: 10.1097/MBP.0b013e32833531ca. PMID: 20075717.
ESH-IP:2002 - Pass General population
Stergiou GS, Tzamouranis D, Nasothimiou EG, Karpettas N, Protogerou A. Are there really differences between home and daytime ambulatory blood pressure? Comparison using a novel dual-mode ambulatory and home monitor. J Hum Hypertens. 2010 Mar;24(3):207-12. Epub: 2009 Jul 16. doi: 10.1038/jhh.2009.60. PMID: 19609285.
ESH-IP:2002 - Pass General population
Azaki A, Diab R, Harb A, Asmar R, Chahine MN. Questionable accuracy of home blood pressure measurements in the obese population - Validation of the Microlife WatchBP O3® and Omron RS6® devices according to the European Society of Hypertension-International Protocol. Vasc Health Risk Manag. 2017;13:61-9. Epub: 2017 Feb 27. doi: 10.2147/VHRM.S126285. PMID: 28280348. Available from: PMC5338962. eCollection 2017.
ESH-IP:2010 - Fail Obese subjects, BMI ≥30 kg/m²
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Microlife WatchBP O3 Ambulatory (2G) (BP 3SZ1-1)
Fania C, Lazzaretto I, Fontana U, Palatini P. Accuracy of the WatchBP O3 device for ambulatory blood pressure monitoring according to the new criteria of the ISO81060-2 2018 protocol. Blood Press Monit. 2020 Oct;25(5):285-290. Epub: 2020 Jun 23. doi: 10.1097/MBP.0000000000000459. PMID: 32898350.
81060-2:2019 - Pass General population