User's Manual

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Contact Information
Manufactured by:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Company:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Address:
Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
Athorized Component
Please use the TRANSTEK
authorized adaptor
Complied Standards List
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
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
IIEC/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
ISO 81060-2:2009 Non-invasive sphygmomanometers -
Part 2 : Clinical validation of automated measurement type
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
ATHORIZED COMPONENT
COMPLIED STANDARDS LIST
26 27
UE08WCP-060100SPA
100-240V
50-60Hz,400mA
6V 1A
Adaptor
Type:
Input:
Output:
(Conforms to UL Certification)