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Omron 708-BT (HEM-7081-ITE)

Device Name:708-BT
Device Model:HEM-7081-ITE
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:

While the technology used in the Omron 708-BT (HEM-7081-ITE), to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Previous recommendation, now archivedManufacturer declaration of equivalence
ESH (Europe)Self-measurement for adults and pregnancyThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

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 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