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Omron M6 Comfort (HEM-7321-E)
Device Name:
M6 Comfort
Device Model:
HEM-7321-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 M6 Comfort (HEM-7321-E) 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:
The technology used in the Omron M6 Comfort (HEM-7321-E), to measure blood pressure, has been compared to a clinically validated device, but not 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.
BP ESH (Europe) Self-measurement Published evidence
BP Stride BP Self-measurement for adults and pregnancy (Unavailable) (Preferred) Equivalence claim without 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
Relevant Publications:

Bilo G, Sala O, Perego C, Faini A, Gao L, Głuszewska A, Ochoa JE, Pellegrini D, Lonati LM, Parati G. Impact of cuff positioning on blood pressure measurement accuracy: may a specially designed cuff make a difference? Hypertens Res. 2017 Jun;40(6):573-80. Epub: 2017 Jan 12. doi: 10.1038/hr.2016.184. PMID: 28077860.

Measurements from the Omron M6 Comfort (HEM-7321-E) are compared to those from the ERKA "Ecometer New" (This device does not appear to be on the manufacturer's website), though not in a formal validation.

Semi-rigid IntelliWrap Cuff (HEM-FL31-E) used

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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