Topcom 5331 WHO User Manual
Page 2
UK
The features described in this manual are published with reservation to modifications.
NL
De in deze handleiding beschreven mogelijkheden worden gepubliceerd onder
voorbehoud van wijzigingen.
F
Les possibilités décrites dans ce manuel sont publiées sous réserve de modifications.
D
Die in dieser Bedienungsanleitung umschriebenen Möglichkeiten, werden vorbehaltlich
Änderungen publiziert.
S
Funktionerna i denna bruksanvisning publiceras med reservation för ändringar.
DK
Vi forbeholder os retten til ændringer af de specifikationer, der er beskrevet i denne
brugsanvisning.
N
Funksjoner beskrevet i denne manualen kan endres uten nærmere informasjon.
SF
Tässä ohjekirjassa julkaissut tiedot voivat muuttua ilman ennakkoilmoitusta.
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.