Omron HEM-6210
Device Model:
HEM-6210
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:
Japan
Description:
The Omron HEM-6210 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Omron HEM-6210, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Japanese Society of Hypertension Self-measurement (Previous: 2018) Implied equivalence to the Omron RS3 (HEM-6130-E), RS6 (HEM-6221-E) or RS8 (HEM-6310F-E)
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 for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron RS6 (HEM-6221-E)

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

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