Omron RS3 (HEM-6130-E)

Device Name:RS3
Device Model:HEM-6130-E
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600 8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Omron RS3 (HEM-6130-E), to measure blood pressure, is certified by Medaval Ltd. It has passed in two validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Device Family:Omron RS1 (HEM-6120-D)D, Omron RS2 (HEM-6121-E)B (B BIHS Derivative, D DET Equivalence)
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

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. Epub: 2016 Aug 5(10):5 p.

The blood pressure measurement technology, used in the Omron RS3 (HEM-6130-E), is certified by Medaval Ltd.