Samsung SONOACE X6 User manual

Volume 1

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

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MI68-03116A

Version 1.04

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

English

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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 Basic Safety and

Essential Performance [IEC 60601-1:2005/A1:2012]

– Medical 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]

– Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and

Essential Performance- Collateral Standard: Usability [IEC 60601-1-6:2010]

– Medical 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]

– Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-

1:1988 with A1:1991 and A2:1995]

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

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

– Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral

Standard: Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001,

A1:2004]

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

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

– Medical 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]

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

– Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-

1:2003]

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

Essential Performance [CAN/CSA-C22.2 No. 60601-1:14]

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

Essential Performance [ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND

A2:2010(R)2012]

– Biological Evaluation of Medical Devices, Part 1:Evaluation and Testing within a risk

management process [ISO 10993-1:2009]

– Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic

Equipment [IEC 61157:2007]

■ Declarations:

CSA mark with the indicators “C” and “US” means that the

product is certified for both the U.S. and Canadian markets, to

the applicable U.S. and Canadian standards.

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).

This is the GMP symbol for Korean Good Manufacturing

Practice quality system regulation.

Precautions for Use

Before attempting to use the product, be sure to read this manual thoroughly to familiarize

yourself with the operation of the product and the relevant safety information.

■ Keep this manual near the product and refer to it when using the product.

■ Please familiarize yourself with the safety precautions in 'Chapter 1. Safety' and 'Chapter 7.

Maintenance’ in particular.

■ This user manual does not contain clinical opinions or diagnoses. Also, please consult the

reference for each study area before evaluating the measurement result of an application.

■ This product is an ultrasound diagnostic system, and cannot be used on your personal

computer. If you use this product in such an environment, we cannot be held responsible for

any resulting problems.

■ This product must be used by a person who possesses clinical pathology training and/or

certification; use by unqualified persons is prohibited.

■ The manufacturer is not responsible for any damage to this product caused by user

carelessness and/or neglect.

■ Please note that orders are based on the individually agreed specifications and may not

contain all features listed in the user manual.

■ It might be possible that some features, options or probes are NOT available in some

countries.

■ All references to standards / regulations and their revisions are valid for the time of

publication of the user manual.

■ The figures in the user manual for illustrational purposes only and may be different from what

you see on the screen or device.

■ The content and specifications contained in this manual are subject to change without prior

notice.

■ Products that are not manufactured by Samsung Medison are indicated with the trademarks

of their respective owners.

■ The following terms are used to highlight safety precautions that the user must be aware of:

DANGER

Disregarding this instruction may result in death, serious injury, or other

dangerous situations.

WARNING

Follow these instructions to prevent a serious accident or damage to property.

CAUTION

Follow these instructions to prevent a minor accident or damage to property.

NOTE

The accompanying information covers installation, operation, and maintenance

procedures that require careful attention from the user, but have little chance

of leading directly to a dangerous situation.

Revision History

VERSION DATE NOTE

v1.04.02-00 2014.11.20 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.

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

v1.04.02-00 2014.11.20 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.

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.

Table of Contents

1

Table of Contents – Volume 1

Chapter 1 – Safety

Purpose of Use ............................................................................................................................. 3

Contraindications ...................................................................................................................... 3

Safety Signs .................................................................................................................................. 4

Safety Symbols ......................................................................................................................... 4

Symbols .................................................................................................................................... 7

Labels ....................................................................................................................................... 7

Electrical Safety ........................................................................................................................... 8

Prevention of Electric Shock ..................................................................................................... 8

ECG-Related Information ....................................................................................................... 10

ESD ......................................................................................................................................... 11

EMI .......................................................................................................................................... 11

EMC ........................................................................................................................................ 12

Mechanical Safety ...................................................................................................................... 19

Moving the Equipment ............................................................................................................ 19

Safety Note ............................................................................................................................. 20

Biological Safety ........................................................................................................................ 21

ALARA Principle ..................................................................................................................... 21

Environmental Protection ......................................................................................................... 35

Correct Disposal of This Product ............................................................................................ 35

Chapter 2 – Introduction and Installation

Introduction .................................................................................................................................. 3

And Installation ............................................................................................................................ 3

What is SONOACE X6? ................................................................................................................ 3

Features and Advantages of SONOACE X6 ............................................................................ 3

Specifications ............................................................................................................................... 4

Product Configuration and Installation ..................................................................................... 7

Monitor ...................................................................................................................................... 7

Control Panel .......................................................................................................................... 10

Console ................................................................................................................................... 16

Peripheral Devices .................................................................................................................. 19

SONOACE X6 User Manual

2

Probe ...................................................................................................................................... 22

Accessory ............................................................................................................................... 23

Options ................................................................................................................................... 23

Chapter 3 – Setting

Selecting Probe / Application ..................................................................................................... 3

Probe /Application Selection .................................................................................................... 3

Application Change .................................................................................................................. 4

Probe Setting Change .............................................................................................................. 4

Editing Bodymarker .................................................................................................................. 5

Calc Sequence ......................................................................................................................... 7

Entering Patient Data .................................................................................................................. 8

Registering a New Patient ........................................................................................................ 8

Finding Patient Information ...................................................................................................... 9

Modifying Patient Information ................................................................................................. 11

Setting System ........................................................................................................................... 12

General ................................................................................................................................... 12

Display .................................................................................................................................... 15

Misc. ....................................................................................................................................... 17

Setting Measurements .............................................................................................................. 19

General ................................................................................................................................... 19

Obstetrics Measurement Setup .............................................................................................. 24

Fetal Echo Measurement Setup ............................................................................................. 28

Cardiac Measurement Setup ................................................................................................. 29

Urology Measurement Setup ................................................................................................. 30

Vascular Measurement Setup ................................................................................................ 31

Setting DICOM (Optional) ......................................................................................................... 32

Setting DICOM Information .................................................................................................... 32

Network Setup ........................................................................................................................ 33

Adding or Changing the DICOM Server ................................................................................. 33

Editing the DICOM Server Information................................................................................... 39

Deleting DICOM Server ......................................................................................................... 39

Testing DICOM Server ........................................................................................................... 39

DICOM Log ............................................................................................................................ 39

Setting Option ............................................................................................................................ 41

Table of Contents

3

Setting Peripheral Devices ........................................................................................................ 42

Information ................................................................................................................................. 43

Utilities ........................................................................................................................................ 44

Biopsy ..................................................................................................................................... 44

ECG ........................................................................................................................................ 46

Monitor Calibration .................................................................................................................. 48

Preset...................................................................................................................................... 48

Miscellaneous ......................................................................................................................... 49

Chapter 4 – Diagnosis modes

Diagnosis Mode Types and Control ........................................................................................... 3

Diagnosis Mode Types ............................................................................................................. 3

Basic Use .................................................................................................................................. 4

Basic Modes ................................................................................................................................. 8

2D Mode ................................................................................................................................... 8

M Mode ................................................................................................................................... 12

Color Doppler Mode ................................................................................................................ 14

Power Doppler Mode .............................................................................................................. 18

Spectral Doppler Mode ........................................................................................................... 20

Combined Modes ....................................................................................................................... 26

2D/C/PW Mode ....................................................................................................................... 26

2D/PD/PW Mode .................................................................................................................... 27

2D/C/CW Mode ....................................................................................................................... 28

2D/PD/CW Mode .................................................................................................................... 29

2D/C/M Mode .......................................................................................................................... 30

Multi-Image Mode ....................................................................................................................... 31

Dual-2D Mode ......................................................................................................................... 31

Dual-2D/C Mode ..................................................................................................................... 32

Dual-2D/PD Mode ................................................................................................................... 33

3D Mode ...................................................................................................................................... 34

3D ........................................................................................................................................... 34

Acquiring a 3D Image ............................................................................................................. 35

3D View ................................................................................................................................... 36

SONOACE X6 User Manual

4

Chapter 5 – Measurements and Calculations

Measurement Accuracy .............................................................................................................. 3

Causes of Measurement Errors ............................................................................................... 3

Optimization of Measurement Accuracy .................................................................................. 5

Measurement Accuracy Table .................................................................................................. 7

Basic Measurements ................................................................................................................... 9

Distance Measurement .......................................................................................................... 11

Circumference and Area Measurement ................................................................................. 17

Volume Measurement ............................................................................................................ 19

Calculations by Application ..................................................................................................... 21

Things to note ......................................................................................................................... 21

Common Measurement Methods ........................................................................................... 23

OB Calculations ...................................................................................................................... 28

GYN Calculations ................................................................................................................... 35

Cardiac Calculations .............................................................................................................. 37

Vascular Calculations ............................................................................................................. 49

Urology Calculations .............................................................................................................. 52

Fetal Echo Calculations .......................................................................................................... 57

Report ......................................................................................................................................... 62

Viewing Report ....................................................................................................................... 63

Editing Report ......................................................................................................................... 63

Comment ................................................................................................................................ 63

Printing out Report ................................................................................................................. 63

Exporting Report .................................................................................................................... 63

Graph Function ....................................................................................................................... 65

** Reference Manual

Samsung Medison is providing an additional SONOACE X6 Reference Manual. GA tables and

references for each application are included in the Reference Manual.

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Samsung SONOACE X6 User manual

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