Omron HEM-7361T
Device Name:
HEM-7361T
Device Model:
HEM-7361T
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:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Omron HEM-7361T 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 upper arm. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Omron HEM-7361T to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven 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 BP760N (HEM-7320-Z)B,P,Y, Omron HEM-7320-LAY, Omron M6 Comfort (HEM-7321-E)D,P,Y, Omron M6 Comfort IT (HEM-7322U-E)D, Omron M3 Comfort (HEM-7134-E)P, Omron M7 Intelli IT (HEM-7322T-E)P, Omron M3 Comfort (HEM-7155-E)B,P, Omron M4 Intelli IT (HEM-7155T-EBK)B,P, Omron M6 Comfort (HEM-7360-E)B,P, Omron M7 Intelli IT (HEM-7361T-EBK)B,P, Omron X4 Smart (HEM-7155T-ESL)P, Omron X7 Smart (HEM-7361T-ESL)P, Omron M400 Comfort (HEM-7155-D)P, Omron M400 Intelli IT (HEM-7155T-D)P, Omron M500 Intelli IT (HEM-7361T-D)P, Omron X3 Comfort (HEM-7155-EO)P, Omron M3 Comfort (HEM-7155-ALRU)P, Omron X6 Comfort (HEM-7360-EO)P, Omron M4 Intelli IT (HEM-7155T-ALRU)P, Omron M7 Intelli IT (HEM-7361T-ALRU)P, Omron HEM-7156 (HEM-7156-AP)Y, Omron HEM-7361T (HEM-7361T-AP)Y, Omron HEM-7320 (HEM-7320-AU)Y, Omron M6 Comfort AFib (HEM-7380-E)P, Omron M7 Intelli IT AFib (HEM-7380T1-EBK)P, Omron X7 Smart AFib (HEM-7380T1-EOSL)P, Omron HEM-7361TZ
Legend: B BIHS Derivative, D DET Equivalence, P Stride Equivalence, Y Internal declaration, Z Almost Certain
Relevant Publications:

Zhou Y, Xia JH, Zhang W, Li Y, Wang JG. Accuracy of the OMRON HEM-7361T blood pressure monitor in the differentiation between atrial fibrillation and sinus rhythm. Blood Press Monit. 2024 Aug 1;29(4):217-220. Epub: 2024 May 20. doi: 10.1097/MBP.0000000000000706. PMID: 38774977.

The publication describes the use of the Omron HEM-7361T in a scientific study.

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 BP760N (HEM-7320-Z)

Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z). Vasc Health Risk Manag. 2015 Jan;9(11):49-53. doi: 10.2147/VHRM.S72438. PMID: 25657587.

81060-2:2009 - Pass General population

Omron HEM-7320-LA

Grover-Páez F, Cardona-Muñoz EG, Cardona-Müller D, Guzmán-Saldívar VH, Rodríguez-De la Cerda M, Jiménez-Cázarez MB, Totsuka-Sutto SE, Alanis-Sánchez GA, Ramos-Becerra CG. Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population. Blood Press Monit. 2017 Dec;22(6):375-8. Epub: 2017 Sep 22. doi: 10.1097/MBP.0000000000000290. PMID: 28945665 .

ESH-IP:2010 General population (Note: Major violation in DBP range and distribution)

With HEM-FL1 Cuff

Omron M3 Comfort (HEM-7134-E)

Topouchian J, Hakobyan Z, Asmar J, Gurgenian S, Zelveian P, Asmar R. Clinical accuracy of the Omron M3 Comfort® and the Omron Evolv® for self-blood pressure measurements in pregnancy and pre-eclampsia - validation according to the Universal Standard Protocol. Vasc Health Risk Manag. 2018 Aug 31;14:189-97. doi: 10.2147/VHRM.S165524. PMID: 30214220. Available from: PMC6124447. eCollection 2018.

81060-2:2013 - Pass Normotensive pregnancy, Hypertensive pregnancy and Pre-eclampsia (n=45) (Note: Only one set of ISO results provided.)

BHS:1993 - Pass (A/A) Normotensive pregnancy, Hypertensive pregnancy and Pre-eclampsia (n=45)

Validation under the "Universal Protocol" is claimed, though only a consensus document was written, at that time, as referenced. Analysis appears to be according to Criterion 1 of ISO 81060-2:2013 and to BHS 1993.

Takahashi H. Validation of Home Blood Pressure-monitoring Devices Omron EVOLV (HEM-7600T-E), HEM-9210T, and M3 Comfort (HEM-7134-E) According to European Society of Hypertension International Protocol (ESH-IP) Revision 2010. J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46. doi: 10.34363/jocp.49.1_37. Available from: www.jstage.jst.go.jp.

ESH-IP:2010 - Pass General population

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: PMC5749560. eCollection 2018.

ESH-IP:2010 - Pass Type 2 Diabetes Mellitus

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