Omron RS8 (HEM-6310F-E)

Description:

The Omron RS8 (HEM-6310F-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 4-star Medaval rating. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

Assessment:

The accuracy of the technology used in the Omron RS8 (HEM-6310F-E), to measure blood pressure, is certified by Medaval Ltd. It 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	★★★★ Certified Accuracy	Older clinical validation; older protocol with certified adherence
BP	BIHS (UK and IRL)	Self-measurement (Previous)	Published evidence
BP	Stride BP	Self-measurement for adults (Unavailable)	Published evidence

Device Family:

Omron RS8 (HEM-6310F-E)J, Omron HEM-6301J, Omron HEM-6321TJ, Omron HEM-6323TJ, Omron HEM-6324TJ, Omron HEM-6300FJ, Omron HEM-6310FJ, Omron HEM-6311J, Omron HEM-6320TJ
Legend: J JHS Implied 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

Medaval Certification Assessment

Certification Image Medaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Omron RS8 (HEM-6301F-E) wrist monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1612) 6 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Omron RS8 (HEM-6310F-E), is certified by Medaval Ltd.