Omron HEM-6181 - Medaval

Description:

The Omron HEM-6181 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

Assessment:

The technology used in the Omron HEM-6181, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	★ Recommendation	Recent clinical validation; older protocol
BP	Stride BP	Self-measurement for adults	Published evidence
BP	AMA VDL (US)	Self-measurement	Published evidence
BP	MDR Criteria	Self-measurement	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:

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.