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Diagnostic Ultrasound System

Operation Manual
Version 1.03.02
English

MI68-02513A
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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’s systems contain Samsung Medison’s 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.
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 Safety Requirements

* Classification:
Type of protection against electrical shock: Class I
Degree of protection against electrical shock (Patient connection): Type BF equipment
Degree of protection against harmful ingress of water: Ordinary equipment
Degree 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.

Mode of operation: Continuous operation

* Electromechanical safety standards met:

Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988
with A1:1991 and A2:1995]

Medical Electrical Equipment, Part 1: General Requirements for Safety – 1 Collateral

Standard: safety Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]

Medical Electrical Equipment, Part 1: 2. Collateral Standard: Electromagnetic Compatibility

- Requirements and Test [IEC 60601-1-2:2001, A1:2004]

Medical Electrical Equipment – particular Requirements for Safety: Ultrasonic Medical

Diagnostic and Monitoring Equipment [IEC60601-2-37: 2001 with A1:2004, A2:2005]

Medical Electrical Equipment, Part 1: General Requirements for Safety - 4 Collateral

Standard: Programmable Electrical Medical Systems [IEC 60601-1-4: 1996, A1:1999]

Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]

Medical Electrical Equipment, Part 1: General Requirements for Safety [UL60601-1:2003]

Medical Electrical Equipment: General Requirements for Safety [CAN/CSA 22.2 No.601.1-
M90:1990, with Update No. 2 (2003)

ISO10993 : 2009

IEC61157 : 2007
* Declarations:

This is CSA symbol for Canada and United States of America

This is manufacturer’s declaration of product compliance with

applicable EEC directive(s) and the European notified body.

This is manufacturer’s declaration of product compliance with

applicable EEC directive(s).
Read This First

How to Use Your Manual

This manual addresses the reader who is familiar with ultrasound techniques. Only medical
doctors or persons supervised by medical doctors should use this system. Sonography training
and clinical procedures are not included here. This manual is not intended to be used as training
material for the principles of ultrasound, anatomy, scanning techniques, or applications. You
should be familiar with all of these areas before attempting to use this manual or your
ultrasound system.

This manual does not include diagnosis results or opinions. Also, check the measurement
reference for each application’s result measurement before the final diagnosis.

It is useless to make constant or complex adjustments to the equipment controls. The system
has been preset at the factory to produce an optimum image in the majority of patients. User
adjustments are not usually required. If the user wishes to change image settings, the variables
may be set as desired. Optimal images are obtained with little difficulty.

We are not responsible for errors that occur when the system is run on a user’s PC.

Non-Samsung Medison product names may be trademarks of their respective owners.

Please keep this operation manual close to the product as a reference when using the
system.

For safe use of this product, you should read ‘Chapter1. Safety’ in this manual, prior to
starting to use this system.

Some features are not available in some countries. The features with options, and
NOTE specifications that this manual present can be changed without notice.
Government approval is still pending in some nations.
Conventions Used in This Manual

Describes precautions necessary to prevent user hazards of great urgency.

DANGER
Ignoring a DANGER warning will risk life-threatening injury.

Used to indicate the presence of a hazard that can cause serious personal
WARNING
injury, or substantial property damage.

CAUTION Indicates the presence of a hazard that can cause equipment damage.

A piece of information useful for installing, operating and maintaining a

NOTE system. Not related to any hazard.

If You Need Assistance

If you need any assistance with the equipment, like the service manual, please contact the
Samsung Medison Customer Service Department or one of their worldwide customer service
representatives, immediately.
Revision History

VERSION DATE NOTE

v1.03.02-02 2013-01-28 Initial Release

System Upgrades and Manual Set Updates

Samsung Medison Ultrasound is committed to innovation and continued improvement.
Upgrades may be announced that consist of hardware or software improvements. Updated
manuals will accompany those system upgrades.

Verify that Check if this version of the manual is correct for the system version. If not, please
contact the Customer Service Department.