stated Customer Service address or found at the end of
the instructions for use.
• This device is in line with the EU Medical Devices Directive
93/42/EC, the “Medizinproduktegesetz” (German Medi-
cal Devices Act) and the standards EN 1060-1 (non-inva-
sive sphygmomanometers, Part 1: General requirements),
EN 1060-3 (non-invasive sphygmomanometers, Part 3:
Supplementary requirements for electro-mechanical blood
pressure measuring systems) and IEC 80601-2-30 (Medical
electrical equipment – Part 2 – 30: Particular requirements
for the safety and essential performance of automated
non-invasive blood pressure monitors).
• The accuracy of this blood pressure monitor has been
carefully checked and developed with regard to a long use-
ful life. If using the device for commercial medical pur-
poses, it must be regularly tested for accuracy by appropri-
ate means. Precise instructions for checking accuracy may
be requested from the service address.
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