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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:Discontinued but still available
Assessment:

The technology used in the Omron M1 Compact (HEM-4022-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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Previous recommendation, now archivedManufacturer declaration of equivalence
ESH (Europe)Self-measurementPublished 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 (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