Manual Levita BPM ARM 6331 (page 51 of 52) (English, German, Dutch, French)

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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.

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Levita BPM ARM 6331 Manual

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