Omron M6 Comfort (HEM-7321-E)
The technology used in the Omron M6 Comfort (HEM-7321-E), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in two validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
It is recommended by the ESH for self-measurement.
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
Bilo G, Sala O, Perego C, Faini A, Gao L, Głuszewska A, Ochoa JE, Pellegrini D, Lonati LM, Parati G. Impact of cuff positioning on blood pressure measurement accuracy: may a specially designed cuff make a difference? Hypertens Res. 2017 Jun;40(6):573-80. Epub: 2017 Jan 12. doi: 10.1038/hr.2016.184. PMID: 28077860.
Measurements from the Omron M6 Comfort (HEM-7321-E) are compared to those from the ERKA "Ecometer New" (Cannot find this device on ERKA website), though not in a formal validation.
Semi-rigid IntelliWrap Cuff (HEM-FL31-E) used
Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven
Omron M6 Comfort IT (HEM-7322U-E)
Chahine MN, Topouchian J, Zelveian P, Hakobyan Z, Melkonyan A, Azaki A, Diab R, Harb A, Asmar R. Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP). Med Devices (Auckl). 2017 Dec 27;11:11-20. doi: 10.2147/MDER.S142126. PMID: 29343992. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5749560/pdf/mder-11-011.pdf. eCollection 2018.
ESH-IP:2010 - Pass General population