Speidel-Keller Maxi Stabil 3
Device Name:
Speidel + Keller Maxi Stabil 3
Manufacturer:
Brand: Speidel & Keller GmbH, Zollerstraße 2-4, Jungingen D-72417, GERMANY.
OBL: Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Obsolete
Description:
The Speidel-Keller Maxi Stabil 3 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 is now obsolete.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Speidel-Keller Maxi Stabil 3 to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven 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. |
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.
Welch Allyn Maxi Stabil 3
Reinders A, Jones CR, Cuckson AC, Shennan AH. The Maxi Stabil 3: validation of an aneroid device according to a modified British Hypertension Society protocol. Blood Press Monit. 2003 Apr;8(2):83-9. PMID: 12819560.
BHS:1993 - Pass (A/A) General population
SP10:1992 - Pass General population