| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | ★★★★★ Certified Accuracy | Older clinical validation; recent protocol with certified adherence; multiple clinical validations |
| BP | BIHS (UK and IRL) | Self-measurement (Previous) | Published evidence |
| BP | Stride BP | Self-measurement for adults (Unavailable) | Published evidence |
| Consumer Body | Year(s) | Level | Comment | |
| BP | Stiftung Warentest (DE) | Previous: 2018 | Satisfactory |
Legend: 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
Deutsch C, Krüger R, Saito K, Yamashita S, Sawanoi Y, Beime B, Bramlage P. Comparison of the Omron RS6 wrist blood pressure monitor with the positioning sensor on or off with a standard mercury sphygmomanometer. Blood Press Monit. 2014 Oct;19(5):306-13. doi: 10.1097/MBP.0000000000000063. PMID: 25000543.
Ad Hoc protocol With positioning sensor on
Ad Hoc protocol With positioning sensor off
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
Ali EA, Omar SM, Ibrahim Y, Al-Wutayd O, Adam I. Validation of the wrist blood pressure measuring device Omron RS6 (HEM-6221-E) among obese Sudanese patients according to the European Society of Hypertension International Protocol Revision 2010. F1000Res. 2020 Oct 30;9:1284. doi: 10.12688/f1000research.26442.1. PMID: 34691394. Available from: PMC8503788.
ESH-IP:2010 - Pass Obese subjects, BMI 31 kg/m² to 82 kg/m²
Medaval Certification Assessment
Medaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Omron RS6 (HEM-6221-E) wrist monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1611) 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 RS6 (HEM-6221-E), is certified by Medaval Ltd.