Topcom BPM ARM 3301 manual do utilizador Ec Rep

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GR

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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.