gms | German Medical Science

29. Wissenschaftlicher Kongress der Deutschen Hochdruckliga

Deutsche Hochdruckliga e. V. DHL ® - Deutsche Hypertonie Gesellschaft Deutsches Kompetenzzentrum Bluthochdruck

23. bis 25.11.2005, Berlin

Devices for blood pressure self measurement - results of 51 device tests according to the Test Seal Protocol

Geräte zur Blutdruckselbstmessung - Ergebnisse aus 51 Tests nach dem Prüfsiegel-Protokoll

Meeting Abstract

  • U. Tholl - Klinikum Bremerhaven Reinkenheide (Bremerhaven, D)
  • M. Anlauf - Dialysepaxis Cuxhaven (Cuxhaven, D)
  • U. Lichtblau - Hochschule Bremerhaven (Bremerhaven, D)
  • R. Dammer - Hochschule Bremerhaven (Bremerhaven, D)
  • U. Roggenbuck - Universitätsklinikum Essen (Essen, D)
  • H. Hirche - Universitätsklinikum Essen (Essen, D)

Hypertonie 2005. 29. Wissenschaftlicher Kongress der Deutschen Hochdruckliga. Berlin, 23.-25.11.2005. Düsseldorf, Köln: German Medical Science; 2006. Doc05hochP73

The electronic version of this article is the complete one and can be found online at:

Published: August 8, 2006

© 2006 Tholl et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Introduction: Devices for blood pressure self measurement have to be validated according to a protocol to ensure measurement accuracy.

Method: The Test Seal (Prüfsiegel) Protocol was introduced in 1999 by the German Hypertension Soc. According to this protocol devices for upper arm measurement (OA) have to be tested in 96 persons and wrist devices (HG) in another 20 persons, 56 years or older with diabetes (116 persons). Distribution of the test persons has to be equal for sex, age and blood pressure categories. Three trained testers take 12 sequential blood pressure measurements of each test person, comparing device and control measurement (method: Riva Rocci and Korotkoff with mercury manometer). By statistical analysis the mean systolic and diastolic differences (MWs/MWd) - test device minus control measurement and their standard deviation (Sds/Sdd) are calculated. To pass the protocol MWs and MWd may not exceed ± 5 mmHg with a max. Sds/Sdd of 8 mmHg. An additional point score for each comparative measurement has to reach at least 50% of the max. points.

Results: 51 devices have been tested so far (29 OA, 22 HG). 18 OA and 7 HG passed the criteria of the protocol (50%)-(table 1 [Tab. 1]).

Conclusion: There is still a strong need for a mandatory clinical validation to improve the reliability of blood pressure measuring devices for patient self measurement to support the recommendations of international hypertension societies.