V6 - XV6 Service Manual - E - v1.04 - 20240109
V6 - XV6 Service Manual - E - v1.04 - 20240109
V6 - XV6 Service Manual - E - v1.04 - 20240109
Service Manual
English
■ Classification
– Degree of protection against electric shocks (when the patient is in physical contact): Type
BF or type CF mounting
– Degree of safety of use in the presence of flammable anesthetic agent mixed with air,
oxygen, or nitrous oxide: Not suitable for use near flammable anesthetic agent mixed with
air, oxygen, or nitrous oxide
– Mode of operation: Continuous operation
– 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 [ISO 10993-1:
2009]
– Standard Means for Reporting the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment [IEC 61157:2007]
–
Statements
Nemko-CCL 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.
• Keep this service manual near the product and refer to it when using the product.
• Please familiarize yourself with the safety precautions in “Chapter 2. Safety” and “Chapter 10.
Maintenance” in particular.
• This service manual does not include diagnosis results or opinions. Also, check the reference
information for the measured area of the body before using the application’s measurement
results in any diagnosis.
• This product is an ultrasound diagnosis device and cannot be used from the user’s PC. The
manufacturer is not responsible for any problems that may be caused by such attempts.
• This product must only be used by persons who have sufficient knowledge of and/or a
qualification in clinical pathology. Unqualified persons are prohibited from using the product.
• The manufacturer is not responsible for any damage to this product caused by user
carelessness and/or neglect.
• Product orders are based on individually agreed specifications and may not include all
functions specified in this service manual.
• Some functions or options, probes, and the like may not be used in certain countries.
• All reference material on standards, regulations, and related revisions are valid at the time of
the publication of this service manual.
• Screen images in this service manual are examples and may differ from the actual screen or
system.
• The content of this service manual is 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 precautions that the user must pay particular
attention to:
Disregarding this instruction may result in death, serious injury, or other dangerous
situations.
DANGER
WARNING
CAUTION
Patient information stored in repaired and demo products should be handled as follows:
• Patient Information: Refers to information, such as IDs, names, DOBs, and images, which
can be used to identify specific patients.
• Patient information stored on a product during the course of its use must be handled as the
patient desires. (delete or backup)
• When completing a demonstration and/or collecting a trade product, patient information must
be deleted if so requested by the client, to prevent its unintended distribution to outside
parties.
• Before removing the product from hospital premises for repairs, all patient information should
be backed up to a storage device such as external HDD or memory, and then handed over to
the hospital.
• Before removing the product from hospital premises, each patient should sign the patient
privacy agreement.
Request for Repairs and Patient Privacy Agreement
Date: YYYY/MM/DD
【Customer Information】
Hospital
Handler
【Product Information】
Product name
Software version
S/N
Symptom
□ None
Outsourced product
□ Provide details if applicable ( )
【Administration】
Handling date YY MM DD
Customer service
representative
※ Please sign inside the box below if you agree to the following:
□ Data saved on memory devices of products being repaired (e.g., hard disks) may become
lost during tests and repairs.
□ Data saved on a product being repaired must be backed up by the customer.
□ Samsung will not be held responsible for any loss of data not backed up.
□ Samsung Medison does not use patient information for unauthorized purposes, modify
such information, or provide it to third parties.
【Customer Signature】
Contents
Chpater 2. Introduction
2.1. Indications for Use .............................................................................................................. 2
2.1.1. Contraindications ..................................................................................................... 2
2.2. Product Specifications ....................................................................................................... 3
Chapter 8. Troubleshooting
8.1. Power.................................................................................................................................... 2
8.1.1. Power doesn’t Turn on............................................................................................. 2
8.1.2. Power does not turn off............................................................................................ 2
8.1.3. Power Turns Off by itself ......................................................................................... 2
8.1.3. PSU Stand-Alone Self- diagnostics ......................................................................... 3
8.1.3. BP board Self-diagnostics ....................................................................................... 3
8.2. Monitor ................................................................................................................................. 5
8.2.1. Nothing is displayed on the screen .......................................................................... 5
8.2.2. Screen is discolored ................................................................................................ 5
8.3. Error Message ..................................................................................................................... 6
8.3.1. Error Occurs during Booting .................................................................................... 6
8.4. Image .................................................................................................................................... 7
8.4.1. 2D Mode: There is no Image Echo or Image Format .............................................. 7
8.4.2. Line(noise) Appear in 2D image .............................................................................. 7
8.4.3. M, C, PW, CW Mode failure .................................................................................... 7
8.5. Troubleshooting Tree ......................................................................................................... 8
8.5.1. System does not power on. ..................................................................................... 8
8.5.2. No image on the monitor. ........................................................................................ 9
8.5.3. Noise in the image area. ........................................................................................ 10
8.5.4. Track Ball does not work ....................................................................................... 11
8.5.5. System does not turn off ........................................................................................ 12
Chapter 9. Disassembly
9.1. Caution ................................................................................................................................. 2
9.1.1. Preparation .............................................................................................................. 2
9.2. Disassembling the system ................................................................................................. 3
Contents 7
1.7.4. Network.......................................................................................... 49
1.7.5. Cybersecurity ................................................................................. 50
1.8. Battery Pack Management ............................................... 51
1.8.1. Replacing the Battery Pack ............................................................ 51
1.8.2. Recharging the Battery Pack ......................................................... 51
1.8.3. Disposing of the Battery Pack ........................................................ 52
1.9. Protecting the Environment ............................................. 53
Chapter 1. Safety and Maintenance 1 - 3
WARNING
CAUTION
■ This product 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 medical
devices.
■ This product must not be used for ophthalmological applications, or any other
DANGER use that involves the ultrasound beam passing through the eyeball.
■ The manufacturer is not responsible for any injury or damage that may result
from using the product for purposes not specified or not following the safety
information.
■ Make sure that you use the three-dimensional ultrasound diagnostic imaging
CAUTION system for its intended purposes only, since using it for a long period of time
for purposes other than diagnosing the fetus, such as keepsake images or
videos, may have an adverse effect on the fetus.
■ According to the IEC 60601-2-37 Annex CC, when used for cardiac scanning,
the lung surfaces may be exposed to ultrasonic beam; therefore, recommend
minimizing the MI value.
■ Detergents or disinfectants may cause skin irritation. Avoid leaving residues
on the product.
– 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]
– Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and
Essential Performance – Collateral Standard: Usability [IEC 60601-1-6]
– 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]
– Medical Devices – Application of Risk Management to Medical Devices [ISO 14971]
– Biological Safety Evaluation of Medical Devices – Part 1: Evaluation and Testing [ISO
10993-1]
■ Declarations
Symbols Description
Power on/off
Power on
Power off
Symbols Description
Equipotential terminal
Input port
Output port
ECG port
USB port
Network port
Microphone port
1 - 8 V6/XV6 Service Manual
Symbols Description
Probe port
DANGER: Do not place your fingers, hands, or any parts of your body in
the space.
Do not place objects heavier than the weight specified next to the
symbol.
Do not place heavy objects on the monitor while the monitor mount is
folded.
Do not push down on the monitor while the monitor mount is folded.
Chapter 1. Safety and Maintenance 1 - 9
Symbols Description
Indicates the need for the user to consult electronic instructions for use.
(You can access to it by pressing help on the product or download it
from the website.)
www.samsunghealthcare.com
■ Labels
Phrases containing the words ‘WARNING’ and/or ‘CAUTION’ are displayed on the
product’s surface in order to protect it.
1 - 10 V6/XV6 Service Manual
■ Using the system near generators, X-ray machines, or broadcast cables may
result in noise and abnormal visual images. Sharing the power source with
other electrical devices may also cause noise.
■ Do not install or use the product in the Magnetic Resonance(MR)
CAUTION Environment. Doing so may result in improper operation of the product due to
powerful magnetic fields.
■ Optimal conditions for the normal operation of the system are a temperature
of 10–35°C and a humidity of 30–75%.
■ Avoid areas where moisture, direct sunlight, or a heater is near the product;
that are frequently exposed to vibration; that are too dusty or are not properly
ventilated; or where chemicals or gases are present.
■ Avoid using this product close to or on top of another device, as this may
cause malfunctions.
Do not block the vents on the system, peripheral devices, and accessories.
WARNING
Chapter 1. Safety and Maintenance 1 - 11
All connected peripheral devices must comply with the relevant IEC standards (e.g., IEC
60950/EN 60950 for data processing equipment, and IEC 60601-1/EN 60601-1/ANSI AAMI
ES60601-1 for medical devices). Furthermore, all components of the product must comply with
the requirements for medical electrical systems IEC 60601-1/EN 60601-1/ANSI AAMI ES60601-
1. Anybody connecting additional equipment to signal input and output ports of medical
electrical equipment must make sure that the peripherals comply with IEC 60601-1/EN 60601-
1/ANSI AAMI ES60601-1.
1 - 12 V6/XV6 Service Manual
■ Electric shocks may result if this system, including all of its externally
mounted recording and monitoring devices, is not properly grounded.
■ Never open the cover of the product. The interior of this product contains
dangerous high-voltage electricity. Any repairs to the product's internal
WARNING components or replacement of parts must be performed by Samsung
Medison.
■ Always check the product’s housing, cables, cords, and plugs before using
the product. Disconnect the power source and do not use the equipment if
the housing is damaged (for example cracked or chipped), or if the cable is
worn.
■ Always disconnect the system from the wall outlet prior to cleaning the
system.
■ All patient-contact devices, such as probes, must be detached from the
patient prior to using a high-voltage defibrillator.
■ Never use the product in the presence of flammable or anesthetic gas. Doing
so may cause an explosion.
■ Avoid installing the system in such a way that it is difficult for the operator to
disconnect it from the power source.
■ Do not use together with HF surgical equipment. HF surgical equipment may
be damaged, which may result in fire.
■ The product must be connected to a power supply with a protective earth to
prevent electric shock.
■ The system has been designed for 100-240VAC; you should select the input
voltage of any connected 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.
CAUTION ■ An isolation transformer protects the system from power surges. The
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.
■ The auxiliary socket outlets installed on this system are rated 100-240VAC
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.
■ Connecting any devices that are not listed in this User Manual to the
auxiliary socket outlet of the system may cause an electrical hazard.
■ Do not touch SIP/SOP and the patient simultaneously. There is a risk of
electric shock from leakage current.
Chapter 1. Safety and Maintenance 1 - 13
RF Emission
Class A
CISPR 11
The Ultrasound System is suitable for use in all
Harmonic Emission establishments other than domestic and those directly
Class A connected to the public low-voltage power supply
IEC 61000-3-2 network that supplies buildings used for domestic
purposes.
Flicker Emission
Complies
IEC 61000-3-3
Chapter 1. Safety and Maintenance 1 - 15
■ Cables
Cables connected to this product may affect its emissions; use only the cable types and
lengths listed in the table below.
■ Probes
The image probe used with this product may affect its emission. The probe listed in
‘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 affect its emissions.
The use of cables, probes, and peripherals other than those specified may result
in increased emission or decreased Immunity of the Ultrasound System.
WARNING
1 - 16 V6/XV6 Service Manual
Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Environment – Guidance
±2 kV (for power supply ±2 kV (for power supply Mains power quality should
Electrical fast
lines) lines) be that of a typical
transient/burst
±1 kV (for input/output ±1 kV (for input/output commercial or hospital
IEC 61000-4-4 environment.
lines) lines)
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not be applicable in some situations. Electromagnetic propagation is
affected by absorption and reflection of structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio, (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be
predicted with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength, in the location in which
the Ultrasound System is used, exceeds the applicable RF compliance level above, the Ultrasound
System should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Ultrasound System or using a
shielded location with a higher RF shielding effectiveness and filter attenuation.
b When the frequency range exceeds 150 kHz – 80 MHz, the electric field strength should be not higher
than 3 V/m.
c The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6.765 MHz to
6.795MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz
1 - 18 V6/XV6 Service Manual
100 12 12 23 12 20
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 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not be applicable in some situations. Electromagnetic propagation is
affected by absorption and reflection of structures, objects, and people.
GSM 800/900
TETRA 800
Pulse modulationb
800 – 960 iDEN 820 28 28
18 Hz
CDMA 850
LTE Band 5
GSM 1800
CDMA 1900
GSM 1900 Pulse modulationb
1700 – 1990 28 28
DECT 217 Hz
LTE Band 1, 3,
4, 25 UMTS
Blue Tooth
WLAN
Pulse modulationb
2400 – 2570 802.11 b/g/n 28 28
217 Hz
RFID 2450
LTE Band 7
A medical device can either generate or receive electromagnetic interference. The EMC
standards describe tests for both emitted and received interference.
Electromagnetic interference generated by Samsung Medison’s ultrasound system does not
exceed the standard level.
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 sources of
interference are medical devices, information technology products, and radio and television
transmission towers. Tracing the source of radiated interference can be a difficult task.
Customers should consider the following in an attempt to locate the source:
1. Is the interference intermittent or constant?
2. Does the interference show up only with one transducer operating at the same frequency
or with several transducers?
3. Do two different transducers operating at the same frequency have the same problem?
4. Is the interference present if the system is moved to a different location in the facility?
The answers to these questions will help to determine if the problem resides with the
ultrasound system or its operating environment. After you have answered all of the questions,
contact your local service representative.
Chapter 1. Safety and Maintenance 1 - 23
Users may request safety inspections as required, but only trained persons are
allowed to perform the safety inspection.
CAUTION
■ Before transporting the product, make sure that the caster brakes are
released. Also, make sure that any parts that may move, such as the monitor
arm or keyboard, are secured into position before moving.
■ You can use the caster brakes on the product to control their movement.
CAUTION
Make sure that the brakes are engaged before you use the product.
■ Always use the handles on the console and move the product slowly.
■ Excessive shocks, such as a fall, may seriously damage the product.
■ When you need to move the product up or down an inclined plane, make
sure that the control panel is facing the direction in which you are moving and
that it is moved by at least two people.
■ If the product is temporarily left on a slope, it can still fall over even with the
WARNING caster brakes on. Do not leave the product on a slope.
If the product does not work properly after you move it, please contact the
Customer Service Department.
NOTE
The keyboard, control panel, touchscreen and monitor arm should be fixed
before moving them.
CAUTION
Chapter 1. Safety and Maintenance 1 - 25
2. Press the Lever Ⓐ on the control panel with both hands to fix the control panel at the
lowest height.
3. Push the touchscreen back for fixation.
4. Adjust the monitor location appropriately and then use the lock on the monitor arm Ⓑ
for fixation.
1 - 26 V6/XV6 Service Manual
1.4.2.1. Monitor
When adjusting the height or position of the monitor, be careful of the space in the middle of
the monitor arm. Catching your fingers or other body parts in it may result in injury.
■ When moving the product, be sure to keep the monitor arm locked.
■ When rotating the monitor, be sure to release the lock first. Rotating
the monitor while it is locked may cause damage to the internal
CAUTION cables.
1 - 28 V6/XV6 Service Manual
Lever
[Figure 1.5 Safety Note for Control Panel]
Chapter 1. Safety and Maintenance 1 - 29
1.4.2.3. Touchscreen
Touch screen is a fixed type with no angle adjustment. Do not try to adjust the monitor angle
by confusing it with other models.
The touch screen is fixed. Do not push back it to adjust the angle.
CAUTION
x
[Figure 1.6 Fixed type Touch Screen with no anble adjustment]
1 - 30 V6/XV6 Service Manual
■ Be sure to lock the brakes on the wheels before cleaning the ventilation
window. Otherwise, unexpected movement of the product may result in injury.
■ If moisture is flowed into the ventilation window, it may cause product
CAUTION malfunctions. Make sure to use dry tools for cleaning.
Ventilation Window
■ 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 a low setting.
Please refer to the ALARA principle.
WARNING ■ Do not use the product if an error message appears on the screen indicating
that a hazardous condition exists. Note down the message displayed on the
screen, turn off the power, and then contact Samsung Medison’s Customer
Service Department.
■ Do not use a product that exhibits unexpected or abnormal operation.
Discontinuities in the scanning sequence are indicative of a hardware failure
that should be corrected before use.
■ This product limits the temperature that patients are allowed to come into
contact with to 43°C or less. The ultrasound power output (AP&I) is in
compliance with the US FDA’s standards.
mode being used allows the sonographer to apply the ALARA principle with informed
judgment. The probe frequency, system set-up values, scanning techniques, and operator
experience aid the sonographer in meeting the ALARA principle. The decision as to the
amount of acoustic output is, in the final analysis, up to the system operator. This decision
must be based on the following factors: type of patient, type of exam, patient history, ease or
difficulty of obtaining diagnostically useful information, and the potential localized heating of
the patient due to probe surface temperatures. Prudent use of the system occurs when
patient exposure is limited to the lowest index reading for the shortest amount of time
necessary to achieve acceptable diagnostic results.
Although a high index reading does not mean that a biological effect is actually occurring, it
should be taken seriously. Every effort should be made to reduce the possible effects of a
high index reading. Limiting exposure time is an effective way to accomplish this goal.
There are several system controls that the operator can use to adjust the image quality and
limit the acoustic intensity. These controls are related to the techniques that an operator
might use to implement ALARA and can be divided into three categories: direct, indirect, and
receiver control.
Pulse length is the time during which the ultrasonic burst is turned on. The longer the pulse,
the greater the time-average intensity value. The greater the time-average intensity, the
greater the likelihood of temperature increase and cavitations. Pulse length, burst length or
pulse duration is the output pulse duration in Pulsed Doppler. Increasing the Doppler sample
volume, increases the pulse length.
Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The
higher the probe operating frequency, the greater the attenuation of the ultrasonic energy.
Higher probe operating frequencies require higher output intensity to scan at an increased
depth. To scan deeper at the same output intensity, a lower probe frequency is required.
Using more gain and output beyond a point, without corresponding increases in image
quality, can mean that a lower frequency probe is needed.
■ Receiver Controls
Receiver controls are used by the operator to improve image quality. These controls have
no effect on output. Receiver controls only affect how the ultrasound echo is received.
These controls include gain, TGC, dynamic range, and image processing. The important
thing to remember, relative to output, is that receiver controls should be optimized before
increasing output. For example; before increasing output, optimize gain to improve image
quality.
example, may cause the potential for local zone heating to be lower than the thermal index
indicates.
The selection of scanned modes or unscanned modes of operation also 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 scanning. Ensure that the indices are
kept to a minimum, and that exposure time is limited without compromising diagnostic
sensitivity.
acoustic output values measured underwater are derated using a conservative, industry
standard, attenuation coefficient of 0.3dB/cm-MHz.
Conservative values for tissue characteristics were selected for use in the TI models.
Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat
capacity, and tissue thermal conductivity were selected.
A steady state temperature rise is assumed in the industry standard TI models, and the
assumption is made that the ultrasound probe is held steady in one position long enough
for a steady state to be reached.
A number of factors are considered when estimating the accuracy of display values:
Hardware deviation, algorithm accuracy, and measurement deviation. Deviation among
probes and systems in particular is an important factor. Probe deviation results from
piezoelectric crystal efficiencies, process-related impedance differences, and sensitive
lens focusing parameter variations. Differences in the system pulser 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 pulser 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
the calculation of the accuracy estimate displayed. Neither linear propagation nor uniform
attenuation at the 0.3dB/cm-MHz rate occurs in underwater 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 underwater measurements, non-linear propagation and saturation losses
occur as pulser voltages increase.
The display accuracy estimates take into account the variability ranges of probes and
systems, inherent acoustic output modeling errors, and the measurement variability.
Display accuracy estimates are measured according to AIUM measurement standards
but not based on errors caused during the measurement or inherent errors. They are also
independent of the effects of non-linear loss on the measured 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 total
TI is the sum of TIs of the individual modes. Each mode is a vital contributor to this total;
the displayed MI will be from the mode with the largest peak pressure.
1 - 36 V6/XV6 Service Manual
■ 2D Mode Size
Narrowing the sector angle may increase the frame rate. This will increase the TI. The
pulser voltage may be automatically adjusted down with software controls to keep the TI
below the system maximum. A decrease in pulser voltage will decrease MI.
■ Zoom
Increasing the zoom magnification may increase frame rate. This will increase the TI. The
number of focal zones may also increase automatically to improve the resolution. This
action may change the MI, since the peak intensity can occur at a different depth.
■ Focus
In general, higher MI values will occur when the focal depth is near the natural focus of
the probe (transducer).
■ Color Sensitivity
Increasing the color sensitivity may increase the TI. More time is required for the
scanning of color images. Color pulses are the dominant pulse type in this mode.
■ Scale
Using the Scale control to increase the color velocity range may increase the TI. The
system will automatically adjust the pulser voltage to stay below the system maximum. A
decrease in pulser voltage will also decrease MI.
Chapter 1. Safety and Maintenance 1 - 37
■ 2D Mode Size
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 the dominant mode and the TI change will be small.
1.5.1.10. Other
■ Probe
Each probe model available has unique specifications for the contact area, beam shape,
and center frequency. Defaults are initialized when you select a probe. Samsung
Medison’s manufacturer default settings vary, depending on the probe, application, and
mode selected. Defaults have been chosen below the FDA limits for intended use.
■ Depth
An increase in the 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’s
manufacturer default settings vary, depending on the probe, application, and mode
selected. Defaults have been chosen below the FDA limits for intended use.
1 - 38 V6/XV6 Service Manual
P1x1 Maximum value of the time average acoustic output power emitted from any
one-centimetre square region of the active area of the transducer, the one-
centimetre square region having 1 cm dimensions in the x- and y-directions.
pii α (Z) Value of the pulse-intensity integral after attenuation, at a specified distance
from the external transducer aperture. (unit: Watts per square centimeter)
TIB BONE THERMAL INDEX is a themal index for applications such as foetal
(second and third trimester), in which the ultrasound beam passes through
soft tissue and a focal region is in the immediate vicinity of bone. (unit: N/A)
TIS SOFT TISSUE THERMAL INDEX is a thermal index related to soft tissues.
(unit: N/A)
zb,ns DEPTH FOR BONE THERMAL INDEX for non-scanning modes, the
distance along the beam axis from the external transducer aperture to the
plane where the product of attenuated output power and attenuated spatial-
peak temporal-average intensity is a maximum over the distance range
equal to, or greater than, the break-point depth, zbp. (unit: cm)
■ Systematic Uncertainties
1 - 42 V6/XV6 Service Manual
For the pulse intensity integral, attenuated rarefaction pressure, 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.
– Oscilloscope Digitization rates.
– Noise.
The acoustic power is measured using a radiation force for systematic uncertainties
through the use of calibrated NIST acoustic power sources. We also refer to a September
1993 analysis conducted by the 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.
Chapter 1. Safety and Maintenance 1 - 43
1.5.1.16. Training
The users of this ultrasound system must familiarize themselves with the ultrasound system
to optimize the performance of the device and to detect possible malfunctions. It is
recommended that all users receive proper training before using the device. You can receive
training on the use of the product from the Samsung Medison service department, or any of
the customer support centers worldwide.
1 - 44 V6/XV6 Service Manual
1.6. Maintenance
1.6.1. Cleaning and Frequency
Cycle Component Cleaning Method
Since a pH neutral soap solution does not contain strong chemical ingredients, it
will not irritate the skin. The solution must not contain any fragrances, oil, or
alcohol.
NOTE
■ Always wear a protective face mask and gloves when cleaning and
disinfecting the product.
■ Turn off the system and disconnect the power cord from the wall outlet before
cleaning and disinfecting. Otherwise, there is a risk of electric shock or fire.
WARNING
■ Do not clean the electrical contacts or connectors.
■ Clean and disinfect the product every day or after each exam.
To learn how to clean and disinfect probes, please refer to Chapter 9 ‘Probes’ in
this manual.
NOTE
1.6.2.2. Cleaning
The device must be cleaned according to this instruction. Cleaning is an important procedure
that must be carried out before disinfection.
1. Turn off the system and disconnect the power cord from the wall outlet.
2. Wipe off any gel or biological material with a soft, lint-free cloth moistened with detergent
solution (made using manufacturer’s instructions) or tap water, taking care to remove all
visible contamination.
Dispose of the used cloths appropriately according to the local medical waste regulations.
3. For a list of compatible cleaning or disinfectant agents, see the user guide or
‘Disinfectants for System Surfaces, Disinfectants for Monitor Surface’ on the Samsung
Medison website (http://www.samsunghealthcare.com).
Follow the detergent manufacturer’s instructions for preparation, temperature, solution
strength, and duration of contact. If a premixed solution is used, be sure to observe the
solution expiration date.
4. Wipe off the device’s surface according to the disinfectant manufacturer’s instructions for
temperature, wipe durations, and duration of disinfectant contact. For difficult parts to
wipe such as crevices and edges of the device, use a cotton swab wrapped with a cloth
soaked with the detergent. Make sure that liquids or other objects do not enter the inside
of the product.
5. Visually inspect for any remaining soil and if necessary repeat the steps, starting at step 4.
6. According to the detergent manufacturer’s instruction, air dry the device or remove water
from all surface of the device using a soft and clean disposable, lint-free cloth.
7. Examine the device for damage such as cracks, splitting, sharp edges, or projections. If
such damage is found, discontinue use of the device and contact your Samsung Medison
representative.
1.6.2.3. Disinfection
In general, an ultrasound system has an irregular surface, and disinfection of the entire
surface of the product is not recommended. Therefore, users should follow the instructions of
reprocessing method suggested.
You may lose user settings or patient information files because of physical
shocks to the product or internal errors. Therefore, you should back up this
information on a regular basis.
CAUTION
1.7.3. Software
The software may be changed to improve the product’s performance. Users should not attempt
to modify the software by themselves; they must consult staff at Customer Service Department
and ask them to guide them through the modification process.
Minor software updates may be carried out without prior notice from the
manufacturer.
CAUTION
If an error occurs in the operating system (Windows), or you need to upgrade it, please follow
the operating system manufacturer’s instructions.
This product uses the Windows firewall to prevent any hackers or malicious
software from accessing the system through the internet or network.
NOTE
Chapter 1. Safety and Maintenance 1 - 49
1.7.4. Network
1.7.5. Cybersecurity
In recent years, cybersecurity threats have intensified.
Threats manifest in a variety of forms, including system breakdowns caused by virus infections
or leaking of patient data stored on the system, and unfortunately, no security measure can
prevent such threats 100%. Therefore, please comply with the following to prepare for cyber
threats.
■ Do not connect the product to an unsecured public wired or wireless network, and under no
circumstances do you connect to the Internet via this product.
■ To start functions that require network connection (Export, Remote Control etc.), use firewall
to restrict access to the network connected with product.
■ Place this product in an area where it cannot be operated or tampered with physically by
non-designated persons, and shut off power when it is not in use.
■ Only external devices (e.g., USB drive) that have been scanned for viruses and malwares
should be connected to the product.
■ If you suspect that the product is infected, stop using it immediately, shut off the power, and
make sure that you contact the Security Manager (Technical Support).
■ If a new security patch has been released, adjust the schedule with the Service Team to
apply the patch promptly.
■ Samsung Medison provides remediation support for known cybersecurity vulnerabilities of its
products until the end of their lifecycle.
Chapter 1. Safety and Maintenance 1 - 51
The battery pack is a consumable, and will lose performance over time. If the battery life
becomes less than half of what it was when first purchased, it is time for a replacement.
Disconnect the power cord if you are not planning to use the product. Leaving
the product unused and not plugged in to a power outlet for an extended period
of time may deplete the battery completely, making it impossible to recharge the
batteries. In addition, allowing the battery pack to become completely depleted
WARNING may cause communication problems for the product.
■ If the low battery message appears while you are using the product,
immediately save the diagnosis information and connect the AC adapter.
■ Before connecting the AC adapter, make sure it’s the right way up. Forcing
the adapter into the product in the wrong way can damage the product.
WARNING
■ Do not recharge the battery pack using a method other than that described in
this manual. Doing so may lead to a fire or an explosion.
Below is an operating environment temperature for Battery Pack. If the battery temperature
goes beyond a certain degree, stop recharging for safety.
– Operating environment temperature: 10 - 35C
The battery pack can overheat if the operating environment temperature is too
high, or can take much longer than normal to recharge if the temperature is too
low.
CAUTION
1 - 52 V6/XV6 Service Manual
If using the battery pack as the power source, check the battery icon shown on
the screen to find out how much battery charge is left. For more information on
battery icons, refer to the ‘Monitor > Screen Layout’ section of ‘Introduction’.
NOTE
Do not dispose of the battery pack carelessly. Do not incinerate the battery, as
this may cause an explosion or a fire.
WARNING
Chapter 1. Safety and Maintenance 1 - 53
■ For disposal of the system or accessories that have come to the end of their
service lives, contact the vendor or follow appropriate disposal procedures.
■ Waste must be disposed of in compliance with the local regulations.
CAUTION ■ The lithium ion battery used in the product must be replaced by a service
representative or an authorized dealer.
Introduction
2.1. Indications for Use ............................................................. 2
2.1.1. Contraindications ............................................................................. 2
2.2. Product Specifications ....................................................... 3
2.3. Product Configuration ........................................................ 6
2.3.1. Monitor ............................................................................................. 8
2.3.2. Control Panel ................................................................................. 10
2.3.3. Console .......................................................................................... 19
2.3.4. Peripheral Devices ......................................................................... 22
2.3.5. Probes ........................................................................................... 26
2.3.6. Accessories.................................................................................... 27
2.3.7. Optional Functions ......................................................................... 28
2 - 2 V6/XV6 Service Manual
2.1.1. Contraindications
This product must not be used for ophthalmological applications, or any other use that involves
the ultrasound beam passing through the eye.
2D Mode
M Mode
Color Doppler Mode
Pulsed Wave (PW) Spectral Doppler Mode
Continuous Wave (CW) Spectral Doppler Mode
Tissue Doppler Imaging (TDI) Mode
Imaging Modes Tissue Doppler Wave (TDW) Mode
Power Doppler (PD) Mode
ElastoScan™ Mode
3D/4D Mode
Dual Mode
Quad Mode
Combined Mode
Linear Array
LA2-14A, LA3-22AI
Curved Array
CA1-7S, CA1-7SD, CA3-10A, CA4-10M
Endocavity
EA2-11AR, EA2-11ARD, EA2-11AV, EA2-11AVD, miniER7
Probes 3D
(Type BF/IPX7) CV1-8A, CV1-8AD, EV2-10A
Phased Array
PA1-5A, PA3-8
MPTEE
MMPT3-7
Pencil
CW6.0, DP2B
2 - 4 V6/XV6 Service Manual
Main Monitor
Number of Pixel: 1920 x 1080
21.5 inch LCD Monitor
(LED Backlight unit, hereafter referred to as “LCD monitor”)
23.8 inch LCD Monitor (Option)
Monitor
(LED Backlight unit, hereafter referred to as “LCD monitor”)
Touchscreen Monitor
Number of Pixel: 1920 x 1080
14 inch LCD Monitor
(LED Backlight unit, hereafter referred to as “LCD monitor”)
TGC/LGC control
Mode-independent gain control
Acoustic power control (adjustable)
Signal Processing
Dynamic aperture
(Pre-processing)
Dynamic apodization
Dynamic range control (adjustable)
Image view area control
Chapter 2. Introduction 2 - 5
User Interface English, German, French, Spanish, Italian, Chinese, Portuguese, Russian
Operating: 30 – 75%
Humidity Limits
Storage & Shipping: 20 – 90%
Altitude ≤3000m
2 - 6 V6/XV6 Service Manual
① Monitor
② Monitor arm
③ Touch Panel
④ Speaker
⑤ Control Panel & Handle
⑥ USB port
⑦ Probe holder
⑧ Lift & Lift Lever
⑨ ECG port
⑩ Outlet for internal peripheral
devices
⑪ Probe port
⑫ CW Probe Port
⑬ Wheel
① Storage compartments
② Ventilation
③ Cable holder
④ Rear panel
⑤ ID label
⑥ Power connection
2.3.1. Monitor
① Title Area
Displays patient information, hospital name, application, frame rate, depth, probe
information, acoustic output information, and the current date and time.
② Menu Area
Displays Preset Change. You can quickly change the preset of a probe. The EzExam+™
menu will also appear if being used. The Left menu will also appear if being used.
③ Image Area
Displays ultrasound images. TGC, Image information, annotation, and measurement
information are also displayed.
④ Thumbnail Area
Images saved by pressing the preset Store button are shown in the thumbnails. Place a
pointer on a Thumbnail image to enlarge it in the preview image.
⑤ User Information and Status Information Area
Chapter 2. Introduction 2 - 9
Information that is useful to the user, such as current system status, image information,
selectable items, user defined key settings, etc., is displayed.
For more information about user keys, please refer to User manual’s Chapter
3, Utility > Setup > Customize.
NOTE
TIP BatteryAssist™
BatteryAssist™ provides battery power to the system, enabling users to perform
scans when AC power is temporarily unavailable. It also allows to transport the
ultrasound system to another location and start to scan right away.
Please check the battery capacity before use. A ‘Battery’ icon will be displayed on a
product that has a battery in it. The user can check the battery level as shown in the
table below:
Icon Description Tool Tip Message
Charging (61–80%)
Battery/‘Valid Capacity %’
Charging (41–60%)
Charging (21–40%)
For more information, please refer to User manual’s Chapter 3,Utility > Setup >
Customize.
NOTE
2 - 10 V6/XV6 Service Manual
Functions of some buttons on the Control Panel can be changed in Setup >
Customize. Functions configured will appear in User Information and Status
Information area and Contextual Button area on the monitor screen.
NOTE
Chapter 2. Introduction 2 - 11
On/Off
Pointer
Exit
Enter or exit M Mode.
Rotate this dial-button to adjust the M Gain
7 Button value. In 3D View and S-Fusion™, turning
this dial-button will rotate the image around
the x-axis.
Enter 2D Mode.
11 Dial-button Rotate this dial-button to adjust the Gain
value.
Trackball
Chapter 2. Introduction 2 - 15
■ Keyboard (Option)
A keyboard, an optional item that you can connect via a USB port, is available. You can
use the keyboard to enter text, etc.
2.3.2.3. Touchscreen
Items that are available for use in each Operation mode will be enabled on the touchscreen.
You can change the image format or optimize an image to facilitate your diagnosis.
– In a combined mode that uses more than one Operation mode, tap the relevant tab on
the touchscreen to specify settings for each mode.
– You can change the tabs on the touchscreen by dragging them as if you are turning
pages. Press the touch button or use the dial-button on the control panel to select a value.
Displays the Patient Information screen, which is used for selecting a patient
Patient
ID from the list or entering new patient information.
Displays the Probe Selection screen to select or change the probe and
Probe
application.
Displays the Report screen that shows the measurement results of the current
Report
application and other information.
Finishes the exam of the patient currently being diagnosed and resets the
End Exam
related data.
④ Displays the buttons of functions relevant to the operation mode that is currently in use.
⑤ This is the TGC (Time Gain Compensation) area. It displays sliders where you can
control Gain.
1. Use the TGC sliders to adjust the Gain, and press Save as Preset.
2. With the User TGC button, you can save the pattern you want.
3. Select the TGC Preset button to complete the User TGC settings.
4. Press the first button of TGC Preset for center alignment.
QuickPreset: With one touch, the user can select the most common transducer and
preset combinations. QuickPreset increases efficiency to make a full day of scanning
simple and easy.
⑦ Soft Menu Area: The soft menu items that are available in the current input mode are
shown. The menu in use is shown in the border color. Press or rotate the dial-buttons
right below each menu.
2.3.3. Console
The product consists mainly of ultrasound imaging components on the inside, and various
connectors, probe holders, a storage compartment, handles, and wheels on the outside.
① Network port: Connect to a network. You can transfer patient information to another
server via DICOM network.
② HDMI port (Output): Outputs digital signals to the monitor. (Input: Not supported.)
③ USB port: Used to connect to peripheral USB devices.
④ S-VHS Port (Output): Provides a S-VHS connection for a VCR. (Option)
⑤ Audio port (Output): Used for audio signal output. (Input: Not supported.) (Option)
2 - 20 V6/XV6 Service Manual
① Power Switch: Turns on the power of the product, and cuts off power.
② Power Inlet: Accepts the power cord, which connects to an external power supply.
③ Equipotential Terminal: This should be connected to the equipotential connection part in
the exam room.
Chapter 2. Introduction 2 - 21
■ Do not install peripheral devices that are 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 external peripheral devices to the auxiliary socket
CAUTION outlet. Doing so may decrease safety level.
Refer to the user manual of the peripheral device for its operating information.
NOTE
When using a peripheral device via a USB port, always turn the power off
before connecting/disconnecting the device. Connection/disconnection of USB
devices while the power is on may lead to malfunction of the system and the
USB devices.
CAUTION
Chapter 2. Introduction 2 - 23
Sony UP-D897, and Sony UP-D897MD are not available in the US and Canada.
NOTE
■ USB Printer
– Samsung CLP-620NDK, ML-2950
■ Foot Switch
– 3 Pedals HID Type
Set the functions in User manual Chapter 3, Utility > Setup > Customize >
General > Foot Switch.
NOTE
Connecting or removing the Foot Switch while the product is turned on may
cause the system to malfunction.
CAUTION
2 - 24 V6/XV6 Service Manual
■ Wi-Fi Adaptor
– Wi-Fi adaptor (USB Type): Archer T4UH (TP-LINK AC1750)
For more information about how to connect to wireless networks, please refer to
User manual Chpater3 ‘Utility > Setup > Connectivity > Network> Wireless’.
NOTE
The device’s transmitter/receiver protocol specifications may vary depending on the Wi-Fi
Adaptor in use.
Model Archer T4UH (TP-LINK AC1750)
Protocol IEEE 802.11ac
IEEE 802.11a
IEEE 802.11n
IEEE 802.11g
IEEE 802.11b
Signal Rate 5 GHz
11ac: Up to 867 Mbps(dynamic)
11n: Up to 300 Mbps(dynamic)
11a: Up to 54 Mbps(dynamic)
2.4 GHz
11n: Up to 400 Mbps(dynamic)
11g: Up to 54 Mbps(dynamic)
11b: Up to 11 Mbps(dynamic)
Frequency 2.4 GHz, 5 GHz
Transmit Power <20 dBm (EIRP)
Wireless Security Support 64/128 bit WEP, WPA-PSK/WPA2-PSK, 802.1x
Chapter 2. Introduction 2 - 25
Frequency Bandwidth
Protocol Stream Data Rate (Mbit/s) Modulation
(GHz) (MHz)
20 Up to 288.8
802.11n (Wi-Fi 4) 2.4/5
40 Up to 600
20 Up to 346.8
MIMO-OFDM
40 Up to 800
802.11ac (Wi-Fi 5) 5
80 Up to 1733.2
160 Up to 3466.8
■ Misc.
– USB Memory Media
■ The system cannot recognize USB memory. Remove the USB memory from
the console and equip again with an appropriate device.
■ Regarding file formats that are not ordinarily saved: Please check first to see
if it is possible to save the file format on a desktop PC before trying to save
NOTE the file on USB memory.
■ Do not use USB memory media which contain anti-virus programs or are
defective. Otherwise, the product may fail to work properly.
■ Please use a USB drive compatible with Windows 10. Otherwise, some
features may not work correctly.
CAUTION
2 - 26 V6/XV6 Service Manual
2.3.5. Probes
Probes are devices that generate ultrasound waves and process reflected wave data for the
purpose of image formation.
NOTE
■ When connecting a probe, make sure that the connector is not exposed to
any liquid or foreign substance. Otherwise, fire, electric shock, injury, or
damage to the product may occur.
■ The probe may experience connection problems caused by foreign objects. If
CAUTION such a problem occurs, remove any foreign objects and try again.
Chapter 2. Introduction 2 - 27
2.3.6. Accessories
An accessory box containing the items below is supplied with the product.
NOTE
2 - 28 V6/XV6 Service Manual
Optional features vary by country and version. Please check the product to
confirm which features are available.
NOTE
Chapter 3
3. 제품 설치
제3장. 제품 설치
Installing Product
3.1. Transporting.............................................................................................. 2
3.1.1. Precaution during transport ................................................................................... 2
3.1.2. Brakes.................................................................................................................... 2
3.1.3. Precaution on Ramp .............................................................................................. 2
3.1. Transporting
This product is finely-tuned medical electronic equipment; careful attention is required when
transporting it.
Use extra caution when you move the product. Careless transportation or
transfer of the product may result in product damage or personal injury.
WARNING
3.1.2. Brakes
You can use the caster brakes on the product to control their movement. Make sure that the
brakes are engaged before you use the product.
The product weighs more than 80 kg. Be extra careful when transporting it.
Careless transportation of the product may result in product damage or personal
injury.
WARNING
3.2.2. Accessory
An accessory box containing the items is supplied with the product.
If it does not match your order, please contact the Samsung Medison customer service
department or your local vendor.
[Figure 3. 2 Accessory]
NOTE
3–6 V6/XV6 Service Manual
3.3.1. Caution
When installing the product, please pay attention to the following: For more information on use
and setup, please refer to the accompanying manual for this product.
Placing the system near generators, X-ray machines or broadcast cables may
result in abnormal images on the screen due to electrical noise.
Sharing the power source with other electrical devices may also produce the
CAUTION similar problem.
• Optimum conditions for system operation are 10-35 temperatures and 30-75% humidity.
• Avoid excessive humidity.
• Avoid direct sunlight.
• Avoid excessive fluctuations in temperature.
• Avoid installing the product near a heating system.
• Avoid places that are dusty or poorly ventilated.
• Avoid locations that are subject to vibration.
• Avoid locations where chemical substances or harmful gases are present.
Chapter 3 Installing Product 3-7
If the product has been transported or stored outside the operating environment
temperature (10~35C), do not turn on the product immediately. A sudden
change in temperature may cause product malfunction.
CAUTION Refer to the table below and allow standby time before using the product.
Temperature 10
[°C]
-40 -35 -30 -25 -20 -15 -10 -5 0 5 40 45 50 55 60
~35
Standby
20 18 16 14 12 10 8 6 4 2 0 2 4 6 8 10
time[h]
②
③
① Power switch: Turns on the power of the product, and cuts off power.
② Power inlet: Accepts the power cord, which connects to an external power supply.
The product may be shipped with the power cable already connected to the
console.
NOTE
1. Once the system reboots after installation, the System Installation screen will be displayed.
2. Enter the Installation Key.
You can get the Installation Key from GSIS (Global Service Information System) website
after register the hospital information and entering the system information.
GSIS URL: https://gsis.samsunghealthcare.com
Product Inspection
4.1. Inspecting the Functions ......................................................................... 2
4.1.1. Basic Inspections ...................................................................................................... 2
4.1.2. Detailed Inspections.................................................................................................. 3
4.1.1.1. Monitor
Check the screen for color, focus, dots, afterimage, stain, and blurriness.
Check the screen while applying impact on the monitor and check the signal while shaking the
cable to the left and right.
Press any keys on the control panel and see if text appears or breaks.
Verify that the Keyboard LEDs turn on.
■ BodyMark Key
Check if a BodyMarker image appears correctly and whether selection works properly.
■ Indicator Key
Check whether the trackball works properly by rolling it up, down, left, and right.
■ Clear Key
Check the zoom function for proper action and make sure that there are no errors.
■ Check SonoView
■ Measure
■ Patient
Enter information in Patient and check whether the same Patient information is displayed in
Report, SonoView, etc.
■ End Exam
Make an arbitrary measurement in New Patient and see whether the measurement is erased
when you press End Exam.
■ Probe Key
■ 2D Mode
1. Perform a Knife Test to check whether part of the image is not displayed.
2. Perform a Phantom to check for errors in image.
3. Check the Freeze Cine actions (broken image, Auto Run, Auto Run Speed, Trackball
Cine).
4. Check for changes in image brightness when you adjust Gain.
5. Check whether TGC Gain operates correctly by adjusting it and check for changes in
image brightness in accordance with depth.
6. Perform Left/Right Flip, Up/Down Direction, and Rotation to check whether the image
changes its orientation correctly.
7. Check whether the Select Image menus (EE, DR, View Area, Tissue, Frame Rate) work
properly.
8. Check for errors in frequency (Phantom, Res, Pen, Gen).
9. Check for changes in image in accordance with the changes in depth.
10. Check for changes in image by depth when you change the focus.
11. Check whether or not Image Compensation Mode works.
4-4 V6/XV6 Service Manual
■ Dual Mode
■ M Mode
■ 3D/4D Mode
1. Check whether loading is performed correctly when you proceed with Free Hand 3D
SCAN and when you skip to Freeze; check for broken images and noise while proceeding.
2. Check whether loading is performed correctly when you proceed with Static 3D Scan;
check for broken images and noise while proceeding. Check the probe for noise and
whether the probe’s motor works normally.
3. Check whether loading is performed correctly when you proceed with Live 3D Scan;
check for broken images and noise while proceeding. Check the probe for noise and
whether the probe’s motor works normally.
4. Check for errors in ROI 3D, ABC 3D, and Full images.
5. Check whether the 3D image changes to the selected angle.
6. Check whether the 3D image’s contrast changes to the selected value.
7. Check for errors in the image when you change the size of the image.
8. Check the Display Format Image (ACB, Volume CT Image)
9. Step Angle, Rotation Angle, Rot. Axis, and then proceed with Cine; check whether Cine
Loading works in accordance with the Setting items and check for breaks and errors in
the image.
Chapter 4. Product Inspection 4-7
AC POWER Check and record the current voltage of the power outlet. Monthly
FAN Check Bottom Fan, Rear Fan and CPU cooling Fan Monthly
Monitor/Touch panel Check Brightness, Contrast, Stain and Dot of the display Weekly
Track Ball Check the movement of Track Ball up,down,left and right Daily
Probe appearance Check for lens damage, Cap cracks and S/R separation Daily
Probe element Check for element status through Knife Test Monthly
Probe performance Check the image qualtity through the Phantom Annually
제5장. 제품 구조
Product Structure
5.1. Overview ................................................................................................... 3
5.2. System block diagram and Layout ......................................................... 4
5.2.1. Overall System block diagram ............................................................................... 4
5.2.2. System Layout(Body) ............................................................................................ 4
5.1. Overview
Chapter 5 describes the overall system structure of V6/XV6and the function of detailed
components.
5-4 V6/XV6 Service Manual
5.3.2. PC Part
Digital Scan Converter program of the PC integrates the three mode imaged such as B mode, C
mode and D mode into one image with diagnostic meaning and then corrects the image.
The Pre/Post processing part of Digital Scan Converter program processes images according to
various menus and add various digital information to the diagnosis image.
Finally, VGA part converts the digital image data to a video signal for peripheral devices.
PC Part consists of the following components.
• PC Module: Advantech, Com Express PC Module (SOM-5899)
• CPU: Intel i5-8400H
• RAM: 16GB (DDR4 8GB*2)
• Storage: M.2 NVMe SSD 512GB
• OS: Windows 10 64bit
• VGA Card : nVidia Geforce GTX1650
Chapter 5. Product Structure 5-7
5.4.1.1. Specification
• 3/4 Probe Port Support (Optional)
• 1CW Pencil Probe Port Support(Option)
• Probe Insert Check, ID read, Port selection
5.4.1.2. Description
■ Probe Selection
It selects one of four probe ports and the probe port is selected through the user control
transmitted from BE board.
5.4.2.1. Specification
• USB3.0 CP 3ea
• USB2.0 ECG 1ea
• USB2.0 DriveBay 1ea
• USB2.0 BW/Color Printer 2ea
• DP 1ea
• HDMI 2ea
• LAN 1
Chapter 5. Product Structure 5 - 13
5.4.2.2. Description
• Pulser
It transmits the High Voltage Pulse to the Probe after amplifying 128 channel Firing pulse
clock up to ±100V.
• TR Switch
It removes HV inputted from PSA in order not to pass to AFE.
• AFE
After amplifying the input echo signal to a sufficient size, it compensates to a certain size.
Then, it converts it into a digital signal for digital beamforming.
• BF FPGA
It consists of 128 TX channels and creates Firing pulse clock. It performs the digital
beamforming for 128 RX channel.
Lastly, it sums 128 RX channel data and transmits it to BE part.
• CWD
It removes only the clutter noise among CW I,Q signal inputted from LNA of the BF part.
• BE Part
MID processor creates BW Image, Spectral Doppler Image, and Color Doppler Image.
PC Host Interface transfers image data to PC through PCIe GEN3 x4 high speed serial bus.
• Motor controller
It consists of Step motor control part and Motor Drive part to drive the 3D probe.
When driving 3D Probe, the motor drive part drives the probe motor with SIN, COS and the return
path of this signal.
• BE - Internal I/O Part
It supports 1 USB 3.0 port and 1 DP port for CP & ECG Interface, 2 USB2.0 ports for printer.
• BE - User I/O Part
It supports 2 USB3.0 ports, 2 HDMI ports and 1 LAN port for the user.
It can be converted to an analog video signal using HDMI to DVI adapter.
5 - 14 V6/XV6 Service Manual
5.4.3.1. Specification
• S-VHS 1ea
• Audio
■ Only certain countries that require analog signals are applied by default.
NOTE
.
Chapter 5. Product Structure 5 - 15
5.5. PC Part
5.5.1. PC Module
It supports High speed serial bus to receive BE image data and peripheral port for User
interface. It makes various application images with the inputted image data from BE board and
add all kind of digital information on the image and converts into the digital video signal for
monitor.
5.5.1.1. Specification
• PC Module: Advantech, Com Express Module (SOM-5899)
• CPU: Intel(8th core) i5-8400H
• RAM: 16GB DDR4(8GB*2)
• Storage: M.2 NVMe SSD 512GB
• OS: Windows 10 64bit
• VGA: nVidia Geforce GTX1650
• Monitor: 21.5 inch LG display(1920X1080)
5.5.2.1. Specification
• Digital Scan Conversion
• Cine
• Ezexam+
• Zoom
• Edge Enhancement
• Frame Average
• MultiVision(SCI)
• ClearVision(SDMR)
• S-QuickScan
• Elastoscan
• Auto IMT
• Post Measurement
Chapter 5. Product Structure 5 - 17
5.5.2.2. Description
DSC consists of 4 software blocks.
Acquisition block acquire image data from BE FPGA.
Pre/Post filter makes application images such as Quick Scan, Multi vision, Frame Average,
CINE and etc.
Scan Conversion block integrates three mode images such as BW Image, Spectral Doppler
Image, Color Doppler Image as one image with diagnosis meaning .
5 - 18 V6/XV6 Service Manual
5.6.1.1. Specification
■ CP- board
• Encoder 15EA
• Tack- Switch 21EA
• LED 102EA
• Trackball
• USB2.0 HUB
• PIC18F96J94(8bit Microcontroller)
• MSP(Multi-Stream Transport) HUB
• Encoder Interface
• Tack SW Interface
• Trackball Interface
• Keyboard Interface
• LED backlight control
■ CP-Switch board
■ CP-USB board
5.6.1.2. Description
MCU (PIC18F96J94) scans the key values of Track Ball, Encoder, and Key SW while
interfacing between the control panel and the PC and transmits it to the PC. It controls
On/Off of Button Backlight LED.
MST (Multi-Stream Transport) HUB receives the Display Port signal from the PC and divides
the output to the connected Main monitor and Touch monitor.
Chapter 5. Product Structure 5 - 21
5.6.2.1. Specification
5.6.3.1. Specification
■ Input
■ Output
PSU(AC-DC power Module) makes a variety of DC voltages for the entire system.
The output voltages generated by PSU is as follows.
12VD2(12.2) 10A
ATX 12VD(12.2) 9A
24VM(24) 1.5A
3.8VA(3.9) 12.5A
LV 5.5VA(5.4) 6.5A
N5.5VA(-5.7) 0.5A
CW(18V) 0.7A
80V(80V) 0.2A
N80V(-80V) 0.2A
HV 70V(70V) 0.2A
N70V(-70V) 0.2A
100V(100V) 0.05A
N100V(-100V) 0.05A
■ Battery
V6/XV6has two 6900 mAh Lithium-ion batteries and you can run for 40 minutes under the
worst condition like 3D live scan.
• 3D Live scan time : Min 60 minutes
• Sleep mode sustaining time with battery : 70 hour
• Fast Boot time : Max 25 second
V6/XV6PSU is equipped with 9 Power Satus LEDs that show the overall voltage status of the
system. The service engineer can diagnose whether there is a problem in the system power by
the LED status.
The Power Status LED consists of 9 and displays the status of the 8 voltages supplied from the
PSU to the system. It is located next to the input switch on the back of the system, and you can
conveniently check the LED status from the outside without disassembling the device.
· 1 blink : UVP/OCP
· 2 blink : OVP 1. PSU
Status PSU output OK PSU output fail
· 3 blink : OTP 2. Each board
· 4 blink : Fan Error
· On when using Mux Probe If the LED is off, · 1 blink : UVP/OCP 1. PSU
Mux
· FHV OK for PSA/Probe FHV(±100V) fail · 2 blink : OVP 2. Probe
1. PSU
· On during CW mode If the LED is off, · 1 blink : UVP/OCP
CW mode 2. BF board
· CW power OK CW Power fail · 2 blink : OVP
3. CW board
Service Mode
6.1. Service Mode ............................................................................................ 3
6.1.1. How to enter Service Mode ................................................................................... 3
6.3. Configuration
6.3.1. Keyboard/Region
CAUTION
6.3.2. TCP/IP
• Commands: PC’s IP config information is displayed on the right screen.
• LAN: Set wired network connection properties.
• WLAN: Set wireless network connection properties.
• Support: New device addition, driver installation and device manager execution.
6.3.3. Option
This is the menu to manage the application that the License is registered.
• Import Options: Install Option using the USB that option information is saved.
• Install: Install the selected Option.
• Uninstall: locks the option that it is already installed.
6.3.5. Printer
• Printer: set default printer
• Properties: set the printing method for the selected printer.
• Add Printer: Add new printer driver except default printers.
Reboot is required to install the new printer driver.
6.3.6. RMS
Remote Maintenance System : Remotely diagnose system defects and set up the system.
RMS ServiceApplication Run: run RMS Application by pressing [Run] button..
6.3.8. AppLocker
AppLocker : This is a function that restricts files not to execute to prevent arbitrary software
installation.
• Default setting is set to Off (Tender specification).
• When changing the default layout of the touch button to GI or OB/GYN Layout, delete the
user setting and change the default touch layout to the set layout.
it switches from Human Mode to Vet mode or from Vet mode to Human mode.
• Press the Vet mode Button and enter the Enter Mode Key.
6.4. System
NOTE
6.5. Diagnostic
CAUTION
• Alert Popup: When [On] is checked, an error message pops up when an error occurs as a
result of the probe element diagnosis.
6.6.1. Backup
Back up the selected USER file. External storage such as USB is required.
6.6.2. Restore
Restore the selected USER data file. You should have previously backed up data.
6.7. Report
6.7.1. Report
It shows the temperature, BIST, connectivity, and error log information stored in the system.
Self Diagnostic
7.1. PURPOSE FOR USAGE ......................................................... 2
Dummy Probe is a Jig (Tester) used for PSA Board inspection. In case of diagnosing system
without dummy probe, only other items except PSA board can be diagnosed.
For details, refer to page 11 “ Test Items According to Dummy Probe”.
Dummy Probe has not been provided since 2020. For related
matters, please contact the Area Service Manager of the head
office.
NOTE
Chapter 7. Self Diagnostic 7-3
∙ No Dummy Probe : When testing without the dummy probe, continue to click
[Enter] key when a dummy probe insertion message pops up.
∙ Dummy Probe 1EA : When the dummy probe message pops up, insert the dummy probe
into the probe port.
② When the Built-In Self Test box pops up, select the test item from the Menu and press
[RUN] button.
[PASS]
[FAIL]
When the Self-Diagnostic is running, the test result for each test item is displayed on the
screen. The test result is displayed in real time, and the test result is summarized and
displayed when the final test is completed .
7 - 6 V6/XV6 Service Manual
󠇍 Folder name
• The folder name is created in the form of YYYYMMDD_HHMMSS .
• Every time the test is run, one folder is automatically created, and Log files are saved in
the folder..
7 - 8 V6/XV6 Service Manual
󠇍 File name:
• [HWINFO].ini : the system’s H/W & S/W information.
• 00_STDOUT.txt : Test result - details
• 01_RESULT.txt : Test result - Result
• 02_SUMMARY.txt : Test result - Summary
• 03_ANALYSIS.txt : Test result – Analysis content for each test
Chapter 7. Self Diagnostic 7-9
■ If the system does not shut down normally after completing the
test, the system may not boot normally.
■ Be sure to shut it down according to normal shutdown
CAUTION procudure.
When Built-In Self Test is complete, click [Close] button to end the test.
7 - 10 V6/XV6 Service Manual
No One
No Test Item Sub Test Item
Dummy Dummy
1 Power Voltage ○ ○
2 Power SMPS ○ ○
3 Power CAP SW ○ ○
8 Bus I2C ○ ○
11 Analog ADC ○ ○
12 Analog RX ○ ○
13 Analog TX ○ ○
14 Analog ATGC ○ ○
15 CW CW ○ ○
Parameter Check
Sub Item Description Parameter
Description Point
FPGA0_VCCINT 0.95V Main
FPGA1_VCCINT 0.95V Main
FPGA2_VCCINT 0.95V Main
FPGA1_AUX_1.8V 1.8V Main
FPGA2_AUX_1.8V 1.8V Main
FPGA0_AUX_1.8V 1.8V Main
FPGA_IO_1.8V 1.8V Main
FPGA_IO_3.3V 3.3V Main
VCCINT_0.95V 0.95V Main
MGTAVCC_1.0V 1.0V Main
Measure Main
Voltage BE_DCDC_1.2V 1.2V Main
powers.
BE_DCDC_1.8V 1.8V Main
BE_DCDC_2.5V 2.5V Main
BE_DCDC_3.3V 3.3V Main
MAIN_12V2 12V Main
FIX_HV_100V 100V PSU
FIX_HV_N100V -100V PSU
BHV_80V 80V PSU
BHV_N80V -80V PSU
CHV_70V 70V PSU
CHV_N70V -70V PSU
HV_80V 80V PSU
HV_N80V -80V PSU
HV_70V 70V PSU
HV_N70V -70V PSU
12VD2 12V PSU
5VD 5V PSU
Check PSU output 24VM 24V PSU
SMPS
voltage SB_5V 5V PSU
1.6VA 1.6V PSU
2.3VA 2.3V PSU
3.8VA 3.8V PSU
5.5VA 5.5V PSU
N5.5VA -5.5V PSU
12VA 12V PSU
Battery
Check
Test Item Sub Item Description Parameter
Point
MOT_SIN_DRV_V
MOT_SIN_RTN_V
Motor Motor Test Motor drive DAC/AMP check Main
MOT_COS_DRV_V
MOT_COS_RTN_V
제7장. 고장 진단
Troubleshooting
8.1. Power......................................................................................................... 2
8.1.1. Power doesn’t Turn on........................................................................................... 2
8.1.2. Power does not turn off ......................................................................................... 2
8.1.3. Power Turns Off by itself ....................................................................................... 2
8.1.4. PSU Stand-Alone Self-diagnostics ........................................................................ 3
8.1.5. BP board Self-diagnostics ..................................................................................... 4
8.1. Power
1. Make sure the power cord is properly plugged and the power switch is on.
2. Plug another device into the power outlet to see if it works.
– If the another appliance works, the power connection part has failed.
– If the another appliance does not work, the power outlet has failed
3. Turn on the power switch and check if the System Power Button is turned on.
– If the Power Button LED is on, it is more likely due to something other than the
connection.
– If the Power Button LED does not turn on, a power failure is expected.
4. Check PC and PSU.
1. Turn off the circuit breaker of the PSU after turning off the system.
2. Pull out PSU after unplugging the power cord from the power outlet.
3. Select Dip switch No. 2 of the PSU to “ON”.
4. Turn on the circuit breaker of the PSU single unit after plugging the power code into the
power outlet.
5. If only one LED blinks continuously or no LED lights up, the PSU is fail.
※If the four LEDs below continue to light up sequentially, It’s a normal.
6. After checking the PSU, select Dip switch No.2 to “OFF” again.
※ The system will be automatically turned off unless you return the Dip Switch to it’s
original position.
8-4 V6/XV6 Service Manual
8.2. Monitor
8.4. Image
YES
Circuit breakers NO
Circuit breaker ON
is on ?
YES
YES NO
Status LED is on ? Replace PSU
YES
NO
NO NO
CP LED turned orange? CP LED blinking? Check PC or SSD
YES YES
No Monitor/Touch image
NO NO
Monitor power/HDMI signal
LED Backlight is on ? Replace the cable or PSU
is OK ?
YES YES
NO
NO
YES
Test the analog part
Is there still noise? Is BIST result pass ?
with BIST
NO YES
NO
Does it work normally? Replace the trackball
YES
NO
YES
NO
Normal Does it work normally?
YES
Normal
Check CP Module
8 - 12 V6/XV6 Service Manual
YES
제8장. 분해 및 조립
Disassembly
9.1. Caution ...................................................................................................... 2
9.1.1. Preparation ............................................................................................................ 2
9.1. Caution
This chapter describes the procedure for disassembling V6 system. Refer to this chapter when
upgrading or servicing the system’s hardware.
■ Do not wear an antistatic wrist strap while working with the product in
powered on state. Otherwise, you may sustain electrical injury.
9.1.1. Preparation
You will need the following items: Phillips (+) screwdriver, antistatic gloves, and antistatic wrist
strap.
Turn off the power of the product and disconnect the battery.
Wear antistatic gloves and wrist strap when disassembling or reassembling the product.
They help prevent accidents for the engineer and product failure caused by static
electricity
NOTE
⑤ Among 3 USB ports, Only very left port is USB3.0 and the other two are
USB2.0 Port. When assembling, USB3.0 LEFT cable must be inserted at the
very left port. If you insert it to other port, Power button may be out of order.
NOTE
⑥ Remove 4 cables. If there is no printer option, the cable are not provided.
Chapter 9. Disassembly 9-5
2. ①② unscrew 8 screws at the bottom side to separate the Control Panel Top Cover.
③ separate Monitor Arm cover.
④ separate Top cover.
When working without holding the monitor arm, the arm may fall and hurt
the worker.
For safety, be sure to remove the screw while holding the monitor arm
CAUTION
with your hand.
Chapter 10
Probes
10.1. Probes ................................................................................. 2
10.1.2. Ultrasound Transmission Gel ......................................................... 14
10.1.3. Using Sheaths................................................................................ 16
10.1.4. Probe Safety Precautions .............................................................. 18
10.1.5. Cleaning, Disinfecting, and Sterilizing Probes ................................ 20
10.1.6. MPTEE Probe (Option) .................................................................. 35
10.2. Biopsy ............................................................................... 42
10.2.1. Biopsy Kit Components .................................................................. 43
10.2.2. Using Biopsy Kit ............................................................................. 44
10.2.3. Assembling the Biopsy Kit.............................................................. 47
10.2.4. Cleaning and Disinfecting the Biopsy Kit........................................ 52
10 - 2 V6/XV6 Service Manual
10.1. Probes
The probe is a device that sends and receives ultrasound for acquiring image data.
The system limits patient contact temperature to 43 degrees Celsius, and acoustic output 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.
Thermal
Probes Application Preset
Index
Thermal
Probes Application Preset
Index
Thermal
Probes Application Preset
Index
■ Function List
The functions available in this product for various probes and applications are as follows:
Multi Panoramic Freehand
Probes Application Har S-Har. CEUS+ ElastoScan+™
Vision + 3D
Abdomen X O O O X X O
MSK X O O O X X O
Vascular X O O O X X O
Pediatric X O O O X X X
Abdomen X O O O X X O
X O O X O O
MSK O
(Only General)
LA3-14AD Small Parts X O O O X O O
Vascular X O O O X X O
Pediatric X O O O X X X
MSK X O O O X X O
LA3-22AI
Intraoperative X O O O X X O
MSK X O O O X X O
Small Parts X O O O X X O
L3-22
Vascular X O O O X X O
Pediatric X O O O X X X
Abdomen O O O O X X O
MSK O O O O X X X
Vascular O O O O X X X
CA1-7AD OB O O O O X X O
GYN O O O O X X X
Pediatric O O O O X X X
Urology O O O O X X X
O
(Only
Abdomen O O O O
Abdomen,
X O
Penetration)
MSK O O O O X X X
CA1-7S Vascular O O O O X X X
OB O O O O X X O
GYN O O O O X X X
Thoracic O O O O X X X
Pediatric O O O O X X X
Chapter 10 Probes 10 - 7
Urology O O O O X X X
O
(Only
Abdomen O O O O
Abdomen,
X O
Penetration)
MSK O O O O X X X
Vascular O O O O X X X
CA1-7SD
OB O O O O X X O
GYN O O O O X X X
Thoracic O O O O X X X
Pediatric O O O O X X X
Urology O O O O X X X
Abdomen O O O O X X O
MSK O O O O X X X
Vascular O O O O X X X
OB O O O O X X O
CA3-10A
GYN O O O O X X X
Thoracic O O O O X X X
Pediatric O O O O X X X
Urology O O O O X X X
Abdomen X O O O X X X
CA4-10M Vascular X O O O X X X
Pediatric X O O O X X X
OB X O O X X X X
EA2-11AR GYN X O O X X O O
O
Urology X O O X X
(Only Prostate)
O
OB X O O X X X X
EA2-11ARE GYN X O O X X O O
O
Urology X O O X X
(Only Prostate)
O
OB X O O X X X X
EA2-11AV GYN X O O X X O O
O
Urology X O O X X
(Only Prostate)
O
OB X O O X X X X
EA2-11AVE
GYN X O O X X O O
10 - 8 V6/XV6 Service Manual
OB X O O X X X X
miniER7 GYN X O O X X O O
O
Urology X O O X X
(Only Prostate)
O
Abdomen O O O O X X X
OB O O O O X X X
CV1-8A
GYN O O O O X X X
Urology O O O O X X X
Abdomen O O O O X X X
OB O O O O X X X
CV1-8AE
GYN O O O O X X X
Urology O O O O X X X
OB X O O X X X X
O
O
(Only Uterus,
EV2-10A GYN X O O X (Only
Adnexa, Cervix,
X
Uterus1)
Penetration)
O
Urology X O O X X
(Only Prostate)
X
Abdomen O O X X X X X
Cardiac O O X X X X X
Pediatric O O X X X X X
PA1-5A
Thoracic O O X X X X X
Vascular O O X X X X X
TCD O O X X X X X
Abdomen O O X X X X X
Cardiac O O X X X X X
PA3-8B Pediatric O O X X X X X
Vascular O O X X X X X
TCD O O X X X X X
Abdomen O O X X X X X
Cardiac O O X X X X X
PA4-12B Pediatric O O X X X X X
Vascular O O X X X X X
TCD O O X X X X X
Chapter 10 Probes 10 - 9
MMPT3-7 Cardiac O O X X X X X
Cardiac X X X X X X X
CW6.0 Vascular X X X X X X X
TCD X X X X X X X
Cardiac X X X X X X X
DP2B Vascular X X X X X X X
TCD X X X X X X X
S-
HQ- Shadow Nerve
Probes Application CM MV-Flow™ Shearwave
Vision™ HDR™ Track™
Imaging™
Abdomen X X X X X X
O
MSK X X (Only X X O
General)
O
Vascular X (Only Carotid, X X X X
Arterial)
Pediatric X X X X X X
Abdomen X X X X X X
O O
MSK X (Only (Only X O O
General) General)
LA3-14AD O
O
Small Parts X (Only Breast, X X
(Only Breast)
X
Thyroid)
Vascular X X X X X X
Pediatric X X X X X X
O O
(Only (Only
LA3-22AI MSK X General, General, X X O
Superficial, Superficial,
Superficial1) Superficial1)
10 - 10 V6/XV6 Service Manual
S-
HQ- Shadow Nerve
Probes Application CM MV-Flow™ Shearwave
Vision™ HDR™ Track™
Imaging™
Intraoperative X X X X X X
O O
(Only (Only
MSK X General, General, X X O
Superficial, Superficial,
Superficial1) Superficial1)
L3-22
Small Parts X X X X X X
Vascular X X X X X X
Pediatric X X X X X X
O
O O
(Only
Abdomen X
Abdomen,
(Only (Only X X
Abdomen) Abdomen)
Renal)
MSK X X X X X X
Vascular X X X X X X
O
CA1-7AD (Only 1st
O O
Trimester,
OB (Only Fetal
2nd
X (Only 2nd X X
Heart) Trimester)
Trimester, 3rd
Trimester)
GYN X X X X X X
Pediatric X X X X X X
Urology X X X X X X
O
O
(Only O O
(Only
Abdomen X Abdomen, (Only (Only
Abdomen,
X
Penetration Abdomen) Abdomen)
Penetration)
Renal)
MSK X X X X X X
Vascular X X X X X X
O
O (Only 1st O
CA1-7S (Only Fetal Trimester, (Only 2nd
OB Heart, 1st 2nd
X
Trimester, 3rd
X X
Fetal Heart) Trimester, 3rd Trimester)
Trimester)
GYN X X X X X X
Thoracic X X X X X X
Pediatric X X X X X X
Urology X X X X X X
O O
O O
(Only (Only
CA1-7SD Abdomen X (Only (Only
Abdomen,
X
Abdomen, Abdomen) Abdomen)
Penetration, Penetration)
Chapter 10 Probes 10 - 11
S-
HQ- Shadow Nerve
Probes Application CM MV-Flow™ Shearwave
Vision™ HDR™ Track™
Imaging™
Renal)
MSK X X X X X X
Vascular X X X X X X
O
O (Only 1st O
(Only Fetal Trimester, (Only 2nd
OB Heart, 1st 2nd
X
Trimester, 3rd
X X
Fetal Heart) Trimester, 3rd Trimester)
Trimester)
GYN X X X X X X
Thoracic X X X X X X
Pediatric X X X X X X
Urology X X X X X X
Abdomen X X X X X X
MSK X X X X X X
Vascular X X X X X X
O
(Only 1st
O O
Trimester,
OB (Only Fetal
2nd
X (Only 2nd X X
CA3-10A Heart) Trimester)
Trimester, 3rd
Trimester)
GYN X X X X X X
Thoracic X X X X X X
Pediatric X X X X X X
Urology X X X X X X
Abdomen X X X X X X
Vascular X X X X X X
CA4-10M O
(Only Neo
Pediatric X
Head, Ped
X X X X
Abd)
OB X O X X X X
O O
EA2-11AR GYN X (Only Uterus, X (Only Uterus, X X
Uterus2) Uterus2)
Urology X X X X X X
OB X X X X X X
O
EA2-11ARE GYN X X X (Only Uterus, X X
Uterus2)
Urology X X X X X X
10 - 12 V6/XV6 Service Manual
S-
HQ- Shadow Nerve
Probes Application CM MV-Flow™ Shearwave
Vision™ HDR™ Track™
Imaging™
OB X O X X X X
O O
EA2-11AV GYN X (Only Uterus, X (Only Uterus, X X
Uterus2) Uterus2)
Urology X X X X X X
OB X X X X X X
O
EA2-11AVE GYN X X X (Only Uterus, X X
Uterus2)
Urology X X X X X X
OB X X X X X X
O O
GYN X
(Only Uterus)
X
(Only Uterus)
X X
miniER7
O
Urology X O X (Only X X
Prostate)
Abdomen X X X X X X
O
O (Only 1st O
O
(Only Fetal Trimester, (Only 2nd
OB Heart, 1st 2nd
(Only 1st
Trimester, 3rd
X X
CV1-8A Trimester)
Fetal Heart) Trimester, 3rd Trimester)
Trimester)
GYN X X X X X X
Urology X X X X X X
Abdomen X X X X X X
O O
OB X X (Only 1st (Only 2nd X X
CV1-8AE Trimester) Trimester)
GYN X X X X X X
Urology X X X X X X
OB X O X X X X
O O
EV2-10A GYN X
(Only Uterus)
X
(Only Uterus)
X X
Urology X X X X X X
Abdomen X X X X X X
Cardiac O X X X X X
Pediatric X X X X X X
PA1-5A
Thoracic X X X X X X
Vascular X X X X X X
TCD X X X X X X
Chapter 10 Probes 10 - 13
S-
HQ- Shadow Nerve
Probes Application CM MV-Flow™ Shearwave
Vision™ HDR™ Track™
Imaging™
Abdomen X X X X X X
Cardiac O X X X X X
PA3-8B Pediatric X X X X X X
Vascular X X X X X X
TCD X X X X X X
Abdomen X X X X X X
Cardiac O X X X X X
PA4-12B Pediatric X X X X X X
Vascular X X X X X X
TCD X X X X X X
MMPT3-7 Cardiac O X X X X X
Cardiac X X X X X X
CW6.0 Vascular X X X X X X
TCD X X X X X X
Cardiac X X X X X X
DP2B Vascular X X X X X X
TCD X X X X X X
10 - 14 V6/XV6 Service Manual
■ The tip of injection nozzle may cause damage to the probe lens.
■ When applying the ultrasound gel to the probe, make sure that the tip of the
ultrasound gel injection nozzle does not touch the surface of the probe lens.
CAUTION
Chapter 10 Probes 10 - 15
■ Do not use the Gel Warmer for purposes other than to control the
temperature of ultrasound gel.
■ Do not place the probe or any other equipment inside the Gel Warmer.
CAUTION ■ Do not touch the power terminal of the Gel Warmer while you are examining
a patient. There is a risk of electric shock from leakage current.
■ Do not apply excessive force to the Gel Warmer, or you may damage its
support parts.
10 - 16 V6/XV6 Service Manual
1. Remove the sheath from the packaging, and fill it with ultrasound gel. Be sure to put on
sterilized surgical gloves.
2. Insert the probe into the sheath and pull the latex tip to cover the probe completely. If
possible, cover the probe cable as well.
3. Ensure that there are no air bubbles trapped within the ultrasound gel. If necessary,
secure the sheath to the probe and the probe cable.
4. Dispose of the sheath after use.
10 - 18 V6/XV6 Service Manual
Sufficient washing and disinfecting must be carried out to prevent infection. This
is the responsibility of the user who manages and maintains the disinfection
procedures for the equipment. Always use legally approved cleansing solutions
and sheaths.
CAUTION
■ If damage to the product (lens, cable) that can cause electric shock is found,
discontinue use of the device immediately and contact your Samsung
Medison representative.
■ Do not immerse the probe into liquid.
WARNING
■ Do not touch the probe connectors or the connection pins on the product.
■ 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.
■ Do not apply excessive force to twist, pull or bend the probe cable.
■ 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.
10 - 20 V6/XV6 Service Manual
■ Always use protective equipment such as face mask, eyewear, and gloves
when cleaning, disinfecting, and sterilizing probes.
■ Inspect the housing, strain relief, lens and seal for damage, and check for
WARNING any functional degradation before and after cleaning and disinfecting the
probe.
■ Using an inappropriate cleaning or disinfecting agent may damage the
probe.
Classification
Contact Area Application Probe Level Selection
Criteria
* Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers - Appendix E
* The FDA reprocessing guidance “Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug
Administration Staff” March 17, 2015, (https://www.fda.gov/media/80265/download)
The care method for your probes determines the appropriate disinfectant for your probe.
An appropriate cleaner, disinfectant or ultrasound gel should be used for all probes. For
the latest details about compatible cleaner, disinfectants, and ultrasound gel, please see
Samsung Medison website and the User Guide.
– User Guides: This is provided as a booklet upon purchase of the product.
– Website: http://www.samsunghealthcare.com
Chapter 10 Probes 10 - 21
■ Always use protective equipment such as face mask, eyewear, and gloves
when cleaning, disinfecting, and sterilizing probes.
■ If a premixed solution is used, be sure to observe the solution expiration
date.
WARNING
■ Probes must be cleaned after each use. Cleaning the probe is an essential
step before effective disinfection or sterilization. Be sure to follow the
manufacturer’s instructions when using cleaner, disinfectant, disinfection
system and sterilization system.
■ Before storing probes, ensure that they are thoroughly dry. If it is necessary to
dry the probe lens after cleaning, use a soft cloth and a blotting motion,
instead of a wiping motion.
Chapter 10 Probes 10 - 23
■ Cleaning
Never clean the probe with methanol or ethanol. Doing so may cause serious
problems to the product.
CAUTION
■ Disinfection
Do not use iodine, steam, heat, or ethylene oxide to disinfect the product.
WARNING
■ Do not leave the probe in disinfectant solution for more than one hour.
■ The probe must be rinsed immediately after disinfection.
■ For MPTEE Probes, only use the Immersion Method for disinfection.
CAUTION
10 - 24 V6/XV6 Service Manual
1 Lens
2 Housing
3 Transducer
4 Strain Relief
5 Cable
6 Connector
■ MPTEE Probe
1 Lens
2 Tip
3 Transducer
4 Tube
5 Shaft
6 Control handle
7 Dial
8 Strain Relief
9 Cable
10 Tube
■ Only use a surgeon’s brushes on the housing. Do not use brushes on the
other parts, including the probe lens, the strain relief, the areas surrounding
the strain relief, and the cables, than the housing when cleaning probes.
Using any types of brushes can damage the probe lens, the strain relief, the
CAUTION areas surrounding the strain relief, and the cables. For MPTEE probes, use
surgeon’s brushes only on the area between the scan head at the end of the
probe and the area marked as 100 cm but excluding the lens.
■ 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.
■ Do not bend or crimp the gastroscope or cable.
■ Do not use isopropyl alcohol on the strain relief/housing joint, the strain relief,
or the cable.
■ Wiping Method
1. Disconnect the probe from the system.
2. Remove the biopsy bracket or needle guide from the probe. Collect the reusable parts,
reusable biopsy bracket, or needle guide that need to be disinfected or sterilized, and
discard the disposable parts in the clinical waste bin (For more information on cleaning
and disinfection/sterilization of the reusable parts, please refer to the ‘Cleaning and
Disinfecting Biopsy Kits’ in this chapter.).
3. For a list of compatible cleaners, see the User Guide or Samsung Medison website:
http://www.samsunghealthcare.com.
Follow the cleaner manufacturer's instructions for preparation, temperature, solution
strength, and duration of contact. Ensure that the solution strength and duration of
contact are appropriate for the intended clinical use of the device. If a premixed solution is
used, be sure to observe the solution expiration date.
4. Remove any visible gel or biological material on the surface with wipes or soft cloth
soaked with the cleaner (made using manufacturer's instructions). For difficult to reach
areas such as seams, cracks and crevices of the device, use a surgeon’s brush wrapped
with a wipe or cloth soaked with the cleaner.
Use a gentle wiping motion for the probe lens, the strain relief, the areas surrounding the
strain relief, and the cables. When wiping the probe, hold the housing. Do not suspend
the probe by the cable. Do not apply excessive force to twist, pull or bend the probe cable.
These can damage probes.
Dispose of the used wipes or cloth appropriately according to the local medical waste
regulations.
5. Wipe off the probe surface with fresh wipes or cloth soaked with the cleaner, following the
cleaner manufacturer’s instruction on the temperature, wiping time, and cleaner contact
time.
6. Visually inspect for any remaining soil and if necessary repeat the steps, starting at step 4.
Chapter 10 Probes 10 - 27
7. Make sure to follow the rinse (and neutralization) instructions from the cleaner
manufacturer for rinsing the probe. If insufficient instructions are supplied, then, as a
minimum, thoroughly rinse the probe with a clean lint-free cloth dampened with pure
water until all signs of residual debris and cleaning solution are removed. (at minimum of
two minutes) For difficult to reach areas such as seams, cracks and crevices of the
device, use a surgeon’s brush wrapped with a clean lint-free cloth dampened with pure
water.
8. Repeat the step 7 (rinsing) at least three times with a fresh clean lint-free cloth dampened
with pure water each time.
9. Following the dry instructions from the cleaner manufacturer, air-dry the probe or remove
water from all surfaces of the probe with a clean, dry, disposable soft, lint-free cloth or
wipe. If it is necessary to dry the probe lens after cleaning, use a soft cloth and a blotting
motion, instead of a wiping motion.
10. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or
projections. If such damage is found, discontinue use of the device and contact your
Samsung Medison representative.
10 - 28 V6/XV6 Service Manual
■ Immersion Method
1. Disconnect the probe from the system.
2. Remove the biopsy bracket or needle guide from the probe. Collect the reusable parts,
reusable biopsy bracket, or needle guide that need to be disinfected or sterilized, and
discard the disposable parts in the clinical waste bin (For more information on cleaning
and disinfection/sterilization of the reusable parts, please refer to the ‘Cleaning and
Disinfecting Biopsy Kits’ in this chapter.).
Rinse off any visible gel or biological material with running tap water. If it is hard to
remove materials with running tap water, wipe off any gel or biological material with a
moist cloth or sponge moistened with cleaner (made using manufacturer's instructions) or
tap water, taking care to remove all visible contamination.
Dispose of the used cloth or sponge appropriately according to the local medical waste
regulations.
3. For a list of compatible cleaner s, see the User Guide or Samsung Medison website:
http://www.samsunghealthcare.com.
Follow the cleaner manufacturer’s instructions for preparation, temperature, solution
strength, and duration of contact. Ensure that the solution strength and duration of
contact are appropriate for the intended clinical use of the device. If a premixed solution is
used, be sure to observe the solution expiration date.
– For MPTEE probes, immerse only the area between the scan head at the end of
the probe and the area marked as 100 cm.
The area between the Scan Head and the area marked 100 cm
6. Continue soaking the probe until the total cleaner contact time specified by the cleaner
manufacturer is reached.
7. After the cleaner contact time, brush the probe housing with a surgeon’s brush at
minimum of one minute to remove any visible soil. Pay close attention to seams, cracks
and crevices during brushing time. Do not use brushes on the other parts than the
housing; Using any types of brushes can damage the other parts, including the probe
lens, the strain relief, the areas surrounding the strain relief, and the cables, than the
housing.
– For MPTEE probes, use surgeon’s brushes only on the area between the scan head
at the end of the probe and the area marked as 100 cm but excluding the lens.
8. Visually inspect for any remaining soil and if necessary repeat the steps, starting at step 4.
9. Make sure to follow the rinse (and neutralization) instructions from the cleaner
manufacturer for rinsing the probe. If insufficient instructions are supplied, then, as a
minimum, thoroughly rinse the probe with tap water at 22ºC to 43ºC (72ºF to 110ºF) to
prevent the coagulation of blood and proteins until all signs of residual debris and
cleaning solution are removed (at minimum of one minute)
10. Repeat the step 9 (rinsing) at least three times.
11. Following the dry instructions from the cleaner manufacturer, air-dry the probe or remove
water from all surfaces of the probe with a clean, dry, disposable soft, lint-free cloth. If it
is necessary to dry the probe lens after cleaning, use a soft cloth and a blotting motion,
instead of a wiping motion.
12. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or
projections. If such damage is found, discontinue use of the device and contact your
Samsung Medison representative.
10 - 30 V6/XV6 Service Manual
■ Always use protective equipment such as face mask, eyewear, and gloves
when cleaning, disinfecting, and sterilizing probes.
■ Inspect the housing, strain relief, lens and seal for damage, and check for
any functional problem before and after disinfecting the probe.
WARNING
■ Never use disinfectants after the expiration date.
■ The area the probe will contact during use dictates the level of disinfection
required for a probe. Ensure that the solution strength and duration of contact
are appropriate for disinfection.
■ Low-Level Disinfection
Low-level disinfection of probes uses the wipe method with a low-level disinfectant.
Before performing this procedure, read the warnings and cautions in the “Warnings and
Cautions During Cleaning, Disinfecting, Sterilizing Probes” section and “Table for
Choosing the Correct Probe-Care Method” in this chapter.
1. Clean the probe according to the procedures in “Cleaning Probes” in this chapter.
2. After cleaning, choose low-level disinfectants that are compatible with your probe. For
a list of compatible disinfectants, see the User Guide or Samsung Medison website:
http://www.samsunghealthcare.com.
Follow disinfectant manufacturer’s instructions for preparation, temperature, solution
strength, and duration of contact. Ensure that the solution strength and duration of
contact are appropriate for the intended clinical use of the device. If a premixed
solution is used, be sure to observe the solution expiration date.
3. Wipe the probe surfaces, following disinfectant manufacturer’s instructions for
temperature, wipe durations, and duration of disinfectant contact. Pay close attention
to seams, cracks and crevices during wiping time. Ensure that the disinfectant solution
does not enter the device or the connector.
– Some probes can be disinfected up to the cable. Do not disinfect the cable that is
within 50 cm of the end of the cable from the connector. For a list of probes that
can be disinfected up to the cable, see the User Guide or Samsung Medison
website: http://www.samsunghealthcare.com.
– When disinfecting the connector, wipe only the outer surfaces of the connector; do
not allow any type of fluid to enter through other parts than the connector surfaces,
including the strain relief, electrical contacts, or areas surrounding the locking-lever
shaft.
4. Make sure to follow the rinse (and neutralization) instructions from the disinfectant
manufacturer for rinsing the probe. If insufficient instructions are supplied, then, fill a
sink or a bowl with pure water and rinse the probe. Immerse the probe up to the
immersion point shown in the figure below. (at minimum of one minute)
Chapter 10 Probes 10 - 31
– Some probes can be immersed up to the cable. Do not immerse the cable that is
within 50 cm of the end of the cable from the connector. For a list of probes that
can be immersed up to the cable, see the User Guide or Samsung Medison
website: http://www.samsunghealthcare.com.
5. Repeat the step 4 (rinsing) at least three times with a fresh batch of pure water each
time.
6. Following the dry instructions from the disinfectant manufacturer, air-dry the probe or
remove water from all surfaces of the probe with a sterile, lint-free cloth and store it
properly (e.g. in a sterile bag) to prevent any further contamination. If it is necessary to
dry the probe lens after cleaning, use a soft cloth and a blotting motion, instead of a
wiping motion.
7. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or
projections. If such damage is found, discontinue use of the device and contact your
Samsung Medison representative.
■ High-Level Disinfection
High-level disinfection of probes typically uses the immersion method with a high level
disinfectant or the disinfection system method. Before performing this procedure, read the
warnings and cautions in the “Warnings and Cautions During Cleaning, Disinfecting,
Sterilizing Probes” section and “Table for Choosing the Correct Probe-Care Method” in
this chapter.
■ Inspect the housing, strain relief, lens and seal for damage, and check for
any functional problem before and after disinfecting the probe.
■ Ensure that the cycle is appropriate for the desired disinfection level.
WARNING
<Immersion Method>
1. Clean the probe according to the procedures in “Cleaning Probes” in this chapter.
2. After cleaning, choose high-level disinfectants that are compatible with your probe. For
a list of compatible disinfectants, see the User Guide or Samsung Medison website:
http://www.samsunghealthcare.com.
Follow disinfectant manufacturer’s instructions for preparation, temperature, solution
strength, and duration of contact. Ensure that the solution strength and duration of
contact are appropriate for the intended clinical use of the device. If a premixed
solution is used, be sure to observe the solution expiration date.
3. Immerse the probe into the appropriate disinfectant solution for your probe as shown
in the figure below. Make sure that there are no air bubbles on the probe surfaces.
Follow the instructions on the disinfectant label for the duration of probe immersion.
Do not immerse probes longer than the minimum time needed for your level of
disinfection.
– Some probes can be disinfected up to the cable. Do not disinfect the cable that is
within 50 cm of the end of the cable from the connector. For a list of probes that
can be cleaned up to the cable, see the User Guide or Samsung Medison website:
http://www.samsunghealthcare.com.
– For MPTEE probes, immerse only the area between the scan head at the end of
the probe and the area marked as 100 cm.
The area between the Scan Head and the area marked 100 cm
4. Make sure to follow the rinse (and neutralization) instructions from the disinfectant
manufacturer for rinsing the probe. If insufficient instructions are supplied, then, fill a
disinfected sink or a disinfected bowl with pure water and rinse the probe at minimum
of one minute.
– For MPTEE probes, use sterile pure water.
5. Repeat the step 4 (rinsing) at least three times with a fresh batch of pure water each
time.
– For MPTEE probes, use sterile pure water.
6. Following the dry instructions from the disinfectant manufacturer, air-dry the probe or
remove water from all surfaces of the probe with a sterile, lint-free cloth and store it
properly (e.g. in a sterile bag) to prevent any further contamination. If it is necessary to
dry the probe lens after cleaning, use a soft cloth and a blotting motion, instead of a
wiping motion.
7. Register the disinfection data for traceability according to local regulations.
8. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or
projections. If such damage is found, discontinue use of the device and contact your
Samsung Medison representative.
<Disinfection System Method>
1. Clean the probe and cable according to the procedures in “Cleaning Probes” in this
chapter. Observe all warnings and cautions.
2. Refer to the user instructions of the disinfection system for details of proper use,
storage and disposal of waste.
3. Place the transducer of the probe in the disinfection system, following the user
instructions of the disinfection system.
4. Start the desired disinfection process and wait until the end of the cycle.
5. Remove the probe at the end of the cycle from the disinfection system and store it
properly (e.g. in a sterile bag) to prevent any further contamination.
6. Register the disinfection data for traceability according to local regulations.
7. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or
projections. If such damage is found, discontinue use of the device and contact your
Samsung Medison representative.
■ Always use protective equipment such as face mask, eyewear, and gloves
when cleaning, disinfecting, and sterilizing probes.
■ In intraoperative applications, sterilized probes should be used with sterile gel
and a sterile probe cover certified and approved by relevant national/local
WARNING authorities.
■ Sterile probe covers are disposable and must not be reused.
10 - 34 V6/XV6 Service Manual
■ Probes must be cleaned after each use. Cleaning the probe is an essential
step before effective disinfection or sterilization. Be sure to follow the
manufacturer’s instructions when using disinfectant, disinfection system, and
sterilization system.
CAUTION ■ Use low temperature plasma sterilization system to sterilize probes. Using
sterilization solution, autoclave, gas (EtO), or other methods not approved by
Samsung Medison will damage your probe and void your warranty.
■ Do not allow sharp objects, such as scalpels and cauterizing knives, to touch
probes or cables.
■ For MPTEE probes, do not use any method of sterilization, including
methods using materials such as iodine, steam, heat, or ethylene oxide.
■ Inspect the housing, strain relief, lens and seal for damage, and check for
any functional problem before and after sterilizing the probe.
■ Ensure that the cycle is appropriate for the desired disinfection or sterilization
WARNING level.
Using a probe that is not compatible with a sterilization system or not following
the instructions of the sterilization system manufacturer can damage the probe.
This could also void the probe warranty.
CAUTION
1. Clean the probe and cable according to the procedures in “Cleaning Probes” in this
chapter. Observe all warnings and cautions.
2. Refer to the user instructions of the sterilization system for details of proper use,
storage and disposal of waste.
3. Place the probe in the sterilization system, following the user instructions of the
sterilization system.
4. Start the desired sterilization process and wait until the end of the cycle.
5. Remove the probe at the end of the cycle from the sterilization system and store it
properly (e.g. in a sterile bag) to prevent any further contamination.
6. Register the sterilization data for traceability according to local regulations.
7. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or
projections. If such damage is found, discontinue use of the device and contact your
Samsung Medison representative.
Chapter 10 Probes 10 - 35
■ The MPTEE probe should be used only by a qualified physician who has
received appropriate training in proper operation of the probe and in
endoscopic techniques as dictated by current relevant medical practices.
■ Familiarize yourself with the use and safety instructions for the MPTEE probe
WARNING completely before using it.
■ Inspect the MPTEE probe for any sharp areas or rough surfaces both with
the tilting section straight and tilted. If damage is found, discontinue use of
the product and contact Samsung Medison’s Customer Service Department.
Using damaged probes may result in electric shocks and other hazards to the
patients and/or users.
■ The use of a bite-guard is mandatory. Failure to use the bite-guard may result
in damage to the probe, which could result in electric shocks and other
hazards to the patients and/or users. This could also void the probe warranty.
■ In order to minimize the risk of "U-turning" of the tilting section in the
esophagus, inspect if the tilting of the tip is properly manipulated before use.
(The up/down and/or left/right tilting may after prolonged use develop an
unwanted amount of free play.) If any abnormal operation is found including
an unwanted amount of free play of the tilting section or excess of the
maximal tilting angles, discontinue use of the product and contact Samsung
Medison’s Customer Service Department.
■ Only use the probe as an internal insertion probe.
■ Do not apply excessive force when inserting or operating the
transesophageal probe.
■ Do not transport the product while the MPTEE probe is placed in the probe
holder. The probe is not secured, and it may fall.
■ The image obtained with the MPTEE probe may differ from the image
displayed on screen. It is necessary to perform an inspection in advance to
reduce the risk of difference in images.
10 - 36 V6/XV6 Service Manual
■ The user is responsible for the correct configuration and use. Please make
sure to read the User Manual thoroughly.
■ The ability of a patient to swallow or accommodate the probe should be
considered. Any history of gastro-esophageal diseases must be determined
CAUTION and considered as well as the possible effects of other therapies the patient
is undergoing. All gastro-esophageal abnormalities must be considered as
well.
■ Only use water-soluble coupling gel for the MPTEE probe.
■ Do not use ultrasound gels that contain any of the following agents for the
MPTEE probe:
– Oils such as mineral oil and lanolin
– Alcohols such as ethanol and denatured alcohol
– Iodine
– All lotions or gels that contain aromatic substances
– Gels that contain aloe vera, methyl or ethyl para benzoic acid
■ Never rub or spray the MPTEE probe with an anesthetic agent.
■ The MPTEE probe must be handled with care. It may be damaged when
dropped or abused. In particular keep sharp objects away from the lens. Do
not touch the lens unnecessarily. Never exert force onto the lens.
■ Avoid forceful manipulations and excessive force in using the probe, which
could result in patient injury.
■ To protect the patient and the probe, keep the probe in brake inactive state
on both knobs when introducing or withdrawing the probe and make sure the
tilting section is straight.
■ Never manually tilt the distal tip of the probe directly; always use the dials for
controlling tilting of the tip.
■ To avoid the risk of electric shock, the MPTEE probe must only be connected
to a supply with protective earth.
■ The connector is not watertight, and should always be kept dry.
■ The control handle should not be immersed into liquid.
■ All internal component repairs and part replacements must be performed by
qualified Samsung Medison’s Customer Service personnel. To prevent
electric shock, never open the cover or panels of the product.
■ Do not twist, tightly coil, or apply excessive force on the probe cable or shaft.
Insulation failure may result.
Chapter 10 Probes 10 - 37
■ Tip Tilting
Use dials to tilt the tip. Rotate the small dial (①) clockwise to tilt the tip to the right. Rotate
the small dial (①) counterclockwise to tilt the tip to the left. Rotate the large dial (②)
clockwise to tilt the tip upward. Rotate the large dial (②) counterclockwise to tilt the tip
downward. When rotating the dials a click is felt at the central position, indicating the tip is
in a straight position (no tilting).
1 Left 3 Up
2 Right 4 Down
A Brake Inactive
B Brake Active
A Counterclockwise
B Clockwise
Do not use the product with a probe temperature outside the range of 25°C to
42°C. It may cause damage to the human body.
DANGER
■ Prolonged pressure on the esophagus by the tip of the probe may lead to a
Pressure Necrosis phenomenon. Thus, the tip should be removed from the
esophagus wall when you are not scanning by releasing the tip in the straight
position (no tilting). If continuous monitoring is required, the probe tip should
CATUION often be re-positioned.
■ Whenever active scanning is not desired, ‘freeze’ the image and release the
tip in the straight position (no tilting).
■ Position the lens such, that good acoustical contact is established. Before
rotating the scan plane, actuate the Brake Mode on the up/down movement.
If this is not done, rotating the scan plane can mean loss of acoustical
contact.
41.0°C ≤ MPTEE
Estimated surface temperature is xx.x°C.
Temperature < 42.0°C
42.0°C ≤ MPTEE Estimated surface temperature is xx.x°C. Please reduce the power
Temperature < 42.5°C value.
42.5°C ≤ MPTEE Estimated surface temperature is xx.x°C, near the thermal limit of
Temperature < 43.0°C 43.0°C. Please reduce the power value.
50.0°C < MPTEE Error condition detected. The System has stopped transmitting and
Temperature or MPTEE returned to the Probe Selection Dialog. Please contact a Service
Temperature < 5.0°C Representative.
Chapter 10 Probes 10 - 41
For the MPTEE probe, the following warnings are displayed depending on the status of
the circuit:
– Short circuit or open circuit: Error condition detected. The System has stopped
transmit and returned to the Probe Selection Dialog. Please contact a Service
Representative.
The probe is intended to be inserted into the human body; always keep it clean.
Never place the probe on the floor.
CAUTION
10 - 42 V6/XV6 Service Manual
10.2. 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 imaging system shows the needle, which penetrates through the skin surface
and veins, along with the examined body part, minimizing the potential risks to the patient.
① Bracket: Prevents the needle guide from shaking by securing it to the probe tightly.
② Needle Guide: Guides the angle (direction) of the needle so that it may reach the biopsy
target accurately. It also secures the needle so that the needle does not waver.
③ 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 bracket from being contaminated by any unwanted
substances (blood or other bodily fluids) discharged during examinations.
Ultrasound gel: Ensures the best quality images by filling the air space between the probe
and the sheath with the ultrasound gel.
10 - 44 V6/XV6 Service Manual
■ Biopsy kits not supplied by Samsung Medison may not be compatible with
the probes. Always use biopsy kits supplied by Samsung Medison, since
improper setup may adversely affect the patient.
WARNING ■ Be sure to read the instructions for installing a sheath and aligning the needle
guide thoroughly before performing a biopsy.
■ Always ensure that the probe and the needle guide are secured on both the
left and the right sides.
Chapter 10 Probes 10 - 45
6. When the examination site is reached, take the needle out of the needle guide.
7. Detach the needle guide, bracket, and sheath from the probe.
8. Dispose of the components that are not designed for reuse.
■ The needle used for alignment verification must not be used for the actual
procedure. Always use a sterile needle for each biopsy procedure.
■ To assist in accurate projection of the needle, use a straight, new needle for
WARNING each alignment procedure.
■ The needle guideline only displays the projected path of the needle. Since
the default line may be different from the actual line, the actual location of the
needle must be checked by monitoring the echo from the needle.
2. Mount the bracket onto the probe. If the surface of probe is fluted, mount the bracket in
accordance with it.
3. Insert the needle into the needle guide and start the exam.
10 - 48 V6/XV6 Service Manual
5. Insert the needle into the needle guide and start the exam.
Biopsy
Probes
Bracket Reusable/ Needle Multi Angle
Model Name Components
Material Disposable Gauge Depth
Bracket Reusable
BP-KIT-053 0.591,
Acetal 16, 18, 20,
LA3-14AD 0.984,
[BP-KIT-053-NG] Needle Guide & Copolymer Disposable
22
1.575 (in)
Probe Cover Kit
Stainless
BP-KIT-080 Needle Guide Reusable 16-18 2°
steel
Stainless
BP-KIT-090 Needle Guide Reusable 16-18 0°
steel
Bracket Reusable
CV1-8A BP-KIT-059 Acetal 14, 16, 18, 1.969,
CV1-8AE [BP-KIT-059-NG] Needle guide & Copolymer 20, 22, 25 3.937 (in)
Disposable
Probe Cover Kit
Biopsy
Probes
Bracket Reusable/ Needle Multi Angle
Model Name Components
Material Disposable Gauge Depth
Probe Cover Kit 7, 8, 9, 10,
12FR
When installing a biopsy kit for use in the S-Fusion™ Prostate preset, do not use
the two biopsy kits (BP-KIT-079, BP-KIT-080) of EA2-11AR, EA2-11ARD, EA2-
11AV and EA2-11AVD probes as it may cause damage to the probe lenses or
cases.
CAUTION
NOTE
10 - 52 V6/XV6 Service Manual
■ Always use protective equipment such as face mask, eyewear and gloves
when cleaning and disinfecting biopsy kit.
■ Disposable biopsy brackets and disposable biopsy kit parts must be disposed
WARNING of as medical waste after each use.
■ Always refer to the biopsy kit user manual for the latest information on the
supported methods and disinfectants.
■ A stainless steel biopsy bracket is reusable; a plastic biopsy bracket may be
reusable. A plastic biopsy needle guide is in general disposable.
CAUTION
■ Plastic biopsy kits can only be disinfected by using a chemically compatible
cold-disinfectant, either manually or with a medical washer-disinfector. Do not
use an autoclave, gas or radiation.
1. Clean the reusable parts of the biopsy bracket, according to the “Cleaning Biopsy Kits” in
this chapter.
2. After cleaning, choose high-level disinfectants that are compatible with your reusable
biopsy bracket. For the compatible disinfectants, see biopsy kit manufacturer’s
instructions.
Follow disinfectant manufacturer’s instructions for preparation, temperature, solution
strength, and duration of contact. Ensure that the solution strength and duration of
contact are appropriate for the intended clinical use of the device.
Chapter 10 Probes 10 - 53
3. Immerse the parts in high-level disinfectants and allow soaking for the prescribed time
following the manufacturer’s instructions.
4. Rinse the device thoroughly with sterile water and dry the components. Dispose of the
used drying cloths appropriately according to the local medical waste regulations.
5. Inspect the components for damage such as cracks, rust, or breakage; and if damage is
found, stop using the device and contact the Samsung Medison Customer Support
Department.
6. Properly pack the disinfected bracket and label it according to the local regulations.
11.1. Overview
These parts codes may not be the latest Version. If you want the latest Version, refer to CM.
The latest version of the CM(Compatibility Matrix table) can be downloaded from GSIS.
Body
MI63-
Cover COVER-SIDE-R
02464A
Parts
Body
MI63-
Cover COVER-SIDE-L
02465A
Parts
Body
MI63-
Cover COVER-MONITOR CABLE
03039A
Parts
Chapter 11. Service Parts List 11 – 3
Categ Part
Description Part Image
ory Code
Body
MI63-
Cover COVER-BODY REAR UPPER
03102B
Parts
Body
MI63-
Cover COVER-FOOT
03135A
Parts
Body
MI63-
Cover COVER-LIFT TOP
03136A
Parts
Body
MI64-
Cover HANDLE-REAR
02266A
Parts
Body
MI66-
Cover WHEEL Lock(Front, Back Left)
01438A
Parts
11 – 4 V6/XV6 Service Manual
Categ Part
Description Part Image
ory Code
Body
MI66-
Cover WHEEL Free(Back Right)
01439A
Parts
Body
MI63-
Cover COVER-CP PROBE HOLDER L
03105B
Parts
Body
MI63-
Cover COVER-CP PROBE HOLDER R
03106B
Parts
Body
MI97-
Cover ASSY COVER-PSA
04710A
Parts
Body
MI97-
Cover ASSY COVER-TOP BODY
04712A
Parts
Chapter 11. Service Parts List 11 – 5
Categ Part
Description Part Image
ory Code
Boddy
MI97-
Cover ASSY COVER-REAR BODY
05690A
Parts
11 – 6 V6/XV6 Service Manual
Control
MI61-
Panel HOLDER-PROBE S
04057B
Parts
Control
MI61-
Panel HOLDER-PROBE M
04058B
Parts
Control
MI61-
Panel HOLDER-PROBE L
04059B
Parts
Control
MI61-
Panel HANGER-CP BOTTOM
04748A
Parts
Chapter 11. Service Parts List 11 – 7
Part
Category Description Part Image
Code
Control
MI63-
Panel COVER-CP SPEAKER
03357A
Parts
Control
MI63-
Panel COVER-CP REAR
02798B
Parts
Control
MI63-
Panel COVER-CP REAR PARTIAL
02799B
Parts
Control
MI59-
Panel TRACK BALL
01351A
Parts
Control
MI61-
Panel HOLDER-CP KNOB
03227A
Parts
Control
MI63-
Panel COVER-USB RUBBER
02459A
Parts
11 – 8 V6/XV6 Service Manual
Part
Category Description Part Image
Code
Control
MI63-
Panel COVER-CP TOP MAIN
03107B
Parts
Control
MI64-
Panel KNOB-ENCODER SINGLE
02144A
Parts
Control
MI64-
Panel BUTTON-TOGGLE SWITCH
02331A
Parts
Control
MI64-
Panel KNOB-ENCORDER
02163A
Parts
Control
MI64-
Panel BUTTON-MAIN RUBBER
02334A
Parts
Chapter 11. Service Parts List 11 – 9
Part
Category Description Part Image
Code
Control
MI67-
Panel RUBBER-CAP KEY
01109A
Parts
Control
MI92-
Panel ASSY BOARD-CP_SWITCH
03176A
Parts
Control
MI92-
Panel ASSY BOARD-CP_USB
03178A
Parts
Control
MI92-
Panel ASSY BOARD-CP
03294A
Parts
Control
MI95-
Panel ASSY CAP KEY-POWER
01629A
Parts
Control
MI64-
Panel BUTTON-ENCORDER M
02014A
Parts
11 – 10 V6/XV6 Service Manual
Part
Category Description Part Image
Code
Control
MI64-
Panel BUTTON-ENCORDER 2D
02017A
Parts
Control
MI64-
Panel BUTTON-ENCODER PD(Y
02235A
Parts
Control
MI64-
Panel BUTTON-ENCODER PW(Z)
02237A
Parts
Control
MI64- BUTTON-ENCODER
Panel
02239A C(REF.SLICE)
Parts
Control
MI64-
Panel BUTTON-ENCODER MENU
02241A
Parts
Chapter 11. Service Parts List 11 – 11
Part
Category Description Part Image
Code
Control
MI63-
Panel COVER-LIGHT DEPTH
02814A
Parts
Control
MI63-
Panel COVER-LIGHT FOCUS
02912A
Parts
Control
MI63-
Panel COVER-LIGHT ZOOM
02913A
Parts
Control
MI63-
Panel COVER-LIGHT BODY MARKER
03143A
Parts
11 – 12 V6/XV6 Service Manual
Part
Category Description Part Image
Code
Control
MI63-
Panel COVER-LIGHT ANGLE
03211A
Parts
Control
MI64-
Panel BUTTON-TRACKBALL ERASER
02148A
Parts
Control
MI64- BUTTON-TRACKBALL
Panel
02149A MEASURE
Parts
Control
MI64-
Panel BUTTON-FREEZE
02150A
Parts
Chapter 11. Service Parts List 11 – 13
Part
Category Description Part Image
Code
Control
MI64-
Panel BUTTON-TRACKBALL CALIPER
02151A
Parts
Control
MI64-
Panel BUTTON-TRACKBALL CHANGE
02155A
Parts
Control
MI64- BUTTON-TRACKBALL ARC
Panel
02157A FLAT
Parts
Control
MI64-
Panel BUTTON-TRACKBALL SET
02158A
Parts
11 – 14 V6/XV6 Service Manual
Part
Category Description Part Image
Code
Control
MI64-
Panel BUTTON-SINGLE
02187A
Parts
Control
MI64-
Panel BUTTON-QUAD
02189A
Parts
Control
MI64-
Panel BUTTON-U1
02192A
Parts
Control
MI64-
Panel BUTTON-U2
02193A
Parts
Chapter 11. Service Parts List 11 – 15
Part
Category Description Part Image
Code
Control
MI64-
Panel BUTTON-P1
02195A
Parts
Control
MI64-
Panel BUTTON-P2
02196A
Parts
Control
MI64-
Panel BUTTON-P3
02197A
Parts
Control
MI64-
Panel BUTTON-3D
02204A
Parts
11 – 16 V6/XV6 Service Manual
Part
Category Description Part Image
Code
Control
MI64-
Panel BUTTON-4D
02205A
Parts
Control
MI64-
Panel BUTTON-QSCAN
02207A
Parts
Control
MI64-
Panel BUTTON-TRACKBALL TEXT
02251A
Parts
Control
MI64-
Panel BUTTON-POINTER
02252A
Parts
Chapter 11. Service Parts List 11 – 17
Part
Category Description Part Image
Code
Control
MI64-
Panel BUTTON-EXIT SQUARE
02253A
Parts
Control
MI64-
Panel BUTTON-LEFT SQUARE
02254A
Parts
Control
MI64-
Panel BUTTON-RIGHT SQUARE
02255A
Parts
Control
MI64-
Panel BUTTON-CW CIRCLE
02256A
Parts
Control
MI61-
Panel HANGER-REAR CABLE
01658C
Parts
11 – 18 V6/XV6 Service Manual
Part
Category Description Part Image
Code
Control
MI63-
Panel ABSORBER-SPEAKER
02458A
Parts
Control
MI96-
Panel ASSY MONITOR UNIT 23.8”
01527D
Parts
Control
MI96-
Panel ASSY MONITOR UNIT 21.5”
01558B
Parts
Control
MI96-
Panel ASSY TOUCH PANEL 14”
01598A
Parts
Control
6502-
Panel CABLE CLAMP
001244
Parts
Control
MI61-
Panel MAGNET
01705A
Parts
Chapter 11. Service Parts List 11 – 19
Part
Category Description Part Image
Code
Control
MI97-
Panel ASSY ARM-MECHANISM
05248B
Parts
Control
MI67-
Panel RUBBER-DAMPER LCD
01060A
Parts
Control
MI95- ASSY ALPHA KEYBOARD-WR
Panel
01850A (Option, WR)
Parts
Control
MI95- ASSY ALPHA KEYBOARD-WR
Panel
01851A (Option, DE)
Parts
Control
MI95- ASSY ALPHA KEYBOARD-WR
Panel
01852A (Option, RU)
Parts
11 – 20 V6/XV6 Service Manual
System
MI39-
Cable CBF HARNESS-ECG_USB
02025A
Parts
System
MI39-
Cable CBF HARNESS - PRINTER_USB
02525A
Parts
System
MI39-
Cable CBF HARNESS-PRINTER_POWER
02229A
Parts
System
MI39-
Cable CBF HARNESS - SPEAKER_EXT
02475A
Parts
Chapter 11. Service Parts List 11 – 21
Categor Part
Description Part Image
y Code
System
MI39-
Cable CBF-TRACKBALL_DATA
02290A
Parts
System
MI39-
Cable CBF CABLE-SPEAKER
01718A
Parts
System
MI39-
Cable CBF HARNESS-CP PWR
02523A
Parts
System
MI39-
Cable CBF HARNESS- USB 3.0 MID
02527A
Parts
System
MI39-
Cable CBF HARNESS - DP
02522A
Parts
11 – 22 V6/XV6 Service Manual
Categor Part
Description Part Image
y Code
System
MI39- CBF HARNESS-GEL PWR_R
Cable
02526A 140mm
Parts
System
MI41-
Cable TRACKBALL_FPCB
01741A
Parts
System
MI39-
Cable WIRE HARNESS-AC CORD(FILTER)
01378A
Parts
System
MI39-
Cable CBF HARNESS-GEL PWR
02306A
Parts
System
MI39- CBF HARNESS ALPHAKEY_DATA_CB
Cable
02298A (Option)
Parts
System
MI39-
Cable CBF HARNESS - BOTTOM_FAN EXT
02459A
Parts
System
System
MI39-
Cable CBF HARNESS - DRIVE POWER
02518A
Parts (OPTION)
Chapter 11. Service Parts List 11 – 23
System MI92-
ASSY BOARD-BP
Parts 03304A
System MI92-
ASSY BOARD-CP DOCKING
Parts 03168C
System 4301-
BATTERY-LI(2ND)
Parts 001104
System MI96-
ASSY STORAGE-NVME,512
Parts 01596A
System MI59-
CARD-VGA;GTX 1650
Parts 01270A
System MI96-
ASSY PC-PC MODULE
Parts 01562A
11 – 24 V6/XV6 Service Manual
Part
Category Description Part Image
Code
System MI92-
ASSY BOARD-PSA 3P
Parts 03207B
System MI92-
ASSY BOARD-PSA 3P-PEN
Parts 03202B
System MI82-
ASSY BOARD-MAIN
Parts 02624A
System MI43-
BATTERY
Parts 01010A
System MI96-
ASSY Battery Charger
Parts 01514A
Chapter 11. Service Parts List 11 – 25
Part
Category Description Part Image
Code
ASSY POWER-DDM
System MI96-
include CAP BD
Parts 01599A
(S-Shearwave)
System MI96-
ASSY FAN-BOTTOM FAN
Parts 01511A
System MI96-
ASSY FAN-TOP;HS80,MID FAN
Parts 01512A
System MI97-
ASSY LIFT
Parts 05653A
11 – 26 V6/XV6 Service Manual
Part
Category Description Part Image
Code
V6 Service Manual
All information in this manual is owned by Samsung Medison Co., Ltd. and is protected by related laws.
This manual is a textbook designed for the training of the service engineers at Samsung Medison Training
Center.
Therefore, unauthorized use of this manual is prohibited, and legal sanctions are imposed if the contents
are reproduced, or distributed.