Omron HEM-6232T (HEM-6232T-AP)
Device Name:
HEM-6232T
Device Model:
HEM-6232T-AP
Manufacturer:
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
Description:
The Omron HEM-6232T (HEM-6232T-AP) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Omron HEM-6232T (HEM-6232T-AP), to measure blood pressure, has been declared, on the manufacturer website, as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
Device Family:
Omron HEM-6232TP,Y, Omron RS7 Intelli IT (HEM-6232T-E)P, Omron HEM-6232T (HEM-6232T-AP)Y
Legend: P Stride Equivalence, Y Internal declaration
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 HEM-6232T

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. Erratum in: Vasc Health Risk Manag. 2019 May 17;15:137.

81060-2:2013 - Pass General population

ESH-IP:2010 - Pass General population

The studies use the same data and are, therefore, not independent.

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 the patients))

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