Omron HEM-7121
The technology used in the Omron HEM-7121, 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 (2016-2020) | Implied equivalence to the Omron HEM-7130, HEM-7320F or HEM-7500F | ||
| Consumer Body | Version | Quartile | Comment | |
| Choice (Australia) | 2019-2020 | A | ||
Islam SMS, Cartledge S, Karmakar C, Rawstorn JC, Fraser SF, Chow C, Maddison R. Validation and Acceptability of a Cuffless Wrist-Worn Wearable Blood Pressure Monitoring Device Among Users and Health Care Professionals: Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Sep 14;7(10):e14706. doi: 10.2196/14706. PMID: 31628788 . Available from: mhealth.jmir.org.
The publication describes the Omron HEM-7121 being used as a validation control device.
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 HEM-7120
Zhang P, Li X, Fang Z, Lu Y, Cui J, Du X, Hu R. Smartphone application-supported validation of three automatic devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7120, Yuwell YE680A and Cofoe KF-65B. Blood Press Monit. Epub: 2021 May 13. doi: 10.1097/MBP.0000000000000547. PMID: 34001755.
ESH-IP:2010 - Pass General population
Omron HEM-7130
Takahashi H, Yoshika M, Yokoi T. Validation of three automatic devices for the self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7130, HEM-7320F, and HEM-7500F. Blood Press Monit. 2015 Apr;20(2):92-7. doi: 10.1097/MBP.0000000000000096. PMID: 25462531.
ESH-IP:2010 - Pass General population
Omron HEM-9200T
Takahashi H, Saito K, Yakura N. Validation of Omron HEM-9200T, a home blood pressure monitoring device for the upper arm, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol. J Hum Hypertens. Epub: 2021 Apr 9. doi: 10.1038/s41371-021-00536-1. PMID: 33837291.
81060-2:2013 - Pass General population
Omron HEM-9700T
Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of an automatic device for the self-measurement of blood pressure in sitting and supine positions according to the ANSI/AAMI/ISO81060-2: 2013 guidelines: the Omron HEM-9700T. Blood Press Monit. Epub: 2019 Feb 14. doi: 10.1097/MBP.0000000000000368.
81060-2:2013 - Pass Sitting position
81060-2:2013 - Pass Supine position
