Omron M1 Compact (HEM-4022-E)

Device Name:M1 Compact
Device Model:HEM-4022-E
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600 8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Omron M1 Compact (HEM-4022-E), to measure blood pressure, has passed in a validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

It is recommended by the BIHS on the basis of a manufacturer declaration of equivalence. It is recommended by the ESH for self-measurement.

Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

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/content/56/6/1047.

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: www.ncbi.nlm.nih.gov/pmc/articles/PMC2291343/pdf/VHRM_0304_389.pdf.

ESH-IP:2002 - Pass General population