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Omron HEM Solar (HEM-4500-Sole)

Device Name:HEM Solar
Device Model:HEM-4500-Sole
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 HEM Solar (HEM-4500-Sole), to measure blood pressure, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been compared to a validated device but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance 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
Japanese Society of HypertensionSelf-measurement (2016-2019)Implied equivalence to the Omron M1 Plus (HEM-4011C-E), M6 Comfort (HEM-7321-E), Spengler KP7500 D, Microlife BP A100 Plus

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

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

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 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