Device Name:
Big Ben Square
Manufacturer:
OBL: Keeler Ltd., Clewer Hill Road, Winsor, Berkshiire SL44AA, UNITED KINGDOM.
OEM: 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:
Discontinued but still available
Description:
The Keeler Big Ben Square is a desk (tabletop), mobile (floor, stand, trolly) or wall-mounted manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Keeler Big Ben Square, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has 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, but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.
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 |
| 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
