Omron MIT Elite Plus (HEM-7301-ITKE7)

Description:

The Omron MIT Elite Plus (HEM-7301-ITKE7) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. 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 MIT Elite Plus (HEM-7301-ITKE7), 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 Assessment	Recommendation	Basis
BP	Medaval	Legacy approval	Older clinical validation; older protocol
BP	BIHS (UK and IRL)	Previous recommendation, now removed (Previous)	Manufacturer declaration of equivalence
BP	DHL (DE)	General use (Previous: 2009)	Published evidence
BP	ESH (Europe)	Self-measurement	Published evidence

Device Family:

Omron Elite 7300W (HEM-7300-EZ)B, Omron MIT Elite Plus (HEM-7301-ITKE7)B, Omron MIT Elite (HEM-7300-WE)B
Legend: B BIHS Derivative

Validation Publications:

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:2007 - Pass General population (Note: 2009)

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 Elite 7300W (HEM-7300-EZ)

Grim CE, Grim CM. The Omron Elite 7300W home blood pressure monitor passes the European Society of Hypertension International Validation Protocol for women and men. Blood Press Monit. 2009 Apr;14(2):87-90. doi: 10.1097/MBP.0b013e328329d294. PMID: 19305188.

ESH-IP:2002 - Pass General population