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Samsung PT60A User manual

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SAMSUNG MEDISON
DIAGNOSTIC ULTRASOUND SYSTEM
PT60A
User Manual
SAMSUNG MEDISON
DIAGNOSTIC ULTRASOUND SYSTEM
Version 1.01
English
PT60A
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 Safety [CAN/CSA C22.2 No. 601.1-
M90: 1990, with R2003, with R2005]
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 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
Be sure to read this manual thoroughly to familiarize yourself with the operation of the product and the
relevant safety information before attempting to use the product.
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 8. Maintenance
in particular.
This manual does not include diagnosis results or opinions. Also, check the reference information for the
measured area of the body before using the application’s measurement results in any diagnosis.
This product is an ultrasound diagnosis device and cannot be used with your PC. The manufacturer is not
responsible for any problems that may be caused by such attempts.
This product must only be used by persons who are trained and/or certified to operate clinical diagnostic
devices. Unqualified persons must not use this product.
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 contents and specifications described in this manual may be changed without 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 an installation, operation, or maintenance
procedure that requires careful attention from the user, but has little chance of leading directly to
a dangerous situation.
Revision History
The revision history of this manual is as follows.
VERSION DATE NOTE
v1.01.02-00 2014.12.15 Initial Release
Product Upgrade and Manual Update
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.
13
Table of Contents
Table of Contents
Chapter 1 Safety
Purpose of Use ............................................................................................................................ 1-3
Contraindications .............................................................................................................................................................. 1-3
Safety Information ..................................................................................................................... 1-4
Safety Symbols .................................................................................................................................................................... 1-4
Symbols ................................................................................................................................................................................. 1-5
LABEL ...................................................................................................................................................................................... 1-6
Electrical Safety .......................................................................................................................... 1-7
Prevention of Electric Shocks ........................................................................................................................................ 1-7
ECG-Related Information ................................................................................................................................................ 1-9
ESD ........................................................................................................................................................................................... 1-9
EMI .........................................................................................................................................................................................1-10
EMC ......................................................................................................................................................................................1-10
Mechanical Safety .................................................................................................................... 1-17
Safety Notes .......................................................................................................................................................................1-17
Moving the Equipment ..................................................................................................................................................1-17
Biological Safety ......................................................................................................................1-18
ALARA Principle ................................................................................................................................................................1-18
Protecting the Environment ..................................................................................................1-33
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment) .............................................................................................................1-33
Battery Pack ..............................................................................................................................1-34
Correct Disposal of Batteries in This Product ........................................................................................................1-35
Chapter 2 Introduction
Product Specifications .............................................................................................................. 2-3
Product Configuration .............................................................................................................. 2-5
Monitor .................................................................................................................................................................................. 2-6
Console .................................................................................................................................................................................2-9
Peripheral Devices ...........................................................................................................................................................2-11
Video Out ............................................................................................................................................................................2-13
14
User Manual
Battery Pack ........................................................................................................................................................................2-15
Probes ................................................................................................................................................................................... 2-17
PT60A CART (Optional) ..................................................................................................................................................2-18
Accessories .........................................................................................................................................................................2-19
CRADLE ................................................................................................................................................................................2-20
Optional Functions .......................................................................................................................................................... 2-21
Chapter 3 Starting Diagnosis
System Power ............................................................................................................................. 3-3
AC Adapter Connection ................................................................................................................................................... 3-3
Turning the Power On ..................................................................................................................................................... 3-4
Shutting Down the System ............................................................................................................................................ 3-4
Probes and Presets .................................................................................................................... 3-5
Selecting Probe and Preset ............................................................................................................................................ 3-6
Managing Presets .............................................................................................................................................................. 3-6
Patient Information .................................................................................................................. 3-8
Patient Information for Each Application ...............................................................................................................3-11
Searching Patient Information ....................................................................................................................................3-16
Chapter 4 Diagnosis Modes
Information ................................................................................................................................. 4-3
Types of Diagnosis Modes .............................................................................................................................................. 4-3
Basic Operating Instructions.......................................................................................................................................... 4-4
Basic Mode .................................................................................................................................. 4-6
2D Mode ................................................................................................................................................................................ 4-6
Biopsy Guide ......................................................................................................................................................................4-11
Needle Mate .......................................................................................................................................................................4-12
M Mode ................................................................................................................................................................................4-13
Color Doppler Mode .......................................................................................................................................................4-15
Power Doppler Mode .....................................................................................................................................................4-19
PW Spectral Doppler Mode .........................................................................................................................................4-21
Combined Mode ......................................................................................................................4-24
2D/C/PW Mode .................................................................................................................................................................4-24
2D/PD/PW Mode ..............................................................................................................................................................4-24
Multi-Image Mode ................................................................................................................... 4-25
Dual Mode ..........................................................................................................................................................................4-25
15
Table of Contents
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 ..................................................................................................................................................5-10
Circumference and Area measurement ..................................................................................................................5-17
Volume measurement ....................................................................................................................................................5-19
Calculations by Application ...................................................................................................5-20
Things to Note ...................................................................................................................................................................5-20
Common Measurement Methods .............................................................................................................................5-22
OB Calculations .................................................................................................................................................................5-24
Gynecology Calculations .............................................................................................................................................5-27
Vascular Calculations ......................................................................................................................................................5-29
Echocardiographic Measurement (Cardiac Calculations) ................................................................................5-31
Report ........................................................................................................................................5-32
Viewing Reports ..............................................................................................................................................................5-32
Adding Comments ..........................................................................................................................................................5-34
Store SR ................................................................................................................................................................................5-34
Printing Reports ................................................................................................................................................................ 5-35
Closing Reports ................................................................................................................................................................. 5-35
Chapter 6 Image Management
Cine / Loop .................................................................................................................................. 6-3
Annotating Images .................................................................................................................... 6-5
Annotation ........................................................................................................................................................................... 6-5
BodyMarker .......................................................................................................................................................................... 6-9
Exiting Annotation ..........................................................................................................................................................6-10
Saving, Playing and Transferring Images ............................................................................6-11
Saving Images ...................................................................................................................................................................6-11
Transferring Images ........................................................................................................................................................6-12
SonoView Mode .......................................................................................................................6-13
Exam Mode ......................................................................................................................................................................... 6-15
16
User Manual
Chapter 7 Utilities
System Settings .......................................................................................................................... 7-3
General System Settings .................................................................................................................................................7-4
Patient .................................................................................................................................................................................... 7-6
Screen Display Settings (Imaging)............................................................................................................................... 7-7
Annotation Settings .......................................................................................................................................................... 7-9
Measurement Settings ...................................................................................................................................................7-10
Peripheral Device Settings ...........................................................................................................................................7-13
Network Settings..............................................................................................................................................................7-15
DICOM Settings ................................................................................................................................................................7-17
Service ..................................................................................................................................................................................7-24
Info ......................................................................................................................................................................................... 7-25
Chapter 8 Maintenance
Operational Environment ........................................................................................................ 8-3
Product Maintenance................................................................................................................ 8-4
Cleaning and disinfecting ............................................................................................................................................... 8-4
Accuracy Checks ................................................................................................................................................................. 8-5
Battery Pack Management ...................................................................................................... 8-6
Replacing the Battery Pack ............................................................................................................................................. 8-6
Recharging the Battery Pack ..........................................................................................................................................8-7
Storing the Battery Pack ..................................................................................................................................................8-9
Disposing of the Battery Pack ....................................................................................................................................... 8-9
Information Maintenance ...................................................................................................... 8-10
Backing Up User Setting ................................................................................................................................................8-10
Backing Up Patient Information .................................................................................................................................8-10
Software...............................................................................................................................................................................8-10
17
Table of Contents
Chapter 9 Probes
Probes .......................................................................................................................................... 9-3
Ultrasound Transmission Gel ......................................................................................................................................... 9-8
Using Sheaths ...................................................................................................................................................................... 9-9
Probe Safety Precautions ..............................................................................................................................................9-10
Cleaning and Disinfecting the Probe .......................................................................................................................9-12
Biopsy .........................................................................................................................................9-21
Biopsy Kit Components .................................................................................................................................................9-21
Using the Biopsy Kit ........................................................................................................................................................9-22
Assembling the Biopsy Kit ............................................................................................................................................9-25
Cleaning and Disinfecting the Biopsy Kit ...............................................................................................................9-28
Reference Manual
Samsung Medison is providing an additional PT60A Reference Manual (English version).
Purpose of Use ..................................................1-3
Contraindications ...................................................................1-3
Safety Information ..........................................1-4
Safety Symbols .........................................................................1-4
Symbols .......................................................................................1-5
LABEL ...........................................................................................1-6
Electrical Safety ................................................1-7
Prevention of Electric Shocks ..............................................1-7
ECG-Related Information ......................................................1-9
ESD ................................................................................................ 1-9
EMI ...............................................................................................1-10
EMC ............................................................................................1-10
Mechanical Safety ........................................ 1-17
Safety Notes .............................................................................1-17
Moving the Equipment .......................................................1-17
Biological Safety ........................................... 1-18
ALARA Principle .....................................................................1-18
Protecting the Environment ........................ 1-33
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)...................1-33
Battery Pack .................................................. 1-34
Correct Disposal of Batteries in This Product ..............1-35
Chapter 1
Chapter 1 Safety
Safety
/