|BP||Medaval||★★★★★ Certified Accuracy||Recent clinical validation; recent protocol with certified adherence; multiple clinical validations|
|BP||BIHS (UK and IRL)||Previous recommendation, now archived||Published evidence|
|BP||DHL (DE)||General use (2013)||Published evidence|
|BP||Stride BP||Self-measurement for adults||Published evidence|
Legend: B BIHS Derivative, D DET Equivalence, J JHS Implied Equivalence, Y Internal declaration
Takahashi H, Yoshika M, Yokoi T. Validation of Omron RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2013;9:265-72. Epub: 2013 May 28. doi: 10.2147/VHRM.S44569. PMID: 23745050.
ESH-IP:2010 - Pass General population
Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.
DHL:2007 - Pass General population (Note: 2013)
Medaval Certification Assessment
Medaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Omron RS3 (HEM-6130-E) wrist monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1610) 6 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.
With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Omron RS3 (HEM-6130-E), is certified by Medaval Ltd.