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Samsung ACCUVIX XG User manual

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SAMSUNG MEDISON
DIAGNOSTIC ULTRASOUND SYSTEM
ACCUVIX XG
User Manual
Volume 1
SAMSUNG MEDISON
DIAGNOSTIC ULTRASOUND SYSTEM
Version 1.04
English
ACCUVIX XG
User Manual
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.
Safety Requirements
■■
Classifications:
■X
Type of protection against electrical shock: Class I
■X
Degree of protection against electrical shock (Patient connection): Type BF Applied Part
■X
Degree of protection against harmful ingress of water: Ordinary equipment
■X
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.
■X
Mode of operation: Continuous operation
■■
Electromechanical safety standards met:
■X Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential
Performance [IEC 60601-1:2005/A1:2012]
■X 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]
■X Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Usability [IEC 60601-1-6:2010]
■X 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]
■X Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with
A1:1991 and A2:1995]
■X Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standard: Safety
Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]
■X Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001, A1:2004]
■X Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999]
■X 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]
■X Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]
■X Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-1:2003]
■X Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance
[CAN/CSA-C22.2 No. 60601-1:14]
■X 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]
■X Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management
process [ISO 10993-1:2009]
■X 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 the manufacturer’s declaration of product compliance with
applicable EEC directive(s) and the European notified body.
This is the 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
You should be familiar with all of these areas before attempting to use this manual or your ultrasound
system.
■■
Please keep this user guide close to the product as a reference when using the system.
■■
For safe use of this product, you should read ‘Chapter 1. Safety’ and ‘Chapter 8. Maintenance’ in this
manual, prior to starting to use this system.
■■
This manual does not include diagnosis results or opinions. Also, check the measurement reference for
each application’s result measurement before making the final diagnosis.
■■
This product is an ultrasound scanner and cannot be used from a user’s PC. We are not responsible for
errors that occur when the system software is run on a user’s PC.
■■
Only medical doctors or persons supervised by medical doctors should use this system. Persons who
are not qualified must not operate this product.
■■
The manufacturer is not responsible for any damage to this product caused by carelessness and/or
neglect by the user.
■■
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.
■■
Information contained in this user manual is subject to change without prior notice.
■■
Products that are not manufactured by Samsung Medison are marked with the trademark of their
respective copyright holders.
■■
The headings below describe vitally important precautions necessary to prevent hazards.
DANGER: Describes precautions necessary to prevent user hazards of great urgency. Ignoring a
DANGER warning will risk life-threatening injury.
WARNING: Used to indicate the presence of a hazard that can cause serious personal injury, or
substantial property damage.
CAUTION: Indicates the presence of a hazard that can cause equipment damage.
NOTE: A piece of information useful for installing, operating and maintaining a system. Not related
to any hazard.
Revision History
The revision history of this manual is as follows.
VERSION DATE NOTE
v1.04.00-00 2014.12.19 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 thatCheck 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.
15
Table of Contents
Table of Contents – Volume 1
Chapter 1 Safety
Purpose of Use ............................................................................................................................ 1-3
Contraindications .............................................................................................................................................................. 1-3
Safety Sign .................................................................................................................................. 1-4
Safety Symbols .................................................................................................................................................................... 1-4
Symbols ................................................................................................................................................................................. 1-5
Labels ..................................................................................................................................................................................... 1-6
Electrical Safety .......................................................................................................................... 1-7
Prevention of Electric Shock .......................................................................................................................................... 1-7
ECG-Related Information ................................................................................................................................................ 1-9
ESD ........................................................................................................................................................................................... 1-9
EMI ........................................................................................................................................................................................1-10
EMC ......................................................................................................................................................................................1-11
Mechanical Safety .................................................................................................................... 1-18
Moving the Equipment ..................................................................................................................................................1-18
Safety Note .........................................................................................................................................................................1-19
Biological Safety ......................................................................................................................1-22
ALARA Principle ................................................................................................................................................................1-22
Environmental Protection ...................................................................................................... 1-36
Correct Disposal of This Product (Waste Electrical & Electronic Equipment) ............................................1-36
Chapter 2 Introduction
Specifications ............................................................................................................................. 2-3
Product Configuration .............................................................................................................. 2-5
Monitor ................................................................................................................................................................................. 2-8
Control Panel .....................................................................................................................................................................2-10
Console ................................................................................................................................................................................2-16
Peripheral Devices ...........................................................................................................................................................2-18
Probe ..................................................................................................................................................................................... 2-21
Accessories .........................................................................................................................................................................2-22
Optional Functions .......................................................................................................................................................... 2-23
16
User Manual
Chapter 3 Starting Diagnosis
Power Supply .............................................................................................................................. 3-3
Powering On ........................................................................................................................................................................ 3-3
Powering Off ........................................................................................................................................................................ 3-3
Probes & Applications ............................................................................................................... 3-4
Probe Selection Screen .................................................................................................................................................... 3-4
Probe Selection and Application ................................................................................................................................. 3-5
Renaming a Userset .......................................................................................................................................................... 3-5
Patient Information ................................................................................................................... 3-6
Patient Information for Application ............................................................................................................................3-9
Finding Patient Information ......................................................................................................................................... 3-16
Managing Patient Exams...............................................................................................................................................3-18
Changing Measurements .............................................................................................................................................3-25
Chapter 4 Diagnosis Modes
Information ................................................................................................................................. 4-3
Diagnosis Mode Type ....................................................................................................................................................... 4-3
Basic Use ................................................................................................................................................................................ 4-4
Basic Mode .................................................................................................................................. 4-7
2D Mode ................................................................................................................................................................................ 4-7
M Mode ................................................................................................................................................................................4-20
Color Doppler Mode .......................................................................................................................................................4-23
Power Doppler Mode .....................................................................................................................................................4-28
PW Spectral Doppler Mode ..........................................................................................................................................4-31
CW Spectral Doppler Mode .........................................................................................................................................4-36
TDI Mode .............................................................................................................................................................................4-38
TDW Mode ..........................................................................................................................................................................4-38
ElastoScan Mode ..............................................................................................................................................................4-39
Combined Mode ......................................................................................................................4-46
2D/C/PW Mode .................................................................................................................................................................4-46
2D/PD/PW Mode ..............................................................................................................................................................4-46
2D/C/CW Mode ................................................................................................................................................................. 4-46
2D/PD/CW Mode .............................................................................................................................................................. 4-46
2D/C/M Mode ....................................................................................................................................................................4-47
2D/C Live Mode ................................................................................................................................................................4-47
2D/TDI/TDW .......................................................................................................................................................................4-47
17
Table of Contents
Multi-Image Mode ................................................................................................................... 4-49
Dual Mode ..........................................................................................................................................................................4-49
Quad Mode .........................................................................................................................................................................4-50
3D/4D Mode .............................................................................................................................. 4-51
3D Stand By .......................................................................................................................................................................4-55
3D View - MPR ...................................................................................................................................................................4-59
VOCAL .................................................................................................................................................................................4-70
3D XI ......................................................................................................................................................................................4-79
XI VOCAL .............................................................................................................................................................................4-89
4D ...........................................................................................................................................................................................4-96
XI STIC ...................................................................................................................................................................................4-97
3D Utility Menu ............................................................................................................................................................. 4-101
Chapter 5 Measurements and Calculations
Measurement Accuracy ............................................................................................................ 5-3
Causes of Measurement Errors .....................................................................................................................................5-3
Optimization of Measurement Accuracy .................................................................................................................. 5-5
Measurement Accuracy Table ....................................................................................................................................... 5-7
Basic Measurements ................................................................................................................. 5-8
Distance Measurement ..................................................................................................................................................5-11
Circumference and Area Measurement ..................................................................................................................5-18
Volume Measurement ....................................................................................................................................................5-20
Calculations by Application ...................................................................................................5-23
Things to note ...................................................................................................................................................................5-23
Common Measurement Methods .............................................................................................................................5-26
OB Calculations .................................................................................................................................................................5-31
Gynecology Calculations...............................................................................................................................................5-43
Cardiac Calculations ........................................................................................................................................................ 5-46
Vascular Calculations ......................................................................................................................................................5-64
Fetal Heart Calculations .................................................................................................................................................5-90
Urology Calculations .......................................................................................................................................................5-95
Abdomen Calculations ..............................................................................................................................................5-100
Small Parts Calculations ............................................................................................................................................. 5-104
TCD Calculations .......................................................................................................................................................... 5-111
Pediatric Hips Calculations ........................................................................................................................................ 5-115
Musculoskeletal Calculations ................................................................................................................................... 5-117
18
User Manual
Report ......................................................................................................................................5-118
Viewing Report .............................................................................................................................................................. 5-118
Editing Report ................................................................................................................................................................ 5-120
Adding Comment ......................................................................................................................................................... 5-122
Printing Report ............................................................................................................................................................... 5-123
Saving Report ................................................................................................................................................................. 5-123
Transferring Report ...................................................................................................................................................... 5-124
Store SR ............................................................................................................................................................................. 5-124
Edit Template ................................................................................................................................................................. 5-125
Insert Image .................................................................................................................................................................... 5-127
Stress Echo Report ........................................................................................................................................................ 5-128
Graph ................................................................................................................................................................................. 5-129
History ............................................................................................................................................................................... 5-131
Fetal Description ........................................................................................................................................................... 5-134
Closing Report ................................................................................................................................................................ 5-134
** Reference Manual
Samsung Medison is providing an additional ACCUVIX XG Reference Manual. GA tables and references
for each application are included in the Reference Manual.
Chapter1
Indication for Use ........................................... 1-3
Contraindications ...................................................................1-3
Safety Sign ....................................................... 1-4
Safety Symbols .........................................................................1-4
Symbols .......................................................................................1-5
Labels .......................................................................................... 1-6
Electrical Safety .............................................. 1-7
Prevention of Electric Shock ................................................1-7
ECG-Related Information ......................................................1-9
ESD ................................................................................................ 1-9
EMI ..............................................................................................1-10
EMC ............................................................................................1-11
Mechanical Safety ........................................ 1-18
Moving the Equipment .......................................................1-18
Safety Note ...............................................................................1-19
Biological Safety ...........................................1-22
ALARA Principle .....................................................................1-22
Environmental Protection .......................... 1-36
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)...................1-36
Safety
Chapter 1 Safety
/