Hartmann Veroval BPM25 Instructions For Use Manual page 93

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Legal requirements and guidelines
The Veroval wrist blood pressure monitor conforms to the
®
European regulations, which are based on the European
Medical Device Directive 93/42/EEC, and bears the CE mark.
The device complies, for example, with the European Standard
EN 1060: Non-invasive sphygmomanometers – Part 3:
Additional requirements for electro-mechanical blood pressure
measuring systems and the standard IEC 80601-2-30.
Clinical testing of measuring accuracy was performed in
accordance with EN 1060-4.
Beyond statutory requirements, the monitor has been clinically
validated by the ESH-IP2 Protocol of the European Society of
Hypertension (ESH).
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