SONOACE R3 Technical Manual Rev 01

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 Equipment, Part 1General Requirements for Safety. - IEC/EN 60601-1-1 Safety requirements for medical electrical 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 60601-1 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).

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 service department of SAMSUNG 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 product, you should read ‘Chapter 2. Safety’ in this manual, prior to starting to useing this system. ˙A ˙N ˙G ˙E ˙R ˙ D Describes precautions necessary to prevent user hazards of great urgency. Ignoring a DANGER warning will risk life-threatening injury. ˙A ˙R ˙N ˙ ˙IN ˙G ˙ W Used to indicate the presence of a hazard that can cause serious personal injury, or substantial property damage. ˙A ˙U ˙ T˙ ˙IO ˙N ˙ C Indicates the presence of a hazard that can cause equipment damage. ˙O ˙ T˙ E ˙ N 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 ... 1-1 Features and Advantages of SonoAce R3 ... 1-2 Product Configuration ... 1-3 1.3.1 Console... 1-3 1.3.2 LCD Monitor ... 1-4 1.3.3 Control Panel... 1-5 1.3.4 Probe ... 1-5 Specifications... 1-6

Chapter 2. Safety 2.1 2.2

2.3

2.4

2.5 2.6

Overview ... 2-1 Safety-Related Information... 2-2 2.2.1 Safety Symbols ... 2-2 2.2.2 LABEL... 2-3 Electrical Safety ... 2-4 2.3.1 Prevention Electric Shock ... 2-4 2.3.2 ESD... 2-4 2.3.3 EMI ... 2-5 2.3.4 EMC ... 2-5 Mechanical Safety ... 2-11 2.4.1 Moving Equipment ... 2-11 2.4.2 Safety Note... 2-11 Biological Safety ... 2-12 2.5.1 ALARA Principle ... 2-12 Environmental Protection ... 2-24

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Contents Chapter 3. Installing the Product 3.1 3.2

3.3

3.4 3.5

3.6 3.7 3.8 3.9

3.10

3.11

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Overview ... 3-1 Transportation ... 3-3 3.2.1 Precautions for Transportation... 3-3 3.2.2 Temperature and Humidity ... 3-3 Unpacking ... 3-4 3.3.1 Unpacking the Box... 3-4 3.3.2 Checking Package contents ... 3-5 Precautions for Installation ... 3-6 3.4.1 Precautions... 3-6 Installations Procedure ... 3-7 3.5.1 Installation Safety ... 3-7 3.5.2 Connecting the Power Cord ... 3-8 3.5.3 Connecting the Network Cable ... 3-9 3.5.4 Connecting the Probe ... 3-9 Starting the Product ... 3-10 Shutting down the Product ... 3-11 Connecting the Peripherals ... 3-12 3.8.1 External Peripherals ... 3-12 System Setting ... 3-14 3.9.1 General System Setup ... 3-14 3.9.2 Display Setup ... 3-16 3.9.3 Misc ... 3-18 Measure Setting ... 3-19 3.10.1 General ... 3-19 3.10.2 Doppler ... 3-20 3.10.3 Report ... 3-21 3.10.4 OB ... 3-22 3.10.5 Fetal Echo ... 3-25 3.10.6 Cardiac... 3-26 3.10.7 Urology... 3-26 3.10.8 Vascular ... 3-27 Setting DICOM ( Optional )... 3-28 3.11.1 Setting DICOM Information ... 3-28 3.11.2 Network Setup... 3-29 3.11.3 Adding or Changing the DICOM Server ... 3-29 3.11.4 Editing the DICOM Server... 3-32 3.11.5 Deleting DICOM Server... 3-32

3.12 3.13

3.14

3.11.6 Testing DICOM Server ... 3-32 3.11.7 DICOM Log ... 3-32 Setting Option ... 3-34 Setting Peripheral Devices ... 3-35 3.13.1 Video Out Type ... 3-35 3.13.2 Foot Switch... 3-35 3.13.3 Printer 1 ... 3-35 3.13.4 Printer 2 ... 3-35 Information ... 3-36

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Contents Chapter 4. Checking the Product 4.1 4.2 4.3 4.4

4.5

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Overview ... 4-1 Starting the Product ... 4-2 Monitor ... 4-3 4.3.1 Monitor Display ... 4-3 Control Panel ... 4-5 4.4.1 Detail Control Panel ... 4-6 4.4.2 Soft Menu ... 4-8 4.4.3 Keyboards ... 4-9 Checking the Performance ... 4-11 4.5.1 Basic Check ... 4-11 4.5.2 Detail Check ... 4-12

Contents 제5장 제품 구조 5.1 5.2 5.3

5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16 5.17

개요 5-1 System Block Diagram ... 5-3 EKO7의 기본 구조 ... 5-4 5.3.1 개요 ... 5-4 5.3.2 Ultrasound System Part ... 5-4 5.3.3 PC Part ... 5-5 5.3.4 User Interface Part ... 5-5 5.3.5 AC to DC Power Module ... 5-5 PSA 5-6 Beamformer Board... 5-8 CW Board 5-11 Back End Board ... 5-14 PCI Board 5-18 DVI Board 5-19 VGA Card 5-21 VCRIN Board... 5-22 PC Mother Board ... 5-23 Software DSC... 5-24 LCD IF Board... 5-26 Rear Board ... 5-27 Control Panel ... 5-28 Power Supply ... 5-30

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Contents Chapter 6. Basic Maintenance 6.1 6.2 6.3

6.4

6.5

6.6

6.7

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Overview ... 6-1 System Information ... 6-2 Admin Mode ... 6-3 6.3.1 Entering Admin Mode ... 6-3 6.3.2 Admin Mode Functions... 6-4 Upgrade . ... 6-6 6.4.1 Software Upgrade ... 6-6 6.4.2 Hardware Upgrade ... 6-9 Backup & Restore ... 6-10 6.5.1 Backup User Setting ... 6-10 6.5.2 Restore User Setting ... 6-12 Adding and Deleting Options... 6-14 6.6.1 Option type ... 6-14 6.6.2 Registering Option ... 6-14 Control Panel ... 6-16

Contents Chapter 7. Troubleshooting 7.1 7.2

7.3

7.4

7.5

Overview ... 7-1 Power ... 7-2 7.2.1 Power Failure ... 7-2 7.2.2 Power cannot turned off ... 7-2 7.2.3 Power is automatically turned off ... 7-2 Monitro ... 7-3 7.3.1 Blank Screen ... 7-3 7.3.2 Screen Color Abnomal ... 7-3 Error Messages ... 7-4 7.4.1 System hangs after an error during booting... 7-4 7.4.2 System works even if error occurred ... 7-4 Image ... 7-5 7.5.1 No BW Image Echo & No BW Mode Image Format ... 7-5 7.5.2 Noise Link Rain over the BW Mode Image (Noise) ... 7-5 7.5.3 PW & Color Doppler Mode Trouble ... 7-5

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Contents Chapter 8. Disassembly and Reassembly 8.1 8.2

8.3

8.4

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Overview ... 8-1 Disassembly and Reassembly of the Body Cover ... 8-3 8.2.1 Preparations ... 8-3 8.2.2 Body Rear & Middle Cover ... 8-3 8.2.3 Disassembly of the Main Part and LCD/Control Panel ... 8-4 Disassembly and Reassembly of the Main System Part ... 8-5 8.3.1 Preparations ... 8-5 8.3.2 Power & HDD & Side Fan ... 8-5 8.3.3 PSA & Rear & Rear Fan & Handle... 8-6 8.3.4 LCD & Inverter & USB Board... 8-7 Disassembly and Reassembly of the Control Panel ... 8-8 8.4.1 Preparations ... 8-8 8.4.2 Disassembly Control Panel and LCD... 8-8 8.4.3 Control Panel... 8-9

Contents Chapter 9. Probe 9.1 9.2 9.3 9.4 9.5 9.6

Overview ... 9-1 Probe List ... 9-2 Thermal Index (TI Table) ... 9-5 Ultrasound Transmission Gel ... 9-6 Sheaths ... 9-7 Probe Precautions... 9-9

Chapter 10. User Maintenance 10.1 10.2

10.3

Overview ... 10-1 System Maintenance ... 10-2 10.2.1 Installation Maintenance... 10-2 10.2.2 Cleaning and Disinfections... 10-2 10.2.3 Fuse Replacement ... 10-3 10.2.4 Accuracy Check ... 10-4 Administration of Information... 10-5 10.3.1 User Setting Back-up... 10-5 10.3.2 Patient Information Back-up ... 10-5 10.3.3 Software... 10-5

Chapter 11. Service Part List 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 11.10

Overview ... 11-1 Body Cover ... 11-2 Ultrasound System Part ... 11-4 LCD Part ... 11-5 PC Part ... 11-6 Power Part ... 11-8 User Interface Part ... 11-9 ETC Part ... 11-10 Options ... 11-11 Probes ... 11-12

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Chapter 1. General Information 1.1

Overview Chapter 1 contains the information necessary to plan the Troubleshooting of SonoAceR3. The SonoAceR3 is a high-resolution color ultrasound scanner with high penetration and a variety of measurement functions.

Contents 1.1

Overview ...1-1

1.2

Features and Advantages of SonoAceR3...1-2

1.3

Product Configuration ...1-3

1.4

1.3.1

Console...1-3

1.3.2

LCD Monitor ...1-4

1.3.3

Control Panel...1-5

1.3.4

Probes...1-5

Specifications ...1-6

Chapter 1. General Information

1-1

1.2

Features and Advantages of SonoAceR3 z

High-end Digital Beamforming : The SonoAceR3 utilizes the newly developed Digital Beam forming technology.

z

A variety of applications : The SonoAceR3 is optimized for use in a variety of ultrasound departments, cardiac, vascular, abdomen, Obsterics, Urology, Gynecology.

z

Various diagnostic Modes : 2D Mode, M Mode, Color Doppler Mode, Power Doppler Mode, PW Spectral Doppler Mode, etc.

z

Measurement and Report Functions : Besides the basic distance, area, circumference and volume measurement functions, the SonoAceR3 also provides application-specific measurement functions. The report function collates measurement data.

z

Review of Scanned Images : The SonoAceR3 displays Cine images of 512 frames and loop images of 4096 lines.

z

SonoViewTM : This is a total ultrasound image management system, which allows a user to archive, view and exchange documents.

z

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

z

Peripheral/Accessory Connection : A variety of peripheral devices including VCRs and printers can be easily connected to the SonoAceR3.

Chapter 1. General Information

1-2

1.3

Product Configuration This Product consists of the monitor, the control panel, the console and, the probes and the cart(optional).

1.3.2

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. The outside of the console consists of various connection ports and handles.

Handle

LCD Monitor

Control Panel

[Figure 1-1] Console of SonoAce R3

Chapter 1. General Information

1-3

Probe Connector

[Figure 1-2] Front and Back of SonoAce R3

1.3.2

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

[Figure 1-3] LCD Monitor Chapter 1. General Information

1-4

1.3.3

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

Alpha-Numeric

Button

Dial Button Track Ball

Slide Volume

[Figure 1-4] Control Panel

1.3.4

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

˙O ˙ T˙ E˙ N For more information, refer to ‘Chapter 9. Probes’.

Chapter 1. General Information

1-5

1.3.5

SonoAceR3 Cart (Optional) The SonoAce R3 System can be placed on a cart during use or for transport. For more information on installing and using the SonoAce R3, please refer to the installation guide that comes with it.

[Figure 1-5] SonoAce R3 Cart

Chapter 1. General Information

1-6

1.4

Specifications

Physical Dimensions

Height: 375mm (with handle) Width: 402mm (with probe holder) Depth: 188mm(with control panel) Weight: More than 8.7kg

Imaging modes

2D real-time Dual 2D real-time 2D/M-mode Power Doppler Color Doppler for Option Pulsed-wave Doppler for Option 3D-mode (Freehand) for Option Simultaneous

Gray Scale

256 (8 bits)

Focusing

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

Probes

Curved Linear Array : C2-4/20, CN2-8, CN4-9 Linear Array : L5-12/60, LN5-12/40 Endocavity Curved Linear Array : EC4-9

Probe connections

One probe connectors Two probe connectors for option

Monitor

15 inch LCD monitor

Rear Panel Input/Output Connections

USB 3ports LAN(10/100 BASE-T) DVI Output BW Printer remote control BW Output S-VHS Output Sound Output

Image Storage

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

Application

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

Electrical Parameters

100-120V/200-240V, 250VA, 50/60Hz

Chapter 1. General Information

1-7