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Omron RS8 (HEM-6310F-E)
Device Model:
HEM-6310F-E
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Ireland
Device Manual:
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 and 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval ★★★★ Certified Accuracy Recent clinical validation; recent protocol with certified adherence
BIHS (UK and IRL) Self-measurement Published evidence
Stride BP Self-measurement for adults Published evidence
Device Family:
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 ImageMedaval 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.