Levita BPM ARM 6400, User Manual, Page: 2 / 28

2 REV 1.1 - U8006182
NEDERL
ANDS
NL De in deze handleiding beschreven mogelijkheden worden gepubliceerd onder
voorbehoud van wijzigingen.
UK The features described in this manual are published with reservation to modifications.
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
Represented in Europe by:
EMERGO EUROPE
Molenstraat 15, 2513 BH, The Hague, The Netherlands
TEL : +31-70-3458570 FAX : +31-70-3467299
EC REP
This Blood Pressure Monitor complies with the EC Directives and bears the CE Mark
"CE 0197".
This blood pressure monitor als complies with mainly the 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.topcom.net/support/cedeclarations.php
HL_BPMArm6400 Levita NL-UK.book Page 2 Monday, January 11, 2010 2:51 PM