Omron M3 (HEM-7154-E)
The technology used in the Omron M3 (HEM-7154-E), to measure blood pressure, has been compared to a clinically validated device but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Accuracy Assessment | Recommendation | Basis | ||
---|---|---|---|---|
Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
Stride BP | Self-measurement for adults (Preferred) | Equivalence claim without published evidence |
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.
Omron BP765 (HEM-7311-ZSA)
Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z). Vasc Health Risk Manag. 2015 Jan;9(11):49-53. doi: 10.2147/VHRM.S72438. PMID: 25657587.
81060-2:2009 - Pass General population