SONOACE X6 Service Manual Rev 00

Safety Requirements Classifications: - 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;

This is CSA symbol for Canada and United States of America

0123

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).

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 shall not be held liable for any injury and damage caused by not following this warning. For safe use of this product, you should read ‘Chapter 2. Safety’ in this manual, prior to starting to useing this system.

DANGER

WARNING

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.

CAUTION Indicates the presence of a hazard that can cause equipment damage.

NOTE

A piece of information useful for installing, operating and maintaining a system. Not related to any hazard.

`````Contents Chapter 1. General Information 1.1 1.2 1.3

1.4

Overview Features and Advantages of SONOACE X6 Product Configuration 1.3.1 Console 1.3.2 LCD Monitor 1.3.3 Control Panel 1.3.4 Probe Specifications

1-1 1-1 1-2 1-3 1-3 1-5 1-6 1-7 1-8

Chapter 2. Safety

2-1

2.1 2.2

2-1 2-2 2-2 2-4 2-6 2-6 2-7 2-8 2-8 2-9 2-15 2-15 2-16 2-17 2-17 2-29

2.3

2.4

2.5 2.6

Overview Safety – Related Information 2.2.1 Safety Symbols 2.2.2 Label Electrical Safety 2.3.1 Prevention Electric Shock 2.3.2 ECG - Related Information 2.3.3 ESD 2.3.4 EMI 2.3.5 EMC Mechanical Safety 2.4.1 Moving the Equipment 2.4.2 Safety Note Biological Safety 2.5.1 ALARA Principle Environmental Protection

Contents

Contents Chapter 3. Installing the Product 3.1 3.2

3.3

3.4

3.5

3.6 3.7

3.8

3.9

Contents

Overview Transportation 3.2.1 Precautions for Transportation 3.2.2 Temperature and Humidity 3.2.3 Transportation of the Product Unpacking 3.3.1 Unpacking the Box 3.3.2 Checking Package Contents Precautions for Installation 3.4.1 Precautions 3.4.2 Installation Location Installation Procedure 3.5.1 Installation Safety 3.5.2 Connecting the Power Cord 3.5.3 Connecting the Network Cable 3.5.4 Connecting the Foot switch 3.5.5 Connecting the Probe Starting the Product Shutting down the Product 3.7.1 Power Switch 3.7.2 Cut-off Switch Connecting the Peripherals 3.8.1 BW Printer 3.8.2 Color Printer 3.8.3 Line Printer 3.8.4 VCR 3.8.5 USB Storage Device System Setting 3.9.1 General System Setup 3.9.2 Display Setup 3.9.3 Misc 3.9.4 Peripherals Setup 3.9.5 Information 3.9.6 DICOM Setup (Option) 3.9.7 Option Setup

3-1 3-1 3-3 3-3 3-3 3-4 3-5 3-5 3-6 3-7 3-7 3-8 3-9 3-9 3-10 3-11 3-11 3-12 3-13 3-15 3-15 3-15 3-16 3-16 3-17 3-18 3-18 3-19 3-20 3-20 3-22 3-24 3-25 3-26 3-27 3-34

Contents Chapter 4. Checking the Product 4.1 4.2 4.3 4.4

4.5

Overview Starting the Product Monitor 4.3.1 Monitor Display Control Panel 4.4.1 Power On/Off 4.4.2 Starting and Finishing Exam 4.4.3 Selecting Diagnosis mode and Gain Control 4.4.4 Image Adjustment 4.4.5 TGC 4.4.6 Measurement and Annotation 4.4.7 Trackball and its related control 4.4.8 SONOVIEW and Report 4.4.9 Save and Print 4.4.10 Alphanumeric keyboard 4.4.11 Flexible Soft Buttons 4.4.12 Function Buttons Checking the Performance 4.5.1 Basic Check 4.5.2 Detail Check

4-1 4-1 4-2 4-6 4-4 4-6 4-6 4-6 4-7 4-9 4-10 4-10 4-11 4-12 4-12 4-13 4-13 4-14 4-15 4-15 4-16

Contents

Contents Chapter 5. Product Structure 5.1 5.2 5.3

5.4 5.5 5.6 5.7 5.8 5.9 5.10

Overview System Block Diagram Basic Structure of SONOACE X6 5.3.1 Overview 5.3.2 Ultrasound System Part 5.3.3 User Interface Part 5.3.4 Power Part PSA Front End Board CW Board Back End Board Rear Board Control Panel Power Supply

Chapter 6. Basic Maintenance 6.1 6.2 6.3 6.4

6.5

6.6

6.7

Contents

Overview System Information Entering Admin Mode Upgrade 6.4.1 Software Upgrade 6.4.2 Hardware Upgrade Backup & Restore 6.5.1 Backup User Setting 6.5.2 Restore User Setting Adding and Deleting Options 6.6.1 Option type 6.6.2 Registering Options 6.6.3 Deleting Options Control Panel Test

5-1 5-1 5-3 5-4 5-4 5-5 5-5 5-5 5-6 5-9 5-13 5-15 5-22 5-23 5-24

6-1 6-1 6-2 6-3 6-6 6-6 6-9 6-10 6-10 6-11 6-13 6-13 6-13 6-14 6-15

Contents Chapter 7. 7.1 7.2

7.3

7.4

7.5

Troubleshooting

7-1

Overview Power 7.2.1 Power Failure 7.2.2 Power cannot be turned off 7.2.3 Power is automatically turned off Monitor 7.3.1 Blank Screen 7.3.2 Screen Color is Abnormal Error Messages 7.4.1 System hangs after an error during booting 7.4.2 System works even if error occurred 7.4.3 Error code Image 7.5.1 No BW Image Echo 7.5.2 No BW Mode Image Format 7.5.3 Noise Link Rain over the BW Mode Image (Noise) 7.5.4 PW Doppler Mode Trouble 7.5.5 CW Doppler Mode Trouble 7.5.6 Color Doppler Mode Trouble 7.5.7 Motion Mode Trouble

7-1 7-2 7-2 7-2 7-3 7-4 7-4 7-4 7-5 7-5 7-5 7-5 7-6 7-6 7-6 7-6 7-7 7-7 7-7 7-7

Contents

Contents Chapter 8. Disassembly and Reassembly 8.1 8.2

8.3

8.4

8.5

8.6

8.7

8.8

Contents

Overview Disassembly and Reassembly of the External Case 8.2.1 Preparations 8.2.2 Cover Front Lower 8.2.3 Cover Top Plate 8.2.4 Cover Rear Lower Disassembly and Reassembly of the LCD Monitor 8.3.1 Preparations 8.3.2 LCD Monitor 8.3.3 LCD Monitor Arm Disassembly and Reassembly of the Ultrasound System PCB Part 8.4.1 Preparations 8.4.2 PSA ASSY 8.4.3 CW Board, FE Board, BE Board 8.4.4 DC to DC Power Module Disassembly and Reassembly of the HDD & DVD 8.5.1 Preparations 8.5.2 HDD & DVD Disassembly and Reassembly of the Rear Panel 8.6.1 Preparations 8.6.2 Rear Right Board & Rear Left Board 8.6.3 Back Fan Disassembly and Reassembly of the Power Supply 8.7.1 Preparations 8.7.2 AC to DC Power Module 8.7.3 DC to DC Power Module Disassembly and Reassembly of the Control Panel 8.8.1 Preparations 8.8.2 Control Panel 8.8.3 Key Matrix Board 8.8.4 Track Ball 8.8.5 Alpha Numeric Keyboard 8.8.6 Speaker

8-1 8-1 8-4 8-4 8-4 8-5 8-6 8-7 8-7 8-7 8-8 8-9 8-9 8-9 8-10 8-11 8-12 8-12 8-12 8-13 8-13 8-13 8-14 8-16 8-16 8-16 8-16 8-17 8-17 8-17 8-18 8-19 8-20 8-20

Content Chapter 9. Probe

9-1

9.1 9.2 9.3 9.4 9.5 9.6 9.7

9-1 9-2 9-3 9-4 9-5 9-5 9-8

Overview Probe List Thermal Index (TI Table) Ultrasound Transmission Gel Sheaths Probe Precautions Cleaning and Disinfecting the Probe

Chapter 10. User Maintenance 10.1 10.2

10.3

Overview System Maintenance 10.2.1 Installation Maintenance 10.2.2 Cleaning and Disinfections 10.2.3 Fuse Replacement 10.2.4 Cleaning the Air Filter 10.2.5 Accuracy Check Administration of Information 10.3.1 User Setting Back-up 10.3.2 Patient Information Back-up 10.3.3 Software

Chapter 11. Service Part List 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8

Overview Cover Ultrasound System Part Rear Plan Power Part LCD Monitor Control Panel Probe

10-1 10-1 10-2 10-2 10-3 10-5 10-6 10-6 10-7 10-7 10-7 10-7 11-1 11-1 11-2 11-4 11-5 11-6 11-7 11-9 11-10

Contents

1 1.1

General Information Overview Chapter 1 contains the information necessary to plan the Troubleshooting of SONOACE X6 The SONOACE X6 is a high-resolution color ultrasound system with high penetration and a variety of measurement functions Contents General Information 1.1 1.2 1.3

1.4

Overview Features and Advantages of SONOACE X6 Product Configuration 1.3.1 Console 1.3.2 LCD Monitor 1.3.3 Control Panel 1.3.4 Probes Specifications

1-1 1-2 1-3 1-3 1-5 1-6 1-7 1-8

Chapter 1. General Information

1-1

1.2

Features and Advantages of SONOACE X6 y High-end Digital Beamforming : The SONOACE X6 utilizes the newly developed Digital Beam forming technology. y A variety of applications : The SONOACE X6 is optimized for use in a variety of 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, Power Doppler Mode, PW Spectral Doppler Mode, CW Spectral Doppler Mode(Option), etc. y 3D images can be obtained. y Measurement and Report Functions : Besides the basic distance, area, circumference and volume measurement functions, the SONOACE X6 also provides application-specific measurement functions. The report function collates measurement data. y Review of Scanned Images : The SONOACE X6 displays Cine images of 512 frames and loop images of 4096 lines. TM

y SonoView : This is a total ultrasound image management system, which allows a user to archive, view and exchange documents. y Digital Imaging and Communications 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 X6.

Chapter 1. General Information

1-2

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 of the console mainly contains devices that produce ultrasound images. On the exterior of the console is composed of various connectors, probe holders, storage compartments, handles, wheels, etc.

LCD Monitor

LCD Arm

Control Panel

DVD-RW Drive

Probe Connector

Pencil probe Connector

Wheel

[Figure 1-1] Console of SONOACE X6

Chapter 1. General Information

1-3

[Figure 1-2] Rear and side of SONOACE X6

Chapter 1. General Information

1-4

1.3.2

LCD Monitor The LCD monitor of this system is a color VGA monitor, which displays ultrasound images and additional information. Use the monitor arm to adjust the height or position of the monitor.

[Figure 1-3] LCD Arm

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:

Alphanumerics Keyboard Slide Volume Button Dial Button Track Ball

[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 1. General Information

1-7

1.4

Specifications

Physical Dimensions

Height: 1378mm (with monitor) Width: 483mm Depth: 691mm Weight: More than 60.75kg

Monitor

15 inch LCD monitor

Electrical Parameters

100-120V/200-240VAC, 8/5A, 50/60Hz

Pressure Limits

Operating: 700hPa to 1060hPa Storage: 700hPa to 1060hPa

Humidity Limits

Operating: 30% to 75% Storage & Shipping: 20% to 90%

Temperature Limits

Operating: 10 C ~ 35 C Storage & Shipping: -25OC ~ 60OC

Imaging modes

2D imaging mode Dual 2D imaging mode M imaging mode 2D/M imaging mode Color Doppler Imaging (CDI) mode Power Doppler Imaging (PDI) mode Pulse Wave (PW) Spectral Doppler imaging mode Continuous Wave (CW) Spectral Doppler imaging mode 3D imaging mode (Freehand) Simultaneous mode

Focusing

Transmit focusing, maximum of eight points (four points simultaneously selectable) Digital dynamic receive focusing (continuous)

Application

General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal

O

Chapter 1. General Information

1-8

O

Trackball operation of multiple cursors Measurement Packages

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

Image Storage

Maximum 512 frames for CINE memory Maximum 4096 Lines for LOOP memory Image filing system

Gray Scale

256 (8 bits) TGC control Mode-independent gain control Acoustic power control (adjustable) Dynamic aperture Dynamic apodization Dynamic range control (adjustable)

Signal processing (Pre-processing)

Image view area control M-mode sweep speed control HD zoom Frame average Gamma-scale windowing Image orientation (left/right and up/down) White on black/black on white

Probes

Curved Linear Array C3-7EP C4-9ED Linear Array HL5-12ED L5-12/50EP Endocavity Curved Linear Array NER4-9ES NEV4-9ES Phased Array P2-4AH CW CW2.0 CW4.0

Chapter 1. General Information

1-9