Omron R6 (HEM-6000-E7)

Device Name:R6
Device Model:HEM-6000-E7
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:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Omron R6 (HEM-6000-E7), to measure blood pressure, has passed in three validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Device Family:Boots 65-90-412B, Omron R7 (HEM-637-E7)D, Omron R7 (HEM-637-IT)B,D, Omron R6 (HEM-6052-2)D, Omron R7 (HEM-637-E2)B (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 R7 (HEM-637-IT)

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, OztaƟ 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