Omron RS2 (HEM-6121-E)

Description:

The Omron RS2 (HEM-6121-E) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

Assessment:

While the technology used in the Omron RS2 (HEM-6121-E), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Self-measurement (Previous)	Manufacturer declaration of equivalence to the Omron RS3 (HEM-6130-E)
BP	DHL (DE)	General use (Previous: 2016)	Manufacturer declaration of equivalence

	Consumer Body	Year(s)	Level	Comment
BP	Stiftung Warentest (DE)	Previous: 2016-2018	Good

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 for Equivalent Devices:

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.

Omron RS3 (HEM-6130-E)

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)