- Type of protection against electrical shock: Class I
- Degree of protection against electrical shock (Patient connection):Type BF equipment
- Degree of protection against harmful ingress of water: Ordinary equipment
- Degree of safety of application in the presence of a flammable anesthetic material with air
or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide.
- Mode of operation: Continuous operation
Electromechanical safety standards met:
- IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1General Requirements for Safety.
- IEC/EN 60601-1-1 Safety requirements for medicalelectrical systems.
- IEC/EN 60601-1-2 Electromagnetic compatibility -Requirements and tests.
- IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment.
- IEC 61157 Declaration of acoustic output parameters.
- ISO 10993-1 Biological evaluation of medical devices.
- UL 2601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.
- CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.
Declarations;
0123
This is CSA symbol for Canada and United States of
America
This is manufacturer’s declaration of product compliance
with applicable EEC directive(s) and the European notified
body.
This is manufacturer’s declaration of product compliance
with applicable EEC directive(s).
This is GMP symbol for Good Manufacturing Practice of
Korea quality system regulation.
READ THIS FIRST
Before asking for the product to be repaired, read this service manual thoroughly, learn how to
troubleshoot, and make sure you understand the precautions fully.
The repair of the system and the replacement of parts must be carried out by an authorized
dealer or the customer care department of MEDISON Co., Ltd.
The company is shall not be held liable for any injury and damage caused by not following this
warning.
For safe use of this systemproduct, you should read ‘Chapter 2. Safety’ in this manual, prior to
starting to useing this system.
DANGER
WARNING
CAUTION
NOTE
Describes precautions necessary to prevent user hazards of great
urgency. Ignoring a DANGER warning will risk life-threatening injury.
Used to indicate the presence of a hazard that can cause serious
personal injury, or substantial property damage.
Indicates the presence of a hazard that can cause equipment damage.
A piece of information useful for installing, operating and maintaining
a system. Not related to any hazard.
Contents
Chapter 1. General Information 1-1
1.1 Overview 1-1
1.2 Features and Advantages of SONOACE X8 1-2
1.3 Product Configuration 1-3
1.3.1Console 1-3
1.3.2LCD Monitor 1-5
1.3.3Control Panel 1-6
1.3.4Probe 1-7
1.4 Specifications 1-8
Chapter 2. Safety 2-1
2.1 Overview 2-1
2.2 Safety – Related Information 2-2
2.2.1Safety Symbols 2-3
2.2.2Label 2-4
2.3 Electrical Safety 2-6
2.3.1Prevention Electric Shock 2-6
2.3.2ECG - Related Information 2-7
2.3.3ESD 2-8
2.3.4EMI 2-8
2.3.5EMC 2-9
2.4 Mechanical Safety 2-15
2.4.1Precautions on Ramps 2-15
2.4.2Safety Note 2-16
2.4.3Safety Note for Monitor 2-16
2.5 Biological Safety 2-17
2.5.1ALARA Principle 2-17
2.6 Environmental Protection 2-29
Contents
Contents
Chapter 3. Installing the Product 3-1
3.1 Overview 3-1
3.2 Transportation 3-3
3.2.1Precautions for Transportation 3-3
3.2.2Temperature and Humidity 3-3
3.2.3Transportation of the Product 3-4
3.3 Unpacking 3-5
3.3.1Unpacking the Box 3-5
3.3.2Checking Package Contents 3-6
3.4 Precautions for Installation 3-7
3.4.1Precautions 3-7
3.4.2Installation Location 3-8
3.5 Installation Procedure 3-9
3.5.1Installation Safety 3-9
3.5.2Connecting the Power Cord 3-10
3.5.3Connecting the Network Cable 3-11
3.5.4Connecting the Foot switch 3-11
3.5.5Connecting the Probe 3-12
3.6 Starting the Product 3-13
3.7 Shutting down the Product 3-14
3.8 Connecting the Peripherals 3-15
3.8.1BW Printer 3-15
3.8.2Color Printer 3-15
3.8.3Line Printer 3-16
3.8.4USB Storage Device 3-16
3.9 System Setting 3-18
3.9.1General System Setting 3-18
3.9.2Peripherals Setup 3-22
3.9.3System Information 3-24
3.9.4DICOM Setup (Option) 3-25
3.9.5Utilities Setup 3-36
3.9.6Option Setup 3-40
`
Contents
Contents
Chapter 4. Checking the Product 4-1
4.1 Overview 4-1
4.2 Power On/Boot up 4-2
4.3 Control Panel 4-3
4.3.1Detail Control Panel 4-4
4.4 Checking the Performance 4-16
4.4.1Basic Check 4-16
4.4.2Detail check 4-17
Chapter 5. Product Structure 5-1
5.1 Overview 5-1
5.2 System Block Diagram 5-3
5.3 Basic Structure of SONOACE X8 5-4
5.3.1Overview 5-4
5.3.2Ultrasound System Part 5-5
5.3.3PC Part 5-5
5.3.4User Interface Part 5-6
5.3.5AC to DC Power Module 5-6
5.4 PSA 5-7
5.5 Beamformer Board 5-9
5.6 CW Board 5-12
5.7 Back End Board 5-17
5.8 PCI Board 5-22
5.9 DVI Board 5-24
5.10 VGA Card 5-26
5.11 PC Mother Board 5-28
5.12 Software DSC 5-30
5.13 LCD IF Board 5-32
5.14 Rear Board 5-34
5.15 Motor Control Board 5-35
5.16 Control Panel 5-37
5.17 Power Supply 5-39
Contents
Contents
Chapter 6. Basic Maintenance 6-1
6.1 Overview 6-1
6.2 System Information 6-2
6.3 Windows Mode 6-3
6.4 Upgrade 6-4
6.4.1Software Upgrade 6-4
6.4.2Hardware Upgrade 6-5
6.5 Admin Mode 6-6
6.5.1Entering Admin Mode 6-6
6.5.2Admin Mode Functions 6-7
6.6 Adding and Deleting Options 6-12
6.6.1Option Type 6-12
6.6.2Registering Options 6-13
6.6.3Deleting Options 6-16
6.6.4Option Status 6-17
Chapter 7. Troubleshooting 7-1
7.1 Overview 7-1
7.2 Power 7-2
7.2.1Power Failure 7-2
7.2.2Power cannot be turned off 7-2
7.2.3Power is automatically turned off 7-3
7.3 Monitor 7-4
7.3.1Blank Screen 7-4
7.3.2Screen Color is Abnormal 7-4
7.4 Error Messages 7-5
7.4.1System hangs after an error during booting 7-5
7.4.2System works even if error occurred 7-5
7.5 Image 7-6
7.5.1No BW Image Echo 7-6
7.5.2No BW Mode Image Format 7-6
7.5.3Noise Link Rain over the BW Mode Image (Noise) 7-6
7.5.4PW Doppler Mode Trouble 7-7
7.5.5CW Doppler Mode Trouble 7-7
7.5.6Color Doppler Mode Trouble 7-7
7.5.7Motion Mode Trouble 7-7
7.5.83D and LIVE 3D Trouble 7-7
Contents
Contents
Chapter 8. Disassembly and Reassembly 8-1
8.1 Overview 8-1
8.2 Disassembly and Reassembly of the Exteral Case 8-4
8.2.1Preparations 8-4
8.2.2Cover Front Lower 8-4
8.2.3Cover Body Rear 8-5
8.2.4Cover Rear Upper 8-6
8.2.5Cover Base Rear 8-7
8.3 Disassembly and Reassembly of the LCD Monitor 8-8
8.3.1Preparations 8-8
8.3.2LCD Monitor 8-8
8.4 Disassembly and Reassembly of the Ultrasound System PCB Part 8-10
8.4.1Preparations 8-10
8.4.2PSA ASSY 8-10
8.4.3CW Board, BF Board, BE Board 8-11
8.4.4Motor Board 8-12
8.4.5LCD IF Board 8-13
8.5 Disassembly and Reassembly of the HDD 8-14
8.5.1Preparations 8-14
8.5.2HDD 8-14
8.6 Disassembly and Reassembly of the PC Part 8-15
8.6.1Preparations 8-15
8.6.2PC Part 8-15
8.6.3DVI Board, PCI Board, VGA Card 8-17
8.6.4Rear Board 8-18
8.6.5PC Mother Board 8-19
8.7 Disassembly and Reassembly of the Power Supply 8-20
8.7.1Preparations 8-20
8.7.2AC to DC Power Module 8-20
8.7.3DC to DC Power Module 8-21
8.7.4PC Power Supply 8-22
8.8 Disassembly and Reassembly of the Control Panel 8-23
8.8.1Preparations 8-23
8.8.2Control Panel 8-23
8.8.3Key Matrix Board 8-24
8.8.4Track Ball 8-25
8.8.5Alpha Numeric Keyboard 8-26
Contents
Contents
8.9 Disassembly and Reassembly of the DVD 8-27
8.9.1Preparations 8-27
8.9.2DVD 8-27
8.10 Disassembly and Reassembly of the ECG Module 8-28
8.10.1Preparation 8-28
8.10.2ECG Module 8-28
Chapter 9. Probe 9-1
9.1 Overview 9-1
9.2 Probe List 9-2
9.3 Thermal Index (TI Table) 9-5
9.4 Ultrasound Transmission Gel 9-6
9.5 Sheaths 9-7
9.6 Probe Precautions 9-8
9.7 Cleaning and Disinfecting the Probe 9-10
Chapter 10. User Maintenance 10-1
10.1 Overview 10-1
10.2 System Maintenance 10-2
10.2.1Installation Maintenance 10-2
10.2.2Cleaning and disinfections 10-3
10.2.3Cleaning the Air Filter 10-4
10.2.4Fuse Replacement 10-5
10.3 Administration of Information 10-6
10.3.1User Setting Back-up 10-6
10.3.2Patient Information Back-up 10-6
10.3.3Software 10-6
Contents
Contents
Chapter 11. Service Part List 11-1
11.1 Overview 11-1
11.2 Cover 11-2
11.3 Ultrasound System Part 11-4
11.4 PC Part 11-6
11.5 Power Part 11-8
11.6 User Interface Part 11-9
11.7 Electric Part 11-11
11.8 Cable Part 11-12
11.9 Option 11-13
11.10Probe 11-14
Contents
1 General Information
1.1Overview
Chapter 1 contains the information necessary to plan the Troubleshooting of
1.1 Overview 1-1
1.2 Features and Advantages of SONOACE X8 1-2
1.3 Product Configuration 1-3
1.3.1Console 1-3
1.3.2LCD Monitor 1-5
1.3.3Control Panel 1-6
1.3.4Probe 1-7
1.4 Specifications 1-8
SONOACE X8
The SONOACE X8 is a high-resolution color ultrasound scanner with high
penetration and a variety of measurement functions
Contents General Information
Chapter 1. General Information
1-1
f
r
1.2Features and Advantages of SONOACE X8
y High-end Digital Beamforming : The SONOACE X8 utilizes the newly developed
Digital Beam forming technology.
y A variety of applications : The SONOACE X8 is optimized for use in a variety o
ultrasound departments, including general, abdomen, obstetrics, gynecology,
vascular, extremity, pediatric, cardiac, breast, urology, and etc.
y Various diagnostic Modes : 2D Mode, M Mode, Color Doppler Mode, Powe
y 3D / 4D images can be obtained.
y Measurement and Report Functions : Besides the basic distance, area,
circumference and volume measurement functions, the SONOACE X8 also
provides application-specific measurement functions. The report function
collates measurement data.
y Review of Scanned Images : The SONOACE X8 displays Cine images of 5242
frames and loop images of 8192 lines.
y SonoView
TM
: This is a total ultrasound image management system, which
allows a user to archive, view and exchange documents.
y Digital Imaging and Communication in Medicine (DICOM) Function : This is
used to archive, transmit and print DICOM images through a network.
y Peripheral/Accessory Connection : A variety of peripheral devices including
VCRs and printers can be easily connected to the SONOACE X8.
Chapter 1. General Information
1-2
f
1.3 Product Configuration
This Product consists of the monitor, the control panel, the console, and the probes.
1.3.1 Console
The console consists of two parts – the inner unit and the outer unit. The interior o
the console mainly contains devices that produce ultrasound images. On the
exterior of the console are various connectors, probe holders, storage
compartments, handles, wheels, etc.
LCD Arm
DVD-R Drive
LCD Monitor
USB Port
Control Panel
Handle
CW Doppler Connector
[Figure 1-1] Console of SONOACE X8
Chapter 1. General Information
Probe Connector
Air Filter
Wheels
1-3
[Figure 1-2] Console of SONOACE X8
Chapter 1. General Information
1-4
r
1.3.2 LCD Monitor
The monitor of this system is a color VGA monitor, which displays ultrasound
images and additional information. Use the monitor arm to adjust the height o
position of the monitor.
[Freely Movement] [Articulation (360
[Figure 1-3] LCD Arm
o
)]
Chapter 1. General Information
1-5
1.3.3 Control Panel
The control panel can be used for controlling the system. It consists of the
following four sections:
1) Function keys for mode selection and scanning, located on the right side of the
control panel.
2) Function keys for annotation and measurements, located around the Trackball.
3) Menu selection buttons, located on the left side of the control panel.
4) An alpha-numeric keyboard, located under the control panel.
Button
Dial-Button
Slide
Track Ball
Alpha-Numeric Key Board
[Figure 1-4] Control Panel
Chapter 1. General Information
1-6
1.3.4 Probe
Probes are devices that generate ultrasound waves and process reflected wave
data for the purpose of image formation.
NOTE
For more information, refer to `Chapter 9 Probes’.
Chapter 2 contains the information necessary to Safety
Contents Safety
Chapter 2. Safety
2-1
2.2 Safety - Related Information
2.2.1
The International Electro Technical Commission (IEC) has established a
Safety Symbols
set of symbols for medical electronic equipment, which classify a
connection or warn of potential hazards. The classifications and symbols
are shown below.
Power switch (Supplies/cuts the power for product)
Indicates a caution for risk of electric shock.
Indicates dangerous voltages over 1000V AC or over
1500V DC.
Warning, Caution
Identifies an equipotential ground.
Identifies the point where the system safety ground is
fastened to the chassis. Protective earth connected to
conductive parts of Class I equipment for safety
purposes.
Electrostatic discharge
Data Output port
Data Input port
Data Input/Output port
Chapter 2. Safety
2-2
Symbols Description
Left and right Audio / Video input
Left and right Audio / Video output
Print remote output
Foot switch connector
ECG connector
USB connector
Microphone connector
Protection against the effects of immersion.
Protection against dripping water.
Probe connector
Chapter 2. Safety
2-3
2.2.2 Labels
To protect the system, you may see ‘Warning’ or ‘Caution’ marked on the
surface of the product
1) Front
[Figure 2-1] Labels of Front
Chapter 2. Safety
2-4
2) Rear
[ Figure 2-2] Labels of Rear
3) Monitor
[Figure 2-3] Labels of Monitor
Chapter 2. Safety
2-5
t
y
r
2.3 Electrical Safety
This equipment has been verified as a Class I device with Type BF applied parts.
2.3.1 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 equipmen
is connected with connecting leads made up of angled sockets to the equipotential
bonding network in medical rooms.
[Figure 2-4] Equipotential bonding
Additional equipment connected to medical electrical equipment must compl
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 o
the technical service department.
Chapter 2. Safety
2-6
WARNING
CAUTION
y Electric shock may exist result if this system, including and all of its
externally mounted recording and monitoring devices, is not properly
grounded.
y 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.
y 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.
y Always disconnect the system from the wall outlet prior to cleaning the
system.
y 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.
y The use of flammable anesthetic gas or oxidizing gases (N20) should be
avoided.
y The system has been designed for 100-120VAC and 200-240VAC; you
should select the input voltage of monitor, printer and VCR. Prior to
connecting an OEM power cord, verify that the voltage indicated on the
power cord matches the voltage rating of the OEM device.
y An isolation transformer protects the system from power surges. The
isolation transformer continues to operate when the system is in standby.
y Do not immerse the cable in liquids. Cables are not waterproof.
y The operator does not contact the parts (SIP/SOP) and the patient
simultaneously
2.3.2 ECG-Related Information
WARNING
y This device is not intended to provide a primary ECG monitoring function,
and therefore does not have means of indicating an inoperative
electrocardiograph.
y Do not use ECG electrodes of HF surgical equipment. Any malfunctions in
the HF surgical equipment may result in burns to the patient.
y Do not use ECG electrodes during cardiac pacemaker procedures or other
electrical stimulators.
y Do not use ECG leads and electrodes in an operating room.
Chapter 2. Safety
2-7
y
y
a
r
f
2.3.3
CAUTION
ESD
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturall
occurring phenomenon. ESD is most prevalent during conditions of low humidity,
which can be caused by heating or air conditioning. During low humidit
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
discharge of the electrical energy build-up from a charged individual to a lesser o
non-charged individual or object.
The ESD caution symbol is on the probe connector and the rear panel.
[Figure 2-5] ESD symbol
y 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.
2.3.4 EMI
Although this system has been manufactured in compliance with existing EMI
(Electromagnetic Interference) requirements, use of this system in the presence o
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.
y 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.
Chapter 2. Safety
2-8
n
s
m
CAUTION
In cases where EMI is causing disturbances, it may be necessary to
relocate this system.
2.3.5 EMC
The testing for EMC(Electromagnetic Compatibility) of this system has bee
performed according to the international standard for EMC with medical device
(IEC60601-1-2). This IEC standard was adopted in Europe as the European nor
(EN60601-1-2).
2.3.5.1 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.
Emission test Compliance Electromagnetic environment -guidance
RF Emission
(Radiation)
CISPR 11
RF Emission
(Radiation)
CISPR 11
Harmonic Emission
IEC 61000-3-2
Group 1
Class B
Group 1
Class B
Class A
The Ultrasound System uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
The Ultrasound System is suitable for use in
all establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
Flicker Emission
IEC 61000-3-3
Complies
network that supplies building used for
domestic purpose.
Chapter 2. Safety
2-9
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