Omron HEM-1025
While the technology used in the Omron HEM-1025, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.
| 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 (2016-2018) | Implied equivalence to the Omron HEM-1020 or i-Q132 SpotArm (HEM-1010-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 HEM-1020
Takahashi H, Yoshika M, Yokoi T. Validation of home blood pressure-monitoring devices, Omron HEM-1020 and Omron i-Q132 (HEM-1010-E), according to the European Society of Hypertension International Protocol. Blood Press Monit. 2011 Aug;16(4):203-7. doi: 10.1097/MBP.0b013e328348b688. PMID: 21701384.
ESH-IP:2002 - Pass General population
