Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Primary Client Use:
Intended for self-measurement and home use
Single measurements only
Availability according to Countries or Regions:
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.
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.
||★★★★ Certified Accuracy
||Recent clinical validation; recent protocol with certified adherence
||BIHS (UK and IRL)
||Self-measurement for adults
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
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.