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Omron M6 Comfort (HEM-7000-E)

Device Name:M6 Comfort
Device Model:HEM-7000-E
Manufacturer:Sole: 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:Discontinued but still available
Assessment:

The technology used in the Omron M6 Comfort (HEM-7000-E), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
MedavalLegacy approvalOlder clinical validation; older protocol
BIHS (UK and IRL)Used as seed device for derivative(s)
ESH (Europe)Self-measurement for adults and pregnancyPublished evidence
Stride BPSelf-measurement for adultsPublished evidence

Validation Publications

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

ESH-IP:2002 - Pass General population

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 M6 Comfort (HEM-7221-E)

Topouchian J, Agnoletti D, Blacher J, Youssef A, Chahine MN, Ibanez I, Assemani N, Asmar R. Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol. Vasc Health Risk Manag. 2014 Jan 16;10:33-44. doi: 10.2147/VHRM.S53968. PMID: 24476688. Available from: PMC3897354.

ESH-IP:2010 - Pass General population

Omron M7 (HEM-780-E)

El Feghali RN, Topouchian JA, Pannier BM, El Assaad HA, Asmar RG; European Society of Hypertension. Validation of the OMRON M7 (HEM-780-E) blood pressure measuring device in a population requiring large cuff use according to the International Protocol of the European Society of Hypertension. Blood Press Monit. 2007 Jun;12(3):173-8. PMID: 17496467.

ESH-IP:2002 - Pass General population

Coleman A, Steel S, Freeman P, de Greeff A, Shennan A. Validation of the Omron M7 (HEM-780-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit. 2008 Feb;13(1):49-54. doi: 10.1097/MBP.0b013e3282cb57b6. PMID: 18199924.

ESH-IP:2002 - Pass General population

de Greeff A, Beg Z, Gangji Z, Dorney E, Shennan AH. Accuracy of inflationary versus deflationary oscillometry in pregnancy and preeclampsia: OMRON-MIT versus OMRON-M7. Blood Press Monit. 2009 Feb;14(1):37-40. doi: 10.1097/MBP.0b013e32831e305d. PMID: 19252437.

BHS:1993 - Pass (A/A) Pregnancy (n=30)

SP10:1992 - Pass Pregnancy (n=30)

BHS:1993 - Pass (B/B) Pre-eclampsia (n=15)

SP10:1992 - Fail Pre-eclampsia (n=15) (Note: Failed SBP)

Nouwen E, Snijder M, van Montfrans G, Wolf H. Validation of the Omron M7 and Microlife 3BTO-A blood pressure measuring devices in preeclampsia. Hypertens Pregnancy. 2012;31(1):131-9. Epub: 2011 Feb 18. doi: 10.3109/10641955.2010.544799. PMID: 21332327.

ESH-IP:2010 - Fail Pre-eclampsia