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.
