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This Blood Pressure Monitor complies with the EC Directives and
This product is in compliance with the essential requirements and
other relevant provisions of the directive 93/42/EEC. The declaration
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
requirements
•
EN 1060-3
Supplementary requirements for electromechanical blood
pressure measuring systems.
•
EN 1060-4
procedures to determine the overall system accuracy of
automated non-invasive sphygmomanometers.
EC
REP
The features described in this manual are published with reservation to modifications.
bears the CE Mark "CE 0197".
of conformity can be found on:
Non-invasive sphygmomanometers - General
Non-invasive sphygmomanometers -
Non-invasive sphygmomanometers - Test
Authorized Representative in the European Community
Topcom Europe NV,
Grauwmeer 17
3001 Heverlee, Belgium,
Manufacturer
Andon Health 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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