Omron M2 Basic (HEM-7120-E)
The technology used in the Omron M2 Basic (HEM-7120-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.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BIHS (UK and IRL)||Self-measurement||Manufacturer declaration of equivalence|
|ESH (Europe)||Self-measurement||The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.|
|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.
Takahashi H, Yoshika M, Yokoi T. Validation of three automatic devices for the self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7130, HEM-7320F, and HEM-7500F. Blood Press Monit. 2015 Apr;20(2):92-7. doi: 10.1097/MBP.0000000000000096. PMID: 25462531.
ESH-IP:2010 - Pass General population
Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of an automatic device for the self-measurement of blood pressure in sitting and supine positions according to the ANSI/AAMI/ISO81060-2: 2013 guidelines: the Omron HEM-9700T. Blood Press Monit. Epub: 2019 Feb 14. doi: 10.1097/MBP.0000000000000368.
81060-2:2013 - Pass Sitting position
81060-2:2013 - Pass Supine position