Samsung Accuvix A30 User manual Vol.1

Volume 1
Samsung Medison provides the following warranty to the purchaser of this unit. This warranty is valid for a period of one year from the date of installation and covers all problems caused by faulty workmanship or faulty material. Samsung Medison will, as sole and exclusive remedy and at no charge, replace any such defective unit returned to Samsung Medison within the designated warranty period.
The warranty does not cover damages and loss caused by outside factors including, but not limited to, re, ood, storm, tidal wave, lightning, earthquake, theft, abnormal conditions of operation, and intentional destruction of the equipment. Damage caused by equipment relocation is not covered.
The warranty is void in cases where the equipment has been damaged as a result of an accident, misuse, abuse, dropping, or when attempts to modify or alter any part or assembly of the equipment have taken place.
Parts with cosmetic defects or deterioration will not be replaced. Replacement of batteries, training materials, and supplies are not covered.
Samsung Medison will not be responsible for incidental or consequential damages of any kind arising from or connected with the use of the equipment.
Samsung Medison will not be responsible for any loss, damage, or injury resulting from a delay in services rendered under the warranty
This limited warranty is in lieu of all other warranties expressed or implied, including warranties of merchant ability or tness for any particular use. No representative or other person is authorized to represent or assume for Samsung Medison any warranty liability beyond that set forth herein.
Defective equipment shipped from you to Samsung Medison must be packed in the replacement cartons. Shipping and insurance costs are the responsibility of the customer. To return defective material to Samsung Medison contact the Samsung Medison Customer Service Department.
Samsung Medison or a local distributor will make available, upon request, circuit diagrams, a component parts list, descriptions, calibration instructions and other information which will assist your appropriately quali ed technical personnel to repair those parts of the equipment which are designed by Samsung Medison as repairable.
CAUTION: United State federal law restricts this device to sale by or on the order of physicians.
WARRANTY
MANUFACTURER : SAMSUNG MEDISON CO., LTD.
42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Customer Service Department : SAMSUNG MEDISON CO., LTD.
TEL : 82-2-2194-1234 FAX : 82-2-2194-1071
Website: www.samsungmedison.com
EC Representative : SAMSUNG ELECTRONICS (UK) LTD.
Blackbushe Business Park, Saxony Way,
Yateley, Hampshire, GU46 6GG, UK
WARRANTY
Samsung Medison provides the following warranty to the purchaser of this unit. This warranty is valid for a period of one year from the date of installation and covers all problems caused by faulty workmanship or faulty material. Samsung Medison will, as sole and exclusive remedy and at no charge, replace any such defective unit returned to Samsung Medison within the designated warranty period.
The warranty does not cover damages and loss caused by outside factors including, but not limited to,  re,  ood, storm, tidal wave, lightning, earthquake, theft, abnormal conditions of operation, and intentional destruction of the equipment. Damage caused by equipment relocation is not covered.
The warranty is void in cases where the equipment has been damaged as a result of an accident, misuse, abuse, dropping, or when attempts to modify or alter any part or assembly of the equipment have taken place.
Parts with cosmetic defects or deterioration will not be replaced. Replacement of batteries, training materials, and supplies are not covered.
Samsung Medison will not be responsible for incidental or consequential damages of any kind arising from or connected with the use of the equipment.
Samsung Medison will not be responsible for any loss, damage, or injury resulting from a delay in services rendered under the warranty
This limited warranty is in lieu of all other warranties expressed or implied, including warranties of merchant ability or  tness for any particular use. No representative or other person is authorized to represent or assume for Samsung Medison any warranty liability beyond that set forth herein.
Defective equipment shipped from you to Samsung Medison must be packed in the replacement cartons. Shipping and insurance costs are the responsibility of the customer. To return defective material to Samsung Medison contact the Samsung Medison Customer Service Department.
Samsung Medison or a local distributor will make available, upon request, circuit diagrams, a component parts list, descriptions, calibration instructions and other information which will assist your appropriately quali ed technical personnel to repair those parts of the equipment which are designed by Samsung Medison as repairable.
CAUTION: United State federal law restricts this device to sale by or on the order of physicians.
MANUFACTURER : SAMSUNG MEDISON CO., LTD.
42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Customer Service Department : SAMSUNG MEDISON CO., LTD.
EC Representative : SAMSUNG ELECTRONICS (UK) LTD.
TEL : 82-2-2194-1234 FAX : 82-2-2194-1071
Website: www.samsungmedison.com
Blackbushe Business Park, Saxony Way,
Yateley, Hampshire, GU46 6GG, UK
Diagnostic Ultrasound System
Operation Manual
Version 2.00.00
English
MI68-02411A
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 systems contain Samsung Medison 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
Classications:
X
Type of protection against electrical shock: Class I
X
Degree of protection against electrical shock (Patient connection): Type BF equipment
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]
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 60601-1-6:2006]
X Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential
Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC60601-2-37:2007]
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: General Requirements for Safety – 1 Collateral Standard: Safety
Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]
X Medical Electrical Equipment, Part 1: General Requirements for Safety – 2 Collateral Standard:
Electromagnetic Compatibility – Requirements and Test [IEC 60601-1-2:2001, A1:2004]
X Medical Electrical Equipment, Part 1: General Requirements for Safety – 4 Collateral Standard:
Programmable Electrical Medical Systems [IEC 60601-1-4: 1996, A1:1999]
X Medical Electrical Equipment, Part 2: Particular Requirements for Safety – 37 Ultrasonic Medical Diagnostic
and Monitoring Equipment [IEC60601-2-37: 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 [UL60601-1:2003]
X Medical Electrical Equipment, Part 1: General Requirements for Safety [CAN/CSA 22.2 No.601.1-M90:1990,
with R2003, with R2005]
X Biological Evaluation of Medical Devices [ISO10993 : 2009]
X Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
[IEC61157:2007]
Declarations
This is the CSA symbol for Canada and the United States of America.
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.
Read This First
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.
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: 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: The accompanying information covers an installation, operation, or maintenance
procedure that requires careful attention of the user, but has little chance of leading directly to a dangerous situation.
If You Need Assistance
If you require a copy of the service manual or assistance with the product, please contact Samsung Medison customer service department or your distributor.
Revision History
This operation manual’s revision history is as follows:
VERSION DAT E NOTE
v2.00.00-02 2012-06-07 Initial Release
System Upgrades and Manual Set Updates
Upgrades may be announced that consist of hardware or software improvements. Updated manuals will accompany those system upgrades.
Check if this version of the manual is correct for the system version. If not, please contact the Customer Service Department.
Table of Contents
Table of Contents – Volume 1
Chapter 1 Safety
Indication for Use .......................................................................................................................................... 1-3
Contraindications ..............................................................................................................................................................1-3
Safety Signs ..................................................................................................................................................... 1-4
Safety Symbols .................................................................................................................................................................... 1-4
Symbols ................................................................................................................................................................................. 1-5
Labels ...................................................................................................................................................................................... 1-6
Electrical Safety .............................................................................................................................................. 1-9
Prevention of Electric Shock .......................................................................................................................................... 1-9
ECG-Related Information ..............................................................................................................................................1-11
ESD .........................................................................................................................................................................................1-11
EMI .........................................................................................................................................................................................1-12
EMC........................................................................................................................................................................................1-12
Mechanical Safety ...................................................................................................................................... 1-19
Moving the Equipment ..................................................................................................................................................1-19
Safety Notes .......................................................................................................................................................................1-20
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 .................................................................................................................................................................................. 2-7
Control Panel .......................................................................................................................................................................2-9
Console ................................................................................................................................................................................2-14
Peripheral Devices ...........................................................................................................................................................2-16
Probes ...................................................................................................................................................................................2-19
Accessories .........................................................................................................................................................................2-20
Optional Functions ..........................................................................................................................................................2-21
15
Operation Manual
Chapter 3 Starting Diagnosis
Power Supply ..................................................................................................................................................3-3
Powering On ........................................................................................................................................................................ 3-3
Powering Off ........................................................................................................................................................................ 3-3
Probes & Applications ................................................................................................................................3-4
Probe and Application Selection ................................................................................................................................. 3-5
Probe Userset Management .......................................................................................................................................... 3-6
Patient Information ......................................................................................................................................3-9
Patient Information Entry .............................................................................................................................................3-11
Changing Measurements .............................................................................................................................................3-22
Work list Search.................................................................................................................................................................3-25
Searching for Patient Information .............................................................................................................................3-26
Restarting the Exam ........................................................................................................................................................3-34
Chapter 4 Diagnosis Modes
Information......................................................................................................................................................4-3
Diagnosis Mode Types ..................................................................................................................................................... 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 ..........................................................................................................................................................................4-40
ElastoScan Mode ..............................................................................................................................................................4-42
Combined Mode ........................................................................................................................................ 4-49
2D/C/PW Mode .................................................................................................................................................................4-49
2D/PD/PW Mode ..............................................................................................................................................................4-49
2D/C/CW Mode .................................................................................................................................................................4-49
2D/PD/CW Mode ..............................................................................................................................................................4-49
2D/C/M Mode ....................................................................................................................................................................4-50
Dual Live Mode .................................................................................................................................................................4-50
2D/TDI/TDW .......................................................................................................................................................................4-50
16
Table of Contents
MULTI-IMAGE MODE ................................................................................................................................. 4-52
Dual Mode ..........................................................................................................................................................................4-52
Quad Mode .........................................................................................................................................................................4-53
3D/4D Mode................................................................................................................................................. 4-54
3D Stand By ........................................................................................................................................................................4-58
3D View - MPR ...................................................................................................................................................................4-62
VOCAL ..................................................................................................................................................................................4-72
3D XI ......................................................................................................................................................................................4-81
XI VOCAL ..............................................................................................................................................................................4-90
4D ...........................................................................................................................................................................................4-97
XI STIC ...................................................................................................................................................................................4-98
3D Utility Menu .............................................................................................................................................................. 4-102
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 Measurements ................................................................................................................................................5-11
Circumference and Area Measurement ..................................................................................................................5-17
Volume Measurement ....................................................................................................................................................5-19
Calculations by Application ................................................................................................................... 5-22
Things to note ...................................................................................................................................................................5-22
Common Measurement Methods .............................................................................................................................5-27
OB Calculations .................................................................................................................................................................5-32
Gynecology Calculations...............................................................................................................................................5-41
Cardiac Calculations ........................................................................................................................................................5-44
Vascular Calculations ......................................................................................................................................................5-60
Fetal Heart Calculations .................................................................................................................................................5-71
Urology Calculations .......................................................................................................................................................5-75
Abdomen Calculations .................................................................................................................................................5-79
Small Parts Calculations ................................................................................................................................................5-82
TCD Calculations .............................................................................................................................................................5-87
Pediatric Hip Calculations .............................................................................................................................................5-89
Musculoskeletal Calculations ......................................................................................................................................5-91
17
Operation Manual
Reports ........................................................................................................................................................... 5-92
Report View ........................................................................................................................................................................5-92
Editing Reports .............................................................................................................................................................. 5-100
Data Management ........................................................................................................................................................ 5-107
Closing Reports .............................................................................................................................................................. 5-108
Reference Manual
Samsung Medison is providing an additional Accuvix A30 Reference Manual (English version).
18
Chapter 1
Safety
Indication for Use .............................................1-3
Contraindications ................................................................... 1-3
Safety Signs ......................................................1-4
Safety Symbols ......................................................................... 1-4
Symbols ....................................................................................... 1-5
Labels ........................................................................................... 1-6
Electrical Safety ................................................1-9
Prevention of Electric Shock ................................................1-9
ECG-Related Information ....................................................1-11
ESD ..............................................................................................1-11
EMI ...............................................................................................1-12
EMC .............................................................................................1-12
Mechanical Safety ........................................ 1-19
Moving the Equipment .......................................................1-19
Safety Notes .............................................................................1-20
Biological Safety ........................................... 1-22
ALARA Principle .....................................................................1-22
Environmental Protection ........................... 1-36
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)...................1-36
Chapter 1 Safety
Indication for Use
The Accuvix A30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.

Contraindications

The Accuvix A30 system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
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’.
1-3
Operation 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.
Accuvix A30 is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified 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 classifications and symbols are shown below:
Symbols Description Symbols Description
AC (Alternating Current) voltage source Left and right Audio / Video input
Electric shock hazard warning Left and right Audio / Video output
Classification based on degree of protection against electric hazard (Type BF)
Classification based on degree of protection against electric hazard (Type CF)
Power switch (Supplies/cuts the power to the product)
OFF (Cuts the power to a part of the product)
WARNING: The accompanying information must be followed to prevent serious accidents and/or damage to property.
Remote print output
Foot switch connector
ECG connector
USB connector
Microphone connector
1-4
CAUTION: The accompanying information helps to avoid accidents and/or damage to property.
Protection against the effects of immersion
Chapter 1 Safety

Symbols Description Symbols Description

Refer to the operation manual Protection against dripping water
ON (Supplies power to a part of the product)
Identifies an equipotential ground ESD (Electrostatic Discharge) caution
Indicates dangerous voltages over 1000V AC or 1500V DC
Protective earth connected to conductive parts of Class I equipment for safety purposes
Data Output port Do not lean against the product
Data Input port Follow the operation manual
Data Input/Output port
Probe connector
Do not sit on the control panel
Do not push the product

Symbols

Symbols Description Symbols Description
Authorized Representative In The European Community
Manufacturer
1-5
Operation Manual

Labels

Phrases containing the words ‘warning’ and/or ‘caution’ are displayed on the product’s surface in order to protect it.
1-6
[Label 1. ID label]
275-K-A858C
Do not push the product with excessive force or lean against it.
䇋࣓⫼࡯᥼ѻક⾈៪䴴೼݊ϞDŽ
ŝࠥ⦽ ⯹ᮝಽ ᱽ⣩ᮥ ၡÑӹ ʑݡḡ ษᝎ᜽᪅
.
Не толкайте изделие и не опирайтесь на
него.
A T T E N T I O N
[Label 2. Tip-over caution label]
Chapter 1 Safety
[Label 3. Control panel caution label]
1-7
Operation Manual
MADE IN KOREA
275-K-A544C
MADE IN KOREA
275-K-A511C
MADE IN KOREA
275-K-B083B
SAMSUNG MEDISON CO., LTD.
CW 2.0
SAMSUNG MEDISON CO., LTD.
CW 4.0
SAMSUNG MEDISON CO., LTD.
CW 6.0
[Label 4. Probe ID Label]
1-8
Electrical Safety
This equipment has been verified as a Class I device with Type BF applied parts.
CAUTION:
X
As for US requirement, the LEAKAGE CURRENT might be measured from a center-tapped circuit when the equipment connects in the United States to 240V supply system.
X
To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded power outlet.

Prevention of Electric Shock

Chapter 1 Safety
In a hospital environment, hazardous current can form due to potential differences between exposed conductive parts and connected devices. The solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up of sockets which are angled to the equipotential bonding network in medical rooms.
Connection Lead (Socket)
Equipotential Connector
[Figure 1.1 Equipotential Bonding]
Equipotential Terminal
Earth in Medical
1-9
Operation Manual
Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data-processing equipment). Furthermore, all configurations must comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible for the system complying with the requirements for medical electrical systems.
WARNING:
X
Electric shock may result if this system, including all of its externally mounted recording and monitoring devices, is not properly grounded.
X
Never remove the cover from the product. Hazardously high voltage flows through the product. All internal adjustments and replacements must be made by a qualified Samsung Medison Customer Service Department.
X
Always check the product’s casing, cables, cords, and plugs for damage before using the product. Disconnect and do not use the power source if the face is cracked, chipped, torn, the housing is damaged, or if the cable is abraded.
X
Always disconnect the system from the wall outlet prior to cleaning it.
X
All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to the application of a high voltage defibrillation pulse.
X
The use of flammable anesthetic gas or oxidizing gases (N2O) should be avoided. Doing so may cause an explosion.
X
Avoid placing the system where it is likely to be difficult to operate, or disconnect.
X
Do not use HF surgical equipment with the system. Any malfunctions in the HF surgical equipment may result in burns to the patient.
X
The System must only be connected to a supply mains with protective earth to avoid risk of electric shock.
1-10
CAUTION:
X
The system has been designed for 100-120VAC and 200-240VAC; you should select the input voltage of the printer and VCR. Prior to connecting a peripheral power cord, verify that the voltage indicated on the power cord matches the voltage rating of the peripheral device.
X
An isolation transformer protects the system from power surges. This continues to operate when the system is on standby.
X
Do not immerse the cable in liquids. Cables are not waterproof.
X
The auxiliary socket outlets installed on this system are rated 100-120V and 200-240V, with a maximum total load of 150VA. Only use these outlets for supplying power to equipment that is intended to be part of the ultrasound system. Do not connect additional multiple-socket outlets or extension cords to the system.
X
Do not connect any peripheral devices not listed in this manual to the auxiliary socket outlets of the system.
X
Do not touch SIP/SOP and the patient simultaneously. There is a risk of electric shock from current leakage.
Chapter 1 Safety

ECG-Related Information

WARNING:
X
This product does not support ECG monitoring. Therefore, it will not recognize incompatible ECG signals.
X
Do not use the ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical equipment may result in burns to the patient.
X
Do not use ECG electrodes during cardiac pacemaker procedures or other electrical stimulators.
X
Do not use ECG leads and electrodes in an operating room.
ESD
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. The static shock, or ESD, is a discharge of the electrical energy build-up from a charged individual to a lesser or uncharged individual or object. An ESD occurs when an individual with an electrical energy build-up comes in to contact with conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals.
CAUTION:
X
The level of electrical energy discharged from a system user or a patient to an ultrasound system can be significant enough to cause damage to the system or probes.
X
Always perform the pre-ESD preventive procedures before using connectors marked with the ESD warning label.
− Apply anti-static spray to carpets or linoleum.
− Use anti-static mats.
− Ground the product to the patient table or bed.
X
It is highly recommended that the user be given training on ESD-related warning symbols and preventive procedures.
1-11
Operation Manual
EMI
This product complies with EMI (Electromagnetic Interference) standards. However, using the system inside an electromagnetic field can lower the quality of ultrasound images and even damage the product.
If this occurs often, Samsung Medison suggests a review of the environment in which the system is being used, to identify possible sources of radiated emissions. These emissions could be from other electrical devices used within the same room or an adjacent room. Communication devices, such as cellular phones and pagers, can cause these emissions. The existence of radios, TVs, or microwave transmission equipment nearby can also cause interference.
CAUTION: In cases where EMI is causing disturbances, it may be necessary to relocate the system.
EMC
The testing for the EMC (Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC60601-1-2). This IEC standard was adopted in Europe as the European norm (EN60601-1-2).
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment guidance
RF Emission CISPR 11
RF Emission CISPR 11
Harmonic Emission IEC 61000-3-2
Flicker Emission IEC 61000-3-3
Group 1
Class B
Class A
Complies
The Ultrasound System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The Ultrasound System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
1-12
Chapter 1 Safety
Approved Cables, Transducers and Accessories for EMC
Approved Cable for Electromagnetic Compliance
Cables connected to this product may affect its emissions. Refer to the table below for recommended cable types and lengths:
Cable Type Length
VGA Shielded Normal
RS232C Shielded Normal
USB Shielded Normal
LAN(RJ45) Twisted pair Any
S-Video Shielded Normal
Foot Switch Shielded 2.5m
B/W Printer Unshielded Coaxial Normal
MIC Unshielded Any
Printer Remote Unshielded Any
Audio R.L Shielded Normal
VHS Shielded Normal
ECG AUX input Shielded < 3m
Parallel Shielded Normal
Probe
The probes listed in ‘Chapter 9. Probes’ of this manual comply with Group1 Class B emission requirements of International Standard CISPR 11.
Approved Accessories for Electromagnetic Compliance
Accessories used with this product may affect its emissions.
CAUTION: When connecting other customer-supplied accessories to the system, such as a remote printer, it is the user’s responsibility to ensure the electromagnetic compatibility of the system. Use only CISPR 11 or CISPR 22, CLASS B compliant devices.
1-13
Operation Manual
WARNING: The use of cables, transducers, and accessories, other than those specified, may result in increased emissions or decreased immunity of the Ultrasound System.
Immunity test IEC 60601 test level Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
Power frequency magnetic field (50/60 Hz)
IEC 61000-4-8
NOTE: Uт is the AC mains voltage, prior to application of the test level.
±6KV contact
±8KV air
±2KV for power supply lines ±1KV for input/output lines
±1KV differential mode
±2KV common mode
<5% Uт for 0.5 cycles (>95% dip in Uт)
40% Uт for 5 cycles (60% dip in Uт)
70% Uт for 25 cycles (30% dip in Uт)
<5% Uт for 5 s (<95% dip in Uт )
3 A/m 3 A/m
±6KV contact
±8KV air
±2KV for power supply lines ±1KV for input/output lines
±1KV differential mode
±2KV common mode
<5% Uт for 0.5 cycles (>95% dip in Uт)
40% Uт for 5 cycles (60% dip in Uт)
70% Uт for 25 cycles (30% dip in Uт)
<5% Uт for 5 s (<95% dip in Uт )
Electromagnetic environment
guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of this product requires continued operation during power mains interruptions, it is recommended that this product be powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.
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Immunity test
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
IEC 60601
test level
3Vrms 150 kHz to 80MHz
3 V/m 80MHz to 2.5GHz
Compliance level
Electromagnetic
environment guidance
0.01V Portable and mobile RF communications equipment should be used no closer to any part of the Ultrasound System, including cables, than the recommended separation distance. This is calculated using the equation applicable to the frequency of the transmitter.
Recommended separation distance
80MHz a 800MHZ
800MHz a 2,5GHz
3V/m Where P is the transmitter’s maximum output
power rating in watts (W) according to the transmitter’s manufacturer, and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
b
a
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio, (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be predicted with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength, in the location in which the Ultrasound System is used, exceeds the applicable RF compliance level above, the Ultrasound System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Ultrasound System or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than V1 V/m.
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Operation Manual
Recommended separation distances between portable and mobile RF
communications equipment and ACCUVIX A30
This product is intended for use in an electromagnetic environment, in which radiated RF disturbances are controlled. The customer or the user of this product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product. These distances are recommended below, according to the maximum output power of the communications equipment.
Separation distance, according to frequency of transmitter [m]
Rated maximum output
power of transmitter
[W]
0.01 35.00 0.11 0.23
0.1 110.68 0.36 0.73
1 350.00 1.16 2.33
10 1106.80 3.68 7.37
100 3500.00 11.66 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W), according to the transmitter’s manufacturer.
NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
150kHz to 80MHz
V1=0.01Vrms E1=3V/m E1=3V/m
80MHz to 800MHz
800MHz to 2.5GHz
Electromagnetic Environment – Guidance
The Ultrasound System must only be used in a shielded location with a minimum RF shielding effectiveness, and each cable should also be connected and used within the shielded location. Field strengths outside the shielded location from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m.
It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification.
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Chapter 1 Safety
CAUTION: If the system is connected to other customer-supplied equipment, such as a local area network (LAN) or a remote printer, Samsung Medison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic phenomena.
Avoiding Electromagnetic Interference
Typical interference on ultrasound imaging systems varies depending on electromagnetic phenomena. Please refer to the following table:
Imaging Mode ESD
1
RF
2
Power Line
3
For sector imaging probes, white radial bands or flashes in the centerlines of the
2D
image. For linear imaging probes, white vertical
White dots, dashes, diagonal lines, or diagonal lines near
the center of the image. bands, sometimes more pronounced on the sides of the image.
Increase in the image background noise or white M mode lines.
Color flashes, radial or vertical bands, increase in background noise, or changes in color image.
Horizontal lines in the spectral display or tones, abnormal noise in the audio, or both.
White dots, dashes, diagonal
lines, or increase in image
background noise.
Color flashes, dots, dashes,
or changes in the color noise
level.
Vertical lines in the spectral
display, popping type noises
in the audio, or both.
M
Color
Doppler
Change of operating mode, system settings, or system reset. Brief flashes in the displayed or recorded image.
1. ESD caused by discharging of electric charge build-up on insulated surfaces or persons.
2. RF energy from RF transmitting equipment such as portable phones, hand-held radios, wireless devices, commercial radio and TV, and so on.
3. Conducted interference on power lines or connected cables caused by other equipment, such as switching power supplies, electrical controls, and natural phenomena such as lightning.
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Operation Manual
A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference.
Samsung Medison ultrasound systems do not generate interference in excess of the referenced standards.
The Ultrasound System is designed to receive signals at radio frequency and is therefore susceptible to interference generated by RF energy sources. Examples of other sources of interference are medical devices, information technology products, and radio and television transmission towers. Tracing the source of radiated interference can be a difficult task. Customers should consider the following in an attempt to locate the source:
− Is the interference intermittent or constant?
− Does the interference show up only with one transducer operating at the same frequency or with several transducers?
− Do two different transducers operating at the same frequency have the same problem?
− Is the interference present if the system is moved to a different location in the facility?
The answers to these questions will help determine if the problem resides with the system or the scanning environment. After you answer this question, contact your local Samsung Medison customer service representative.
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Chapter 1 Safety
Mechanical Safety

Moving the Equipment

WARNING: The product weighs more than 100kg. Be extra careful when transporting it. Careless
transportation of the product may result in product damage or personal injury.
Before transporting the product, check that the wheel brakes are unlocked. Also, make sure to retract the
monitor arm completely, so that it is secured in a stationary position.
Always use the handles at the back of the console and move the product slowly.
This product is designed to resist shocks. However, excessive shock, for example – if the product falls over, may cause serious damage.
If the system operates abnormally after being repositioned, please contact Samsung Medison customer service department.
The Brakes
You can use the brakes to control the movement of the product. The front wheel brakes are on the center of the consol pedal and the back wheel brakes are on the top of each wheel. The brakes at the front can help you to control the two front wheels simultaneously, using the pedal.
X
The front wheel brakes: To lock the brakes, press the front part of the brake with your foot. To unlock the brakes, press the back of the pedal.
X
To lock the brakes, press the bottom part of the brake with your foot. To unlock them, press the part labeled OFF at the top of the brake with your foot.
We recommend that you lock the brakes when using the product.
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Operation Manual
Precautions on Ramps
Always make sure that the control panel is facing the direction of movement.
WARNING: Be aware of the castors, especially when moving the system. Samsung Medison recommends that you exercise caution when moving the product up or down ramps.
When moving the product down a ramp or resting it temporarily on a ramp, the product may tilt over even with the brakes on depending on the direction the product is facing. Do not leave the product on ramps.

Safety Notes

CAUTION:
X
Do not press the control panel excessively.
X
Never attempt to modify the product in any way.
X
Check the operational safety when using the product after a prolonged break in service.
X
Make sure that other objects, such as metal pieces, do not enter the system.
X
Do not block the ventilation slots.
X
Do not pull on the power cord to unplug it. Doing so can damage the cord and cause short­circuiting and cord snapping. Always unplug by pulling on the plug itself.
X
Excessive bending or twisting of cables, on parts that are applied to the patient, may cause failure or intermittent operation of the system.
X
Improper cleaning or sterilization, of parts that are applied to the patient, may cause permanent damage.
X
Servicing the product, including repairs and replacement of parts, must be done by qualified Samsung Medison service personnel . Assuming that the product is used in accordance with the guidelines contained in this manual and maintained by qualified service personnel, the expected lifespan of the product is approximately 7 years.
For detailed information on cleaning and disinfecting the product, refer to “Chapter 8. Maintenance”.
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Chapter 1 Safety
275-K-A730B
Monitor Safety Note
When adjusting the height or position of the monitor, be careful of the space in the middle of the monitor arm. Having your fingers, or other body parts, caught in it may result in injury.
[Figure 1.2 Monitor Safety Note]
Control Panel Caution
CAUTION:
X
Do not press on the control panel with excessive force or lean against it.
X
Do not sit on the control panel or apply too much pressure to it.
When adjusting the control panel’s height or position, be mindful of the space between the panel and the lift. Having your fingers, or other body parts, caught in it may result in injury.
275-K-B003A
[Figure 1.3 Control Panel Caution]
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Operation Manual
Biological Safety
For safety instructions concerning probes and biopsies, refer to “Chapter 9. Probes”.
WARNING:
X
Ultrasound waves may have damaging effects on cells and, therefore, may be harmful to the patient. If there is no medical benefit, minimize the exposure time and maintain the ultrasound wave output level at low. Please refer to the ALARA principle.
X
Do not use the system if an error message appears on the video display indicating that a hazardous condition exists. Note the error code, turn off the power to the system, and call Samsung Medison customer service department.
X
Do not use a system that exhibits erratic or inconsistent functioning. Discontinuities in the scanning sequence are indicative of a hardware failure that should be corrected before use.
X
The system limits the maximum contact temperature to 43 degrees Celsius, and the ultrasonic wave output observes American FDA regulations.

ALARA Principle

Guidance for the use of diagnostic ultrasound is defined by the “As Low As Reasonably Achievable” (ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight of qualified personnel. No set of rules can be formulated that would be sufficiently complete to dictate the correct response to every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bioeffects.
Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, the Ultrasound System provides controls that can be manipulated during the exam to optimize the results.
The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound, not only in the technology but also in its applications, have resulted in the need for increased and improved information to guide the user. The output indices are designed to provide that important information.
There are a number of variables, which affect the way in which the output display indices can be used to implement the ALARA principle. These variables include mass, body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because the user controls it. The ability to limit the index values over time supports the ALARA principle.
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Chapter 1 Safety
Applying ALARA
The system imaging mode used depends upon the information needed. 2D-mode and M-mode imaging provide anatomical information, while Doppler, Power, and Color imaging provide information about blood flow. Scanned modes, like 2D-mode, Power, or Color, disperse or scatter the ultrasonic energy over an area, while an unscanned mode, like M-mode or Doppler, concentrate the ultrasonic energy. Understanding the nature of the imaging mode being used allows the sonographer to apply the ALARA principle with informed judgment. The probe frequency, system set-up values, scanning techniques, and operator experience aid the sonographer in meeting the ALARA principle. The decision as to the amount of acoustic output is, in the final analysis, up to the system operator. This decision must be based on the following factors: type of patient, type of exam, patient history, ease or difficulty of obtaining diagnostically useful information, and the potential localized heating of the patient due to probe surface temperatures. Prudent use of the system occurs when patient exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve acceptable diagnostic results.
Although a high index reading does not mean that a biological effect is actually occurring, it should be taken seriously. Every effort should be made to reduce the possible effects of a high index reading. Limiting exposure time is an effective way to accomplish this goal.
There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA and can be divided into three categories: direct, indirect, and receiver control.
Direct Controls
Application selection and the output intensity control directly affect acoustic intensity. There are different ranges of allowable intensity or output depending on your selection. Selecting the correct range of acoustic intensity for the application is one of the first things required during any exam. For example, peripheral vascular intensity levels are not recommended for fetal exams. Some systems automatically select the proper range for a particular procedure, while others require manual selection. Ultimately, the user bears the responsibility for proper clinical use. Samsung Medison systems provide both automatic and user-definable settings.
Output has direct impact on acoustic intensity. Once the application has been established, the output control can be used to increase or decrease the output intensity. The output control allows you to select intensity levels less than the defined maximum. Prudent use dictates that you select the lowest output intensity consistent with good image quality.
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Operation Manual
Indirect Controls
The indirect controls are those that have an indirect effect on acoustic intensity. These controls affect imaging mode, pulse repetition frequency, focus depth, pulse length, and probe selection.
The choice of imaging mode determines the nature of the ultrasound beam. 2D-mode is a scanning mode, Doppler is a stationary or unscanned mode. A stationary ultrasound beam concentrates energy on a single location. A moving or scanned ultrasound beam disperses the energy over a wide area and the beam is only concentrated on a given area for a fraction of the time that is necessary in unscanned mode.
Pulse repetition frequency or rate refers to the number of ultrasound bursts of energy over a specific period of time. The higher the pulse repetition frequency, the more pulses of energy in a given period of time. Several controls affect pulse repetition frequency: focal depth, display depth, sample volume depth, color sensitivity, number of focal zones, and sector width controls.
The focus of the ultrasound beam affects the image resolution. To maintain or increase resolution at a different focus requires a variation of output over the focal zone. This variation of output is a function of system optimization. Different exams require different focal depths. Setting the focus to the proper depth improves the resolution of the structure of interest.
Pulse length is the time during which the ultrasonic burst is turned on. The longer the pulse, the greater the time-average intensity value. The greater the time-average intensity, the greater the likelihood of temperature increase and cavitations. Pulse length, burst length or pulse duration is the output pulse duration in pulsed Doppler. Increasing the Doppler sample volume, increases the pulse length.
Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The higher the probe operating frequency, the greater the attenuation of the ultrasonic energy. Higher probe operating frequencies require higher output intensity to scan at an increased depth. To scan deeper at the same output intensity, a lower probe frequency is required. Using more gain and output beyond a point, without corresponding increases in image quality, can mean that a lower frequency probe is needed.
Receiver Controls
Receiver controls are used by the operator to improve image quality. These controls have no effect on output. Receiver controls only affect how the ultrasound echo is received. These controls include gain, TGC, dynamic range, and image processing. The important thing to remember, relative to output, is that receiver controls should be optimized before increasing output. For example; before increasing output, optimize gain to improve image quality.
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Chapter 1 Safety
Additional Considerations
Ensure that scanning time is kept to a minimum, and ensure that only medically required scanning is performed. Never compromise quality by rushing through an exam. A poor exam will require a follow-up, which ultimately increases the scanning time. Diagnostic ultrasound is an important tool in medicine, and, like any tool, should be used efficiently and effectively.
Output Display Features
The system output display comprises two basic indices: a mechanical index and a thermal index. The thermal index consists of the following indices: soft tissue (TIs), bone (TIb) and cranial bone (TIc). One of these three thermal indices will be displayed at all times. Which one depends upon the system’s default setting or user choice, depending upon the application at hand.
The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1. The thermal index consists of the three indices, and only one of these is displayed at any one time. Each probe application has a default selection that is appropriate for that combination. The TIb or TIs is continuously displayed over the range of 0.0 to the maximum output, based on the probe and application, in increments of 0.1.
The application-specific nature of the default setting is also an important factor of index behavior. The default setting is a system control state, which is preset by the manufacturer or the operator. The system has default index settings for the probe application. The default settings are invoked automatically by the Ultrasound System when power is turned on, new patient data is entered into the system database, or a change in application takes place. The decision as to which of the three thermal indices to display should be based on the following criteria:
Appropriate index for the application: TIs is used for imaging soft tissue; and TIb for a focus at or near bone.Some factors might create artificially high or low thermal index readings, e.g. the presence of fluid or bone, or the flow of blood. A highly attenuated tissue path, for example, will cause the potential for local zone heating to be less than the thermal index displays.
Scanned modes versus unscanned modes of operation affect the thermal index. For scanned modes, heating tends to be near the surface; for unscanned modes, the potential for heating tends to be deeper in the focal zone.
Always limit ultrasound exposure time but do not rush the exam. Ensure that the indices are kept to a minimum and that exposure time is limited without compromising diagnostic sensitivity.
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Operation Manual
Mechanical Index (MI) Display
Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The potential for mechanical biological effects varies with peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. However, there is no specific MI value that means that a mechanical bioeffect will actually occur. The MI should be used as a guide for implementing the ALARA principle.
Thermal Index (TI) Display
The TI informs the user about the potential for temperature increase occuring at the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, mode of operation, etc. The TI should be used as a guide for implementing the ALARA principle.
The bone thermal index (TIb) informs the user about potential heating at or near the focus, after the ultrasound beam has passed through soft tissue or fluid, for example, at or near second or third trimester fetal bone.
The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near the surface of, for example, cranial bone. TIc is displayed when you select a trans-cranial application.
The soft tissue thermal index (TIs) informs the user about the potential for heating within soft homogeneous tissue.
You can select TI Display in Utility > Setup > Display > Display.
Precision and Accuracy of Mechanical and Thermal Indices Displays
The mechanical and thermal indices on the system are precise to 0.1 units.
The MI and TI display accuracy estimates for the system are given in the Acoustic Output Tables Manual. These accuracy estimates are based on the various range of probes and systems, inherent acoustic output modeling errors, and measurement variation, as described below.
The displayed values should be interpreted as relative information to help the system operator achieve the ALARA principle through prudent use of the system. The values should not be interpreted as actual physical values from investigated tissue or organs. The initial data that is used to support the output display is derived from laboratory measurements based on the AIUM measurement standard. The measurements are then put into algorithms for calculating the displayed output values.
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Chapter 1 Safety
Many of the assumptions used in the process of measurement and calculation are conservative in nature. Over-estimation of actual in situ exposure, for the vast majority of tissue paths, is built into the measurement and calculation process. For example, the measured water tank values are derated using a conservative, industry standard, attenuation coefficient of 0.3dB/cm-MHz.
Conservative values for tissue characteristics were selected for use in the TI models. Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat capacity, and tissue thermal conductivity were selected.
A steady state temperature rise is assumed in the industry standard TI models, and the assumption is made that the ultrasound probe is held steady in one position long enough for a steady state to be reached.
A number of factors are considered when estimating the accuracy of display values: hardware variations, algorithm accuracy estimation and measurement variation. Variation among probes and systems is a significant factor. Probe variation results from piezoelectric crystal efficiencies, process­related impedance differences, and sensitive lens focusing parameter variations. Differences in the system pulse voltage control and efficiencies are also a contributor to variability. There are inherent uncertainties in the algorithms used for estimating acoustic output values over the range of possible system operating conditions and pulse voltages. Inaccuracies in laboratory measurements are related to differences in hydrophone calibration and performance, positioning, alignment and digitization tolerances, as well as variation among test operators.
The conservative assumptions of the output estimation algorithms of linear propagation, at all depths, through a 0.3dB/cm-MHz attenuated medium are not taken into account in calculation of the accuracy estimate displayed. Neither linear propagation, nor uniform attenuation at the 0.3dB/ cm-MHz rate, occur in water tank measurements or in most tissue paths in the body. In the body, different tissues and organs have dissimilar attenuation characteristics. In water, there is almost no attenuation. In the body, and particularly in water tank measurements, non-linear propagation and saturation losses occur as pulse voltages increase.
The display accuracy estimates take into account the varying ranges of probes and systems, inherent acoustic output modeling errors, and measurement variations. Display accuracy estimates are not based on errors in, or caused by measuring according to, the AIUM measurement standards. They are also independent of the effects of non-linear loss on the measured values.
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Operation Manual
Control Eects – Control Aecting the Indices
As various system controls are adjusted, the TI and MI values may change. This will be most apparent as the POWER control is adjusted; however, other system controls will affect the on-screen output values.
Power
Power controls the system acoustic output. Two real-time output values are on the screen: a TI and an MI. They change as the system responds to POWER adjustments.
In combined modes, such as simultaneous Color, 2D-mode and pulsed Doppler, the individual modes each add to the total TI. One mode will be the dominant contributor to this total. The displayed MI will be from the mode with the largest peak pressure.
2D-mode Controls
2D-Mode Size
Narrowing the sector angle may increase the frame rate. This action will increase the TI. Pulse voltage may be automatically adjusted down via software controls to keep the TI below the system maximums. A decrease in pulse voltage will decrease the MI.
Zoom
Increasing the zoom magnification may increase the frame rate. This action will increase the TI. The number of focal zones may also increase automatically to improve resolution. This action may change the MI, since the peak intensity can occur at a different depth.
Persistence
A lower persistence will decrease the TI. Pulse voltage may be automatically increased. An increase in pulse voltage will increase the MI.
Focal No.
More focal zones may change both the TI and MI by changing the frame rate or focal depth automatically. Lower frame rates decrease the TI. The MI displayed will correspond to the zone with the largest peak intensity.
Focus
Changing the focal depth will change the MI. Generally, higher MI values will occur when the focal depth is near the natural focus of the transducer.
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Chapter 1 Safety
Color and Power Controls
Color Sensitivity
Increasing the color sensitivity may increase the TI. More time is spent scanning for color images. Color pulses are the dominant pulse type in this mode.
Color Sector Width
Narrower color sector width will increase color frame rate and the TI will increase. The system may automatically decrease pulse voltage to stay below the system maximum. A decrease in pulse voltage will decrease the MI. If pulsed Doppler is also enabled, then pulsed Doppler will remain as the primary mode and the TI change will be small.
Color Sector Depth
Deeper color sector depth may automatically decrease color frame rate or change color focal zone or color pulse length. The TI will change due to the combination of these effects. Generally, the TI will decrease with increased color sector depth. MI will correspond to the peak intensity of the dominant pulse type, which is a color pulse. However, if pulsed Doppler is also enabled then pulsed Doppler will remain the dominant mode and the TI change will be small.
Scale
Using the SCALE control to increase the color velocity range may increase the TI. The system will automatically adjust pulse voltage to stay below the system maximums. A decrease in pulse voltage will also decrease MI.
Sec Width
A narrower 2D-mode sector width in Color imaging will increase the color frame rate. The TI will increase and the MI will not change. If pulsed Doppler is also enabled, then pulsed Doppler will remain as the primary mode and the TI change will be small.
M-mode and Doppler Controls
Speed
M-mode and Doppler sweep speed adjustments will not affect the MI. When M-mode sweep speed changes, the TI changes.
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Operation Manual
Simultaneous and Update Methods
Use of combination modes affects both the TI and MI through the combination of pulse types. During simultaneous mode, the TI is additive. During auto-update and duplex, the TI will display the dominant pulse type. The displayed MI will be from the mode with the largest peak pressure.
Sample Volume Depth
When Doppler sample volume depth is increased, the Doppler PRF may automatically decrease. A decrease in PRF will decrease the TI. The system may also automatically decrease the pulse voltage to remain below the system maximum. A decrease in pulse voltage will decrease the MI.
Doppler, CW, M-mode, and Color Imaging Controls
When a new imaging mode is selected, both the TI and the MI will change to default settings. Each mode has a corresponding pulse repetition frequency and maximum intensity point. In combined or simultaneous modes, the TI is the sum of the contribution from the modes enabled and the MI is for the focal zone and mode with the largest derated intensity. If a mode is turned off and then reselected, the system will return to the previously selected settings.
Probe
Each probe model available has unique specifications for contact area, beam shape, and center frequency. Defaults are initialized when you select a probe. Factory defaults vary with probe, application, and selected mode. Defaults have been chosen below the FDA limits for intended use.
Depth
An increase in 2D-mode depth will automatically decrease the 2D-mode frame rate. This would decrease the TI. The system may also automatically choose a deeper 2D-mode focal depth. A change of focal depth may change the MI. The MI displayed is that of the zone with the largest peak intensity.
Application
Acoustic output defaults are set when you select an application. Factory defaults vary with probe, application, and mode. Defaults have been chosen below the FDA limits for intended use.
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Chapter 1 Safety
Related Guidance Documents
For more information about ultrasonic bioeffects and related topics refer to the following:
X
AIUM Report, 28th January, 1993, “Bioeffects and Safety of Diagnostic Ultrasound”.
X
Bioeffect Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1998: 1998: Vol. 7, No. 9 Supplement.
X
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM, NEMA.
1998).
X
Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998).
X
Second Edition of the AIUM Output Display Standard Brochure, Dated 10th March, 1994. (A copy of this document is shipped with each system.)
X
Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. FDA. September 1997.
X
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA., 1998)
X
WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non-Thermal Mechanisms for Biological Effects of Ultrasound, Ultrasound in Medicine and Biology, 1998: Vol. 24, Supplement 1.
Acoustic Output and Measurement
Since the first usage of diagnostic ultrasound, the possible human biological effects (bioeffects) of ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its Bioeffects Committee (Bioeffect Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement), sometimes referred to as the Stowe Report, which reviewed available data on possible effects of ultrasound exposure. Another report, “Bioeffects and Safety of Diagnostic Ultrasound,” dated 28th January, 1993, provides more up to date information.
The acoustic output for this system has been measured and calculated in accordance with the December 1985 “510(K) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices,” except that the hydrophone meets the requirements of “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD 2-1992).
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Operation Manual
In Situ, Derated, and Water Value Intensities
All intensity parameters are measured in water. Since water does not absorb acoustic energy, these water measurements represent a worst case value. Biological tissue does absorb acoustic energy. The true value of the intensity at any point depends on the amount and type of tissue and the frequency of the ultrasound that passes through the tissue. The intensity value in the tissue, In Situ, has been estimated using the following formula:
In Situ = Water [
Where: In Situ = In Situ Intensity Value
Water = Water Value Intensity
e = 2.7183
a = Attenuation Factor
Tissue a (dB/cm-MHz)
Brain .53
Heart .66
Kidney .79
Liver .43
Muscle .55
l = skin line to measurement depth (cm)
f = Center frequency of the transducer/system/mode combination (MHz)
- (0,23 alf)
e
]
Since the ultrasonic path during an examination is likely to pass through varying lengths and types of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used for general reporting purposes. Therefore, the In Situ value which is commonly reported uses the formula:
In Situ (derated) = Water [
Since this value is not the true In Situ intensity, the term “derated” is used.
The maximum derated and the maximum water values do not always occur at the same operating condition. Therefore, the reported maximum water and derated values may not be related to the In Situ (derated) formula. For example, a multi-zone array transducer that has maximum water value intensities in its deepest zone: the same transducer may have its largest derated intensity in one if its shallowest focal zones.
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-(0,069 lf)
e
]
Chapter 1 Safety
Acoustic Output and Measurement
The terms and symbols used in the acoustic output tables are defined in the following paragraphs.
ISPTA.3 The derated spatial-peak temporal-average intensity (milliwatts per square centimeter).
ISPPA.3 The derated spatial-peak pulse-average intensity (watts per square centimeter). The value
of IPA.3 at the position of global maximum MI (IPA.3@MI) may be reported instead of ISPPA.3 if the global maximum MI is reported.
MI The Mechanical Index. The value of MI at the position of ISPPA.3, (MI@ISPPA.3) may be
reported instead of MI (global maximum value) if ISPPA.3 is 190W/cm2.
Pr. 3 The derated peak rarefactional pressure (megapascals) associated with the transmit pattern,
giving rise to the reported MI value.
WO The ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, WO
is the total time-average power; For operating conditions subject to reporting under ISPPA.3, WO is the ultrasonic power associated with the transmit pattern, giving rise to the value reported under ISPPA.3
Fc The center frequency (MHz). For MI and ISPPA.3, Fc is the center frequency associated with
the transmit pattern, giving rise to the global maximum value of the respective parameter. For ISPTA.3, for combined modes involving beam types of unequal center frequency, Fc is defined as the overall ranges of center frequencies of the respective transmit patterns.
ZSP The axial distance at which the reported parameter is measured (centimeters).
x-6,y-6 These are respectively the in-plane (azimuth) and out-of-plane (elevation) -6 dimensions in
the x-y plane where ZSP is found (centimeters).
PD The pulse duration (microseconds) associated with the transmit pattern, giving rise to the
reported value of the respective parameter.
PRF The pulse repetition frequency (Hz) associated with the transmit pattern, giving rise to the
reported value of the respective parameter.
EBD The entrance beam dimensions for the azimuth and elevation planes (centimeters).
EDS The entrance dimensions of the scan for the azimuth and elevation planes (centimeters).
1-33
Operation Manual
Acoustic Measurement Precision and Uncertainty
The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below.
Quantity Precision Total Uncertainty
PII.3 (derated pulse intensity integral) 3.2 % +21 % to -24 %
WO (acoustic power) 6.2 % +/- 19 %
Pr.3 (derated rarefaction pressure) 5.4 % +/- 15 %
Fc (center frequency) < 1 % +/- 4.5 %
Systematic Uncertainties – for the pulse intensity integral, derated rarefaction
pressure, Pr.3
Center frequency and pulse duration, the analysis includes considerations of the
eects on accuracy of:
Hydrophone calibration drift or errors.
Hydrophone / Amp frequency response.
Spatial averaging.
Alignment errors.
Voltage measurement accuracy, including:
− Oscilloscope vertical accuracy.
− Oscilloscope offset accuracy.
− Oscilloscope clock accuracy.
− Oscilloscope digitization rates.
− Noise.
The systematic uncertainties of acoustic power measurements using a radiation force are measured through the use of calibrated NIST acoustic power sources.
We also refer to a September 1993 analysis done by a working group of the IEC technical committee 87 and prepared by K. Beissner, as a first supplement to IEC publication 1161.
1-34
Chapter 1 Safety
The document includes analysis and discussion of the sources of error/measurement effects due to:
− Balance system calibration.
− Absorbing (or reflecting) target suspension mechanisms.
− Linearity of the balance system.
− Extrapolation to the moment of switching the ultrasonic transducer (compensation for ringing and thermal drift).
− Target imperfections.
− Absorbing (or reflecting) target geometry and finite target size.
− Target misalignment.
− Ultrasonic transducer misalignment.
− Water temperature.
− Ultrasonic attenuation and acoustic streaming.
− Coupling or shielding foil properties.
− Plane-wave assumption.
− Environmental influences.
− Excitation voltage measurement.
− Ultrasonic transducer temperature.
− Effects due to non-linear propagation and saturation loss.
The overall findings of the analysis give a rough Acoustic Power accuracy figure of +/-10% for the frequency range of 1 - 10 MHz.
Training
The users of this ultrasound system must familiarize themselves with the ultrasound system to optimize the performance of the device and to detect possible malfunctions. It is recommended that all users receive proper training before using the device. You can receive training on the use of the product from the Samsung Medison service department, or any of the customer support centers worldwide.
1-35
Operation Manual
Environmental Protection
CAUTION:
X
For disposing of the system or accessories that have come to the end of their lifespan, contact the vendor or follow appropriate disposal procedures.
X
You are responsible for complying with the relevant regulations for disposing of wastes.
X
The lithium ion battery used in the product must be replaced by a Samsung Medison service engineer or an authorized dealer.

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

Applicable in countries with separate collection systems
This marking on the product, accessories or literature indicates that the product and its electronic accessories (e.g. charger, headset, USB cable) should not be disposed of with other household waste at the end of their working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources.
Household users should contact either the retailer where they purchased this product, or their local government oce, for details of where and how they can take these items for environmentally safe recycling.
Business users should contact their supplier and check the terms and conditions of the purchase contract. This product and its electronic accessories should not be mixed with other commercial wastes for disposal.
1-36
Chapter 2
Introduction
Specifications ...................................................2-3
Product Configuration ....................................2-5
Monitor ........................................................................................2-7
Control Panel .............................................................................2-9
Console ......................................................................................2-14
Peripheral Devices .................................................................2-16
Probes ........................................................................................2-19
Accessories ...............................................................................2-20
Optional Functions ...............................................................2-21
Specications
Height: 1,415 – 1,760mm (with monitor)
Physical Dimensions
Imaging modes
Width: 549mm Depth: 1,002 -1,137mm Weight: 111kg (with monitor)
2D-Mode M-Mode Color Doppler Pulsed Wave (PW) Spectral Doppler Continuous Wave (CW) Doppler Tissue Doppler Imaging (TDI) Tissue Doppler Wave (TDW) Power Doppler (PD) Directional Power Doppler (DPD) Color M-Mode Anatomical M mode 3D imaging mode 4D imaging mode
Chapter 2 Introduction
Gray Scale
Focusing
Probes
(Type BF / IPX7)
Probe connections
Monitor
ECG
Rear Panel
Input / Output
Connections
256 (8 bits)
Transmit focusing, maximum of eight points (four points simultaneously selectable) Digital dynamic receive focusing (continuous)
Linear Array
L4-7, L5-13IS, L5-13/50, L7-16IS, LS6-15
Curved Array
C1-4, C2-6IC, CF4-9 (old name: C5-8), EC4-9IS, SC1-6, VR5-9
Phased Array
P2-4BA
3D
V2-6, V4-8, V5-9
CW
CW 2.0, CW 4.0, CW 6.0
5 Active Probe Ports (including pencil probe)
21.5 inch LCD monitor (LED backlight unit, LED connector) called "LCD monitor" henceforth
Type BF
Audio in / out Microphone External Trigger in / out External monitor DVI-I Network USB Foot switch
2-3
Operation Manual
Image Storage
Application
Electrical Parameters
Measurement Packages
Signal Processing
(Pre-Processing)
Signal Processing (Post-Processing)
Measurement
Auxiliary
User Interface
Pressure Limits
Humidity Limits
Temperature Limits
Maximum 12700 frames for CINE memory Maximum 8192 lines for LOOP memory Image filing system
Obstetrics, Gynecology, Urology, Abdomen, Cardiac, Vascular, Small Part, Pediatric, TCD, MSK, Contrast
100-240V~, 1100VA, 50/60Hz or 100-120/200-240V~, 1100VA, 50/60Hz
OB, Gynecology, Cardiac, Vascular, Fetal Heart, Urology, Abdomen, Small Parts, Muskuloskeletal, TCD, Pediatric Hips * Refer to Chapter 5 for additional information
TGC control Mode-independent gain control Acoustic power control (adjustable) Dynamic aperture Dynamic apodization Dynamic range control (adjustable) Image view area control M-mode sweep speed control
Frame average Edge enhancement/blurring Gamma-scale windowing Image orientation (left/right, up/down, and rotation) White on black/black on white Zoom
Trackball operation of multiple cursors 2D mode: Linear measurements and area measurements using elliptical approximation or trace M mode: Continuous readout of distance, time, and slope rate Doppler mode: Velocity and trace
USB Video Printer USB to RS-232 Serial Cable Foot Switch(IPX1) USB Flash Memory Media USB HDD Monitor
English, German, French, Spanish, Italian, Russian, Chinese
Operating: 700hPa to 1060hPa Storage: 700hPa to 1060hPa
Operating: 30% to 75% Storage & Shipping: 20% to 90%
Operating: 10°C ~ 35°C Storage & Shipping: -25°C ~ 60°C
2-4
Chapter 2 Introduction
Product Conguration
This Product consists of the monitor, the control panel, the console, the peripheral devices, and the probes.
Item Descriptions
7
8
5
1
2
3
4
6
9 0
1
2
3
4
5
6
7
8
9
0
!
@
#
$
Monitor
Monitor arm
DVD drive
Speaker
Control panel
Probe holder
Keyboard
Lift
ECG port
CW probe port
Probe port
Air filter
Brake
Wheels
$
!
#
@
[Figure 2.1 Front of the ACCUVIX A30]
2-5
Operation Manual
1
2
Item Descriptions
Handle
1
Storage compartments
2
Ventilation
3
USB and LAN ports
4
Rear panel
5
Cable holder
6
Power connection part
7
Tips!
3
4
56
7
[Figure 2.2 Back of the ACCUVIX A30]
Principles of Operation
Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a probe. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. For example, in the case of tissue, an echo is created where a signal passes from an adipose tissue region to a muscular tissue region. The echoes return to the probe where they are converted back into electrical signals.
These echo signals are highly amplified and processed by analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. All signal transmission, reception and processing characteristics are controlled by computer.
2-6
Chapter 2 Introduction

Monitor

Ultrasound images and other information are displayed on the color LCD monitor.
Screen Layout
The monitor displays ultrasound images, operation menus and a variety of other information. The screen consists mainly of 1 Title Area, 2 Preview Area, 3 Image Area, 4 Thumbnail Area, and 5 User Information.
1
4
2
3
5
[Figure 2.3 Monitor Display]
Title Area
Displays patient name, hospital name, application, frame rate and depth, probe information, acoustic output information, and date and time.
Preview Area
Displays the selected thumbnail image. EZ Exam’s menu will also appear if being used.
Image Area
Displays ultrasound images. TGC, image information, annotation, and measurement information are also displayed.
2-7
Operation Manual
Thumbnail Area
Up to five saved images are displayed. (Save by pressing the Save button.) Pressing Quad icon displays up to 16 saved images. Click a thumbnail to enlarge.
User Information Area
The user information area provides a variety of information necessary for system use. Information such as current system status, image information, selectable items, etc. are displayed.
2-8

Control Panel

The system can be controlled by using the control panel.
Chapter 2 Introduction
TGC
Patient
Probe
Report
User 1
CW/LR
3D/4D
M/x
Angle/TB
Color/Ref. Slice
PW/z
PD/y
Zoom
2D
Focus
Depth
User 2
Print
User
3
Save
Freeze
[Figure 2.4 Control Panel]
The control panel consists of a keyboard, soft menus, buttons, dials, dial-buttons, a slider, and a trackball.
The dial-button can be used both as a dial and a button.
2-9
Operation Manual
Functions of the Control Panel
The following are the descriptions and instructions for the controls on the control panel. For more information on controls with multiple functions, see Chapter 3 onwards in this manual.
On/O
Patient
Probe
SONOVIEW
Report
End Exam
2D
M / x
PD / y
PW / z
Color/Ref. Slice
3D/4D
Button
Button
Button
Button
Button
Button
Dial-button
Dial-button
Dial-button
Dial-button
Dial-button
Button
Turns the system on/o.
Displays the Patient Information screen for patient selection and information entry.
Displays the Probe screen, which allows you to select or change probes and diagnosis items.
Runs SONOVIEW - the image ling program.
Displays the Report screen that shows the measurement results of the current application and other information.
Finishes the exam of the currently selected patient and resets the related data.
Button: Press this dial-button to start 2D mode. Dial: Adjusts the 2D gain.
Button: Press this dial-button to start/stop M mode. Dial: Adjusts the M gain. Also, turning this dial-button when in 3D View, rotates the image along the x-axis.
Button: Press this dial-button to start/stop Power Doppler mode Dial: Adjusts the PW gain. Also, turning this dial-button, when in 3D View, rotates the image along the y-axis.
Button: Press this dial-button to start/stop PW Spectral Doppler mode. Dial: Adjusts the PD gain. Also, turning this dial-button, when in 3D View, rotates the image along the z-axis.
Button: Press this dial-button to start/stop Color Doppler mode. Dial: Adjusts the C gain. Moves the reference slice horizontally in the 3D View.
Starts or ends 3D/4D mode.
2-10
CW/LR
Angle / TB
Depth
Focus
Dial-button
Dial-button
Dial-button
Dial-button
Button: Press this dial-button to start/stop CW Spectral Doppler mode. Dial: Adjusts the CW gain. Adjusts left and right margins of ROI in 3D View­MPR. LR is an abbreviation for “Left-Right”.
Button: Adjusts the angle of the sample volume in Spectral Doppler mode. It is also used to adjust the body marker’s probe cursor or indicator angle. Dial: Adjusts top and bottom margins of ROI in 3D View-MPR. TB is an abbreviation for “ Top-B ottom”.
Adjusts the scanning depth of the image.
Changes location and number of focus on the target location you wish to study.
Chapter 2 Introduction
Zoom
Q Scan
Freeze
Save
Print
User 1
User 2-3
Set / Exit
Pointer
Clear
Dial-button
Button
Button
Button
Button
Button
Dial-button
Button
Button
Button
You can magnify an image.
Press this button to turn the Quick Scan function on. The “Q Scan’’ mark will appear at the top of an image. It can be used only in specic applications with specic probes.
Pauses/resumes scanning.
Saves an image or a report displayed on the screen in the system database.
Prints an image on the screen using the printer connected to the system.
This button is used to perform special functions that you have preset. The function of each button can be set in Utility > Setup > User Dened Key.
This button is used to perform special functions that you have preset. The function of each button can be set in Utility > Setup > User Dened Key.
This button is used to perform special functions that you have preset. The function of each button can be set in Utility > Setup > User Dened Key. Set: Select an item or value using the trackball. Used to also change the function of the trackball. Exit: Exits the currently used function and returns to the previous function.
When this is pressed, an arrow marker appears to point to parts of the displayed image.
Deletes text, indicator, body marker, and measurement result, etc. displayed on an image.
Change
Calculator
Caliper
Trackball
TGC
Button
Button
Button
Trackball
Slider
This is used to change the current trackball function.
Starts to take measurements of each diagnosis item.
Starts to measure distance, circumference, area, and volume.
Moves the cursor on the screen. Also scrolls through CINE images.
Adjusts TGC values for each depth using 8 settings. TGC stands for Time Gain Compensation.
CAUTION: Too great a difference in the gain value settings of adjacent TGC sliders may cause stripes in an image.
2-11
Operation Manual
Keyboard
The keyboard is used to type in text.
[Figure 2.5 Keyboard]
Touch-Screen
The touch screen is an operating tool that can be touched by the user to input data. The functions that are available in the current mode are shown in the form of buttons or a dial-button.
Touch Screen Layout
1 Information Area: Shows the title of the touch screen currently displayed.
2 Tab Area: Shows diagnostic modes and utilities under dierent tabs. The touch screen can be
changed by pressing one of the tabs.
3 Menu Area: The menu items that are available in the current input mode are shown in the form
of buttons. The user can access the desired menu item by pressing the corresponding button. The menu currently in use is shown in orange.
4 Soft Menu Area: The soft menu items that are available in the current input mode are shown on
screen. The menus in use are shown with orange borders. Press or rotate the dial-buttons right below each menu.
Tips!
When there are two Soft Menus
When there are two menus available – upper and lower, both menus can be adjusted with the corresponding dial-button. Press a desired menu button on the touch screen and then use the dial-button.
2-12
1
Chapter 2 Introduction
2
3
4
[Figure 2.6 Touch Screen]
Adjusting the Control Panel
CAUTION:
X
Do not apply excessive force to the control panel.
X
Use the handle at the back of the product when moving it.
Adjusting to the right and left
Hold the control panel handle and move it carefully to the right or left.
Adjusting the height
Press the lever on the control panel handle and move it carefully up or down.
2-13
Operation Manual
275-K-B107A
SOUND R
SOUND L
DVI R.G.B
⌂ᮥᩕḡษᝎ᜽᪅
Do not remove the cap. Abdeckung nicht entfernen.
Ne pas retirer le cache.
Не снимайте крышку.
ЉՈЈܔ澞
䜻䝱䝑䝥䜢ྲྀ䜚እ䛥䛺䛔䛷䛟䛰䛥䛔䚹
TRIG
WARNING

Console

The console consists of two parts – the inner and outer units. The interior of the console mainly contains devices that produce ultrasound images. On the exterior of the console are various connectors, probe holders, storage compartments, handles, and wheels, etc.
Rear Panel
A monitor and other peripheral devices are connected via the rear panel at the back of the system.
Item Descriptions
1
Audio port (Output): Used to output audio signals.
2
Microphone port (Input): Connect a microphone to this port.
3
1
2
4
[Figure 2.7 Rear Panel]
NOTE: Connecting the Full HD wide monitor is recommended if you use the DVI port and connector. If you connect an RGB monitor, it might not display properly.
3
Trig port (In/Out): Not used.
4
DVI port (Output): Outputs digital signals to the monitor.
2-14
Power Connection Part
The power connection part is located at the bottom on the rear panel.
Chapter 2 Introduction
1
3
2
[Figure 2.8 Power Connection Part]
1 Power switch: Supplies or blocks power to the entire system.
2
Power Inlet: For the power cable to connect to external power.
3 Power Outlet (Input): The part to which power is provided from the internal power device of the
product.
Probe Holders
Probe holders are mounted at the left and right-hand sides of the control panel.
2-15
Operation Manual

Peripheral Devices

CAUTION: Do not place peripheral devices, not listed in this manual, inside the patient
environment. If you place them in the patient environment, it may cause electrical hazard.
N
N N
N
[Figure 2.9 Patient Environment]
NOTE: Refer to the operation manual of the peripheral device for its operating information.
Internal Peripheral Devices
These are peripheral devices mounted in the system.
DVD-Multi
DVD-RW, DVD+RW, DVD-R, DVD+R, CD-R, CD-RW, CD-ROM
Hard Disc Drive
At least 500 GB
2-16
Chapter 2 Introduction
External Peripheral Devices
These are peripheral devices that can be connected for use when needed and are connected via the USB port located at the rear panel.
CAUTION: When using a peripheral device via a USB port, always turn the power off before connecting/disconnecting the device. Connection/disconnection of USB devices during power-on may lead to malfunction of the system and the USB devices.
NOTE:
X
When removing the removable disk, use Utility > Storage manager.
USB ports are located both on the front panel and the rear panel of the console.
We recommend that you connect USB storage devices (flash memory media, etc.) to the ports on the front panel and other USB peripheral devices to the rear panel for convenience.
The following products are recommended:
USB video printer
X
Black and White: Mitsubishi P-95DE, Sony UP-D897
X
Color: Mitsubishi CP-30DW, Sony UP-D25MD
CAUTION:
X
You must install a Microsoft Windows XP™ or above compatible printer and driver. Contact Samsung Medison customer service department for inquiries about printer driver installation.
X
When connecting the printer, ensure that the printer is configured under Microsoft Windows™ or system setup and has been chosen as the default printer.
X
Please check the port that the printer uses before connecting. Printers should be connected to the printer port while the USB printer should be connected to the USB port.
USB to RS-232C Serial Cable
USB to Serial (RS-232C) Converter with FTDI Chipset (FTDI FT232BM Compatible)
NOTE: For more information about the Open Line Transfer, refer to 'Chapter 5. Measurements and Calculations'.
2-17
Operation Manual
Foot Switch
To configure the foot switch function, go to Utility > Setup > Peripherals > Foot Switch. Select from Freeze, Update, Record, Print1, Save, Store Clip, and Volume Start, or EZ Exam.
WARNING: Foot Switch cannot be used in the operating room.
Misc.
Flash Memory Media
NOTE:
X
The system cannot recognize USB 1.1 flash memory. Remove the flash memory from the console and equip again with an appropriate device.
X
Regarding file formats that are not ordinarily saved: Please check first to see if it is possible to save the file format on a desktop PC before trying to save the file on flash memory.
2-18
Chapter 2 Introduction

Probes

Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation.
NOTE: For detailed information, refer to ‘Chapter 9. Probes’.
Connecting probes
Be sure to connect or disconnect probes when the power is off to ensure the safety of the system and the probes.
1. Connect probes to the probe connectors on the front panel of the system. A maximum of ve probes including the CW probe can be connected at one time. The CW probe should only be connected to its own connector.
2. To install, turn the connector turning handle clockwise.
[Figure 2.10 Probe Connector]
2-19
Operation Manual

Accessories

An accessory box containing the items below is supplied with the product.
CAUTION: Main cord set, separately certified according to the relevant standards, is to be used when supplied to EU and USA/CAN.
NOTE: Accessories can be different according to the country.
FUSE
POWER CORD
SONO GEL
GROUND CABLE
MANUAL
DVI2RGB GENDER
WINDOWS XP LABEL
[Figure 2.11 Accessories]
2-20

Optional Functions

This product has the following optional functions:
Chapter 2 Introduction
4D 3D XI CW Function Cardiac Measurement DICOM Spatial Compound XI STIC Auto IMT
ElastoScan Panoramic 3DMXI Upgrade HDVI VolumeNT ADVR ECI FRV
For further information about optional functions, please refer to the relevant chapters in this manual.
2-21
Chapter 3
Starting Diagnosis
Power Supply ....................................................3-3
Powering On .............................................................................. 3-3
Powering Off .............................................................................3-3
Probes & Applications .....................................3-4
Probe and Application Selection ....................................... 3-5
Probe Userset Management ...............................................3-6
Patient Information .........................................3-9
Patient Information Entry ...................................................3-11
Changing Measurements ...................................................3-22
Work list Search ......................................................................3-25
Searching for Patient Information...................................3-26
Restarting the Exam .............................................................3-34
Chapter 3 Starting Diagnosis
Power Supply
Boot up the system for use.
CAUTION: Make sure to connect the probes and peripheral devices that will be used before powering on the system. If you attempt to connect them during system use, it may lead to patient injury or irreparable damage to the console.

Powering On

Press the On/O button when the power is off. Booting begins, and the product logo appears on the screen. When booting is completed, the 2D mode screen appears in End Exam status.
CAUTION: Before starting the diagnosis, you must register the patient information.
NOTE:
X
The product should turn on about 10 seconds after the power switch at the back of the product is turned on.
X
During system booting, do not press any key on the keyboard. It may cause product malfunction.
X
If you turn on the power after turning it off suddenly, the system may turn on and off momentarily. This is one of the characteristics of the Intel® PC main board, not a system error.
Powering O
Press the On/O button while using the system to initiate shutdown.
CAUTION: Pressing the On/O button for longer than five seconds will immediately turn the
power off and result in damage to the hard disk. Please refrain from such use unless there is a serious emergency.
3-3
Operation Manual
Probes & Applications
Before scanning, select a probe, an application and a Preset/Userset.
Press the Probe button on the control panel and the Probe screen will be displayed on the touch screen. From this screen, you can select or change the probe, application, Preset or Userset.
Press the Probe button again or the Exit button to exit from the Probe screen without applying the changes.
CAUTION: Refer to ‘Chapter 9. Probes’ for more information on probes and applications and the Preset/Userset supported by the system.
Probe Screen
The Probe screen consists of the following items:
1 2
3
[Figure 3.1 Probe – Touch Screen]
X
Probe tab (1): Displays a list of probes currently connected to the system.
X
Application group: Displays a list of applications (2) and their presets that the selected probe supports(3).
4
3-4
X
Userset group (4): Displays a list of settings you can configure according to your preferences.
Chapter 3 Starting Diagnosis

Probe and Application Selection

Select Probe Application Probe Preset/Userset. Tapping the Preset/Userset loads the settings and initiates the diagnosis mode. The selected probe and settings are shown in the title area of the monitor. The selected probe and Preset/Userset are displayed in yellow on the Probe screen.
Changing Pages
Use the Page Index dial-button to change the touch screen page.
3-5
Operation Manual

Probe Userset Management

Adding a Probe Userset
The application and settings currently in use are added to the Userset.
1. Tap ‘+’ in the Userset group on the touch screen. The Name window is then shown on the touch screen.
2. Enter the name you want to use and tap Ok. Click Cancel to cancel.
3. Userset and the application name are added to Userset group.
Tips!
Userset Group Name
The application name of the Userset which is added to the Userset list first time is entered as the name of Userset group. Go to Edit > Rename > Application to edit the name of Userset group.
Changing the Position of the Group
You can change the position of the application group or Userset group currently in use.
1. Tap Edit on the touch screen.
2. Rotate the App Name dial-button to change the position.
3. Tap Edit again to conrm the new position.
Overwriting a Userset
You can save the current probe settings to the selected Userset.
1. Tap Edit on the touch screen.
2. Tap Overwrite on the touch screen. The conrmation message ‘Save Success’ will be displayed on the monitor.
3. Tap Edit again to conrm the overwritten value.
3-6
Chapter 3 Starting Diagnosis
Renaming a Userset
NOTE: You cannot edit or delete the Userset name currently in use.
1. Tap Edit on the touch screen.
2. Use the Rename dial-button to select the Userset to rename. Select Application or Preset.
3. Tap the dial-button to display the Rename window on the touch screen.
X Application: The Application Rename window will be displayed. Change a Userset group name
using this screen.
X Preset: The Rename window will be displayed. Change a Userset name using this screen. You
cannot change an application shown with the Userset name.
4. Change the name and tap Ok. Click Cancel to cancel.
5. Tap Edit again to conrm the change.
Deleting a Userset
NOTE: You cannot edit or delete the Userset currently in use.
1. Tap Edit on the touch screen.
2. Select a userset and tap Delete on the touch screen.
3. Tap Edit again to conrm the change.
3-7
Operation Manual
Exporting/Importing a Userset
NOTE: The Userset Manager button is only active when a USB flash memory device is being used.
You can export and import Usersets to and from external storage media.
1. Tap Edit on the touch screen.
2. Select a Userset and tap Userset Manager on the touch screen. The Userset Export/Import window is then shown on the monitor.
3. To save the Userset on USB ash memory, tap the Export button. To copy a userset from USB ash memory to the system, tap the Import button. Tap Close on the screen.
4. Tap Edit again to conrm the change.
3-8
[Figure 3.2 Userset Export / Import]
Chapter 3 Starting Diagnosis
Patient Information
Press the Patient button on the control panel and the Patient Information screen will appear. In this screen, you can enter, search, or change patient information.
NOTE: The ID and name fields are required.
Once you have entered the patient information, tap on the OK button on the monitor or the touch screen to exit. Press Cancel to cancel. Alternatively, you can press the control panel’s Patient button once more or the Exit button.
Patient Information Screen
The Patient Information screen consists of two sections.
1 Page Tab: Pages related to patient information entry are shown as tabs.
2 Study Information Tab: Depending on the selected menu option, the patient information entry or
management screen is shown.
1
2
[Figure 3.3 Patient Information]
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Operation Manual
Use the trackball and the Set button to select the desired field. Press a button on the touch screen to enter information using the touch screen.
Press OK on the screen to save the information and exit. Press Cancel or Exit on the touch screen to cancel.
[Figure 3.4 Patient Information – Touch Screen]
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Chapter 3 Starting Diagnosis

Patient Information Entry

From the Patient Information screen, tap on the Patient tab. Alternatively, use the touch screen’s Page dial-button to select Patient.
1
2
[Figure 3.5 Patient Information]
The Patient Information Entry screen has the following layout:
1 Basic Patient Information: Enter or edit ID, name, age, gender, and other types of basic patient
information.
2 Application Information: Add or edit required information for individual applications. To select an
application, select the corresponding tab or use the touch screen’s Category dial-button.
Clear Measurements
Clears all measured values previously entered.
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Operation Manual
Basic Patient Information Entry
ID
Enter a patient ID.
X
To enter it manually, enter an ID in the ID eld.
X
To enter it automatically, select Auto ID Creation and click New. The icon, next to the ID eld, is changed to .
X
If you enter an ID that already exists, the icon, next to the ID eld, is changed to .
Name
Enter the patient’s full name. The name that you have entered will appear in the title area and reports.
X
Last Name: Enter the patient’s last name.
X
First Name: Enter the patient’s first name.
X
Middle: Enter the patient’s middle names if they have any.
Ez Exam Setup
Ez Exam Setup allows you to specify exam items and their order.
NOTE: For more information on Ez Exam Setup, refer to ‘Chapter 7. Utilities’.
Accession
When viewing the work list for a patient via the DICOM server, this information is automatically displayed in the appropriate fields.
Representation
Specify how the names of Asian patients, including Korean, Chinese and Japanese are displayed.
X
Roman: Type in Roman letters.
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X
Ideographic: Type in ideographic letters.
Chapter 3 Starting Diagnosis
X
Phonetic: Type in phonetic letters.
NOTE:
X
This button appears on the screen only in a product that supports Asian patient names.
X
For information on specifying the order or way in which names are displayed, refer to ‘Screen Display Settings’ in ‘Chapter 7. Utilities’.
Birth
Enter the patient’s birth date in the specified format.
Age
Enter the patient’s age in “yy-mm” format. When a birth date is specified in the Birth field, this information is automatically calculated and displayed.
Gender
Select the patient’s gender.
General
Enter additional information. Information entered in General is applied to all application information entry screens.
Height
Enter the patient’s height. Height can be specified in inches (in.) or centimeters (cm). Tap on the Unit button to change units. When the unit is changed, the entered number is automatically recalculated and displayed in the new unit of measurement.
Weight
Enter the patient’s weight. Supported units are ounces (oz), pounds (lb), and kilograms (Kg). Press the corresponding unit button to change the unit of measurement.
BSA
When the height and weight are entered, the BSA (Body Surface Area) is automatically calculated and displayed.
HR
Enter a heart rate.
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Operation Manual
Diag. Physician
Enter the name of the physician who diagnosed the patient. When there is more than one physician involved, you can use the Combo button to make a selection.
Tips!
Typing in Korean, Japanese or Chinese
Diag. Physician, Ref. - The Physician, Sonographer, Description and Indication can be entered in Korean, Japanese or Chinese. Choose the desired language by using the Language button on the touch screen.
Korean: Entry in Korean.
X
Alpha: Entry in English.
X
Ref. Physician
Enter the name of the referring physician. When there is more than one sonographer involved, you can use the Combo button to make a selection.
Sonographer
Enter the name of the sonographer who scanned the patient. When there is more than one sonographer involved, you can use the Combo button to make a selection.
Description
Enter a description of the diagnosis. If a description is entered, it can be searched for and viewed under Description in SONOVIEW.
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[Figure 3.6 General Information]
Chapter 3 Starting Diagnosis
OB
Enter the obstetrical information.
LMP (Last Menstrual Period)
Enter the last menstrual period for a patient. You can enter it manually or have it automatically calculated and displayed with the GA entered.
Ovul. Date
Enter the expected ovulation date. LMP, GA, and EDD will be automatically calculated and displayed.
Tips!
Calculating LMP and EDD (LMP) with Ovul. Date
The following formulae are used:
LMP = Ovul. Date - 14
X
EDD = (280 -14) + Ovul. Date
X
NOTE: Values that have been calculated and entered cannot be changed.
GA (LMP)
Indicates the gestational age of a patient. You can enter it manually or have it automatically calculated and displayed with the LMP entered.
EDD (LMP)
With the LMP or GA entered, EDD (expected date of delivery) is calculated and displayed.
Tips!
Calculating EDD (LMP)
EDD can be calculated by entering LMP or GA.
When LMP is entered: GA and EDD are automatically calculated and displayed on the screen.
X
When GA is entered: LMP and EDD are automatically calculated and displayed on the screen.
X
Estab. Due Date
Enter the expected delivery date in the prescribed format. Once the expected delivery date is entered, LMP, GA (LMP), and EDD (LMP) are automatically calculated and displayed.
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Operation Manual
Number of Fetuses
Enter the number of fetuses. Up to four may be entered.
Day of Cycle
Enter a menstrual period in number of days (dd).
Ectopic
Enter the number of ectopic pregnancies.
Gravida
Enter the number of pregnancies.
Aborta
Enter the number of miscarriages.
Para
Enter the number of deliveries.
New Pregnancy
Deletes the patient’s existing OB information.
[Figure 3.7 OB Information]
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Gynecology
Enter the gynecological information.
NOTE:
X
In the GYN information input screen, even if the Ovul. Date is entered, LMP and EDD will not be calculated automatically.
X
For other gynecological information, refer to the OB section.
Chapter 3 Starting Diagnosis
[Figure 3.8 Gynecology Information]
Adult Echo
Enter cardiologic information.
BP
Enter systolic/diastolic pressure (blood pressure).
Additional Information
Select the applicable check boxes.
Smoker Hypertension
Diabetes Hyperlipidemia
Family History Surgery History
Murmur Heart Failure
Coronary Heart Disease Angina
Myocardial Infarction Jugular Venous Distension
Dyspnea Syncope
Arrhythmia Rheumatic Heart Disease
Congenital Heart Disease Heart Valve Disease
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Operation Manual
BP
Enter systolic/diastolic pressure (blood pressure).
[Figure 3.9 Adult Echo Information]
Ped. Echo
Enter pediatric cardiac information.
Additional Information
Select the applicable check boxes.
Murmur Dyspnea
Palpitation Fever
Cyanosis Paroxysm
Fainting Chest Pain
Cardiomegaly Dextrocardia
Pacemaker Family History
VSD (Ventricular Septal Defect) ASD (Atrial Septal Defect)
PDA (Patent Ductus Arteriosus) COA (Coarctation of the Aorta)
TOF (Tetralogy of Fallot) PS (Pulmonic Stenosis)
AS (Aortic Stenosis) TGA (Transposition of the Great Arteries)
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[Figure 3.10 Pediatric Echo Information]
Chapter 3 Starting Diagnosis
Fetal Heart
Enter additional information about the fetal heart. Information that can be entered in this section is identical to the information in the cardiac section.
[Figure 3.11 Fetal Heart Information]
Vascular
Enter vascular information.
Additional Information
Select the applicable check boxes.
Smoker Hypertension
Diabetes Hyperlipidemia
Family History Surgery History
Dizziness Headache
Migraine Stroke
Peripheral Neuropathy
[Figure 3.12 Vascular Information]
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Operation Manual
TCD
Enter additional information for Transcranial Doppler (TCD).
Additional Information
Select the applicable check boxes.
Smoker Hypertension
Diabetes Family History
Dizziness Vertigo
Migraine Headache
Diplopia Dysarthria
Dysphagia Tinnitus
Stroke Peripheral Neuropathy
TIA Numbness
Paralysis
[Figure 3.13 TCD Information]
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Urology
Enter urological information.
PSA
Enter the Prostate Specific Antigen (PSA) value.
[Figure 3.14 Urology Information]
Chapter 3 Starting Diagnosis
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Operation Manual

Changing Measurements

From the Patient Information Entry screen, tap on the Measure Data button.
NOTE: Appears only when a patient ID has been selected.
Insert Measurement Data Screen
Tap on the Insert Measurement Data tab. You can enter the existing obstetrical measurements.
[Figure 3.15 Insert Measurement Data]
Exam Date
Enter the measurement date.
Fetus
If there are multiple fetuses, identify each one. Up to four fetuses (A, B, C, D) can be specified.
Exam No.
Up to eight exam numbers can be entered for each date. The Exam number is displayed at the bottom of the screen.
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Chapter 3 Starting Diagnosis
New Data
Cancel all measurement data entered for all exams and enter new measurement data.
Clear
Cancel entering the measurement data.
Insert
Complete entering the measurement data.
Page Browse
Use the [>>] or [<<] button.
Study Information
Loads application-specific Patient Information screen.
View Measurement Data Screen
Tap on the View Measurement Data tab. Measured values can be viewed on the screen or saved in an Excel file. The * symbol next to the Date indicates that the data is the current measurement data.
[Figure 3.16 View Measurement Data]
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Operation Manual
Package
Select a measurement package to display on the screen.
Refresh
Update the measurement data. Newly calculated measurements, or the measurements entered, are added.
Save
The Save To Excel window appears, allowing you to save information on the screen in an Excel file.
1. Designate the path.
X To create a folder, select Create.
X To delete a folder, select Delete.
2. Enter the le name. By default, the Excel le name is set to the measurement ID.
3. Select Save to nish. Press Close to cancel.
NOTE: Checking the HTML checkbox saves information as an HTML file instead of an Excel file.
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[Figure 3.17 Save to Excel]
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