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Omron MIT Elite (HEM-7300-WE7)

Device Name:MIT Elite
Device Model:HEM-7300-WE7
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 MIT Elite (HEM-7300-WE7), to measure blood pressure, has passed in clinical validation studies, in pregnancy populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
MedavalRecommended for pregnancy onlyValidation in pregnancy
BIHS (UK and IRL)Self-measurement and professional use for adults and, except for those with large arm circumferences, during pregnancyPublished evidence plus manufacturer declaration of equivalence
Stride BPSelf-measurement for pregnancy (Preferred)Published evidence

Validation Publications

Chung Y, Brochut MC, de Greeff A, Shennan AH. Clinical accuracy of inflationary oscillometry in pregnancy and pre-eclampsia: Omron-MIT Elite Pregnancy Hypertens. 2012 Oct;2(4):411-5. Epub: 2012 May 20. doi: 10.1016/j.preghy.2012.04.001. PMID: 26105612. (Details from: www.pregnancyhypertension.org/article/S2210-7789(12)00030-X/abstract).

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

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

Exact MIT Elite not specified

James L, Nzelu D, Hay A, Shennan A, Kametas NA. Validation of the Omron MIT Elite blood pressure device in a pregnant population with large arm circumference. Blood Press Monit. 2017 Apr;22(2):109-11. Epub: 2017 Feb 1. doi: 10.1097/MBP.0000000000000239. PMID: 28151753.

BHS:1993 - Fail (D/D) Pregnancy with Obesity

Exact MIT Elite not specified

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

Omron MIT Elite Plus (HEM-7301-ITKE7)

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)