Topcom BPM ARM 5100 WHO User Manual
Page 2
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.
EC
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