22
can be requested from the 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 Medical Devices Act) and the standards
EN 1060-1 (non-invasive sphygmomanometers, Part 1:
General requirements), EN 1060-3 (non-invasive
sphygmomanometers, Part 3: Supplementary require-
ments for electro-mechanical blood pressure measur-
ing 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
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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