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Test Seal Protocol (Prüfsiegel) - Results of 40 device tests
Prüfsiegel-Protokoll - Ergebnisse aus 40 Geräteprüfungen
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Veröffentlicht: | 10. August 2005 |
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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).