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o 1-1 Safety Signs 5

o 1-2 Electrical Safety 7
c) 1-3 Mechanical Safety 15
1-4 Biological Safety 17
1-5 Probe Precautions 27
1-6 Environmental Protection 28
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MEDISON
Safety Signs
Please read this chapter before using the MEDISON ultrasound system. It is relevant to the ultrasound
system, the probes, the recording devices, and any of the optional equipment.SonoAce X4 is intended
for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for
direct use of the medical device.
1-1-1 Safety Symbols

The International Electro Technical Commission (lEG) has established a set of symbols for medical
electronic equipment, which classify a connection or warn of potential hazards. The classifications
and symbols are shown below.
Description
[I] Isolated patient connection (Type SF applied part).
C:> Power switch (Supplies/cuts the power for product)

o OFF (Cuts the power to a part of the product)
o ON (Supplies power to a part of the product)
A Refer to the User Manual.
V Identifies an equipotential ground.
~ Indicates dangerous voltages over 1000V AC or over 1500V DC.
Identifies the point where the system safety ground is fastened to the chassis. Protective
~
tT\.'
'.
earth connected to conductive parts of Class I equipment for safety purposes.
> VGA output port or Parallel port.
-t>' ECG port.
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Symbols Description
Left and right Audio / Video input
Remote print output
Foot switch connector
ECG connector
USB connector
Protection against the effects of immersion.

IPX 7
Protection against dripping water.

IPX 1
--'=- Probe connector
1-1-2 Labels
To protect the system, you may see 'Warning' or 'Caution' marked on the surface of the product.
It describes the precautions necessary to prevent user hazards of great urgency. If a

DANGER
DANGER is ignored, it might cause users a fatal injury such as loss of life.
It is used to indicate the presence of a hazard that can cause serious personal injury, or
WARNING
substantial property damage if a WARNING is ignored
It is used to indicate the presence of a hazard that can cause equipment damage if a
CAUTION
CAUTION is ignored.
It is a piece of information not related to any hazard, but useful in installing, operating and
NOTE
maintaining the system.
Chapter 1 Safety 6
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MEDISON
Electrical Safety
This equipment has been verified as a Class 1 device with Type SF applied parts.
1-2-1 Prevention of Electric Shock

In a hospital, dangerous currents are due to the potential differences between connected equipment
and touchable conducting parts found in medical rooms. The solution to the problem is consistent
equipotential bonding. Medical equipment is connected with connecting leads made up of angled
sockets to the equipotential bonding network in medical rooms.
'<
Earth in Medical Room
Ground Cable
[Figure 1-1 Equipotential bonding]
Additional equipment connected to medical electrical equipment must comply with the respective IEC
or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall
comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3
Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical
equipment configures a medical system and is therefore responsible that the system complies with the
requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority
over the above mentioned requirements. If in doubt, consult your local representative or the technical
service department.
Lt. CAUTION I
The system has been designed for 1QQ-12QVAC and 2QQ-24QVAC; you should select the input voltage of
monitor, printer and VCR. Prior to connecting an GEM power cord, verify that the voltage indicated on the
power cord matches the vo~age rating of the GEM device.
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.
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& WARNING I
Electric shock may exist result if this system, including and all of its externally mounted recording and
monitoring devices, is not properly grounded.
Do not remove the covers on the system; hazardous voltages are present inside. Cabinet panels must be
in place while the system is in use. All internal adjustments and replacements must be made by a qualified
MEDISON Customer Service Department.
Check the face, housing, and cable before use. Do not use, if the face is cracked, chipped, or torn, the
housing is damaged, or if the cable is abraded.
Always disconnect the system from the wall outlet prior to cleaning the system.
All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to
application of a high voltage defibrillation pulse.
Do not touch the SIP/SOP and patient simultaneously. Doing so may cause a leakage current exceeding
the maximum allowable values.
The use of flammable anesthetic gas or oxidizing gases (N20) should be avoided.
1-2-2 ECG-Related Information
& WARNING I
This device is not intended to provide a primary ECG monitoring function, and therefore does not have
means of indicating an inoperative electrocardiograph.
Do not use ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical equipment may
resu~in bums to the patient.
Do not use ECG electrodes during cardiac pacemaker procedures or other electrical stimulators.
Do not use ECG leads and electrodes in an operating room.
1-2-3 ESD
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring
phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by
heating or air conditioning. During low humidity conditions, electrical charges naturally build up on
individuals, creating static electricity. An ESD occurs when an individual with an electrical energy
build-up comes in contact with conductive objects such as metal doorknobs, file cabinets, computer
equipment, and even other individuals. The static shock or ESD is a discharge of the electrical
energy build-up from a charged individual to a lesser or non-charged individual or object.
The ESD caution symbol is on the probe connector and the rear panel.
[Figure 1-2 ESD symbol]
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Lt. CAUTION I
The level of electrical energy discharged from a system user or patient to an ultrasound system can be
significant enough to cause damage to the system or probes.
The following precautions can help to reduce ESD :

Anti-static spray on carpets or linoleum
Anti-static mats
A ground wire connection between the system and the patient table or bed.
1-2-4 EMI
Although this system has been manufactured in compliance with existing EMI(Electromagnetic
Interference) requirements, use of this system in the presence of an electromagnetic field can
cause momentary degradation of the ultrasound image.
If this occurs often, MEDISON suggests a review of the environment in which the system is being
used, to identify possible sources of radiated emissions. These emissions could be from other
electrical devices used within the same room or an adjacent room. Communication devices such
as cellular phones and pagers can cause these emissions. The existence of radios, TVs, or
microwave transmission equipment nearby can also cause interference.
Lt. CAUTION
In cases where EMI is causing disturbances, it may be necessary to relocate this system.
1-2-5 EMC
The testing for EMC(Electromagnetic Compatibility) of this system has been performed according to
the intemational standard for EMC with medical devices (IEC60601-1-2). This IEC standard was
adopted in Europe as the European norm (EN60601-1-2).
1) Guidance and manufacturer's declaration - electromagnetic emission

This product is intended for use in the electromagnetic environment specified below. The customer
or the user of this product should assure that it is used in such an environment.
. .. -
RF Emission
Group 1
(Radiation)
Class A The Ultrasound System uses RF energy only for its intemal
CISPR 11
function. Therefore, its RF emissions are very low and are not
RF Emission likely to cause any interference in nearby electronic equipment.
Group 1
(Radiation)
Class A
CISPR 11
Harmonic Emission
Class A The Ultrasound System is suitable for use in all
IEC 61000-3-2
establishments, including domestic establish-ments and those
directly connected to the public low-voltage power supply
Ricker Emission network that supplies building used for domestic purpose.
Complies
IEC 61000-3-3
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2) Approved Cables, Transducers and Accessories for EMC
CD Approved Cable for Electromagnetic Compliance

Cables connected to this product may affect its emissions; Use only the cable types and
lengths listed below table.
.. .
VGA Shielded Normal
Parallel Shielded Normal
RS232C Shielded Normal
USB Shielded Normal
LAN(RJ45) Twisted pair Any
S-Video Shielded Normal
Foot Switch Shielded 2.5m
BNJ Printer Unshielded Coaxial Normal
MIC Unshielded Any
Printer Remote Unshielded Any
Audio R.L Shielded Normal
VHS Shielded Normal
ECG AUX input Shielded <3m
@ Approved Transducer for Electromagnetic Compliance

The image transducer used with this product may affect its emission.
CID Approved Accessories for Electromagnetic Compliance

Accessories used with this product may effect its emissions.
& CAUTION I
When connecting other customer-supplied accessories to the system, such as a remote printer or VCR, it
is the user's responsibility to ensure the electromagnetic compatibility of the system. Use only CISPR 11 or
CISPR 22, CLASS B compliant devices.
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MEDISON
IEC 60601 Electromagnetic

Immunity test Compliance level
Test level environment -guidance
Electrostatic Floors should be wood, concrete or

6KV Contact 6KV Contact
discharge (ESD) ceramic tile. If floors are covered with
synthetic material, the relative humidity
8KVair 8KV air
IEC 61000-4-2 should be at least 30%.
Electrical fast 2KV for power 2KV for power Mains power quality should be that of a
transientlburst supply lines supply lines
typical commercial or hospital
1KVfor 1KV for input/
IEC 61000-4-4 environment.
input/output lines output lines
1KV differential
Surge 1KV differential Mains power quality should be that of a
mode
mode typical commercial or hospital
2KVcommon
IEC 61000-4-5 2KV common mode environment.
mode
<5% Ur <5%Ur
(>95% dip in Ur) (>95% dip in UT)
for 0.5cycle for 0.5cycle
Mains power quality should be that of a
Voltage dips, short 40% Ur 40% Ur typical commercial or hospital
interruptions and (60% dip in Ur ) (60% dip in Ur ) environment. If the user of this product
voltage variations for 5 cycle for 5 cycle
requires continued operation during
on power supply
power mains interruptions, it is
input lines 70% Ur 70% Ur
(30% dip in Ur) (30% dip in Ur) recommended that this product be
IEC 61000-4-11 for 25 cycle for 25 cycle powered from an uninterruptible power
supply or a battery.
<5% Ur <5%Ur
(<95% dip in Ur) 95% dip in Ur)
for 5s for 5 s
Power frequency Power frequency magnetic fields should

(50/60Hz)
be at levels characteristic of a typical
magnetic field 3A/m 3A/m
location in a typical commercial or
IEC 61000-4-8 hospital environment.
NOTE Ur is the a.c. mains voltage prior to application of the test level.
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IEC60601
Immunity test
Test level
Portable and mobile RF communi-cations
equipment should be used no closer to any
part of the Ultrasound System, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
3Vrms
Conducted RF transmitter.
150 kHz to 0.01V
IEC 61000-4-6 Recommended separation distance
80MHz
d = [3,,5~Jr
VI
3/J .[ji
ril = ["ill P 80MHz to 800MHZ
d= [ ~ (JP BOOMHz to 205GHz

where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF

3 V/m transmitters, as deter-mined by an
Radiated RF
80 MHzto 3V/m electromagnetic site survey, a should be
IEC 61000-4-3
2.5GHz less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of

equipment marked with the following
symbol:
((~))
NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Ultrasound System
is used exceeds the applicable RF compliance level above, the Ultrasound System should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Ultrasound System or
using a shielded location with a higher RF shielding effectiveness and filter attenuation.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V,] V/m .
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3) Recommended separation distances between portable and mobile RF communications equipment

and the SonoAce X4
This product is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of this product can help Prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and this product as recommended below, according to the maximum output power of
the communications equipment.
... . .. .
.....

0.01 35.00 0.11 0.23

0.1 110.68 0.36 0.73
350.00 1.16 2.33
10 1106.80 3.68 7.37
100 3500.00 11.66 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distanced
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where pis
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
4) Electromagnetic environment-guidance
The Ultrasound System must be used only in a shielded location with a minimum RF shielding
effectiveness and, for each cable that enters the shielded location. Field strengths outside the
shielded location from fixed RF transmitters, as determined by an electromagnetic site survey,
should be less than 3V/m.
It is essential that the actual shielding effectiveness and filter attenuation of the shielded location
be verified to assure that they meet the minimum specification.
Lt. CAUTION I
If the system is connected to other customer-supplied equipment, such as a local area network (LAN) or a
remote printer, Medison cannot guarantee that the remote equipment will work correctly in the presence of
electromagnetic phenomena.
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5) Avoiding Electromagnetic Interference

A medical device can either generate or receive electromagnetic interference. The EMC standards
describe tests for both emitted and received interference.
Medison Ultrasound Systems do not generate interference in excess of the referenced standards.
An Ultrasound System is designed to receive signals at radio frequency and is therefore susceptible
to interference generated by RF energy sources. Examples of other source of interference are medical
device, information technology products, and radio and television transmission towers. Tracing the
source of radiated interference can be a difficult task. Customers should consider the following in an
attempt to locate the source:
Is the interference intermittent or constant?
Does the interference show up only with one transducers operating at the same frequency or
with several transducer?
Do two different transducer operating at the same frequency have the same problem?
Is the interference present if the system is moved to a different location in the facility?
The answers to these questions will help determine if the problem reside with the system or
the scanning environment. After you answer the question, contact your local MEDISON
customer service department.
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Mechanical Safety
1-3-1 Moving the Equipment
When you move the equipment, you should use the handle at the backside of the console. The monitor
can be separated and easily removed from the unit if necessary.
The adjustable wheels under the console facilitate easy transporting of the product.
The components are installed securely and can withstand considerable shock, but excessive shock
may cause system failure. On rare occasions a component may become disconnected inside the
system. If the system operates abnormally after repositioning, please contact the MEDISON Customer
Service Department.
Lt. WARNING I
The system can weigh approximately 101 kg (202Ib), depending upon configuration, and could cause injury
should it topple over.
1) The Brakes
The brakes are on the front wheels of the console. Press the brakes with your feet to lock or release them.
You can use the brakes to control the movement of the product such as by preventing its movement
while scanning.
2) Precautions on Ramps
Always make sure that the control panel is facing the direction of movement.
Lt. WARNING I
Be aware of the castors, especially when moving the system. MEDISON recommends that you exercise
caution when moving the product up or down ramps.
When moving the product down a ramp or resting it temporarily on a ramp, the product may tilt over
even with the brakes on depending on the direction of the product. Do not rest the product on ramps.
[Good example] [Bad example]
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1-3-2 Safety Note
& CAUTION I
Never attempt to modify the product in any way.
Check the operational safety when using the product after a prolonged break in service.
Make sure that other objects, such as metal pieces, do not enter the system.
Do not block the ventilation slots.
To prevent damage to the power cord, be sure to grip the plug head? not the cord - when unplugging.
Excessive bending or twisting of cables on patient-applied parts may cause failure or intermittent operation
of the system.
Improper cleaning or sterilization of a patient-applied part may cause permanent damage.
1-3-3 Safety Note for Monitor

When adjusting the position of the monitor, be careful not to get your fingers caught in between the
monitor and the arm.
[Figure 1-3 Safety Note for Monitor]
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Biological Safety
Lt. WARNING I
Ultrasound waves may have damaging effects on cells and, therefore, may be harmful to the patient. If
there is no medical benefit, minimize the exposure time and maintain the ultrasound wave output level at
low. Please refer to the ALARA principle.
Do not use the system if an error message appears on the video display indicating that a hazardous
condition exists. Note the error code, turn off the power to the system, and call your local MEDISON
Customer Service Department.
Do not use a system that exhibits erratic or inconsistent updating. Discontinuities in the scanning sequence
are indicative of a hardware failure that should be corrected before use.
The system limits the maximum contact temperature to 43 degree Celsius, and the ultrasonic waves output
observes American FDA regulations.
1-4-1 ALARA Principle

Guidance for the use of diagnostic ultrasound is defined by the "as low as reasonably achievable"
(ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight
of qualified personnel. No set of rules can be formulated that would be sufficiently complete to
dictate the correct response for every circumstance. By keeping ultrasound exposure as low as
possible, while obtaining diagnostic images, users can minimize ultrasonic bioeffects.
Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer' s
responsibility to control the total energy transmitted into the patient. The sonographer must reconcile
exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure
time, the ultrasound system provides controls that can be manipulated during the exam to optimize
the results of the exam.
The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultra-
sound not only in the technology but also in the applications of the technology, have resulted in the
need for more and better information to guide the user. The output indices are designed to provide
that important information
There are a number of variables, which affect the way in which the output display indices can be
used to implement the ALARA principle. These variables include mass, body size, location of the
bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure
time is an especially useful variable, because the user controls it. The ability to limit the index
values over time support the ALARA principle.
1) Applying ALARA
The system-imaging mode used depends upon the information needed. 2D-mode and M-mode
imaging provide anatomical information, while Doppler imaging provide information about blood
flow. Scanned modes, like 2D-mode disperse or scatter the ultrasonic energy over an area, while an
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unscanned mode, like M-mode or Doppler, concentrates ultrasonic energy. Understanding the
nature of the imaging mode being used allows the sonographer to apply the ALARA principle
with informed judgment. The probe frequency, system set-up values, scanning techniques, and
operator experience aid the sonographer in meeting the definition of the ALARA principle.
The decision as to the amount of acoustic output is, in the final analysis, up to the system operator.
This decision must be based on the following factors: type of patient, type of exam, patient history,
ease or difficulty of obtaining diagnostically useful information, and the potential localized heating of
the patient due to probe surface temperatures. Prudent use of the system occurs when patient
exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve
acceptable diagnostic results.
Although a high index reading does not mean that a bioeffect is actually occurring, a high index reading
should be taken seriously. Every effort should be made to reduce the possible effects of a high index
reading. Limiting exposure time is an effective way to accomplish this goal.
There are several system controls that the operator can use to adjust the image quality and limit the
acoustic intensity. These controls are related to the techniques that an operator might use to implement
ALARA. These controls can be divided into three categories: direct, indirect, and receiver control.
2) Direct Controls
Application selection and the output intensity control directly affect acoustic intensity. There are different
ranges of allowable intensity or output based on your selection. Selecting the correct range of acoustic
intensity for the application is one of the first things required during any exam. For example, peripheral
vascular intensity levels are not recommended for fetal exams. Some systems automatically select
the proper range for a particular procedure, while others require manual selection. Ultimately, the
user bears the responsibility for proper clinical use. The MEDISON system provides both automatic
and user-definable settings.
Output has direct impact on acoustic intensity. Once the application has been established, the output
control can be used to increase or decrease the intensity output. The output control allows you to
select intensity levels less than the defined maximum. Prudent use dictates that you select the lowest
output intensity consistent with good image quality.
3) Indirect Controls
The indirect controls are those that have an indirect effect on acoustic intensity. These controls affect
imaging mode, pulse repetition frequency, focus depth, pulse length, and probe selection.
The choice of imaging mode determines the nature of the ultrasound beam. 2D-mode is a scanning
mode, Doppler is a stationary or unscanned mode. A stationary u~rasound beam concentrates energy
on a single location. A moving or scanned ultrasound beam disperses the energy over a wide area and
the beam is only concentrated on a given area for afraction of the time necessary in unscanned mode.
Pulse repetition frequency or rate refers to the number of ultrasound bursts of energy over a specific
period of time. The higher the pulse repetition frequency, the more pulses of energy in a given period
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of time. Several controls affect pulse repetition frequency: focal depth, display depth, sample volume
depth, number of focal zones, and sector width controls.
Focus of the ultrasound beam affects the image resolution. To maintain or increase resolution at a
different focus requires a variation in output over the focal zone. This variation of output is a function
of system optimization. Different exams require different focal depths. Setting the focus to the proper
depth improves the resolution of the structure of interest.
Pulse length is the time during which the ultrasonic burst is tumed on. The longer the pulse, the greater
the time-average intensity value. The greater the time-average intensity, the greater the likelihood of
temperature increase and cavitations. Pulse length or burst length or pulse duration is the output
pulse duration in pulsed Doppler. Increasing the Doppler sample volume increases the pulse length.
Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The higher
the probe operating frequency, the greater the attenuation of the ultrasonic energy. Higher probe
operating frequencies require higher output intensity to scan at a deeper depth. To scan deeper at
the same output intensity, a lower probe frequency is required. Using more gain and output beyond a
point, without corresponding increases in image quality, can mean that a lower frequency probe is needed.
4) 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.
5) Additional Considerations
Ensure that scanning time is kept to a minimum, and ensure that only medically required scanning is
performed. Never compromise quality by rushing through an exam. A poor exam will require a
follow-up, which ultimately increases the time. Diagnostic ultrasound is an important tool in medicine,
and, like any tool, should be used efficiently and effectively.
6) Output Display Features

The system output display comprises two basic indices: a mechanical index and a thermal index.
The thermal index consists of the following indices: soft tissue (Tls) and bone (Tlb). One of these
three thermal indices will be displayed at all times. Which one depends upon the system preset or
user choice, depending upon the application at hand.
The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1.
The thermal index consists of the three indices, and only one of these is displayed at anyone time.
Each probe application has a default selection that is appropriate for that combination. The Tlb or Tls
is continuously displayed over the range of 0.0 to maximum output, based on the probe and
application, in increments of 0.1.
The application-specific nature of the default setting is also an important factor of index behavior. A
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default setting is a system control state which is preset by the manufacturer or the operator. The
system has default index settings for the probe application. The default settings are invoked automatically
by the ultrasound system when power is tumed on, new patient data is entered into the system database,
or a change in application takes place.
The decision as to which of the three thermal indices to display should be based on the following criteria:
Appropriate index for the application: Tls is used for imaging soft tissue; and Tlb for afocus at or near bone.
Some factors might create artificially high or low thermal index readings e.g. presence of fluid or bone,
or the flow of blood. A highly attenuating tissue path, for example, will cause the potential for local
zone heating to be less than the thermal index displays.
Scanned modes versus unscanned modes of operation affect the thermal index. For scanned modes,
heating tends to be near the surface; for unscanned modes, the potential for heating tends to be
deeper in the focal zone.
Always limit ultrasound exposure time. Do not rush the exam. Ensure that the indices are kept to a
minimum and that exposure time is limited without compromising diagnostic sensitivity.
7) Mechanical Index (Ml) Display

Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded.
The threshold level varies, however, with the type of tissue. The potential for mechanical bioeffects
varies with peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher
the Ml value, the greater the likelihood of mechanical bioeffects occurring but there is no specific MI
value that means that a mechanical effect will actually occur. The MI should be used as a guide for
implementing the ALARA principle.
8) Thermal Index (Tl) Display

The Tl informs the user about the potential for temperature increase occuring at the body surface,
within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of
the temperature increase in specific body tissues. The actual amount of any temperature rise is
influenced by factors such as tissue type, vascularity, and mode of operation etc. The TI should be
used as a guide for implementing the ALARA principle.
The bone thermal index (Tlb) informs the user about potential heating at or near the focus after the
ultrasound beam has passed through soft tissue or fluid, for example, at or near second or third
trimester fetal bone.
The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near
the surface, for example, cranial bone.
The soft tissue thermal index (Tls) informs the user about the potential for heating within soft homo-
geneous tissue.
You can select either Tls or Tlb using the TlslTlb selection on the Miscellaneous system setups. Tic
is displayed when you select a trans-cranial application.
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9) Mechanical and Thermal indices Display Precision and Accuracy

The Mechanical and Thermal Indices on the system are precise to 0.1 units.
The MI and TI display accuracy estimates for the system are given in the Acoustic Output Tables manual.
These accuracy estimates are based on the variability range of probes and systems, inherent acoustic
output modeling errors and measurement variability, as described below.
The displayed values should be interpreted as relative information to help the system operator achieve
the ALARA principle through prudent use of the system. The values should not be interpreted as actual
physical values investigated tissue or organs. The initial data that is used to support the output display
is derived from laboratory measurements based on the AlUM measurement standard. The measure-
ments are then put into algorithms for calculating the displayed output values.
Many of the assumptions used in the process of measurement and calculation are conservative in nature.
Over-estimation of actual in situ exposure, for the vast majority of tissue paths, is built into the mea-
surement and calculation process. For example:
The measured water tank values are de-rated using a conservative, industry standard, attenuation
coefficient of 0.3dB/cm-MHz.
Conservative values for tissue characteristics were selected for use in the TI models. Conservative
values for tissue or bone absorption rates, blood perfusion rates, blood heat capacity, and tissue thermal
conductivity were selected.
Steady state temperature rise is assumed in the industry standard TI models, and the assumption is
made that the uttrasound probe is held steady in one position long enough for steady state to be reached.
A number of factors are considered when estimating the accuracy of display values: hardware variations,
algorithm accuracy estimation and measurement variability. Variability among probes and systems
is a significant factor. Probe variability results from piezoelectric crystal efficiencies, process-related
impedance differences, and sensitive lens focusing parameter variations. Differences in the system
pulse voltage control and efficiencies are also a contributor to variability. There are inherent uncer-
tainties in the algorithms used for estimating acoustic output values over the range of possible system
operating conditions and pulse voltages. Inaccuracies in laboratory measurements are related to
differences in hydrophone calibration and performance, positioning, alignment and digitization
tolerances, and variability among test operators.
The conservative assumptions of the output estimation algorithms of linear propagation, at all depths,
through a O.3dB/cm-MHz attenuated medium are not taken into account in calculation of the accuracy
estimate displayed. Neither linear propagation, nor uniform attenuation at the 0.3dB/cm-MHz rate,
occur in water tank measurements or in most tissue paths in the body. In the body, different tissues
and organs have dissimilar attenuation characteristics. In water, there is almost no attenuation. In the
body, and particularly in water tank measurements, non-linear propagation and saturation losses
occur as pulse voltages increase.
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The display accuracy estimates take into account the variability ranges of probes and systems, inhe-
rent acoustic output modeling errors, and measurement variability. Display accuracy estimates are
not based on errors in, or caused by measuring according to, the AlUM measurement standards.
They are also independent of the effects of non-linear loss on the measured values.
10 ) Control Effects
Control affecting the indices
As various system controls are adjusted, the TI and MI values may change. This will be most apparent
as the power control is adjusted; however, other system controls will affect the on-screen output values.
11) 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 M mode and PW Doppler, the individual modes each
add to the total TI. One mode will be the dominant contributor to this total. The displayed MI will be
from the mode with the largest peak pressure.
12) 2D-mode Controls

CD 2D-mode size
Narrowing the sector angle may increase the frame rate. This action will increase the TI. Pulse
voltage may be automatically adjusted down with software controls to keep the TI below the system
maximums. A decrease in pulse voltage will decrease MI.
Zoom
Increasing the zoom magnification may increase frame rate. This action will increase the TI. The
number of focal zones may also increase automatically to improve resolution. This action may change
MI since the peak intensity can occur at a different depth.
@ Persistence
A lower persistence will decrease the TI. Pulse voltage may be automatically increased. An increase
in pulse voltage will increase MI.
CD Focal no.
More focal zones may change both the TI and MI by changing frame rate or focal depth automatically.
Lower frame rates decrease the TI. MI displayed will correspond to the zone with the largest peak
intensity.
Focus on
Changing the focal depth will change the MI. Generally, higher MI values will occur when the focal
depth is near the natural focus of the transducer.
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13) M-mode and Doppler Controls

CD Speed
M-mode and Doppler sweep speed adjustments will not affect the MI. When M-mode sweep speed
changes, TI changes.
Simultaneous and Update Methods

Use of combination modes affects both the TI and MI through the combination of pulse types.
During simultaneous mode, the TI is additive. During auto-update and duplex, the TI will display
the dominant pulse type. The displayed MI will be from the mode with the largest peak pressure.
@ Sample Volume Depth

When Doppler sample volume depth is increased the Doppler PRF may automatically decrease.
A decrease in PRF will decrease the TI. The system may also automatically decrease the pulse
voltage to remain below the system maximum. A decrease in pulse voltage will decrease MI.
14) Doppler, M-mode and Imaging Controls

When a new imaging mode is selected, both the TI and the MI will change to default settings. Each
mode has a corresponding pulse repetition frequency and maximum intensity point. In combined or
simultaneous modes, the TI is the sum of the contribution from the modes enabled and MI is the MI
for the focal zone and mode with the largest derated intensity. If a mode is tumed off and then reselected,
the system will retum to the previously selected settings.
CD Probe
Each probe model available has unique specifications for contact area, beam shape, and center
frequency. Defaults are initialized when you select aprobe. MEDISON factory defau~s vary with probe,
application, and selected mode. Defau~s have been chosen below the FDA limits for intended use.
Depth
An increase in 2D-mode depth will automatically decrease the 2D-mode frame rate. This would
decrease the TI. The system may also automatically choose a deeper 2D-mode focal depth. A
change of focal depth may change the MI. The MI displayed is that of the zone with the largest
peak intensity.
@ Application
Acoustic output defaults are set when you select an application. MEDISON factory defaults vary with
probe, application, and mode. Defaults have been chosen below the FDA limits for intended use.
15) Related Guidance Documents

For more information about ultrasonic bioeffects and related topics refer to the following;
AlUM Report, January 28, 1993, "Bioeffects and Safety of Diagnostic Ultrasound"
Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1998:
Vol. 7, No. 9 Supplement
Chapter 1 Safety 22
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Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AlUM, NEMA. 1998)
Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AlUM, 1998)
Second Edition of the AlUM Output Display Standard Brochure, Dated March 10, 1994. (A copy of
this document is shipped with each system.)
Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound Systems and
Transducers. FDA. September 1997. FDA.
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment. (Revision 1, AlUM, NEMA. 1998)
WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on
Thermal and Non-Thermal Mechanisms for Biological Effects of Ultrasound, Ultrasound in Medicine
and Biology, 1998: Vol. 24, Supplement1.
16) Acoustic Output and Measurement

Since the first usage of diagnostic ultrasound, the possible human biological effects (bioeffects) of
uttrasound exposure have been studied by various scientific and medical institutions. In October 1987,
the American Institute of Ultrasound in Medicine(AIUM) ratified a report prepared by its Bioeffects
Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med.,
Sept. 1988: Vo1.7, No.9 Supplement), sometimes referred to as the Stowe Report, which reviewed
available data on possible effects of ultrasound exposure. Another report "Bioeffects and Safety of
Diagnostic Ultrasound," dated January 28, 1993 provides more up to date information.
The acoustic output for this system has been measured and calculated in accordance with the
December 1985 "510(1<) Guide for Measuring and Reporting Acoustic Output of Diagnostic Uttrasound
Medical Devices," except that the hydrophone meets the requirements of "Acoustic Output Mea-
surement Standard for Diagnostic Ultrasound Equipment" (NEMA UD 2-1992)
17) In Situ, Derated, and Water Value Intensities

All intensity parameters are measured in water. Since water does not absorb acoustic energy, these
water measurements represent a worst case value. Biological tissue does absorb acoustic energy.
The true value of the intensity at any point depends on the amount and type of tissue and the frequency
of the ultrasound that passes through the tissue. The intensity value in the tissue, In Situ, has been
estimated using the following formula:
In Situ = Water [ e(023a1f)]
where: In Situ = In Situ Intensity Value
Water = Water Value Intensity
e=2.7183
a = Attenuation Factor
Tissue a(dB/cm-MHz)
Brain .53
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Heart .66
Kidney .79
Liver .43
Muscle .55
I =skin line to measurement depth (cm)
f =Center frequency of the transducer/system/mode combination(MHz)
Since the ultrasonic path during an examination is likely to pass through varying lengths and types of
tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used for general
reporting purpose; therefore, the In Situ value which is commonly reported uses the formula:
In SItu =Water [ e(O.2 aIf ]
3 J
Since this value is not the true In Situ intensity, the term "derated" is used.
The maximum derated and the maximum water values do not always occur at the same operating
condition; therefore, the reported maximum water and derated values may not be related to the In
Situ (derated) formula. Take for example a multi-zone array transducer that has maximum water value
intensities in its deepest zone: the same transducer may have its largest derated intensity in one if its
shallowest focal zones.
18) Acoustic Output and Measurement

The terms and symbols used in the acoustic output tables are defined in the following paragraphs.
ISPTA.3 The derated spatial-peak temporal-average intensity (milliwatts per square centimeter).
ISPPA.3 The derated spatial-peak pulse-average intensity (watts per square centimeter). The
value of IPA.3 at the position of global maximum MI (IPA.3@MI) may be reported instead
of ISPPA.3 if the global maximum MI is reported.
MI The Mechanical Index. The value of MI at the position of ISPPA.3, ([email protected]) may be
reported instead of MI (global maximum value) if ISPPA.3 is ?190W/cm2
Pr.3 The derated peak rarefactional pressure (megapascals) associated with the transmit pattern
giving rise to the reported MI value.
WO The ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, WO is
the total time-average power;. For operating conditions subject to reporting under ISPPA.3,
WO is the ultrasonic power associated with the transmit pattern giving rise to the value
reported under ISPPA.3
Fc The center frequency (MHz). For MI and ISPPA.3, Fc is the center frequency associated
with the transmit pattem giving rise to the global maximum value of the respective parameter.
For ISPTA.3, for combined modes involving beam types of unequal center frequency, Fc
is defined as the overall range of center frequencies of the respective transmit pattems.
ZSP The axial distance at which the reported parameter is measured (centimeters).
x-6,y-6 are respectively the in-plane (azimuth) and out-of-plane (elevation) -6? dimensions
in the x-y plane where ZSP is found (centimeters).
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PD The pulse duration (microseconds) associated with the transmit pattern giving rise to the
reported value of the respective parameter.
PRF The pulse repetition frequency (Hz) associated with the transmit pattern giving rise to the
reported value of the respective parameter.
EBD The entrance beam dimensions for the azimuth and elevation planes (centimeters).
EDS The entrance dimensions of the scan for the azimuth and elevation planes (centimeters).
19) Acoustic Measurement Precision and Uncertainty

The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below.

PI1.3 (derated pulse intensity integral) 3.2% +21 %to - 24%
Wo (acoustic power) 6.2% +/-19 %
Pr.3 (derated rarefaction pressure) 5.4% +/-15 %
Fc (center frequency) <1 % +/- 4.5 %
Systematic Uncertainties.
For the pulse intensity integral, derated rarefaction pressure Pr.3, center frequency and pulse duration,
the analysis includes considerations of the 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 systematic uncertainties Acoustic power measurements using a Radiation Force are measured
through the use of calibrated NIST acoustic power sources.
We also refer to a September 1993 analysis done by a working group of the IEC technical committee
87 and prepared by K. Beissner, as a first supplement to IEC publication 1161.
The document includes analysis and discussion of the sources of error/measurement effects due to:
Chapter 1 Safety 25
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Balance system calibration.

Absorbing (or reflecting) target suspension mechanisms.
Linearity of the balance system.
Extrapolation to the moment of switching the ultrasonic transducer (compensation for ringing
and thermal drift).
Target imperfections.
Absorbing (reflecting) target geometry and finite target size.
Target misalignment.
Ultrasonic transducer misalignment.
Water temperature.
Ultrasonic attenuation and acoustic streaming.
Coupling or shielding foil properties.
Plane-wave assumption.
Environmental influences.
Excitation voltage measurement.
Ultrasonic transducer temperature.
Effects due to nonlinear propagation and saturation loss.
The overall findings of the analysis give a rough Acoustic Power accuracy figure of +/- 10% for the
frequency range of 1 - 10 MHz.
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Probe Precautions
The probe can easily be damaged by improper use or by contacting certain chemical substances.
Always follow the instructions in the user manual to inspect the probe cable, case and lens before and
after each use.
Check for cracks, broken parts, leaks and sharp edges. If there is any damage, immediately stop using
the probe and contact the MEDISON Customer Support Department. Using damaged probes may
result in electric shocks and other hazards to the patients and/or users.
& CAUTION I
Do not apply mechanical shock to the probe.
Do not place the probe cable on the floor where the cable can be run over by equipment wheels, etc. Do
not apply excessive force to bend or pull the cable.
Do not immerse the probe into any inappropriate substances such as alcohol, bleach, ammonium chloride,
and hydrogen peroxide.
Do not expose the probe to temperatures of +50?C or higher.
1-5-1 Use and Infection Control of the Probe

The ultrasonographic image scanner uses ultrasound, and it makes direct contact with the patient when
in use. Depending on the types of examinations, such contact can be made to a wide variety of locations
including the ordinary skin or the location of blood transfusion during a surgery.
The most effective method to prevent infection among patients is to use each probe only once.
However, probes may need to be re-used as they are complex in design and expensive. Consequently,
protective devices such as sheaths must be used, and the safety instructions must be folowed carefully in
order to minimize the risk of infection among patients.
& WARNING I
No neurosurgical treatments or examinations should be carried out on a patient with Creutzfeldt-Jakob
disease (critical brain disease caused by virus). If the probe has been used on such a patient, it cannot be
sterilized by any method whatsoever.
& CAUTION I
Sufficient washing and disinfecting must be carried out for preventing infection. This is the responsibility of
the user who manages and maintains the disinfection procedures for the equipment. Always use legally
approved detergents and sheaths.
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1-5-2 Electric Shocks

The probe uses electrical energy. If it touches conductive materials, there are risks of electric shocks to
the patient or the user.
Lt. WARNING I
Regularly receive short-circuit examination from the MEDISON Customer Support Department.Do not
immerse the probe into liquid.
Do not immerse the probe into liquid
Do not drop the probe or apply mechanical shocks.
Inspect the housing, strain relief, lens and seal for damage, and check for any functional problem before
and after each use.
Do not apply excessive force to twist, pull or bend the probe cable. It may result in a short circuit.
The power protection fuse protects the probe and the product from excess current. If the power monitoring
protection circuit detects excess current, it immediately shuts off the current to the probe in order to prevent
the probe surface from overheating and to restrict the ultrasound power output.
The temperature of the product for making contact with patients is limited under 43 C. The ultrasound
power output (AP&I) is in compliance with US FDA standards.
Environmental Protection
Lt. CAUTION I
The equipment and accessories are to be disposed of safely after the life span is exceeded and national
regulations must be observed.
The lithium battery in the PC should be replaced by a MEDISON service man or an authorized dealer.
The waste sheaths are to be disposed of safely and national regulations must be observed.
Chapter 1 Safety 28
' ~.~~~~.I~.~~~~~~.~ ,
s
o 2-1 What is SonoAceX4? 30
Q 2-2 Specifications 31
o 2-3 Product Configuration and Installation 35
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What is SonoAce X4?

The SonoAce X4 is a high-resolution BW ultrasound scanner with high penetration and a variety of
measurement functions.
2-1-1 Features and Advantages of SonoAce X4

1) High-end Digital Beam Forming - The SonoAce X4 utilizes the newly developed Digital Beam
forming technology.
2) A variety of applications - The SonoAce X4 is optimized for use in a variety of ultrasound departments,
including abdomen, obstetrics, gynecology, vascular, cardiac and urology applications.
3) Various diagnostic Modes - 2D Mode, M Mode, PW Spectral Doppler Mode(optional), etc.
4) 3D images can be obtained.
5) Measurement and Report Functions - Besides the basic distance, area, circumference and volume
measurement functions, the SonoAce X4 also provides application-specific measurement functions.
The report function collates measurement data.
6) Review of Scanned Images - The SonoAce X4 displays Cine images of 512 frames and loop
images of 4096 lines.
7) SonoView - This is a total ultrasound image management system, which allows a user to archive,
view and exchange documents.
8) DICOM (Digitallmaging and Communication in Medicine) Function - This is used to archive,
transmit and print DICOM images through a network.
9) Peripheral/Accessory Connection - A variety of peripheral devices including VCRs and printers
can be easily connected to the SonoAce X4.
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Specifications
2-2-1 Specifications
:> Height: 1330mm (with monitor)
:> Width: 450mm
:> Depth: 700mm
:> Weight: More than 63kg
2-2-2 Imaging modes

:> 2D real-time
:> Dual 2D real-time
:> 2DIM-mode
:> Pulsed-wave Doppler
:> 3D-mode
:> Simultaneous
2-2-3 Gray Scale

:> 256 (8 bits)
2-2-4 Focusing
:> Dynamic transmit focusing, maximum of eight points (four points simultaneo-usly selectable)
:> Digital dynamic receive focusing (continuous)
2-2-5 Probes
:> Curved Linear Array
C3-7ED, C2-5ET, C4-9ED, C2-4ES
:> Linear Array
HL5-9ED, L5-9EC, L5-9EE
:> Endocavity Curved Linear Array
EC4-9ED, EC4-9ES
2-2-6 Probe connections

:> 2 probe connectors,
:> 3 probe connectors for option.
2-2-7 Monitor
:> 12 inch BM! monitor
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2-2-8 Rear Panel Input Connections

:> VHS and Audio
:> ECG
:> Keyboard
:> Patient monitor video and 9V de power
:> BM! printer video and remote control
:> VGA monitor
:> Parallel port
:> USB 2.0 2port
:> Foot Switch
2-2-9 Front Panel Input Connections

:> USB 2.0 2port
2-2-10 Image Storage

:> Cine loop memory (maximum 512 frames)
:> Image filing system
2-3-11 Application
:> General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast,
Musculoskeletal, Cardiac, Neonatal, Pediatric
2-3-12 Electrical Parameters

:> 100-120V/200-240VAC, 8/5A, 50/60Hz
2-2-13 Automatic Calculation and Quantification

Automatic measurement of various parameters
:> Obstetrics in 2D
Standard Gestational Age tables: GS, CRL, VS, BPD, OFD, HC, APD, TAD, MAD, AC, FTA, FL,
SL, TID, APTD, APTDXTID, HUM, ULNA, TIB, RAD, FIB, CLAV, VERT, CEREB, OOD, 10D,
CM, NF, NT, Lat Vent, FOOT, EAR, MP
Volume Flow, Umbilical Artery, Mid Cereb Artery, Left and Right Uterine Artery, Left and Right
Fetal Carotids, Fetal Aorta, Ductus Venous, Fetal Heart, Placenta Artery
Fetal Weight: Campbell, Hadlock 1-4, Hansmann, Merz, Osaka, Shepard, Tokyo1, Tokyo2,
Shinozuka1, Shinozuka2
Estimated Fetal Weight: Brenner, Doubilet, Osaka, Hadlock, Tokyo, Williams
User-defined tables
:> Gynecology : Uterus, Cervix, Left and Right Ovary, Left and Right Ovarian Artery, Left and Right
Follicles, Cyst, Mass
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:> Cardiac: Simpson, VoI.AIL, 2D Measure, LV Mass, Lt. Ventricle(M), Ao.LA(B), AolLA(M), MV(M),
MV inflow, MV Regurg, LVOT Doppler, AoV Systollic, AoV Regurg, TV Inflow, TV Regurg,
PV Systolic, PV Regurg, Pulm. Veins, Hepatic Veins, Tissue Doppler, Qp:Qs, Heart Rate
:> Vascular: Rt./Lt Subclavian, Rt.ILt. Prox CCA, Rt.ILt. Mid CCA, Rt.ILt. Distal CCA, Rt.ILt. Bulb, Rt.ILt.
Prox ICA, Rt.ILt. Mid ICA, Rt./Lt. DistalICA, Rt.ILt. ECA, Rt.ILt. Vertebral, Volume Flow,
Heart Rate, General
:> Urology: Bladder Volume, Prostate Volume, Transitional Zone Prostate Volume, Residual Volume,
Left and Right Kidney Vol.
:> Fetal Echo: 2D Echo, CTAR, Main Pulmonary Artery, Ductus Arteriosus, Inferior Vena Cava, Ductus
Venosus, Ascending Aorta, Descending Aorta, MV Inflow, MV Regurg, TV Inflow, TV
Regurg, Preload Index
2-2-14 Signal processing (Post-processing)

:> TGC control
:> Mode-independent gain control
:> Acoustic power control (adjustable)
:> Dynamic aperture
:> Dynamic apodization
:> Dynamic range control (adjustable)
:> Image view area control
:> M-mode sweep speed control
:> HDZoom
:> Frame average
:> Gamma-scale windowing
:> Image orientation (left/right and up/down)
:> White on black/black on white
2-2-15 Measurement
:> Trackball operation of multiple cursors
:> 2D: Linear measurements and area measurements using elliptical approximation or trace
:> M-mode: Continuous readout of distance, time, and slope rate
:> Doppler: Velocity and trace
2-2-16 Auxiliary
:> Black-and white printer
:> Line printer
:>VCR
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:> Monitor
:> Foot switch
2-2-17 Pressure Limits

:> Operating: 700hPa to 1060hPa
:> Storage: 700hPa to 1060hPa
2-2-18 Humidity Limits

:> Operating: 30% to 75%
:> Storage & Shipping: 20% to 90%
2-2-19 Temperature Limits

:> Operating: 10C _35C
:> Storage & Shipping: -25C _60C
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Product Configuration and Installation

The SomAce X4 consists of the monitor, the control panel, the console, the peripheral devices, and the probes.
2-3-1 Console
The console consists of two parts the inner unit and the outer unit. The inner section is responsible for
ultrasound image generation. The outer section is designed to support the use of other devices and
includes monitor and probe connection sockets, the probe holder, storage devices like HODs, storage
space for peripheral devices and the system power switch.
[Figure 2-1 Console]
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1) Console
Monitor - - - .
~w:tm;mla~a--- Control Panel
UE==~~8--- CD RW Drive / USB Port
1111"'......-1-+--- Probe Connector
1+--- Wheel Swivel -----to\.\
[Figure 2-2 Console Name]
2) Console Size
,.....1 - - - - - 6' cm -----1~~,
+------ 4 cm-----+
cm
[Figure 2-3 Console Size]
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3) Rear Panel
USB PORT-~ I001 y ..-t+-- VGA (Output)
LAN (In/Out)------1f--...
Printer Remote---+--_ @ D'

+t-+--- ECG Connector
BW Prineter--+-...
VHS (Output)--t--_
Audio (Output)--+--.
~+--++--- Foot Switch
Audio (Output)--+--.
[Figure 2-4 Rear Panel]
CD VGA (Output)
The VGA signal is sent to the monitor.
cv LAN (Input/Output)
DICOM can be connected via the LAN port. Patient information is transferred to another server
via the DICOM network.
@ Audio (Output)
The input/output of Audio signals is possible.
CD VHS (Output)
Connect the VCR using the VHS method.
BW Printer (Output)
Echo printer connection.
Printer Remote (Output)

Remote Echo printer connection.
(J) ECG Connector

ECG Module connection.

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2-3-2 Main Power On/Off Switch

The main power on/off switch locates under the rear panel. Powers the product On/Off.
~-U!--~~~~~J- ... Main Power On/Off Switch
re]
[Figure 2-5 Main Power On/Off Switch)
2-3-3 Monitor
The monitor of this system displays ultrasound images and additional information. This monitor is
connected to the main body through a central pivot, allowing it to be tilted to the optimal viewing angle.
1) Monitor Display
The monitor displays ultrasound images, operation menus and a variety of other information. The
screen is divided into five sections: Title, Image, Menu, Feedback, and Flexible Soft Menu sections.
r Title
""
Menu Image Area
Feedback Area
Flexible Soft Menu

\..
o o
[Figure 2-6 Monitor Display)

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CD Title
This section displays the Logo, Patient Name, Hospital Name, Application, Frame Rate & Depth,
Probe Information, Acoustic Output Information and Date & Time.
SONOACE 2'151218-010 FPS 250 Uk:m ... '.01 2005-12-19

X4 .... ...... HLS-8ED Den T1B D.' 12:58:14 PM
[Figure 2-7 Title]
ImageArea
The ultrasound image, image information, annotation, and measurement information are displayed
in the image area.
[Figure 2-8 Image Area]
@Menu
The menu is divided into 3 kinds: Image adjustment menu, Measurement menu, and Utility menu.
Use Menu dial-button to select an item from the menu.
OB
Fetal Biometry
Fetal Long Bones
Fetal Cranium
20 Fetal Others
FA 5 AR
OR 90 Volume Row
EE 0 Umbo Artery
Reject 16 MCA
Frame Rate Fast Lt. Vterine Artery

View Area 100% Rt. Vterine Artery Utility
Tissue Normal Plac. Artery
Apex Up Lt. Fetal Carotids Biopsy
Trapezoid Off Rt. Fetal Carotids ECG
Power 100 Fetal Aorta Gamma Off
20 Post Ductus Venous Preset
Gamma Off etal HR Miscellaneous
[Figure 2-9 Menu - 20. OB, Utility]
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CD Feedback Area
This feedback area provides a variety of information necessary for system use e.g. current
system status and Body Markers.
[Figure 2-10 Body Marker Feedback]
Flexible Soft Menu

The Flexible Soft Menu is displayed on the screen at all times. The items shown on the monitor
vary, depending on the status of the system.
[Figure 2-11 Flexible Soft Menu]
2-3-4 Control Panel

The control panel can be used for controlling the system. It consists of the following four sections:
Up down Switch 1 2 Dial-Button
r-------(3 Dial
[Figure 2-12 Control Panel]
NOTE
Please refer to Product Installation in the Operation Manual.
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2-3-5 Probe
The probe is a device that sends and receives ultrasound for acquiring image data. It is also called a
Transducer or Scanhead. The ultrasonographic image scanner uses the image data received by the
probe to display the images of each organ on the screen. For best quality images, select the appro-
priate probe for the each application.
The system limits patient contact temperature to 43 degrees Celsius, and acoustic power values to
their respective U.S. FDA limits. A power protection fuse circuit protects against over-current
conditions. If the power monitor protection circuit senses an over-current condition, then the drive
current to the probe is shut off immediately, preventing overheating of the probe surfaces and limiting
acoustic output. Validation of the power protection fuse circuit is performed under normal system
operation. For invasive probes, additional protections are designed to keep patient contact surface
temperature under 43 degrees Celsius in the event of a single fault failure.
The applications for each probe are shown below.
Product Applications
C3-7ED General, OB, Gynecology, Abdomen, Fetal Heart, Renal
C2-5ET General, OB, Gynecology, Abdomen, Fetal Heart, Renal
C4-9ED General, Neonatal, Pediatric, Vascular
C2-4ES General, Abdomen, Cardiac
EC4-9ED General, OB, Gynecology, Urology
EC4-9ES General, OB, Gynecology, Urology
L5-9EC General, Breast, Small Parts, Vascular, Musculoskeletal
L5-9EE General, Breast, Small Parts, Vascular, Musculoskeletal
HL5-9ED General, Breast, Small Parts, Vascular, Musculoskeletal
- - - - - - - - - - - - - - - - - - - - - - - - - - - Chapter 2 Product Introduction' 41

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1) C3-7ED
Probe type : Curved linear array

Number of elements: 128
Center frequency: 3.5MHz
Radius of curvature: 50mm
Field of view: 70
Applications: Abdomen, OB, Gynecology,
Renal, Fetal Heart
2) C2-5ET

Field of view : 76
Applications: Abdomen, OB, Gynecology,
Renal, Fetal Heart
3) C4-9ED

Field of view : 150
Applications: Neonatal, Pediatric, Vascular

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MEDISON
4) EC4-9ES

Radius of curvature: 19.4mm
0
Field of view : 150
Applications: OB, Gynecology, Urology
5) EC4-9ED

Radius of curvature: 19.4mm
0
Field of view : 150
Applications: OB, Gynecology, Urology
6)C2-4ES

Radius of curvature : 20mm
0
Field of view : 120
Applications: Abdomen, Cardiac

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7) L5-9EC
Probe type : Linear array

Radius of curvature: Flat
Field of view: 38.4mm
Applications: Small Part, Breast, Vascular,
Musculoskeletal
8) L5-9EE

Field of view: 50mm
Musculoskeletal
9) HL5-9ED

Field of view: 38.4mm
Musculoskeletal

. '. ~.r~~~.I~.~~I~~~~ ,
o 3-1 Environmental Requirements 46

Q 3-2 Unpacking 47
Q 3-3 Product Installation 49
c) 3-4 Changing Product Input/OutputVoltage 52
c) 3-5 Power On/Off 53
Q 3-6 Performance Test 54
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Environmental Requirements
When installing:
1) Avoid humidity.
2) Avoid direct sunlight.
3) Avoid places with extreme temperature variations.
4) Optimal conditions for the system are temperatures of 10-35C and humidity of 30-75%.
5) Avoid heat sources.
6) Avoid dusty and unventilated areas.
7) Avoid places where the system is likely to be exposed to vibration or impacts.
8) Avoid places where the system is likely to be exposed to chemical substances or gases.
Lt. CAUTION I
Placing the system near generators, X-Ray machines, or broadcast cables may resu~ in screen noise and
abnormal visual images. Using the power source with other electric devices may also induce noise.
Chapter 3 Product Installation 46

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Unpacking
The package contains three boxes for the ultrasound diagnostic equipment, the monitor, and accessories.
3-2-1 Opening Product Box

1) Cut or remove the package tapes.
2) Cut or remove the external package strapping.
3) Gently take the main box apart. Take out the probe box and keep it in a safe place.
4) Take out the accessories box and keep it.
5) Store the packaging materials for future transportation of the product.
[Figure 3-1 Opening Product Box]
3-2-2 Opening the 15" Monitor Box

2) Gently lift up the 15 monitor and place it on a flat and safe place.
Chapter 3 Product Installation' 47

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3-2-3 Accessories
This product contains a box of accessories.

2) Take the accessories out and keep them in a safe place.
3) The power cord and ground cable are required for connecting this system.
MANUAL
d
SONO GEL
~~
FUSE
0 SET COVER
~
VTRCORD
8 POWER CORD
[Figure 3-2 Accessories]

0
GROUNG CABLE

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Product Installation
3-3-1 Assembling the Monitor
Follow the instruction to Assemble the monitor.
You must remove the back

cover in order to Assemble the
monitor.
--+'+-....------1~ Rear Upper Cover 1) Required items:

1 large screwdriver (+)
1 small screwdriver (+)
Disassembling the Rear upper

cover
Use the screw (+) to remove
the screws CD - .
,,
,,,
,,
,,,
,
,,,
,,
-- IlItII!I
\1\\\\\\ n/,'I
-,,
,,,
,,
,
,,
: /11/1111
//1/#//
Remove screws CD-@ as
shown below.
Use the small screwdriver (+) to

,
,, remove the two screws CD and 0).
,,
,,

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MEDISON
III Assemble the monitor.
Tighten up the screw in the

neck of monitor
Assemble the monitor cables.

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3-3-2 Connecting probes

Be sure to connect or disconnect probes when the power is off to ensure the safety of the system and
the probes.
1) Connect probes to the probe ports on the front panel of the system. A maximum of two probes
(three probes optional) can be connected at one time.
2) Turn the connector-locking handle clockwise after inserting the probe into the probe port.
3) When the system is powered on, the probe last in use is automatically activated.

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Changing Product Input/Output Voltage

This section contains instructions for changing the input/output voltage for the product.
1 Input Voltage Selector Output Voltage Selector

The system input voltage may be The system output voltage may be
selected as 100-120V or 200-240V. selected as 1OQ-120Vor 200-240V.
This voltage is for use by the printer
and/or VCR. The output vo~age
selected regardless of the input
voltage.
[Figure 3-3 AC-DC Power Module]
Lt. WARNING
Always disconnect the system from the wall outlet prior to making any changes to the inpuUoutput voltage
of the system.
Lt. CAUTION I
The system is designed to use 10Q-120VAC and 200-240VAC. Printer and VCR may be connected to the
system outlet for power source.

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Power On/Off
The power switch of this product is a contact switch.
Press the power switch to initiate the system operation. You may also press the power switch while the
system is in operation to turn the power off.
& CAUTION I
Please check that the voltage for peripheral devices matches the voltage of the power outlets prior to
connecting power to peripheral devices.
-----~----,--.:;;;:::::=::::=------,
-o
[Figure 3-4 Power Switch]

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Performance Test
3-6-1 Initialization and Monitor Tests
1) If the system has not been turned on yet, please use a hospital power cord of 10 amperes or higher.
2) Insert printer paper and video tape appropriate for the system specifications.
3) Connect probes securely to the two probe connectors.
4) Tum the system power on. Once the power is turned on, installation will initiate according to the built-
in program.
5) After the system initialization process, self-test will be carried out (for about 3-5 minutes) and the 2D
Mode Display will be shown on the screen.
6) You may view the current system version from the monitor by selecting the System Setup menu.
7) You may apply other 2D images by selecting other probes.
8) Check the following from the monitor:
CD Adjust brightness and contrast of the monitor from minimum levels to maximum levels to see if
there are any distortions in the display.
Check that the image appears in the centre of the monitor. Also check the vertical and
horizontal resolutions.
@ Check for problems/distortions at each corner.
3-6-2 Functional Tests

1) After successful completion of initialization and monitor test, please check the following:
CD Check that the image appears in the correct coordinates of the monitor.
Check that all lamps on control panel light up properly.
@ Check that toggle switches, slides and trackball work properly.
2) If any of them appears to have problems, perform the "initialization" procedures one more time.
3-6-3 User Interface Tests

You may run User Interface Tests to check functionality of the operating system user interface. The
Control Panel functions may also be adjusted from the monitor screen. You may run other tests
simultaneously while running this test. For more details on each key and functionality, refer to the
SonoAce X4 Operation Manual.
3-6-4 20 Image Tests

1) Tum the power off. Once the system has completely shut off after 10-20 seconds, tum the power on again.
2) Select Curved Array Probe.
3) Apply 2D phantom image.
4) Set the Power level to 100%.
5) Adjust the TGC Gain to produce a 2D image with minimum noise and perform the test. Note:
Attenuation of the image on the far side must not be set to minimum.

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6) Adjust the vertical and horizontal images and adjust the phantom position appropriately.
7) Once phantom has been placed appropriately, make axial and lateral image adjustments to keep the
image with minimum noise.
8) When phantom image adjustment is complete, adjust the focusing on all holes within all phantom structures.
9) Use various menu keys to produce optimal images for each condition.
CD 2D mode: Direction, Application, M line, Density, Focus +, -, 2D, THI, DEPTH, FOCAL POS, TSI
OPT, ZOOM, POWER, TGC, DUAL
MMode: Direction, Application, Density Format, M, THI, DEPTH, FOCAL POS ZOOM, POWER, TGC
10) You may adjust various menu keys to achieve optimal images for PW Mode as well as 2D images.
CD PW Doppler: PWD, ANGLE, Simultaneous, SV Size +-, VOLUME, FILTER, SWEEP, BASELINE,
SCALE, INVERT
3-6-5 Freehand 3D Test

2) Select Curved Array Probe.
3) Press the 3D button to produce 3D images.
4) Adjust X, Y, Z, Rect. L, Mag, and Th. L to produce desired images.
5) After building a desired image, press the Freeze button to view the produced 3D image on the
monitor screen.
6) Press the 2D button to return to normal mode.
3-6-6 Image Saving Test

2) Select a probe.
3) Press the STORE button to save the image.
4) Press the END EXAM button.
5) Select the REVIEW menu in SONOVIEW to view the saved image.
3-6-7 End of Testing

1) Once all tests have been performed, you may start using the system.
2) If there seems to be any problem during the tests, please restart the system and run the tests again.
3) If problems persist, please contact the Medison Customer Service Centre.

.,.~:~~.~ ,
s
o 4-1 System Setup 57
Q 4-2 Measurement Settings 61
o 4-3 DreaM Settings (Optional) 62
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System Setup
This section contains instructions on general system settings that do not affect imaging functions.
Settings may be changed to suit various user's needs and preferences.
1) Press the [F6] SetUp button on the keyboard. The Setup window will appear.
2) Select [System] from the Setup menu.
3) Set the specific system values according to each item on the screen.
4) Press [OK] to save the settings. Press [Cancel] or [X] to close the window.
4-1-1 General
Select the General tab from the System menu.
Insb1Won ,",onl\llW:
'MEDfSOH ("IIl1
Dol
2\IOtI.IOlU
YYY'/' M-DO
MM O-YYY'/
OO-M -YYY'/
set
0-
()ff
[Figure 4-1 System Settings - General]
1) Institution
Enter the name of the hospital/institution.
2) Language
Select the language for display. Available languages are English, Deutsch, Francais, Italiano, Espanol,
Russian, and Simplified Chinese. Language selection will take effect only after a system reboot.
Key button input method will automatically change according to the language selection.
3) Date
You may set the date and choose its format.
4) Time
You may set the time and choose its format.
* How to change date and time
G) Select Set from Date and Time box.
Chapter 3 Setup' 57
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MEDISON
le
Mea OlCO'ol o,uon Per\p/loofals 1111""""lIon

GelHnI DI$oIar
Instl_
v.., 2005
Dal. .....1/1 12
2CI05.IMI
001
.. y"yy ... "
MM 0-
00- -y ..... 15
_""e-
"0.
Mlnde 13
Oif OK Clonc<'
OK c..e..
[Figure 4-2 System Setup - Date and Time]
Set date and time using the trackball and the [Set] button.
@ Press [OK] to finish. Press [Cancel] or [X] to cancel any changes.
5) Boot Up Caps Lock Status

Turned "Off" by default, this setting determines the initial condition of Caps Lock at system boot-up.
The Caps Lock function allows the user to type in upper case letters without having to press the
[Shift] key on the keyboard.
6) Brief Set
Select [Brief Set] to use the brief text function. Its default value is 'Off'.
Using the brief text function allows fast and easy input of texts. For example, to enter the text 'Tumor',
you only need to enter 'Tu' and the system will search the word from the abbreviation list and auto-
matically enter the word 'Tumor'.
* How to edit the Brief Set.

Press the [Edit] button on the screen. The Brief Table Edit table window will be appeared. To add a
new abbreviation, click New, and to completely delete an existing abbreviation, click the entry to be
deleted and then click Delete.
'Delay(msec)' sets seconds to input the Full word after enter the abbreviation. The unit value is msec,
and 1OOOmsec is 1second.
Chapter 3 Setup' S8
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_ r._
le
'"
Ai"'!",..... ~~I NWI)'
Anltnor T"llNal V I
kllUl..
er
00",,",
common Ducl
C4K;um
00-
00
c.'~
[Figure 4-3 Brief Set Edit]
4-1-2 Display
Sets display-related options. Select the Display tab from the [System] menu to make settings for
[display].
le
0iC0'0I o.tion ~Is Inlomoation
Au10 Fr 10 min.
. . 1-
TGC Line
1!1 min.
2D Imllli SiLe
.011 1
Off 11 3
0.
[Figure 4-4 System Setup - Display]
Chapter 3 Setup' 59
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1) Auto Freeze
After the preset time span (minutes) of inactivity, the scan mode is automatically frozen.
2) Screen Saver
After the preset time span (minutes) of inactivity, the screen saver starts automatically.
3) Post Map
This sets the display of the Post Map in the Feedback section at the bottom of the screen.
4)TGC Line
This sets the display of TGC Line. Select "Off' to hide TGC Line from the screen. Select "Off after 3 sec."
to have TGC Line appear on the screen for 3 seconds after adjusting the TGC value. Select "On" to
show TGC Line on the screen at all times.
5) 2D Image Size
The size of the image displayed on the screen may be set to 100%, 95% or 90%.
6) TI (Thermal Index) Display
The system sets TI values automatically. However, this menu allows the user to choose manually
from one of the three TI parameters as desired: Default, Tls or Tlb.
7) Simultaneous Mode
This menu determines whether or not simultaneous mode is enabled in PW Spectral Doppler Mode.
Off: Select this option if you do not wish to use simultaneous mode.
Allow 2D/PW: Select this option if you wish to use simultaneous 2DIPW mode.
Chapter 3 Setup' 60
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Measurement Settings
To change measurement settings, follow the instructions below :
1) Press the F6 SetUp button on the keyboard. The Setup window will appear.
2) Select Measure from the Setup menu.
4) Press OK to save the settings. Press Cancel or X to close the window.
JC
Sys! \ltCO'oI 0._ ""-"Is "'1""",,lIon

Geoe<ol 08 f'eoIal E<to CMdooc: U<~ va_
OoooIcr Rcoor1
Me e tettl Display COunl
-
'mea
U...
Ir. . .
-- -
[Figure 4-4 Measurement Settings Window]
NOTE
For more information, see "Chapter 3. Settings" in the Operation Manual.
Chapter 3 Setup' 61
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MEDISON
DICOM Settings (Optional)

This section contains instructions for operating DICOM (Digitallmaging and Communication in
Medicine) and setting DICOM servers. Select the DICOM tab from the Setup menu.
NOTE
For more information, refer to the server equipment user's manual or the DICOM Conformance Statement.
Port r-----~
-
Ut
AE1lIIe
----
IP_
U
Port
11.1
[Figure 4-5 DlCOM Settings Window 1
4-3-1 DICOM Server Information

You may configure the DICOM information for the system. After entering information for the items below,
select [Acquisition in Progress] for automatically transmitting the DICOM information. Also, you may select
[Print after Each Image] for automatic printing.
1) AETitle
Enter the DICOM AE (Application Entity) title. This is used for identifying DICOM-enabled devices on
the network (Le., US1, US2),
2) Station Name
Enter the name of the system. This is often used in combination with "AE Title" to identify the system
on a DICOM Network (Le., SonoAce1, SonoAce2).-
3) Port
Enter the Port Number of the server in use.
4) Network Status
This displays the current network status.
Chapter 3 Setup' 62
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4-3-2 Network Settings

Press [System Network Settings] to set the system's IP address on the network. Select "Using Dynamic
IP Configuration" to allow the system to set the IP address automatically. If the user enters an incorrect
IP address manually, the system will not establish connection to the network. Press [Apply] to apply the
network settings. Press [Cancel] to cancel the process.
4-3-3 Adding and Changing DICOM Server

Press [Add] to add a new set of DICOM server information or press Edit to change the current
server information.
1) Service
Select the type of server to use.
2) Alias
Enter the name of the server.
3) AETitle
Enter the designated AE title of the server.
4) Transfer Mode
Select the transfer mode.
Batch: Pressing the [End Exam] button transfers all the saved images in batch.
Send As You Go: Pressing the [Save] button saves and transfers the image simultaneously.
Manual: The user may manually select and transfer images from SonoView.
5) Connect Timeout
Connection will terminate if the DICOM server does not respond during the set period. The unit
is in seconds (s).
6) IP Address
Enter server's IP address.
7) Port
Enter server's port number.
8) Retry Interval
Set how many minutes the system will wait until attempting retransmission in case of transmission failure.
9) Maximum Retries
Set how many times the system will retry transmission in case of transmission failure.
4-3-4 Removing DICOM Server

Press Delete to remove the current DICOM server information.
4-3-5 Testing DICOM Server

Press Test to test connection to the current DICOM server.
Chapter 3 Setup' 63
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4-3-6 DICOM Log

Press [Log] and the DICOM Log screen will appear. You may delete or copy the current DICOM log file.
A DICOM log file contains records related to DICOM activities.
Press [Close] to close the DICOM Log screen.
1) Log Settings
You may set the DICOM Log.
Delete archive log file after: This determines how long log files are kept. The unit is in days. Log files
will be deleted once the set duration is exceeded. This option does not take effect if there is only one
log file in the system.
Log file maximum size: This determines the maximum size of a log file. The unit is in Kbytes.
2) Explanation
You may view the settings under Log Settings.
3) DICOM Log
You may view, copy or delete saved DICOM Log files.
Viewing DICOM Log: Select a log file from "Select log files to copy" and press View selected file.
Copying DICOM Log:

Select a log file and select destination under "Copy to."
Select whether the log file will be deleted after copying under "Delete files after copy." If this option is
selected the log file will be deleted from the system after copying.
Press [Copy selected files].
Deleting DICOM Log: Select a log file and press [Delete selected files].
Chapter 3 Setup' 64
s
o 5-1 Connecting Peripheral Devices 66
o 5-2 Peripheral Device Settings 68
o 5-3 Testing Peripheral Devices 69
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MEDISON
Connecting Peripheral Devices

This section contains instructions for connecting peripheral devices to the system console.
Peripheral devices include a VCR, Echo Printer, Foot Switch, USB MO Drive, Flash Memory Media, etc.
5-1-1 Echo Printer and VCR

Refer to Fig. 5-1 for connecting an Echo Printer and VCR.
I
fA ~
OUT$ IN
~oH

I
[00
r~ [ :. -J
VG'
8J
~I~
@ c:f
L--..J L--..J
Echo Printer ~
~
er
P'>.
~
- er (f) 2::-
OUT IN (!)
@ @ er
1~&
-
VHS
.(!)
@
AUDIO @
@ @ I L ~~
.....
,-~
-
Rear Board
VCR
[Figure 5-1 Echo Printer and VCR Connection Diagram]
5-1-2 USB
You can connect devices such as storage devices and USB printers via the USB connectors located
on the rear panel and the front panel of the product.
Lt. CAUTION I
Please connect or disconnect USB devices only when the system is completely tumed off. Connecting or
disconnecting USB devices while the system is turned on may lead to malfunction of the system and/or
USB devices.
Chapter 5 Installing Peripheral Devices' 66

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1) Storage Devices
A variety of storage devices can be connected to the SonoAce X4 via the USB port, enabling
backup & restoring of SonoView or Measure Package data.
Supported storage devices are USB MO Drivers, USB CDRW Drivers, and Flash Memory media.
CD SonoView supports: USB MO Driver, Flash Memory media
Measure Package supports: USB MO Driver, Flash Memory media
This product recommends use of the following Flash Memory media.
CD IOMEGA Mini Drive
SANDISK Cruzer Mini USB Flash Drive
@RiDATAEZdriveUSB2.0
Imation iFlASH USB 2.0
@ Transcend Zet Flash
@ Imation Bule 1GB
Lt. CAUTION
The USB MO Driver should not be used with other USB storage devices.
2) Inkjet Printer
SonoAce X4 supports Post script compatible printers. You can connect printers to the USB ports on
the rear panel or the front panel.
Supported printers: HP DeskJet880C, HP DeskJet895C, HP LaserJet1200,
HP DeskJet6122, HP DeskJet5550, HP DeskJet6540,
HP DeskJet6840, HP LaserJet 1320, HP LaserJet 2420,
HP Color LaserJet 3600, HP Businesslnkjet1200series,
HP OfficeJet Pro K550
Do not install an inkjet printer within 1.5m of the patient.
/1 "
/ I I '
/1 I , '\
/ I I,
~~ ----------
,
~\
,
,
I
I
I
\
, ,
,
,
[Figure 5-2 Inkjet Printer Installation Environment]
3) Foot Switch
The footswitch connector is located on the rear panel of the system.

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MEDISON
Peripheral Device Settings

This section contains instructions on general system settings that do not affect imaging functions.
Settings can be changed to suit the various needs and preferences of the user.
1) Press the [F6] SetUp button on the keyboard. The Setup window will appear.
2) Select System from the [Peripherals] menu.
The following describes how to set up the video output type, video input type, printer, foot switch and
network. Select the Peripherals tab from the Setup menu.
[Figure 5-3 Peripherals Settings Window]
5-2-1 Video Output Type

Set the output type of the VCR Port as NTSC or PAL. The setting is applied immediately after setup.
5-2-2 Foot Switch

This assigns functions to the left and right pedals of the foot switch. Four options are available: Dual,
Store, Freeze and Update.
5-2-3 Printer
Setup the printer.
Connect a USB printer to a USB port on the system. Select the printer model from the screen and press
OK to start using the printer immediately.
The USB printer can only be used to print out Report and SonoView screens.

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MEDISON
Testing Peripheral Devices

5-3-1 B & W Printer Tests
A BM! Printer must be installed in order to perform this test.
1) When the printer installation is complete, check that paper is loaded in the printer. If not, load the
appropriate printing paper.
2) Use the Freeze function to produce a 20 image.
3) Click the Printer button to print the image displayed on the monitor screen. If image printing quality is
not satisfactory, adjust the brightness and contrast of the printer as appropriate.
5-3-2 VCR Tests

A VCR must be installed in order to perform this test.
1) When the VCR installation is complete, check that a video tape is loaded. If not, insert a blank video tape.
2) Use 20 Mode and PW Mode simultaneously to record VCR.
3) Rewind the recorded tape in order to play the recorded video.
4) When rewinding is complete, select the menu Utility -> VCR -> Play. Then press the Play button on
the VCR to play the recorded video. If there is noise on the video and/or audio, replace the VCR and
rerun the test.
5) Select the menu Utility -> VCR -> STOP to return to the previous screen.
6) The VCR input must be set to external input.
5-3-3 Foot Switch Tests

A Foot Switch must be installed in order to perform this test.
1) Check that a Foot Switch is connected to the rear panel.
2) In 20 Mode, press the Foot Switch to see whether the Freeze function works properly.

'.~:~~~~.~~:~~.~r~ ,
E-,r,
0 6-1 Overview 71
0 6-2 Internal System Structure 72
0 6-3 System Block Diagram 74
0 6-4 PSABoard 75
0 6-5 Front End Board 78
0 6-6 Back End Board 83
6-7 Key Matrix Board 90
6-8 Supported I/O Port 92
0 6-9 Power 93
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MEDISON
Overview
The SA X4 system consists of 8 main parts.
CDPSA
Front End Board
@ Back End Board
Key Control Unit
@ Power Supply Unit
@ AD Power Module
(J) DD Power Module
@Monitor
The Main Board comprises two parts and features the following characteristics.
48 TX-based channels are operated by Digital Beamforming and the built-in CD RW Drive facilitates
convenient image backup and speedy software service.
Improved compatibility w~h extemal USB MOD and Flash Memory provides aflexible upgrade environment.
This product features PW (optional) and Quick Scan Mode, which is incorporated in premium class
systems only.
Power and video connections from the monitor are directly wired within the system frame, and the four
casters facilitate easy movement of the system.
- - - - - - - - - - - - - - - - - - - - - - - - - - - Chapter 6 System Structure' 71

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Internal System Structure

This section contains a description of the internal system structure.
6-2-1 Main Board Location

This section describes the location of the Front-End Board and the Back-End Board.
~---+---CD
~-----+--
.-------t--@
[Figure 6-1 Main Board Location]
Figure 6-1 shows the Main Board inside the Front Cover.
CD Front-End Board
(2) Back-End Board
CID Power Supply Unit

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MEDISON
6-2-2 Sub Board Location

This section contains description of the locations of the Mother Board, Rear Board, HDD, CD RW
_ ......- - G )
4---CD
:.-=---0
------------------------~
__ . _ _ub Board Location]
CD Mother Board
Rear Board
@HDD&CDRW
6-2-3 Key Control Panel

This section contains description of the locations of the key Metrix Board, Alphanumeric key Board, Track Ball.
[Figure 6-3 Key Control Pannel Location]
CD Key Metrix Board

Alphanumeric Key Board
@TrackBall
- - - - - - - - - - - - - - - - - - - - - - - - - - - Chapter 6 System Structure 73
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System Block Diagram

This is the system block diagram.
PSA Control Pannel
2 PROBE Connector ~ Mode Switch

Irclude HV SW mc Slidepots
Irclud Probe ID Reader
Irclude BD Version
~roDe Il!
Probe Select ...
~ ~TX Pulser
I.~ Alphanumeric Keyboard
J
Front End Board
Folding Structure
48ch TX pulser / board
48ch Umiter
I.~ Track Ball
J
48ch Preamp
24chTGCAmp
24ch AID converterBipolar TX pulses
Synthetic Aperture
RX Dynamk; Aperture Funtion, RX Apodization Funtion
Trapezoldallmaging

Max 4 TX Focal point Supported
Coick Generator(61.6Mhz)

HV Voitage, Curr Censing
Probe control (ID read & Select) HDD J CD/RW J USB Port J
---r-X- X X
r-- Back End Board I : RF Data

DSP Part
Real time 2D gray-scaled imaging (2D-mode)

PC Part

......... Manufacturer: Advantech
Pre-gain Shrrt (0-5) ~ Model: SOM-4450
BIW Input Controller (BIW) clock generation
Full Spectrum Imaging (2 Band)
'11
r
~ GX-1300Mhz Processor
l1li'" PCI / Local BUS Intertace
BIW Output Controller(Separate BIW & Mdata) ....... Control Part
Pulsed wave (PW) spectral Doppler Peripheral Port Intertace
Sum Average Boxcar Fiiter """IIIIf
Clutter Fiiter (High Pass Fiiter)
Hilbert Transform (Doppler Sound)
FFT (Doppler Spectrum)
HPRF Supported (at Unear PROBE)
B-mDde Data : PW-mode Data

... ...
DSC Part
VM Part
Mid Intertace
Frame Average Post Process
Image Syrch Generation (512'440)
Scan Converter
BIW, Loop Dual Display Window Generation
Cl NE : Max 512(Fast Mode),
Image Header Mapping (BIW, M, Doppler)
Max 256(in high density mode) .... ECG Image mapping
Frame Interpolation . . . . . .~ Image Grabber Memory (Gray Bar, B dual,
HDZoom .... B/Loop, Sonoview data)
Quick Scan Field Memory (Video Frame Memory)
Edge Enhancement
Loop Control
Loop: Max 4096
_......
.1 ~ 'VGAOut
NI to I Process
CCIR601
3D DMA Part Horizontal Interpolation (Scaling)
Vertical Interpolation (Scaling)
ECG control
Interlace VGA Out
RTCControl Interlace CV Out
VIM Intertace
...
1 -I
VGA RGB Out
PCBus
Data Bus <l ~ ....._R_e_a_r_pa_n_n_e_1...} Interlace RGB Out
Interlace CV Out
[Figure 6-4 System Block Diagram)
Chapter 6 System Structure' 74

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MEDISON
(11 PSABoard
6-4-1 PSA Board Overview
PSA is responsible for the functions required in interfacing the system and probes.
There are two 156-pin probe connectors and a relay circuit for selecting the two probes.
The PSA Board of this system is essentially different from other Medison products because it incorporates
a High Voltage Switch Block.
6-4-2 PSA Board Specification

1) High Voltage Switching (48CH <-> 128elements)
2) 128 Element 2 Probes
3) Included HV SW( ECN3290 )
4) Included Probe ID Reader
5) Included BD Version
6-4-3 PSA Board Block Diagram
48Ch 128Ch PROBE A

Front End Board ~ ..~
CANNON 156
High Voltage 128Ch Relay
Switch ~ Switch
128Ch PROBE B
~ CANNON 156
Mother Board ...... BUFFER
...... RELAY
DRIVER
" ,J+ PROBE ID
READER
r
DC-DC Power
...... POWER
Module
-
BOARD
VERSION
--+
Control Signal
Signal Flow~
[Figure 6-5 PSA Board Block Diagram]

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MEDISON
6-4-4 PSA Board Description

1) High Voltage Switching Process
Up to 128 elements are supported through 48 channels, and therefore 18 high voltage switches are
used on 8 channels.
The control logic for high voltage switching reside in the Front End Board, and control signals are
connected to and controlled through the connector.
48CH
49 97 128
128EL
[Figure 6-6 High Voltage Switching Process]
2) Relay Switch
The relay switch is used for selecting either one of the two probes.
This relay switch receives the PROBE_SEL signal from the Front-End Board and makes the switch
select a probe.
FE HVSNJ Relay V23079
F
B
R
0 48
N CHO-CH47 0-127
T
128
E
N 0 A
0
PROBE_BEL
--------------------~
[Figure 6-7 Relay Switch Diagram]
3) Probe ID
Reads the probe ID and sends the data to the Front End Board.
4) Board Version
Identifies the Board Version

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6-4-5 PSA Board Picture
[Figure 6-8 PSA Board Front]
[Figure 6-9 PSA Board Back]
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Front End Board

6-5-1 Front End Board Overview
The Front-End Board contains a TX pulser and a Digital Beamforming Part. It uses six Beamforming
ASIC (MCB014B), 48 TX channels and 24 RX channels.
It generates transmitting pulses for operating the probe elements and it also performs the digital beam-
forming function by processing the received echo signals multiple times.
The built-in pulser generates pulses on 48 channels. The received echo signals are limited and amplified
to a certain level by the limiter and preamp, and the 49 channels are converted into 24 channels by folding.
Signals are appropriately amplified, depending on the depth, by the TGC control. The post-ADC digital
signals are time-adjusted at FIFO and then summed at BFIC. This process is called beamforming.
In addition, the beamformer performs various functions such as Dynamic Apodization, Multi Beam
Receiving, and TGC for improving the image quality.
6-5-2 Front End Board Specification

1) Folding Structure
2) 48ch TX pulser / board
3) 48ch Limiter
4) 48ch Preamp
5) 24ch TGC Amp (Dual Channel TGC Amp, AD8332: 16 units)
6) 24ch AID converter (8 Channel AID Converter, ADS5122: 3 units)
7) Bipolar TX pulses
8) Synthetic Aperture supported
9) RX Dynamic Aperture function (max 16 steps)
10) RX Apodization function (different curves supported for each mode)
11) Trapezoidallmaging supported
12) Max 4 TX Focal points supported
13) Clock Generator
14) HV voltage/current sensing
15) Probe control (ID read & Select )
- - - - - - - - - - - - - - - - - - - - - - - - - - Chapter 6 System Structure' 78

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6-5-3 Front End Board Block Diagram
BF Control
HV Power Buffers Back End Board

Pulse control
Pulser
PSA Board <lIIII (48 ch) signal
buffers HV, CP
control
BFIC ~ Back End Board

(24ch)
Umiter & Fdd' TGC LPF &
PSA Board ~ Pre-Amp ~ 1119 ~ ~ ADC ~
(48ch) (48)24ch) (24ch) (24ch)
TGC curve / reference

generator & buffers Back End Board
Probe Control (ID Read & Select) Back End Board
HV Voltage & current sensing Mother Board
Clock Generator Mother Board
---+
Control Signal
Signal Flow' ~
[Figure 6-10 Front End board Block Diagram]
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - Chapter 6 System Structure' 79

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6-5-4 Front End Board Description

1) TX Pulser
The exciting pulse generated by the MCB014B passes through the TX Pulse Buffer (74LV574) to
produce a high-power bipolar pulse, which is transmitted to each element of the transducer. The
high-power bipolar pulse is the TX pulse.
MHIC0201-3 circuits are incorporated into the board instead of using hybrid IC. One MHIC0201-3
circuit contains 1 block and each block contains 2 channels. The system uses 24 blocks.
2) Receive Channel
The Receive Channel features a Limiter, TGC amp, Low-Pass Filter, and AID Converter.
BFIC
RX Path Block AD Block

[Figure 6-11 RX Path Block & AD Block Diagram]
CD High Voltage Switch

A separate element selection is required as the system supports up to 128 elements on 48
channels. The system uses 18 8-ehannel high voltage switches, which are contained in the PSA.
Limiter
Rx signals passing through the high voltage switches contain TX pulses of up to 180 Vpp and
millivolts of echo signals. Thus the TX pulse has to be filtered before the TGC, and the Limiter
is used for this purpose.
@PreAmp
This amplifies the signals by about 20dB.
CD Fold & Reorder
Reordering basically reorganizes the sequence of signals. Cross Point Switches (CD22M3494)
reorder echo signals that have differing centres depending on the scanline.
Sc(n)
Ele(n-4) I Ele(n-3) I Ele(n-2) I Ele(n-1) Ele(n) I Ele(n+1) I Ele(n+2) I Ele(n+3) I

I
i CHO i
CH1
CH2
CH3
[Figure 6-12 Reordering & Folding when scanline is in between elements]
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TGC Amp
The TGC (Time Gain Compensation) Amp (AD8332) contains 2 channels in each chip. This
compensates the ultrasound wave signals bouncing off the medium for the loss of power by their
travel time (distance).
Compensation is made within the range of 7.5dB to 55.5dB, which can be achieved by using the
HI Gain Mode.
Low-Pass Filter
The Low-Pass Filter, the final station of the analog receive channel, is an anti-aliasing filter that
only suppresses noise in the stop band, which is not the range of ultrasound signals, but it also
minimizes the aliasing effect that may occur in high-frequency probes such as 7.5MHz probes
due to the sampling clocking limitation of digital beamforming IC in the next station.
(J) ADC
This converts analog signals into digital signals for use in digital beamforming.
3) Digital Beamforming
Echo signals that return from one particular target do not arrive at the transducer at the same time,
but arrive at slightly different times. In order to compensate for this time difference, the digital
beamforming method (shown in Figure 6-13) uses sampling and memory to align echo signals in
time sequence and add an echo to them for beamforming.
000 I signal
Transducer Sampling Memory
[Figure 6-13 Digital Beamforming (PSDF: Pipelined Sampled Delay Focusing)]

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6-5-5 Front End Board Pictures
Limit / PreAmp / TGC
Fold & Recorder
ADC
Pular
Low Pass Filter
BFIC
Control
[Figure 6-14 Front Side of Front-End Board]
[Figure 6-15 Rear Side of Front-End Board]
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Chapter 6 System Structure' 82

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Back End Board

6-6-1 Back End Board Overview
The Back-End Board consists of four parts: a Digital Signal Processing (DSP) Part, Digital Scan Converter
(DSC) Part, Video Manager (VM) Part, and PC Part, in addition to a Doppler sound analog Part.
The DSP Part receives RF and CW I/Q data from the Beamformer board to produce a BW image
and Spectral Doppler Spectrum, and sends them to the DSC board.
The DSC Part receives Doppler Data and BW Data (2D and M), which are saved in the DSC Module.
The data is then Scan Converted and sent to the Video Manager Module at appropriate V sync and H sync.
The Video Manager displays the VGA 640 x 480 image on the monitor screen.
An area of 512 x 440 only is allocated for displaying ultrasound images, and this area is also used
for showing external input signals such as from a VCR. The VGA display uses the non-interlace
method, much like a PC monitor, and VCR images are displayed using the interlace method.
In order to operate the PC Part, an industrial PC is usually incorporated into the system.
The industrial PC used in the SA X4 is Advantech's ETX Type PC Module SOM-4450.
Operating System in use is Linux, which supports a wide array of peripherals.
6-6-2 Back End Board Specification

1) Embedded PC
2) Real time 2D gray-scaled imaging
3) FSI (Full spectrum imaging) supported
4) Motion mode (M-mode) - Scroll speed 120,180,240,300Hz
5) Pulsed wave (PW) spectral Doppler
6) HPRF supported (at Linear Probe)
7) Cine for 256 (in high density mode) or 512 (in fast mode) frames
8) Loop Review for 4096 lines
9) FreeHand 3D mode
10) ECG mode
11) Write Zoom, Read Zoom, Frame Average, Frame Interpolation, Edge Enhance,
12) POST GAIN CONTROL
13) Quick-Scan
14) 4 USB 2.0 ports supported (2 ports on the front panel and 2 ports on the rear panel)
15) Screen Size 640x480 (Image Size 512x440)
16) NI21 supported (VCR Record, ECHO Printer)
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6-6-3 Back End Board Block Diagram

From Front End Board
I
Produces 2D Image
Produces 1&0 Signals

~ DSP
FPGA
Doppler
DSP
Basic Do~ler
Data process
~ Soung out
Loopf3D
SDRAM
--=-J
Memory BWdata
scan conversion
Cine DSC
SDRAM
Memory J I I FPGA
Frame
Memory
SDRAM
~ -=J DSP
Real time cntrol
Post
Control
SDRAM Video DAC III ~ VGA RGB out
Nltol VM
SDRAM Video DAC . . . .~lnterlaCe
Control JI I FPGA RGB out
Converts Image
V-sync, H-sync to
------~~
Field Memory Encoder . . . .~lnterlaCe
P VHS out
VGA V-sync,H-sync ' _
Generates
Image ~
V-sync DSC
H-sync
PC Peripheral Port Interlace
[Figure 6-16 Back End Board Block Diagram]
Chapter 6 System Structure' 84

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6-6-4 DSP Part

1) DSP Part Block Diagram
This section describes the DSP Part Block Diagram.
Beamfoorer RF III
~~
Synthetic
it
Aperture
Doppler, Clutter Rlter
DSP FFTCiraJit
~QdaIa
BIWdata MCB025
FSI #0
DSP
FPGA SDRAM
Pre-Gain Shift 256M
Input Control
Rtters
Output Control
BIWdata MCB025
FSI #1 ~QdaIa
. BNI, C\l1'lJ.. Data oLI

I:JDSCpal
Synthetic
Aperture
SRAM J SRAMJ
#0 #1
[Figure 6-17 DSP Part Block Diagram]
The DSP Part consists of a 2D mode part, a Spectral Doppler Part, and a Calor Doppler Part.
The 2D mode part receives the beamformed output signals, generates BNV signal (2D image) data and
sends it to the DSC Part.
The Spectral doppler mode part separates the RF signals received for Doppler direction separation into
I (Inphase) signals and Q (Quadrature) signals. Then it uses the clutter filter to remove the clutter noise
in which is a kind 0 wall noise from vein wall out of the signals. The signals with wall noise removed are
sent to the PCC Board for the Doppler Sound process, and they are sent to the FFT circuit, where the
basic Doppler elements Power, Velocity, and Variance are analyzed.

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2) DSP Part Specification

* Real time 2D gray-scaled imaging
CD Pre-Gain Shift(Q,..,,5)
B/W Input Controller (B/W) Clock Generation
@ FSI(Full spectrum imaging) Supported
B/W Out Controller (Separate B/W & M data)
* Pulsed wave (PW) spectral Doppler

CD Sum Average Boxcar Filter
Clumer Filter (High Pass Filter)
@ Hibert Transform (Doppler Sound)
CD FFT (Dopplet Spectrum)
HPRF Supported (at Linear PROBE)
6-6-5 DSC Part
1) DSC Part Block Diagram
This section describes the DSC Part Block Diagram.
Save and manager

D& M data LOOP /30
DSP
Image Storage
_ __F_ra_m_e_.......
Memory JL.._ .....
.,.... FPGA
CPLD
J
~~~ I..... (Host
-::M=e=m=Ory=#=1=~~.
Tem>orary Image Storage CINE
~ .. Control)
_
Real Time Controler
ECG Data J
[Figure 6-18 DSC Part Block Diagram]
The DSC Part is an image filter circuit that improves image quality. It consists of the scan conversion
part-which writes the received scan line data and reads the monitor by the h-sync cycle, frame memory
part, and zoom and freehand 3D path parts.
The DSC Part sums data from 2D mode and Spectral Doppler mode produced by different paths
together as one set of common data.
It facilitates various functions such as Digital Scan Conversion and Frame Average, 3D (DMA), Cine,
RTC, Read Zoom, and Edge Enhance along with Memory.

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2) DSP Part Specification

CD Mid Inter1ace
Frame Average
@ Scan Converter
CINE: Max512(Fast Mode),
@ Max 256(in high density mode)
@ Frame Interpolation
(J) HD Zoom
@QuickScan
Edge Enhancement
@l Loop Control
6-6-6 Video Manager Part

1) Video Manager Part Block Biagram
This section describes the Video Manager Block Diagram.
Video DAC VGA RGBout
I
Post
Controller
J Video DAC Interlace RGB out
I
--.:::J
I Field Memory
J --.:::J
Encoder Interlace CV out
[Figure 6-19 Video Manager Part Block Diagram1
The Video Manager Part converts the image data (512 x 440) received from the DSC Part into RGB
values (640 x 480) for displaying on the monitor and keys it in with the PC's VGA data. The keyed data
is tumed into interlace and non-interlace signals for displaying the final output through a VGA monitor,
interlace monitor, echo printer, etc.
The Video Manager Part has the following features.
2) Video Manager Part Specification

* Post Process
CD Image Synch Generation (512 * 440)
BM!, Loop Dual Display Window generation
@ Image Header Mapping (BM!, M, Doppler)
ECG Image mapping

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@ Image Grabber Memory (Gray Bar, B dual, BlLoop, Sonoview data)

@ Field Memory (Video Frame Memory)
(j)VGA Out
* Nltol Process
CDCCIR601
Horizontal Interpolation (Scaling)
@ Vertical Interpolation (Scaling)
Interlace VGA Out
@ Interlace CV Out
6-6-7 PC Part
This section describes the PC Part.
CD Manufacturer: Advantech
Model: SOM-4450
@ Equipped with an embedded NS GX1-300Mhz processor, the SOM-4450 ETX System-an-Module
is a low-power high-performance core engine used in various applications.
1) PCI / Local BUS Interface
The PCllLocal BUS Interface Part features PLX's PC19054 and XC95144.
The PCI9054 connects to the PCI Bus of the PC, converting it into a Local Bus so that various devices
on the Local Bus can be allocated in absolute address ranges for their direct use.
Depending on each state (read, write) of PCI9054, the XC95144 generates decoded signals for
controlling the peripheral devices connected to the Local Bus.
When in SonoView or 3D Mode, signals are received from VM and DSC to open the DMA channel
and data is obtained in units of lines or frames.
2) Miscellaneous Control Parts
The CPLD generates overall control signals for VGA Path Control, Audio Path Control, etc.
3) Peripheral Port Interface
Peripherals provided by the SOM-4450 PC Module are as follows.
CD 2 IDE (Ultra DMA33) / 1 FDD
1 Parallel / 2 Serial
@Soundout
2 USB (1.1 compliant)
@ Ethernet (100M BASE-T Ethernet)
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Chapter 6 System Structure 88

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6-6-8 Back-End Board Picture
[Figure 6-20 Front Side of Back-End Board]
[Figure 6-21 Rear Side of Back-End Board]
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Key Matrix Board

6-7-1 Key Matrix Board Overview
The Key Matrix of SonoAce X4 provides a UI (User Interface).
It interfaces the user with the system, for instance by relaying commands to the system when the user
clicks a function button, so that the system can execute the assigned operation. It also performs a power
control function by linking with the power on/off switch.
For SonoAce X4, the UI consists of a Key Matrix BID, Alpha Numeric Key Interface BID, and Trackball.
6-7-2 Key Matrix Board Block Diagram
PC
nterface DS IRESET
r1
1233
COM2_RXD
RXD
~ D[0.. 7]
MAX232
J. TXD
89C51
SA[0..7)
NlR
IRD
11.0592
ALE
MHz J SA[0..2) fTMRINT
I I~ RESETL
ADC ClK
-+ SD[0..7)
+
33V_RESET
33V_ADC ClK
ADCOE 74HC 3.3V_ADC OE
A DC0808 245 3.3V ADC START
ADC START
3.3V_ADC ALE
XC95144XL-TQ144
ADC ALE
.. FOOTSWl
4N25 r
J SR[0..7)
.. FOOTSW2
4N25 DOT
J MATRIX SC[0..7)
PR INTREMOTE
OIl RELAY
J
EDO A
ENCODER1
SW
J
EDO B
:
:
ENCODER2 EDl A
EDl B
SW
J
ENCODER3
:
ED2 A
sw ED2 B
J
[Figure 6-22 Key Matrix Board Block Diagram]

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6-7-3 Power Control

Pressing the POWER ON switch on the system keyboard sends the ON signal from Key Matrix to
POWER, tuming the system on.
Pressing the POWER OFF switch on the system keyboard makes (1) POWER_SW change its signal
from H -> L. If the signal remains the same for about 2 seconds or more (2) the POWER_DOWN signal
changes from H -> L, in which case the Key Matrix sends the (3) "POFF" value to the PC through
RS232 communication. The PC terminates the Main Software and once terminated, it sends to the Key
Matrix the (4) "eSP' value. Finally, the Key Matrix BID sends (5) POWER_DOWN H -> L to
POWER and the system power shuts down.
3 "POFF"
Power 2 POWER_DOWN KM BID PC
4 "cSF"
5 POWER_DOWN
..
[Figure 6-23 Power Control Diagram)
6-7-4 Key Matrix Board Unit Picture
[Figure 6-24 Key Matrix Board)
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Supported 1/0 Port

6-8-1 LAN
Connector: RJ45 (10BASE-T, 100BASE-T)
Electrical characteristic: 1000hm Impedance
Speed: 10Mbps, 100Mbps
Reference Specification: IEEE 802.3X
6-8-2 USB
Connector: USB Series A Connectors
Electrical characteristics: 3.6V (Low, Full), 480mV (High), each 900hm Impedance
Speed: 1.5Mbps (Low), 12Mbps (Full), 480Mbps (High)
Reference Specification: Universal Serial Bus Specification Revision 2.0
6-8-3 IDE Hard disk

Connector: IDE Standard Connectors (Support UDMA66)
Electrical characteristic: 3.3V LVTTL
6-8-4 VIDEO Output

Connector: DSUB 15Pin, BNC
Electrical characteristic: Analog RGB 0.7Vpp, 750hms Impedance
- - - - - - - - - - - - - - - - - - - - - - - - - Chapter 6 System Structure' 92

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Power
6-9-1 DC-DC Power Module Overview
The power unit of the SA X4 has the following features.
1)Power sequence control function using Mycom.
2)Voltage channels of various ranges and stable and consistent output voltage on each channel.
3)The output voltage display allows the user to check power-related errors.
4)High-performance monitoring of various errors (over current, over voltage, output short-circuit, low
voltage, etc.) by Mycom.
5)Power protection function.
6-9-2 DC-DC Power Module Output Voltages

These are the De-DC power Module output voltages.
Remark
+1.8V 2A 3.6W
Max 10A can be supplied

+3.5V 8A 28W
when 1.8V is not in use.
+5VA, +5VD 8A 40W
-5VA O.5A 2.5W
+12VD,+12VP
3A 36W
+12VFAN
-12VA,-12VD O.5A 6W
+15V 2A 30W
+HV O.2A 16W
-HV O.2A 16W
+97V, -97V O.1A 9.7W
SUM 197W

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6-9-4 Power Monitoring Function of DC-DC Power Module Output

This section describes the Mycom Power monitoring function.
[Figure 6-25 Mycom Display]
1) OlP (Overload Protection)

Disconnects all output power for protection of the system and lights up the "OlP" lED when the
output voltage drops below 80% or short-circuits for 500msec or longer.
2) OVP (Over Voltage Protection)
Disconnects all output power for protection of the system and lights up the "OVP" lED when the
output voltage exceeds 110% of the rated voltage for 1OOmsec or longer.
3) OTP (Over Temperature Protection)
Disconnects all power and lights up the 'TP" lED if the temperature of the heat sink exceeds 80-82
degreesC.
4) Output Voltage Check (5V, 12V, 97V, HW)
All lED lights are green in normal condition. In case of an error, the main power is disconnected,
lEDs are tumed off, and a yellow lED for the given error is turned on.
6-9-5 DC-DC Power Module Picture
[Figure 6-26 DC-DC Power Module]

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6-9-6 AC-DC Power Module

The SA X4 Power Supply is designed to operate at 115Vac or 230Vac.
Please adjust the voltage selector correctly before use.
An INPUT Voltage Selector is used for selecting the power and voltage of the system.
An OUTPUT Voltage Selector is used for selecting the voltage of a printer and VCR directly supplied
from the system.
Please refer to the diagram below for more information.
CD-+----i~
1-4H--t--@
[Figure 6-27 AC-DC Power Module]
" A
Power Cable
Power supply cable
2 Fuse Holder
Houses two fuses
3 Input Voltage Selector
Input voltage selector (115V/230V)
4 Main Power Switch
Main power switch
5 Output Voltage Selector
Output voltage selector (115V/230V)
Output power directly supplied by the system.

6, 7 Output Voltage
Power outlet for printer, VCR, etc

'.~:~e:e.~:~~ ,
o 7-1 Option Setup 97

o 7-2 Infonnation 98
o 7-3 Administration Mode 99
o 7-4 BIOS Setup 105
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Option Setup
This function displays software serial number information and allows the user to selectldeselect software options.
Details in Option Setup cannot be charged by the user. It is intended to be used by professional technicians only.
The Option Setup screen is illustrated below.
1) Press the F6 SetUp button on the keyboard. The Setup window will appear.
2) Select the Option tab from the Setup menu.
_.
0.--
lma
0tC0..
Fltlt -
1999-S7n-l2S7-93.t5
~ . " :407 :1':

1GOll~3ll84-~-
[Figure 7-1 Option Setup]
7-1-1 Option Unlock

Follow this instruction to select software options.
1) Press Unlock and the Unlock Code window will appear as shown.
2) Enter the correct password in the Unlock Code window. Options available for use will be displayed.
3) Options cannot be selected for use unless the correct password is entered. Press Cancel if the
password is not correct.
x
0.--
Ima",Fltnc
0tC0.. 5398 1 - 2401 - 2142
F'_3D
PulSe .. _
[Figure 7-2 Unlock Code]

Chapter 6 Service Setup' 97
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7-1-2 Option Lock

Follow this instruction to lock software options.
1) Press [Lock] and the Lock Code window will appear as shown.
2) Enter the correct password "********,, in the Lock Code window.
3) Options cannot be deselected unless the correct password is entered.
I m Key
I.o<kJ
DlCOM
Ft fund 30
OK
[Figure 7-3 Deselecting Options]
Information
This function displays Version information for the system software.
Select the Information tab from the Setup menu and press [Detaillnfo]. to view detailed system information.
[Figure 7-4 Information]

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Administration Mode
This section describes Administration mode (hereinafter called ooadmin modeO). This mode facilitates
software upgrades and backup & restore data operations.
7-3-1 Entering Admin Mode

1) You have to enter a password with a combination from the alphanumeric keyboard in order to enter
AdminMode.
2) In Live Mode, enter the admin password "[Ctrl] + [Enter] + 'admin' + [Enter]" and the admin mode
popup will appear as shown below.
3) You must keep the [Ctrl] key held down until the complete admin password is entered.
4) Enter the password "********,, in the admin mode popup to enter Admin Mode.
Entef Admin Password:

I........
OK Caneel Help
[Figure 7-5 Admin Popup]
7-3-2 Admin mode

This section describes Admin Mode.
!\jo
f---"~ I '- eo....-. I HllOC>ooIoot e-o~ ...-----<

@>---_~ 'ort n... Zone $ o t I q . .
~ ~Seltlnto _ _>
CwoOll ~
.. -----<
>-----+.
@>----
_I
.....
[Figure 7-6 Admin mode]

See it all _.
MEDISON
CD Enter the system serial no in System Serial #.

Saves all settings in the system.
@ Initializes the system back to the factory default settings.
Exports image setting parameter values regarding all probes in the HTML format. (For R&D only)
@ Lock Manager: Executes the Linux-based application for unlockingAocking software options.
@Software Up-grade (Version-up)
(J) Backs up / restores all settings for the system. : All information including general settings and
SonoView settings.
@ Controls overall system operation.
HOD Checking: Checks the hard disk for any problems.
@) Time Zone Setting / Cure DB (Not in use)
@ For debugging (for R&D only)
7-3-3 Up-grade
Follow these instructions to up-grade the system:
1) Insert the CD or MO, or insert a Flash Memory into the USB port.
2) Press the @ Up-grade button in the Admin window.
3) Select the device.
Ad "n
1 .,. SonoAoe )CA ~Df U.
... P*Jee Mleat cnI 0' the roll CJllrIng dtvtCile:

I) IISB RAS1l C/4-I..... M)
2) 1D'~b:Ml", {fM/O<4>. _UOJ
e-.l. t
bp . I
[Figure 7-7 Up-grade Device]
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Chapter 6 Service Setup 100

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MEDISON
4) Select the up-grade version.
P*J....IIt on 0" U. foil owing dtvtCille:
;1 ::~ ff::::;'.~~)
Oft: IE.dt
bp 1
V... ho.. Hlocto<t 1oS8}W1l (I",/odo .r.\J
_ooJoot~IlI.'
1) P3A.IIP..00.00.1 i1t6. , ....
1) .lA.IIP.00.00 16'8.~ .
.
3) p~ ..,..' ,00,0022&8.19< '
'). 00.002816!lJ''',
$) P3A .I.oo.0Q.2U9.l1l1 " ,
.) .JA I.OO'00'2~.Ilp".
Q) CoMel & btt.
.,
8ol...... _ _...
....
[Figure 7-8 Up-grade Version]
5) Hit "y" for the correct file.
"1
Vcu "'" ..loctAd LSll.FU\Sll (I"'/odo .rotJ
Pflto.. Mid upgra:5e N.;
I) 1'3A,up.l.00.oo,I.96.~zIn.
l) I'3A.OIP.l.00.00.16!8. 'Ill.
a) I'3A,U 1.00.00 22ea.~, In
f) PU_ 1.00.00 23 5.tJlln.
!) 1'3A,up.1.00.00 2289.~z In
6) P3A.OIP.1.00.00.2aa6. I III .
Q)e-.l & \
. )6
Yc ~ HI.abd P3,0L"P.1.00 OO.2335.tciJz tn
I. It CCll"T'Ktl CIn) I
8cl.. ...
....
[Figure 7-9 Up-grade File]

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MEDISON
6) When upgrading is complete, the system will ask whether you would like to up-date the image user
settings with factory settings.
u,,-o
,w.t .....
[Figure 7-10 Up-grade Image User Setting]
7) Reboot the system to apply the upgrade.
Ad 'n
'fllt ...~_ e-o~

_Oon.......-_";;=======::::i====-=CO:-~ $tttInc
.N.....'..'".,..,........,
JTIAIJZI!Jle corr.pld.ed,
PIeOCMI.-t.atltM"!I't.n.
IN .
'N'H,,,,,,.,U',.,,,,,,,,,,,
~.canpleU,
P\eoIMI"Mtcrt~"!Ittn.
........, " ", ..
510011
.....
[Figure 7-11 Up-grade Reboot]
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Chapter 6 Service Setup 102

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MEDISON
7-3-4 Back-up User Setting

Follow the instruction to back-up user setting values.
2) Press Back-up User Settings and the following window will appear.
Sl>oll
.....
[Figure 7-12 Back-up User Setting]
3) Select CD, MOD or Flash Memory.
bporl Sew.,. Cwo OIl

- ? OoJOOlwonl,._OOdolo1 -
""'.--
No
-
Sl>oll
.....
[Figure 7-13 Back-up DB data]
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Chapter 6 Service Setup' 103

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MEDISON
CD CD Destination
The CD Media Check Progress bar will appear, checking the media. When bar reaches 100%,
the PC Write Progress bar will appear and the system will start writing to the CD. When the bar
reaches 100%, the CD Writing Complete window and the OK button will appear. Press the OK
button to close the window.
MOD or USB Memory Destination

The progress bar will appear and the system will start writing to the MODIUSB Memory. When
the bar reaches 100%, the OK button will appear. Press the OK button to close the window.
@ Message appears when medium does not exist

The following message will appear if the medium is not ready.
011
---
_1Ioor....
_IIoor-.o ... _ -
[Figure 7-14 Back-up again message]
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - Chapter 6 Service Setup' 104

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MEDISON
7-3-5 Restore User Settings

Follow the instructions to restore backed up user setting values:
2) Press Restore User Settings and the following window will appear.
Shell
.....
[Figure 7-15 Restore User Setting]
3) Select CD, MOD or Flash Memory.

4) The progress bar will appear and the system will start decompressing restore data into the temp directory.
5) Press the Close button to close the Restore User Settings window.
BIOS Settings
NOTE I
BIOS setting values do not need to be changed for setting up the system.
The system is designed to operate with the default BIOS setting values.
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - Chapter 6 Service Setup' 105

'.~i~~~~~~~l:.~~~.~~~~~!: ,
E-,r,
0 8-1 Disassembly and Assembly Overview 107

0 8-2 Disassembling the Main Board 107
0 8-3 Disassembling the Control Panel 112
0 8-4 Disassembling the Control Panel 114
0 8-5 Disassembling the Rear Panel Board 120
0 8-6 Disassembling the AC-DC Power Module 127
0 8-7 Cable Layout 129
See it all _.
MEDISON
Disassembly and Assembly Overview

This chapter contains instructions for disassembling and assembling the SA X4 system.
Lt. WARNING I
Internal parts of the system are subject to high voltages. The system must only be disassembled by
professional Medison technicians.
If working on the system with the power on, do not use an anti-static wristband connected to the system
frame.
Disassembling the Main Board

This section contains instructions for disassembling the Main Board.
1) PSA
2) Front End Board
3) Back End Board
4) Power Board
Chapter 8 Disassembly and Assembly 107

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MEDISON
8-2-1 Disassembling the Front Cover
.. You must remove the Front

Cover in order to disassemble
the Main Board.
Required item:
1 screwdriver (+)
Work summary:
Remove the two screws.
Pull the Front Cover forward.
Use the screwdriver (+) to

remove the screws CD, CV.
Hold the bottom part of the

Front Cover and pull it out.
Do not apply excessive force

when pulling the Front Cover to
avoid any damage.

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MEDISON
.. This is the system with the

Front Cover removed.

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MEDISON
8-2-2 Disassembling the PSA
.. Use the screwdriver (+) to

remove the screws G)-@.
Hold the upper and lower

parts of the PSA and pull it
slightly forward.
The edges of the PSA Board

Cover are very sharp.
Take care not to injure yourself.
The PSA is connected to the
slot on the BF Board.
Do not apply excessive force
when pulling the PSA to avoid
any damage to either part.

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MEDISON
8-2-3 Disassembling the Main Board
.. This is the system with the

PSA removed.
Hold the board handles with
both hands and gently pull the
board out.
FE Board ---~-liIiit";TI:
BE Board ----:::I~
DC-DC Power --~ ...
Gently pull the board out with

both hands as shown.
Disassemble the FE Board,

BE Board, and Power Board
in order.
Be careful not to bend the

boards when pulling them out
by their handles.

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MEDISON
Disassembling the Control Panel
.. You must remove the Rear

Upper in order to disassemble
the monitor.
Required items:
-::r:'-:-----t...
..,._ _SJ,o Rear Upper Cover
1small screwdriver (+)
Disassembling the Rear

Upper cover.
Use the screwdrive (+) to
remove the screwG)-.
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
Remove screw G)-@ as
I
I
I shown below.
I
I
I
I
,,
I
I
Use the small screwdriver(+) to
,."".../ 11111111
(.i I
It/lUll remove the two screw G)and@.
I
I

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MEDISON
.. Disconnect the monitor cables.
Disconnect the cable while

pressing both sides of the cable
connector.
Remove the screw from the

neck of the monitor.
Remove the monitor by lifting it

vertically.
Reverse the steps to reassemble

the system.

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MEDISON
Disassembling the Control Panel

This section contains instructions for disassembling Control Panel.
1) Key Matrix Board
2) Alphanumeric Keyboard
3) Power Switch Board
4) Speakers
5) Trackball
8-4-1 Disassembling the Control Panel Upper Case
.. Control pannel Upper Case

- - Monitor
You must disassemble the
upper case of the control panel,
the Rear Upper Cover, and the
monitor in order to disassemble
~ the control panel.
Required items:
Rear Upper Cover ---:,r-t~
Chapter 8 Disassembly and Assembly' 114

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MEDISON
11 Please refer to section 8-3

Disassembling the monitor
III Remove the screw CD--@

inside the back cover
You must remove the two

screws inside the back cover.
Disassemble the lower part of

the control panel.
, ~---------------------~---------------------,
,,
,, ,
...........
/,,/
< "
You must remove the 12 screws
............ .... .... >
,, ,, on the bottom part of the control
............ ,,,/
........ " . panel.
'<
""""""""'"
"'-------J--------.
Bottom side of control
panel upper case

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MEDISON

remove the screwsG)- .
Disassemble the left-hand side

part of the control panel.
remove the screwsG)-@.
Disassemble the left-hand side

part of the control panel.
remove the screwsG)-@ .

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MEDISON
Lift the control panel up.
Gently lift the upper case of the

control panel vertically.
You have to lift it vertically
because of the monitor support
column.
Disconnect the cable connected

to the control panel.
This is the disassembled

upper case of the control
panel.

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MEDISON
8-4-2
..
Disassembling the Alpha neumeric key Board

remove the screwsCD- .
Disconnect the cables indicated
by arrows.
Cable
8-4-3
..
Disassembling the Power Switch Board

remove the screwsCD- .
by arrows.
Cable Cable Cable
..
8-4-4 Disassembling the Speaker

remove the eight screws.
by arrows.
Screw Cable Cable Screw

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MEDISON
8-4-5 Disassembling the Track Ball

remove the screwsCD-.
by arrows.
Cable
..
8-4-6 Disassembling the Key Matrix Board
Remove the two volume

control and eight TCG volume
knobs.
Be careful not to damage the

volume adjusters when removing
the knobs.

by arrows.

remove the 23 screws from the
positions indicated by the red
circles.

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MEDISON
Disassembling the Rear Panel Board

Follow the instructions to disassemble the HOD, CD RW, Rear Board, Back FAN and Top FAN.
.. You must remove the Rear

Upper Cover in order to
disassemble the rear panel.
...;.:...:;----...... Rear Upper Cover

Required items:
....,..--:l~'\
111 ..--::---:--::::-----1... Rea r Cove r
Disassembling the Rear Upper

Cover Use the screwdriver (+)
to remove the screwsCD - .

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MEDISON
8-5-1 Disassembling the HOD/CD RW
.. Disconnect the power

connectors and data
connectors for the HOD and
CD RW as indicated by the
arrows.
The Rear Upper Cover must be

removed prior to removing the
HOD/CD RW.
Data Cable Power Cable

remove the screws CD-@).
Push the CD RW in from the

front.
.La
I
.. ,
C
.-oF-=. ~
,,-

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MEDISON
.. Pull out the HDD and CD RW

case.
Lift the case up slightly and

then pull it out.
This is the system with the HDD

and CD RW case removed.
The fixing contact points are
indicated with white circles.
Make sure that the case

attaches to the points marked
with circles when reassembling.
Remove the screws from the

HDD and CD RW case.

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MEDISON
8-5-2 Disassembling the Rear Panel Board

remove the screws CD- .
IlE.l' Use the screwdriver (+) to

CD
CID

IMS.Z. Remove the Rear Board in

the direction of the arrows.
Be careful not to damage the

connector on the motherboard.

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MEDISON
8-5-3 Disassembling Back Fan
The rear panel must be

removed before this step.

remove the screws CD-.
Disconnect the JP 10 connector.

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MEDISON
8-5-4 Disassembling Mather Module
ilE.sa Disconnect all connectors on

the motherboard.
remove the screws CD-@.
The rear panel must be removed

before this step.

The Front cover, PSA, FE, BE,

and Power module must be
Please refer to Section 8-2

Disassembling Main Board.
Gently remove the module

from the motherboard toward
t e front.
Chapter 8 Disassembly and Assembly' 125

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MEDISON
1) Remove the 12 screws

indicated with red circles.
o'------' --
2) After removing the rnotherboard
cover. remove the 20screws
o the mothertx>ard.
o
o
8-5-5 Disassembling Top Fan
.. CD
remove the screws CD-@).
The mother module must be

removedd before this step.
Remove the upper case of the

mother module.

Turn the upper case of the

mother module upside down
and remove the 8 screws
indicated with red circles.

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MEDISON
Disassembling the AC-DC Power Module

Follow the instructions to disassemble the AG-OC power module.
Remove the two connectors

on the motherboard.
The rear panel must be

Pull the connector on the AC

power module by squeezing

the connector as shown
below.
Use the Screwdriver (+) to

remove the screws CD ~

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MEDISON
.. Remove the AC-DC power

module.

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MEDISON
Cable Layout
This section describes the cabling layout for the control panel and the mother module.
Refer to this section when assembling/disassembling the system.
8-7-1 Control Panel Cable Layout
[Figure 8-1 Control Panel Cable Layout]
8-7-2 Mother Module Cable Layout
[Figure 8-2 Mother Module Cable Layout]

-
'.:.r~~~l~.~~~~~~~ ,
o 9-1 Replacing Fuses 131

Q 9- 2 Cleaning the Dust Filter 133
o 9-3 Monitor Filter Replacement 134
c) 9-4 Cleaning the Trackball 135
c) 9-5 Things to do when the system does not poweron 137
o 9-6 Things to do when there is no B-Mode Echo 138
o 9-7 Things to do when there is no B-Mode image format
o 139
9-8 Things to do when the M-Mode is defective 140
o 9-9 Things to do when the PW-Mode is defective 140
9-10 Things to do when vertical lines are missing from images
141
o 9-11 Things to do when system booting halts 142
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MEDISON
Replacing Fuses
Power protection fuses protect the system from over currents. If the power monitoring protection circuit
detects excess current, it shuts off the current to the equipment in order to prevent overheating and to
restrict the ultrasound power output.
If fuses blow, replace them as shown below.
Lt. DANAGER
To avoid risk of electric shock, always disconnect the plug from the system prior to fuse replacement.
Fuses are located in the

AC power module.

remove the screws CD, (2).
Disconnect the power cable.
~o
Chapter 9 Trouble Shooting' 131

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MEDISON
Press the middle part of the

fuse holder down and pull
the fuse out.
Fuse holder
III The illustration below shows

removal of the fuses with the
fuse holder held down.
-- Replace the fuses.
100-120VAC 85AJ250V
200-240VAC 5A/250V

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MEDISON
Cleaning the Dust Filter

The air filters minimize the indraft of dust. Clean the air filter to ensure that a clogged filter does not
cause the system to overheat and reduce the noise and the system performance.
It is recommended the air filters be cleaned once every three months.
Lt. CAUTION
Be sure to lock the brakes on the front wheels before cleaning the air filters to avoid injury by any
unexpected movement of the product.
[Figure 9-1 The location of the air filters]
1) Pull the filter under the front of the console to away from the product.
2) Shake the filter to remove the dust and wash in a mild soapy solution.
3) Rinse and air dry or dry with a cloth.
4) Slide the filter back into the product.
NOTE
Allow the wet filter to dry thoroughly before installing. The wet filter can cause the malfunction.

See it all _.
MEDISON
Monitor Filter Replacement

Monitor filter not only makes the eyes less tired but also allow clear viewing of images even in dark
places. Monitor filter also protects the monitor surface, preventing scratches and other similar damages.
Follow the instructions below to replace monitor filter.
'- "-"
~ ~ ~J-'1
~.~ ;:-"
'-
[Figure 9-2 Monitor filter replacement]
1) Press the two latches on the upper part of the monitor.

2) Hold the upper part of the monitor filter and pull it out carefully. Be careful not to drop the monitor filter
when detaching it.
3) Push the new monitor filter in, aligning the lower part of the fi~er to the slot on the bottom of the moniotr.
4) Press the latches again and lightly press the upper part of the filter.
NOTE
You can easily press the latches and detach the filter by using a coin or a thin object.

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MEDISON
Cleaning the Trackball

Follow the instructions to Cleaning the Trackball.
Hold the part marked "0"

with your fingers and turn it
counter-clockwise.
This illustration shows

removal of the trackball ring.
III Once the trackball ring is

removed, push the trackball
up from below the control
panel.

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MEDISON
III Use a cotton rod or brush to

clean the sensors.

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MEDISON
Things to do when the system does not power on
System does not power on
I ~
NO
...... Check the diagnosis room
power
YES l
YES
--------...... Check power supply unit

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MEDISON
Things to do when there is no 2D Mode Echo
If no 2D Mode Echo
NO
1
YES
NO
OK
YES
NO NO
~ Defective FE Board
YES
NO
Defective power
supply unit
YES
Contact Medison
Customer Support Center

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MEDISON
Things to do when there is no 2D Mode image format
Contact Medison Customer Support Center
NO
1
NO
OK
YES
NO NO
Defective FE Board
YES
NO
Defective PSA
J
NO
~----+. Defective BE Board
YES 1
NO
Defective power
supply unit
YES
Contact Medison

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MEDISON
Things to do when the M-Mode is defective
If M-Mode is defective
1 NO NO
~--- ......
~ Defective BE Board
YES YES !
NO
~--- .....
~ Defective FE Board
YES
Contact Medison
Things to do when the PW-Mode is defective
If PW-Mode is defective
1 NO NO
~--- ......
~ Defective BE Board
YES
NO
~
_ - - -..... Defective FE Board
YES
Contact Medison

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MEDISON
Things to do when vertical lines are missing from images

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MEDISON
Things to do when system booting halts

Parts
I 41
s
o 10-1 Ordering Part 144
10-2 Part Number 145
$'" it all __
MEDISON
DJ Ordering Part
This chapter contains information on the SonoAce X4 parts.
Please refer to the SonoAce X4 Compatibility Matrix to check the replacement parts and their
software versions for each system configuration (main PCBs and specific hardware parts).
For installing and verifying system parts, please refer to the figures and part tables in this chapter.
Part numbers are indicated in the corresponding tables.
Prior to ordering parts, please verify whether the existing parts can be replaced according to the
current service policy.
Chapter 10 Parts' 144

sI!I!itall
MEDISON
mE Part Number
10-2-1 Board
Part Name BD-342-PSA Part Name BD-342-FE
Part Description PSA Board Part Description FRONT END Board
Part Name BD-342-BE Part Name BD-342-MTH
Part Description BACK END Board Part Description MOTHER Board

$'" it all __
MEDISON
Part Name BD-342-KM Part Name BD-342-PWRSW
Part Description KEY MATRIX Board Part Description POWER S/W BD
Part Name BD-342-USB Part Name BD-342-RR
Part Description USB BD Part Description REAR PANEL RIGHT Board

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MEDISON
Part Name BD-342-RL
Part Description REAR PANEL LEFT Board

$'" it all __
MEDISON
10-2-2 PC & Power
Part Name PC-MOTH-4450F-01 Part Name HDD-800G-SEAGATE

Part Description PC MOTHER B/D T-SOM4450F, Part Description SEAGATE Barracuda 7200.7
ADVANTEC 80G/ST380011 A
Part Name PC-CD-RW-GCE8527B Part Name AY-342-PWR-DDM

Part Description CDR-52X, CDRW-32X, Part Description POWER AY DC-DC MODULE
READ-52X-LG

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MEDISON
Part Name AY-342-PWR-ADM Part Name
Part Description Power AY AC - DC Module Part Description
10-2-3 Keyboard
Part Name A260-126A Part Name 335-C-010A
Part Description ALPHA-NEUMERIC KEY ASSY Part Description TRACK BALL YEL UNIT 58mm
TAMAGAWA

$'" it all __
MEDISON
10-2-4 ETG
Part Name AY-FAN-342-BACK Part Name AY-FAN-342- TOP
Part Description BACK FAN ASSY Part Description TOP FAN ASSY
Part Name AY -SPEAK -342
Part Description SPEAK CABLE ASSY

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.,.

o 1-1 Safety Signs 5

1-1-1 Safety Symbols

[I] Isolated patient connection (Type SF applied part).

C:> Power switch (Supplies/cuts the power for product)

o ON (Supplies power to a part of the product)

A Refer to the User Manual.

V Identifies an equipotential ground.

~ Indicates dangerous voltages over 1000V AC or over 1500V DC.

> VGA output port or Parallel port.

-t>' ECG port.

Left and right Audio / Video input

Remote print output

Foot switch connector

Protection against the effects of immersion.

Protection against dripping water.

--'=- Probe connector

It describes the precautions necessary to prevent user hazards of great urgency. If a

1-2-1 Prevention of Electric Shock

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

1-2-2 ECG-Related Information

[Figure 1-2 ESD symbol]

The following precautions can help to reduce ESD :

1) Guidance and manufacturer's declaration - electromagnetic emission

2) Approved Cables, Transducers and Accessories for EMC

CD Approved Cable for Electromagnetic Compliance

Parallel Shielded Normal

RS232C Shielded Normal

USB Shielded Normal

LAN(RJ45) Twisted pair Any

S-Video Shielded Normal

Foot Switch Shielded 2.5m

BNJ Printer Unshielded Coaxial Normal

MIC Unshielded Any

Printer Remote Unshielded Any

Audio R.L Shielded Normal

VHS Shielded Normal

ECG AUX input Shielded <3m

@ Approved Transducer for Electromagnetic Compliance

CID Approved Accessories for Electromagnetic Compliance

IEC 60601 Electromagnetic

Electrostatic Floors should be wood, concrete or

Power frequency Power frequency magnetic fields should

IEC 61000-4-8 hospital environment.

d= [ ~ (JP BOOMHz to 205GHz

Field strengths from fixed RF

Interference may occur in the vicinity of

3) Recommended separation distances between portable and mobile RF communications equipment

0.01 35.00 0.11 0.23

5) Avoiding Electromagnetic Interference

[Good example] [Bad example]

1-3-2 Safety Note

Do not block the ventilation slots.

Improper cleaning or sterilization of a patient-applied part may cause permanent damage.

1-3-3 Safety Note for Monitor

[Figure 1-3 Safety Note for Monitor]

1-4-1 ALARA Principle