Omron M2 Compact (HEM-7102-E)

Description:

The Omron M2 Compact (HEM-7102-E) is an automatic 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 self-measurement and home use.

Assessment:

The technology used in the Omron M2 Compact (HEM-7102-E), 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	BIHS (UK and IRL)	Self-measurement	Published evidence
BP	ESH (Europe)	Self-measurement	Published evidence
BP	Stride BP	Self-measurement for adults	Published evidence

Device Family:

Omron HEM-737B, Omron M2 Compact (HEM-7102-E)B,D, Omron MX2 Basic (HEM-742-E2)B,D, Omron HEM-7101 (HEM-7101-SH)D, Omron Pro Logic PL100 (HEM-7101-PR)B
Legend: B BIHS Derivative, D DET Equivalence

Validation Publications:

Asmar R, Khabouth J, Topouchian J, El Feghali R, Mattar J. Validation of three automatic devices for self-measurement of blood pressure according to the International Protocol: The Omron M3 Intellisense (HEM-7051-E), the Omron M2 Compact (HEM 7102-E), and the Omron R3-I Plus (HEM 6022-E). Blood Press Monit. 2010 Feb;15(1):49-54. doi: 10.1097/MBP.0b013e3283354b11. PMID: 20032779.

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 HEM-737

Anwar YA, Giacco S, McCabe EJ, Tendler BE, White WB. Evaluation of the efficacy of the Omron HEM-737 IntelliSense device for use on adults according to the recommendations of the Association for the Advancement of Medical Instrumentation. Blood Press Monit. 1998 Aug;3(4):261-265. PMID: 10212364.

SP10:1992 - Pass General population