🏠
📞  +353 1 6643768
 
📧  info@medaval.ie
Omron 637IT (HEM-637IT-E)
Device Model:
HEM-637IT-E
Manufacturer:
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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Device Manual:
Description:
The Omron 637IT (HEM-637IT-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood pressure measurements are taken from the wrist and 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 637IT (HEM-637IT-E), to measure blood pressure, has passed in three clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval Recommendation Older clinical validation; older protocol; multiple clinical validations
BIHS (UK and IRL) Previous recommendation, now archived for adults, obese adults and the elderly Published evidence
ESH (Europe) Self-measurement Published evidence
Stride BP Self-measurement for adults, obese adults and the elderly Published evidence (corrected from R7 (HEM 637-IT))
Device Family:
Validation Publications:

Altunkan S, Altunkan E. Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in the elderly. Blood Press Monit. 2006 Apr;11(2):97-102. PMID: 16534412.

ESH-IP:2002 - Pass Elderly (Age>65)

Altunkan S, Oztaş K, Altunkan E. Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in adults and obese adults. Blood Press Monit. 2006 Apr;11(2):79-85. PMID: 16534409.

ESH-IP:2002 - Pass General population

Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT). Blood Press Monit. 2006 Jun;11(3):165-71. PMID: 16702826.

ESH-IP:2002 - Pass General population

Relevant Publications:

Altunkan S, Genç Y, Altunkan E. A comparative study of an ambulatory blood pressure measuring device and a wrist blood pressure monitor with a position sensor versus a mercury sphygmomanometer. Eur J Intern Med. 2007 Mar;18(2):118-23. PMID: 17338963.

Measurements from the Omron 637IT (HEM-637IT-E) are compared to those from the Nissei DS-250 and a standard mercury sphygmomanometer, 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 R2 (HEM-6113-E)

Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. 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. 2011;7:709-17. Epub: 2011 Nov 30. doi: 10.2147/VHRM.S27193. PMID: 22174581. Available from: PMC3237100.

ESH-IP:2002 - Pass General population