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Omron HeartGuide (HEM-6411T-MAE)
Device Name:
HeartGuide
Device Model:
HEM-6411T-MAE
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:
Continuous measurement
Availability:
Available Currently
Description:
The Omron HeartGuide (HEM-6411T-MAE) 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:
The technology used in the Omron HeartGuide (HEM-6411T-MAE), to measure blood pressure, has been compared to a clinically 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Stride BP Self-measurement for adults Equivalence claim without published evidence
Device Family:
Omron HEM-6131F, Omron BP652N (HEM-6300-Z)F, Omron HeartGuide (HEM-6411T-MAE)P, Omron Heartguide BP8000-M (HEM-6410T-ZM)P,F, Omron BP4350 (HEM-6232T-Z) GoldF, Omron BP6100 (HEM-6180-Z)F
Legend: P Stride Equivalence, F FDA 510(k)
Relevant Publications:

Bhanvadia SB, Brar MS, Delavar A, Tavakoli K, Saseendrakumar BR, Weinreb RN, Zangwill LM, Baxter SL. Assessing Usability of Smartwatch Digital Health Devices for Home Blood Pressure Monitoring among Glaucoma Patients. Informatics (MDPI). 2022 Dec;9(4):79. Epub: 2022 Oct 6. doi: 10.3390/informatics9040079. PMID: 36873830. Available from: PMC9980658.

Harfmann BD, Neph SE, Gardner MM, Plouffe AA, Vranish JR, Montoye AHK. Comparison of the Omron HeartGuide to the Welch Allyn ProBP 3400 blood pressure monitor. Blood Press Monit. 2024 Feb 1;29(1):45-54. Epub: 2023 Sep 14. doi: 10.1097/MBP.0000000000000672. PMID: 37702590.

Measurements from the Omron HeartGuide are compared to those from the Welch Allyn ProBP 3400, though not in a formal validation.

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 Heartguide BP8000-M (HEM-6410T-ZM)

Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-6410T-ZM and HEM-6410T-ZL. J Clin Hypertens (Greenwich). 2019 Jun;21(6):853-858. Epub: 2019 Feb 25. doi: 10.1111/jch.13499. PMID: 30803128.

81060-2:2013 - Pass General population

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