Subject to errors and changes
26
•
The device complies with the EU Medical Devices
Directive 93/42/EEC, the German Medical Devices Act
(Medizinproduktgesetz) and the standards EN1060-1
(Non-invasive sphygmomanometers – Part1: General
requirements), EN1060-3 (Non-invasive sphygmoma-
nometers – Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems)
and IEC80601-2-30 (Medical electrical equipment – Part
2 – 30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphyg-
momanometers).
•
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 pur-
poses, it must be regularly tested for accuracy by appro-
priate means. Precise instructions for checking accuracy
may be requested from the service address.
