Omron HEM Solar (HEM-4500-Sole)
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 Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | Previous recommendation, now archived | Manufacturer declaration of equivalence | ||
| ESH (Europe) | Self-measurement | Published evidence | ||
| Japanese Society of Hypertension | Self-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 | ||
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
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
