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Omron HEM-6232T

Device Model:HEM-6232T
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:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

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.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
Stride BPSelf-measurement for adults and obese adultsPublished evidence plus equivalence claim
MDR CriteriaSelf-measurementPublished evidence

Device Family:Omron HEM-6232TP, Omron RS7 Intelli IT (HEM-6232T-E)P (P Stride Equivalence)
Validation Publications

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.

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 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)