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Validation of the blood pressure measurement device Erkameter 125 PRO according to the European Society of Hypertension International Protocol revision 2010

Beime, Beate; Deutsch, Cornelia; Krüger, Ralf; Zimmermann, Erik; Bramlage, Peter

doi: 10.1097/MBP.0000000000000216
Devices and Technology
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Objective The aim of the present study was to validate the blood pressure (BP) measurement device Erkameter 125 PRO according to the International Protocol revision 2010 of the European Society of Hypertension (ESH-IP2).

Patients and methods In 33 patients aged 32–79 years, BP measurements were performed alternately using the Erkameter 125 PRO and the reference mercury sphygmomanometer according to ESH-IP revision 2010. For the analysis, a total of 99 comparisons were included.

Results All absolute differences between the test device and the reference were within 10 mmHg for systolic blood pressure (SBP), and all except one for diastolic blood pressure (DBP). A total of 93 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 92 out of 99 for DBP. The mean±SD difference between the Erkameter 125 PRO and the standard reference was −0.5±3.5 mmHg for SBP and 0.5±3.5 mmHg for DBP. As to part 2 of ESH-IP 2010, all patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 patients for DBP.

Conclusion The Erkameter 125 PRO fulfilled the requirements of parts 1 and 2 of the ESH-IP revision 2010 and can be recommended for office BP measurements in adults.

aInstitute for Pharmacology and Preventive Medicine, Cloppenburg

bERKA Kallmeyer Medizintechnik, Bad Tölz, Germany

Correspondence to Beate Beime, MSc, Institute for Pharmacology and Preventive Medicine, Bahnhofstrasse 20, 49661 Cloppenburg, Germany Tel: +49 4471 8503333; fax: +49 4471 8503332; e-mail: beate.beime@ippmed.de

Received June 15, 2016

Received in revised form August 16, 2016

Accepted August 19, 2016

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