This device is in line with the EU Medical Devices Directive 93/42/EC, the „Medizinproduktegesetz" (Ger-
•
man Medical Devices Act) and the standards EN 1060-1 (non-invasive sphygmomanometers, Part 1: General
requirements), EN 1060-3 (non-invasive sphygmomanometers, Part3: Supplementary requirements for electro-
mechanical blood pressure measuring systems) and IEC 80601-2-30 (Medical electrical equipment – Part 2-30:
Particular requirements for basic safety and essential performance of automated non-invasive sphygmoma-
nometers).
The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long
•
useful life.
If using the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate
means. Precise instructions for checking accuracy may be requested from the service address.
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