Omron M1 Plus (HEM-4011C-E)

Description:

The Omron M1 Plus (HEM-4011C-E) is a surface-placed semi-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. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the Omron M1 Plus (HEM-4011C-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)	Previous recommendation, now archived	Published evidence
BP	ESH (Europe)	Self-measurement	Published evidence
BP	Stride BP	Self-measurement for adults	Published evidence

Device Family:

Omron HEM Solar (HEM-4500-Sole)B,D,J, Omron M1 (HEM-4030-E)B,D, Omron M1 Classic (HEM-442C-E)D, Omron M1 Compact (HEM-4022-E)B,D, Omron M1 Plus (HEM-4011C-E)B,D,J
Legend: B BIHS Derivative, D DET Equivalence, J JHS Implied Equivalence

Validation Publications:

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

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 Solar (HEM-4500-Sole)

Parati G, Kilama MO, Faini A, Facelli E, Ochen K, Opira C, Mendis S, Wang J, Atkins N, O'Brien E. A new solar-powered blood pressure measuring device for low-resource settings. Hypertension. 2010 Dec;56(6):1047-53. Epub: 2010 Nov 8. doi: 10.1161/HYPERTENSIONAHA.110.160408. PMID: 21059998. Available from: hyper.ahajournals.org.

ESH-IP:2002 - Fail General population (Note: Passed SBP)

Study includes field test in LR settings