Riester R1 Shock-Proof

Description:

The Riester R1 Shock-Proof 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 R1 Shock-Proof, 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	Equivalence to the Riester Big Ben Square Desk claim without published evidence
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:

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