Contact Information
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Manufactured by:
Company:
Address:
Authorized Component
1
.
please use the TRANSTEK
authorized adapter.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
Complied Standards List
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements and
Clinical investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
IEC 60601-1: 2005+A1
：
2012 Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-11 Medical electrical equipment - Part
1-11: General requirements for basic safety and essential
performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical
systems used in the home healthcare environment
IEC/EN 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety and
essential performance - Collateral
standard:Electromagnetic compatibility - Requirements
and tests
IEC 80601-2-30:2009 Medical electrical equipment-
Part 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
Usability
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 60601-1-6 Medical electrical equipment - Part 1
-6 : General requirements for basic safety and
essential performance - collateral standard : Usability
ISO81060-2 Non-invasive sphygmomanometers —
Part 2: Clinical validation of automated
measurement type
Adapter
Type：
KH0601000UW
Input：
100~240V~
50/60Hz, 0.4A Max
Output：
6V 1000mA
AUTHORIZED COMPONENT
COMPLIED STANDARDS LIST
26
27