The technology used in the Omron HEM-6232T, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
|Medaval||★★ Recommendation||Recent clinical validation; recent protocol|
|Stride BP||Self-measurement for adults and obese adults||Published evidence plus equivalence claim|
|MDR Criteria||Self-measurement||Published evidence|
Saito K, Hishiki Y, Takahashi H. Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2019 Mar 6;15:47-55. doi: 10.2147/VHRM.S188089. PMID: 30881007. Available from: PMC6410757. eCollection 2019.
81060-2:2013 - Pass General population
ESH-IP:2010 - Pass General population
The studies use the same data and are, therefore, not independent.
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 RS7 Intelli IT (HEM-6232T-E)
Tasic D, Topouchian J, Dragisic D, Tasic N, Hakobyan Z, Vatinyan S, Zelveian P, Asmar R. Reproducibility of the European Society of Hypertension - International Protocol for validation of blood pressure measuring devices in obese patients. J Hypertens. 2019 Sep;37(9):1832-1837. doi: 10.1097/HJH.0000000000002106. PMID: 31246893.
ESH-IP:2010 - Pass Arm circumference at least 32 cm or obesity (Note: Validation by Serbian team)
ESH-IP:2010 - Pass Arm circumference at least 32 cm or obesity (Note: Validation by Armenian team)
Karampela I, Dalamaga M, Stratigou T, Antonakos G, Nikolopoulos M, Tzortzis E, Diomidous M. Validation of an Automatic Wrist Blood Pressure Monitor in a Critical Care Setting. Stud Health Technol Inform. 2020 Jun 26;272:171-174. doi: 10.3233/SHTI200521. PMID: 32604628.
IA protocol Critically Ill patients (Note: IA validation (n=45/45 - one pair in each of 45 patients))