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SONOACE R7

Samsung SONOACE R7 User manual

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SAMSUNG MEDISON
DIAGNOSTIC ULTRASOUND SYSTEM
SONOACE R7
User Manual
Volume 1
SAMSUNG MEDISON
DIAGNOSTIC ULTRASOUND SYSTEM
Version 3.02
English
SONOACE R7
User Manual
Safety Requirements
Classications:
X
Type of protection against electrical shock: Class I
X
Degree of protection against electrical shock (Patient connection): Type BF or CF Applied Part
X
Degree of protection against harmful ingress of water: Ordinary equipment
X
Degree of safety of application in the presence of a ammable anesthetic material with air or with
oxygen or nitrous oxide: Equipment not suitable for use in the presence of a ammable 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 certied
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 notied 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 4. 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 nal 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 qualied 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 specications 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 gures in the user manual for illustrational purposes only and may be dierent from what you see
on the screen or device.
Information contained in this operating 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
v3.02.00-00 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 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 – Volume 1
Chapter 1 Safety
Purpose of Use ............................................................................................................................ 1-3
Contraindications ...............................................................................................................................................................1-3
Safety Signs ................................................................................................................................. 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........................................................................................................................................................................................1-10
Mechanical Safety .................................................................................................................... 1-17
Moving the Equipment ..................................................................................................................................................1-17
Safety Note .........................................................................................................................................................................1-18
Biological Safety ......................................................................................................................1-20
ALARA Principle ................................................................................................................................................................1-20
Environmental Protection ......................................................................................................1-34
Correct Disposal of This Product (Waste Electrical & Electronic Equipment) ............................................1-34
Chapter2 Introduction
Specications.............................................................................................................................. 2-3
Product Conguration and Installation ................................................................................ 2-6
Monitor ................................................................................................................................................................................. 2-9
Control Panel .....................................................................................................................................................................2-11
Console ................................................................................................................................................................................2-16
Peripheral Devices ..........................................................................................................................................................2-18
Probe ..................................................................................................................................................................................... 2-21
Accessories .........................................................................................................................................................................2-22
Optional Functions .......................................................................................................................................................... 2-23
14
User Manual
Chapter3 Starting Diagnosis
Power Supply .............................................................................................................................. 3-3
Powering On ........................................................................................................................................................................ 3-3
Powering O ........................................................................................................................................................................ 3-3
Probes & Applications ............................................................................................................... 3-4
Probe Selection and Application ................................................................................................................................. 3-5
Changing Application ...................................................................................................................................................... 3-5
Editing Probe Preset Values ............................................................................................................................................3-5
Patient Information ................................................................................................................... 3-7
Patient Information for Application ............................................................................................................................3-9
Finding Patient Information ......................................................................................................................................... 3-15
Managing Patient Exams...............................................................................................................................................3-17
Changing Measurements .............................................................................................................................................3-23
Chapter4 Diagnosis Modes
Information ................................................................................................................................. 4-3
Diagnosis Mode Type ....................................................................................................................................................... 4-3
Basic Use ................................................................................................................................................................................ 4-4
Basic Mode .................................................................................................................................. 4-6
2D Mode ................................................................................................................................................................................ 4-6
Panoramic ..........................................................................................................................................................................4-13
M Mode ................................................................................................................................................................................4-15
Color Doppler Mode .......................................................................................................................................................4-17
Power Doppler Mode .....................................................................................................................................................4-20
PW Spectral Doppler Mode ..........................................................................................................................................4-22
CW Spectral Doppler Mode .........................................................................................................................................4-26
TDI Mode .............................................................................................................................................................................4-27
TDW Mode ..........................................................................................................................................................................4-27
ElastoScan Mode .............................................................................................................................................................4-28
Combined Mode ......................................................................................................................4-36
2D/C/PW Mode .................................................................................................................................................................4-36
2D/PD/PW Mode ..............................................................................................................................................................4-36
2D/C/CW Mode ................................................................................................................................................................. 4-36
2D/PD/CW Mode .............................................................................................................................................................. 4-36
2D/C/M Mode ....................................................................................................................................................................4-37
2D/C Live Mode ................................................................................................................................................................4-37
15
Table of Contents
Multi-Image Mode ................................................................................................................... 4-38
Dual Mode ..........................................................................................................................................................................4-38
Quad Mode .........................................................................................................................................................................4-39
3D/4D Mode .............................................................................................................................. 4-40
3D/4D Mode .......................................................................................................................................................................4-40
3D StandBy Mode ............................................................................................................................................................4-42
3D View-MPR ......................................................................................................................................................................4-45
3D XI Mode (Optional) ...................................................................................................................................................4-61
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 ................................................................................................................. 5-9
Distance Measurement ..................................................................................................................................................5-11
Circumference and Area Measurement ..................................................................................................................5-16
Volume Measurement ....................................................................................................................................................5-18
Calculations by Application ...................................................................................................5-21
Things to note ...................................................................................................................................................................5-21
Common Measurement Methods .............................................................................................................................5-25
OB Calculation ...................................................................................................................................................................5-31
Gynecology Calculation ................................................................................................................................................5-44
Cardiac Calculation .......................................................................................................................................................... 5-51
Carotid Calculation ..........................................................................................................................................................5-63
Urology Calculation.........................................................................................................................................................5-75
Fetal Echo Calculation ....................................................................................................................................................5-80
LE Artery Calculation ......................................................................................................................................................5-85
UE Artery Calculation .....................................................................................................................................................5-95
LE Vein Calculation ....................................................................................................................................................... 5-100
UE Vein Calculation.......................................................................................................................................................5-104
Radiology Calculation ................................................................................................................................................. 5-109
TCD Calculation ............................................................................................................................................................. 5-117
Thyroid Calculation ...................................................................................................................................................... 5-123
Breast Calculation .........................................................................................................................................................5-125
Testicle Calculation ....................................................................................................................................................... 5-127
Supercial Calculation ................................................................................................................................................5-129
Pediatric Hips Calculation .......................................................................................................................................... 5-131
Musculoskeletal Calculation ..................................................................................................................................... 5-133
16
User Manual
Report ......................................................................................................................................5-134
Viewing Report .............................................................................................................................................................. 5-135
Video Out .........................................................................................................................................................................5-136
Editing Report ................................................................................................................................................................ 5-136
Adding Comment ......................................................................................................................................................... 5-138
Printing Report ............................................................................................................................................................... 5-139
Saving Report ................................................................................................................................................................. 5-139
Transferring Report ...................................................................................................................................................... 5-140
Stress Echo Report ........................................................................................................................................................ 5-140
Graph Function .............................................................................................................................................................. 5-141
Closing Report ................................................................................................................................................................ 5-145
** Reference Manual
Samsung Medison is providing an additional SONOACE R7 Reference Manual. GA tables and references for
each application are included in the Reference Manual.
Chapter1
Purpose of Use ..................................................1-3
Contraindications ....................................................................1-3
Safety Signs ......................................................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 .............................................................................................1-10
Mechanical Safety ........................................ 1-17
Moving the Equipment .......................................................1-17
Safety Note ...............................................................................1-18
Biological Safety ........................................... 1-20
ALARA Principle .....................................................................1-20
Environmental Protection ........................... 1-34
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)...................1-34
Safety
Chapter 1 Safety
1-3
Chapter 1 Safety
Purpose of Use
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound
imaging and uid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic,
Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Supercial), Cardiac Adult, Cardiac Pediatric,
Peripheral vessel.
NOTE: For detailed information on applications and presets, please refer to ‘Chapter 2. Introduction’ and
‘Chapter 9. Probes’ in this user manual.
Contraindications
This product must not be used for ophthalmological applications, or any other use that involves the
ultrasound beam passing through the eyeball.
CAUTION:
X
Federal law restricts this device to sale by or on the order of a physician
X
The method of application or use of the device is described in the manual 'Chapter 3. Starting
Diagnosis' and 'Chapter 4. Diagnosis Modes'.
1-4
User Manual
Safety Signs
Please read this chapter before using the Samsung Medison ultrasound system. It is relevant to the
ultrasound system, the probes, the recording devices, and any of the optional equipment.
SONOACE R7 is intended for use by, or by the order of, and under the supervision of, a licensed
physician who is qualied for direct use of the medical device.
Safety Symbols
The International Electrotechnical Commission (IEC) has established a set of symbols for medical electronic
equipment, which classify a connection or warn of potential hazards. The classications and symbols are
shown below.
Symbols Description Symbols Description
WARNING: The accompanying
information must be followed to prevent
serious accidents and/or damage to
property.
Data Input/Output port
CAUTION: The accompanying
information helps to prevent minor
accidents and/or damage to property.
Input port
Refer to the user manual. Output port
Follow the user manual. Print remote output
CAUTION: Risk of electric shock Foot Switch Port
Type BF applied part (Classication
based on degree of protection against
electric hazard)
ECG port
Debrillation-proof type CF applied
part (Classication based on degree of
protection against electric hazard)
USB port
Power on/o Power on
/