Omron RS6 (HEM-6221-E)
Device Name:
RS6
Device Model:
HEM-6221-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:
Click here to download the Device Manual
Description:
The Omron RS6 (HEM-6221-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 5-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 RS6 (HEM-6221-E), to measure blood pressure, is certified by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★★★★ Certified Accuracy Older clinical validation; recent protocol with certified adherence; multiple clinical validations
BP BIHS (UK and IRL) Self-measurement (Previous) Published evidence
BP Stride BP Self-measurement for adults (Unavailable) Published evidence
Consumer BodyYear(s)LevelComment
BP Stiftung Warentest (DE) Previous: 2018 Satisfactory
Device Family:
Omron HEM-6221Y, Omron RS6 (HEM-6221-E)J,Y, Omron HEM-6210J, Omron HEM-6220-BJ, Omron HEM-6220-PKJ, Omron HEM-6220-SLJ
Legend: J JHS Implied Equivalence, Y Internal declaration
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

Deutsch C, Krüger R, Saito K, Yamashita S, Sawanoi Y, Beime B, Bramlage P. Comparison of the Omron RS6 wrist blood pressure monitor with the positioning sensor on or off with a standard mercury sphygmomanometer. Blood Press Monit. 2014 Oct;19(5):306-13. doi: 10.1097/MBP.0000000000000063. PMID: 25000543.

Ad Hoc protocol With positioning sensor on

Ad Hoc protocol With positioning sensor off

Azaki A, Diab R, Harb A, Asmar R, Chahine MN. Questionable accuracy of home blood pressure measurements in the obese population - Validation of the Microlife WatchBP O3® and Omron RS6® devices according to the European Society of Hypertension-International Protocol. Vasc Health Risk Manag. 2017;13:61-9. Epub: 2017 Feb 27. doi: 10.2147/VHRM.S126285. PMID: 28280348. Available from: PMC5338962. eCollection 2017.

ESH-IP:2010 - Fail Obese subjects, BMI ≥30 kg/m²

Ali EA, Omar SM, Ibrahim Y, Al-Wutayd O, Adam I. Validation of the wrist blood pressure measuring device Omron RS6 (HEM-6221-E) among obese Sudanese patients according to the European Society of Hypertension International Protocol Revision 2010. F1000Res. 2020 Oct 30;9:1284. doi: 10.12688/f1000research.26442.1. PMID: 34691394. Available from: PMC8503788.

ESH-IP:2010 - Pass Obese subjects, BMI 31 kg/m² to 82 kg/m²

Medaval Certification Assessment

Certification ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Omron RS6 (HEM-6221-E) wrist monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1611) 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 RS6 (HEM-6221-E), is certified by Medaval Ltd.

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