Omron HEM-6220-PK
The technology used in the Omron HEM-6220-PK, 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.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| Japanese Society of Hypertension | Self-measurement (2018) | Implied equivalence to the Omron RS3 (HEM-6130-E), RS6 (HEM-6221-E) or RS8 (HEM-6310F-E) | ||
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)
