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Omron RS6 (HEM-6221-E)

Device Name:RS6
Device Model:HEM-6221-E
Manufacturer:Sole: 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
Description: The Omron RS6 (HEM-6221-E) is a clinically validated and certified 5-star automatic blood pressure monitor. Measurements are taken from the wrist and it is intended for self-measurement and home use.

Accuracy AssessmentRecommendationBasis
Medaval★★★★★ Certified AccuracyRecent clinical validation; recent protocol with certified adherence; multiple clinical validations
BIHS (UK and IRL)Self-measurementPublished evidence
Stride BPSelf-measurement for adultsPublished evidence
Consumer BodyYear(s)LevelComment
Stiftung Warentest (DE)Previous: 2018Satisfactory 

Device Family:Omron HEM-6210J, Omron HEM-6220-BJ, Omron HEM-6220-PKJ, Omron HEM-6220-SLJ, Omron RS6 (HEM-6221-E)J (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

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

Cert 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) 5 p. Epub: 2019 Jan 31. Available from: https://www.medaval.ie/MDA/2016/MDA1611.pdf.

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.