Omron M3 Comfort (HEM-7134-E)
Device Name:
M3 Comfort
Device Model:
HEM-7134-E
Manufacturer:

Brand: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.

Other: Omron Healthcare Manufacturing Vietnam Co. Ltd., 28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province 820000, VIET NAM.

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
Availability according to Countries or Regions:
Ireland
Device Manual:
Click here to download the Device Manual
Description:
The Omron M3 Comfort (HEM-7134-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Omron M3 Comfort (HEM-7134-E), to measure blood pressure, has passed in two clinical validation studies, between general and pregnancy populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; older protocol; multiple clinical validations
BP BIHS (UK and IRL) Self-measurement Published evidence
BP Stride BP Self-measurement for adults and pregnancy (Unavailable) (Preferred) Published evidence plus equivalence claim
BP MDR Criteria Pregnancy Published evidence
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
Legend: B BIHS Derivative, D DET Equivalence, P Stride Equivalence, Y Internal declaration
Validation Publications:

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

Relevant Publications:

Takahashi H. 欧州高血圧学会国際プロトコル(ESH-IP)改訂2010年版による家庭血圧監視装置Omron EVOLV(HEM-7600T-E),HEM-9210T,およびM3Comfort(HEM-7143-E)の妥当性確認. [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.] 日本臨床生理学会雑誌 [J Clin Physiol (Jpn)]. 2018 Feb 1;48(1):29-38. Retraction in: J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46.

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 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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