gms | German Medical Science

28. Wissenschaftlicher Kongress der Deutschen Hochdruckliga

24. bis 27.11.2004, Hannover

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Test Seal Protocol (Prüfsiegel) - Results of 40 device tests

Prüfsiegel-Protokoll - Ergebnisse aus 40 Geräteprüfungen

Meeting Abstract (Hypertonie 2004)

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  • U. Tholl - Medizinische Klinik II (Bremerhaven, D)
  • M. Anlauf - BIGT Hochschule Bremerhaven (Bremerhaven, D)
  • U. Lichtblau - BIGT Hochschule Bremerhaven (Bremerhaven, D)
  • U. Roggenbuck - BIGT Hochschule Bremerhaven (Bremerhaven, D)
  • H. Hirche - Institut für medizinische Informatik, Uni Essen (Essen, D)

Hypertonie 2004. 28. Wissenschaftlicher Kongress der Deutschen Hochdruckliga. Hannover, 24.-27.11.2004. Düsseldorf, Köln: German Medical Science; 2005. Doc04hochP123

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/hoch2004/04hoch123.shtml

Published: August 10, 2005

© 2005 Tholl et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

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In 1999 the German Hypertension Society has introduced the 'Test-Seal' Protocol to improve the measurement accuracy of blood pressure measuring devices, constructed for patient self measurement.

Each device has to be tested in 96/116 persons (upper arm/wrist, equally distributed according to the protocol (details see: www.hochdruckliga.info).6 sequential blood pressure measurements comparing device and control value are taken non invasively by three trained testers. The average systolic/diastolic difference (ads/add) may not exceed +/- 5mmHg with a max. mean standard deviation (sds/sdd) of 8 mmHg. At least 50% of the max. point score (P) evaluation must be reached.

40 devices have been tested between 1999 and 2004 (21 upper arm / 19 wrist). 12 upper arm devices and 6 wrist devices fulfill the criteria of the protocol (Table 1 [Tab. 1]).

In conclusion there is still a strong need for the clinical validation of blood pressure measuring devices as only 45% have passed the Test-Seal protocol. The European Standard regulations (EN1060) support these efforts and the Test-Seal validation includes the new protocol (EN1060-part 4).