Omron RS3 Intelli IT (HEM-6161T-E)

Description:

The Omron RS3 Intelli IT (HEM-6161T-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

Assessment:

The technology used in the Omron RS3 Intelli IT (HEM-6161T-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.