Omron M6 Comfort (HEM-7221-E8)

Omron M6 Comfort (HEM-7221-E8)
Device Name:M6 Comfort
Device Model:HEM-7221-E8
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:Available Currently
Assessment:

The technology used in the Omron M6 Comfort (HEM-7221-E8), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in five clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
ESH (Europe)Self-measurement during pregnancyPublished 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-7223-E)D (B BIHS Derivative, D DET Equivalence)
Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

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