Omron RS4 (HEM-6181-E)

Description:

The Omron RS4 (HEM-6181-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:

The technology used in the Omron RS4 (HEM-6181-E), to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance 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	Stride BP	Self-measurement for adults	Equivalence claim without published evidence

Device Family:

Boots 82-01-749 [RS2 (HEM-8616-BS)]P, Omron HEM-6181P,Y, Omron RS4 (HEM-6181-E)P, Omron RS1 (HEM-6160-E)P, Omron RS3 Intelli IT (HEM-6161T-E)P, Omron HEM-6181 (HEM-6181-AP)Y, Omron HEM-6161 (HEM-6161-AP)Y
Legend: P Stride 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 HEM-6181

Saito K, Hishiki Y, Takahashi H. Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2019 Mar 6;15:47-55. doi: 10.2147/VHRM.S188089. PMID: 30881007. Available from: PMC6410757. eCollection 2019. Erratum in: Vasc Health Risk Manag. 2019 May 17;15:137.

81060-2:2013 - Pass General population

ESH-IP:2010 - Pass General population

The studies use the same data and are, therefore, not independent.