8.
Guarantee
The blood-pressure monitor is guaranteed for 3 years from date of purchase. This guarantee includes the in-
strument 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.
Name and company address of the responsible dealer:
9.
Reference to standards
Device standard:
Electromagn. compatibility:
Clinical testing:
The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class IIa have been fulfilled.
10
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
Device fulfills the stipulations of the European standard
EN 60601-1-2
The clinical performance test was carried out in Germany
according to the DIN 58130/1997 procedure N6 (sequential).