Riester E-Mega (2-tube)

Description:

The Riester E-Mega (2-tube) is a palm-style manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use.

Assessment:

While the technology used in the Riester E-Mega (2-tube), 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	This is a manual device. Equivalence to a validated device is possible but this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Professional use	Manufacturer declaration of equivalence to the Riester Big Ben Square Desk
BP	ESH (Europe)	Professional use	The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.

Device Family:

Keeler PalmB, Keeler WindsorB, Keeler Big Ben RoundB, Keeler Big Ben SquareB, Keeler ClassicB, Riester Big Ben Round DeskB, Riester Big Ben Square DeskB, Riester E-Mega (1-tube)B, Riester ExactaB, Riester Minimus IIB, Riester Minimus IIIB, Riester Precisa NB, Riester R1 Shock-ProofB, Riester ri-sanB, Riester Precisa N shock-proofB, Riester Big Ben Round FloorB, Riester Big Ben Square FloorB, Riester Big Ben Round WallB, Riester Big Ben Square WallB, Riester E-Mega (2-tube)B, Riester Big Ben Round RailB, Riester Big Ben Square RailB
Legend: B BIHS Derivative

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.

Riester Big Ben Square Desk

McNally RJ, Dunkerley J, Holland M, Eatough R, Lacy P, McManus RJ, Chapman N, Chowienczyk PJ, Lewis P, Clark CE, Denver E, Neary A, McDonagh STJ, Sheppard JP; British and Irish Hypertension Society. 'Legacy publication of a 2009 validation of the Riester Big Ben Square Desk aneroid device for blood pressure measurement according to the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults (2002)'. Blood Press Monit. 2024 Aug 1;29(4):203-206. Epub: 2024 Mar 11. doi: 10.1097/MBP.0000000000000702. PMID: 38502042.

ESH-IP:2002 - Pass General population