Omron Pro Logic PL100 (HEM-7101-PR)

Description:

The Omron Pro Logic PL100 (HEM-7101-PR) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. 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:

While the technology used in the Omron Pro Logic PL100 (HEM-7101-PR), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Previous recommendation, now archived (Archived)	Manufacturer declaration of equivalence to the Omron M2 Compact HEM-7102-E
BP	ESH (Europe)	Self-measurement	The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.

Device Family:

Omron HEM-737B, Omron M2 Compact (HEM-7102-E)B,D, Omron MX2 Basic (HEM-742-E2)B,D, Omron HEM-7101 (HEM-7101-SH)D, Omron Pro Logic PL100 (HEM-7101-PR)B
Legend: B BIHS Derivative, D DET Equivalence

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 HEM-737

Anwar YA, Giacco S, McCabe EJ, Tendler BE, White WB. Evaluation of the efficacy of the Omron HEM-737 IntelliSense device for use on adults according to the recommendations of the Association for the Advancement of Medical Instrumentation. Blood Press Monit. 1998 Aug;3(4):261-265. PMID: 10212364.

SP10:1992 - Pass General population

Omron M2 Compact (HEM-7102-E)

Asmar R, Khabouth J, Topouchian J, El Feghali R, Mattar J. Validation of three automatic devices for self-measurement of blood pressure according to the International Protocol: The Omron M3 Intellisense (HEM-7051-E), the Omron M2 Compact (HEM 7102-E), and the Omron R3-I Plus (HEM 6022-E). Blood Press Monit. 2010 Feb;15(1):49-54. doi: 10.1097/MBP.0b013e3283354b11. PMID: 20032779.

ESH-IP:2002 - Pass General population