Omron RS3 (HEM-6130-E)

Description:

The Omron RS3 (HEM-6130-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 5-star Medaval rating. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The accuracy of the technology used in the Omron RS3 (HEM-6130-E), to measure blood pressure, is certified by Medaval Ltd. It has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	★★★★★ Certified Accuracy	Older clinical validation; recent protocol with certified adherence; multiple clinical validations
BP	BIHS (UK and IRL)	Previous recommendation, now archived (Archived)	Published evidence
BP	DHL (DE)	General use (Previous: 2013)	Published evidence
BP	Stride BP	Self-measurement for adults (Unavailable)	Published evidence

Device Family:

Omron RS1 (HEM-6120-D)D, Omron RS2 (HEM-6121-E)B, Omron RS3 (HEM-6130-E)B,D,J,Y, Omron HEM-6130J, Omron HEM-6131 (HEM-6131-AP)Y, Omron HEM-6121 (HEM-6121-AP)Y
Legend: B BIHS Derivative, D DET Equivalence, J JHS Implied Equivalence, Y Internal declaration

Validation Publications:

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

Certification Image 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.