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Volume 1
Diagnostic Ultrasound System
Operation Manual
Version 3.00
English
MI68-02890A
PROPRIETRAY INFORMATION AND SOFTWARE LICENSE
The Customer shall keep confidential all proprietary information furnished or disclosed to the Customer
by Samsung Medison unless such information has become part of the public domain through no fault of
the Customer. The Customer shall not use such proprietary information, without the prior written consent
of Samsung Medison, for any purpose other than the maintenance, repair or operation of the goods.
Samsung Medison systems contain Samsung Medison proprietary software in machine-readable form.
Samsung Medison retains all its rights, title and interest in the software except that purchase of this
product includes a license to use the machine-readable software contained in it. The Customer shall not
copy, trace, disassemble or modify the software. Transfer of this product by the Customer shall constitute
a transfer of this license that shall not be otherwise transferable. Upon cancellation or termination of this
contract or return of the goods for reasons other than repair or modification, the Customer shall return to
Samsung Medison all such proprietary information.
Safety Requirements
Classifications:
X of protection against electrical shock: Class I
Type
XDegree of protection against electrical shock (Patient connection): Type BF or CF Applied Part
XDegree of protection against harmful ingress of water: Ordinary equipment
XDegree of safety of application in the presence of a flammable anesthetic material with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
XMode of operation: Continuous operation
Electromechanical safety standards met:
XMedical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential
Performance [IEC 60601-1:2005/A1:2012]
XMedical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
[IEC 60601-1-2:2007]
XMedical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Usability [IEC 60601-1-6:2010]
XMedical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential
Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2007]
XMedical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with
A1:1991 and A2:1995]
XMedical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standard: Safety
Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]
XMedical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001, A1:2004]
XMedical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999]
XMedical Electrical Equipment, Part 2-37: Particular Requirements for Safety - Ultrasonic Medical
Diagnostic and Monitoring Equipment [IEC 60601-2-37:2001 with A1:2004, A2:2005]
XMedical Devices