Topcom BPM ARM 1500 User Manual page 3

Distributor:
Topcom Europe NV,
Grauwmeer 17, 3001 Heverlee, Belgium,
Manufacturer
Health & Life Co., Ltd.
9F No.186, Jian Yi Road, Chung Ho City, Taipei, Taiwan
EC
This Blood Pressure Monitor complies with the EC Directives and bears the CE Mark
"CE 0197".
This blood pressure monitor also complies with mainly following standards,
(including but not limited).
Safety standards
EN 60601-1 - Medical electrical equipment part 1:General requirements for safety
EMC Standard
EN 60601-1-2 Medical electrical equipment part 1-2: General requirements for safety-
Collateral standard: Electromagnetic compatibility - Requirements and tests
Performance standards:
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.
The declaration of conformity can be found on:
http://www.levita-electronics.com/cedeclarations.asp
Puede encontrarse la Declaración de conformidad en:
http://www.levita-electronics.com/cedeclarations.asp
Represented in Europe by:
REP
EMERGO EUROPE
Molenstraat 15, 2513 BH, The Hague, The Netherlands
TEL : +31-70-3458570 FAX : +31-70-3467299