Samsung Medison Diagnostic Ultrasound System

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SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

Volume 1
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SAMSUNG MEDISON
DIAGNOSTIC ULTRASOUND SYSTEM

Version 1.04

English

MI68-03116A
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PROPRIETRAY INFORMATION AND SOFTWARE
LICENSE
The Customer shall keep confidential all proprietary information furnished or disclosed to the
Customer by Samsung Medison, unless such information has become part of the public domain
through no fault of the Customer. The Customer shall not use such proprietary information,
without the prior written consent of Samsung Medison, for any purpose other than the
maintenance, repair or operation of the goods.

Samsung Medison’s systems contain Samsung Medison’s proprietary software in machine-


readable form. Samsung Medison retains all its rights, title and interest in the software except
that purchase of this product includes a license to use the machine-readable software contained
in it. The Customer shall not copy, trace, disassemble or modify the software. Transfer of this
product by the Customer shall constitute a transfer of this license that shall not be otherwise
transferable. Upon cancellation or termination of this contract or return of the goods for reasons
other than repair or modification, the Customer shall return to Samsung Medison all such
proprietary information.
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Safety Requirements

■ Classification:
– Type of protection against electrical shock: Class I

– Degree of protection against electrical shock (Patient connection): Type BF equipment

– Degree of protection against harmful ingress of water: Ordinary equipment

– Degree of safety of application in the presence of a flammable anesthetic material with air
or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide.

– Mode of operation: Continuous operation

■ Electromechanical safety standards met:


– Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and
Essential Performance [IEC 60601-1:2005/A1:2012]

– Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and
Essential Performance- Collateral Standard: Electromagnetic Compatibility -
Requirements and Tests [IEC 60601-1-2:2007]

– Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and
Essential Performance- Collateral Standard: Usability [IEC 60601-1-6:2010]

– Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and
Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC
60601-2-37:2007]

– Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-
1:1988 with A1:1991 and A2:1995]

– Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral
Standard: safety Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]

– Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001,
A1:2004]

– Medical Electrical Equipment, Part 1-4 : General Requirements for Safety - Collateral
Standard: Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999]

– Medical Electrical Equipment, Part 2-37: Particular Requirements for Safety - Ultrasonic
Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37: 2001 with A1:2004,
A2:2005]

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


– Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-
1:2003]

– Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and
Essential Performance [CAN/CSA-C22.2 No. 60601-1:14]

– Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and
Essential Performance [ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND
A2:2010(R)2012]

– Biological Evaluation of Medical Devices, Part 1:Evaluation and Testing within a risk
management process [ISO 10993-1:2009]

– Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment [IEC 61157:2007]

■ Declarations:

CSA mark with the indicators “C” and “US” means that the
product is certified for both the U.S. and Canadian markets, to
the applicable U.S. and Canadian standards.

This is manufacturer’s declaration of product compliance with


applicable EEC directive(s) and the European notified body.

This is manufacturer’s declaration of product compliance with


applicable EEC directive(s).

This is the GMP symbol for Korean Good Manufacturing


Practice quality system regulation.
Precautions for Use
Before attempting to use the product, be sure to read this manual thoroughly to familiarize
yourself with the operation of the product and the relevant safety information.

■ Keep this manual near the product and refer to it when using the product.
■ Please familiarize yourself with the safety precautions in 'Chapter 1. Safety' and 'Chapter 7.
Maintenance’ in particular.

■ This user manual does not contain clinical opinions or diagnoses. Also, please consult the
reference for each study area before evaluating the measurement result of an application.

■ This product is an ultrasound diagnostic system, and cannot be used on your personal
computer. If you use this product in such an environment, we cannot be held responsible for
any resulting problems.

■ This product must be used by a person who possesses clinical pathology training and/or
certification; use by unqualified persons is prohibited.

■ The manufacturer is not responsible for any damage to this product caused by user
carelessness and/or neglect.

■ Please note that orders are based on the individually agreed specifications and may not
contain all features listed in the user manual.

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

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

■ The figures in the user manual for illustrational purposes only and may be different from what
you see on the screen or device.

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

■ Products that are not manufactured by Samsung Medison are indicated with the trademarks
of their respective owners.

■ The following terms are used to highlight safety precautions that the user must be aware of:
Disregarding this instruction may result in death, serious injury, or other
DANGER dangerous situations.

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

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

The accompanying information covers installation, operation, and maintenance


NOTE procedures that require careful attention from the user, but have little chance
of leading directly to a dangerous situation.
Revision History

VERSION DATE NOTE

v1.04.02-00 2014.11.20 Initial Release

System Upgrades and Manual Set Updates


Samsung Medison Ultrasound is committed to innovation and continued improvement.
Upgrades may be announced that consist of hardware or software improvements. Updated
manuals will accompany those system upgrades.

Verify that Check if this version of the manual is correct for the system version. If not, please
contact the Customer Service Department.

If You Need Assistance


If you need any assistance with the equipment, like the service manual, please contact the
Samsung Medison Customer Service Department or one of their worldwide customer service
representatives, immediately.
Revision History

VERSION DATE NOTE

v1.04.02-00 2014.11.20 Initial Release

System Upgrades and Manual Set Updates


Samsung Medison Ultrasound is committed to innovation and continued improvement.
Upgrades may be announced that consist of hardware or software improvements. Updated
manuals will accompany those system upgrades.

Verify that Check if this version of the manual is correct for the system version. If not, please
contact the Customer Service Department.

If You Need Assistance


If you need any assistance with the equipment, like the service manual, please contact the
Samsung Medison Customer Service Department or one of their worldwide customer service
representatives, immediately.
Table of Contents 1

Table of Contents – Volume 1

Chapter 1 – Safety
Purpose of Use .............................................................................................................................3
Contraindications ......................................................................................................................3
Safety Signs ..................................................................................................................................4
Safety Symbols .........................................................................................................................4
Symbols ....................................................................................................................................7
Labels .......................................................................................................................................7
Electrical Safety ...........................................................................................................................8
Prevention of Electric Shock .....................................................................................................8
ECG-Related Information .......................................................................................................10
ESD......................................................................................................................................... 11
EMI.......................................................................................................................................... 11
EMC ........................................................................................................................................12
Mechanical Safety ......................................................................................................................19
Moving the Equipment ............................................................................................................19
Safety Note .............................................................................................................................20
Biological Safety ........................................................................................................................21
ALARA Principle .....................................................................................................................21
Environmental Protection .........................................................................................................35
Correct Disposal of This Product ............................................................................................35

Chapter 2 – Introduction and Installation


Introduction ..................................................................................................................................3
And Installation ............................................................................................................................3
What is SONOACE X6?................................................................................................................3
Features and Advantages of SONOACE X6 ............................................................................3
Specifications ...............................................................................................................................4
Product Configuration and Installation .....................................................................................7
Monitor ......................................................................................................................................7
Control Panel ..........................................................................................................................10
Console ...................................................................................................................................16
Peripheral Devices..................................................................................................................19
2 SONOACE X6 User Manual

Probe ...................................................................................................................................... 22
Accessory ............................................................................................................................... 23
Options ................................................................................................................................... 23

Chapter 3 – Setting
Selecting Probe / Application ..................................................................................................... 3
Probe /Application Selection .................................................................................................... 3
Application Change .................................................................................................................. 4
Probe Setting Change .............................................................................................................. 4
Editing Bodymarker .................................................................................................................. 5
Calc Sequence ......................................................................................................................... 7
Entering Patient Data .................................................................................................................. 8
Registering a New Patient........................................................................................................ 8
Finding Patient Information ...................................................................................................... 9
Modifying Patient Information................................................................................................. 11
Setting System ........................................................................................................................... 12
General................................................................................................................................... 12
Display .................................................................................................................................... 15
Misc. ....................................................................................................................................... 17
Setting Measurements .............................................................................................................. 19
General................................................................................................................................... 19
Obstetrics Measurement Setup.............................................................................................. 24
Fetal Echo Measurement Setup ............................................................................................. 28
Cardiac Measurement Setup ................................................................................................. 29
Urology Measurement Setup ................................................................................................. 30
Vascular Measurement Setup ................................................................................................ 31
Setting DICOM (Optional) ......................................................................................................... 32
Setting DICOM Information .................................................................................................... 32
Network Setup ........................................................................................................................ 33
Adding or Changing the DICOM Server ................................................................................. 33
Editing the DICOM Server Information................................................................................... 39
Deleting DICOM Server ......................................................................................................... 39
Testing DICOM Server ........................................................................................................... 39
DICOM Log ............................................................................................................................ 39
Setting Option ............................................................................................................................ 41
Table of Contents 3

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


Information .................................................................................................................................43
Utilities ........................................................................................................................................44
Biopsy .....................................................................................................................................44
ECG ........................................................................................................................................46
Monitor Calibration..................................................................................................................48
Preset......................................................................................................................................48
Miscellaneous .........................................................................................................................49

Chapter 4 – Diagnosis modes


Diagnosis Mode Types and Control ...........................................................................................3
Diagnosis Mode Types .............................................................................................................3
Basic Use ..................................................................................................................................4
Basic Modes .................................................................................................................................8
2D Mode ...................................................................................................................................8
M Mode ...................................................................................................................................12
Color Doppler Mode................................................................................................................14
Power Doppler Mode ..............................................................................................................18
Spectral Doppler Mode ...........................................................................................................20
Combined Modes .......................................................................................................................26
2D/C/PW Mode .......................................................................................................................26
2D/PD/PW Mode ....................................................................................................................27
2D/C/CW Mode .......................................................................................................................28
2D/PD/CW Mode ....................................................................................................................29
2D/C/M Mode ..........................................................................................................................30
Multi-Image Mode .......................................................................................................................31
Dual-2D Mode .........................................................................................................................31
Dual-2D/C Mode .....................................................................................................................32
Dual-2D/PD Mode...................................................................................................................33
3D Mode ......................................................................................................................................34
3D ...........................................................................................................................................34
Acquiring a 3D Image .............................................................................................................35
3D View...................................................................................................................................36
4 SONOACE X6 User Manual

Chapter 5 – Measurements and Calculations


Measurement Accuracy .............................................................................................................. 3
Causes of Measurement Errors ............................................................................................... 3
Optimization of Measurement Accuracy .................................................................................. 5
Measurement Accuracy Table .................................................................................................. 7
Basic Measurements ................................................................................................................... 9
Distance Measurement .......................................................................................................... 11
Circumference and Area Measurement ................................................................................. 17
Volume Measurement ............................................................................................................ 19
Calculations by Application ..................................................................................................... 21
Things to note......................................................................................................................... 21
Common Measurement Methods ........................................................................................... 23
OB Calculations...................................................................................................................... 28
GYN Calculations ................................................................................................................... 35
Cardiac Calculations .............................................................................................................. 37
Vascular Calculations ............................................................................................................. 49
Urology Calculations .............................................................................................................. 52
Fetal Echo Calculations.......................................................................................................... 57
Report ......................................................................................................................................... 62
Viewing Report ....................................................................................................................... 63
Editing Report......................................................................................................................... 63
Comment ................................................................................................................................ 63
Printing out Report ................................................................................................................. 63
Exporting Report .................................................................................................................... 63
Graph Function....................................................................................................................... 65

** Reference Manual
Samsung Medison is providing an additional SONOACE X6 Reference Manual. GA tables and
references for each application are included in the Reference Manual.
Chapter 1

Safety
Purpose of Use ............................................................................................................. 3
Contraindications ...................................................................................................................... 3

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


Safety Symbols ......................................................................................................................... 4
Symbols .................................................................................................................................... 7
Labels ....................................................................................................................................... 7

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


Prevention of Electric Shock ..................................................................................................... 8
ECG-Related Information ....................................................................................................... 10
ESD ......................................................................................................................................... 11
EMI .......................................................................................................................................... 11
EMC ........................................................................................................................................ 12

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


Moving the Equipment ............................................................................................................ 19
Safety Note ............................................................................................................................. 20

Biological Safety......................................................................................................... 21
ALARA Principle ..................................................................................................................... 21

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


Correct Disposal of This Product ............................................................................................ 35
1 - 3 SONOACE X6 User manual

Purpose of Use

The SONOACE X6 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

For detailed information on applications and presets, please refer to ‘Chapter


NOTE 2. Introduction’ and ‘Chapter 8. Probes’ in this user manual

Contraindications
This product must not be used for ophthalmological applications, or any other use that involves
the ultrasound beam passing through the eyeball.

 Federal law restricts this device to sale by or on the order of a physician.


CAUTION  The method of application or use of the device is described in the manual
'Chapter 3. Setting' and 'Chapter 4. Diagnosis Modes'.
1 - 4 SONOACE X6 User manual

Safety Signs

Please read this chapter before using the ultrasound system. It is relevant to the ultrasound
system, the probes, the recording devices, and any of the optional equipment.

SONOACE X6 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 Electro Technical 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

WARNING: The accompanying information must be followed to prevent


serious accidents and/or damage to property.

CAUTION: The accompanying information helps to prevent minor


accidents and/or damage to property.

Refer to the user manual.

Follow the user manual.

CAUTION: Risk of electric shock

Type BF applied part (Classification based on degree of protection against


electric hazard)

Defibrillation-proof type CF applied part (Classification based on degree of


protection against electric hazard)

Power on/off

Power on
Chapter 1. Safety 1 - 5

Symbols Description

Power off

Power ON for part of the product

Power Off for part of the product

V~ Alternating current voltage source

(Direct current voltage source

Dangerous voltage (Indicates dangerous voltages over 1000V AC or


1500V DC)

Protective earth (ground)

Equipotentiality

Data output port

Data input port

Data Input/Output port

Input port

Output port

Print remote output

Foot Switch Port


1 - 6 SONOACE X6 User manual

Symbols Description

ECG port

USB port

Network port

Microphone Port

Probe port

IPX 1 Protected against vertically falling water drops

IPX 7 Protected against the effects of temporary immersion in water

IPX 8 Protected against the effects of continuous immersion in water

CAUTION: Electrostatic sensitive devices (ESD)

Do not sit on the product.

Do not push the product.

Do not lean against the product.


Chapter 1. Safety 1 - 7

Symbols Description

Be mindful of the space. Do not place a finger, and or any part of your
body in the space.

Symbols
Symbols Description

Authorized Representative In The European Community

Manufacturer

Labels
Phrases containing the words ‘warning’ and/or ‘caution’ are displayed on the product's surface
in order to protect it.
1 - 8 SONOACE X6 User manual

Electrical Safety

This equipment is categorized as a Class I device with Type BF applied parts.

 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.
CAUTION
 To help assure grounding reliability, connect to a “hospital grade” or
“hospital only” grounded power outlet.

Prevention of Electric Shock


In a hospital, dangerous currents are due to the potential differences between connected
equipment and touchable conducting parts found in medical rooms. The solution to the problem
is consistent equipotential bonding. Medical equipment is connected with connecting leads
made up of angled sockets to the equipotential bonding network in medical rooms.

[Figure 1-1. Equipotential bonding]

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 shall comply with the requirements for medical electrical systems (see IEC
60601-1-1 or clause 16 of the 3 Ed. of IEC 60601-1, respectively). Anybody connecting
additional equipment to medical electrical equipment configures a medical system and is
therefore responsible that the system complies with the requirements for medical electrical
systems. Attention is drawn to the fact that local laws take priority over the above-mentioned
requirements. If in doubt, consult your local representative or the technical service department.
Chapter 1. Safety 1 - 9

 Electric shock may exist result if this system, including and all of its
externally mounted recording and monitoring devices, is not properly
grounded.

 Do not remove the covers on the system; hazardous voltages are


present inside. Cabinet panels must be in place while the system is in
use. All internal adjustments and replacements must be made by a
qualified Samsung Medison Customer Service Department.

 Check the face, housing, and cable before use. Do not use and
disconnect the power source, if the face is cracked, chipped, or torn, the
housing is damaged, or if the cable is abraded.

 Always disconnect the system from the wall outlet prior to cleaning the
system.
WARNING
 All patient contact devices, such as probes and ECG leads, must be
removed from the patient prior to application of a high voltage
defibrillation pulse.

 The use of flammable anesthetic gas or oxidizing gases (N2O) should be


avoided.

 Avoid places where the system is likely to be difficult to operate the


disconnection device.

 Do not use together with HF surgical equipment. HF surgical equipment


may be damaged, which may result in fire.

 The System must only be connected to a mains supply with protective


earth to avoid risk of electric shock.

 The system has been designed for 100-120VAC and 200-240VAC; you
should select the input voltage of 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.

 An isolation transformer protects the system from power surges. The


CAUTION isolation transformer continues to operate when the system is in standby.

 Do not immerse the cable in liquids. Cables are not waterproof.

 Make sure that the inside of the system is not exposed to or flooded with
liquids. In such cases, fire, electric shock, injury, or damage to the
product may occur.
1 - 10 SONOACE X6 User manual

 The auxiliary socket outlets installed on this system are rated 100-
120VAC and 200-240VAC with maximum total load of 150VA. Use these
outlets only 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.
CAUTION  Do not connect any peripheral devices that are not listed in this manual
to the auxiliary socket outlet of the system. It may cause an electrical
hazard.

 Do not touch SIP/SOP and the patient simultaneously. There is a risk of


electric shock from leakage current.

ECG-Related Information
 This device is not intended to provide a primary ECG monitoring
function, and therefore does not have means of indicating an inoperative
electrocardiograph.

 Do not use ECG electrodes of HF surgical equipment. Any malfunctions


WARNING in the HF surgical equipment may result in burns to the patient.

 Do not use ECG electrodes during cardiac pacemaker procedures or


other electrical stimulators.

 Do not use ECG leads and electrodes in an operating room.


Chapter 1. Safety 1 - 11

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. During low humidity conditions, electrical charges naturally build up
on individuals, creating static electricity. An ESD occurs when an individual with an electrical
energy build-up comes in contact with conductive objects such as metal doorknobs, file
cabinets, computer equipment, and even other individuals. The static shock or ESD is a
discharge of the electrical energy build-up from a charged individual to a lesser or non-charged
individual or object.

 The level of electrical energy discharged from a system user or patient to


an ultrasound system can be significant enough to cause damage to the
system or probes.

 Always perform the pre-ESD preventive procedures before using


connectors marked with the ESD warning label.

CAUTION - Apply anti-static spray on carpets or linoleum.

- Use anti-static mats.

- Ground the product to the patient table or bed.

 It is highly recommended that the user be given training on ESD-related


warning symbols and preventive procedures.

EMI
Although this system has been manufactured in compliance with existing EMI(Electromagnetic
Interference) requirements, use of this system in the presence of an electromagnetic field can
cause momentary degradation of the ultrasound image.

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.

In cases where EMI is causing disturbances, it may be necessary to


CAUTION relocate this system.
1 - 12 SONOACE X6 User manual

EMC
The testing for 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 emission


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

The Ultrasound System uses RF energy only for its


RF Emission internal function. Therefore, its RF emissions are very low
Group 1
CISPR 11 and are not likely to cause any interference in nearby
electronic equipment.

RF Emission The Ultrasound System is suitable for use in all


Class A establishments other than domestic, and may be used in
CISPR 11 domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
Harmonic Emission buildings used for domestic purposes, provided the
Class A
IEC 61000-3-2 following warning is heeded:
Warning: This system is intended for use by healthcare
professionals only. This system may cause radio
Flicker Emission interference or may disrupt the operation of nearby
Complies equipment. It may be necessary to take mitigation
IEC 61000-3-3
measures, such as re-orienting or relocating the
Ultrasound System or shielding the location.
Chapter 1. Safety 1 - 13

▌ Approved Cables, Probes and Peripherals for EMC

■ Cables
Cables connected to this product may affect its emissions; Use only the cable types and
lengths listed below table.

Cable Type Length

VGA Shielded Normal

Parallel Shielded Normal

RS232C Shielded Normal

USB Shielded Normal

LAN(RJ45) Twisted pair Any

S-Video Shielded Normal

Foot Switch Shielded 2.99m

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

■ Probes
The image probe used with this product may affect its emission. The probe listed in
‘Chapter 8. Probes’ when used with this product, have been tested to comply with the
group1 Class A emission as required by International Standard CISPR 11.

■ Peripherals
Peripherals used with this product may effect its emissions.

When connecting other customer-supplied accessories to the system, it is the


CAUTION user’s responsibility to ensure the electromagnetic compatibility of the system.

The use of cables, probes, and peripherals other than those specified, may
WARNING result in increased emissions or decreased immunity of the Ultrasound
System.
1 - 14 SONOACE X6 User manual

Electromagnetic
Immunity test IEC 60601 Test level Compliance level
environment -guidance

Floors should be wood,


Electrotatic concrete or ceramic tile.
±6KV Contact ±6KV Contact
discharge (ESD)
If floors are covered with
synthetic material, the relat-
±8KV air ±8KV air ive humidity should be at
IEC 61000-4-2
least 30%.

Electrical fast ±2KV ±2KV


transient/burst for power supply lines for power supply lines Mains power quality should
be that of a typical commer-
±1KV ±1KV cial or hospital environment.
IEC 61000-4-4 for input/output lines for input/output lines

Surge ±1KV differential mode ±1KV differential mode


Mains power quality should
be that of a typical commer-
cial or hospital environment.
IEC 61000-4-5 ±2KV common mode ±2KV common mode

<5% Uт for 0.5 cycles <5% Uт for 0.5 cycles


(>95% dip in Uт) (>95% dip in Uт)

Voltage dips, Mains power quality should


short interruptions 40% Uт for 5 cycles 40% Uт for 5 cycles be that of a typical commer-
and voltage cial or hospital environment.
(60% dip in Uт ) (60% dip in Uт ) If the user of this product
variations on
power supply requires continued operation
input lines during power mains interrup-
70% Uт for 25 cycles 70% Uт for 25 cycles tions, it is recommended that
this product be powered from
(30% dip in Uт) (30% dip in Uт) an uninterruptible power
IEC 61000-4-11 supply or a battery.

<5% Uт for 5 s <5% Uт for 5 s


(<95% dip in Uт ) (<95% dip in Uт )

Power frequency
(50/60Hz) Power frequency magnetic
magnetic field fields should be at levels
3 A/m 3 A/m characteristic of a typical
location in a typical commer-
cial or hospital environment.
IEC 61000-4-8

NOTE Uт is the a.c. mains voltage prior to application of the test level.
Chapter 1. Safety 1 - 15

IEC 60601 Compliance Electromagnetic


Immunity test
Test level level environment - guidance

Conducted RF 3 Vrms 3V Portable and mobile RF communications


equipment should be used no closer to any part
IEC 61000-4-6 150 kHz of the Ultrasound System, including cables,
to 80MHz than the recommended separation distance.
This is calculated using the equation applicable
to the frequency of the transmitter.
Recommended separation distance

80MHz to 800MHz

800MHz to 2.5GHz

Radiated RF 3 V/m 3V/m Where P is the transmitter’s maximum output


power rating in watts (W) according to the
IEC 61000-4-3 80 MHz transmitter’s manufacturer, and d is the
to 2.5GHz recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in
each frequency range. b
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 broadcast and TV broadcast cannot be
predicted theoretically 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 re-orienting 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 3V/m.
1 - 16 SONOACE X6 User manual

▌ Recommended separation distances between portable and mobile RF


communications equipment and the SONOACE X6
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 as recommended
below, according to the maximum output power of the communications equipment.

Rated maximum Separation distance, according to frequency of transmitter [m]


output power of
transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
[W]

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

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.

▌ Electromagnetic environment – guidance


It is recommended to use ultrasound systems in shielded locations offering RF shielding
effectiveness, with shielded cables. 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.

If the system is connected to other customer-supplied equipment, such as a


local area network (LAN) or a remote printer, Samsung Medison cannot
CAUTION guarantee that the remote equipment will work correctly in the presence of
electromagnetic phenomena.
Chapter 1. Safety 1 - 17

▌ Avoiding Electromagnetic Interference


Typical interference on Ultrasound Imaging Systems varies depending on Electromagnetic
phenomena. Please refer to following table:
Imaging Mode ESD1 RF2 Power Line3

2D or 3D Change of operating For sector imaging probes, White dots, dashes,


mode, system settings, white radial bands or diagonal lines, or diagonal
or system reset. flashes in the centerlines of lines near the center of the
the image. image.
Brief flashes in the
displayed or recorded For linear imaging probes,
image. white vertical bands,
sometimes more
pronounced on the sides of
the image.
M Increase in the image White dots, dashes,
background noise or white diagonal lines, or increase
M mode lines. in image background noise
Color Color flashes, radial or Color flashes, dots,
vertical bands, increase in dashes, or changes in the
background noise, or color noise level.
changes in color image.
Doppler Horizontal lines in the Vertical lines in the
spectral display or tones, spectral display, popping
abnormal noise in the type noise in the audio, or
audio, or both. both.
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 powerlines or connected cables caused by other equipment, such as
switching power supplies, electrical controls, and natural phenomena such as lightning.
1 - 18 SONOACE X6 User 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 System do not generate interference in excess of the


referenced standards.

An Ultrasound System is designed to receive signals at radio frequency and is therefore


susceptible to interference generated by RF energy sources. Examples of other source of
interference are medical device, 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 transducers operating at the same
frequency or with several transducer?

 Do two different transducer 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 reside with the system
or the scanning environment. After you answer the question, contact your local Samsung
Medison customer service department.
Chapter 1. Safety 1 - 19

Mechanical Safety

Moving the Equipment


Only the front wheels of the system can be used for steering. Therefore to maneuver the system
in tight spaces, use repeated back-and-forth movements to position the system into the desired
space. If the system operates abnormally after repositioning, please contact the Samsung
Medison Customer Service Department. On rare occasions a component may become
disconnected inside the system. The components are installed securely and can withstand
considerable shock, but excessive shock may cause system failure.

The system has a brake for the front wheels. Press down on brake with your foot to lock it and
lift up to release. Release the brake when moving the system.

 The system can weigh approximately 60kg, depending upon configuration,


and could cause injury should it topple over.

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. The monitor can be separated and easily removed from the
unit if necessary.
1 - 20 SONOACE X6 User manual

Safety Note
 Never attempt to modify the product in any way.

 Check the operational safety when using the product after a prolonged break
in service.

 Make sure that other objects, such as metal pieces, do not enter the system.

 Do not block the ventilation slots.

 To prevent damage to the power cord, be sure to grip the plug head – not the
cord – when unplugging.
CAUTION
 Excessive bending or twisting of cables on patient-applied parts may cause
failure or intermittent operation of the system.

 Improper cleaning or sterilization of a patient-applied part may cause


permanent damage.

 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.

Please refer to “Chapter 7. Maintenance” for detailed information on protecting, cleaning and
disinfecting the equipment.
Chapter 1. Safety 1 - 21

Biological Safety
For more safety information on probes and biopsy, please refer to Chapter 8 'Probes.'

 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.

 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 your local Samsung Medison Customer
WARNING
Service Department.

 Do not use a system that exhibits erratic or inconsistent updating.


Discontinuities in the scanning sequence are indicative of a hardware
failure that should be corrected before use.

 The system limits the maximum contact temperature to 43 degree Celsius,


and the ultrasonic waves 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 for 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 of the exam.

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 the applications of the technology, have
resulted in the need for more and better 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 support the ALARA principle.
1 - 22 SONOACE X6 User manual

▌ 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, concentrates 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 definition of 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 bioeffect is actually occurring, a high
index reading 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. These controls 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 based 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. The Samsung Medison system provides 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 intensity output. 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.
Chapter 1. Safety 1 - 23

▌ 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 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.

Focus of the ultrasound beam affects the image resolution. To maintain or increase
resolution at a different focus requires a variation in 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 or 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 a deeper 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.
1 - 24 SONOACE X6 User manual

▌ 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 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) and bone (TIb).
One of these three thermal indices will be displayed at all times. Which one depends upon
the system preset 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 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. A 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. presence of
fluid or bone, or the flow of blood. A highly attenuating 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. Do not rush the exam. Ensure that the indices are
kept to a minimum and that exposure time is limited without compromising diagnostic
sensitivity.
Chapter 1. Safety 1 - 25

▌ 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 bioeffects 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 but there is no specific MI value that means that a mechanical effect 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, and 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, for example, cranial bone.

The soft tissue thermal index (TIs) informs the user about the potential for heating within soft
homogeneous tissue.

You can select either TIs or TIb using the TIs/TIb selection on the Miscellaneous system
setups. TIc is displayed when you select a trans-cranial application.

▌ Mechanical and Thermal indices Display Precision and Accuracy


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 variability range of probes and
systems, inherent acoustic output modeling errors and measurement variability, 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 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.

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:
1 - 26 SONOACE X6 User manual

The measured water tank values are de-rated 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.

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
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 variability. Variability
among probes and systems is a significant factor. Probe variability results from piezoelectric
crystal efficiencies, process-related 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,
and variability 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 variability ranges of probes and
systems, inherent acoustic output modeling errors, and measurement variability. 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.

▌ Control Effects - Control affecting 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 a 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.
Chapter 1. Safety 1 - 27

▌ 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 with software controls to keep the TI
below the system maximums. A decrease in pulse voltage will decrease MI.

■ Zoom
Increasing the zoom magnification may increase frame rate. This action will increase the
TI. The number of focal zones may also increase automatically to improve resolution.
This action may change 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 MI.

■ Focal no.
More focal zones may change both the TI and MI by changing frame rate or focal depth
automatically. Lower frame rates decrease the TI. 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.

▌ 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 the dominant mode and the TI change will be small.
1 - 28 SONOACE X6 User manual

▌ Color Sector Depth


Deeper color sector depth may automatically decrease color frame rate or select a new 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 color frame rate. The TI
will increase. 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, TI changes.

■ 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 MI.
Chapter 1. Safety 1 - 29

▌ Doppler, 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 MI is the MI 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. Samsung Medison
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. Samsung Medison
factory defaults vary with probe, application, and mode. Defaults have been chosen
below the FDA limits for intended use.

▌ Related Guidance Documents


For more information about ultrasonic bioeffects and related topics refer to the following;

- AIUM Report, January 28, 1993, “Bioeffects and Safety of Diagnostic Ultrasound”

- Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med.,


Sept. 1998: Vol. 7, No. 9 Supplement

- Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM,


NEMA. 1998)

- Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998)

- Second Edition of the AIUM Output Display Standard Brochure, Dated March 10, 1994. (A
copy of this document is shipped with each system.)

- Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound


Systems and Transducers. FDA. September 1997. FDA.
1 - 30 SONOACE X6 User manual

- Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA. 1998)

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, Supplement1.

▌ 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 (Bioeffects 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
January 28, 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)

▌ 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:
− ( 0.23 alf )
In Situ = Water [ e ]

where: In Situ = In Situ Intensity Value


Water = Water Value Intensity
e = 2.7183
a = Attenuation Factor
Tissue a(dB/cm-MHz)
Brain 0.53
Heart 0.66
Kidney 0.79
Liver 0.43
Muscle 0.55

l = skin line to measurement depth (cm)


Chapter 1. Safety 1 - 31

f = Center frequency of the transducer/system/mode combination(MHz)

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 purpose; therefore, the In Situ value which is commonly
reported uses the formula:
− ( 0.069 lf )
In Situ (derated) = Water [ e ]

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. Take 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.

▌ 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,


([email protected]) may be reported instead of MI (global maximum value) if
2
ISPPA.3 is 190W/cm

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 range of center frequencies of the respective transmit
patterns.

ZSP The axial distance at which the reported parameter is measured


(centimeters).
1 - 32 SONOACE X6 User manual

x-6,y-6 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).

▌ 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


3.2% +21 % to -24%
integral)

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 effects 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.


Chapter 1. Safety 1 - 33

‒ Oscilloscope Digitization rates.

‒ Noise.

The systematic uncertainties 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.

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 (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 nonlinear 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.
1 - 34 SONOACE X6 User manual

▌ 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.
Chapter 1. Safety 1 - 35

Environmental Protection

 The console and peripherals could be sent back to manufacturers for


recycling or proper disposal after their useful lives.

CAUTION  Disposal of waste shall be disposed in accordance with national laws.

 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 office, 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.

State of California Proposition 65 Warning (US only)

This product contains chemicals known to the State of California to cause


WARNING cancer and reproductive toxicity.
Chapter 2

Introduction
And Installation

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

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

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


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

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

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


Monitor ...................................................................................................................................... 7
Control Panel .......................................................................................................................... 10
Console ................................................................................................................................... 16
Peripheral Devices .................................................................................................................. 19
Probe ...................................................................................................................................... 22
Accessory ............................................................................................................................... 23
Options.................................................................................................................................... 23
Chapter2. Introduction And Installation 2 - 3

What is SONOACE X6?


The SONOACE X6 is a high-resolution color ultrasound scanner with high penetration and a
variety of measurement functions.

Features and Advantages of SONOACE X6


■ High-end Digital Beam Forming – The SONOACE X6 utilizes the newly developed Digital
Beam forming technology.

■ A variety of applications – The SONOACE X6 is optimized for use in a variety of ultrasound


departments, including abdomen, obstetrics, gynecology, vascular, cardiac and urology
applications.

■ Various diagnostic Modes - 2D Mode, M Mode, Color Doppler Mode, Power Doppler Mode,
PW Spectral Doppler Mode, CW Spectral Doppler Mode(optional) etc.

■ 3D images can be obtained.


■ Measurement and Report Functions – Besides the basic distance, area, circumference and
volume measurement functions, the SONOACE X6 also provides application-specific
measurement functions. The report function collates measurement data.

■ Review of Scanned Images – The SONOACE X6 displays Cine images of 512 frames and
loop images of 4096 lines.

■ SonoView - This is a total ultrasound image management system, which allows a user to
archive, view and exchange documents.

■ DICOM (Digital Imaging and Communication in Medicine) Function - This is used to archive,
transmit and print DICOM images through a network.

■ Peripheral/Accessory Connection – A variety of peripheral devices including VCRs and


printers can be easily connected to the SONOACE X6.
2 - 4 SONOACE X6 User manual

Specifications

Height: 1378mm (with monitor)


Width: 483mm
Physical Dimensions Depth: 691mm
Weight: More than 60.75kg
Weight: Approx. 75kg (with Safe Working Load)
2D real-time
Dual 2D real-time
2D/M-mode
Color Doppler
Imaging modes Pulsed-wave Doppler
Continuous-wave Doppler (Optional)
Power Doppler
3D-mode (Freehand)
Simultaneous
Gray Scale 256 (8 bits)
Dynamic transmit focusing, maximum of eight points (four points
Focusing simultaneously selectable)
Digital dynamic receive focusing (continuous)
Curved Linear Array
C2-5, C2-5EP, C2-8, C2-4ES, C3-7EP, C4-9ED
Linear Array
HL5-12ED, L3-8, L5-12/50, L5-12EP, L5-12/50EP, LN5-12

Probes Endocavity Curved Linear Array


(Type BF / IPX7) ER4-9/10ED, EV4-9/10ED, NER4-9ES, NEV4-9ES, BCC4-9
Phased Array
P2-4AH, P3-7AC, SP3-8
CW
CW2.0, CW4.0
Three probe connectors
Probe connections Four probe connectors for option
※ Including one CW probe connector.
15 inch LCD monitor (LED Backlight unit)
Monitor
called "LCD monitor" henceforth
ECG Type BF
Chapter2. Introduction And Installation 2 - 5

VHS and S-VHS VCR left and right audio


ECG
Microphone

Rear Panel Input Patient monitor video and 9V dc power


Connections B/W printer video and remote control
VGA monitor
Parallel port
USB
Maximum 512 frames for CINE memory
Image Storage Maximum 4096 Lines for LOOP memory
Image filing system
General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part,
Application
Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal
Electrical Parameters 100-120V/200-240VAC, 8/5A, 50/60Hz
Obstetrics
Gynecology
Cardiology
Automatic
Calculation and Fetal Echo
Quantification Vascular
Urology
* Refer the Chapter 5 for additional information
TGC control
Mode-independent gain control
Acoustic power control (adjustable)
Dynamic aperture
Signal processing
Dynamic apodization
(Pre-processing)
Dynamic range control (adjustable)
Image view area control
M-mode sweep speed control
HD zoom
Frame average

Signal processing Gamma-scale windowing


(Post-processing) Image orientation (left/right and up/down)
White on black/black on white
Trackball operation of multiple cursors
2D: Linear measurements and area measurements using elliptical
Measurement approximation or trace
M-mode: Continuous readout of distance, time, and slope rate
2 - 6 SONOACE X6 User manual

Doppler: Velocity and trace


Black-and white printer
Color printer
Auxiliary VCR
Monitor
Foot switch (IPX1)

User Interface English, German, French, Spanish, Italian, Russian, Chinese


Operating: 700hPa to 1060hPa
Pressure Limits
Storage: 700hPa to 1060hPa
Operating: 30% to 75%
Humidity Limits
Storage & Shipping: 20% to 90%
Operating: 10 OC ~ 35OC
Temperature Limits
Storage & Shipping: -25OC ~ 60OC
Chapter2. Introduction And Installation 2 - 7

Product Configuration and Installation


The SONOACE X6 consists of the monitor, the control panel, the console, the peripheral
devices, and the probes.

Monitor
When the system powers on, the monitor screen becomes white for 1 or 2
NOTE seconds. This is the effect of the residual power and does not affect the
use of the equipment.

The monitor of this system is a color VGA monitor, which displays ultrasound images and
additional information. This monitor is connected to the main body through a central pivot,
allowing it to be tilted to the optimal viewing angle.

▌ Monitor Display
The monitor displays ultrasound images, operation menus and a variety of other information.
The screen is divided into six sections: ①Title, ②Menu, ③Image, ④Thumbnail, ⑤Feedback,
and ⑥Flexible Soft Menu sections.

[Figure 2.1 Monitor Display]


2 - 8 SONOACE X6 User manual

■ Title
This section displays the Logo, Patient Name, Hospital Name, Application, Frame Rate &
Depth, Probe Information, Acoustic Output Information and Date & Time.

■ Menu
The menu is divided into 3 kinds: Image adjustment menu, Measurement menu, and
Utility menu. Use Menu dial-button to select an item from the menu.

■ Image Area
The ultrasound image, image information, annotation, and measurement information are
displayed in the image area.

■ Thumbnails Area
Saved images, by pressing the Save button on the control panel, are displayed in the
thumbnails area. This area shows up to four images.

Thumbnails are showed when you check ‘on’ in Setup> System > Misc.

Click a thumbnail with a pointer to enlarge.

NOTE Refer to ‘Chapter 3. Settings’ for detail.

■ Feedback Area
This feedback area provides a variety of information necessary for system use e.g.
current system status and Body Markers.

■ Flexible Soft Menu


The Flexible Soft Menu is displayed on the screen at all times. The items shown on the
monitor vary, depending on the status of the system.
Chapter2. Introduction And Installation 2 - 9

※ Principles of Operation of the Diagnostic Ultrasound System

Medical ultrasound images are created when the computer's digital memory converts the
high-frequency wave signals that are transmitted and received by the probe.

As ultrasound waves propagate through the human body, they generate reflected signals
whenever they encounter a change in density. For example, reflected signals are generated
when signals pass from fatty tissues to muscle tissues. Reflected signals return to the probe
where they are converted into electronic signals. The reflected signals are amplified and
processed by analog and digital circuits that have filters for various frequencies and
response time options. Then they are again converted into high-frequency electronic
signals, and saved as a series of digital image signals. The monitor displays the image
signals stored on the storage device in real time.

The entire process of transmitting, receiving, and processing signals is controlled by the
computer
2 - 10 SONOACE X6 User manual

Control Panel
The control panel can be used for controlling the system.

[Figure 2.2 Control Panel]

The user can manipulate the control panel using ① Up/Down Switch, ② Dial-Button, ③ Dial, ④
Slide, ⑤ Button, and ⑥ Trackball. The dial-button can be used both as a dial and a button.

▌ Control Panel Map


The following are descriptions and instructions for the controls on the control panel. For
more information on the buttons with multiple functions, see Chapter 3 and later of this
manual.

■ Power On/Off
This is used toTurn the system on/off.
Press the button for about 1 second to turn the product On for use, and
On/Off press and hold down the button for 2 seconds to turn the product Off after
use. Once turned Off, the system needs a 5-second interval before
restarting by pressing the button.
Chapter2. Introduction And Installation 2 - 11

■ Starting and Finishing Exam


This is used to change another probe.
Probe If you use Two-probe connector (optional), this is used to appear a window
to select/change probes and applicati-ons.

This is used to appear a window for patient selection and information


Patient
entry.

This is used to finish the exam of the currently selected patient and reset
End Exam
the related data.

■ Selecting Diagnosis mode and Gain Control


For further information on each Mode, refer to ‘Chapter 4. Diagnosis
NOTE Modes’.

This is used to view two-dimensional anatomy images in the direction of


scanning in real time. Pressing this button while in 2D mode does not turn
2D
it off. However, pressing the 2D button will return the system to 2D Mode
from other image modes.

This is used to turn M Mode on. The M Mode is used to observe the
M motion patterns of objects occurring over time along a single vector. Press
this button again to turn M Mode off.

This is used to turn Color Doppler Mode on. Color Doppler Mode shows
C the pattern of blood flow on 2D image in real time. Press C button again to
turn Color Doppler Mode off.

This is used to turn Power Doppler Mode on. Power Doppler Mode
PD displays the color intensity of blood flow within the ROI in the 2D image.
Press PD button again to turn Power Doppler Mode off.

This is used to turn PW Spectral Doppler Mode on. This mode is used to
PW show vascular or cardiac blood flow. 2D Mode can be used
(Optional) simultaneously. Press this button again to turn PW Spectral Doppler Mode
off.

This is used to turn CW Spectral Doppler Mode on. CW Spectral Doppler


CW
Mode gives information on the speed/direction of blood flow in the form of
(Optional)
a spectral trace and audio signal.

This is used to turn Dual Mode on. Dual Mode is used to compare two 2D
Dual images. Use the Set button Dual button or Update button to change the
activated image in Dual Mode. Press 2D button to turn Dual Mode off.

This is used to turn Harmonic Imaging on. Press this button again to turn
Harmonic
the mode off. This button is only activated with the specific probe.
2 - 12 SONOACE X6 User manual

This adjusts 2D Gain, 2D Post Gain or activates the Freeze function.


- 2D Gain function – Use the dial in 2D mode to adjust Gain.
- Freeze function – Press the button while scanning to stop the video
Gain/Freeze/PGC scanning. LED of this button in frozen state is displayed as blue and
Cine, Save, Echo Print, and Measurements are available. Press this
button again, LED is displayed as green.
- 2D PGC(Post Gain Control) function - Changes the post curve in the
frozen state to provide effects similar to changing Gain, TGC, DR, etc.

Gain/PGC This adjusts Gain or Post Gain.

■ Image Adjustment
This switch is used to focus on the area of interest. Raise/ lower the switch
Focus
to raise/lower the focusing point.

This switch is used to adjust the scanning depth of the image. Raise/
Depth
lower the switch to decrease/ increase the scanning depth of an image.

Raising this switch causes a Zoom box to appear. Modify the size of Zoom
box with the Change button and Trackball, and press Set button to apply
HD Zoom it to the image.
Press Exit button or adjust Depth switch to exit. The position of the
magnified area can be adjusted with the Trackball.

This is used to perform the Read Zoom function. Adjust the size/position
of a 2D image with Change button and the Trackball. Roll the Trackball
Zoom upwards to view the lower portion of the image, and vice versa. To
observe the right/left portion of the image, move the Trackball to the
left/right. Press Exit button or Zoom button to exit Zoom mode.

This is used to adjust Gain, TGC, etc. automatically to optimize Contrast


and Brightness.
Quick Scan
The ‘Q’ mark is displayed on the top of the image.
Press this button again to exit.

Menu function - Press dial button to activate the available menu item of
current scan mode. Rotate the dial button to the right/left to move up/down
a menu.
Menu/ Angle
Angle function - Adjust the angle of sample volume in PW Spectral
Doppler Mode. It is also used to adjust the Indicator angle or the Probe
angle of Body Marker.
Chapter2. Introduction And Installation 2 - 13

■ TGC (Time Gain Control)


TGC Eight slides are used to adjust TGC (Time Gain Compensation) values.

Care should be taken when adjusting TGC values. Too large


CAUTION difference in the gain value settings of two adjacent slides may lead
to inaccurate image generation.

■ Measurement and Annotation


This is used to measure distance, volume, circum-ference, and area.
Caliper Press the button repeatedly to cycle through all the available
measurement methods.

This is used to appear a different measurement menu, depending on the


examination subject and diagnosis mode. The examination subject
Calculator
changes each time the button is pressed. Select an appropriate item to
perform the measurement.

This button is used to appear an arrow marker. It points the parts of the
Indicator
displayed image.

This button is used to erase the text, Indicator, Body Marker, and
Clear
measurement data from the displayed image.

Body Marker This button is used to appear a Body Marker list.

For more information about Measurement, refer to ‘Chapter 5 Measurements


NOTE and Calculations’. For more information about annotation, refer to
‘Chapter 6 Image Managements’.

■ Trackball and its related control


This is used to move the cursor on the display and to scroll through CINE
Trackball
images.

This is used to change the current Trackball function. It is used during


Change measurements to alter the position of the last point. It is also used to
adjust the position of the text cursor.

There are two buttons on each side of the Trackball.


SET; This is used in conjunction with the Trackball to set a specific item or
value. In Spectral Doppler Mode and 3D mode, it is also used as update
function. It shows as green color.
Set / Exit
EXIT; This is used to exit the current mode and return to initial settings. It
shows as blue color.
The function of each button can be set in Utility > Setup > Peripherals >
Key Setup.
2 - 14 SONOACE X6 User manual

■ SonoView and Report


When this is pressed on the keyboard, SonoView, the Image Filing
SonoView
program, is activated.

When this is pressed on the keyboard, a report program containing


Report
measurement results from the current diagnosis mode appears.

For more information about SonoView, refer to ‘Chapter 6 Image


NOTE Managements’ and for more information about Report, refer to
‘Chapter 5 Measurements and Calculations’.

■ Save and Print


This is used to save a currently displayed image or measurement report in
Save the system database. The user can manage the saved image and report
with SonoView.

Echo Print This is used to print out the current image via an Echo printer.

■ Alphanumeric Keyboard

[Figure 2.3 Alphanumeric keyboards]

The alphanumeric keyboards are used to type in text. Some function keys are related to
measurement.
Press this button in HD Zoom mode to hide the Zoom Navigation Box.
Z Key
Press it again to show the box.
Chapter2. Introduction And Installation 2 - 15

■ Flexible Soft Buttons

These buttons activate the corresponding


Flexible Soft Menu at the bottom of the screen.

■ Function Buttons
[F1]
This is used to input text.
Text

[F2]
This is used to display M line or hide.
M Line

[F3]
This is used to start the biopsy.
Biopsy

[F4] This button is used to display information of image on the upper right side
Data on / off of screen or hide.

[F5]
This is used to start 3D Mode.
3D

[F7] This button is used to appear the Storage Manager window, where saving,
Storage Manager transmission, backup and other functions are available.

[F8] This button is used to appear the Setup window for setting system
Setup parameters.

[F9]
This button is used to appear the utility menu.
Utility

[F10]
This is used to appear a window to select/change probes and applications.
Application
2 - 16 SONOACE X6 User manual

Console
The console consists of two parts – the inner unit and the outer unit. The inner section is
responsible for ultrasound image generation. The outer section is designed to support the use
of other devices and includes monitor and probe connection sockets, the probe holder, storage
devices like HDDs, storage space for peripheral devices and the system power switch.

[Figure 2.4 Console]


Chapter2. Introduction And Installation 2 - 17

▌ Rear Panel
A monitor, printer, VCR, etc. are connected via the rear panel at the back of the system.

VGA (Output)
The VGA signal is sent to the monitor.

LAN (Input/Output)
DICOM can be connected via the LAN port.
Patient information is transferred to another
server via the DICOM network.

Audio (Output)
The input/output of Audio signals is possible.

VHS (Output)
Connect the VCR using the VHS method.

Printer (Output)
Echo printer connection.

Printer Remote (Output)


Remote Echo printer connection.

ECG Connector
ECG Module connection.

[Figure 2.5 Rear Panel]

▌ Main Power On/Off Switch


The main power on/off switch locates under the rear panel. Powers the product On/Off.
2 - 18 SONOACE X6 User manual

[Figure 2.6 Main Power On/Off Switch]

▌ Probe Holder
A probe holder is mounted at the right/left side of the control panel.
Chapter2. Introduction And Installation 2 - 19

Peripheral Devices

 When using a peripheral device from a USB port, always turn the power off
before connecting/disconnecting the device. Connection/discon-nection of
USB devices during power-on may lead to malfunction of the system and
USB devices.

CAUTION  Do not install a peripheral device that is not listed in this user manual in the
patient environment. If you install an unlisted device in the patient
environment, it may cause an electrical hazard.

 Do not connect additional Peripheral Devices to the auxiliary socket


outlets. When connecting, the level of safety may be reduced.

[Figure 2.7 The patient environment]

NOTE Refer to the user manual of peripheral device about its operating.

▌ Internal Peripheral Devices


These are peripheral devices mounted in the system.

■ DVD-Multi
DVD-RW, DVD-RAM, DVD-R, DVD+R, DVD-ROM, CD-R, CD-RW, CD-ROM
2 - 20 SONOACE X6 User manual

■ Hard Disc Drive


More than 80Gbytes.

▌ 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.

 When remove the removable disk, use Storage manager.

 USB ports are located both on the front panel and the rear panel of the
NOTE console.
We recommend that you connect USB storage devices (MO drive,
flash memory media, etc.) to the ports on the front panel and other
USB peripheral devices to the rear panel for added convenience.

The following products are recommended:

■ Video Cassette Recorder (VCR)

■ Video Page printer


– Black and White : SONY UP-897MD, Mitsubishi P91W, Mitsubishi P93W

– Color : SONY UP-20, SONY UP-21MD

■ Inkjet Printer

Contact Samsung Medison’s customer service department about


NOTE abailable printers.

Contact Samsung Medison’s customer service department for


CAUTION inquiries about printer driver installation.

■ USB Magnetic Optical (MO) Disk Drive


1 Fujitsu DynaMO 1300U2B or later version

The USB MO Drive should not be used with other USB storage
CAUTION devices simultaneously.

■ USB to RS-232C Serial Cable


USB to Serial (RS-232C) Converter with FTDI Chipset (FTDI FT232BM Compatible)
Chapter2. Introduction And Installation 2 - 21

For more information about the Open Line Transfer, refer to


NOTE ‘Chapter 5. Measurements and Calculations’.

■ Foot Switch
Set the function of the foot switch in Setup > Peripherals > Foot Switch; Dual, Freeze,
Update, or Store.

■ Flash Memory Media


Imation iFLASH USB 2.0 1GB, Imation USB Swing Blue 1G

 If you use the USB 1.1 flash memory, the system cannot
recognize it. In the case of this, delete the flash memory from the
console and quip again.

 USB ports are located both on the front panel and the rear panel
of the console. We recommend that you connect USB storage
NOTE devices (MO drive, flash memory media, etc.) to the ports on the
front panel and other USB peripheral devices to the rear panel for
added convenience.

 Do not use flash memory media which contain anti-virus


programs or are defective. Otherwise, the product may fail to
work properly
2 - 22 SONOACE X6 User manual

Probe
Probes are devices that generate ultrasound waves and process reflected wave data for the
purpose of image formation.

NOTE For more information, refer to ‘Chapter 8 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 ports on the front panel of the system. A maximum of three
probes (four probes optional) can be connected at one time. Connect the Biplane and
CW probes to their respective dedicated connectors.

2. Turn the connector-locking handle clockwise after inserting the probe into the probe port.

When the system is powered on, the probe last in use is automatically activated.

[Figure 2.8 Probe Connector]


Chapter2. Introduction And Installation 2 - 23

Accessory
This system provides a box including accessories.

Main cord set, separately certified according to the relevant standards, is to


CAUTION be used when supplied to EU and USA/CAN.

[Figure 2.9 Accessories]

NOTE Accessories can be different according to the country.

Options
The SONOACE X6 has the following optional functions:

■ Image filing-SONOVIEW
■ DICOM
■ Freehand 3D
■ Pulse wave Doppler
■ Color Doppler
■ Cardiac S/W Package
Chapter 3

Setting
Selecting Probe / Application ...................................................................................... 3
Probe /Application Selection ..................................................................................................... 3
Application Change ................................................................................................................... 4
Probe Setting Change .............................................................................................................. 4
Editing Bodymarker .................................................................................................................. 5
Calc Sequence ......................................................................................................................... 7

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


Registering a New Patient ........................................................................................................ 8
Finding Patient Information ....................................................................................................... 9
Modifying Patient Information ................................................................................................. 11

Setting System............................................................................................................ 12
General ................................................................................................................................... 12
Display .................................................................................................................................... 15
Misc. ........................................................................................................................................ 17

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


General ................................................................................................................................... 19
Obstetrics Measurement Setup .............................................................................................. 24
Fetal Echo Measurement Setup ............................................................................................. 28
Cardiac Measurement Setup .................................................................................................. 29
Urology Measurement Setup .................................................................................................. 30
Vascular Measurement Setup ................................................................................................ 31

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


Setting DICOM Information..................................................................................................... 32
Network Setup ........................................................................................................................ 33
Adding or Changing the DICOM Server ................................................................................. 33
Editing the DICOM Server Information ................................................................................... 39
Deleting DICOM Server .......................................................................................................... 39
Testing DICOM Server ........................................................................................................... 39
DICOM Log ............................................................................................................................. 39

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


3 - 2 SONOACE X6 User manual

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

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

Utilities ......................................................................................................................... 44
Biopsy ...................................................................................................................................... 44
ECG ......................................................................................................................................... 46
Monitor Calibration .................................................................................................................. 48
Preset ...................................................................................................................................... 48
Miscellaneous .......................................................................................................................... 49
Chapter3. Setting 3 - 3

Selecting Probe / Application

Before scanning, select a probe and an application. Refer to `Chapter 8 Probes’ for more
information about the probes available for this system.

On the control panel, press the [F10] Application button to bring up the Application window on
the screen. This window can be used to select or change applications and probes, and to edit
probe preset.

To switch to another probe without using Application window, press Probe


NOTE button on the control panel.

[Figure 3.1 Application]

Probe /Application Selection


1. Select a probe and an application using the Trackball and Set button.

2. After selecting them, click Ok in the Application Window. To cancel the selection, press
Cancel.
3 - 4 SONOACE X6 User manual

Application Change
1. After checking the currently selected probe, select an application using the Trackball and
Set button.

2. After selecting it, click Ok in the Application Window. To cancel the selection, press
Cancel.

Probe Setting Change


While the probe settings are preset with the optimal values for each application, the user may
change the preset values using the following method.

1. After checking the currently selected probe/application, change the probe setting using
the Trackball and Set button. Click Save to save the changed values.

2. Click Ok in the Application Window. To cancel the selection, press Cancel.

3. Change the names of the user-definable settings other than ‘Default’ values using the
Rename.

To change the probe setting values, see ‘Utility’.


Chapter3. Setting 3 - 5

Editing Bodymarker
Press Edit Bodymarker in the Application window to bring up the Bodymarker manager. Select
some bodymarkers to use in the system or change the order of bodymarkers.

[Figure 3.2 Bodymarker Manager]

‘Group’ shows system supporting bodymarkers with the application. Use Prev or Next to display
Bodymarkers of other applications.

‘User defined Bodymarker preset’ shows selected bodymarekrs.

▌ Add Bodymarkers
Select a bodymarker on ‘Group’ using the Trackball. Press Set button to add to the ‘User
defined Bodymarker preset’.

▌ Delete Bodymarkers
Select a bodymarker on ‘User defined Bodymarker preset’ using the Trackball. Press Set
button to delete.
3 - 6 SONOACE X6 User manual

▌ Change the order of Bodymarkers


Select a bodymarker on ‘User defined Bodymarker preset’ using the Trackball. Press Set
button to delete. With pressing the Exit button on the control panel, move the position using
the Trackball. Release the Exit button to finish changing the order.

▌ Back to default Bodymarker


Press the Default on ‘User defined Bodymarker preset’ to back to default Bodymarker.

▌ Delete all Bodymarkers


Press the Delete on ‘User defined Bodymarker preset’ to delete all bodymarkers. It deletes
bodymarkers only in ‘User defined Bodymarker preset’.

▌ Save Bodymarkers
Press the Save on ‘User defined Bodymarker preset’ to save current setting. When you
press the Bodymarker button on the control panel during using the system, this setting will
be displayed.

Refer to ‘Chapter 6 Image managements’ for more information about


NOTE displaying Bodymarker.
Chapter3. Setting 3 - 7

Calc Sequence
To change the order and content of the Calculation Package of each application, click the Calc
Sequence. If you want to return to the initial settings, click Default in the window.

[Figure 3.3 Calc Package Sequence Change]


3 - 8 SONOACE X6 User manual

Entering Patient Data


Be sure that the patient information has been correctly entered before scanning.

The patient information includes basic information such as patient ID, patient name, birth date,
gender as well as other application specific data.

Patient ID and name are mandatory information when registering a new


NOTE patient.

All patient data are classified according to the patient ID. If the ID is not entered, the Ok is not
activated. (Extra information can be entered when needed.)

Press Patient on the control panel, and the Patient Information window shown below appears.
You can register and modify patient information.

[Figure 3.4 the Patient Information]

Registering a New Patient


1. After clicking the New, enter the patient name, ID and other information using the
Trackball, Set button and keyboard.

– While Auto ID Creation is checked, click the New. A new Patient ID is automatically
provided by the system.

– When an existing ID is entered, the ID field icon changes to .

2. After entering patient information correctly, click Ok. Or click Cancel or X to cancel.
Chapter3. Setting 3 - 9

Finding Patient Information

▌ Finding Patient Information using ID


Enter the Patient ID to change his or her information.

▌ Finding Patient Information using the Search Function


1. Click Search in the Patient Information window, and the Search window shown below
appears.

[Figure 3.5 Patient Search]

2. Type in patient ID or name, and the list of registered patients appears.

– If there is no ID or name that satisfies the search key, the Select and Ok are not
activated.

– To display all registered ID, click Show All. To select all ID on the list, click Select All.

– To delete the ID and its all information, select the patient and click Delete.

3. After selecting ID, press Select or Ok to display information of the selected patient. To
stop the search or close the current search dialog box, click Cancel or X.

WARNING If a patient ID is deleted, all data and images stored in SonoView are erased.
3 - 10 SONOACE X6 User manual

▌ Finding Patient Information using Worklist


The system connects to the hospital’s DICOM Modality Worklist server and obtains
information on scheduled patients and examinations. Searching a patient by Worklist allows
you to enter the patient information automatically.

Use the DICOM tab in the Settings screen to select the Worklist
NOTE server. For more information, see “DICOM Settings.”

1. Press Worklist in the Patient Information screen and the Modality Worklist window will
appear. (If “Open MWL on Patient Key” is selected under the DICOM server settings,
pressing the Patient button opens the Modality Worklist window first.)

2. Select Worklist Server, enter one or more search conditions in “Search Criteria”, and then
press Search button. A list of scheduled patients that match the search conditions will
appear.

3. Select a patient and press OK. The patient information will appear.

4. Press the X button on the window to quit searching patients and close the Modality
Worklist window. If you wish to enter patient information directly without using Worklist
data, press Manual Entry.

ID, Name, Accession #, Birth, Age, or Gender cannot be changed


NOTE when entering patient information by using Worklist.

[Figure 3.6 Modality Worklist]


Chapter3. Setting 3 - 11

Modifying Patient Information


To modify information in the Patient Information window:

1. Modify the information using the Trackball, Set button and keyboard.

2. After modifying patient information correctly, click Ok. To cancel editing, click Cancel or X.

For more details on patient backup, see the ‘Information Management’


NOTE section in ‘Chapter 6. Image Managements’.
3 - 12 SONOACE X6 User manual

Setting System
This mode is used for system settings. It does not affect image output. The setup may be
modified depending on specific needs or preferences.

1. Press the [F8] SetUp button on the keyboard. Setup window is appeared.

2. Select System in the Setup menu.

3. Set the specific system values according to each item on the screen.

4. Press Ok to finish the setup. To close the screen, press Cancel or X.

General
Select the General tab in the System menu.

[Figure 3.7 System Setup – General]

■ Institution
Enter the name of the hospital/institution.
Chapter3. Setting 3 - 13

■ Language
This sets the language to be used. English, Deutsch, Français, Italiano, Español, Russian,
and Simplified Chinese are available. To display the screen in the selected language,
reboot the system after completing setup. The input setup of key button is automatically
updated.

■ Date
Set the date and its format.

■ Time
Set the time and its format.

※ How to set the date and time.

[Figure 3.8 System Setup – Date/Time]

1. Click Set in the Title tab of System menu.

2. Set the Date/Time using the Trackball and Set button.

3. After finishing setup correctly, click Ok. To cancel setup, click Cancel.
3 - 14 SONOACE X6 User manual

■ Boot up caps lock status


This menu sets the initial status of Caps Lock after system boot-up. Its default value is
‘Off’. This Caps Lock enables capital letter entry without the need to press the Shift key.

■ Autotext Set
Select Autotext Set to use the Autotext text function. Its default value is ‘Off’.

Using the Autotext text function allows fast and easy input of text statements. For
example, to enter the text ‘Tumor’, you only need to enter ‘Tu’ and the system will search
the word from the abbreviation list and automatically enter the word ‘Tumor’.

※ How to edit the Autotext Set.

Press the Edit button on the screen. The Autotext Table Edit table window will be
appeared. To add a new abbreviation, click New, and to completely delete an existing
abbreviation, click the entry to be deleted and then click Delete.

‘Delay(msec)’ sets seconds to input the full word after enter the abbreviation. The unit
value is msec, and 1000msec is 1second.

[Figure 3.9 Autotext Set Edit]


Chapter3. Setting 3 - 15

Display
To set the information about images and related data, select the Display tab in the System
menu.

■ Auto Freeze
After the preset time span (Minute) of inactivity, the scan mode is automatically frozen.

■ Screen Saver
After the preset time span (Minute) of inactivity, the screen saver is automatically started.

■ Post Map
This sets the display of the Post Map in the Feedback section at the bottom of the screen.

■ TGC Line
This sets whether or not the TGC line is displayed. If ‘Off’ is selected, the TGC Line is not
shown. If ‘Off after 3 seconds’ is selected, the TGC value appears when a TGC value is
adjusted, but disappears after 3 seconds. If ‘On’ is selected, the TGC Line is always
shown.

■ TI (Thermal Index) Display


The system sets TI values automatically. However, this menu allows the user to choose
manually from one of the three TI parameters as desired: Default, TIs or TIb.

■ HPRF
Enable or disable High Pulse Repetition Frequency (HPRF) supported in the PW Spectral
Doppler mode. If it is set to ‘On,’ HPRF is supported by default.

■ Bodymarker After Freeze


Determine whether the system will automatically switch to the Body Marker mode when
the Freeze button is pressed. If it is set to ‘On,’ a Body Marker appears when the Freeze
button is pressed during scanning. If it is set to ‘Off,’ a Body Marker appear only when
BodyMarker is pressed during scanning.

■ 2D Image Size
The Image size can be set to 100%, 95% or 90%.
3 - 16 SONOACE X6 User manual

■ Display Gender
This sets whether or not the gender of the patient is displayed. If ‘On’ is selected, the
patient’s gender is shown.

■ Simultaneous Mode
This menu determines whether or not simultaneous mode is enabled in PW Spectral
Doppler Mode.

– ‘Off’: Select this if you do not wish use simultaneous mode.

– ‘Allow 2D/PW: Select this if you wish to use simultaneous mode in 2D/PW mode.

– ‘Allow 2D/C/PW: Select this if you wish to use simultaneous mode in 2D/C/PW mode.

[Figure 3.10 System Setup – Display]


Chapter3. Setting 3 - 17

Misc.
Select the Misc. tab in the System menu.

[Figure 3.11 System Setup – Misc.]

■ OB Measure Shortcut Key


You can use this feature to start a desired obstetrics measurement instantly while
scanning.

■ Shortcut Key Setup


Assign commonly used obstetrics measurement items to number keys in the
alphanumeric keyboard.

■ Hibernation
To booting speed up, set this item as ‘On’.

The system turns off with normal shutdown after 30th booting
NOTE with ‘Hibernation On’. However the system will start with
‘Hibernation On’ on the next booting.
3 - 18 SONOACE X6 User manual

■ Thumbnail
To use thumbnail list, set this item as ‘On’. Thumbnails of saved images are showed up
on the right side of the screen.

■ Set/Exit Key Setup


Set the position of the Set and Exit buttons.

■ Active Plane

NOTE This option is available only if the Biplane probe is used.

Select which of the two elements in the Biplane probe will be used as the default element.
In Single mode, images scanned with the selected element are displayed.

For detailed information on the Biplane probe, please refer to “Chapter 8 Probes".
Chapter3. Setting 3 - 19

Setting Measurements
Select Measure in the Setup menu to set up measurement functions.

1. Press the [F8] SetUp button on the keyboard. Setup window is appeared.

2. Select Measure in the Setup menu.

3. Set the specific system values according to each item on the screen.

4. Press Ok to finish the setup. To close the screen, press Cancel or X.

General
Select the General tab in the Measure menu to set general measurement settings.

[Figure 3.12 Measurement Settings- General]


3 - 20 SONOACE X6 User manual

▌ General
Select General tab.

■ Measure Item Display Count


Select the number of measurement items to be between 1 and 4. If you select ‘Hide’,
measurement items are not displayed.

NOTE If you select ‘4’, reboot the system after completing setup

■ Circ/Area Method
Select either the ‘Ellipse’ or ‘Trace’ caliper to be the default tool for measurement.

■ Default Volume Method


Select either the ‘3 Distance’, ‘1 Distance’ or ‘Distance + Ellipse’ items to be used as the
default tool in volume measurement.

■ Distance Method
Set either ‘Line’ or ‘Trace’ as the distance measurement method.

■ Caliper Display Unit


Set either ‘cm’ (centimeter) or ‘mm’ (millimeter) as the caliper display unit.

■ Trackball Speed
Set the Trackball speed to either ‘Fast’, ‘Medium’ or ‘Slow’.

■ Result Display
Set the output format of measurement results in the report. When ‘Average Value’ is
selected, the report shows the average value of the last three measurement results.
When ‘Last Measured Value’ is selected, the last measurement value is shown.
Chapter3. Setting 3 - 21

▌ Doppler
Select the Doppler tab in the General tab.

[Figure 3.13 Measurement Settings - Doppler]

■ Y-Axis Unit
This sets the vertical (Y) axis unit in Spectral Doppler Mode.

■ Trace Direction
When Auto Trace and Limited Trace functions are used in Spectral Doppler Mode, this
sets the range of the measurement values.

■ Control Threshold
The trace threshold can be adjusted by rotating the Menu dial-button when tracing is not
finished after Auto trace / Limited trace.

■ Mean Trace
This menu specifies the use of Mean Trace Line on the screen for Auto trace / Limited
trace.
3 - 22 SONOACE X6 User manual

※ How to change Doppler setting during measurement

Press the space bar after pressing the Calculator button to bring up the Setting Measure
Method window shown below.

[Figure 3.14 Setting Measure method]


Chapter3. Setting 3 - 23

▌ Report
Select the Report tab in the General tab.

Select items to mark the header on the report. The header will be shown only the item has
its data.

[Figure 3.15 Report Setting]


3 - 24 SONOACE X6 User manual

Obstetrics Measurement Setup


To set up obstetrics related measurement, select the OB tab in the Measure menu.

[Figure 3.16 Measurement Settings – Obstetrics]

■ Display SD Value
This menu sets whether SD (Standard Deviation) is displayed or not. If ‘Yes’ is selected,
the SD value is shown on the screen and on the report. If ‘No’ is selected, it is not shown
and its range value appears on the report.

■ HC Auto Calc
This menu is used to set the HC Auto Calculation. ‘Yes’ shows the HC value on the
screen and in the report using the result of OFD and BPD calculation. ‘No’ will not show
the HC value on the screen.

■ Fetal Weight
This menu is used to set the measurement items used for fetal examination. In the fetal
weight and fetal weight growth fields, more measurement items can be added.

– Unit: This sets the unit of fetal weight measurement. You can choose from grams [g],
ounces [oz], and pounds [lb].

– Auxiliary Unit: This sets the auxiliary unit of fetal weight measurement. Unit sets the
Chapter3. Setting 3 - 25

available auxiliary unit. For instance, set the unit as Gram [g], available units are None,
oz, lb, or lb+oz. If you select lb+oz as an auxiliary unit, the value will be shown like as
xx lb yy oz.

– Display SD: This menu sets the SD information shown in the result display section: No,
SD or Percentile. Both SD and Percentile appear in the report.

■ Preset
Measurement items used during exams are set.

Set a specific preset in the Name field. If ‘General’ is selected, all items can be used. If
‘Fetal Biometry’ is selected, only Fetal Biometry-related items can be used.

– User Preset

If the beside the Name field is selected, a user can set a new preset.

Enter a title in the Preset Name field and a Autotext explanation in the Description field.
Press Ok.

[Figure 3.17 New Preset window]

After a new preset is made, register items in the right-hand list to use in obstetrics
measurement. When is clicked, the items in the right list are moved to the left list
to be used with the user preset. To delete the items from the left list, select them and
click .

To delete a user preset, select it and click . Because `General and Fetal Biometry’
are system presets, cannot be deleted.

– Table and Equation

The measurement items used in the Preset menu are GA and Fetal Growth. The
measurement values of GA and Fetal Growth are shown in table or equation form.

When is clicked, the contents of the GA or Fetal Growth’s table and equation
contents are shown. When is clicked, a user can set a specific value, and when
is clicked, the table and equation set by the user are erased. However, the default
values provided by the system are not erased.

For more information about each table and equation, refer to the Reference Manual.
3 - 26 SONOACE X6 User manual

■ Graph
The user can select graphs to mark on the OB report or print. Press Graph button and
select items. After selecting/deselecting a specific item, click Close.

[Figure 3.18 Graph window]

– MCA/UA Graph

Set MCA/UA graph and reference. Selected graphs will be included in the OB report.

– HC/AC Graph

Include HC/AC ratio in the graph.

– Report Graph

Select graph to include in the report. ‘All’ displays all graphs, and ‘Data Exist’ displays
only the graph has its data.

– Print Graph

Select graph to print. ‘All Graph in Report’ prints all graphs of the report, and ‘Data
Exist’ prints only the graph has its data. ‘Current Page’ prints the current page of
report.
Chapter3. Setting 3 - 27

■ Backup / Restore
– Backup

If you want to back up a new user preset to Mo Media, Flash Memory or a HDD, press
Backup/Restore on the screen. When the setting window is displayed, select the disk
and directory. Directories can be created or deleted using the New Dir. or Remove Dir.
Take care when deleting directories or files. Once a file or directory is erased, it cannot
be restored.

During user-preset backup, all user reference tables/equations are backed up.
Separate tables/equations backup is therefore not necessary.

– Restore

To bring up the backed up user preset, click Backup/Restore. When the


Backup/Restore screen appears, select the disk and directory which the user preset
is to be restored to.

[Figure 3.19 Measurement Settings - Backup/Restore]


3 - 28 SONOACE X6 User manual

Fetal Echo Measurement Setup

[Figure 3.20 Measurement Setting - Fetal Echo]

During obstetric measurement, Fetal volume can be measured in M Mode. The calculation
method is set in the ‘LV Volume Calculation’.The options are the same as those in the cardiac
package (Teichholz, Cubed, or Gibson).
Chapter3. Setting 3 - 29

Cardiac Measurement Setup


To set up cardiac measurement, select the Cardiac tab in the Measure menu.

■ 2D Circumference and Area Method


Select either the ‘Ellipse’ or ‘Trace’ caliper to be the default tool for area measurement.

■ LV Volume Calculation
The LV Volume Calculation method is set with this menu.

[Figure 3.21 Measurement Setting window – Cardiac]


3 - 30 SONOACE X6 User manual

Urology Measurement Setup


To set up urology measurement, select the Urology tab in the Measure menu. This menu sets
the formula used to calculate volume values during urology measurement.

[Figure 3.22 Measurement Setting window – Urology]

■ Volume Method
‒ 3 Distance: The volume value is calculated using three diameters in the longitudinal
and transverse planes. (4 / 3 x 3.14 x A x B x C / 8)
‒ 3 Distance x Factor: The volume value is calculated using three diameters from the
longitudinal plane and transversal plane and a factor (F) value entered by a user.
( A x B x C x F)
‒ Ellipsoid: The volume value is calculated using the lengths of the Main axis and the
beside axis. (4 / 3 x 3.14 x Main / 2 x (Beside / 2)2)
‒ Sum of 20 Disks: The volume value is calculated by summing the areas in the 20-
parallel planes. (d / 20 x (A1 + A2 + ... A20), d : the sum of distances between disks)

3 Distances: A = 1st Dia. ; B = 2nd Dia. ; C = 3rd Dia.


NOTE The default factor value (F) is ‘0.5’. If it is changed, a value between 0 and
100 (0 < factor <= 100) is recommended.

■ Predicted PSA Correction Factor


The Predicted PSA Correction Factor can be changed. The default value is 0.12.
Chapter3. Setting 3 - 31

Vascular Measurement Setup


Select the Vascular tab in the Measure menu. You can set the peak velocity used in the
calculation of the ‘A/B Ratio’ and ‘ICA/CCA Ratio’.

[Figure 3.23 Measurement Setting window – Vascular]


3 - 32 SONOACE X6 User manual

Setting DICOM (Optional)


Select the DICOM tab in the Setup menu. This function is used to set up the DICOM server and
other DICOM-related functions.

For more information, refer to the user manual of the corresponding server
NOTE and the DICOM Conformance Statement.

[Figure 3.24 Setting DICOM]

Setting DICOM Information


Enter the DICOM information for the product in use. For automatic DICOM transmission, select
‘Acquisition in Progress’ after completing the fields. For automatic print out, select ‘Print After
Each image’.

■ AE Title
Enter the DICOM Application Entity title of the ultrasound system. This title uses to
distinguish the ultrasound system in the network. (Ex. US, US2)

■ Station Name
Enter a name to differentiate pieces of ultrasound system. (Ex. SONOACE1,
SONOACE2)
Chapter3. Setting 3 - 33

■ Port
Enter the Port Number of the server being used.

■ Network Status
Display the current status of the network.

Network Setup
To set the network like IP address, press System Network Settings. To set the IP value
automatically, press ‘Using Dynamic IP Configuration’. If you enter the wrong IP address, the
network will not run.

To finish the network setup, press the Apply. To cancel setup, press the Close.

Adding or Changing the DICOM Server


Press Add to enter the information related to the DICOM Server.

■ Service
Select the kind of server to use; Store, Print, Worklist.

■ Alias
Enter the name of the server being used.

■ AE Title
Enter the AE title of the server being used.

■ IP Address
Enter the IP address of the server being used.

■ Port
Enter the Port Number of the server being used.
3 - 34 SONOACE X6 User manual

▌ Store Server Information


Select STORE under Services. Configure the Image Storage Service using DICOM

■ Service
Select the kind of server to use.

■ Alias
Enter the name of the server being used.

■ AE Title
Enter the AE title of the server being used.

■ Transfer Mode
Select any one of the three image transfer methods.

– Batch: send all images when you click the End Exam.

– Send As You Go: send the image whenever you press the Save button.

– Manual: send the image manually only in the SonoView.

■ Connect Timeout
Set how many seconds the system will wait until get response.

■ IP Address
Enter the IP address of the server being used.

■ Port
Enter the Port Number of the server being used.

■ Retry Interval
Set how many seconds the system will wait if the transmission fails.

■ Maximum Retries
Set how many times the system will retry.
Chapter3. Setting 3 - 35

[Figure 3.25 DICOM Configuration-Store]

▌ Print Server Information


Select PRINT under Services. Configure the Print Service using DICOM.

 You can configure a printer connected to the DICOM network only.

NOTE  Depending on the printer, some of the following functions may not be
available. Before configuring a printer service, please refer to the user
manual for the printer or the DICOM Conformance Statement.

■ Color
Specify whether to use colors. Select Grayscale or RGB.

■ Format
Specify the paper layout. Select from 1ⅹ1, 1ⅹ2, 2ⅹ2, 2ⅹ3, 3ⅹ3, 3ⅹ4, 3ⅹ5, 4ⅹ4,
4ⅹ5 and 4ⅹ6.

■ Orientation
Specify the paper orientation. Select Landscape or Portrait.

■ Magnification
When resizing an image to print, specify the interpolation. Select from Replicate, Bilinear,
Cubic and None.

■ Border Density
Specify the border density of an image to print. Select Black or White.

■ Empty Density
Specify the background color of an image to print. Select Black or White.
3 - 36 SONOACE X6 User manual

■ Min Density
Specify the minimum brightness of an image to print. If this option is not specified, the
default value is applied.

■ Max Density
Specify the maximum brightness of an image to print. If this option is not specified, the
default value is applied.

■ Medium Type
Specify the paper type. Select from Paper, Clear Film, Blue Film, Mammo Clear Film and
Mammo Blue Film.

■ Film Size
Specify the paper size. Select from 8 inchⅹ10 inch, 5 inchⅹ11 inch, 10 inchⅹ12 inch, 10
inchⅹ14 inch, 11 inchⅹ14 inch, 11 inchⅹ17 inch, 14 inchⅹ14 inch, 14 inchⅹ17 inch,
24cmⅹ24cm, 24cmⅹ30cm, A4 and A3.

■ Destination
Specify the paper pathway. Select Magazine or Processor.

■ Smoothing Type
This option is available only when Magnification is set to CUBIC. Enter a value specified
in the DICOM Conformance Statement for the printer.

■ Priority
Specify a priority for the print command. Select from High, Med and Low.

■ Copies
Enter the number of copies between 1 and 99.

■ Configuration Info
Specify the unique value for a printer. Please refer to the DICOM Conformance Statement
for the printer.
Chapter3. Setting 3 - 37

[Figure 3.26 DICOM Configuration - Print]

▌ Worklist Server Settings

■ Open MWL on Patient key


Sets the screen that appears when pressing the Patient button on the control panel.

If this function is selected, pressing the Patient button opens the Modality Worklist
window. If not selected, pressing the Patient button opens the Patient Information screen.

■ Update Method
Sets the method for updating Worklist.

– Only on user Request: Update only when asked by the user.

※ Tip!

To update a worklist, in the Search tab on the Patient Information screen, select
Worklist for Search Source and press Search.

– On Startup and Every_ Min.: Worklist is updated at the system boot-up and then
updated continually at a set interval. Note that Worklist is not updated while the
Modality Worklist window is open.

■ Scheduled Station AE Title


Sets the range of AE Title to fetch from the hospital’s Worklist server.

– All: Obtains the list of patients saved under all AE Titles within the server.

– This System: Obtains the list of patients for the AE Titles set under the DICOM tab.

– Another: Obtains the list of patients for the AE Title directly entered by the user.
3 - 38 SONOACE X6 User manual

NOTE This function is available only if when the Worklist server is configured.

■ Start Date
Set the range of dates to search.

– Today: Obtains the list of patients for the current date.

– Prior_days, Next_days: Obtains the list of patients for dates between n days prior to
the current date and n days after the current date.

– Period

From Date: Enter a date and the system obtains the list of patients starting from the
date entered up until the current date.

To Date: Enter a date and the system obtains the list of patients starting from the
current date up until the date entered.

From Date To Date: Enter two separate dates and the system obtains the list of
patients between the two dates entered.

[Figure 3.27 DICOM Configuration – Worklist]


Chapter3. Setting 3 - 39

Editing the DICOM Server Information


Press Edit in the setting DICOM window to edit the server information already entered.

Deleting DICOM Server


Press the Delete in the setting DICOM window to erase the current server information.

Testing DICOM Server


Press the Test in the setting DICOM window to check the connection between the system and
the DICOM server.

DICOM Log
Press the Log in the setting DICOM window, and the screen will be changed. Set or copy the
current DICOM log file.

DICOM log file is the history of all DICOM services performed so far on the product.

Press the Close to finish the DICOM log.

■ Log Settings
Set the DICOM Log.

– Delete archived log file after: set the number of days to wait before deleting the
archived history. After that period, the log file will be deleted. However there is only
one log file, it will not be deleted.

– Log File Maximum Size: set the maximum size of each history file archived. Set the
unit as Kbytes.

■ Explanation
View the log setting.
3 - 40 SONOACE X6 User manual

■ DICOM Log
View, copy, or delete the DICOM log files.

– View Selected File: Select the log file from ‘Select log files to copy’ and press the View
selected file.

– Copy Selected Files:

1. Select the log files and set the storage file format on the ‘Copy to’.

2. Set the ‘Delete files after copy’ whether to delete the log files saved in the hard disk
of the system.

3. Press the Copy selected files.

– Delete Selected Files: Select the log file and press the Delete Selected Files.
Chapter3. Setting 3 - 41

Setting Option
The S/W serial No information of the system is shown in this window. You can select/cancel
S/W options. A user cannot modify options. Select the Option tab in the Setup menu.

If the password you enter is not correct, the options are not activated. If the password is not
correct, click Cancel.

[Figure 3.28 Setting Option]


3 - 42 SONOACE X6 User manual

Setting Peripheral Devices


The following describes how to set up the video output type, video input type, printer, foot switch
and network. Select the Peripherals tab in the Setup menu.

[Figure 3.29 Peripherals Setting]

■ Video Input Type


Set the video input type as VHS or S-VHS.

■ Foot Switch
Assign functions to the left and right pedals of the foot switch. Four options are available:
Dual, Store, Freeze and Update.

■ Printer
Select a printer to use. After connecting a USB printer to the USB port of the system,
select the printer type on the screen and click Ok. The printer can then be used
immediately.

The USB printer can only be used to print out Report and SonoView screens.

‒ HP DeskJet 5650 ‒ HP DeskJet 6980


‒ HP Color LaserJet 3600
‒ HP DeskJet 5940 ‒ HP LaserJet 1320
‒ HP OfficeJet J5780
‒ HP DeskJet 6540 ‒ HP LaserJet 2420
‒ HP OfficeJetProK550
‒ HP DeskJet 6940 ‒ HP LaserJet P2015
Chapter3. Setting 3 - 43

Information
The information menu displays information about the system S/W version. Select the
Information tab in the Setup menu. Press the Detail Info. to view more detailed information.

Click License Info. to display license information

[Figure 3.30 Information]

* The S/W version of your system may be different from that in the figure above.
3 - 44 SONOACE X6 User manual

Utilities
Press [F9] Utility button on the keyboard. The Utility menu appears at the left side of the
screen. You can select a menu with the Menu dial-button on the control panel.

[Figure 3.31 Utility menu]

Biopsy
The Biopsy function is designed to obtain cells of abnormal tissue via the Biopsy Needle.

To change Biopsy Guideline settings, press Utility button on the control panel. If Biopsy
Guideline is disabled you cannot mark guidelines on the screen.

NOTE Prior to use Biopsy, edit the biopsy guideline first.

▌ Editing Biopsy guide line

 Note that the Biopsy Guide Line cannot be edited when the
Trapezoidal function is in use for the Linear Probe.
NOTE
 If the system is rebooted, the Biopsy Guide Line settings are
restored to the default.

1. Select Edit in the Biopsy menu. The warning message will appear.

2. If you press the Ok, the Biopsy Edit screen appears. Press the Cancel to escape from
the Biopsy menu.

3. After the Biopsy Edit screen appears, you can adjust the Biopsy Guide Line with the soft
menu on the keyboard.
Chapter3. Setting 3 - 45

– Flexible soft button [1] Start: Move the Trackball up and down to designate the
starting point of the Biopsy Guide Line.

– Flexible soft button [2] Angle: Move the Trackball right and left to decide the
direction of Biopsy Guide Line movement.

4. Press Flexible soft button [4] Save to setting. The confirmation message will appear
before saving settings.

5. Press the OK button on the message to apply the changed Biopsy Guide Line. Press
Flexible soft button [5] Cancel to cancel saving.

[Figure 3.32 Biopsy Edit]

▌ Starting and Finishing Biopsy

Before performing biopsy, make sure that the Biopsy Guide Line is
NOTE adjusted.

1. Select On in the Biopsy menu. The message below appears. The warning message will
appear.

2. Press OK, and the Biopsy Guide Line will appear on the screen.

3. Insert a needle along the Guide Line. And then perform biopsy as desired.

4. To finish the biopsy, select Off in the Biopsy menu.


3 - 46 SONOACE X6 User manual

ECG
The ECG (echocardiogram) function allows viewing of the cardiac pulsation.

To turn on ECG, select ECG in the pop-up menu. The ECG setting menu appears.

▌ Starting ECG and terminating


Use the Flexible Soft dial-button [1] to turn on or off the ECG.

[Figure 3.33 ECG]

▌ ECG Setup

■ Size
Set the size of ECG. ‘Large’, ‘Normal’, or ‘Small’ is available.

■ Position
Set the position of ECG from 0 to 300. When its number is large, ECG will be displayed in
upper side of screen.

■ Trigger
Set the Trigger interval or Off.

■ Trigger Time
Set the Trigger time.

CAUTION If the ECG is less then 30Hz, the Heart Rate (HR) is not displayed.
Chapter3. Setting 3 - 47

▌ Dual ECG
Compare two cardiac images.

Press Dual button on the control panel. Use the Set button or Dual button to change the
activated image in Dual Mode.
3 - 48 SONOACE X6 User manual

Monitor Calibration
Select Monitor Calibration in Utility menu.

■ Gamma: Set up contrast and brightness.


■ Brightness: Set up brightness.
■ Contrast: Set up contrast.
■ R Gain: Set the red color proportion.
■ G Gain: Set the green color proportion.
■ B Gain: Set the blue color proportion.
■ Default: Go back to default setting.
■ Save: Save the setting.

Preset
Preset allows the user to adjust Image Settings and select a Setting to apply to the system.

Select Preset in the utility menu.

[Figure 3.34 Preset]

■ Setting: Use the Menu dial-button to make your selection. You can use the default Image
Setting or choose from the User1 ~ User5 slots. If you select the value from User1 to User5,
you can setup the image setting.

■ Load: Select the desired Setting value and press Load to apply the value to the current
screen.

■ Save: After Image Setting, select the desired Setting value and press the Save.
Chapter3. Setting 3 - 49

Miscellaneous
Select Miscellaneous in the utility menu.

[Figure 3.35 Miscellaneous]

▌ Histogram
Shows the brightness level of the selected area in a histogram.

1. Press Histogram in the Miscellaneous menu.

2. Specify an area that a histogram is to cover. Use the Trackball and the Set button to
specify area 1, 2 and 3.

– Press the Change button to change the shape of the selected area into an ellipse.

3. Histogram 1, 2 and 3 will appear on the screen.

[Figure 3.36 Histogram]


3 - 50 SONOACE X6 User manual

▌ Demo Images
Select Demo Image in the menu. This function displays DEMO images obtained from this
system.

To adjust the display time, use the Flexible Soft button [1] Slower and [2] Faster. To
change to the previous or next one, use the Flexible Soft button [3] Prev, or Flexible Soft
button [4] Next. Press the Flexible Soft button [5] Play/Pause to pause the image cycle;
press it again to resume the cycle.

To end the Demo function, press Exit button on the control panel or Esc key on the
keyboard.
Chapter 4

Diagnosis Modes
Diagnosis Mode Types and Control ........................................................................... 3
Diagnosis Mode Types ............................................................................................................. 3
Basic Use .................................................................................................................................. 4

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


2D Mode ................................................................................................................................... 8
M Mode ................................................................................................................................... 12
Color Doppler Mode................................................................................................................ 14
Power Doppler Mode .............................................................................................................. 18
Spectral Doppler Mode ........................................................................................................... 20

Combined Modes........................................................................................................ 26
2D/C/PW Mode ....................................................................................................................... 26
2D/PD/PW Mode .................................................................................................................... 27
2D/C/CW Mode ....................................................................................................................... 28
2D/PD/CW Mode .................................................................................................................... 29
2D/C/M Mode .......................................................................................................................... 30

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


Dual-2D Mode ......................................................................................................................... 31
Dual-2D/C Mode ..................................................................................................................... 32
Dual-2D/PD Mode ................................................................................................................... 33

3D Mode ...................................................................................................................... 34
3D ........................................................................................................................................... 34
Acquiring a 3D Image ............................................................................................................. 35
3D View................................................................................................................................... 36
Chapter4. Diagnosis Modes 4 - 3

Diagnosis Mode Types and Control

Diagnosis Mode Types


This product supports a variety of diagnosis modes including Basic Mode, Combined Mode,
Multi-Image Mode, and 3D Mode.

■ Basic Mode: Consists of different modes, each of which has a specific usage and function.
By default, 2D Mode is applied together with other mode.

■ Combined Mode: For an image, two or three Basic Modes are applied at the same time. By
default, 2D Mode is applied together with other mode. An image is viewed in a single screen.

■ Multi-Image Mode: The screen is divided into two (dual) sub screens, each of which is used
to view an image. Since each sub screen can display a different image, it can be a very
useful feature, allowing multilateral views of an organ.

■ 3D Mode: Freehand 3D images can be obtained.


The types of diagnosis mode that are available with the product are shown below:
Mode Type
2D Mode
Color Doppler Mode
Power Doppler Mode
Basic Mode
M Mode
PW Spectral Doppler Mode
CW Spectral Doppler Mode
2D/C/PW Mode
2D/PD/PW Mode
Combined Mode 2D/C/CW Mode
2D/PD/CW Mode
2D/C/M Mode
Multi-Image Mode Dual Mode
3D Mode Freehand 3D Mode

NOTE The functionalities for each mode may be restricted by the selected probe.
4 - 4 SONOACE X6 User manual

Basic Use
The items that can be used commonly in each diagnosis mode are shown below:

■ Gain
Use the Gain dial-button on the control panel. You can adjust the brightness of an image.
If you rotate the Gain dial-button clockwise, its value increases.

■ TGC (Time Gain Compensation)


Use the TGC slide on the control panel.

In general, ultrasound penetration gets weaker with depth. TGC can be used to
compensate for this effect.

The product provides eight TGC slides for varying depths, allowing you to adjust Gain by
area. Among the eight slides, the top slide represents the shallowest area, while the
lower slides represent the deeper ones.

Move the slide to the right (+) to increase Gain, brightening the image.

Too large a difference in the gain value settings of two adjacent


CAUTION slides may lead to inaccurate image generation.

■ Focus
Use the Focus switch on the control panel. Raise/lower the Focus switch raise/lower the
focusing point.

■ Depth
Use the Depth switch on the control panel. Raise/lower the Depth switch to
decrease/increase the scanning depth of an image. The allowable range for adjustment
varies with the selected probe.

■ HD Zoom
This function allows you to magnify and scan an image in real time.

1. Use the HD Zoom switch on the control panel to start Write Zoom mode. The Write
Zoom box will appear on the screen.

2. Use the Change button to move and resize the Zoom box. Each time you press the
Change button, the current state of the Zoom box is displayed in the lower left of the
screen.

– Zm Pos.: You can move the Zoom box. Use the Trackball to move the Zoom box
and press the Set button to specify its position.
Chapter4. Diagnosis Modes 4 - 5

– Zm Size: You can resize the Zoom box. Use the Trackball to resize the Zoom box
and press the Set button to specify its size.

3. Press the Set button to start the Write Zoom function. Magnify an image and scan it.

4. Press the Exit button to exit Zoom Mode. Changing the depth also exits Zoom Mode
automatically.

※ Tip! Zoom Navigation Box

You can view the position of the magnified area through the Zoom Navigation Box on
the screen. In HD Zoom mode, press the Z key on the keyboard to make the Zoom
Navigation Box disappear and Zoom Position deactivate. Press Z key again, and the
Zoom Navigation Box is shown again.

■ Zoom
This function allows you to zoom an image saved in a hard disk.

In HD Zoom mode, it is available to press the Zoom button on the control panel to start
the Read Zoom mode. However, in Read Zoom mode, you cannot enter the HD Zoom
mode with the Zoom button.

1. Press the Zoom button on the control panel to start Read Zoom mode. The Read
Zoom box will appear on the screen.

2. Use the Trackball to move the Zoom box. You can locate the Zoom box in an image
with the Zoom Navigation box on the left side of the screen.

3. View the magnified image. If you rotate the dial-button clockwise, the image is
magnified.

4. Press the Exit or Zoom button to exit Zoom Mode. Changing the depth also exits
Zoom Mode automatically.

■ QuickScan
Use the Quick Scan button on the control panel. The ‘Q Scan’ mark will appear at the top
of an image.

In 2D Mode, it is used to optimize the contrast and brightness of an image by adjusting


Gain and TGC automatically. In PW Spectral Doppler Mode, it is used to optimize the
spectrum by adjusting Scale and Baseline automatically. Press the Exit button to quit the
Quick Scan Mode.

■ Harmonic
Press the Harmonic button on the control panel. ‘HGen’, ‘HRes’, ‘HPen’ mark is
displayed in the image information area.

This product provides the OHI (Optimal Harmonic Imaging) function that optimizes an
image with high frequencies.
4 - 6 SONOACE X6 User manual

NOTE The Harmonic function is available with specific probes only.

■ Post Map Settings


Use the Menu/Angle dial-button on the control panel and press 2D Post, M Post, PW
Post, or CW Post on the menu to bring up the sub-menu. On this sub-menu, select an
appropriate map from Type1~5, User1~3.

When select User, you can make your own Map.

Select Return to escape this status.

※ User Post Map Edit

1. Press Edit in the menu. The User Post Map image and its Flexible Soft Menu
appear on the screen.

[Figure 4.1 The Flexible soft menu of Post map]

– Add: Add a new point between the currently selected point and the adjacent
point.

– Delete : Delete the currently selected point .

– Save : Save the map.

– Cancel : Cancel Map editing and return to the original map.

– Apply : Apply the Map setting to the image.

2. Each map point is selected with the Change button on the control panel, and you
can set the shape of the map with the Trackball and Set button.

■ Chroma Settings
Use the Menu/Angle dial-button on the control panel to press Chroma on the menu, and
then select On or Off. If you change the color, select Color on the menu and choose the
color.
Chapter4. Diagnosis Modes 4 - 7

■ Gamma Settings
Use the Menu/Angle dial-button on the control panel to press Gamma on the menu, and
then select Off, Weak, Medium or Hard. Adjusts the contrast.

– Weak: make the image brightly.

– Medium: make the image medium bright.

– Hard: make the image darkly.

■ M Line
Press the [F2] M Line key on the keyboards. It shows M Line on the image.
4 - 8 SONOACE X6 User manual

Basic Modes

2D Mode
This basic mode, also referred to as B Mode (Brightness mode), shows anatomy scan planes.

[Figure 4.2 2D Mode]

▌ 2D Mode Selection
Press the 2D button on the control panel.

2D Mode is the default mode and the 2D button is not a toggle button. Instead, it is used to
return to basic 2D Mode when in other image modes.
Chapter4. Diagnosis Modes 4 - 9

▌ Changing 2D Image Format

■ Changing Image Direction


– Changing Left/ Right Orientation (Horizontal Orientation Direction)

Press the Flexible Soft button [1] Direction.

– Changing Up/down Orientation (Vertical Orientation. Apex)

Select Apex in the 2D menu using the Menu/Angle dial-button.

■ Changing View Area


Select View Area in the menu using the Menu/Angle dial-button on the control panel.

You can adjust View Area using the Flexible soft button [3] Size + and [4] Size –
buttons in the Flexible Soft Menu.

Widening / narrowing the View Area, decreases/increases the frame rate (FPS). If you
want to view other unseen parts, press the Pos.L and Pos.R buttons in Flexible Soft
Menu to move the View Area to the right or left.

To apply changed view area and go to scan mode, press the Flexible Soft button [5]
Return.

During using a linear probe, flexible soft button [1] Pos.L, and [2] Pos.R
NOTE are not available.

▌ 2D Image Optimization

■ Extended Resolution (Ext. Res.)


Use the Flexible soft button [2] Ext. Res.

Increases the resolution by increasing the number of channels. Note that the frame rate
falls in proportion to the number of channels.

■ Frequency
Use the Flexible soft button [3] Frequency.

Use the button to change the frequency of the current probe. Select from Res, Pen and
Gen.

– Res (Resolution): Low frequency

– Gen (General): General frequency


4 - 10 SONOACE X6 User manual

– Pen (Penetration): High frequency


The selected frequency is displayed in the title area, allowing you to determine the
state of the current frequency easily.

■ Density
Press Flexible soft button [4] Density.

Use the dial-button to select the scan line density. If it is set to High, the number of scan
lines increases, enhancing the image resolution. However, the frame rate is reduced.

■ Frame Average Control


Use the Menu/Angle dial-button on the control panel to press FA in the menu. Select a
value between 0~9.

The Frame Average function is used to average frames together on the screen, thereby
reducing the speckles, which make diagnosis difficult. Setting the Frame Average value
as high makes the display movements smoother but slower. (Though the actual frame
rate doesn’t drop.) Turn the function off in OB and cardiac examination where organs are
highly active.

■ Dynamic Range Control


Use the Menu/Angle dial-button on the control panel to press DR in the left menu. Select
a value between 40~180.

This function is used to change the range of contrast by adjusting the ratio of
minimum/maximum input signal value ratio. Increase/decrease Dynamic Range to
smooth/roughen the image.

■ Edge Enhance Control


Use the Menu/Angle dial-button on the control panel to press EE in the menu. Select a
value between 0~9.

This function is used to view more accurate images of organ or tissue boundaries.
Increase the Edge Enhance value to obtain clearer pictures of boundaries.

■ Reject Level Control


Use the Menu/Angle dial-button on the control panel to press Reject in the left menu.
Select a value between 1~32

This function is used to eliminate noise or low level echoes for clearer signals.

■ Focus Number Control


Press the Flexible Soft button [5] Focus No. Use [3] Focus + or [4] Focus - to set the
focus number.
Chapter4. Diagnosis Modes 4 - 11

■ Frame Rate Control


Use the Menu/Angle dial-button on the control panel to press Frame Rate in the left
menu. Select Fast, Normal, or Slow.

The Frame Rate is the number of images generated per second. The Frame Rate should
be set to Fast when viewing fast moving organs.

■ Tissue Property Control


Use the Menu/Angle dial-button on the control panel to select Tissue in the menu.

Select the desired ultrasound speed according to the patient’s tissue type. The Tissue
menu consists of Cystic, Adipose, Normal, and Solid.

■ Trapezoid Function
This function is used to view the trapezoid-shaped 2D image when using the Linear
probe. Use the Menu/Angle dial-button on the control panel to select Trapezoid in the
menu.

When adjusting image depth, some depth values do not support the Trapezoid function.
Using HD Zoom switch makes the Trapezoid function off.

■ FSI (Full Spectrum Imaging)


Use the Menu/Angle dial-button on the control panel to select FSI in the menu.

This function synthesizes images with data obtained with frequencies of different
characteristics. Therefore, shallow observation depths yield higher resolution and deep
observation depths yield higher penetration. Select a value between 1 – 3.

■ Format

NOTE This item is displayed only in 2D menu under dual model.

Use the Menu dial-button on the control panel to select Format in the menu. ‘Hor’ means
Top Down Format, in dual mode image, and ‘Ver’ means Side by Side Format, in which
the two images are set side-by-side.

■ 2D Post
Use the Menu dial-button on the control panel to select 2D Post in the menu.

Select Loop Format in the menu using the Menu dial-button on the control panel. ‘Hor’
means Top Down Format, in which 2D image is set above the PW Spectral Doppler
image, and ‘Ver’ means Side by Side Format, in which the two images are set side-by-
side.
4 - 12 SONOACE X6 User manual

M Mode
In M Mode, you can observe the motion patterns of an area of anatomy - along a 2D image
reference line (M Line). This mode is especially useful for cardio-valvular observation.

[Figure 4.3 M Mode]

▌ M Mode Selection
Press the M button on the control panel. Press M button again. M Mode turns off and 2D
Mode turns on.

▌ Changing M Mode Format

■ Image Direction Change


Press the Flexible soft button [1] Direction to change the direction of the image.
Chapter4. Diagnosis Modes 4 - 13

■ M Line Control
Move the M Line to change the observation location. The M Line can be moved left and
right by using the Trackball on the control panel.

■ M Image Size Change


To adjust the size (Large, Normal or Small) of the 2D image and the M image, select an
M Mode image size with the Flexible Soft button [5] M Size.

■ Sweep Speed Control


Choose from 120Hz, 180Hz, 240Hz or 300Hz with the Flexible soft button [2] Speed
button on the control panel.

■ Loop Format Change


Select Top Down Format or Side-by-Side Format using the Flexible Soft button [3]
Loop Format. Top Down Format sets the 2D image and M image at the top and bottom
of the screen. Side-by-Side Format sets the images side by side.

■ M Post
Use the Menu dial-button on the control panel to select M Post in the menu.

NOTE Refer to ‘2D Mode’ for more information about other items in the menu.
4 - 14 SONOACE X6 User manual

Color Doppler Mode


This mode displays the colored blood flow pattern of the ROI (Region of Interest) within the 2D
image.

It is appropriate for examining the presence of the blood flow, its average speed and direction.
The 2D Mode image is also shown allowing the marking and adjustment of the ROI within the
entire image.

[Figure 4.4 Color Doppler Mode]

▌ Entering & Exiting C Mode


Press the Color button on the control panel. Press the button again, and C Mode will be
terminated and the mode switched to 2D.
Chapter4. Diagnosis Modes 4 - 15

▌ Changing Color Image Format

■ Controlling Color Bar Baseline Control


The colors above the baseline represent the direction/speed of blood flow moving toward
the probe, and the colors below the baseline represent the direction/speed of blood flow
away from the probe.

Use the Flexible soft button [2] Baseline switch on the control panel.

Baseline can be adjusted only when the Color Doppler Mode value is set to Velocity.

■ Color Bar Invert


Use the Menu dial-button on the control panel to select Invert in the menu.

■ Changing Color Display Information


Select Color Mode in C-Menu using the Menu dial-button on the control panel.

Use the Menu dial-button to cycle through the available settings - Velocity, Power,
Variance, and Vel + Var.

▌ Color Image Optimization

■ Changing ROI Box Position


The ROI is the area within the 2D image where color (blood flow) information is displayed
in Color Doppler Mode. Use the Trackball to change the ROI Box position.

■ Changing ROI Box Size


Enter the ROI Box Size Control Mode by rotating the Menu dial-button without opening
the pop-up menu or pressing the Change button on the control panel. Adjust the ROI Box
size with the Trackball. To return to the ROI Box Position Change Mode, rotate the Menu
dial-button without opening the pop-up menu or press Change button again.

■ Scale (PRF) Control


Use the Flexible soft button [1] Scale on the control panel. If you raise/lower the switch,
PRF (Pulse Repetition Frequency) increases/decreases so that the speed range of blood
flow is widened/narrowed.
4 - 16 SONOACE X6 User manual

■ Wall Filter Control


Wall filter is an electrical filter used to eliminate low-frequency Doppler signals caused by
the motions of vessel walls. Eliminate Doppler signals whose frequencies are lower than
the Cutoff Frequency by adjusting the Cutoff Frequency.

Use the Flexible soft button [3] Filter on the control panel. If you raise the Filter switch,
the Cutoff Frequency of the Wall Filter decreases, and vice versa.

■ Sensitivity Control
Select Sensitivity in C-Menu using the Menu dial-button on the control panel. Select the
value (8~31).

To increase/decrease Sensitivity, raise/lower the Sensitivity value. Increasing the Color


Sensitivity decreases the frame rate, and vice versa.

■ Balance Control
This function is used to adjust the range of the color image displayed by comparing the
gray level of the 2D image with the Doppler signal value of the color image. If the Balance
value increases, the color image is seen even where the 2D image signal is strong
(bright), thereby increasing the color image range.

Select Balance using the Menu dial-button on the control panel and adjust the value
(1~16).

■ Steer Function
When Linear probe is selected, this function adjusts the ultrasound beam angle to
prevent the loss of color information caused by the ultrasound beam angle.

Pressing the Steer button on the control panel steers the ROI to the left, center and right
- in that order.

■ Display Function
Color Doppler Mode supports Color + B/W Image, Color Only, and B/W Only display.

Select Display in the menu using the Menu dial-button on the control panel. In Freeze,
use the Flexible Soft Button [5] to select the function.
Chapter4. Diagnosis Modes 4 - 17

■ TDI (Tissue Doppler Image) Function


This function is used to show the movements of the cardiac tissues. To use the TDI
function, use the Menu dial-button on the control panel to select Tissue Doppler from
the menu on the left-hand side of the screen.

It uses the color information of Color Doppler Mode or Power Doppler Mode. It also uses
the change of cardiac tissue of PW Spectral Doppler Mode as time goes by. It is only
used in the specific application (General, Cardiac, Pediatric) of Phased Array probe.

■ C Post
Select C Post in the menu. You can select Color Map.

■ Capture
Select Capture in the menu. You can select Capture on or off and Frame value.

■ Color Tag
Select Color Tag in C-Menu using the Menu dial-button on the control panel.

NOTE For further information about other items in the menu, refer to ‘2D Mode’.
4 - 18 SONOACE X6 User manual

Power Doppler Mode


This mode displays the color intensity of blood flow within the ROI in the 2D image.

It is appropriate for examining the presence and amount of blood flow. The 2D Mode image is
also shown, allowing the marking and adjustment of the ROI within the entire image.

Following applications of Phased array probes are not available in power


NOTE Doppler mode; General, Cardiac, Pediatric.

[Figure 4.5 Power Doppler Mode]

▌ Power Doppler Mode Selection


Press the PD button on the control panel. Pressing PD button again turns PD Mode off, and
2D Mode on.
Chapter4. Diagnosis Modes 4 - 19

▌ PD Mode Screen

■ Color Bar
Colors show the existence and amount of blood flow in PD Mode. The top of the color bar is
the brightest section, where the amount of blood flow is at its highest.

▌ Power Doppler Image Optimization

■ Display
Select Display in the Menu using the Menu dial-button on the control panel. You can
select BW+PD, PD Only, or BW Only.

■ Multi Freq (Multi Frequency)


Select Multi Freq in the Menu using the Menu dial-button on the control panel. This
controls the frequency in the ROI box. Select Pen or Gen.

■ PD Post
Select PD Post in the menu. You can select PD Map.

For further information about other PD Image optimization, refer to ‘Color


NOTE Doppler Mode’.
4 - 20 SONOACE X6 User manual

Spectral Doppler Mode


Spectral Doppler Mode gives information on the speed/direction of blood flow at a specific site
in the form of a spectral trace and audio signal. It is divided into PW (Pulsed Wave) Spectral
Doppler Mode and CW (Continuous Wave) Spectral Doppler Mode.

▌ PW Spectral Doppler Mode


PW Spectral Doppler Mode gives information on the speed of blood flow at a specific site in
the form of a spectral trace and audio signal. Since the pulse is transmitted being divided
according to time, distance (depth) information can be obtained. The mode is suitable for
measuring relatively slow blood flow such as that in abdominal and peripheral vessels. The
2D Mode image is shown simultaneously allowing the marking and adjustment of specific
sites within blood vessels.

Press the PW button on the control panel. Press PW button again to enter 2D Mode.

[Figure 4.6 PW Spectral Doppler Mode]


Chapter4. Diagnosis Modes 4 - 21

▌ CW Spectral Doppler Mode (Optional)


CW Spectral Doppler Mode gives information on the speed/direction of blood flow in the form
of a spectral trace and audio signal. The 2D Mode image is shown simultaneously allowing
the marking and adjustment of specific sites within blood vessels.

Press the CW button on the control panel. Press CW button again to enter 2D Mode.

[Figure 4.7 CW Spectral Doppler Mode]


4 - 22 SONOACE X6 User manual

▌ Spectral Doppler Mode Screen


On the Spectral Doppler Mode image, the horizontal axis represents time, and the vertical
axis represents speed (or frequency).

■ Sample Volume
When Sample Volume is on the blood flow of 2D image, it represents Doppler Spectrum.
Its position is moved with the Trackball and displayed in the [email protected] mm format. The
format means that the Sample Volume of ‘xx.x’ mm size is located at a depth of ‘yy.y’ mm.

For example, [email protected] mm means that the Sample Volume of 2.0mm size is located at a
depth of 16.7mm.

NOTE Sample Volume is available only in PW Spectral Doppler Mode.

▌ Spectral Doppler Mode Format Change

■ Changing PW Spectral Doppler Image Size


To adjust the image position, the 2D image is shown together. The size of the 2D image
and PW Spectral Doppler image can be changed.

Select PW Size in the menu using the Menu dial-button on the control panel. Select the
size (Large, Normal, or Small).

This function is activated in Simultaneous mode is on.

■ Activating Simultaneous Function


The PW Spectral Doppler image and 2D image can be displayed simultaneously or
separately. This function is not available in Steered CW Spectral Doppler Mode.

Select Simultaneous in the menu using the Menu dial-button on the control panel. If
Simultaneous is selected again when this mode is already on, the mode is deactivated.

Activate the Simultaneous function option by setting Simultaneous function as ‘Allow


2D/PW’ or ‘Allow 2D/C/PW’in the Misc. tab in the Setup window.

NB. Simultaneous function decreases Doppler PRF, thus decreasing the measurable
speed range.

■ Doppler Baseline Control


Press the Flexible Soft Button [2] Baseline on the control panel to raise/lower the
Baseline.
Chapter4. Diagnosis Modes 4 - 23

■ Doppler Axis Invert


Press the Flexible Soft Button [4] Invert on the control panel. The ‘+ velocity value’ and
‘- velocity value’, shown at the Doppler axis, change positions.

■ Loop Format Change


Select Loop Format in the menu using the Menu dial-button on the control panel. ‘Hor’
means Top Down Format, in which 2D image is set above the PW Spectral Doppler
image, and ‘Ver’ means Side by Side Format, in which the two images are set side-by-
side.

▌ Spectral Doppler Image Optimization

■ Sample Volume Position Control


Use the Trackball on the control panel.

■ Sample Volume Size Control


Adjust the Sample Volume size by pressing the Change button and using the Trackball
on the control panel. Press Change button again to return to the Sample Volume Position
Control screen. The icon showing the two Trackball functions (SV Pos/SV Size) is shown
for a second and disappears.

■ Sample Volume Angle Control


Press the Flexible Soft Button [5] Angle for accurate measurement of speed.

■ Doppler Sound Volume Control


Use the Audio Slide Volume control on the control panel.

■ Average Control
The Average Control is used to increase spectrum quality.

Select Average in the menu using the Menu dial-button on the control panel. Select the
Average value (Low, Middle or High).

■ Spectrum Enhancement
The Spectrum Enhancement is used to compensate the signal of low gain Spectral
Doppler Spectrum. This function is available in Loop Only Mode or Simultaneous
Function and is not available in TDI function.

Select Spectrum Ehc. In the menu using the Menu dial-button on the control panel.
Select the value from 1 to 8.
4 - 24 SONOACE X6 User manual

■ HPRF (High PRF) Function


This function measures blood flow whose speed exceeds specified limits at a specified
depth. It doubles the original scale. This function is available only in PW Spectral Doppler
Mode.

NOTE To use HPRF function, select ‘On’ in the Seup > System > Display tab.

– HPRF Activation

To activate HPRF, increase the Scale values at the required depth. The Phantom Gate
appears over the sample volume in D Line. Once HPRF is activated, the PRF doesn’t
increase even if the scale values are raised.

[Figure 4.8 HPRF]


Chapter4. Diagnosis Modes 4 - 25

– HPRF Exit

To exit HPRF, decrease Scale values by one notch while HPRF is activated. The
maximum PRF values in PW Spectral Doppler Mode are shown.

– Sample Volume Position Control

To move the Sample Volume position in the PW Only status, the system calculates
PRF values and the Phantom Gate position, and updates them on the PW Spectral
Doppler image. Exit HPRF when HPRF cannot be activated.

When Sample Volume is moved in the 2D Only status, the PRF values don’t change.
In PW Only status, the PRF values and Phantom Gate position are calculated and
updated on the PW Spectral Doppler image.

HPRF is not activated in Simultaneous Mode. It is also not activated if


NOTE [PRF*2] exceeds 23KHz.

 The Phantom Gate position can be located outside the 2D image area in
Zoom Mode.

CAUTION  Ensure that the Sample Volume and Phantom Gate are not positioned
over the area to be measured. If more than two SVs are located in the
vessels, all Doppler components will appear in the spectrum, causing
noise.

For further information about Wall Filter, Dynamic Range and Steer Control,
NOTE refer to ‘2D Mode’ and ‘Color Doppler Mode’.
4 - 26 SONOACE X6 User manual

Combined Modes

2D/C/PW Mode
Color Doppler Mode and PW Spectral Doppler Mode are displayed simultaneously.

Press the PW button on the control panel in Color Doppler Mode. In PW Spectral Doppler Mode
press the Color button.

[Figure 4.9 2D/C/PW Mode]


Chapter4. Diagnosis Modes 4 - 27

2D/PD/PW Mode
PD Mode and PW Spectral Doppler Mode are displayed simultaneously.

Press the PW button on the control panel in PD Mode. In PW Spectral Doppler Mode press the
PD button.

[Figure 4.10 2D/PD/PW Mode]


4 - 28 SONOACE X6 User manual

2D/C/CW Mode
Color Doppler Mode and CW Spectral Doppler Mode are displayed simultaneously.

Press the CW button on the control panel in Color Doppler Mode. In CW Spectral Doppler Mode
press the Color button.

[Figure 4.11 2D/C/CW Mode]


Chapter4. Diagnosis Modes 4 - 29

2D/PD/CW Mode
PD Mode and CW Spectral Doppler Mode are displayed simultaneously.

Press the CW button on the control panel in PD Mode. In CW Spectral Doppler Mode press the
PD button.

Following applications of Phased array probes are not available in


NOTE 2D/PD/CW mode; General, Cardiac, Pediatric.

[Figure 4.12 2D/PD/CW Mode]


4 - 30 SONOACE X6 User manual

2D/C/M Mode
Color Doppler Mode and M Mode are displayed simultaneously.

Press the M button on the control panel in Color Doppler Mode, or press the Color button on
the control panel in M Mode. (Only available in Cardiac related application of specific probe)

[Figure 4.13 B/C/M Mode]


Chapter4. Diagnosis Modes 4 - 31

Multi-Image Mode
The multi-image viewing function is only available when the images and conditions on both
sides are identical.

Dual-2D Mode
This mode allows you to compare 2D images side by side.

Press the Dual button on the control panel in 2D Mode, M Mode and PW Spectral Doppler
Mode. Press the 2D button to exit Dual-2D Mode and return to the basic 2D Mode.

To change the active image, press the Update, Dual, or Set button.

[Figure 4.14 Dual-2D Mode]


4 - 32 SONOACE X6 User manual

Dual-2D/C Mode
This mode allows you to compare Color Doppler Mode images side by side.

Press the Dual button on the control panel in Color Doppler Mode. In Dual-2D Mode press the
Color.

[Figure 4.15 Dual-2D/Color Doppler Mode]


Chapter4. Diagnosis Modes 4 - 33

Dual-2D/PD Mode
This mode allows you to compare PD Mode images side by side.

Press the Dual button on the control panel in PD Mode. In Dual-2D mode press the PD button.

[Figure 4.16 Dual-2D/PD Mode]


4 - 34 SONOACE X6 User manual

3D Mode

3D
The 3D Mode displays tissues or objects in the human body as three-dimensional images inste-
ad of two-dimensional images.

The 3D mode uses the Volume data acquired by the probe as continuous 2D images for ren-
dering, producing three-dimensional volume data displays of objects that can better assist in the
diagnosis process.

Volume rendering refers to the calculation process used in formulating a 3D volume structure
from 2D scans. Using the gray value of the light path through each pixel of the 2D image, the
corresponding voxel, or volume element, of the 3D image is calculated. The rendering
algorithm determines the way the way the 3D structure is visualized. Surface rendering is
employed in the SONOACE X6.

▌ How to Improve 3D Image Quality


 Consider the direction, division and size of the viewpoint, as well as the visibility of an
object.

 Before 3D scanning, adjust the contrast of the specific textures in 2D Mode.

 The ROI box determines the contents of the image box to be rendered. The images
outside the ROI box, except for the ultrasound data, are not included in the rendering
process and are cut out.

 The bigger the ROI box, the slower the rendering speed. Therefore, set an appropriate
ROI box size.

 To determine surface contour, the surfaces of objects should be insulated with hypo-
echoic textures - such as amniotic fluid - which don’t generate echos.

 To obtain a high quality 3D surface, adjust the low-threshold value.

 In order to acquire a clear image from the ROI box start boundary to the specific surface,
noise can be eliminated if the gray scale value is smaller than the surface value.

 High-threshold is generally set at the maximum value of 255. If the Surface Rendering
Algorithm is higher than the threshold value, it marks the boundaries of the surface. The
boundary can be adjusted with the threshold-high slider.
Chapter4. Diagnosis Modes 4 - 35

Acquiring a 3D Image
The following explains how to acquire a 3D image.

1. Press the [F5] 3D button on the keyboard.

2. The ROI box appears. Set the required area using the Trackball, and press the Set
button. The position and size of the area can be changed by pressing the Change button
before pressing Set button.

3. Pressing Set button starts the 3D scanning of the area. A maximum of 200 frames can be
scanned at one time. A bar, indicating the scanning progress, appears at the bottom of
the screen.

4. To scan the specific frame and finish scanning, press Set button again. To cancel the
scanning during the process, press the Exit button.

5. Once scanning is completed, ‘3D View Mode’ is turned on.

 To see the 3D scan of a fetus in a frontal view, position the fetal head in the
direction of “Direction Mark”, putting it in the coronal plane. Then scan the
fetus from back to abdomen.
NOTE
 The 3D image of the fetal face is more easily found in the coronal plane than
in the sagittal plane.
4 - 36 SONOACE X6 User manual

3D View
3D images can be seen through the 3D View application.

[Figure 4.17 3D View]

▌ Viewing a 3D Image
 Select the menus using the Trackball and the Set button.

 To return to the initial screen of 3D View, press the Init 3D button.

 The Preview function allows the operator to check changes in the values of Rotation,
Magnification, and Position in advance. To obtain a clearer image in the Preview screen,
press the Set button.

 To close 3D View Mode, press the X on the screen. All scanned data and 3D images will
be lost if 3D View Mode is closed before saving data. Therefore, ensure that all the
necessary images are saved using the Save button on the control panel prior to pressing
the X.
Chapter4. Diagnosis Modes 4 - 37

▌ 3D Image Optimization

■ Threshold (Low, High) Adjustment


Adjust the slide bar of the threshold using the Trackball and the Set button.

If the slide bar is moved to the left, cyst components – and not bone components – are
shown. If the slide bar is moved to the right, bone components – and not cyst
components – are shown.

■ Gamma Adjustment
Adjust the ‘Bias’ and ‘Pos’ slide bars on the right side of the screen using the Trackball
and Set button.

– Pos (Position): Designates the bending start point of the Gamma Curve.

– Bias: Sets the brightness and contrast by adjusting the curve bend.

The changed values are applied to the Gamma curve and 3D image.

■ Changing ROI Size


Adjust the ROI control slide bar using the Trackball and the Set button. Changed values
can be checked in the Preview screen.

■ Initialization
To return to the initial status in 3D View Mode, press the Init 3D button or the Flexible
Soft button [5] INIT 3D in Rotation, Position, or Magnification Modes.

■ Rotation
After entering Rotation mode by pressing the Rotation button, the 3D image can be
rotated using the Trackball.

Moving the Trackball right or left rotates the 3D image about the X axis, and moving it up
or down rotates the image about the Y axis. Moving it while pressing the Set button
rotates the image about the Z axis.

The rotated 3D image is shown in the Preview screen. After checking the changed values,
apply them to the entire screen by pressing the Flexible Soft button [4] Apply.

Pressing the Exit applies the changes to the 3D image and exits Rotation mode.

To activate Position, Magnification or Cut Mode functions while rotating the image,
press the Flexible Soft Menu of the corresponding function. To return to the initial image,
press the Flexible Soft button [5] INIT 3D.
4 - 38 SONOACE X6 User manual

[Figure 4.18 Flexible Soft Menu - Rotation Mode]

※ Other ways to rotate the image

1. The ROT slide bar at the bottom of the screen can be adjusted using the Trackball
and the Set in the 3D View initial screen.

2. Use the Flexible Soft Menu in the initial 3D View screen. Use the Flexible Soft button
[1] ~ [3] to rotate the 3D image 90° degrees about each axis.

[Figure 4.19 Flexible Soft Menu – 3D Mode]

■ Position
The 3D image position can be adjusted with the Trackball after entering Position mode.
After checking changed values in the Preview screen, apply the changes to the entire
screen by pressing the Flexible Soft button [4] Apply.

Pressing the Exit applies the changes to the 3D image and exits Position mode.

To activate the Rotation, Magnification or Cut Mode functions while adjusting the image
position, press the corresponding Flexible Soft Menu of each function. To return to the
initial image, press the Flexible Soft button [5] INIT 3D.

[Figure 4.20 Flexible Soft Menu – Position Mode]

※ Other ways to move the image

Use the Flexible Soft Menu in the 3D View initial screen. To move the 3D image right or
left, use the Flexible Soft button [4] Shift Left or [5] Shift Right.

[Figure 4.21 Flexible Soft Menu – 3D Mode]


Chapter4. Diagnosis Modes 4 - 39

■ Magnification
To magnify or reduce the image size, enter Magnification mode by pressing the
Magnification button, and move the Trackball right or left. After checking changed
values in the Preview screen, apply the changes to the entire screen by pressing the
Flexible Soft button [4] Apply.

Pressing the Exit button applies the changes to the 3D image and exits the Magnification
mode.

To activate the Rotation, Position or Cut Mode function while adjusting the image size,
press the corresponding Flexible Soft Menu of each function. To return to the initial image,
press the Flexible Soft button [5] INIT 3D.

[Figure 4.22 Flexible Soft Menu – Magnification Mode]

■ Cut Mode
Press the Cut Mode button on the left side of the screen to enter Cut mode. Determine
the area to cut using the Trackball, and press the Set button. Then, the "+" cursor
appears. After contouring the area to cut, press Set button again, and the cutting is
finished. To cancel the cutting area, press the Exit button.

Press the Flexible Soft button [1] Inside Contour to outline an area to be cut. The
Flexible Soft button [2] Point Eraser function is used to cut a portion of the image. The
default setting is Inside Contour.

To cancel cutting, press the Flexible Soft button [3] Undo. To redo the cancelled job,
press the Flexible Soft button [4] Redo.

To cancel all cuttings and return to the initial 3D screen, press the Flexible Soft button
[5] Undo All.

[Figure 4.23 Flexible Soft Menu – Cut Mode]

■ Multi-planar View
Press Multiplanar, and 3D multiplanar screen appears. Shows volume data in cross-
section images of Coronal Section, Sagittal Section, and Axial Section.
4 - 40 SONOACE X6 User manual

[Figure 4.24 Multi-planar view]

■ Reference Plane
Select the reference plane on the Multi Planar window:

– A plane: Coronal Section

– B plane: Sagittal Section

– C plane: Axial Section

Multi Planar has its standard coordinates system and rotates/moves along that system.
However the reference plane rotates/moves along the own coordinates system of
reference plane. If you select a reference plane, it rotates/moves along the coordinates
system of reference plane. The other planes are rotate/move along its standard
coordinates system.
Chapter4. Diagnosis Modes 4 - 41

Use X/Y/Z slide on the screen to rotate reference plane.

[Figure 4.25 The standard coordinates systems of Multi-planar]

[Figure 4.26 The coordinates system of the reference plane]

To init all setting, press Init on the screen. To finish the 3D Multiplanar and go back to 3D
View, press X.

Refer to ‘3D Image Optimization’ for more information like Gamma Curve
NOTE setting.
Chapter 5

Measurements
And Calculations

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


Causes of Measurement Errors ................................................................................................ 3
Optimization of Measurement Accuracy.................................................................................... 5
Measurement Accuracy Table ................................................................................................... 7

Basic Measurements.....................................................................................................9
Distance Measurement............................................................................................................ 11
Circumference and Area Measurement .................................................................................. 17
Volume Measurement ............................................................................................................. 19

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


Things to note .......................................................................................................................... 21
Common Measurement Methods ............................................................................................ 23
OB Calculations ....................................................................................................................... 28
GYN Calculations .................................................................................................................... 35
Cardiac Calculations................................................................................................................ 37
Vascular Calculations .............................................................................................................. 49
Urology Calculations................................................................................................................ 52
Fetal Echo Calculations ........................................................................................................... 57

Report ...........................................................................................................................62
Viewing Report ........................................................................................................................ 63
Editing Report .......................................................................................................................... 63
Comment ................................................................................................................................. 63
Printing out Report ................................................................................................................... 63
Exporting Report ...................................................................................................................... 63
Graph Function ........................................................................................................................ 65
Chapter 5.Measurements and Calculations 5 - 3

Measurement Accuracy
Measurement values can vary, depending on the nature of the ultrasound, the body’s response
to ultrasound, the measurement tools, algorithms, product settings, probe type and user
operation.

Before using this product, make sure to read and understand the following information
regarding the causes of measurement errors, and measurement optimization.

Causes of Measurement Errors

▌ Image Resolution
The resolution of ultrasound images may be limited by the available space.

– Errors due to a signal range may be minimized by adjusting focus settings. Optimizing
focus settings increases the resolution of the measurement area.

– In general, lateral resolution is lower than axial resolution. Therefore, measurements


should be performed along the axis of the ultrasound beam to obtain accurate values.

– Gain has a direct impact on resolution. Gain can be adjusted by using the Gain button for
each mode.

– In general, increasing the frequency of ultrasound enhances resolution.

▌ Pixel Size

– An ultrasound images in the product consist of pixels.

– Since a single pixel represents the basic unit of an image, a measurement error may
result in the displacement of approximately ±1 pixel when compared to the original image
size.

– However, this error becomes significant only when a narrow area in an image is
measured.
5 - 4 SONOACE X6 User manual

▌ Ultrasound Velocity

– The velocity of ultrasound used during measurement is usually 1,540 m/s on average.

– The velocity of ultrasound may vary depending on the cell type.

– The possible range of error is between approximately 2-5% depending on the structure of
cells (about 2% for typical cells and about 5% for fatty cells).

▌ Doppler Signal Adjustment

– During velocity measurement, an error may occur depending on the cosine angle
between the blood flow and the ultrasound beam.

– For Doppler velocity measurements, the most accurate results can be ensured when the
ultrasound beam is aligned in parallel with the blood flow.

– If that is not possible, the angle between them should be adjusted by using the Angle
option.

▌ Aliasing

– PW Spectral Doppler Mode uses a signal sampling technique to calculate the frequency
(or velocity) spectrum.

– Adjust the baseline or the velocity scale to minimize aliasing. A lower frequency probe
can also be used to reduce aliasing.

– Aliasing is dramatically reduced in CW Spectral Doppler Mode.

▌ Calculation Equation

– Some of the calculation equations used for clinical purposes originate from hypotheses
and approximation.

– All calculation equations are based on medical reports and articles.

▌ Human Error

– Human error may occur due to inappropriate use or lack of experience.

– This can be minimized through compliance with and thorough understanding of the
manuals.
Chapter 5.Measurements and Calculations 5 - 5

Optimization of Measurement Accuracy

▌ 2D Mode

– Resolution is in proportion to the frequency of the probe.

– Penetration is in inverse proportion to the frequency of the probe.

– The highest resolution can be obtained at the focus of the probe where the ultrasound
beam is narrowest.

– The most accurate measurements can be obtained at the focus depth. The accuracy
decreases as the distance from the focus increases, widening the beam width.

– Using the zoom function or minimizing the depth display makes distance or area
measurements more accurate.

▌ M Mode

– The accuracy of time measurements can be increased when the sweep velocity and the
display format are set to high values.

– The accuracy of distance measurements can be increased when the display format is set
to higher values.

▌ Doppler Mode

– It is recommended to use lower frequency ultrasound for measurement of faster blood


flows.

– The size of the sample volume is limited by the axial direction of the ultrasound.

– Using lower frequency ultrasound increases penetration.

– The accuracy of time measurements can be increased when the sweep velocity is
increased.

– The accuracy of velocity measurements can be increased when the vertical scale is set
to smaller values.

– It is most important to use an optimal Doppler angle to enhance the accuracy of velocity
measurements.
5 - 6 SONOACE X6 User manual

▌ Color/Power Doppler Mode

– A protocol is not specified for images in Color Doppler Mode or Power Doppler Mode.
Therefore, the same limitations imposed when measurements are taken in B/W images
apply to the accuracy of the measurements taken in these modes.

– It is not recommended to use images in Color/Power Doppler Mode for measurement of


accurate blood flow velocity.

– The amount of blood flow is calculated based on the average velocity rather than the
peak velocity.

– In all applications, the amount of blood flow is measured in PW/CW Spectral Doppler
Mode.

▌ Cursor Position

– All measurements are affected by input data.

– To ensure accurate positioning of the cursor:

Adjust the images on the screen so that they are displayed at maximum granularity.

Use the front edge or boundary point of a probe to make the start and end points of a
measurement object more distinct.

Make sure that the probe direction is always aligned during measurement.
Chapter 5.Measurements and Calculations 5 - 7

Measurement Accuracy Table


The following tables show the accuracy of the measurements available using the product.
Ensure that the results of measurement accuracy checks are kept within the ranges specified in
the table. Except for certain applications or probes, the following accuracy ranges should be
maintained for measurement of a straight distance.

To ensure accurate measurements, an accuracy check should be performed


NOTE at least once per year. If the measurement accuracy falls outside the ranges
specified in the following table, contact Samsung Medison Customer Service.

▌ Modes Performance

(1) Specification
Modes Test Accuracy
Description
performance Methodology Based on
Frequency Depth

Linear <± 2MHz <± 10cm

Phased Array <± 4MHz <± 8cm


Penetration Probe Phantom Acquisition
Endo-Cavity <± 5.5MHz <± 5cm

Convex <± 7.5MHz <± 3cm

Mode db

M <75
Sensitivity M , PW , CW Phantom Acquisition
PW <90

CW <90

(1) Displays the depth with ‘cm’,

(2) Based on center frequency of each probe.


5 - 8 SONOACE X6 User manual

▌ 2D Mode
(1)
System Tolerance Test Accuracy (2)
Measurements Range
(Whichever is greater) Methodology Based on

Axial Distance: < ±4% or 2mm Phantom Acquisition 0.01 – 25 cm

Lateral Distance: < ±4% or 2mm Phantom Acquisition 0.01 – 35 cm

Axial Resolution: < ±4% or 3mm Phantom Acquisition 0.01 – 25 cm

Lateral Resolution < ±4% or 3mm Phantom Acquisition 0.01 – 35 cm

(1) Measurement accuracy depends on the table and human errors.

(2) Distance is displayed with ‘cm’ and with the second digit.

▌ M Mode
(1)
System Tolerance Test Accuracy (2)
Measurements Range
(whichever is greater) Methodology Based on

Depth : < ±5% or 3 mm Phantom Phantom 1 – 25 cm

Time: < ±5% Signal generator Phantom 0.01 – 11.3 sec

(1) Measurement accuracy depends on the table and human errors.

(2) Distance is displayed with ‘cm’ and with the second digit. Velocity is displayed with ‘cm/s’
and with the second digit.

▌ Spectral Doppler Mode

Doppler System Tolerance (2)


Methodology Range
Measurement (whichever is greater)

PW: 0.1cm/s – 8.8 m/s


Velocity < ± 15% Phantom
CW: 0.1cm/s - 19.3 m/s

Time: < +/- 5%. Signal generator 0.01 - 11.3 sec

(1) Measurement accuracy depends on the table and human errors.

(2) Distance is displayed with ‘cm’ and with the second digit. Velocity is displayed with ‘cm/s’
and with the second digit.
Chapter 5.Measurements and Calculations 5 - 9

Basic Measurements
Press the Caliper button on the control panel.

Take basic measurements of distance and area regardless of the application.


NOTE For information on measurements for each application, please refer to
“Measurements by Application” in this chapter.

The available measurement methods vary depending on the current diagnosis mode. Please
refer to the following table:

Diagnosis
Measurements Measurement Methods
Mode

2D Distance
2D 2D Line Trace
2D Hip Joint

Distance M M Distance

Doppler Velocity
CW, PW Doppler Velocity (A/B)
Doppler Trace

2D Ellipse
Circumference & Area 2D
2D Trace

3 Distance
Volume 2D 1 Distance
Distance + Ellipse

[Table 5.1 Basic Measurement]


5 - 10 SONOACE X6 User manual

▌ Basic Measurement Operations


The following is the information on common button operations for basic measurements:

■ Select/Change Measurement Method


Use the Flexible Soft dial-button on the control panel. The Flexible Soft menu items
displayed vary depending on the diagnosis mode. The selected measurement method is
displayed in the user information area.

■ Delete Measurement Result


Press the Clear button on the control panel.

■ Print Measurement Result


Press the Print button on the control panel.

■ Finish Basic Measurements


Press the Exit button on the control panel.

To change various settings such as measurement units, press [F8] Setup


NOTE on the control panel and select Measure > General > General. For more
information, please refer to Chapter 3 “Setting.”
Chapter 5.Measurements and Calculations 5 - 11

Distance Measurement

▌ 2D Distance (Line)
This is a basic measurement that is available in all diagnosis modes. You can specify two
points in a 2D image and measure the straight distance between them.

You can measure up to 4 distances. When taking more than one measurement, use
measurement cursors with different shapes (+, X, #, *) to differentiate them.

1. Select the Flexible Soft button [1] Distance. “2D Distance” is displayed in the user
information area.

2. Use the Trackball and the Set button on the control panel to specify both end points of
the measurement area.

– Place the cursor at a desired position with the Trackball, and press the Set button.

※ Tip! Repositioning Point

Pressing the Change button before pressing the Set button to complete positioning
resets the position of a point just set.

3. If you specify both end points, the distance between them will be automatically calculated.

4. When the measurement is finished, its result is shown on the screen.

– The measured distances are shown as “Dist.” and can be differentiated with their
measurement cursor. The ratio (+/x, #/*) and average for each measurement data is
calculated and displayed as a percentage.

5. A new measurement cursor appears. When more than 4 measurements are taken,
measurements are deleted in the order in which they have been taken.
5 - 12 SONOACE X6 User manual

▌ 2D Distance (Trace)
It is a basic measurement that is available in all diagnosis modes. You can specify a point in
a 2D image and trace a curve from that point to measure the distance between them.

You can measure up to 4 distances. When taking more than one measurement, use
measurement cursors with different shapes (+, X, #, *) to differentiate them.

1. Select the Flexible Soft button [1] Line Trace. “2D Line Trace” is displayed in the user
information area.

2. Use the Trackball and the Set button on the control panel to specify the start point of the
measurement area.

– Place the cursor at a desired position with the Trackball, and press the Set button.

3. With the Trackball, draw a desired curve and press the Set button to specify the end
point.

※ Tip! Editing Curve

Before pressing the Set button to specify the end point, you can rotate the
Flexible Soft dial-button [5] Delete (trace) to delete a part of the curve being
traced.

4. If you specify both end points, the length of the curve will be automatically calculated.

5. When the measurement is finished, its result is shown on the screen.

– The measured distances are shown as “Dist.” and can be differentiated with their
measurement cursor. The ratio (+/x, #/*) and average for each measurement data is
calculated and displayed as a percentage.

6. A new measurement cursor appears. When more than 4 measurements are taken,
measurements are deleted in the order in which they have been taken.
Chapter 5.Measurements and Calculations 5 - 13

▌ 2D Hip Joint
This is a basic measurement that is available in all diagnosis modes. You can measure the
angle of two straight lines to a straight line in a 2D image. This measurement is commonly
used in the obstetrics application.

1. Select the Flexible Soft button [4] Hip Joint. “2D Hip Joint” is displayed in the user
information area.

2. Use the Trackball and the Set button on the control panel to specify the first straight line.

– Place the cursor at a desired position with the Trackball, and press the Set button.

※ Tip! Repositioning Point

Pressing the Change button before pressing the Set button to complete
positioning resets the position of a point just set.

3. Repeat the above process to specify two other straight lines.

4. The angle between them will be calculated automatically.

– α: The angle between the first and second straight lines.

– β: The angle between the first and third straight lines.

5. When the measurement is finished, its result is shown on the screen. The angles α and β,
and the Hip Joint Type are displayed on the screen.

6. A new measurement cursor appears. When more than 3 straight lines are specified, the
lines are deleted in the order in which they have been specified.

Please refer to the table below for Hip Joint Type information:

Type α β

1a 60 ≤ α< 90 0 < β< 55

1b 60 ≤ α< 90 55 ≤ β< 90

2a/b 50 ≤ α< 60 0 < β< 90

2c 43 ≤ α< 50 77 ≤ β< 90

d 43 ≤ α< 50 0 < β< 77

3/4 0 < α< 43

[Table 5.2 Hip Joint Type Table]


5 - 14 SONOACE X6 User manual

▌ M Distance
This is a basic measurement that is available in M Mode only. You can specify two points in
an M image and measure the distance, elapsed time and velocity between them.

1. Select the Flexible Soft button [1] M Distance. “M Distance” is displayed in the user
information area.

2. Specify two points and measure the straight distance between them. The method for
measuring a line is the same as in “2D Distance.”

3. When the measurement is finished, its result is shown on the screen.

– The measured distances are shown as “Dist.” and can be differentiated with their
measurement cursor.

– The elapsed time (Time) and velocity (Slope) are also displayed.

4. A new measurement cursor appears. When more than 4 measurements are taken,
measurements are deleted in the order in which they have been taken.

▌ Doppler Velocity
This is a basic measurement that is available in Spectral Doppler Mode only. You can specify
two points in a Spectral Doppler image and measure the distance between them, and the
velocity at each point to calculate the velocity change, time change and acceleration.

In a Spectral Doppler image, the X- and Y-axes represent time and


NOTE velocity, respectively.

You can measure acceleration for up to two segments and differentiate the points of
segments into Point 1 and 2.

1. Select the Flexible Soft menu [1] D Velocity. “D Velocity” is displayed in the user
information area.

2. Specify two points and measure the straight distance between them. The method for
measuring a line is the same as in “2D Distance.”

3. When the measurement is finished, its result is shown on the screen.

– Vel. 1: Velocity at Point 1 – Time: Time Change

– Vel. 2: Velocity at Point 2 – Acc : Acceleration

– PGmax – RI: Resistivity Index

– V2-V1: Velocity Change – S/D: Systolic to Diastolic Ratio

4. A new measurement cursor appears. When more than 2 measurements are taken,
measurements are deleted in the order in which they have been taken.
Chapter 5.Measurements and Calculations 5 - 15

The equations used for D Velocity measurement are as follows:

V1 − V2
– RI =
V1

– dV = V2 − V1

(V2 − V1 ) dV
– Acceleration = =
(T2 − T1 ) dT

▌ Doppler Velocity (A/B)


This is a basic measurement that is available in Spectral Doppler Mode only. You can specify
two points in a Spectral Doppler image and measure the velocity at each point to calculate
the ratio of the velocity between them.

You can calculate up to 4 sets of velocity ratios. The points representing each set are
differentiated into Point A and B.

1. Select the Flexible Soft button [1] D A/B. “D A/B” is displayed in the user information
area.

2. Specify two points to measure velocity for.

– Place the cursor at a desired position with the Trackball, and press the Set button.

3. When the measurement is finished, its result is shown on the screen.

– Vel. A: Velocity at Point A – PGmax

– Vel. B: Velocity at Point B – A/B: Velocity Ratio

4. A new measurement cursor appears. When more than 4 sets are measured,
measurements are deleted in the order in which they have been taken.
5 - 16 SONOACE X6 User manual

▌ Doppler Trace
This is a basic measurement that is available in Spectral Doppler Mode only. You can specify
a point in a Spectral Doppler image and trace a curve from that point to calculate the velocity,
integral value and average velocity of blood flow.

1. Select the Flexible Soft button [1] D Trace. “D Trace” is displayed in the user
information area.

2. Trace a curve. The method for measuring a curve is the same as in “2D Line Trace.”

3. When the measurement is finished, its result is shown on the screen.

– Vmax: Max. Velocity – PGmean

– Vmean: Average Velocity – VTI: VTI (Velocity Time Integral)

– PGmax – Time: Time Change

4. A new measurement cursor appears.

The equations used for D Trace measurement are as follows:

– dT = T2 − T1

– VTI = ∫ v × dt , (VTI : Velocity Time Integral )

VTI
– V mean =
Duration of flow
Chapter 5.Measurements and Calculations 5 - 17

Circumference and Area Measurement

▌ 2D Ellipse
This is a basic measurement that is available in all diagnosis modes. You can measure the
circumference and area of a circular (elliptical) object in a 2D image.

You can measure up to 4 distances. When taking more than one measurement, use
measurement cursors with different shapes (+, X, #, *) to differentiate them.

1. Select the Flexible Soft button [2] Ellipse. “2D Ellipse” is displayed in the user
information area.

2. Use the Trackball and the Set button on the control panel to specify the diameter (axis)
of the measurement area.

– Place the cursor at a desired position with the Trackball, and press the Set button.

※ Tip! Repositioning Point

Pressing the Change button before pressing the Set button to complete
positioning resets the position of a point just set.

3. Specify the size of the circle (ellipse).

– Adjust the size using the Trackball, and press the Set button.

4. When the measurement is finished, its result is shown on the screen.

– Circ.: Circumference of Object – Avg.(C): Average Circumference

– Area: Area of Object – Avg.(A): Average Area

5. A new measurement cursor appears. When more than 4 straight lines are specified, the
lines are deleted in the order in which they have been specified.

The equations used for ellipse measurement are as follows:

1  A   B  
2 2

– Circ = 2π ⋅ ⋅   +    , (A: Long axis, B: Short axis)


2  2   2  

– Area = π × a × b , (a, b: Axis)


5 - 18 SONOACE X6 User manual

▌ 2D Trace
This is a basic measurement that is available in all diagnosis modes. You can measure the
circumference and area of an irregular object in a 2D image.

You can measure up to 4 distances. When taking more than one measurement, use
measurement cursors with different shapes (+, X, #, *) to differentiate them.

1. Select the Flexible Soft button [2] Trace. “2D Trace” is displayed in the user information
area.

2. Use the Trackball and the Set button on the control panel to specify the start point for
tracing over the contour of the measurement area.

– Place the cursor at a desired position with the Trackball, and press the Set button.

3. Trace the curve so that the measurement cursor returns to the start point, and then press
the Set button.

Trace lines must be closed. If you press the Set button before tracing
NOTE is complete, tracing may be done over a straight line between the
current point and the start point, resulting in a significant error.

4. When the measurement is finished, its result is shown on the screen.

– Circ.: Circumference of Object – Avg.(C): Average Circumference

– Area: Area of Object – Avg.(A): Average Area

5. A new measurement cursor appears. When more than 4 straight lines are specified, the
lines are deleted in the order in which they have been specified.

The equations used for Trace measurement are as follows:

– Circ = sum {X (n ) − X (n − 1)}2 + {Y (n ) − Y (n − 1)}2 , (N = 1,2… last point)


– [ ]
Area = sum X (n − 1) × Y (n) − X (n) × Y (n − 1) , (N = 1,2… last point)
Chapter 5.Measurements and Calculations 5 - 19

Volume Measurement

▌ 3 Distance
This is a basic measurement that is available in all diagnosis modes. You can measure the
volume of an object in a 2D image by using 3 straight lines.

1. Select the Flexible Soft button [3] 3 Distance. “3 Distance” is displayed in the user
information area.

2. Specify two points and measure the straight distance between them. The method for
measuring a line is the same as in “2D Distance.”

3. Measure the length of the remaining two straight lines as in the above. Measure other
two distance using the same method with 2.

4. When the measurement is finished, its result is shown on the screen. The volume of the
object along with the length of each straight line are calculated.

5. A new measurement cursor appears. When more than 3 straight lines are specified, the
lines are deleted in the order in which they have been specified.

The equations used for 3 Distance measurement are as follows:

4 D D D
– Vol = π ⋅ 1 ⋅ 2 ⋅ 3 , (D: distance)
3 2 2 2

▌ 1 Distance
This is a basic measurement that is available in all diagnosis modes. You can measure the
volume of an object in a 2D image by using only one straight line.

You can measure up to 4 sets of volumes. When measuring more than one set, use
measurement cursors with different shapes (+, X, #, *) to differentiate them.

1. Select the Flexible Soft button [3] 1 Distance. “1 Distance” is displayed in the user
information area.

2. Specify two points and measure the straight distance between them. The method for
measuring a line is the same as in “2D Distance.”

3. When the measurement is finished, its result is shown on the screen. The volume of the
object along with the length of the straight line are calculated.

4. A new measurement cursor appears. When more than 4 straight lines are specified, the
lines are deleted in the order in which they have been specified.

The equations used for 1 Distance measurement are as follows:


5 - 20 SONOACE X6 User manual

3
4  D
– Vol = π ⋅   , (D: distance)
3 2

▌ Distance + Ellipse
This is a basic measurement that is available in all diagnosis modes. You can measure the
volume of an object in a 2D image by using one straight line and one circle (ellipse).

You can measure up to 2 sets of volumes. When measuring more than one set, use
measurement cursors with different shapes (+, X) to differentiate them.

1. Select the Flexible Soft button [3] Distance + Ellipse. “Distance + Ellipse” is displayed
in the user information area.

2. Specify two points and measure the straight distance between them. The method for
measuring a line is the same as in “2D Distance.”

3. Specify the size of the circle (ellipse). The method for measuring a circle (ellipse) is the
same as in “2D Ellipse.”

4. When the measurement is finished, its result is shown on the screen.

– Dia.: Length of Straight Line

– A: Length of A-axis in Ellipse

– B: Length of B-axis in Ellipse

5. A new measurement cursor appears. When more than 2 sets are measured,
measurements are deleted in the order in which they have been taken.

The equations used for Distance + Ellipse measurement are as follows:

π
– Vol = × a × b × d , (a : Short axis , b : Long axis , d : Distance )
6
Since Dual Mode simultaneously displays two images on the screen, you
NOTE don't have to return to the diagnosis mode to measure volume in Dual Mode.
Chapter 5.Measurements and Calculations 5 - 21

Calculations by Application
Press the Calculator button on the control panel.

Things to note

▌ Before Taking Measurements


 Please ensure that the information for the current patient is correct. When the patient is
not registered, press the Patient button on the control panel to register the patient.

 Ensure that the probe and application displayed in the title area are the ones that you
want to use. If needed, press the Probe button to change the probe, application or preset.

▌ Measurement Operations
The following gives information on the common button operations for measurements:

■ Select/Change Application
Use the Calculator button on the control panel. Each time the Calculator button is
pressed, the application toggles in the order determined under Measure Setup. The
order in which applications appear can be specified at [F10] Application > Calc
Sequence.

■ Menu A / Menu B
When there are a lot of measurement items (menus), they are divided into two menu
groups. Select them using the Flexible Soft button [1] or the Change button on the
control panel.

■ Select Measurement Item


After moving the cursor by using the Trackball or the Menu / Angle dial-button on the
control panel, press the Set button or the Menu / Angle dial-button.
5 - 22 SONOACE X6 User manual

■ Change Method
This menu can be selected by pressing the Flexible Soft button [1] Chg Method or the
Change button on the control panel. Once the measurement is started, the selected
measurement method cannot be changed.

In case of measuring distance, choose a measurement method from Line or Trace. When
circumference and area are measured, choose a measurement method from Ellipse and
Trace.

■ Delete Measurement Result


Press the Flexible Soft Button [2] Rm Data or the Clear button on the control panel. It
erases all the measurement data.

The measurement results are deleted from the screen but still
NOTE shown on the report for the corresponding application.

■ Cancel/Undo
Press the Flexible Soft button [3] Cancel/Undo to cancel the latest measurement.

■ Measurement Result Display Settings


Press the Flexible Soft button [4] Rslt Disp Cnt. Select number of the measurement
result to display. The information related to the item number is displayed in the screen for
about a second.

■ Return to Parent Menu


After placing the cursor under Return in the Measurement menu, press the Set button or
the Menu / Angle dial-button.

■ Print Measurement Result


Press the Print button on the control panel.

■ Exit Measurement
Press the Exit button on the control panel.

■ End Diagnosis
Press the End Exam button on the control panel. The diagnosis for the current patient
ends and all measurement results are saved.

For information on settings for each application, please refer to


NOTE Chapter 3 “Setting”.
Chapter 5.Measurements and Calculations 5 - 23

Common Measurement Methods


This section provides information on the common measurement methods used for applications.

▌ Measurements in Spectral Doppler Mode


In general, if you trace a Doppler spectrum, you can obtain results for various measurement
items automatically. There are 3 ways to trace a Doppler spectrum.

SONOACE X6 also allows you to select a specific item under the Measurement menu and
take measurements individually without tracing a Doppler spectrum.

■ Auto Trace
A spectrum is traced automatically. It is enabled in the Measurement menu in Spectral
Doppler Mode.

1. Press Auto Trace in the Measurement menu.

2. The system traces a spectrum automatically.

3. When Trace is complete, the measurement results are displayed on the screen.

※ Things to consider for Doppler Spectrum Auto Trace

The state of a Doppler spectrum may affect measurement results. Please see the
following:

Causes for Trace Failure

– If Gain is changed for a Doppler image in the Freeze state, Contour Trace and
Peak Trace will not work.

– If there is little or no noise in an image without a spectrum, Contour Trace will


not work.

– If there is severe noise in an image, Contour Trace will not work.

– If the Clutter filter is set too high, Auto Trace or Limited Trace may not work.

Causes for Inaccurate Peak Trace

– If PRF (Pulse Repetition Frequency) is lower than the velocity of the


observation area, aliasing may occur. If the original signals are separated from
aliasing, Trace can be done but the peak measurement may not be accurate.

– If the peak of a spectral waveform is not clear or occurs intermittently, Trace


can be done but the peak measurement may not be accurate.

– If the Doppler Gain is set to high or low, it becomes difficult to distinguish


5 - 24 SONOACE X6 User manual

spectrums. This may result in measurement error(s).

– If the Wall Filter is set too high, only part of the spectrum is displayed. In this
case, Trace can be done but Peak measurement may not be accurate.

– If abnormal noise or artifact occurs, Trace can be done but Peak measurement
may not be accurate.

Misc.

– Use of the CW Probe may result in measurement error(s).

– Limited Trace is supported only for two-peak spectrums such as Mitral Valve
Inflow and Tricuspid Valve Inflow in the cardiology application.

■ Limited Trace
If you specify a measurement range, a spectrum is traced automatically. It is enabled in
the menu in Spectral Doppler Mode.

1. Press Limited Trace in the Measurement menu. A bar appears allowing you to
specify a measurement area.

2. Specify the measurement range.

– Place the bar at a desired position with the Trackball, and press the Set button.

3. The system traces spectrums within the specified range automatically.

4. When Trace is complete, the measurement results are displayed on the screen.

■ Manual Trace
A spectrum is traced manually. It is enabled in the menu in Spectral Doppler Mode.

1. Press Manual Trace in the Measurement menu. A measurement cursor appears over
a spectrum.

2. Trace the spectrum. The measuring method is the same as in “D Trace.”

3. When Trace is complete, the measurement results are displayed on the screen.
Chapter 5.Measurements and Calculations 5 - 25

■ Itemized Measurement
In the Measurement menu, select an individual item and take a measurement.

1. Press the Calculator button on the control panel after obtaining a desired image.

2. Select a desired item in the Measurement menu. The “+” cursor appears over a
spectral waveform.

3. Position the “+” cursor and press the Set button.

4. The measurement results for the selected item are displayed on the screen.

Measurement items for Doppler Spectrum are as follows:

Item Type Unit Equation

PSV (Peak Systolic Velocity) Velocity cm/s or m/s

EDV (End Diastolic Velocity) Velocity cm/s or m/s

TAMV (Time Average Mean Velocity) Velocity cm/s or m/s

TAPV (Time Average Peak Velocity) Velocity cm/s or m/s

PGmean (Mean Pressure Gradient) Calculation None

Pgmax (Max Pressure Gradient), Calculation None 4 x PSV 2

S/D (Ratio of PSV to EDV) Calculation Ratio (PSV / EDV)

D/S (Ratio of EDV to PSV) Calculation Ratio EDV /PSV

RI (Resistivity Index) Calculation Ratio (PSV – EDV) / PSV

PI (Pulsatility Index) Calculation Ratio (PSV – EDV) / Vmean


5 - 26 SONOACE X6 User manual

▌ Volume Flow Measurement


Select Volume Flow in the Measurement menu.

Volume Flow allows you to measure and calculate an area or distance. For information on
distance or area measurements, please refer to “Basic Measurements.” The TAMV (Time
Avg. Mean Velocity) value is automatically measured.

■ Vesl. Area (Vessel Area)


Measure the area of a blood vessel and calculate TAMV and Volume Flow.

VolumeFlow ( A) = Area × TAMV × 60

■ Vesl. Dist. (Vessel Distance)


Measure the width of a blood vessel and calculate TAMV and Volume Flow.

π ×d2
VolumeFlow ( D) = × TAMV × 60
4

▌ Stenosis Measurement
You can measure the stenosis of each blood vessel system by measuring and calculating an
area or distance.

■ %StA (Stenosis Area)


Measure the area of the inner and outer walls of a blood vessel.

1. Select the %StA menu and the first cursor will appear in 2D Mode.

2. Measure the area of the vessel’s outer wall using the Circ/Area measurement method.

3. When the second cursor appears, measure the area of the vessel’s inner wall under
stenosis.

%Stenosis Area. = (Outer Area – Inner Area) / Outer Area × 100


Chapter 5.Measurements and Calculations 5 - 27

■ %StD (Stenosis Distance)


Measure the diameter of a blood vessel.

1. Select the %StD menu and the first cursor will appear in 2D Mode.

2. Measure the total diameter of a blood vessel using the Distance measurement
method.

3. When the second cursor appears, measure the diameter of the vessel’s inner wall
under stenosis.

%Stenosis Dist. = (Outer Distance – Inner Distance) / Outer Distance × 100

▌ Heart Rate Measurement

■ HR (Heart Rate)
You can calculate heart rates for a certain period of time.

1. Select HR in the Measurement menu. A bar appears allowing you to specify a


measurement area.

2. Specify the measurement range.

– Place the bar at a desired position with the Trackball, and press the Set button.

3. The system measures the heart rate within the specified range automatically. The
measurement results are displayed on the screen.
5 - 28 SONOACE X6 User manual

OB Calculations

▌ Before Obtaining OB Calculations

■ OB Basic Information
Type the information needed for OB diagnosis in the patient information window.

Enter LMP, then EDD (Estimated Delivery Date) and GA (Gestational Age) are
automatically calculated. LMP is required for the calculation of values such as EDD and
SD.

– EDD (LMP) = LMP + 280days

– GA (LMP) = Current System Date - LMP

A maximum of four fetuses can be input in the Gestations item. The default item value is
‘1’. In the case of twins, enter ‘2’.

For further information about patient information menus and how to input patient
information, refer to ‘Entering Patient Data’ in ‘Chapter 3 Settings’.

■ OB Measurement Menu Setup


Set GA Equation, GA Table and OB Measurement menus. The user can manually write,
back up and restore the GA Table. For more information on GA Equation and Table, refer
to the Reference Manual.

For more information about other measurement menus and setup, refer to ‘Setting
Measurements’ in ‘Chapter 3. Settings’.

For twins, distinguish fetuses by specifying them as Fetus A and Fetus


NOTE B in the Measurement menu. Press the Change button on the control
panel to change a fetus to measure.
Chapter 5.Measurements and Calculations 5 - 29

▌ Measurement Menu
The measurement menu items are arranged in the order in which they are used most during
obstetrics diagnosis.

When the measurements for the selected items are complete, the measurements and
gestational age are displayed on the screen. The measurement method for each item is the
same as for basic measurement.

Measured items are automatically recorded in a report.

[Figure 5.1 OB Measurement Menu]

 For information on basic measurements, please refer to “Basic


Measurements” in this chapter.
NOTE
 For references on measurement items, please refer to “Reference
Manual – Part 1.”
5 - 30 SONOACE X6 User manual

▌ Pregnancy Calculation
1. Press the Calculator button on the control panel to select the OB menu.

2. Select a measurement item, and a cursor appears on the screen.

3. Make a measurement using the Trackball and Set button.

Distance measurement is most important in Fetal Biometry and Fetal Long Bones. The items
that measure circumference are HC, AC, etc. The items that measure area are FTA, etc.

■ How to Measure a Distance Measurement Item


– BPD: Measure the maximum transverse diameter value when symmetrical thalamus
appears on the midline.

– OFD: Measure the distance from the front of the head to the back in the same way as
in BPD.

– CRL: Measure the distance from head to rump of embryo.

– FL: Femur length measurement. Measure the length of the femur that is closer to the
probe.

– MAD : Calculate the average value of the transverse and anterior-posterior lengths of
the fetal abdomen.

MAD = (APD + TAD) / 2

■ How to Measure a Circumference Measurement Item


HC: Calculate head circumference in the same way as in BPD. If the user measures BPD
and OFD, HC is automatically calculated.

HC = π * ( BPD 2 + OFD 2 ) / 2

Exception: when you use Merz reference, HC = 2.325 × BPD 2 + OFD 2


AC: Calculate abdominal circumference on the fetal transverse image when DV (ductus
venosus) is shown clearly. If the user measures APD and TAD, AC is automatically
calculated. At that time, position the cursor on the outside including the skin.

AC = π * ( APD 2 + TAD 2 ) / 2

Exception: when you use Merz reference, AC = π × ( APD + TAD ) / 2

FTA: This is the measurement of the fetal trunk area (chest or abdomen). Draw a circle
using the trace or ellipse, and the value is automatically calculated.

FTA = AC 2 / 4 / π
Chapter 5.Measurements and Calculations 5 - 31

NOTE For more information, refer to ‘Basic Measurements’.

■ Measurement Item Position (Measurement points)


BPD, OFD, HC –fetal head

BPD HC

OFD

APD, TAD, APTD, TTD – fetal abdomen or fetal trunk

TTD, AC
TAD

APTD,
APD
FTA –fetal trunk

FL – fetal femur
5 - 32 SONOACE X6 User manual

LV – fetal Vertebrae

In a report, a maximum of three mean average of new GA values and recently measured
values are recorded automatically. (If an item is measured less than three times, the value
may not be accurate.) The average values are used for GA and EDD calculation, and
displayed on a graph.

▌ Calculating Fetal Weight (EFW)


Measuring one set of the following table and estimated fetal weight will be calculated
automatically. . Refer to ‘Estimated Fetal Weight Formula’ in the Reference Manual.

– BPD. AC – AC, FL

– BPD, FL, FTA – BPD, AC, FL

– BPD, APTD, TTD, FL – HC, AC, FL

– BPD, APTD, TTD, SL – BPD, HC, AC, FL

– BPD, TTD – AC

For reference, Osaka University /Tokyo University methods are mainly used
NOTE in Asia, Merz method in Europe, and Shepard/ Hadlock methods on the
American continent.
Chapter 5.Measurements and Calculations 5 - 33

▌ AFI Calculation Method


The AFI is calculated by adding up the values of four measurements (Q1, Q2, Q3, Q4).

1. Measurements are performed by dividing the pregnant woman’s abdomen into four parts.
The distance between the fetus and the farthest point of each area is measured.

2. Select and measure each quadrant. Or select and measure all quadrants by selecting the
All menu.

3. To obtain the specific image from each quadrant plane, press the Freeze button to go to
the diagnosis mode. After obtaining the image, press Freeze button again to return to the
measurement mode.

4. The measurement values taken from each plane are added and displayed on the screen.

▌ Measurements in Spectral Doppler Mode

Menu Sub menu Result

Trace – Auto, Limited, Manual Doppler Waveform Trace

PSV Velocity

EDV Velocity

Volume Flow %StA Calculation

%StD Calculation

Vessel Area Area

Vessel Distance Distance

Umbilical Artery Same as above Same as above

MCA(Mid Cereb Artery) Same as above Same as above

Rt. / Lt. Uterine Artery Same as above Same as above

Placenta Artery Same as above Same as above

Rt. / Lt. Fetal Carotids Same as above Same as above

Fetal Aorta Same as above Same as above

Ductus Venous Same as above Same as above

The measurement items in Spectral Doppler Mode are measured using the same method.
The Volume Flow and Stenosis can be obtained. For more information, refer to ‘Volume Flow
Measurement Method’.
5 - 34 SONOACE X6 User manual

▌ Fetal HR Calculation

Menu Sub menu Result

Fetal HR Fetal Heart Rate Time interval & no. of beats


Chapter 5.Measurements and Calculations 5 - 35

GYN Calculations

▌ Before Obtaining GYN Calculations


Patient information needed for GYN diagnosis can be inputted in the patient information
window.

Gynecology Basic Information are GRAVIDA, PARA, ABORTA, Exp. Ovul., and Day of Cycle.

▌ Measurement Items
The measurement menu items are arranged in the order in which they are used most during
gynecology diagnosis. The measurement method for each item is the same as for basic
measurement.

Measured items are automatically recorded in a report.

[Figure 5.2 GYN Measurement Menu]

 For information on basic measurements, please refer to “Basic


Measurements” in this chapter.
NOTE
 For references on measurement items, please refer to “Reference
Manual – Part 1.”
5 - 36 SONOACE X6 User manual

▌ GYN Measurements in 2D Mode

Menu Sub menu Input Meas.

Uterus Length Distance

Uterus Height Distance

Uterus Width Distance

Uterus Endo. Thickness Distance

Cervix Length Distance

Cervix Height Distance

Cervix Width Distance

Length Distance

Right / Left Ovary Height Distance

Width Distance

Cyst / Mass Same as above Same as above

Right / Left Follicle Required for 1 to 12 Follicles Distance

When the Long axis image and Transverse axis image of the uterus are needed for
measuring volume, press the Freeze button to return to the scan mode.

▌ GYN Measurements in Spectral Doppler Mode

Menu Sub menu Input Meas.

Trace – Auto, Limited, Manual Doppler Waveform Trace

Right / Left Ovarian Artery Peak E Velocity

Peak A Velocity

The user can obtain the values such as PSV, EDV, Vmean, Gmean, Gpeak, S/D, TAM, PI
and RI from the spectral waveform in Spectral Doppler Mode. For more information, refer to
‘Doppler Spectrum Measurement Method’.
Chapter 5.Measurements and Calculations 5 - 37

Cardiac Calculations

NOTE Since the cardiac blood flow is fast, m/s is used as a velocity unit.

▌ Before Obtaining Cardiac Calculations

■ Cardiac Basic Information


Enter the patient information required for cardiology diagnosis in the Patient Information
window. The basic information for cardiology includes Height, Weight, HR (Heart Rate),
RAP (Right Arterial Pressure) and BP (Blood Pressure). When the patient's height and
weight are entered, BSA (Body Surface Area) is automatically calculated and displayed.

For more information about patient information menus and how to enter information,
please refer to “Entering Patient Data” in Chapter 3 “Setting.”

■ Cardiac Measurement Menu Setup


Set the related menus for convenient measurement. You can specify how an area and
volume can be calculated. Please refer to the “Setting Measurements” section in Chapter
3 “Setting” for more information on measurement menus and settings.
5 - 38 SONOACE X6 User manual

▌ Measurement Items
The measurement menu items are arranged in the order in which they are used most during
cardiology diagnosis.

The measurement method for each item is the same as for basic measurement.

Measured items are automatically recorded in a report.

 For information on basic measurements, please refer to “Basic


Measurements” in this chapter.
NOTE
 For references on measurement items, please refer to “Reference
Manual – Part 2.”

[Figure 5.3 Cardiac Measurement Menu]


Chapter 5.Measurements and Calculations 5 - 39

▌ Cardiac Measurements in 2D Mode

Menu Sub menu Input Meas.

A4C Diastole 20 Diameter & Length

A4C Systole 20 Diameter & Length


Simpson
A2C Diastole 20 Diameter & Length

A2C Systole 20 Diameter & Length

Vol. A/L LV Vol. Diastole Area & Length


(Volume
Area/Length) LV Vol. Systole Area & Length

All Distance (Thickness)

IVSd (Inter Ventricular Septal thickness Diastolic) Distance (Thickness)

IVSs (Inter Ventricular Septal thickness Systolic) Distance (Thickness)

LVDd (Left Ventricle Diameter Diastolic) Distance (Thickness)


2D Measure
LVDs(Left Ventricle Diameter Systolic) Distance (Thickness)

LVPWd (Left Ventricle Posterior Wall Dimension


Distance (Thickness)
Diastolic)

LVPWs (Left Ventricle Posterior Wall Dimension


Distance (Thickness)
Systolic)

Epi. Area (Epicardial) Area


LV (Left Ventricle)
Endo. Area (Endocardial) Area
Mass
LV Length (Left Ventricle Length) Distance

LVOT Dia (Left Venticle Outflow Tract Diameter) Length


Ao/LA
(Aorta/Left Ao Root Dia (Aorta Root Diameter) Length
Atrium)
LA Dia (Left Atrium Dimension) Length

■ Simpson and Vol. A/L


Measure the cardiac circumference and axis.

– 20 Diameter & Length: A cursor to trace the area appears. After the area
measurement, a new cursor to measure length appears. After drawing an axis within
the area, calculate the area by dividing it equally into 20 sections with the axis as a
standard.
5 - 40 SONOACE X6 User manual

■ 20 Measure
Make the measurements of the sub-menus of 2D Measure.

– All measures six items of 2D Measure (IVSd, IVSs, LVDd, LVDs, LVPWd, LVPWs) at
once using the Rotational Guide Line.

Move the Guide Line using the Trackball and adjust angle using Menu dial button.
After pressing Set button to fix Guide Line, set the measure point with the Trackball.
Six items are measured at once.

– IVSd and IVSs measure the AIVS and PIVS at the heart diastole and heart systolic
phases.

– LVDd and LVDs measure ENDO at the heart diastole and heart systolic phases.

– LVPWd and LVPWs measure EPI at the heart diastole and heart systolic phases.

– AIVS: Anterior Interventricular Septum


PIVS: Posterior Interventricular Septum
ENDO: Endocardial Surface of Left Ventricular Wall
EPI: Epicardial Surface of Left Ventricular Wall

■ LV Mass
When measuring LV Mass, the user can obtain the images at different angles needed for
the sub-menus by using the Freeze button on the control panel. In Dual 2D Mode,
simultaneous images are activated, and the image doesn’t have to be scanned during the
measurement.

– LV (Left Ventricle) is used only when measuring mass. It can be measured only in
the case of the diastole of Left Ventricle.

– Myocardial thickness = SQRT(Dia.A / Pi) – SQRT(Sys.A / Pi)

■ Ao/LA
The sub-menus of Ao/LA are measured as shown below.

– Ao-LA measures Aorta and Left Atrium in sequence.

– LVOT Dia measures the point of Aortic Valve Annulus.

– Ao Root Dia measures the distance from Anterior Aortic Wall to Posterior Aortic Wall.

– LA Dia measures the distance from Posterior Aortic Wall to Left Arterial Wall.
Chapter 5.Measurements and Calculations 5 - 41

▌ Cardiac Measurements in M Mode

Menu Sub menu Input Meas.

IVSd (Inter Ventricular Septal thickness Diastolic) Distance (Thickness)

LVDd (Left Ventricle Diameter Diastolic) Distance (Thickness)

LVPWd (Left Ventricle Posterior Wall Dimension


Distance (Thickness)
Diastolic)

IVSs (Inter Ventricular Septal thickness Systolic) Distance (Thickness)


Lt. Ventricle
LVDs (Left Ventricle Diameter Systolic) Distance (Thickness)

LVPWs (Left Ventricle Posterior Wall Dimension Systolic) Distance (Thickness)

RVDd (Right Ventricle Diameter Diastolic) Distance (Thickness)

All (IVSd, LVDd, LVPWd, IVSs, LVDs, LVPWs) Same as above

Ao Root Dia (Aortic Root Dimension) Distance

AoV Cusp Sep. (Aortic Valve Cusp Separation) Distance

LA Dia (Left Atrial Dimension) Distance


Ao/LA
(Aorta/Left
Atrium) LV PET (Left Ventricle Pre Eject Time) Time

LV ET (Left Ventricle Eject Time) Time

All (Ao Root Dia, AoV Cusp Sep., LA Dia, LV PET, LV


Same as above
ET)

A-C Interval Time interval

D-E (D – E Excursion) Distance

MV (Mitral E-F Slope Slope (Velocity)


Valve)
EPSS (E Point Septal Separation) Distance (Thickness)

All Points (D-E Excursion, E-F slope, A-C Interval,


Same as above
E Point Septal Separation)

Heart Rate Heart Rate Time interval & no. of beats


5 - 42 SONOACE X6 User manual

■ Lt. Ventricle
– The sub-menus of Lt. Ventricle are measured in the same way as in 2D Measure.

– RVDd is measured in the same way as in LVDd.

■ Ao/LA
The sub-menus of Ao/LA are measured as shown below.

– Ao Root Dia measures the distance between the Anterior Aortic Wall and Posterior
Aortic Wall.

– AoV Cusp Sep. measures the distance between the Coronary Cusp and Non
Coronary Cusp.

– LA Dia measures the distance between the Posterior Aortic Wall and Left Arterial Wall.

– LV PET measures the distance between the ECG’s Q Wave and Aortic Valve Opening.

– LV ET measures the distance between the Aortic Valve Opening and Aortic Valve
Closing.

■ MV
The sub-menus of MV are measured as shown below.

– A-C Interval calculates the time duration by measuring the distance between the A
point and C point in the Mitral Valve measurement screen.

– D-E measures the distance between the E point of the Anterior Mitral Valve and the D
point of the Mitral Valve Opening.

– E-F Slope calculates the velocity by measuring the distance between the E point and
F point in the Mitral Valve measurement screen.

– EPSS measures the distance between the E point in the Mitral Valve and Posterior
Interventricular Septum. The user can measure only in the upper direction of the E
point, and only in the lower direction in Apex.

■ Heart Rate
Select Heart Rate, and heart rate is calculated.

– Set the start and end points of the spectral waveform with a bar.

– Rotate the Menu / Angle dial-button to select ‘Number of Beats’. Calculate the
average mean of the Fetal HR.
Chapter 5.Measurements and Calculations 5 - 43

▌ Cardiac Measurements in Color Doppler Mode

Menu Sub menu Input Meas.

PISA(Proximal Isovelocity Surface Area) Radius Distance


MV (Mitral Valve)
Regurg
PISA-Alias Vel. Velocity

PISA-Radius Distance
AoV (Aortic Valve)
Regurg
PISA-Alias Vel. Velocity

PISA Radius Distance


TV (Tricuspid
Valve) Regurg
PISA-Alias Vel. Velocity

PISA Radius Distance


PV (Pulmonary
Valve) Regurg
PISA-Alias Vel. Velocity

■ PISA-Radius
Measure the distance between Valve and First Isovelocity.

■ PISA-Alias Vel.
Multiply the result value of PISA-Radius by the color bar’s regurgitant peak velocity.

– PISA: Proximal Isovelocity Surface Area

The velocity value is needed to measure the items above. So select


Velocity or Vel + Var as the color display. For more information, refer
NOTE to ‘Color Image Format Change’ in the ‘Color Doppler Mode’
section.
5 - 44 SONOACE X6 User manual

▌ Cardiac Measurements in Spectral Doppler Mode

Menu Sub menu Input Meas.

Trace –Limited, Manual Doppler Waveform Trace

E-DT-A Velocity & Time

Peak E Velocity

Peak A Velocity
MV (Mitral Valve)
Acc (Acceleration Time) Time or Calculated from Trace
Inflow
Dec (Deceleration Time) Time or Calculated from Trace

PHT (Pressure Half Time) Time or Calculated from Trace

IVRT (IsoVolumic Relaxation Time) Time

R-R Interval (Rate-Rate Interval) Time Interval & No. of beats

Trace – Auto, Limited, Manual Doppler Waveform Trace


MV (Mitral Valve)
Peak V (Velocity) Velocity
Regurg
VTI (Velocity Time Integral) Calculated

Trace – Auto, Limited, Manual Doppler Waveform Trace

LVOT (Left Peak V (Velocity) Velocity


Ventricular
Outflow Tract)
Doppler VTI (Velocity Time Integral) Calculated

Dia (Diameter) Distance

Trace – Auto, Limited, Manual Doppler Waveform Trace

Peak V (Velocity) Velocity

VTI (Velocity Time Integral) Calculated


AoV (Aortic Valve)
Systolic
Acc (Acceleration Time) Time or Calculated from Trace

Ejection (Ejection Time) Time

R-R Interval (Rate-Rate Interval) Time Interval & No. of beats

Trace –Limited, Manual Doppler Waveform Trace


AoV (Aortic Valve)
Regurg
Peak V (Velocity) Velocity
Chapter 5.Measurements and Calculations 5 - 45

Menu Sub menu Input Meas.

VTI (Velocity Time Integral) Calculated

PHT (Pressure Half Time) Time or Calculated from Trace

Trace –Limited, Manual Doppler Waveform Trace

E-DT-A Velocity & Time

Peak E Velocity

Peak A Velocity
TV (Tricuspid
Valve) Inflow
Acc (Acceleration Time) Time or Calculated from Trace

Dec (Deceleration Time) Time or Calculated from Trace

PHT (Pressure Half Time) Time or Calculated from Trace

R-R Interval (Rate-Rate Interval) Time Interval & No. of beats

Trace – Auto, Limited, Manual Doppler Waveform Trace


TV (Tricuspid
Peak V (Velocity) Velocity
Valve) Regurg
VTI (Velocity Time Integral) Calculated

Trace – Auto, Limited, Manual Doppler Waveform Trace

Peak V (Velocity) Velocity


PV Systolic
Acc (Acceleration Time) Time or Calculated from Trace

R-R Interval (Rate-Rate Interval) Time Interval & no. of beats

Trace – Auto, Limited, Manual Doppler Waveform Trace

Peak V (Velocity) Velocity


PV Regurg
VTI (Velocity Time Integral) Calculated

PHT (Pressure Half Time) Time or Calculated from Trace

Dias Vel. (Diastolic Velocity) Velocity

Sys Vel. (Systolic Velocity) Velocity


Plum. Veins
(Pulmonary Veins)
A. Rev Vel. (Artery Reversal Velocity) Velocity

A. Rev Dur. (Artery Reversal Duration) Time

Tissue Doppler E-DT-A Velocity & Time


5 - 46 SONOACE X6 User manual

Menu Sub menu Input Meas.

Peak E’ Velocity

Peak A’ Velocity

Peak S Velocity

Acc (Acceleration Time) Time or Calculated from Trace

Dec (Deceleration Time) Time or Calculated from Trace

IVCT (IsoVolume Contraction Time) Time or Calculated from Trace

IVRT (IsoVolume Relaxation Time) Time or Calculated from Trace

Sys. VTI ([Systemic] Flow Area Trace) Calculated

Sys. HR ([Systemic] Heart Rate) Heart Rate

Sys. Dia ([Systemic] Outflow Tract Diameter) Diameter


Qp:Qs
Pulm. VTI ([Pulmonic] Flow Area Trace) Calculated

Pulm. HR ([Pulmonic] Heart Rate) Heart Rate

Pulm. Dia ([Pulmonic] Outflow Tract


Diameter
Diameter)

Heart Rate Heart Rate Time interval & no. of beats

All N/A

Dias Vel. (Diastolic Velocity) Velocity


Hepatic Vein
Sys Vel. (Systolic Velocity) Velocity

Rev Vel. (Reversal Velocity) Velocity

For more information, refer to ‘Doppler Spectrum Measurement Method’.

NOTE The Auto Trace function is not provided in MV Inflow and TV Inflow.
Chapter 5.Measurements and Calculations 5 - 47

 The values of Peak, Acc Time, Dec Time. Ejection Time, VTI, PHT, R-R Interval, etc. are
automatically measured by tracing the Spectral Doppler image. Each item can also be
selectively measured.

– Peak V: Measures the higher velocity value.

– Peak E: Measures the Ventricular Systolic peak.

– Peak A: Measures the Atrial Systolic peak.

– Acc: Measures the time duration when blood flow is accelerated. Dec Measures the
time duration when blood flow is decelerated.

– [E-DT-A]: Measure Peak E,Dec., and Peak A in order.

– Ejection: Measures the time duration by measuring the distance between the Aortic
Valve Opening and Aortic Valve Closing.

– VTI: Calculates the value using the formula of VTI = Sum of Vi × ∆t after tracing the
Spectral Doppler image.

– PHT: Calculates Half-Time using the Pressure gradient value obtained between the E
point of Valve and the baseline.

– R-R Interval: Measures the distance between consecutive R waves on the ECG.

 LVOT Doppler

Measure Left Ventricular Outflow. Its sub-menu Dia. measures the Aortic Valve Annulus
point in the 2D image.

 The sub-menus of Plum. Veins are measured as shown below.

– Dias Vel. and Sys Vel. measure the velocity at the diastole and systolic phases.

– A. Rev Vel. measures the Peak Velocity at Atrial Reversal.

– A. Rev Dur. measures the time duration by measuring the distance between the
Mitral Valve Closing and the heart diastole phase.

 In the sub-menu of Tissue Doppler, Peak S measures the systolic peak, and IVCT and
IVRT measure Isovolumic Contraction and Isovolumic Relaxation phases, respectively.

 The sub-menus of Qp:Qs are measured as shown below.

– Sys. VTI and Pulm. VTI measure the VTI by tracing LVOT Flow and RVOT Flow
respectively.

– Sys. HR and Pulm. HR measure the heart rate by measuring diastole phase and
systolic phase respectively in LVOT Flow and RVOT Flow.

– Sys. Dia and Pulm. Dia measures the distance of Outflow Tract in the 2D images of
LVOT Flow and RVOT Flow, respectively.
5 - 48 SONOACE X6 User manual

 Select Heart Rate to calculate the heart rate.

– Select and measure the start and end points of the spectral waveform.

– Measure the average value of the heart rate by selecting ‘Number of Beats’ with the
Menu / Angle dial-button.

 Select Hepatic Vein to measure Hepatic Vein.

– Dias Vel. measures the Peak Velocity at diastole.

– Systolic Vel. measures the Peak Velocity at systole.

– Reversal Vel. measures the Peak Velocity at reversal.


Chapter 5.Measurements and Calculations 5 - 49

Vascular Calculations

▌ Before Obtaining Vascular Calculations


Set the related menus for convenient measurement.

The user can also set the Peak Velocity used to calculate ‘A/B Ratio’ and ‘ICA/CCA Ratio’.

For more information, refer to ‘Setting Measurements’ in ‘Chapter 3. Settings’.

▌ Measurement Items
The measurement menu items are arranged in the order in which they are used most during
vascular diagnosis.

The measurement method for each item is the same as for basic measurement.

Measured items are automatically recorded in a report.

 All vascular systems are measured using the same method. For
information on basic measurements, please refer to “Basic
Measurements” in this chapter.

NOTE  It is convenient to calculate each measurement value on the Spectral


Doppler image.

 For references on measurement items, please refer to “Reference


Manual – Part 2.”

[Figure 5.4 Vascular Measurement Menu]


5 - 50 SONOACE X6 User manual

▌ Vascular Measurements
Menu Sub menu Input Meas.

Trace – Auto, Limited, Manual Doppler Waveform Trace

PSV Velocity

EDV Velocity

Rt./ Lt. Subclavian %StA Calculation

%StD Calculation

Vessel Area Area

Vessel Distance Distance

(Proximal Common Carotid Artery)


Rt./Lt. Prox CCA Same as above
Same as above

Rt./Lt. Mid CCA Same as above Same as above

Rt./Lt. Distal CCA Same as above Same as above

Rt./Lt. Bulb Same as above Same as above

(Proximal Internal Carotid Artery)


Rt./Lt. Prox ICA Same as above
Same as above

Rt./Lt. Mid ICA Same as above Same as above

Rt./Lt. Distal ICA Same as above Same as above

(External Carotid Artery)


Rt./Lt. ECA Same as above
Same as above

Rt./Lt. Vertebral Same as above Same as above

General Same as above Same as above

 The values such as PSV, EDV, Vmean, Gmean, Gpeak, S/D, PI, RI, etc. can be obtained
from the spectral waveform in Spectral Doppler Mode. There are four measurement
methods: Auto Trace, limited Trace, Manual Trace, and Measurement Each Item One by
One. For more information, refer to ‘Doppler Spectrum Measurement Method’.
 Stenosis % Calculation: There are two ways to obtain the Stenosis % of each vascular
system: %StA using the area and %StD using the distance. Refer to ‘Volume Flow
Measurement’ for more information.
 Vessel Area Measurement: There are two ways to obtain Vessel Area: Vesl. Area using
the circumference and Vesl. Dist using the distance.
 The user can obtain the Volume Flow values using the TAM (Time Average Mean
Velocity) value obtained from the spectral waveform and the Vessel Area value obtained
using Vesl. Area or Vesl. Dist.
Chapter 5.Measurements and Calculations 5 - 51

▌ Volume Flow Measurements


The Volume Flow menu is shown below. For more information, refer to ‘Volume Flow
Measurement Method’.

Menu Sub menu Result

Auto Trace Doppler Waveform Trace


Volume Flow
Vessel Distance Distance

▌ Heart Rate Calculations


Select Heart Rate to calculate the heart rate.

– Select and measure the start and end points of the spectral waveform.

– Calculate the average value of the heart rate by selecting ‘Number of Beats’ with the
Menu / Angle dial-button.

Menu Sub menu Result

Heart Rate Heart Rate Time interval & no. of beats


5 - 52 SONOACE X6 User manual

Urology Calculations

▌ Before Obtaining Urology Calculations


For more convenient measurement, set the related menus.

The user can select the Volume Method. There are four types of Volume Method. The factor
value can be set manually for the formulas that need it.

For more information, refer to ‘Settings Measurements’ in ‘Chapter 3. Settings’.

▌ Measurement Items
The measurement menu items are arranged in the order in which they are used most during
urology diagnosis.

The measurement method for each item is the same as for basic measurement.

Measured items are automatically recorded in a report.

 For information on basic measurements, please refer to “Basic


Measurements” in this chapter.
NOTE
 For references on measurement items, please refer to “Reference
Manual – Part 2.”

[Figure 5.5 Urology Measurement Menu]


Chapter 5.Measurements and Calculations 5 - 53

▌ Volume Measurements
1. Select the Urology menu by pressing the Calculator button on the control panel.

2. Select the required measurement item and menu, and a cursor appears on the screen.

3. Perform the measurement using the Trackball and the Set button on the control panel.

– The measurement of Transitional Zone Prostate Volume, Bladder Volume, Left Kidney
Volume, and Right Kidney Volume is the same as in Prostate Volume.

– There are two ways to measure in each menu: one is measuring the item values from
one image, and the other is measuring the item values from several images. The
measurement methods of each menu vary with the Volume Method set in the Setup
menu.

– If 3Distance or 3Distance * Factor is set in Setup, three diameter values can be


obtained in order.

Menu Sub menu Result

All

1st Dia. (Diameter) Distance


Bladder Volume
2nd Dia. (Diameter) Distance

3rd Dia. (Diameter) Distance

All

1st Dia. (Diameter) Distance


Prostate Volume
2nd Dia. (Diameter) Distance

3rd Dia. (Diameter) Distance

Pre All

Pre 1st Dia. (Diameter) Distance

Pre 2nd Dia. (Diameter) Distance

Residual Volume Pre 3rd Dia. (Diameter) Distance

Post All

Post 1st Dia. (Diameter) Distance

Post 2nd Dia. (Diameter) Distance


5 - 54 SONOACE X6 User manual

Menu Sub menu Result

Post 3rd Dia. (Diameter) Distance

All

1st Dia. (Diameter) Distance


Transitional Zone
Prostate Volume
2nd Dia. (Diameter) Distance

3rd Dia. (Diameter) Distance

All

1st Dia. (Diameter) Distance


Left (Right) Kidney
2nd Dia. (Diameter) Distance
Volume
3rd Dia. (Diameter) Distance

Renal Pelvis Distance


Chapter 5.Measurements and Calculations 5 - 55

– If Ellipsoid is set in Setup, Main Diameter and Beside Diameter values can be
obtained in order.

Menu Sub menu Result

All

Bladder Volume Main Dia. (Diameter) Distance

Beside Dia. (Diameter) Distance

All

Prostate Volume Main Dia. (Diameter) Distance

Beside Dia (Diameter) Distance

Pre All

Pre Main Dia. (Diameter) Distance

Pre Beside Dia. (Diameter) Distance


Residual Volume
Post All

Post Main Dia. (Diameter) Distance

Post Beside Dia. (Diameter) Distance

All
Transitional Zone
Main Dia. (Diameter) Distance
Prostate Volume
Beside Dia. (Diameter) Distance

All

Main Dia. (Diameter) Distance


Left (Right) Kidney
Volume
Beside Dia. (Diameter) Distance

Renal Pelvis Distance


5 - 56 SONOACE X6 User manual

– If Sum of 20 Disks is set in Setup, the user can calculate the measurement value by
measuring the prostate circumference and prostate axis using the Trackball and the
Set button.

Menu Sub menu Result

Bladder Volume Bladder Vol. 20 Diameter & Area

Prostate Volume Prostate Vol. 20 Diameter & Area

Pre Vol. 20 Diameter & Area


Residual Volume
Post Vol. 20 Diameter & Area

Transitional Zone
Transitional Zone Prostate Vol. 20 Diameter & Area
Prostate Volume

Left (Right) Kidney Vol. 20 Diameter & Area


Left (Right) Kidney
Volume
Renal Pelvis Distance

▌ Volume Flow Measurements


The Volume Flow menu is shown below. For more information, refer to ‘Volume Flow
Measurement Method’.

Menu Sub menu Result

Trace – Auto, Limited, Manual Doppler Waveform Trace

PSV Velocity

EDV Velocity

Volume Flow %StA Calculation

%StD Calculation

Vessel Area Area

Vessel Distance Distance


Chapter 5.Measurements and Calculations 5 - 57

Fetal Echo Calculations

▌ Before Obtaining Fetal Echo Calculations


Set the related menus for convenient measurement.

The user can also set the measurement method to calculate volume.

Refer to the ‘Setting Measurements’ section in “Chapter 3. Settings” for more information.

▌ Measurement Items
The measurement menu items are arranged in the order in which they are used most during
fetal echo diagnosis.

The measurement method for each item is the same as for basic measurement. In addition,
measurement items are similar to those for cardiac calculation.

Measured items are automatically recorded in a report.

 For information on basic measurements, please refer to “Basic


Measurements” in this chapter.
NOTE
 For references on measurement items, please refer to “Reference
Manual – Part 2.”

[Figure 5.6 Fetal Echo Measurement Menu]


5 - 58 SONOACE X6 User manual

▌ Fetal Echo Measurements in 2D Mode

Menu Sub menu Input Meas.

Asc. Aorta (Ascending Aorta) Distance

MPA (Main Pulmonary Artery) Distance

Duct. Art (Ductus Arteriosus) Distance

Left Atrium Distance

Right Atrium Distance

Right Ventricle Distance


2D Echo
Inter Ventricular Septum Distance

Lt. Ventricle Dia.(Diastole) Distance

Lt. Ventricle Sys.(Systole) Distance

LVPW (Left Ventricle Posterior Wall) Distance

Heart Circ. (Circumference) Circ/Area

Thoracic Circ. (Circumference) Circ/Area

Thorax AP (Anteroposterior) Diameter (ThAPD) Distance

Thorax Transverse Diameter (ThTD) Distance


CTAR (Cardio-Thorax
Area Ratio)
Heart AP Diameter (HAPD) Distance

Heart Transverse Diameter (HTD) Distance

 Use the Distance measurement method to measure Asc. Aorta (Ascending Aorta), MPA
(Main Pulmonary Artery), Duct. Art (Ductus Arteriosus), Lt. Atrium (Left Atrium), Rt.
Atrium(Right Atrium), Rt. Ventricle(Right Ventricle), IVS (Inter Ventricular Septum), LVDd
(Left Ventricle Diameter Diastole), LVDs (Left Ventricle Diameter Systole), and LVPW
(Left Ventricle Posterior Wall).

 Use the Circ/Area calculation method to measure Heart Circ. (Heart Circumference), and
Thora Circ. (Thoracic Circumference).

 The CTAR menu measures and compares the size of the fetal chest and heart. You can
obtain the value by comparing ThAPD, ThTD, HAPD, and HTD values.

HAPD × HTD
CTAR = × 100
ThAPD × ThTD
Chapter 5.Measurements and Calculations 5 - 59

▌ Fetal Echo Measurements in M Mode

Menu Sub menu Input Meas.

IVSd (Inter Ventricular Septal Thickness Diastolic) Distance (Thickness)

LVDd (Left Ventricle Diameter Diastolic) Distance (Thickness)

LVPWd (Left Ventricle Posterior Wall Dimension


Distance (Thickness)
Diastolic)

IVSs (Inter Ventricular Septal Thickness Systolic) Distance (Thickness)


Fetal M Mode
LVDs (Left Ventricle Diameter Systolic) Distance (Thickness)

LVPWs (Left Ventricle Posterior Wall Dimension


Distance (Thickness)
Systolic)

RVDd (Right Ventricle Diameter Diastolic) Distance (Thickness)

All (IVSd, LVDd, LVPWd, IVSs, LVDs, LVPWs) Same as above

Fetal HR Fetal Heart Rate Time interval & no. of beats

 Measure the sub menus of Fetal M Mode as shown below.

– IVSd and IVSs measure AIVS and PIVS at the diastolic and systolic phases
respectively.

– LVDd and LVDs measure ENDO at the diastolic and systolic phases respectively.

– LVPWd and LVPWs measure EPI at the diastolic and systolic phases respectively.

– AIVS: Anterior Interventricular Septum


PIVS: Posterior Interventricular Septum
ENDO: End cardinal Surface of Left Ventricular Wall
EPI: Epicardial Surface of Left Ventricular Wall

– RVDd is measured in the same way as in LVDd.

 Select Fetal HR to calculate the fetal heart rate.

– Select and measure the start and end points of the spectral waveform.

– Calculate the average value of the heart rate by selecting ‘Number of Beats’ with the
Menu / Angle dial-button.

– This links up with the Fetal HR in Obstetrics.


5 - 60 SONOACE X6 User manual

▌ Fetal Echo Measurements in Spectral Doppler Mode

Menu Sub menu Input Meas.

Trace – Auto, Limited, Manual Doppler Waveform Trace


MPA (Main Pulmonary
PSV Velocity
Artery)
EDV Velocity

Ductua Arteriosus Same as above Same as above

Inferior Vena Cava Same as above Same as above

Ductus Venosus Same as above Same as above

Ascending Aorta Same as above Same as above

Descending Aorta Same as above Same as above

Peak E Velocity
MV (Mitral Valve) Inflow
Peak A Velocity

MV (Mitral Valve)
Velocity Velocity
Regurgitation

Peak E Velocity
Tricuspid Valve Inflow
Peak A Velocity

Tricuspid Valve
Velocity Velocity
Regurgitation

Systolic Flow Velocity

PLI (PreLoad Index) Diastolic Flow Velocity

Atrial Reversal Flow Velocity

Fetal HR Fetal Heart Rate Time interval & no. of beats


Chapter 5.Measurements and Calculations 5 - 61

 Select Auto Trace. The image is automatically traced and the measurement values
calculated.

 Select Limited Trace, and the baseline appears on the image. Set the start and end
points of the spectral waveform using the baseline, and the measurement value is
automatically calculated. The user can reposition the baseline by pressing the Change
button.

 Select Manual Trace, and a cursor appears on the image. Trace the Doppler waveform,
and the measurement value is automatically calculated.

 The user can select and measure each item manually.

– PSV measures the Peak Systolic velocity.

– EDV measures the End Diastolic velocity.

– Peak E measures the Ventricular Systolic peak.

– Peak A measures the Atrial Systolic peak.

 Select Fetal HR to calculate the fetal heart rate.

– Select and measure the start and end points of the spectral waveform.

– Measure the average value of the heart rate by selecting ‘Number of Beats’ with the
Menu / Angle dial-button.

– This links up with the Fetal HR in obstetrics.


5 - 62 SONOACE X6 User manual

Report
Check the measurement and calculation results in the report of each application.

 Press the Report button on the keyboard to check the report of the specific application.

 The applications not yet measured are not shown.

 The deviated data from the valid range will be displayed with Invalid mark(*).

 To return to the diagnosis mode, press the X on the report screen, or press the Exit
button on the control panel or the Report button on the keyboard.

[Figure 5.7 Report Screen – Example]


Chapter 5.Measurements and Calculations 5 - 63

Viewing Report
 The measurement and calculation items and their values are displayed.

 When the report screen has more than two pages, use the left/right arrow button on the
report screen. To search and check the reports of other applications, use the Next
Package to move to the specific package.

Editing Report
Press the Edit to edit the specific information. After editing, press the Ok at the top of the
screen to return to the original report screen, and the edited values are shown in the [ ]
bracket in the report.

Comment

Press the Comment . Press the Ok at the top of the screen after entering some comment
to return to the original report screen.

Printing out Report

Press the Print in the report screen. If there is no connection with a printer, this button
will not be displayed.

Exporting Report

 Press the Export on the screen to save the report as MO Disk or Flash Memory.
The Export Report window appears on the screen to designate File Name and File
Format as shown below.

 The Export is not activated if the drive is not connected.

 The file name is automatically given, but the file name can also be inputted manually. The
user can choose a file format of either Excel or Text.
5 - 64 SONOACE X6 User manual

▌ Open Line Transfer


Transfer the report to another computer or printer. Press the Open Line Transfer on the
Export Report window.

 Connect the USB to RS-232C serial cable to the USB port of the rear
panel prior to use this function.
NOTE  If the operating system of the PC connected to this system via the USB
to RS-232C Serial Cable is Windows XPTM, errors may be caused during
report transferring.

Set the computer or printer, connects to this system, like following;

– 9,600 Baud

– 8-bit data

– No parity

– 1 stop bit
Chapter 5.Measurements and Calculations 5 - 65

Graph Function
 This function is used to display the GA values such as BPD, HC, AC and FL, allowing the
user to diagnose fetal growth.

 The function can be used only in the OB report. Press Graph on the screen.

 The graph is created using ID, LMP, and measurement date as standards.

 To change to the report screen, press Report on the screen.

 To return to the diagnosis mode, press the X on the graph screen, or press the Exit
button on the control panel.

Only after the patient name, ID and LMP are entered, the graph and report
NOTE are automatically saved in the HDD.

▌ Viewing Graph
 The graph of the recently measured values is drawn according to the gestation period
(week) and fetal size (mm).

 The G.A. values, including the fetal weight, are displayed at the bottom of the screen.
Select a specific item on the combo box using the Trackball and the Set button, and a
graph appears.

▌ Viewing History
 To view the history information, press the History on the OB report screen. To return to
the graph screen, press the button again.

 Select Fetus and Date Display Type to study.


User Manual
Volume 2
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Version 1.04

User Manual
English

MI68-03116A
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Table of Contents 1

Table of Contents – Volume 2

Chapter 6 – Image Managements


Image Managements ....................................................................................................................3
Reviewing Images (CINE / LOOP) ...............................................................................................3
Annotating Images .......................................................................................................................5
Text ...........................................................................................................................................5
Body Marker .............................................................................................................................7
Indicator ....................................................................................................................................9
Saving and Transferring Images ..............................................................................................11
Saving Images ........................................................................................................................ 11
Transferring Images ................................................................................................................ 11
Printing and Recording Images ................................................................................................12
Printing Images .......................................................................................................................12
Recording Images...................................................................................................................12
SONOVIEW .................................................................................................................................13
Starting SONOVIEW ...............................................................................................................13
Exam View ..............................................................................................................................15
Exam Review ..........................................................................................................................20

Chapter 7 – Maintenance
System Maintenance....................................................................................................................3
Installation Requirements .........................................................................................................3
Cleaning and disinfections ........................................................................................................4
Fuse Replacement....................................................................................................................6
Cleaning The Air Filters ............................................................................................................7
Accuracy Check ........................................................................................................................8
Administration of Information.....................................................................................................9
User Setting Back up ................................................................................................................9
Patient information Back-up .....................................................................................................9
Software ....................................................................................................................................9
2 SONOACE X6 User Manual

Chapter 8 – Probes
Probes ........................................................................................................................................... 3
Ultrasound transmission Gel .................................................................................................... 6
Sheaths .................................................................................................................................... 7
Probe Precautions .................................................................................................................... 8
Cleaning and Disinfecting the Probe ........................................................................................ 9
Biplane Probe ......................................................................................................................... 22
Biopsy ......................................................................................................................................... 24
Biopsy KIT Components ......................................................................................................... 24
Using the Biopsy Kit ............................................................................................................... 25
Cleaning and Disinfecting Biopsy Kit ..................................................................................... 27
Assembling the Biopsy Kit ...................................................................................................... 29

** Reference Manual
Samsung Medison is providing an additional SONOACE X6 Reference Manual. GA tables and
references for each application are included in the Reference Manual.
Chapter 6

Image Managements

Image Managements .................................................................................................... 3

Reviewing Images (CINE / LOOP) ............................................................................... 3

Annotating Images ....................................................................................................... 5


Text ........................................................................................................................................... 5
Body Marker.............................................................................................................................. 7
Indicator .................................................................................................................................... 9

Saving and Transferring Images ............................................................................... 11


Saving Images ........................................................................................................................ 11
Transferring Images................................................................................................................ 11

Printing and Recording Images ................................................................................ 12


Printing Images ....................................................................................................................... 12
Recording Images ................................................................................................................... 12

SONOVIEW .................................................................................................................. 13
Starting SONOVIEW ............................................................................................................... 13
Exam View .............................................................................................................................. 15
Exam Review .......................................................................................................................... 20
Chapter 6. Image Managements 6 - 3

Reviewing Images (CINE / LOOP)


Images are automatically saved in the memory during scanning. The saved images can be
useful when a patient is diagnosed and reviewed.

The saved images can be in CINE or LOOP depending on the diagnosis mode.

– CINE: Images that are saved in all modes other than M Mode and Spectral Mode.

– LOOP: Images that are saved in M Mode and Spectral Mode.

[Figure 6.1 Reviewing Images]

▌ Starting and Finishing Image Review


During scanning, press the Freeze button on the control panel. The scanning is stopped and
the system switches to the image review mode screen.

Press the Freeze button again to return to the scan mode.


6-4 SONOACE X6 User manual

▌ How to Review Images


Use the Trackball on the control panel. You can search for saved images in chronological
order by rotating the Trackball to the left or right. The number of images saved so far and the
number of the image currently under review are displayed in the user information area.

The Flexible Soft menu is changed when images are reviewed.

 [1] Auto Run

Use the Flexible Soft button [1]. CINE Mode or LOOP Mode is automatically played and
repeated. To stop Auto Run, press this button again.

 [2] CINE/LOOP

Use the Flexible Soft button [2]. This option appears only when both CINE and LOOP
are available, as in M Mode or Spectral Doppler Mode. You can select an image to play in
CINE and LOOP by pressing the dial-button. The selection is displayed in the left side of
the user information area.

 [3] Cine Edit

Use the Flexible Soft button [3]. Set the range of the Cine mode. When you press this
button, the Flexible Soft button [3]~[5] is changed;

– Set Cine start point: press the Flexible Soft button [3] Frame Start and set the start
point using the Set button.

– Set Cine end point: press the Flexible Soft button [4] Frame End and set the start
point using the Set button.

– Finish setting: press the Flexible soft button [5] Cine Save to save the start and the
end point.

※ Tip! Set using the Change button

Set the start point using the Set button and press the Change button to set the end
point

 [4] Cine Save

Use the Flexible Soft button [4]. Save the Cine whole Cine images.

 [5] Speed (%)

Use the Flexible Soft button [5]. Change the speed of Auto Run. When you press this
button repeatedly, it changes as 10%, 40%, 70% and 100%.

▌ Reviewing Images in Multi-Image Mode


Only images in an active area can be reviewed in multi-image mode. To review images in
another area, change the active area by using the Set or the Dual button on the control
panel.
Chapter 6. Image Managements 6 - 5

Annotating Images

Text
You can enter comments or text over an image. This function can be useful when the diagnosis
area is differentiated or displayed.

▌ Starting Text Input Mode


Press the [F1] Text button in the Alphanumeric Keyboard. The system will switch to text
input mode.

[Figure 6.2 Text Input Mode]


6-6 SONOACE X6 User manual

▌ Typing Text
1. Move the cursor by using the Trackball on the keyboard.

2. Enter text by using the Alphanumeric Keyboard.

While entering text, the keys in Alphanumeric Keyboards have the specific functions shown
below.

Move the cursor position up by one row on the same column of the
[↑] Key
current cursor.

Move the cursor position down by one row on the same column of the
[↓] Key
current cursor.

Move the cursor position to the left by one column on the same row
[←] Key
of the current cursor.

Move the cursor position to the right by one column on the same row
[→] Key
of the current cursor.

▌ Autotext
This function allows you to enter text automatically by using an abbreviation. In this way, you
can enter text easily and quickly. When Autotext is enabled, the autotext list appears on the
screen.

[Figure 6.3 The Autotext List]

NOTE Select [8] Setup > System > General > Autotext Set

▌ Deleting Text
Press the Clear button on the control panel. All the text entered on the screen will be deleted.

▌ Exiting Text Input Mode


Press Exit on the control panel or the [F1] Text key on the keyboard.
Chapter 6. Image Managements 6 - 7

Body Marker
You can place a Body Marker over an image. This function can be useful when the diagnosis
area is differentiated or displayed.

[Figure 6.4 Body Marker]


6-8 SONOACE X6 User manual

▌ Starting Body Marker Input Mode


Press the Body Marker button on the control panel. The system will switch to Body Marker
input mode and Body Markers will appear in the user information area.

▌ Entering Body Marker


1. Body markers will appear on the Flexible Soft menu.

– The types of Body Marker shown in the Flexible Soft Menu vary with the diagnosis
mode.

– A maximum of 5 body markers are displayed on the screen at any one time. When
there are more Body Markers than this, press the Body Marker button repeatedly to
move to other pages.

2. Press the Flexible Soft button for the Body Marker that you want. The Body Marker will
appear in the image.

3. Position the probe cursor on the Body Marker using the Trackball.

4. Use the Angle dial on the control panel to adjust the angle of the probe cursor.

5. Press the Set button to finish. Press the Exit button to cancel.

▌ Changing Body Marker Position


1. Press the Change button on the control panel.

2. Move the Body Marker to a desired position by using the Trackball.

3. Press the Change button on the control panel again to confirm the new position.

▌ Deleting Body Marker


Press the Clear button on the control panel.

▌ Exiting Body Marker Input Mode


Press the Exit button on the control panel.

Select ‘On’ in Setup> System >Display > Bodymarker After Freeze to


NOTE start Bodymarker input mode automatically when pressing the Freeze
button.
Chapter 6. Image Managements 6 - 9

Indicator
You can place an Indicator over an image. This function can be useful when the diagnosis area
is differentiated or displayed. You can place one or more Indicators on specific positions.

[Figure 6.5 Indicator Display]


6 - 10 SONOACE X6 User manual

▌ Starting Indicator Input Mode


Press the Indicator button on the control panel. The system will switch to the Indicator input
mode.

▌ Entering Indicator
1. Press the Indicator button on the control panel and an Indicator will appear on the
screen.

2. Move the Indicator to a desired position by using the Trackball.

3. Adjust the Indicator direction by using the Angle dial on the control panel.

4. Press the Set button to finish. Press the Exit button to cancel.

▌ Deleting Indicator
Press the Clear button on the control panel and all Indicators displayed on the screen will be
deleted.

Press the Flexible Soft dial-button [1] Undo to delete the last entered indicator only.
Chapter 6. Image Managements 6 - 11

Saving and Transferring Images

Saving Images
Press the Save button on the control panel. Images are stored and managed according to
patients. Therefore, if the Save button is pressed without entering basic patient information, a
window to enter patient information appears. General images, 3D images, etc. can be saved,
and then edited and managed with SONOVIEWTM.

Ensure a patient ID is entered, since images are saved according to the ID. If
WARNING not, an image can be lost, and serious errors can occur in the previously
saved images.

▌ Saving an Image with Text

NOTE It’s convenient to save an image with description for later search.

For more information about entering text, refer to ‘Annotating Images’ in this chapter.

Transferring Images
Send images using DICOM. For more information on the DICOM server settings and DICOM
operation, see the section on “Setting DICOM” in ‘Chapter 3. Settings’.

▌ Transferring Images in Real Scan Mode


There are two methods of sending images: sending one scanned image at a time
immediately after each scan, and sending selected images after the scanning process is
complete. For more information about transferring images, see the section on “Transfer
Mode” in ‘Chapter 3. Settings’.

▌ Transferring Images in SONOVIEW


Select an exam in the Exam View screen to transfer all images in the exam, or select and
transfer images one by one in the Exam Review screen. For more information, see the
section on “SONOVIEWTM” in this chapter.
6 - 12 SONOACE X6 User manual

Printing and Recording Images

Printing Images
Press the Echo Print button on the control panel to print out a scanned image using an echo-
printer. For details on how to set-up a printer, refer to ‘Chapter 3. Settings’.

Recording Images
To record an image with the VCR during scanning, press the recording button of the connected
standard VCR.
Chapter 6. Image Managements 6 - 13

SONOVIEW
SONOVIEW used in the SONOACE X6 is an integrated image management system. The
Personal Computer or Embedded PC loaded into the product supports the system.

A variety of functions are provided in SONOVIEW: Saving/Filing of specific images, image


viewing, deleting images one by one, and exporting documents with a standard PC.

The file types used in this system follow the international standard DICOM (Digital Imaging and
Communication in Medicine). As a result, the PACS (Picture Archiving Communication System)
can be implemented in the SONOACE X6 without any additional costs, and it’s easy to
exchange documents with other hospitals or equipment. (cf. DICOM and PACS are well
established in advanced countries, but not yet in Korea.)

This system supports the Bitmap file format (ie. *. BMP), which is most commonly used on
standard office PCs. It is therefore easy to exchange data on images.

Thanks to these functions, SONOVIEW has enabled systematic management and research of
patient medical history.

Starting SONOVIEW
Press the SONOVIEW button on the control panel. If the ID has already been entered, the
images saved during the current examination will be displayed on the Review screen.

[Figure 6.6 SONOVIEW - Review]


6 - 14 SONOACE X6 User manual

 If the ID has not yet been entered, the patient information window will be
displayed prior to saving the images. Please enter the ID in the patient
information window before saving the images or using SONOVIEWTM.
NOTE
 Each patient’s data is identified by the patient’s unique ID. For efficient
management of IDs, we recommend the use of the patients’ chart numbers
or the last 6 digits of patients’ social security numbers.
Chapter 6. Image Managements 6 - 15

Exam View
If you select an icon on the Exam View screen, the name of icon will be
NOTE displayed.

▌ Starting Exam View


Press Exam Search on the Review screen. The Exam View screen appears.

[Figure 6.7 Exam View Screen]

In the center of the Exam View screen is the exam list with information on the patients’ IDs,
names, age, genders, examination dates, and the number of images saved. On the top right-
hand corner of the screen are the total number of examinations, number of selected
examinations, number of selected images and the size of selected images.

▌ Selecting Exam
Use the trackball and the Set button to select an examination. To cancel the exam selection,
press the Set button once again.

Press Select All to select all examinations at once, or press Deselect All to deselect all
exams.

To view exams saved in a storage devices, select Hard drive, MO drive, FLASH, or ODD
from Source on the screen. Selecting a source brings up information on the used space and
total space for the source.
6 - 16 SONOACE X6 User manual

▌ Searching Exam
Enter the patient’s ID, name, and exam date, and press Search to bring up an exam list with
examinations that are identical or similar to the search conditions. You can search exams
using as little as a single character or number for your search string.

■ Searching by Period
Select a period from the combo box at the top of the exam List. Today, 1Week, 1Mon,
3Mon, and 1Year show the exams for the respective periods dating back from the current
date, and All Exams shows all examinations.

■ Showing All Exam


Select Show All at the top of the exam list. All exam lists saved in the selected source
will be displayed.

▌ View Exam
Use the trackball and the Set button to select an exam to view, and then press Review
Exam at the top of the screen. The screen will switch to the Review screen and show
images for the selected exam.

▌ Deleting Exam
Use the trackball and the Set button to select an exam to delete, and then press Delete
Exam at the bottom of the screen or press the Del key on the keyboard. To select multiple
images, select images while holding down the Ctrl button on the keyboard.

▌ Exam Export
Multiple exams can be selected and exported simultaneously.

1. Select exam(s) and press Export to bring up the Export window.

2. Select MO drive, Flash Memory, or ODD as the destination drive for the export. Current
directories and files in the selected drive will be displayed on the screen.

3. Select BMP, JPEG, TIFF, or DICOM as the file format.

4. Specify the file name. Exams and images share the same file name: if there are multiple
images in the exam, each file name will end with a serial number.

5. Specify the directory name. After entering the directory name, press Make Directory to
create a folder in the destination medium. The new folder will be reflected as a directory
in the selected drive. To delete the directory, press Remove Directory.
Chapter 6. Image Managements 6 - 17

When you use the ODD, Make Directory and Delete Directory are
NOTE not available.

6. Once all fields have been entered, press Export. To cancel, press X at the top right-hand
corner of the screen.

[Figure 6.8 Exam Export]

▌ Exam Backup
MO, ODD, and Flash Memory can be used.

1. Install the target medium for backup.

– MO or ODD: Insert the medium in the drive and wait until the LED light goes out.

– If using Flash Memory, connect it to the USB port on the front or rear panel of the
product.

2. Select exam(s) and press Backup Exams

3. At the medium selection window, select MO, ODD or Flash and then press OK.

Once the backup process is complete, you will be prompted whether to delete the exam(s)
saved in the hard disk. Select your response for whether to delete or keep the exam(s). If
you select “delete,” all backed up exam(s) will be deleted from the hard disk completely.
6 - 18 SONOACE X6 User manual

▌ Exam Restore
MO, ODD, and Flash Memory can be used.

1. Connect the MO, ODD, or Flash Memory with exam backup information to the product
and wait until the LED light goes out.

2. Use Source at the top left-hand corner of the screen to select the connected medium.

3. When the saved exam list appears, select appropriate exam(s) and perform Review,
Delete, DICOM Send and other necessary functions. Note that the Delete function cannot
be performed when using ODD.

To move exam(s) to the system hard disk, select the exam(s) and press Restore.

■ Using USB MO Drive


USB MO drives can be connected to the USB port on the rear panel. Only one MO drive
can be used at a time, and if two or more drives are connected, only one will be
recognized.

When you have finished using the drive, you must use the Eject function from Storage
Manager to remove the MO disk or disconnect the drive after turning the product off.

If you are using a new MO disk for the first time, use the ‘MO Format’
WARNING function from Storage Manager to format the disk first.

■ Using USB Flash Memory


USB flash memory can be connected to the USB port on the rear panel. Only one flash
memory can be used at a time.

You do not need to format new USB flash memory. If you need to format the USB flash
memory, ensure that the file system type used is ‘FAT’ or ‘FAT32.’

To disconnect the USB flash memory from the product, use the ‘Unplug’
WARNING function from Storage Manager to remove it from the product.

■ Using ODD
Only one ODD drive can be used at a time. After using the ODD, use the Eject function
from Storage Manager to eject the medium.

If using a re-writable ODD, you can erase all recorded data using the Format function
from Storage Manager.
Chapter 6. Image Managements 6 - 19

▌ Sending Exam
This function uses the DICOM network. The DICOM Send button will not work if the DICOM
function is not configured.

1. Select exam(s) and press Send at the bottom of the screen.

– If you want to add a new server after selecting exam(s), select Add from the DICOM
Send window, enter the necessary information, and then press Ok.

– Press Modify to view or edit the server information after selecting exam(s).

– Select Delete to delete the server after selecting exam(s), or select Test to check the
DICOM connection to the server.

2. When all steps are complete, press Send to send the selected exam(s) to the selected
server.

▌ Printing Exam
This function uses printer(s) on the DICOM network. DICOM Print will not work if the DICOM
function is not configured.

1. Select exam(s) and press DICOM Print.

2. Steps for printing exams are the same as for sending exams.
6 - 20 SONOACE X6 User manual

Exam Review
Saved images can be managed using measurement, printing, sending and many other
functions.

[Figure 6.9 Exam Review]

If you select an icon on the Exam View screen, the name of icon will be
NOTE displayed.

▌ Exam Information
Patient names, IDs, and exam dates are displayed in the left-hand center of the Exam
Review screen.

▌ Opened Exams
This displays the list of exams currently in progress or exams selected from Exam View.

If multiple exams are selected from Exam View, you can use the trackball and the Set button
to quickly browse through the exams. For example, after selecting multiple exams from
Exam View, press Review Exam to switch to the Review screen and bring up the list of
selected exams in Opened Exams.
Chapter 6. Image Managements 6 - 21

▌ Close Exam
Closes the current exam(s).

▌ Exam Search
The Exam View screen appears. You can browse through exams to select, change, save,
send, or backup. For more information, see ‘Exam View.’

■ Single Exam
This displays all the images for selected exams in the order they are saved.

Use the trackball over the Preview window at the bottom of the screen to select image(s)
to show on the screen. Images will be numbered according to their order.

■ Compare Exams
This function is useful for comparing multiple images.

1. Select images in the Preview window at the bottom of the screen. The border of
selected images will go bright.

2. Place the cursor over the image display window and press the Set button on the
control panel to display the image at the selected location. A maximum of 4 images
can be compared at the same time.

▌ Selecting imaages and Full Screen Image View

■ Selecting Images
Use the trackball on the control panel to move the cursor over an image and press the
Set button. To select multiple images, use the trackball and the Set button while holding
down the Ctrl key on the keyboard.

■ Full Screen Image View


This displays a full screen view of one selected image.

Place the cursor over the image and press the Set button on the control panel twice. To
return to the Review screen, press the Exit button or press Close on the screen.

When in full screen image view, use the arrows on the screen to navigate to the previous
or next images.
6 - 22 SONOACE X6 User manual

▌ Using Preview
This function previews selected exam(s).

Images displayed on the current screen are indicated with white borders. You can use the
arrow buttons on the right to browse through the images if there are 4 or more images.

▌ Printing
This function prints images or simple reports.

1. Press Print from the Exam Review screen.

2. Select settings from the Print window.

– Column : sets the number of column of image

– Row : sets the number of row of image

– Portrait : sets the paper horizontally

– Landscape : sets the paper vertically

– Image Only : prints only images

– Report Only : prints only report

– Images and Report : prints both images and report

3. Press Ok and Print screen will be displayed. Select printer and paper.

4. Click Print to start printing. Press Cancel to cancel.

▌ Report
You can query the report for the selected exam or enter new information in it.

1. Press Add Comments from the Exam Review screen.

2. Enter details in the Report window.

3. Press Ok to save the information. Press Cancel to cancel.


Chapter 6. Image Managements 6 - 23

▌ DICOM Send (Optional)


This function uses DICOM to send selected images. This button is deactivated for products
that do not support the DICOM option.

1. Select image(s) and press DICOM Send on the Exam Review screen.

2. The number of selected images will be displayed on the screen. Press Ok to bring up the
DICOM window.

3. After confirming the settings, press Send to send the image(s). Press Cancel to cancel.

▌ DICOM Printing (Optional)


This function uses DICOM to print selected images. This button is deactivated for products
that do not support the DICOM option.

1. Select image(s) and press DICOM Print on the Exam Review screen.

2. The number of selected images will be displayed on the screen. Press Ok to bring up the
DICOM window.

3. After confirming the settings, press Print to print the image(s). Press Cancel to cancel.

For more information on DICOM printers, please refer to the printer manual or the DICOM
Conformance Statement.

▌ E-mail
This function sends e-mails with image attachments.

1. Select image(s) and press E-mail on the Exam Review screen.

2. Enter the user’s name, e-mail address, the recipient’s e-mail address, subject and
message. Please note that server names and e-mail addresses are case-sensitive.

3. Press Send to send the e-mail. Press Cancel to cancel.

In order to use the E-mail function, you must specify the e-mail (SMTP) server and you must
own an e-mail account on the mail server.

You can specify the Outgoing Mail Server on the E-mail Setup screen.

If e-mails cannot be sent even though the mail server is functional, check that
NOTE the ICMP (ping) is open for the mail server. If the ICMP (ping) is closed, the
e-mail function may not work properly.
6 - 24 SONOACE X6 User manual

▌ Magnification
This function magnifies a part of the image displayed on the screen.

1. Press Magnifier on the Exam Review screen. The mouse cursor changes to a
magnifying glass shape.

2. Place the magnifying glass over an area and press the Set button.

▌ Delete
Select image(s) and press Delete Image on the Exam Review screen. To delete many
images at once, use Trackball and Set button during pressing Ctrl key on the keyboard.

Current exam cannot be deleted. The deleted exams are not be


WARNING recovered.

▌ Export
This function saves the images in BMP, JPEG, TIFF or DICOM file formats.

1. Press Export on the Exam Review screen. The mouse cursor changes to a floppy
diskette shape.

2. Place the floppy diskette shape over an area and press the Set button. The Export
window will be displayed.

3. Enter the directory and file names for the image file(s) and press Export to save the
images in the selected file format.

Do not use blank spaces in file names or directory names. The Export
NOTE function will not work for file names or directory names containing blank
spaces.

▌ Text
Use this function to insert text into the image.

1. Press Add Text on the Exam Review screen.

2. Place the cursor over the image and press the Set button. The image will be displayed in
full screen view.

3. Move the cursor to a desired location and insert the text. To change the font size or color,
press Font Style.
Chapter 6. Image Managements 6 - 25

▌ Distance
This function measures the distance between any two points on 2D images.

1. Press Distance on the Exam Review screen.

2. Place the cursor over the image and press the Set button. The image will be displayed in
full screen view.

3. Move the cursor to a desired location and press the Set button to set the start point.

4. Use the trackball to move the cursor to another location and press the Set button to set
the end point. Press the Change button before assigning the end point to change the
position of the start point. The distance between the two points will be displayed on the
screen.

You can use the same method to take multiple measurements. Note that the measurement
results are not saved with the image.

To finish measurement, press the Exit button on the control panel or Close on the screen.

▌ Ellipse
Use this function to draw an ellipse over the 2D image, and then measure the perimeter and
area of the ellipse.

1. Press Ellipse on the Exam Review screen.

2. Place the cursor over the image and press the Set button. The image will be displayed in
full screen view.

3. Move the cursor to a desired location and press the Set button to set the start point.

4. Use the trackball to move the cursor to another location and press the Set button to set
the end point. Press the Change button before assigning the end point to change the
position of the start point.

5. After adjusting the size of the ellipse, press the Set button to confirm the size of the
ellipse. The perimeter and area of the ellipse will be displayed on the screen.

You can use the same method to take multiple measurements. Note that the measurement
results are not saved with the image.

To finish measurement, press the Exit button on the control panel or Close on the screen.
6 - 26 SONOACE X6 User manual

▌ Image Selection Window (Layout)


Use this function to configure the number of images to show on the Exam Review screen.

On the Exam Review screen, press Layout and select items from 1*1 to 3*3 in the Image
Layout window.

▌ Closing SONOVIEW
Press the X button on the screen. Alternatively, you can press the SonoView button or the
Exit button on the control panel to close SonoView.
Chapter 7

Maintenance

System Maintenance .......................................................................................................3


Installation Requirements ...................................................................................................... 3
Cleaning and disinfections ..................................................................................................... 4
Fuse Replacement ................................................................................................................. 6
Cleaning The Air Filters.......................................................................................................... 7
Accuracy Check ..................................................................................................................... 8

Administration of Information ...........................................................................................9


User Setting Back up ............................................................................................................. 9
Patient information Back-up ................................................................................................... 9
Software ................................................................................................................................. 9
Chapter 7. Maintenance 7 - 3

System Maintenance

 The user must ensure that the safety inspections are performed every 2
years according to the requirements of safety standard EN 60601-1. Only
trained persons are allowed to perform the safety inspections mentioned
NOTE
above.

 The expected service life of this equipment is 7 years.

Installation Requirements
When installing:

 Optimal conditions for the system are temperatures of 10° ~ 35° C and humidity of
30% ~ 75%.

 Avoid humidity.

 Avoid direct sunlight.

 Avoid places with extreme temperature variations.

 Avoid heat sources.

 Avoid dusty and unventilated areas.

 Avoid places where the system is likely to be exposed to vibration or impacts.

 Avoid places where the system is likely to be exposed to chemical substances or gases.

Placing the system near generators, X-Ray machines, or broadcast cables may
CAUTION result in screen noise and abnormal visual images. Using the power source with
other electric devices may also induce noise.
7 - 4 SONOACE X6 User manual

Cleaning and disinfections


Using inappropriate detergent or disinfectant may damage the product. Please read the
following carefully.

 Turn off the system and disconnect the system power cord from the wall
outlet. Otherwise, it may result in electric shock or fire.
WARNING
 Always use protective eyewear and gloves when cleaning and
disinfecting the equipment.

▌ Cleaning

 Do not use a spray directly on the product exterior. It may cause cracks
in the appliance, or the color to deteriorate.
CAUTION
 Do not use chemical substances such as wax, benzene, alcohol, paint
thinner, insecticide, aerosol deodorant, lubricant.

■ Console
Use a soft cloth lightly dampened with a mild soap to clean the exterior surfaces of the
system.

■ Cleaning Monitor
Gently wipe the LCD surface with a soft, dry cloth.

For information on cleaning and disinfection of the probe & biopsy kit,
NOTE please refer to Chapter 8 “Probes.”
Chapter 7. Maintenance 7 - 5

▌ Disinfection

CAUTION Use only recommended disinfectants on system surfaces.

A disinfectant qualified by the FDA 510(k) process is recommended. The following


disinfectants are recommended because of both their biological effectiveness (as qualified
through the FDA 510(k) process) and their chemical compatibility with Samsung Medison
ultrasound products.

Solutions Country Type Active ingredient FDA 510(k)

Cidex USA Liquid Gluteraldehyde K934434

Cidex Plus USA Liquid Gluteraldehyde K923744

1. Turn off the system and disconnect the system power cord from the wall outlet.

2. Mix the disinfection solution compatible with your system according to label instructions
for solution strength.

3. Wipe the system surfaces with the disinfectant solution, following the disinfectant label
instructions for wipe durations, solution strength, and disinfectant contact duration.

4. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant
label.
7 - 6 SONOACE X6 User manual

Fuse Replacement
The power protection fuse protects the product from excess current. If the power monitoring
protection circuit detects excess current, it shuts off the current to the equipment in order to
prevent overheating and to restrict the ultrasound power output.

If the fuse blows, replace it as shown below.

To avoid risk of electric shock, always disconnect the plug from the system
DANGER prior to fuse replacement.

[Figure 7.1 Fuse replacement]

1. Disconnect the power cord from the system. (See ①)

2. Take the fuse out by pressing the middle of fuse. (See ②)

3. Insert the fuse holder into the appliance inlet.

4. After installing the new fuse, connect the power cord to the system.

Fuse information is shown in the following table.

Input Ratings Fuse Ratings Company Order No.

100-120VAC T8A/250V Schurter 0001.2515


200-240VAC T5AL/250V Orisel 50T2505A
Chapter 7. Maintenance 7 - 7

Cleaning The Air Filters


The air filters minimize the indraft of dust. Clean the air filter to ensure that a clogged filter does
not cause the system to overheat and reduce the noise and the system performance.

It is recommended the air filters be cleaned once every three months.

Be sure to lock the brakes on the front wheels before cleaning the air filters
CAUTION to avoid injury by any unexpected movement of the product.

1. Pull the filter under the front of the


console to away from the product.

2. Shake the filter to remove the dust and


wash in a mild soapy solution.

3. Rinse and air dry or dry with a cloth.

4. Slide the filter back into the product.

[Figure 7.2 The location of the air filters]

Allow the wet filter to dry thoroughly before installing. The wet filter can cause
NOTE the malfunction.
7 - 8 SONOACE X6 User manual

Accuracy Check

The product’s maintenance status may affect the measurements obtained using the product.
The product should be maintained in an optimal state to ensure reliable measurements.

To ensure optimal operation of the product, perform an accuracy check every year. The equati-
ons and table related to measurement accuracy are included in “Chapter 5 Measurements” in
this manual.
Chapter 7. Maintenance 7 - 9

Administration of Information

You may lose information files on user settings or patients, because of shock on
CAUTION the product or internal error. Thus, back-up on a regular basis.

User Setting Back up


Always keep a backup copy of all information related to the user settings in case of data loss.
Clients cannot back-up the user settings of the product. Contact the Samsung Medison
Customer Service Department to attain support for back-up. However, clients may back up the
user setting on GA Table used in obstetrics diagnosis. For further information please refer to
‘Chapter 3. Settings’.

Patient information Back-up


The SonoView program can be used for backing up patients’ basic information and scanned
images. The user can choose to save the data, and the data is also saved in the system by
default. If the system needs to be reinstalled due to product failure, etc., the Samsung Medison
customer support staff will restore the patients’ basic information and scanned images that are
saved in the system. For more information on this, see ‘Chapter 6. Image Managements’.

Software
The product software may be updated to enhance performance. The user cannot make any
changes to the software. Please contact the Samsung Medison customer service representative
for help in software changes.

Minor software updates may be carried out without the prior notice from the
CAUTION manufacturer.

Should errors occur in the operating system (Linux), and should you desire to upgrade the
operating system, please follow the instructions of the operating system manufacturer.

This product uses the Windows firewall to prevent any hacker or malicious
NOTE software from accessing the system through the internet or network.
Chapter 8

Probes
Probes ........................................................................................................................... 3

Ultrasound transmission Gel..................................................................................................... 6


Sheaths ..................................................................................................................................... 7
Probe Precautions .................................................................................................................... 8
Cleaning and Disinfecting the Probe ........................................................................................ 9
Biplane Probe ......................................................................................................................... 22

Biopsy ......................................................................................................................... 24

Biopsy KIT Components ......................................................................................................... 24


Using the Biopsy Kit ................................................................................................................ 25
Cleaning and Disinfecting Biopsy Kit ...................................................................................... 27
Assembling the Biopsy Kit ...................................................................................................... 29
Chapter 8. Probes 8 - 3

Probes
The probe is a device that sends and receives ultrasound for acquiring image data. It is also
called a Transducer or Scanhead.The ultrasonographic image scanner uses the image data
received by the probe to display the images of each organ on the screen. For best quality
images, select the appropriate probe for the each application.

The system limits patient contact temperature to 43 degrees Celsius, and acoustic power values
to their respective U.S. FDA limits. A power protection fuse circuit protects against over-current
conditions. If the power monitor protection circuit senses an over-current condition, then the
drive current to the probe is shut off immediately, preventing overheating of the probe surfaces
and limiting acoustic output. Validation of the power protection fuse circuit is performed under
normal system operation. For invasive probes, additional protections are designed to keep
patient contact surface temperature under 43 degrees Celsius in the event of a single fault
failure.

▌ Probe List
The ultrasound image scanner uses probes to obtain graphic data of the human body and
then displays it on the screen. Always use application-specific probes in order to obtain the
best quality images. It is also important to configure the probe with the best settings for the
particular organ being scanned.

■ Probe Application and Preset


Probes, applications and settings available for this product are as follows:

Product Applications

C2-5 General, OB, Gynecology, Abdomen, Fetal Heart, Renal

C2-5EP General, OB, Gynecology, Abdomen, Fetal Heart, Renal

C2-4ES General, Abdomen

C2-8 General, OB, Gynecology, Abdomen, Fetal Heart, Renal

C3-7EP General, OB, Gynecology, Abdomen, Fetal Heart, Renal

C4-9ED General, Pediatric, Vascular, Neonatal

HL5-12ED General, Breast, Small Parts, Vascular, Musculoskeletal

L3-8 General, Small Parts, Vascular

L5-12EP General, Breast, Small Parts, Vascular, Musculoskeletal

L5-12/50 General, Breast, Small Parts, Vascular, Musculoskeletal


8 - 4 SONOACE X6 User manual

Product Applications

L5-12/50EP General, Breast, Small Parts, Vascular, Musculoskeletal

LN5-12 General, Breast, Small Parts, Vascular, Musculoskeletal

ER4-9/10ED General, OB, Gynecology, Urology

EV4-9/10ED General, OB, Gynecology, Urology

NER4-9ES General, OB, Gynecology, Urology

NEV4-9ES General, OB, Gynecology, Urology

BCC4-9 General, Urology

P2-4AH General, Abdomen, Cardiac, Pediatric, TCD

P3-7AC General, Cardiac, Pediatric

SP3-8 General, Cardiac, Pediatric

CW2.0 General, Cardiac

CW4.0 General, Pediatric, Cardiac

 Besides, user can have or select own preset between User1-5.


NOTE
 Refer to ‘Chapter3. Setting’ for how to set probe and its preset.
Chapter 8. Probes 8 - 5

▌ TI Table
TI (Thermal Index) is displayed on the title of the screen and shows the estimate of the
temperature increase in specific body tissues. The thermal index consists of the following
indices: soft tissue (TIs), bone (TIb), and cranial bone (Tic). This product will show the TI
automatically by the probe and application. See the following table.

Application

Musculoskeletal
Gynecology

Small Parts
Fetal Heart
Obstetrics

Abdomen
OB Early

Pediatric
Neonatal
Vascular
Probe

Urology
General

Cardiac

Breast

Renal

TCD
C2-5 TIs TIb TIs TIs TIs TIb TIs

C2-5EP TIs TIb TIs TIs TIs TIb TIs

C2-4ES TIs TIs

C2-8 TIs TIb TIs TIs TIs TIb TIs

C3-7EP TIs TIb TIs TIs TIs TIb TIs

C4-9ED TIs TIs TIc TIs

HL5-12ED TIs TIs TIs TIs TIs

L3-8 TIs TIs TIs

L5-12EP TIs TIs TIs TIs TIs

L5-12/50EP TIs TIs TIs TIs TIs

L5-12/50 TIs TIs TIs TIs TIs

LN5-12 TIs TIs TIs TIs TIs

ER4-9/10ED TIs TIb TIs TIs

EV4-9/10ED TIs TIb TIs TIs

NER4-9ES TIs TIb TIs TIs

NEV4-9ES TIs TIb TIs TIs

BCC4-9 TIs TIs


8 - 6 SONOACE X6 User manual

Application

Musculoskeletal
Gynecology

Small Parts
Fetal Heart
Obstetrics

Abdomen
OB Early

Pediatric
Neonatal
Vascular
Probe

Urology
General

Cardiac

Breast

Renal

TCD
P2-4AH TIs TIs TIs TIs TIs

P3-7AC TIs TIs TIs

SP3-8 TIs TIs TIs

CW2.0 TIs TIs

CW4.0 TIs TIs TIs

Ultrasound transmission Gel


Using an inappropriate ultrasound gel may damage the probe. For proper transmission of the
acoustic beam, only use ultrasound transmission gel only approved by Samsung Medison.
Refer to the table of ‘Cleaning and Disinfecting the Probe’ section in ‘Appendix A Maintenance’
for detail.

 The use of inappropriate ultrasound gels could result in damages in the


probe. Using damaged probe could cause injuries such as electric shock in
users or patients.

 Do not use ultrasound gels or contact media that contain the following
contents.

WARNING – Oils such as mineral oil, cooking oil, gasoline, solvents, rust inhibitors,
lanolin, paraffin-based grease, ester and excessive silicon-based
release agent.
– Alcohols such as acetone, methanol, plasticizer (dioctylphtalate) or
denatured alcohols.
– Glacial acetic acid and iodine.
 All types of lotions or gels that contain aromatic substances.
Chapter 8. Probes 8 - 7

Sheaths
Sheaths are recommended for clinical applications of an invasive nature, including
intraoperative, transrectal, transvaginal, and biopsy procedures. Samsung Medison does not
supply sheaths so that you should purchase appropriate ones on your own.

 Always keep sheaths in a sterile state.

 Sheaths are disposable. Do not reuse them.

 If sheaths are torn or soiled after use, wash and disinfect the probe.

 In neurosurgical applications, a disinfected probe must be used with sterile


gel and a sterile pyrogen-free sheath.
WARNING
 If the sterile sheath becomes compromised during neurosurgical
applications involving a patient with Creutzfeldt-Jakob disease, the probe
cannot be successfully sterilized by any disinfection method.

 Some sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Please refer to the FDA Medical
Alert released on March 29, 1991.

▌ Installing the Sheath


1. Use sterile gloves.

2. Unpack the sheath and fill it with acoustic coupling gel.

3. Insert the probe into the sheath and pull the latex tip to cover the probe completely.
If possible, cover the probe cable as well.

4. Ensure that there is no air bubble within the ultrasound gel.

5. If necessary, secure the sheath to the probe and the probe cable.

6. Dispose of the sheath after use.


8 - 8 SONOACE X6 User manual

Probe Precautions
The probe can easily be damaged by improper use or by contacting certain chemical
substances. Always follow the instructions in the user manual to inspect the probe cable, case
and lens before and after each use.

Check for cracks, broken parts, leaks and sharp edges. If there is any damage, immediately
stop using the probe and contact the Samsung Medison Customer Support Department. Using
damaged probes may result in electric shocks and other hazards to the patients and/or users.

 Do not apply mechanical shock to the probe.

 Do not place the probe cable on the floor where the cable can be run over
by equipment wheels, etc. Do not apply excessive force to bend or pull the
cable.
CAUTION
 Do not immerse the probe into any inappropriate substances such as
alcohol, bleach, ammonium chloride, and hydrogen peroxide.

 Do not expose the probe to temperatures of +50°C or higher.

▌ Use and Infection Control of the Probe

No neurosurgical treatments or examinations should be carried out on a


patient with Creutzfeldt-Jakob disease (critical brain disease caused by
WARNING virus). If the probe has been used on such a patient, it cannot be sterilized by
any method whatsoever.

Sufficient washing and disinfecting must be carried out for preventing


infection. This is the responsibility of the user who manages and maintains
CAUTION the disinfection procedures for the equipment. Always use legally approved
detergents and sheaths.

The ultrasonographic image scanner uses ultrasound, and it makes direct contact with the
patient when in use. Depending on the types of examinations, such contact can be made to
a wide variety of locations including the ordinary skin or the location of blood transfusion
during a surgery.

The most effective method to prevent infection among patients is to use each probe only
once. However, probes may need to be re-used as they are complex in design and
expensive. Consequently, protective devices such as sheaths must be used, and the safety
instructions must be followed carefully in order to minimize the risk of infection among
patients.
Chapter 8. Probes 8 - 9

▌ Electric Shocks
The probe uses electrical energy. If it touches conductive materials, there are risks of electric
shocks to the patient or the user.

 Regularly receive short-circuit examination from the Samsung Medison


Customer Support Department.Do not immerse the probe into liquid.

 Do not immerse the probe into liquid

 Do not drop the probe or apply mechanical shocks.

 Inspect the housing, strain relief, lens and seal for damage, and check for
any functional problem before and after each use.

WARNING  Do not apply excessive force to twist, pull or bend the probe cable. It may
result in a short circuit.

 The power protection fuse protects the probe and the product from excess
current. If the power monitoring protection circuit detects excess current, it
immediately shuts off the current to the probe in order to prevent the probe
surface from overheating and to restrict the ultrasound power output.

 The temperature of the product for making contact with patients is limited
under 43°C. The ultrasound power output (AP&I) is in compliance with US
FDA standards.

Cleaning and Disinfecting the Probe


 Always use protective eyewear and gloves when cleaning and disinfecting
probes.
WARNING
 Inspect the housing, strain relief, lens and seal for damage, and check for
any functional problem after cleaning and disinfecting the probe.

Using an inappropriate detergent or disinfectant may damage the probe.

Only use the disinfect and disinfectants approved by the country’s


NOTE
government in Canada.
8 - 10 SONOACE X6 User manual

▌ Information of Detergent, Disinfectant, and Ultrasound Gel


Use an appropriate one with following tables. All probes are under tested in IPX 7 Criteria.

Disinfectants

Sani-Cloth Germicidal
Clieanisept Wipes
Sani-Cloth Active

Super Sani-Cloth
Trasneptic Spray
Sani-Cloth Plus

Asepti-Wipes II
Sani-Cloth HB

Asepti-Wipes
Incidin Foam
Ster-Bac Blu

CaviWipes 7)
Setptiwipes

MetriWipes
T-Spray II

Cidex 2%
Names
T-Spray

Type S S W W W W W L S S W W W W W W L
Ammonium
Quaternary

(N-Alkyl)

IPA

NA
Active Ingredient

C2-5 ● ● ●

C2-5EP ●

C2-4ES ● ● ●

C2-8 ● ●

C3-7EP ● ●

C4-9ED ● ●

HL5-12ED ● ●

L3-8 ● ● ●

L5-12EP ●

L5-12/50 ● ●

L5-12/50EP ● ●

LN5-12 ● ● ●

ER4-9/10ED ● ● ●

EV4-9/10ED ● ● ●
Type

SP3-8

CW4.0
CW2.0
Names

P3-7AC
P2-4AH
BCC4-9
NEV4-9ES
NER4-9ES
Active Ingredient





S
T-Spray II






S


T-Spray





W

◆ ◆ ◎
Sani-Cloth HB
W

Quaternary Sani-Cloth Plus


Ammonium
W

(N-Alkyl) Sani-Cloth Active


W

Setptiwipes
W

Clieanisept Wipes
L

Ster-Bac Blu


S

▣ ▲
Trasneptic Spray
S

Incidin Foam
Disinfectants



W

Super Sani-Cloth
W

Sani-Cloth Germicidal
IPA
W

Asepti-Wipes
W

Asepti-Wipes II
W

CaviWipes 7)
Chapter 8. Probes

MetriWipes

L

NA Cidex 2%
8 - 11
8 - 12

L3-8
C2-8
C2-5
Type

LN5-12
Names

C3-7EP
C2-4ES
C2-5EP

C4-9ED

L5-12EP

L5-12/50
HL5-12ED

NEV4-9ES
NER4-9ES
L5-12/50EP

EV4-9/10ED
ER4-9/10ED
Active Ingredient
L














Ortho-phthalaldehyde Cidex OPA 2, 3, 6, 7)














Cidex Plus 2, 7)
L 2, 7)
Metricide



L
SONOACE X6 User manual

Omnicide (28)
L

Omnicide 14NS






L

Omnicide - FG2







L

Nuclean
Glutaraldehyde












L

Wavicide-01 3)
L

Sekusept Extra
Disinfectants

Salvanios pH 7
L

Salvanios pH10
L

Steranios 2%



S

Surfaces Hautes
L

Nonionic surfactant Sekusept Plus







L

Milton
Sodium Hypochlorite
L

Bleach 5.25%
Type

SP3-8

CW4.0
CW2.0
Names

P3-7AC
P2-4AH
BCC4-9
Active Ingredient
L





Ortho-phthalaldehyde Cidex OPA 2, 3, 6, 7)

x
L



Cidex Plus 2, 7)
2, 7)


L

◇ ▣
Metricide


L

Omnicide (28)
L

Omnicide 14NS
L

Omnicide - FG2
L

Nuclean
Glutaraldehyde



L



Wavicide-01 3)


L

Sekusept Extra
Disinfectants


L

Salvanios pH 7
L

Salvanios pH10


L

Steranios 2%

S

Surfaces Hautes
L

Nonionic surfactant Sekusept Plus



L
Chapter 8. Probes

Milton
Sodium Hypochlorite
L

Bleach 5.25%
8 - 13
8 - 14

L3-8
C2-8
C2-5
Type

LN5-12
Names

C3-7EP
C2-4ES
C2-5EP

C4-9ED

L5-12EP

L5-12/50
HL5-12ED

NER4-9ES
L5-12/50EP

EV4-9/10ED
ER4-9/10ED
Active Ingredient


L
NA Virkon






L
Sporox
Hydrogen Peroxide

x
x
x
x
x
x



L
Sporox Ⅱ
SONOACE X6 User manual

Gigasept
Succindialdehyde,
formaldehyde 3)

x
L

Gigasept AF


L
Disinfectants

Bersteinsaure Gigasept FF

Chlorhexidine gluconate
L

Hibitane
solution
P

Peracetic Acid PeraSave

Dodecylphenolethoxylate,








Enzol
Sodium Xylene Sulfonate

NA Alkazyme






L

Cidezyme
Proteolytic Enzymes
L












Klenzyme
Cleaner

Isopropyl

x
x
x
x
L







alcohol(70%)
Alcohol
Isopropyl
L

alcohol(80%)
Type

SP3-8

CW4.0
CW2.0
Names

P3-7AC
P2-4AH
BCC4-9
NEV4-9ES
Active Ingredient


L

NA Virkon
L

Sporox
Hydrogen Peroxide

x
x

L


Sporox Ⅱ
L

Gigasept
Succindialdehyde,
formaldehyde 3)

x
x
L


Gigasept AF


L
Disinfectants



Bersteinsaure Gigasept FF

Chlorhexidine gluconate
L


Hibitane
solution
P

▲ Peracetic Acid PeraSave

Dodecylphenolethoxylate,



● Sodium Xylene Sulfonate
Enzol


NA Alkazyme
L

Cidezyme
Proteolytic Enzymes
L




Klenzyme
Cleaner
Chapter 8. Probes

Isopropyl
x
x
L

alcohol(70%)
Alcohol
Isopropyl
L

alcohol(80%)
8 - 15
8 - 16 SONOACE X6 User manual

Cleaner Gel

Aquasonics 100 3)

GE Ultrasound
Natural Image
Ethanol 75%

Clear Image
Contact Gel

Wavelength
McKesson
Metrizyme

Sonogel
Names

Kendall

Scan
Type L L L G G G G G G G G

Ammonium Chlorides
Propylene Glycol

(Chloroxylenol)
Alcohol

PCMX

NA
Active Ingredient

C2-5 ● ●

C2-5EP ●

C2-4ES ● ●

C2-8 ● ●

C3-7EP ● ● ●

C4-9ED ● ●

HL5-12ED ● ●

L3-8 ● ● ●

L5-12EP ● ●

L5-12/50 ● ● ●

L5-12/50EP ● ● ●

LN5-12 ● ● ●

ER4-9/10ED ● ● ●

EV4-9/10ED ● ● ●

NER4-9ES ●

NEV4-9ES ●
Type

SP3-8

CW4.0
CW2.0
Names

P3-7AC
P2-4AH
BCC4-9
Active Ingredient
L

Alcohol Ethanol 75%





L

Propylene Glycol Metrizyme


Cleaner

PCMX
L

McKesson
(Chloroxylenol)


G

Ammonium Chlorides Natural Image







G

Aquasonics 100 3)

GE Ultrasound
G

Contact Gel
G

Clear Image
Gel

NA Kendall

G

Scan
Chapter 8. Probes

Wavelength

G

Sonogel
8 - 17
8 - 18 SONOACE X6 User manual

※ Symbols
(1) Compatible but no EPA Registration
(2) FDA 510(k) cleared
(3) Has CE mark
(4) Discontinued
(5) Under Development
(6) ANVISA Registered
Health Canada Approved;
(7) CaviWipes (DIN: 02242209), Cidex OPA (DIN: 02239732),
Cidex Plus (DIN: 02158396), Metricide (DIN: 01963996)
S Spray
W Wipe
L Liquid
P Powder
G Gel
x Not compatible(DO NOT USE)
● Compatible
Staining may occur on housing parts; however, the acoustic

performance and image quality a e not affected.
■ Must not be used longer than 5 minutes.
◐ Must not be used longer than 10 minutes.

▲ Must not be used longer than 15 minutes.


◆ Must not be used longer than 20 minutes.

◇ Must not be used longer than 25 minutes.

◎ Must not be used longer than 30 minutes.

▣ Must not be used longer than 50minutes.

Blank Untested (DO NOT USE)


Chapter 8. Probes 8 - 19

Following is information about manufacturer (or Distributor) of Detergent, Disinfectant, and


Ultrasound Gel.

Product Manufacturer or Distributor Telephone number

Aquasonics Parker Co. +1-800-631-8888(USA)


+1-800-445-6741(USA)
Cidex CIVCO Co.
+1-319-656-4447(Worldwide)
+1-800-445-6741(USA)
Enzol CIVCO Co.
+1-319-656-4447(Worldwide)
GIgasept AF S&M(Schulke&mayr) Co. +44-114-254-3500(UK)
Gigasept FF S&M(Schulke&mayr) Co. +44-114-254-3500(UK)
Isopropyl alcohol (70%) Local drugstore None
Klenzyme Steris Co. +1-800-548-4873(USA)
+1-800-445-6741(USA)
Metricide CIVCO Co.
+1-319-656-4447(Worldwide)
Metrizyme Metrex Research Corp. +1-800-841-1428(USA)
Milton Product & Gamble Australia Pty. Ltd. +61-1800-028-280(Australia)
+1-800-526-3867(USA)
Nuclean Nation Diagonostics Co.
+44(0)-148-264-6020(UK)
Omnicide Cottrell Ltd. +1-800-843-3343 (USA)
Sani-cloth PDI Nice/Pak Products Co. +1-914-365-1602(USA)
Sekusept Extra Henkel Hygiene GmbH. +49-0211-797-0(Germany)
Sporox II Sultan Chemist Inc. +1-800-637-8582(USA)
+1-800-445-6741(USA)
T-Spray CIVCO Co.
+1-319-656-4447(Worldwide)
Virkon Antec International LTD. +1-403-286-1771(USA)
Wavicide Wave Energy System Inc. +1-800-252-1125(USA)
8 - 20 SONOACE X6 User manual

▌ Cleaning
Cleaning is an important procedure that is carried out before disinfecting the probe. The
probe must be cleaned after each use.

 Do not use a surgical brush when cleaning probes. The use of even soft
brushes can damage the probe.
CAUTION  During cleaning and disinfection, keep the parts of the probe that must
remain dry higher than the other parts during wetting until all parts are dry.
This will help prevent liquid from entering non-liquid-tight areas of the probe.

1. Disconnect the probe from the system.

2. Remove any biopsy adapters or biopsy needle guides. (Biopsy adapters are re-usable
and can be disinfected).

3. Discard sheaths. (Sheaths are single-use items).

4. Use a soft cloth lightly dampened with mild soap or compatible cleaning solution to
remove any particulate matter and body fluid that remain on the probe or cable.

5. To remove remaining particulates, rinse with water up to the immersion point.

6. Wipe with a dry cloth.

7. If necessary, wipe first with a water-dampened clothe to remove soap residue.

▌ Disinfection
Only disinfect vaginal and rectal probes. A 10-6 reduction in pathogens should be reached
following the disinfection procedures in this Manual and using the following Samsung
Medison recommended solutions.

 If a pre-mixed solution is used, be sure to observe the solution expiration


date.
WARNING  The type of tissue it will contact during use dictates the level of disinfection
required for a device. Ensure that the solution strength and duration of
contact are appropriate for disinfection.
Chapter 8. Probes 8 - 21

 Using a non-recommended disinfectant or not following the recommended


disinfection method can damage and/or discolor the probe and will void the
probe warranty.
CAUTION  Do not immerse probes for longer than one hour, unless they are sterilizable.

 Only sterilize probes using liquid solutions. Avoid using autoclave, gas (EtO),
or other non-Samsung Medison -approved methods.

1. Follow the instructions on the disinfectant label for storage, use and disposition of the
disinfectant.

2. Mix the disinfectant compatible with your probe according to label instructions for solution
strength.

3. Immerse the probe into the disinfectant as shown in the illustration below.

4. Using the instructions on the disinfectant, rinse the probe after the immersion process is
complete.

5. Air dry the probe or towel it dry with a clean cloth.

[Figure 8.1 Disinfection]


8 - 22 SONOACE X6 User manual

Biplane Probe
The Biplane probe allows you to scan two objects simultaneously using two elements. It is
mainly used in urology.

▌ Configuration
The following illustration shows the Biplane probe with its two elements.

① Horizontal element
② Vertical element

[Figure 8.2 Biplane Probe]

NOTE The biopsy function is only available using the vertical element.
Chapter 8. Probes 8 - 23

▌ Connecting and Removing


The Biplane probe is connected using a probe connector and a dedicated Biplane probe
connector.

① Main connector
② Sub connector

[Figure 8.3 Connecting Biplane Probe]

You must observe the following instructions for connecting and removing the
CAUTION probe. Otherwise, you may cause serious damage to the probe.

■ Connecting the Probe


First, connect the sub connector (②) and then connect the main connector (①).

■ Removing the Probe


First remove the main connector, and then remove the sub connector.
8 - 24 SONOACE X6 User manual

Biopsy
A biopsy is an examination method that surgically extracts tissue from the patient for
examination. The probe and the biopsy kit are used together when conducting a biopsy with the
ultrasonographic image scanner.

The ultrasound system shows the needle, which penetrates through the skin surface and veins,
along with the examination location, minimizing the risk to the patient.

Biopsy KIT Components


The biopsy kit consists of the adapter, needle guide and needle. The components vary
depending on the probe type.

[Figure 8.4 Biopsy Kit Components]

‒ Adaptor: Secures the needle guide to the probe tightly.

‒ Needle Guide: Guides the angle (direction) of the needle so that it can reach the
examination location accurately. It also secures the needle so that the needle is not loose.

‒ Needle: This is the needle that is inserted into the patient’s body. The biopsy kit supplied
by Samsung Medison does not contain a needle.

‒ Sheath: Prevents the probe and adaptor from getting soiled by any unwanted substances
during the examination (blood and other body fluids).

‒ Ultrasound Gel: The space between the probe and the sheath is filled with the ultrasound
gel to obtain images of the best quality.
Chapter 8. Probes 8 - 25

Using the Biopsy Kit


 Verify the condition of the biopsy needle before use. Do not use a bent
biopsy needle.

 The biopsy needle may bend during tissue penetration. The precise
location of the needle must be checked by monitoring the echo generated
WARNING from the needle.

 Never use the biopsy kit to biopsy prostate tissue.

 Verify the condition of the biopsy needle before use. Do not use a bent
biopsy needle.

▌ Before Using Biopsy Kit


Ultrasonographic scanning using the biopsy kit must be conducted by medical doctors or
experienced medical staff with appropriate qualifications. Always, without fail, verify all safety
prevention procedures and disinfection.

Use only Samsung Medison -approved biopsy kits. Other bands may not properly fit
Samsung Medison probes. Improper installation may result in patient discomfort.

Inspect all components. Ensure that the biopsy kit you are using is the correct one for the
probe, the system, and system software.

 Do not attempt to use the biopsy until you read the instructions for installing
the sheath and verifying alignment of the needle guide.

WARNING  Always ensure that the probe and the needle guide are secured on both the
left and the right.

 Do not use in IVF, CVS, or PUBS procedures.

▌ Biopsy Procedure
The system generates a needle guideline though the displayed real-time ultrasound images
to indicate the anticipated path of the needle. You can use this guideline to ensure that the
needle or instrument is following the correct path.

1. Ready the patient according to the procedure appropriate for the examination objectives.

2. Install the sheath and the biopsy kit.

3. Set the system controls for the biopsy procedure.If necessary, apply acoustic gel to the
patient.

4. Begin scanning the patient. Adjust the patient so that the location for examination fits into
the needle guideline on the screen.

5. Insert the needle into the needle guide. Perform the puncture by sliding the needle
8 - 26 SONOACE X6 User manual

through the groove in the guide until the needle intercepts the target.

To keep the needle securely in the needle guide, press down on the top of the biopsy
adapter with your index finger.

6. When the examination location is reached, take the needle out of the needle guide.

7. Detach the needle guide, adapter and sheath from the probe.

8. Dispose of the components that are not designed for reuse.

▌ Needle Guide Alignment


Alignment of the needle guide displayed on the system is for the purpose of verifying
whether the needle and the needle guide are properly installed. This must be done prior to
the biopsy examination. Do not use the needle guide if the needle is not following the
intended path. Contact Samsung Medison Customer Service Department for service.

Reverberation or other tissue artifacts may produce false needle images which can cause
confusion. Ensure the needle path is along the guideline, and that you are not using a false
needle image to locate the needle.

 The needle used for this alignment verification must not be used for the
actual procedure. Always use a new, sterile needle for each biopsy
procedure.
WARNING
 To assist in accurate projection of the needle, use a straight, new needle
for each alignment procedure.

1. Attach the biopsy kit.

2. Set the system depth for the procedure to be performed and select the Biopsy menu.

3. Immerse the probe into the water bath, and insert the needle into the needle guide.

4. Confirm that the needle image is on the needle guidelines. If so, the needle guide is
properly aligned.

5. If the needle image is out of the needle guideline, check the needle guide or the probe
adapter.
Chapter 8. Probes 8 - 27

Cleaning and Disinfecting Biopsy Kit


Wash and disinfect the biopsy kit to reduce pathogens to the level of 10-6. Some components of
the biopsy kit may be disposable. Please read the biopsy kit user manual carefully before use.

Refer to the table of ‘Cleaning and Disinfecting the Probe’ section in this chapter for detail.

Always use protective eyewear and gloves when cleaning and disinfecting
WARNING biopsy kit.

▌ Cleaning and disinfection of stainless steel biopsy kit

■ Cleaning
1. After use, remove the biopsy kit from the probe.

2. Disassemble the biopsy kit into its component parts, if applicable.

3. Using a small brush and water, scrub each part to remove trapped material from the
biopsy kit.

4. Rinse with water to remove remaining particulates.

■ Disinfection
1. Disinfect the adapter by autoclaving (Steam) or using gas (Ethylene Oxide).

2. After disinfection, follow the proper post-disinfection procedure for the disinfection
method used. (Please refer to the disinfection user manual, etc.)

3. Inspect the biopsy kit for damage such as cracks, rust or breakage. If damage is
evident, discontinue use of the biopsy kit and contact Samsung Medison Customer
Service Department.

▌ Cleaning and Disinfection of plastic biopsy kit

■ Cleaning
1. After use, remove the biopsy kit from the probe.

2. Disassemble the biopsy kit into its component parts, if applicable. Discard the single-
use parts. These parts cannot be disinfected.

3. Using a small brush and water, scrub each part to remove trapped material from the
reusable components.

4. Rinse with water to remove remaining particulates.


8 - 28 SONOACE X6 User manual

■ Disinfection

Plastic biopsy kits can only be disinfected using a chemically


CAUTION compatible cold-disinfectant. Disinfection by autoclaving or by using
gas or radiation will cause damage to these parts.

Please refer to the user manual of the disinfectant for storage, use, and disposition of the
disinfectant.

1. Check the disinfection duration (generally 10 hours) and temperature of the


disinfectant.

2. After disinfection, follow the proper post-disinfection procedure for the disinfection
method used.

3. Inspect the components for damage such as cracks, rust or breakage. If damage is
evident, discontinue use of the biopsy kit and contact Samsung Medison Customer
Service Department.

■ Sterilization
 If the material of the biopsy needle guide is plastic, only single use is
possible.
CAUTION
 Do not gas sterilize or autoclave biopsy adapter.

Plastic biopsy adapter is reusable. Refer to the user instructions of the biopsy kit for
details of sterilization.
Chapter 8. Probes 8 - 29

Assembling the Biopsy Kit

▌ C2-5 Biopsy Guide (Plastic)

■ Specification

Model name BP-KIT-045

Biopsy Bracket 1 EA
Needle Guide(16G) 6 EA
Component Needle Guide(18G) 6 EA
Needle Guide(20G) 6 EA
Needle Guide(22G) 6 EA

Material Acetal Copolymer

Available Gauges 16G, 18G, 20G, 22G

■ Installation
1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.

3. Secure the Needle Guide Clip.


8 - 30 SONOACE X6 User manual

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 31

▌ C2-5Biopsy Guide (Metal)

■ Specification

Model name BP-KIT-042

Biopsy Bracket 1 EA
Needle Guide(16G) 6 EA
Component Needle Guide(18G) 6 EA
Needle Guide(20G) 6 EA
Needle Guide(22G) 6 EA

Material Stainless Steel

Available Gauges 16G, 18G, 20G, 22G

■ Installation
1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
8 - 32 SONOACE X6 User manual

3. Secure the Needle Guide Clip.

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 33

▌ C2-5EP Biopsy Guide

■ Specifications

Model name BP-KIT-021

Biopsy Adapter 1 EA
Component
Needle Guide 8 EA

Material Polyurethane

Available Gauges 16G, 18G, 22G

■ Installation
1. Mount the Biopsy Adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.

3. Secure the Needle Guide Clip.


8 - 34 SONOACE X6 User manual

4. Choose a needle guide of the desired gauge and secure it to the adapter.

5. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 35

▌ C2-8Biopsy Guide

■ Specification

Model name BP-KIT-035

Biopsy Bracket 1 EA
Component
Needle Guide 24 EA

Material Acetal Copolymer

Available Gauges 16G, 18G, 22G

■ Installation
1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
8 - 36 SONOACE X6 User manual

3. Secure the Needle Guide Clip.

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 37

▌ C3-7EP Biopsy guide

■ Specification

Model name BP-KIT-025

Bracket 1EA
Component
Needle Guide 2EA

Material Acetal Copolymer

Available Gauges 16G, 18G, 22G

■ Installation
1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
8 - 38 SONOACE X6 User manual

3. Secure the Needle Guide Clip.

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 39

▌ BCC4-9 Biopsy Guide

NOTE The biopsy function is only available using the vertical element.

■ Specification

Model name BP-KIT-031

Component Adapter 1EA

Material ABS

Available Gauges 16 ~ 18G

■ Installation
1. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
probe.

2. Mount the adapter onto the probe.

3. Place the sheath all the way down to the probe and adapter.
8 - 40 SONOACE X6 User manual

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 41

▌ HL5-12ED Biopsy guide

■ Specifications

Model name BP-KIT-022

Adapter 1EA
Component
Needle Guide Kit (Odd & Even Gauge Clip) 3EA/Each

Body: Acetal Copolymer


Material
Screw: 303 Stainless

Available Gauges 16G, 18G, 22G

※ You can buy a pack of Adapter or needle guide kit. One pack is consisted of 24ea per
each gauge.

■ Installation
1. Mount the Adapter onto the probe.

2. Insert gel into probe cover. And cover it.


8 - 42 SONOACE X6 User manual

3. Install the needle guide onto the Adapter.

4. Lock the needle guide like (a), and do like (b).

(a) (b) (c)

5. Press the needle guide like (c), and install the needle into the needle guide.
Chapter 8. Probes 8 - 43

▌ L3-8 Biopsy Guide

■ Specification

Model name BP-KIT-036

Adapter 1EA
Component
Needle Guide 24EA

Material Acetal Copolymer

Available Gauges 16G, 18G, 22G

■ Installation
1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
8 - 44 SONOACE X6 User manual

3. Secure the Needle Guide Clip.

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 45

▌ L5-12/50 Biopsy Guide (Plastic)

■ Specification

Model name BP-KIT-047

Component Adapter , Needle Guide

Material Plastic

Available Gauges 16G, 18G, 20G, 22G

Multi Angle 4 angle (20mm, 30mm, 40mm, 50mm)

■ Installation
1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
8 - 46 SONOACE X6 User manual

3. Secure the Needle Guide Clip.

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 47

▌ L5-12/50 Biopsy Guide (Metal)

■ Specification

Model name BP-KIT-048

Component Adapter , Needle Guide

Material Stainless Steel

Available Gauges 16G, 18G, 20G, 22G

Multi Angle 4 angle (20mm, 30mm, 40mm, 50mm)

■ Installation
1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.

3. Secure the Needle Guide Clip.


8 - 48 SONOACE X6 User manual

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 49

▌ L5-12EP Biopsy Guide

■ Specifications
Model name BP-KIT-023

Component Biopsy Adapter 1 EA


Needle Guide 8 EA

Material Polyurethane

Available Gauges 16G, 18G, 22G

■ Installation
1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
adapter.
8 - 50 SONOACE X6 User manual

3. Secure the Needle Guide Clip.

4. Choose a needle guide of the desired gauge and secure it to the adapter.

5. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 51

▌ L5-12/50EP Biopsy Guide

NOTE To purchase this biopsy kit, please contact the local office.

■ Specifications
Model name BP-KIT-020

Biopsy Adapter 1EA


Component
Needle Guide 8EA

Material Polyurethane

Available Gauges 16G, 18G, 20G

■ Installation
1. Insert gel into the cover for the Kit and cover the adapter completely.

2. Mount the needle guide for the desired gauge onto the adapter.
8 - 52 SONOACE X6 User manual

3. Lock the needle guide.

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 53

▌ LN5-12 Biopsy Guide

 Specification

Model name BP-KIT-040

Biopsy Adapter 1 EA

16Ga disposable needle guide/probe cover KIT 8EA


Component
18Ga disposable needle guide/probe cover KIT 8EA

22Ga disposable needle guide/probe cover KIT 8EA

Material Acetal Copolymer

Available Gauges 16G, 18G, 22G

 Installation

1. Mount the adapter onto the probe.

2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.

3. Secure the Needle Guide Clip.


8 - 54 SONOACE X6 User manual

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 55

▌ EV4-9/10ED, ER4-9/10ED Biopsy Guide

■ Specifications
Model name BP-KIT-024

Biopsy Adapter 1 EA
Component
Sheath 2 EA

Material Stainless

Available Gauges 16G

■ Installation
1. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter. And then tie with rubber band.

2. Mount the adapter onto the probe

3. Place the sheath again and tie with the rubber band again. Tie the lower part than 1.

4. Insert the needle into the needle guide for use.


8 - 56 SONOACE X6 User manual

▌ NER4-9ES, NEV4-9ES Biopsy guide (Disposable Type)

■ Specifications
Model name BP-KIT-018

Package 24 EA

Component Biopsy Adapter 1 EA

Sheath 2 EA

Material Plastic

Available Gauges 16G

■ Installation
1. Fill the sheath with ultrasound gel and insert the probe.

2. Mount the Adapter onto the probe.

3. Place the thin sheath on the adapter again and insert the needle into the needle guide
for use.
Chapter 8. Probes 8 - 57

▌ NER4-9ES, NEV4-9ES Biopsy guide (Reusable Type)

■ Specifications
Model name BP-KIT-019

Biopsy Adapter 1 EA
Component
Cleaning Brush 5 EA

Material Stainless

Available Gauges 16G

■ Installation
1. Fill the sheath with ultrasound gel and insert the probe.

2. Mount the adapter to the probe and insert the needle.


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Diagnostic Ultrasound System

Reference Manual
Version 1.04
English
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