Omron M1 (HEM-4030-E)

Description:

The Omron M1 (HEM-4030-E) is a hand-held or surface-placed semi-automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. 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 (HEM-4030-E), to measure blood pressure, has been compared to a clinically validated device, but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Self-measurement (Previous)	Manufacturer declaration of equivalence to the Omron M1 Plus (HEM-4011C-E)
BP	ESH (Europe)	Self-measurement	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 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

Omron M1 Plus (HEM-4011C-E)

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