Manual Topcom bpm 5000 (page 2 of 160) (English, German, Dutch, Danish, French, Italian, Polish, Portuguese, Swedish, Turkish, Spanish, Norwegian, Finnish)

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The features described in this manual are published with reservation to modifications.

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.

REP

Authorized Representative in the European Community

Topcom Europe NV,

Grauwmeer 17

3001 Heverlee, Belgium,

Manufacturer

Kodon (Tianjin) Electric & Electronic Apparatus Co.,Ltd.

7/F,Hua Qiao Chuang Ye Plaza,No.10 Jin Ping Rd,

Ya An St,Nankai Dist,Tianjin,China

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Topcom bpm 5000 Manual

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