Riester Big Ben Square Rail
Device Name:
Big Ben Square Rail
Device Model:
1493, 1494, 1498, 1498-123, 1498-130, 1498-100 (See Specifications)
Manufacturer:
Rudolf Riester GmbH, Bruckstraße 31, D-72417 Jungingen, GERMANY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Specifications:
Description:
The Riester Big Ben Square Rail is a rail-mounted manually-operated aneroid sphygmomanometer. 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 professional use.
Assessment:
While the technology used in the Riester Big Ben Square Rail, to measure blood pressure, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BP |
Medaval |
None |
While a clinical validation is claimed, it cannot be checked properly. |
| BP |
BIHS (UK and IRL) |
Professional use |
Manufacturer declaration of equivalence |
| 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 RailBLegend:
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. Epub: 2024 Mar 11. doi: 10.1097/MBP.0000000000000702. PMID: 38502042.
ESH-IP:2002 - Pass General population
