9. GUARANTEE
The blood-pressure monitor is guaranteed for 3 years from date of
purchase. This guarantee includes the instrument and the cuff. The guarantee
does not apply to damage caused by improper handling, accidents, not
following the operating instructions or alterations made to the instrument by
third parties.
The guarantee is only valid upon presentation of the guarantee card filled out
by the dealer.
10. INTERNATIONAL QUALITY STANDARDS
Device standard:
Device corresponds to the requirements of the
European standard for non-invasive blood-pressure
monitor
EN1060-1 / 12:95
EN1060-3 / 09:97
DIN 58130, NIBP – clinical investigation
ANSI / AAMI SP10, NIBP - requirements
Electromagnetic Device fulfils the stipulations of the European
compatibility: standard EN 60601-1-2
Clinical testing: The clinical performance test was carried out in
Germany according to the DIN 58130 / 1997
procedure N6 (sequential).
The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class
IIa have been fulfilled.
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