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ES Las características descritas en este manual pueden ser objeto de futuras
modificaciones.
IT Le caratteristiche descritte nel presente manuale vengono pubblicate con riserva di
modifica.
PT As características descritas neste manual são publicadas sob reserva de modificação.
CZ Možnost úpravy funkcí popsaných v této píruce vyhrazena.
GR ,
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HU A jelen használati útmutatóban leírt adatokra a gyártó fenntartja a változtatás jogát.
PL Waciwoci opisane w niniejszej instrukcji obsugi s publikowane z zatrzeeniem prawa
wprowadzenia zmian.
RO Descrierile din acest manual sunt publicate sub rezerva modificarilor.
SK Vlastnosti popísané v tejto príruke sú publikované s vyhradeným právom na zmenu.
EC
REP
Authorized Representative in the European Community
Topcom Europe NV,
Grauwmeer 17
3001 Heverlee, Belgium,
Manufacturer
Health & Life Co., Ltd.
9F No.186, Jian Yi Road
Chung Ho City, Taipei, Taiwan
This Blood Pressure Monitor complies with the EC Directives
and bears the CE Mark "CE 0197".
This product is in compliance with the essential requirements
and other relevant provisions of the directive 93/42/EEC.
The declaration of conformity can be found on:
http://www.topcom.net/support/cedeclarations.php
The quality of the device has been verified and is in line with the provisions of the
EC council directive 93/42/EEC (EN IEC60601-1-General requirements for
safety, EN IEC 60601-1-2:2001 - Electromagnetic compatibility-Requirements
and tests) dated 14 June 1993 concerning medical devices and the EN
performance standards as follow:
• EN 1060-1 Non-invasive sphygmomanometers - General requirements
• EN 1060-3 Non-invasive sphygmomanometers - Supplementary
requirements for electromechanical blood pressure measuring systems.
• EN 1060-4 Non-invasive sphygmomanometers - Test procedures to
determine the overall system accuracy of automated non-invasive
sphygmomanometers.