Topcom BPM WRIST 3500 User Manual page 2

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Distributed by:
Topcom Europe NV,
Grauwmeer 17, 3001 Heverlee, Belgium
European representative:
EC
REP
Lotus Global Co., Ltd.
Alexandra Road 15
Londen UK
NW8 0DP
Manufacturer
Manufacturer
Andon Health Co., Ltd
7/F,Hua Qiao Chuang Ye Plaza,No.10 Jin Ping Rd,
Ya An St,Nankai Dist,Tianjin,China
This electronic sphygmomanometer (blood pressure monitor) corresponds to the
below standards:
Safety standards
EN 60601-1:1990+A1:1993+A2:1995 - Medical electrical equipment -
Part1:General requirements for safety,
EMC Standard
EN 60601-1-2:2007 - Medical electrical equipment-Part1:General requirements
for safety; Collateral Standard-Electromagnetic compatibility-Requirements and
tests,
Performance standards:
EN 1060-1:1995+A1:2002 - Non-invasive sphygmomanometers - Part 1:
General requirements,
EN 1060-3:1997+A1:2005 - Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring
systems,
ANSI/AAMI SP-10:2002+A1:2003+A2:2006
The declaration of conformity can be found on:
http://www.topcom.net/en/cedeclarations.html

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