Omron HEM-1020 - Medaval

Description:

The Omron HEM-1020 is a waiting-room blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for use as a public facility.

Assessment:

The technology used in the Omron HEM-1020, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Legacy approval	Older clinical validation; older protocol
BP	ESH (Europe)	Professional use	Published evidence
BP	Japanese Society of Hypertension	Self-measurement (Previous: 2016-2021)	Published evidence
BP	Stride BP	Self-measurement for adults	Published evidence

Device Family:

Omron HEM-1020J, Omron i-Q132 SpotArm (HEM-1010-E)J, Omron HEM-1010J, Omron HEM-1011J, Omron HEM-1021J, Omron HEM-1000J, Omron HEM-1025J, Omron HEM-1022J, Omron HEM-1012J, Omron HCR-1602J, Omron HCR-1702J
Legend: J JHS Implied Equivalence

Validation Publications:

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

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 i-Q132 SpotArm (HEM-1010-E)

ESH-IP:2002 - Pass General population