Omron M6 Comfort (HEM-7221-E)
Device Name:
M6 Comfort
Device Model:
HEM-7221-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:
Discontinued but still available
Device Manual:
Click here to download the Device Manual
Description:
The Omron M6 Comfort (HEM-7221-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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Omron M6 Comfort (HEM-7221-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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; recent protocol
BP BIHS (UK and IRL) Self-measurement (Previous) Manufacturer declaration of equivalence to the Omron M7 (HEM-780-E)
BP ESH (Europe) Self-measurement for adults and pregnancy Published evidence
BP Stride BP Self-measurement for adults (Unavailable) (Preferred) Published evidence
Device Family:
Omron i-C10 (HEM-7070-E)B,D, Omron M10-IT (HEM-7080IT-E)B,D, Omron M6 Comfort (HEM-7221-E)B,D, Omron M7 (HEM-780-E)B,D, Omron 708-BT (HEM-7081-ITE)B, Omron BP760 (HEM-7220-Z)D, Omron BP785 (HEM-7222-Z)D, Omron M6 Comfort (HEM-7000-E)B,D, Omron M6 Comfort (HEM-7221-E8)D, Omron M6 Comfort (HEM-7223-E)D
Legend: B BIHS Derivative, D DET Equivalence
Validation Publications:

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

Relevant Publications:

Ware A, Stevens R, Selwood M, Fleming S. Accuracy of blood pressure monitors available in high street pharmacies. Blood Press Monit. 2016 Feb;21(1):59-61. doi: 10.1097/MBP.0000000000000151. PMID: 26427055.

Measurements from the Omron M6 Comfort (HEM-7221-E) are compared to those from the Omron PA-350 (BPM tester), though not in a formal validation.

Doh I, Lim HK, Ahn B. Development of a simulator for the validation of noninvasive blood pressure-monitoring devices. Blood Press Monit. 2016 Jun;21(3):189-91. doi: 10.1097/MBP.0000000000000174. PMID: 26745850.

Measurements from the Omron M6 Comfort (HEM-7221-E) are compared to those from a simulator, 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 M6 Comfort (HEM-7000-E)

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

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

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