Manufacturer; Safety Conformance; About These Instructions For Use - GE Voluson Swift Instructions For Use Manual

1.2 Manufacturer

1.3 Safety Conformance

1.4 About these Instructions for use

Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4
GE Ultrasound Korea, Ltd.
9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of
Korea
The Voluson™ SWIFT / Voluson SWIFT+ conforms to the following standards and
regulations :
•
Classified to ANSIAAMI ES60601-1 2005 R1 2012 Medical Electrical Equipment, Part 1:
General Requirements for Safety by a Nationally Recognized Test Lab
•
Certified to CSA CAN/CSA-C22.2 NO. 60601-1 :14 General requirements for safety
•
CE Marked to Council Directive 93/42/EEC on Medical Devices
•
Conforms to the following standards for safety:
○ IEC/EN 60601-1 Medical electrical equipment - Part1 : General requirements for
safety
EMC Emissions Group 1. Class A device requirements as per Sub clause 5.3 of
○
CISPR 11
○ IEC/EN 60601-1-6 Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral Standard: Usability
IEC/EN 60601-2-37 Medical electrical equipment - Part 2-37: Particular
○
requirements for the safety of ultrasonic medical diagnostic and monitoring
equipment
IEC/EN 62366 Application of usability engineering to medical devices
○
IEC/EN 62366-1 Medical devices-Part1: Application of usability engineering to
○
medical devices
IEC/EN 62304 Software Life Cycle Processes
○
IEC/EN 62359 Ultrasonic - Field characterization - Test methods for the
○
determination of thermal and mechanical indices related to medical diagnostic
ultrasonic fields.
EN/ISO15223-1 Medical devices - Symbols to be used with medical device labels,
○
labelling and information to be supplied - Part 1: General requirements
ISO 10993-1 Biological evaluation of medical devices - Part 1 Evaluation and
○
testing
WEEE ( Waste Electrical and Electronic Equipment)
○
ROHS according to 2011/65/EU
○
IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements
○
for basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
•
Read and understand all instructions in the Instructions for Use before attempting to use
the Voluson™ SWIFT / Voluson SWIFT+.
General
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