Samsung UGEO H60 Service manual

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UGEO H60
Service Manual
Version 1.00.00
Copyright SAMSUNG MEDISON Co., LTD.
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Safety Classifications
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.
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Declarations:
This is the CSA symbol for Canada and United States of America
0123
This is the manufacturer’s declaration of product compliance with applicable EEC directive(s) and the European notified body.
This is the manufacturer’s declaration of product compliance with applicable EEC directive(s).
This is the GMP symbol that shows that the product complies with the Korean Good Manufacturing Practice quality regulation system.
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DANGER
Disregarding this instruction may result in death, serious injury, or other dangerous situations.
WARNING
Follow this information to prevent a serious accident or damage to property.
CAUTION
Hazards or unsafe practices that may result in minor personal injury or property damage.
NOTE
The accompanying information covers an installation, operation, or maintenance procedure that requires careful attention from the user, but has little chance of leading directly to a dangerous situation.
Attention
Read this service manual to familiarize yourself thoroughly with repair procedures and important safety information before attempting to service the product.
Failure to follow this information may cause an accident such as electric shock, as well as mechanical or other hazards to the service engineer, product operator, and/or patient.
1) Refer to the service manual when you service the product.
2) You are strongly urged to familiarize yourself with the operational safety information contained in
Chapter 2 Safety’.
3) This product is an ultrasound diagnosis device and cannot be used from the user's PC. We are not responsible for errors that occur when the system is run on the user’s PC.
4) This product may only be serviced by the Global Service Team of Samsung Medison or an
authorized engineer.
5) Samsung Medison is not responsible for any problems caused by an unauthorized person
servicing the product.
6) The manufacturer is not responsible for any damage to this product caused by user carelessness and/or neglect.
7) The content of this manual may be changed without prior notice.
8) The following terms are used to highlight safety precautions that the user must be aware of:
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If You Need Help
If you need help regarding the product, please contact the Samsung Medison Global Service Team in charge of servicing this product.
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UGEO H60 Service Manual
Table of Contents
Chapter 1 Introduction to Products ....................................................................1-1
1.1 Overview ............................................................................................................... 1-1
1.2 Main Features of UGEO H60 ............................................................................. 1-2
1.3 Components ......................................................................................................... 1-3
1.3.1 Console .................................................................................................... 1-3
1.3.2 Probe ........................................................................................................ 1-4
1.3.3 Product Specification .............................................................................. 1-5
1.3.4 Product Components .............................................................................. 1-8
Chapter 2 Safety .....................................................................................................2-1
2.1 Overview ............................................................................................................... 2-1
2.2 Safety Precautions .............................................................................................. 2-2
2.2.1 Safety Symbols ....................................................................................... 2-2
2.2.2 Location of Label ..................................................................................... 2-5
2.3 Electrical Safety ................................................................................................... 2-6
2.3.1 Prevention of Electric Shock .................................................................. 2-6
2.3.2 ESD .......................................................................................................... 2-7
2.3.3 EMI ........................................................................................................... 2-7
2.3.4 EMC.......................................................................................................... 2-8
2.4 Mechanical Safety ............................................................................................. 2-13
2.4.1 Precautions during Operation .............................................................. 2-13
2.4.2 Precautions during Movement ............................................................ 2-13
2.4.3 Precautions during Monitor Operation ................................................ 2-14
2.5 Biological Safety ................................................................................................ 2-15
2.5.1 ALARA Principles .................................................................................. 2-15
2.6 Protecting Environment .................................................................................... 2-29
Chapter 3 Installing Product ................................................................................3-1
3.1 Overview ............................................................................................................... 3-1
3.2 Delivery ................................................................................................................. 3-3
3.2.1 Precautions when Delivering ................................................................. 3-3
3.2.2 Temperature and Humidity ..................................................................... 3-3
3.3 Unpacking ............................................................................................................ 3-4
3.3.1 Disassembling Product Box ................................................................... 3-4
3.4 Installation Condition ........................................................................................... 3-5
3.4.1 Precautions .............................................................................................. 3-5
3.5 How to Install ........................................................................................................ 3-6
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3.5.1 Installation Safety .................................................................................... 3-6
3.5.2 Connecting the Power Cable ................................................................. 3-6
3.5.3 Connecting Probe ................................................................................... 3-7
3.6 Turning on the Product ....................................................................................... 3-8
3.7 Turning off the Product ........................................................................................ 3-9
3.8 Connecting Peripheral Devices ....................................................................... 3-10
3.9 Settings ............................................................................................................... 3-11
3.9.1 System General Settings ..................................................................... 3-11
3.9.2 Monitor Display Settings ...................................................................... 3-16
3.9.3 Measurement related Settings ............................................................ 3-18
3.9.4 Report ..................................................................................................... 3-28
3.9.5 Annotation .............................................................................................. 3-30
3.9.6 Body Marker .......................................................................................... 3-33
3.9.7 Application ............................................................................................. 3-36
3.9.8 Peripheral Devices Settings ................................................................. 3-37
3.9.9 Connectivity ........................................................................................... 3-41
3.9.10 Service ................................................................................................... 3-51
3.9.11 Help ........................................................................................................ 3-52
3.10 Printer Installation .............................................................................................. 3-53
3.10.1 BW Printer Installation .......................................................................... 3-53
3.10.2 Color Printer Installation ....................................................................... 3-60
Chapter 4 Product Inspection .............................................................................4-1
4.1 Overview ............................................................................................................... 4-1
4.2 Performance Inspection ...................................................................................... 4-2
4.2.1 Basic Inspection ...................................................................................... 4-2
4.2.2 Detailed Inspection ................................................................................. 4-3
Chapter 5 Product Structure................................................................................5-1
5.1 Overview ............................................................................................................... 5-1
5.2 System Block Diagram ....................................................................................... 5-4
5.3 TI (Transducer Interface) Board ......................................................................... 5-5
5.3.1 TI board layout......................................................................................... 5-5
5.3.2 Description ............................................................................................... 5-5
5.3.3 Functional Specifications ........................................................................ 5-6
5.4 TR (Transmit and Receive) Board ..................................................................... 5-7
5.4.1 TR board layout ....................................................................................... 5-7
5.4.2 Description ............................................................................................. 5-7
5.5 PI (PC Interface) Board .................................................................................... 5-10
5.5.1 PI board Layout ..................................................................................... 5-10
5.5.2 PI Board Block Diagram ....................................................................... 5-11
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UGEO H60 Service Manual
5.5.3 Description ............................................................................................. 5-11
5.5.4 Processor Module ................................................................................. 5-12
5.5.5 CPLD (SIC CPLD XC2C256-7VQG100C) ........................................ 5-12
5.5.6 PIC (PC interface controller, PIC FPGA) ............................................ 5-12
5.5.7 FEC (PC interface controller, FEC FPGA) ......................................... 5-12
5.5.8 HDD ........................................................................................................ 5-12
5.5.9 Peripheral ............................................................................................... 5-12
5.5.10 PEX8311 ................................................................................................ 5-13
5.5.11 HDMI Port Block.................................................................................... 5-13
5.5.12 Sound Block .......................................................................................... 5-14
5.6 Main Monitor ...................................................................................................... 5-15
5.6.1 Main Monitor Specification ................................................................... 5-15
5.7 Touch Screen ..................................................................................................... 5-16
5.7.1 Touch Screen Specification .................................................................. 5-16
5.8 I /O Board ........................................................................................................... 5-17
5.8.1 I/O Board cable Connection Diagram ................................................. 5-17
5.8.2 Description ............................................................................................. 5-17
5.8.3 System Cable Grappling ...................................................................... 5-18
5.9 DC POWER ....................................................................................................... 5-19
5.9.1 DC Power Layout .................................................................................. 5-19
5.9.2 Description ............................................................................................. 5-19
5.10 AC POWER ....................................................................................................... 5-20
5.10.1 AC Power Layout .................................................................................. 5-20
5.10.2 Description ............................................................................................. 5-20
5.11 Software DSC .................................................................................................... 5-21
5.11.1 Software DSC Block Diagram ............................................................. 5-21
5.11.2 Description ............................................................................................. 5-21
5.11.3 Specification ........................................................................................... 5-21
5.12 Control Panel ..................................................................................................... 5-23
5.12.1 Control Panel Block Diagram .............................................................. 5-23
5.12.2 Description ............................................................................................. 5-23
5.12.3 Specification ........................................................................................... 5-23
Chapter 6 Basic Maintenance ..............................................................................6-1
6.1 Overview ............................................................................................................... 6-1
6.2 Service Mode ....................................................................................................... 6-2
6.3 System Information ............................................................................................. 6-3
6.4 Adding and Deleting Options ............................................................................. 6-4
6.4.1 Types of Option ....................................................................................... 6-4
6.4.2 Registration of Option ............................................................................. 6-4
6.4.3 Deletion of Option ................................................................................... 6-5
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6.5 Back Up & Restore .............................................................................................. 6-6
6.5.1 Back Up .................................................................................................... 6-6
6.5.2 Restore ..................................................................................................... 6-7
6.5.3 Log Backup .............................................................................................. 6-7
6.5.4 Install Recovery System ......................................................................... 6-7
6.5.5 Up-Grade Soft Ware ............................................................................... 6-7
6.6 Diagnosis .............................................................................................................. 6-8
6.6.1 Control Panel Test ................................................................................... 6-8
6.6.2 Power On Self Test ................................................................................. 6-8
6.6.3 Keyboard Test ......................................................................................... 6-9
6.6.4 Built In Self Test ....................................................................................... 6-9
6.7 DICOM ................................................................................................................ 6-10
6.7.1 Network Settings ................................................................................... 6-10
6.7.2 Network Status Notification .................................................................. 6-11
6.7.3 Network /DICOM Test ........................................................................... 6-12
Chapter 7 Diagnosis .............................................................................................7-1
7.1 Overview ............................................................................................................... 7-1
7.2 Power .................................................................................................................... 7-2
7.2.1 Power does not Turn on ......................................................................... 7-2
7.2.2 Power does not Turn off ......................................................................... 7-2
7.2.3 Power Turns off Automatically ............................................................... 7-2
7.3 Monitor .................................................................................................................. 7-3
7.3.1 Nothing is shown on the Screen ........................................................... 7-3
7.3.2 Screen color Changes ............................................................................ 7-3
7.4 Error Message ..................................................................................................... 7-4
7.4.1 Product Stops after error while booting................................................. 7-4
7.4.2 Product Operates while having Error .................................................... 7-4
7.5 Image .................................................................................................................... 7-5
7.5.1 No BW Mode Image Echo and Format ................................................ 7-5
7.5.2 Lining Phenomenon on BW Mode Image (Noise) .............................. 7-5
7.5.3 PW, Color, M Mode Failure .................................................................... 7-5
7.6 Error Code ............................................................................................................ 7-6
Chapter 8 Assemble and Disassemble ...............................................................8-1
8.1 Overview ............................................................................................................... 8-1
8.2 Disassembling Front Panel ................................................................................ 8-3
8.2.1 Preparation .............................................................................................. 8-3
8.2.2 Disassembling Front Cover ................................................................... 8-3
8.2.3 Disassembling Transducer Interface Board ......................................... 8-3
8.3 Disassembling Rear Side ................................................................................... 8-5
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UGEO H60 Service Manual
8.3.1 Preparation .............................................................................................. 8-5
8.3.2 Disassembling Rear Side....................................................................... 8-5
8.4 Disassembling Upper Panel ............................................................................... 8-6
8.4.1 Preparation .............................................................................................. 8-6
8.4.2 Disassembling Upper Panel .................................................................. 8-6
8.5 Disassembling Side Panel.................................................................................. 8-7
8.5.1 Preparation .............................................................................................. 8-7
8.5.2 Disassembling Side Panel ..................................................................... 8-7
8.6 Disassembling Control Panel ............................................................................. 8-8
8.6.1 Preparation .............................................................................................. 8-8
8.6.2 Disassembling Control Panel ................................................................ 8-8
8.7 Disassembling LCD Monitor ............................................................................ 8-9
8.7.1 Preparation .............................................................................................. 8-9
8.7.2 Disassembling LCD Monitor .................................................................. 8-9
8.8 Disassembling Monitor ARM ............................................................................ 8-10
8.8.1 Preparation ............................................................................................ 8-10
8.8.2 Disassembling LCD Monitor ................................................................ 8-10
Chapter 9 Probe ....................................................................................................9-1
9.1 Overview ............................................................................................................... 9-1
9.2 Probe List ............................................................................................................. 9-2
9.3 TI Table ................................................................................................................. 9-5
9.4 Using Ultrasound Gel .......................................................................................... 9-6
9.5 Probe Safety Precautions ................................................................................... 9-7
9.6 Using Sheaths ..................................................................................................... 9-9
9.7 Cleansing and Disinfection of Probe ............................................................... 9-10
Chapter 10 Maintenance and Management ....................................................... 10-1
10.1 Overview ............................................................................................................. 10-1
10.2 Operating Environment ..................................................................................... 10-2
10.2.1 Product Installation and Storage ......................................................... 10-2
10.3 Product Management ....................................................................................... 10-3
10.3.1 Cleaning ................................................................................................. 10-3
10.3.2 Disinfecting ............................................................................................ 10-3
10.3.3 Replacing Fuse ..................................................................................... 10-4
10.3.4 Managing Air Filter ................................................................................ 10-5
10.3.5 Accuracy Inspection.............................................................................. 10-6
10.4 Information Management ................................................................................. 10-7
10.4.1 User Setting Back-up ............................................................................ 10-7
10.4.2 Patient Information Back-up ................................................................ 10-7
10.4.3 Software ................................................................................................. 10-7
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Chapter 11 Service Component List ................................................................... 11-1
11.1 Overview ............................................................................................................. 11-1
11.2 Body Cover ........................................................................................................ 11-2
11.3 Ultrasound System Parts .................................................................................. 11-4
11.4 Control Panel Parts ........................................................................................... 11-6
11.5 Probe ................................................................................................................ 11-10
Table of Contents 6
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1.1 Overview
Introduction to Products
1
1.2 Main Features of UGEO H60
1.3 Components
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UGEO H60 Service Manual
1
Introduction to Products
1.1 Overview
Chapter 1 describes the basic important information you need to know before repairing UGEO H60. It describes the main features and configuration and the product specification.
UGEO H60, a color ultrasound diagnostor with high resolution and deep penetration, is convenient and offers variety of measurement functions
Table of Contents
1.1 Overview ..................................................................................................................... 1-1
1.2 Main Features of UGEO H60 ................................................................................... 1-2
1.3 Components ............................................................................................................... 1-3
1.3.1 Console ............................................................................................................ 1-3
1.3.2 Probe ................................................................................................................ 1-4
1.3.3 Product Specification ...................................................................................... 1-5
1.3.4 Product Components ...................................................................................... 1-8
Chapter 1 Introduction to Products 1-1
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1.2 Main Features of UGEO H60
Digital Beam forming technology, self-developed at Samsung Medison Co., Ltd.
Is applied.
Various Application: Can be applied to various fields such as General, Obstetrics,
Gynecology, Abdomen, Vascular, Extremity, Cardiac, Urology, Breast
Various Diagnostic Modes: Various types of modes are available such as 2D mode, M mode,
Color Doppler Mode (C mode), Power Doppler Mode (PD mode), PW Spectral Doppler Mode (D mo de)
Stereoscopic Feature: Implements solid and detailed visuals with 3D and 4D imaging mode. Measuring and Reporting Feature: Offers various measurement functions for each specific
area besides measurement functions for distance, area, volume and perimeter. In addition, there is a report function using this measurement result.
Reviewing Scan Video Feature: Provides 2621 frames of Cine video and 4086 lines of
Loop video at maximum.
SonoViewTM Feature: Available on storing, querying and compatible data with integrated
video management system.
Digital Imaging and Communication in Medicine (DICOM) Feature: Can store, transfer, and
print video using network.
Ease of Connection to Peripheral Devices: Can connect to various peripheral devices and
use it.
Chapter 1 Introduction to Products 1-2
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UGEO H60 Service Manual
1.3 Components
UGEO H60 is composed of console, probe and cart (option).
1.3.1 Console
The internal part of console is composed of devices mainly implementing ultrasound image, while the external part is composed of various connected devices and handle.
[Figure 1-1] H60 Front Figure
[Figure 1-2] H60 Side Figure
Chapter 1 Introduction to Products 1-3
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NOTE
Refer to "Chapter 9 Probe" in service manual for more detail.
1.3.2 Probe
Probe is a device collecting data for ultrasound image by using ultrasound.
[Figure 1-3] H60 Rear Figure
Chapter 1 Introduction to Products 1-4
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UGEO H60 Service Manual
1.3.3 Product Specification
Physical Dimensions
Height: 1660 mm (with Monitor) Width: 550 mm Depth: 980 mm(with Keyboard) Weight: 105kg (without accessories)
Imaging modes
2D-Mode M-Mode Color Doppler Pulsed Wave (PW) Spectral Doppler Power Doppler (PD) 3D/ 4D imaging mode Dual modes Quad modes Combined modes
Simultaneous mode Zoom Mode S-Flow
Gray Scale
256 (8 bits)
Focusing
Transmit focusing, maximum of eight points (four points simultaneously selectable) Digital dynamic receive focusing (continuous)
Probes (Type BF / IPX7)
Linear Array
L5-13
Curved Array
CS1-4, C2-8, CF4-9, ER4-9,EVN4-9
3D
3D2-6, 3D4-9, VE4-8
Probe connections
3 Probe Connectors 4 Probe Connectors for option
Monitor
Main Monitor
Display area : 18.5 inch Number of Pixel : 1366 x 768
Touch Screen Monitor
Display area : 10.1 inch Number of Pixel : 1280 x 800
Chapter 1 Introduction to Products 1-5
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Rear Panel Input / Output Connections
Audio Output Port( Right/Left ) VGA monitor LAN USB Port HDMI output HDMI Input (HDMI Input is currently not supported.)
Image Storage
Maximum 45000 frames for CINE memory Maximum 14000 Lines for LOOP memory Image filing system
Application
Obstetrics, Gynecology, Urology, Abdomen, Vascular, Small Part, MSK Pediatric
Electrical Parameters
100~240VAC, 620VA, 50/60Hz
Measurement Packages
Abdomen, Obstetrics, Fetal Echo, Gynecology, MSK, Pediatric Hips, Small Part, Urology, Vascular * Refer the Chapter 5 for additional information
Signal processing (Pre-processing)
Acoustic Power Control Analog TGC Control Dynamic Aperture Control Dynamic Apodization Control Dynamic LPF Control
Signal processing (Post-processing)
Digital TGC Control Slider TGC Control Mode-Independent Gain Control Black Hole/Noise Spike Filtering 1D Lateral/Axial Filtering 2D Edge/Blurring Filtering Frame average M/D Mode Sweep Speed Control Zoom Image View Area Control Image Orientation (left/right and up/down)
Chapter 1 Introduction to Products 1-6
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UGEO H60 Service Manual
Measurement
Trackball operation of multiple cursors 2D mode: Linear measurements and area measurements using elliptical approximation or trace M mode: Continuous readout of distance, time, and slope rate Doppler mode: Velocity and trace
Auxiliary
DVD Multi-Drive Digital B/W Video Printer Digital Color Video Printer USB Printer DVD Recorder Foot switch (IPX8) e-Motion Marker (IPX 7) USB Flash Memory Media USB HDD Monitor
User Interface
English, German, French, Spanish, Italian, Russian, Chinese
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: -25°C ~ 60°C
Chapter 1 Introduction to Products 1-7
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Monitor Monitor Arm Keyboard Control Panel Lift Probe Holder DVD Drive USB Port Speaker Probe Port Wheel
1.3.4 Product Components
This product is composed of monitor, control panel, console, peripheral devices and probe.
Chapter 1 Introduction to Products 1-8
1.3.4.1 Monitor
Color LCD flat monitors displays ultrasound image and extra information.
1) Screen Configuration
The screen of this product has contents such as ultrasound image and extra information, and necessary menu for users to operate the system. The screen configuration is composed of Title area, Measurement menu area, Imaging area, Thumbnail area, User Information as the figure below.
[Figure 1-4] The front of the product
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UGEO H60 Service Manual
Title area
Tips! Displays of current condition of system.
: Shows On condition of Caps Lock
: Shows that there is CD/DVD storage media
[Figure1-5] Screen Configuration
Displays patient information (name, ID, GA), name of hospital and operator, acoustic output information, date and time, etc.
Measurement menu area
Displays measurement menu while measuring each subject diagnosis.
Imaging area
Displays ultrasound image. Displays video information, annotation and various measuring information.
Thumbnail area
Displays stored video by clicking [Store] button. Clicking by pointer will display enlarge image on imaging area. Display up to 17 images.
Displays Body Marker in BodyMarker Mode.
User Information Status Information area
Displays various information needed for users while operating this system. Displays condition of the storage media (HDD, USB, CD), Caps Lock condition, DICOM, etc.
Chapter 1 Introduction to Products 1-9
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: Shows that there is no CD/DVD storage media.
: Shows that there is no USB storage media.
: Shows that there is more than 10% of HDD storage. : Shows that there is less than 10% of HDD storage.
: Shows that DICOM Spooler is empty. : Shows that DICOM Spooler is in operation. : Shows that DICOM Spooler has failed in its operation.
: Shows that LAN is connected. : Shows that LAN is not connected.
1.3.4.2 Control Panel
Users operate the system with control panel.
Control panel is composed of keyboard, soft menu, button, dial, dial-button, slide and track.
Dial-button is a operating tool, combination of dial and button.
[Figure 1-6] Control Panel
Chapter 1 Introduction to Products 1-10
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UGEO H60 Service Manual
On/Off
Button
Turns On/Off the product
Patient
Button
Displays Patient Information screen where you can select the patient ID on the list or input new patient information
Probe
Button
Displays Probe Selection screen where you can select and change the probe and diagnostic subject
SonoView
Button
Displays a screen where you can review or manage stored images
End Exam
Button
Reset the related data after finishing the examination on the diagnosed patients
Report
Button
Displays the report screen which shows measurement result of corresponding diagnostic subject
Button
Inputs BodyMarker on the video
Button
Inputs texts on the video
U1
Button
This button can be set to user's preference. Features of each button can be set from Setup > Peripherals > Customize Key
U2
Button
This button can be set to user's preference. Features of each button can be set from Setup > Peripherals > Customize Key
Button
Displays exclusive videos on the screen
Button
Compares two separate videos
1) Detailed Features of Control Panel
Following are the description and the use of each control on control panel. Controls with various different features are described in more detail after Chapter 3 of this manual.
Chapter 1 Introduction to Products 1-11
Page 25
Button
Compare four separate videos
Depth
Dial-Button
Adjusts the depth of the image which can be observed
Focus
Dial-Button
Moves the position of the focus to the desired target area
Zoom
Dial-Button
Zoom Box appears. Press [Exit] button to exit Zoom mode.
Angle
Dial-Button
Adjusts the angle of sample volume in spectral doppler mode. Also used for adjusting the angle of arrow and adjusting probe angle of Body marker.
Moves Reference Slice to the left and right using [Angle] Dial-Button in 3D View
Q Scan
Button
Uses Quick Scan feature
Store,
S1, S2,
S3
Button
Stores, prints and sends to DICOM Server with having settings of each feature for each.
Features of each Button can be set from Setup > Peripherals > Customize Keys
Freeze
Button
Stops the video which is being scanned or reactivates the stopped video
M
Dial-Button
Starts or exits the M mode. Adjusts gain by turning Dial­Button. Rotates the image in the direction of the x-axis in 3D View
PD
Button
Starts or exits power doppler mode
Color
Dial-Button
Starts or exits color doppler mode. Adjusts gain by turning Dial-Button.
Rotates the image in the direction of the x-axis in 3D View
2D
Dial-Button
Starts 2D mode. Adjusts gain by turning Dial-Button.
Chapter 1 Introduction to Products 1-12
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UGEO H60 Service Manual
PW
Dial-Button
Starts or exits PW spectral doppler mode. Adjusts gain by turning Dial-Button.
Rotates the image in the direction of the y-axis in 3D View
CW
Button
This button is currently not supported
3D / 4D
Button
Used for On / Off on 3D/4D mode.
Set / Exit
Button
[Uses by setting the [Set] or [Exit] feature. Features of each Button can be set from Setup > Peripherals > Customize Keys
- Set: Selects desireditem or value using trackball, or changes the feature of trackball.
- Exit: Exists the current feature and returns to the previous state
Pointer
Button
The arrow pointer appears on the screen in the scan mode
Clear
Button
Deletes text, arrow, body marker, measurement result, etc displayed on the screen
Change
Button
Changes to other feature which is supported in the current trackball feature
Calculator
Button
Starts measuring on each diagnostic subject
Caliper
Button
Starts basic measurement such as distance, volume, circumference and area
Trackball
Trackball
Moves the cursor on the screen. There are video search feature in Cine footage.
CAUTION
Bands might appear on the image if adjusting gain value of adjacent TGC slide with large difference
Chapter 1 Introduction to Products 1-13
Page 27
2) Keybard
Help
Help Manual appears on the screen
Patient
General Information appears on the screen
Patient info.
Shows or hides patient information on the screen
Image Info.
Shows or hides Image Parameter on the screen
DICOM Spooler
DICOM Spooler appears on the screen
Arrow
Starts Arrow mode
Home
Moves cursor to the Home position in Annotation mode
Set Home
Sets the Home position in Annotation mode
Delete Word
Deletes last inputted text in Annotation mode
Used to input texts
[Figure 1-7] Keyboard
Chapter 1 Introduction to Products 1-14
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UGEO H60 Service Manual
Delete All
Deletes all inputted text in Annotation mode
Setup
Setup screen appears
Insert
Select the input method Decrease the brightness of the monitor by pressing the Fn key
Delete
Deletes Text Increase the brightness of the monitor by pressing the Fn key
3) Touch-Screen
It is an operating tool which users directly touch. The available features are shown as Button or Dial Button in the current mode.
Screen configuration of touch-screen
Information area: shows the title of touch screen currently used. TGC: adjusts TGC slide when TGC curve settings on the touch screen is active.
[Figure 1-8] TGC
Menu area: The available menu in the current input mode is shown as Button.
Use by pressing the Button itself, and menus which are being used are shown as yellow.
Chapter 1 Introduction to Products 1-15
Page 29
Tip! When there are two menu for touch screen
In case there are 2 menus on the top and bottom, press corresponding Dial­Button and select the desired menu. Use Dial-Button after pressing the Button on the menu that you wish to use on the touch screen.
CAUTION
Do not move the control panel with excessive force. Use the rear handle to move the product
Soft menu area: shows soft menu available in current input mode. Use by
pressing Dial-Button right below the menu or turning it to left or right.
[Figure 1-9] Display of touch-screen
4) Adjustment of the Control Panel
Horizontal Adjustment
Move the product carefully side to side by holding the handle.
Vertical Adjustment
Move the product carefully up and down by pressing the lever on the handle of control panel.
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UGEO H60 Service Manual
HDMI: delivers digital type image and audio
signals in one cable simultaneously
USB port: connects peripheral devices for
USB
Audio Output (input): is used for output of
audio signal
S-VHS port (I/O): connects VCR in S-VHS
method
D-SUB port: outputs analog signals to
monitor
Network port: connects network Mic port (input): connects microphone
[Figure 1-10] Rear panel
1.3.4.3 Console
Console is divided into two main parts of the internal and external. The internal of the console is consisted of the devices for implementing ultrasound image. The external of the console is composed of various connected devices, probe holder, storage space, handle, wheel, etc.
1) Rear Panel
Located on the back of the product, it connects various peripheral devices such
as monitor, printer, etc..
2) Power connector
Chapter 1 Introduction to Products 1-17
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NOTE
Refer to the user's manual of corresponding product for the use of peripheral device.
CAUTION
Do not install peripheral devices not mentioned in this manual to the patient environment. There is a risk of electric shock when you install peripheral devices in the patient environment.
Located at the bottom of the rear panel
[Figure 1-11] Power connector
Power Inlet: a connected part of power cord connecting external power source Power Outlet: supplies power for peripheral devices or external devices, and
capacity is MAX150VA. Outlet terminal is located on DC power assy.
Power switch / circuit breaker: supplies power for the entire product or cut the
power supply in case of overvoltage or overcurrent.
3) Probe Holder
Holder is located on the left and right of the control panel for storing Probe.
1.3.4.4 Peripheral Devices
1) Internal peripheral devices
These are the peripheral devices located inside of the console.
DVD-Multi
DVD-R, DVD+R, DVD-RW, DVD+RW, DVD-ROM, CD-R, CD-RW, CD-ROM
Hard Disc Drive
Min. 500GB SATA-2 2.5” HDD
2) External peripheral devices
Connect it upon the user's need. The connection is usually made through the corresponding port on the rear panel.
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UGEO H60 Service Manual
Tip!
USB port of the console is located on both side panel and rear panel of the control panel.
It is convenient to connect USB storage devices (flash memory media, etc) on the side panel of the port, and other USB peripheral devices on the rear panel.
CAUTION
For peripheral devices using USB port, make sure you turn the power off before equipping or removing the device to the console. Malfunction of peripheral devices for system or USB can be occurred when the power is not completely off.
[Figure 1-12] Patient Environment
The following products are recommended.
Digital Video Printer
- BW: Sony UP-D897, Mitsubishi P95DE
- Color: Sony UP-D25MD, Mitsubishi CP30DW
USB Printer
HP Officejet 4500, Samsung ML-2950ND, Samsung CLP-620NDK
DVD Recorder
Sony DVO-1000MD
Chapter 1 Introduction to Products 1-19
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CAUTION
Must install printer and driver compatible with English Microsoft Windows XPTM. Contact Samsung Medison customer service for details of installing printer driver.
Check to make sure the printer is same as the one in Windows XPTM or Setup, when connecting to the printer.
Please note that the connecting port is different depending on the printer. General printer is connected to the printer port while USB printer to the USB port.
NOTE
Refer to Chapter 5 Probe for more detail.
Foot Switch
Foot Switch feature can be enabled on Setup > Peripherals > Customize Keys > Foot Switch. You can choose options from Exit, Freeze, Store, S1, S2, S3 and Update.
1.3.4.5 Probe
Probe is a device collecting data for the ultrasound imaging configuration using ultrasound.
1) How to connect the probe
Turn the power off before equipping or removing probe from probe connector for the safety of product and probe.
Connect probe to the probe connector on the front panel of the console. It can
connect up to maximum of 4 probes (including option).
Equip it by turning the handle of the connector clockwise.
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UGEO H60 Service Manual
[Figure 1-13] Probe connectors
1.3.4.6 Accessory
This product includes a box containing various accessories.
[Figure 1-14] Accessories
Chapter 1 Introduction to Products 1-21
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SDMR Spatial Compound Imaging™ (SCI™) DICOM 4D 3D XI Volume NT / IT
Gel warmer Foot switch 4 probe ports e-Motion Marker Network Isolator
1.3.4.7 List of Options
This product has following list of options.
Refer to the corresponding content of this manual for more details of options above.
Chapter 1 Introduction to Products 1-22
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2.1 Overview
Safety
2
2.2 Safety Precautions
2.3 Electrical Safety
2.4 Mechanical Safety
2.5 Biological Safety
2.6 Protecting Environment
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UGEO H60 Service Manual
2
Safety
2.1 Overview
Chapter 2 describes the important considerations for safely repairing UGEO H60. There are details of other additional equipment such as ultrasound system, probe,
recording device. This product should only be used by the qualified doctors who are authorized to
use medical devices or the persons who are authorized by doctors. It can adversely affect the fetus if unqualified medical personnel or regular
personnel use the solid ultrasound (3D, 4D) for a long period for taking commemorative photos or video.
In case of solid ultrasound imaging device, please comply with the intended use because it can adversely affect the fetus when taking videos for other than the purpose of prenatal diagnosis.
Table of Contents
2.1 Overview ..................................................................................................................... 2-1
2.2 Safety Precautions .................................................................................................... 2-2
2.2.1 Safety Symbols ............................................................................................... 2-2
2.2.2 Location of Label ............................................................................................. 2-5
2.3 Electrical Safety ......................................................................................................... 2-6
2.3.1 Prevention of Electric Shock .......................................................................... 2-6
2.3.2 ESD .................................................................................................................. 2-7
2.3.3 EMI ................................................................................................................... 2-7
2.3.4 EMC.................................................................................................................. 2-8
2.4 Mechanical Safety ................................................................................................... 2-13
2.4.1 Precautions during Operation ...................................................................... 2-13
2.4.2 Precautions during Movement .................................................................... 2-13
2.4.3 Precautions during Monitor Operation ........................................................ 2-14
2.5 Biological Safety ..................................................................................................... 2-15
2.5.1 ALARA Principles .......................................................................................... 2-15
2.6 Protecting Environment ........................................................................................ 2-29
Chapter 2 Safety 2-1
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Symbol
Meaning
AC power
Warning about the risk of electric shock
Classification according to the degree of protection against electrical hazards (Type BF)
Classification according to the degree of protection against electrical hazards (Type CF)
Power switch (supplies/cuts off the power)
OFF (cuts off the power on parts of the product)
Warning: to prevent serious accidents or property damage
Caution: to prevent minor accidents or property damage
Refer to the user's manual
ON (supply the power on parts of the product)
Equipotential terminal
2.2 Safety Precautions
2.2.1 Safety Symbols
IEC (International Electrotechnical Commission) has enacted safety and safety symbols for medical electronic devices. Enacted symbols are as following.
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UGEO H60 Service Manual
Symbol
Meaning
High-voltage beyond AC 1000V or DC 1500V
Protective ground terminal
Data output port
Data input port
Data input/output port
Left and right audio / video input port
Left and right audio / video output port
Print remote output
Foot switch connector
USB connector
Watertight device
Underwater device
Probe connector
ESD-related warning symbol
Chapter 2 Safety 2-3
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Symbol
Meaning
Do not sit on the control panel
Do not push
Do not lean on it
Follow the user's manual
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UGEO H60 Service Manual
2.2.2 Location of Label
Labels of 'Warning' and 'Caution' are attached on the product for protecting the product.
[Figure 2-2] TIP-OVER related precautions
[Label 1. ID 라벨]
[Figure 2-1] ID label
[Figure 2-3] Probe ID label
[Figure 2-4] Probe label
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WARNING
There is a risk of electric shock when external recording device
or monitoring device is not properly grounded.
Do not open the cover of the product for any reason. Dangerous
voltages are present inside the product. Internal repairs or component replacement should be conducted by Samsung Medison global technology support group.
Always inspect external, cable, cord, plug, etc of the product
before using. Stop using it when the external is damaged like being cracked or broken, or the cable is worn out.
Plug off the power plug when cleaning the product. All equipments (probe, ECG lead) that have contact with
patients should be isolated from the patients before the use of heart massager of high pressure.
Do not have a contact with patients and signal input/output
terminal of product simultaneously. There is a risk of leakage current exceeding maximum limit.
Do not use the product in the environment of flammable gas or
anesthetic gas. There is a risk of explosion.
Use only the designated adapter when using AC adapter.
CAUTION
Installation of isolating transformer protects the product from surge
voltage. Isolating transformer is in continuous operation even in standby.
Do not immerse the power cord in liquid. Power cord is not waterproof. Do not operate SIP/SOP of product while diagnosing patients. There is
a risk of electric shock from leakage current.
2.3 Electrical Safety
This product is classified as Class I, Type BF.
2.3.1 Prevention of Electric Shock
Only the products in accordance with IEC standard should be used for connected
Chapter 2 Safety 2-6
peripheral devices (IEC60950/EN60950 for data processing device, IEC60601­1/EN60601-1 for medical devices). All components of the product should comply with IEC60601-1-1/EN60601-1-1, the system standard. The personnel who is in charge for adding peripheral devices on signal input/output of medical devices
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UGEO H60 Service Manual
should make sure that all peripheral devices are in accordance with IEC60601-1-
CAUTION
The static caused from the user or the patient can sometimes
damage ultrasound system or probe.
Refer to the following in order to prevent damage caused by
ESD
- Use antistatic spray on carpet or linoleum.
- Use antistatic mat.
- Ground the product between patient tables or beds.
The personnel in association with the use of the product is
recommended to be trained with ESD-related warning symbols and precautionary procedure.
CAUTION
Move the product far away from EMI when the system does not operate properly by electromagnetic field.
1/EN60601-1-1 standard.
2.3.2 ESD
ESD(Electro Static Discharge) is a phenomenon typically caused by friction in the natural state. ESD happens the most when the air is dry such as an environment under heater or air conditioner. Static or ESD happens when electricity from fully charge object charges not fully charged object. In other words, it can happen when a person makes a contact with handle made of metal, file cabinet, computer or even other person.
2.3.3 EMI
This product has passed the standard by EMI (Electro Magnetic Interference). Using the product under the environment of electromagnetic field can degrade the
quality of ultrasound image or damage the product itself. When the ultrasound image has a poor quality of has failed, check to make sure if
there is no device causing electromagnetic field nearby. Electromagnetic field can be caused from the same place or adjacent place, and usually cell phone, pager, radio, TV, microwave, etc are the cause of electromagnetic field.
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2.3.4 EMC
Emission test
Compliance
Electromagnetic environment -guidance
RF Emission
(Radiation)
CISPR 11
Group 1 Class B
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 network that supplies building used for domestic purpose.
RF Emission
(Radiation)
CISPR 11
Group 1 Class B
Harmonic
Emission
IEC 61000-3-2
Class A
Flicker Emission
IEC 61000-3-3
Complies
Cable
Type
Length
DVI
Shielded
Normal
USB
Shielded
Normal
LAN(RJ45)
Twisted pair
Any
MIC
Unshielded
Any
Printer Remote
Unshielded
Any
Audio R.L
Shielded
Normal
EMC(Electro Magnetic Compatibility) inspection of this product is conducted in accordance with medical device international standard IEC60601-1-2. European standard is IEC standard (EN60601-1-2).
2.3.4.1 Guidance and manufacturers declaration – Electromagnetic
This product is used under the following electromagnetic environment. Users should make sure the product is used under the following environment.
Emission
2.3.4.2 EMC approval cable, probe and peripheral devices
1) Cable
Cables connected to this product can affect the electromagnetic emission. Only use the appropriate cables with type and length listed below.
2) Probe
Probes connected to this product can affect the electromagnetic emission.
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UGEO H60 Service Manual
CAUTION
It is the duty of the user to ensure the electromagnetic compatibility of the product if the user connects the peripheral devices. Only use the devices appropriate with CISPR 11 or CISPR 22, CLASS B.
WARNING
Unapproved use of cable, probe and peripheral devices can increase the electromagnetic emission and reduce the tolerance of ultrasound product.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic
environment -guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6KV Contact
±8KV air
±6KV Contact
±8KV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
±2KV for power supply lines
±1KV for input/output lines
±2KV for power supply lines ±1KV for input/ output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
±1KV differential mode
±2KV common mode
±1KV differential mode ±2KV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5% Uт (>95% dip in Uт) for 0.5cycle
40% Uт (60% dip in Uт ) for 5 cycle
70% Uт (30% dip in Uт) for 25 cycle
<5% Uт (<95% dip in Uт ) for 5 s
<5% Uт (>95% dip in Uт) for 0.5cycle
40% Uт (60% dip in Uт ) for 5 cycle
70% Uт (30% dip in Uт) for 25 cycle
<5% Uт (<95% dip in Uт ) for 5 s
Mains power quality should be that of a typical commercial or hospital environment. If the user of this product requires continued operation during power mains interruptions, it is recommended that this product be powered from an uninterruptible power supply or a battery.
Probes listed in 'Chapter 9 Probe' of this service manual have passed the inspection in accordance with Group1 Class B required by CISPR 11.
3) Peripheral devices
Peripheral devices used with this product can affect the electromagnetic emission.
Chapter 2 Safety 2-9
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Power frequency (50/60Hz) magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to
80MHz
0.01V
Portable and mobile RF communications 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 transmitter.
Recommended separation distance
80MHz to 800MHZ
800MHz to 2.5GHz
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to
2.5GHz
3 V/m
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 transmitters, as deter-mined by an electromagnetic site survey, a should be 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.
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UGEO H60 Service Manual
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 [V1] V/m.
Rated maximum
output power of
transmitter [W]
Separation distance according to frequency of transmitter [m]
150kHz to 80MHz
80MHz to 800MHz
800MHz to 2.5GHz
V1=0.01Vrms
E1=3 V/m
E1=3V/m
0.01
35.00
0.11
0.23
0.1
110.68
0.36
0.73
1
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 distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter 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.
2.3.4.3 Recommended interval between radio frequency communication device and UGEO H60
This product is used under the electromagnetic environment where emitted radio frequency disturbance is controlled. Users can maintain a minimum distance with portable radio frequency communication device (transmitter) and prevent electromagnetic interference by adjusting the maximum output of communication device as below.
2.3.4.4 Electromagnetic Environment – Guidance
Ultrasound product should have minimum of blocking radio frequency feature and should be used in the isolated space where cable is connected. The strength of field of fixed radio frequency transmitter should be less than 3V/m in isolated
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CAUTION
Samsung Medison Co., Ltd. is not responsible for any problem caused in electromagnetic environment from connecting remote devices such as remote printer or LAN which users have.
space as determined by electromagnetic test. Inspection should be necessarily conducted in order to prove that the actual
blocking effect and reduced filter of isolated space is in accordance with the minimum standard.
2.3.4.5 Avoiding electromagnetic interference
Medical devices can cause electromagnetic interference or be affected by electromagnetic interference. EMC standard lists the inspections of electromagnetic interference which is caused or is affected.
Electromagnetic interference caused from ultrasound product of Samsung Medison Co., Ltd. Does not exceed the standard.
Ultrasound product is designed to receive radio frequency which makes it easy to be interfered by energy sources of radio frequency. Medical devices, IT products, transmission tower of Radio and TV are other cause of the interference. If there is a difficulty locating the interference, consider the following.
Is the electromagnetic interference intermittent or continuous? Is the electromagnetic interference occurred in only one probe at the same
frequency or in many probes?
Is there a problem when two different probes are used at the same
frequency?
Is there electromagnetic interference even after moving the ultrasound
product to the other place?
The answers to the above will tell you whether there is a problem in the ultrasound system or the product environment. Please contact Samsung Medison Co., Ltd. global technical support group or the engineer with authorization after answering all questions above.
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UGEO H60 Service Manual
CAUTION
Do not apply excessive force to the product. Place the product on stable place. Use of exclusive cart (option) is
recommended.
Do not use the product with placing it on the lap. There is a risk of
burns.
Do not modify the product in any reason. Conduct safe operation before the use if it hasn't been used for a
while.
Be careful not to let a foreign substance, especially ironware in the
product.
Do not block the vents of the product. Do not store the product in a closed space such as a bag with the
power on.
Do not hold the cord when plugging the power off. The cord can be
damaged, which would yield a risk of short-circuiting or disconnecting. Make sure you hold the plug when plugging the power off.
The product can stop operating or can cause malfunction when
excessively twisting the cable connected to the patient.
Inappropriate cleansing or disinfecting on connecting area with patient
can be a cause of product failure.
CAUTION
Make sure to turn the power off and remove the connected cable before the movement.
2.4 Mechanical Safety
2.4.1 Precautions during Operation
2.4.2 Precautions during Movement
Carefully move the product by holding the rear handle of the product. This product can be moved by using the exclusive cart (option).
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NOTE
Try not to stand it on the inclined place when using the exclusive cart. When placing it on the inclined place, enable the locks on the wheel.
CAUTION
Do not push or lean on the control panel with excessive force.
Do not sit on the control panel or apply excessive force on it.
2.4.3 Precautions during Monitor Operation
Pay attention to the space between monitor arms when adjusting the height or position of monitor. There is a risk of finger injury.
[Figure2-5] Precautions during monitor operation
Pay attention to the space between control panel and lift when adjusting the height or position of monitor. There is a risk of finger injury.
[Figure2-6] Precautions on using control panel
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UGEO H60 Service Manual
WARNING
Ultrasound can have harmful effects within the cell and can be a
potential harm to the patient. Try to minimize the exposure time and maintain the output of ultrasound to the minimum when there is no medically special purpose. Refer to the ALARA principles.
Do not use the product when there is a warning message or error
message about dangerous situation on the screen. Write down the message on the screen, turn the product off, and contact Samsung Medison Co., Ltd. Global technical support group.
Do not use the product with unusual and strange behavior. Unusual
operation of continuous scanning is caused from the failure of hardware, and should be repaired before the use.
The product limits the temperature that patient can make contact with to
45 degrees Celsius, and ultrasound power output value (AP&I) complies with standard of U.S. FDA.
2.5 Biological Safety
Refer to 'Chapter 9 Probe' in this manual for the safety precautions about probe.
2.5.1 ALARA Principles
Diagnostic with ultrasound equipment can be conducted with the principle of "As Low As Reasonably Achievable". What is 'reasonable' has been looked with insights and defined by many people. There is, however, no standard such as a perfect formula that can be appropriate for every environment and that can control every situation. The damage from ultrasound can be reduced by minimizing the exposure to the ultrasound during the diagnosis.
Because there is no clear investigation of the damage cause from the ultrasound, it is very important to adjust the amount of ultrasound penetrated on patients. Thus, not only it is important to get the accurate image from ultrasound diagnosis, but also it is important to minimize the exposure time of patient. To balance between the acquisition of accurate image and the exposure time of patient, ultrasound system offers the feature that can optimally adjust the test result during the diagnosis.
It is important to be well-informed of ALARA principle and to implement it. The development of ultrasound diagnosis is possible with the development of not only the ultrasound device itself but also the technique which delivers fine information to the users. This major information, based on various output data of ultrasound,
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plays an important role in implementing ALRA principle. There are many variables affecting the output data which is the fundamental data
of provided information. Location of bone which is related with mass, size and focus, debilitation of the body, exposure time to the ultrasound are the variables, and exposure time is the most significant variable. The reason for that is that exposure time, unlike other variables, is the variable determined by the users of ultrasound device.
2.5.1.1 Applying ALARA
Video mode of the used system is different by the required information. While 2D mode and M mode imaging provides anatomical information, power or color mode imaging provides the blood flow information. While scanned mode such as 2D mode, power or color scatters ultrasound energy throughout the area, unscanned mode such as M mode and doppler concentrates ultrasound energy. By understanding the features of imaging mode used, ultrasound device users make a judgment based on the information by applying ALARA principle. Ultrasound device users can comply with the ALARA principle with probe frequency, system settings, scanning technology and operator's experience. The amount of acoustic output is determined by the system operator in the final analysis. This decision should be based on the facts such as type of patients, experiment type, patient history, easy access to the useful information for diagnosis and potential heat applied on patient's local from surface temperature. In order to produce the correct diagnosis result, exposure time of patient should be limited to the minimum and make use of the system.
Even though numerical value of high index does not actually mean the occurrence of Bioeffect, if the numerical value is high, it should be handled carefully, which means that every effort should be made to reduce the negative effect that high index value may have. One effective way is to limit the exposure time.
There are a few controls that operator can use to adjust the image quality and limit the acoustic intensity. These controls are associated with the required technology for operator to implement ALARA principle, and they are divided into three categories which are direct, indirect and control of the recipient.
2.5.1.2 Direct Controls
Selecting diagnosis subject or output intensity control has direct effect on acoustic intensity. The choice of acceptable range of intensity or output varies depending on the selection. Selecting the range of acoustic intensity is considered to be one of the main priorities in any type of experiment. For example, peripheral vascular intensity level is not recommended in fetal experiments. Some systems automatically select the optimal range for specific diagnosis, while users
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UGEO H60 Service Manual
themselves have to make selection for other diagnosis subject. Ultimately, the responsibility of the clinical use of the product lies on the users. The system of Samsung Medison Co., Ltd. offers both auto-selection set by default and manual selection.
Output has direct effect on acoustic intensity. After diagnosis subject has been set, output control can be used to raise or drop down the intensity output. Intensity level can be set lower than the highest level setting through output control. With careful use, the lowest output intensity along with excellent quality can always be selected.
2.5.1.3 Indirect Controls
Indirect control has indirect effect on acoustic intensity and usually affects the imaging mode, the pulse repetition frequency, focus depth, pulse length, probe selection, etc.
Features of ultrasound beam are determined by the selection of imaging mode. 2D mode is a scanned mode, while doppler mode is stopped or unscanned mode. Stopped ultrasound beam concentrates energy to one place. Moving or scanned ultrasound beam scatters the energy throughout the area and concentrates on one place only for a few minutes of unscanned mode.
Pulse repetition frequency or repetition rate shows the number of ultrasound explosion times of energy over a period of time. The higher the pulse repetition frequency, the longer the energy pulse over a period. The following types of controls have effect on pulse repetition frequency: focus depth, display depth, sample volume depth, color sensitivity, number of focal zones, sector width controls and ultrasound beam focus have effect on the resolution of the image. Various experiments require various focus depth. The resolution can be enhanced with the appropriate depth of focus.
Pulse length is the time during the occurrence of ultrasound. The longer the pulse the greater the average intensity value. The greater the time-average intensity, the bigger the temperature increase and cavitation possibility. Pulse length, ultrasound occurrence length or pulse lasting period is the output pulse lasting period of pulsed doppler. Pulse length becomes greater with the increase of doppler sample volume.
Probe selection also has indirect effect on intensity. Tissue attenuation varies depending on the frequency control. The greater the probe operating frequency, the greater the decrease of ultrasound energy. The greater the probe operating frequency, the stronger output intensity is required in the deeper area while scanning. Lower probe frequency is required for the deeper scanning in the identical output intensity. Therefore, using more gain and output than the required value means that it requires lower probe frequency without the enhancement of
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image quality.
2.5.1.4 Receiver Controls
Users use receiver control to improve the quality of the video. These controls have no effect on output. Receiver control only affects the method which ultrasound echo is transmitted. These controls include gain, TGC, dynamic range and image processing. One thing to consider about output is that receiver control should be optimized before the increase of output. For example, image quality should be enhanced with maximizing gain before increasing output.
2.5.1.5 Additional Considerations
Scanning time should be minimized and scanning should be only used for medical purpose. Do not ever rush the experiment, compromising the quality. Insufficient experiment requires future reinforcement, which results in the delay of time. Diagnostic ultrasound, considered to be one of the important tools in medical field, should be used efficiently and effectively used just like any other tool.
2.5.1.6 Output Display Features
System output display is divided into two major index which are mechanical index and temperature index. Temperature index is again divided into Tis, Tib and tic. One of these 3 temperature index is always displayed on the screen. The item displayed on the screen depends on the diagnostic subject, system setting or user's choice.
Mechanical index varies from 0.0 to 1.9 in increments by 0.1 and displayed continuously. Temperature index is composed of 3 indexes and only one of them is always displayed. Each probe diagnostic subject has its appropriate default selection corresponding to its combination. Based on the probe and diagnostic subject, Tib or Tis is continuously displayed from 0.0 to the maximum output, and the increment is by 0.1.
Features depending on the diagnostic subject of default setting are an important factor of index respond. Default setting, a system control state, is preset by manufacturer or operator. System has the default index setting for probe diagnostic subject. This default setting is automatically read by the ultrasound system when the power is turned on, when a new patient data is read through system database or when there is a change in diagnostic subject. Among the 3 temperature indexes, the one displayed on the screen determined by the following categories.
Appropriate index for diagnostic subject: Tis is used in soft tissue imaging, while Tib is used in adjacent focus on bones. They relax the factors which artificially
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raise or lower the temperature index record such as fluid, location of bone or flow of blood. For example, the case where the actual possibility for local heating is lower than the temperature index display because of there is a tissue pathway that rapidly attenuates.
Operating unscanned mode affects temperature index compare to probe mode. For the case of scanned mode, heating possibility is greater as it is closer to the surface, while heating possibility is greater as it is closer to the focal zone for the case of unscanned mode.
Always limit the ultrasound exposure time. Do not make haste in experiment. Maintain index to the lowest, and always put a limit on the exposure time without compromising with diagnostic sensitivity.
1) Mechanical Index (MI) Display
Mechanical biological effect is the dawn phenomenon when the output has exceeded a certain level of output.
The beginning standard, however, varies by the type of tissue. Possibility of mechanical biological effect varies by the peak pressure and ultrasound index. MI explains these 2 indexes. With great MI value, there is a greater possibility of occurrence of mechanical biological effect. There is no specific MI value which states that the mechanical effect is actually in effect. MI is only used a guide for implementing ALARA principle.
2) Thermal Index (TI) Display
For the users, TI describes the possibility of temperature increase of the focus on the bone of body surface, body tissue or ultrasound beam. TI is the possibility of a temperature rise on distinctive body tissue. Actual temperature rise is affected by indexes such as type of tissue, vascularity and operation mode. TI is only used as a guide for implementing ALARA principle.
Temperature index of bones (TIb) describes soft tissue such as 2-3 months old fetal skeleton and potential heating possible to occur near the focus or nearby the fluid after the ultrasound beam has passed. Skulls temperature index (Tic) describes the potential heating which can occur on or near the surface of the skull. Body tissue temperature index (TIs) describes the potential heating which can occur inside of soft homogeneous tissue.
TIs or TIb can be selected using TIs/TIb selection in miscellaneous system setting. Tic can be displayed if transcranial application has been selected.
3) Mechanical and Thermal indices Display Precision and Accuracy
MI and TI precision appear on system by units of 0.1. Estimated accuracy of MI and TI display of system is shown in the manual of
Acoustic Output Tables. This estimated accuracy is based on the possible change range of probe and system, indigenous Acoustic output modeling error or
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Measurement variability and they are as follows. Displayed values should be interpreted as a reference which helps implementing
ALRA principle for system operators by carefully using the system. These values should not be interpreted as an actual physical value for the tissue or tissue. The initial data used for supporting output display originated from the experimental measurement standard based on the AIUM measurement standard, and these measurement standards are applied in the algorithm in order to compute the displayed output.
Many assumptions used in measurement and calculation are essentially conservative. Over-estimation of actual in-situation exposure about various tissue paths are in the process of measurement and calculation. For example, calculated water tank value is depreciated by considering the interactive effects of attenuation of a conservative industry standard 0.3dB/cm-MHz.
Conservative value of tissue features are selected for the purpose of TI model. Conservative values for the absorption of bone or tissue, blood perfusion rates, blood temperature ability or tissue thermal conductivity are the conservative values of tissue features.
Steady state temperature rise is intended to be used in the TI model selection, and it assumes that the ultrasound probe has been placed in one place for sufficient period of time which can be considered steady.
When evaluating the accuracy of display value, many indexes should be considered. Hardware changes, evaluation algorithm accuracy and measurement variability, variability between probe and system are the important indexes. Probe variability appears as a result of crystal efficiencies of piezoelectric, process­related impedance difference and sensitive lens focusing parameter change. System pulse voltage control and efficiency difference also affects the change. When estimating possible system operating condition and acoustic output value exceeding pulser voltage range, there is the characteristic of uncertainty in algorithm. Inaccuracies of laboratory measurement standard are related with hydrophone calibration and specification, location, alignment and permissible digitalization error and difference in test operator.
Conservative assumptions about output estimated algorithm of linear propagation through attenuated medium of 0.3dB/cm-MHz is not considered in accuracy measurement of the display disregarding the depth of it. Identical attenuation of linear transfer or 0.3dB/cm-MHz also does not occur in the most of tissue pathways of water tank measurement or inside of the body. In the body, many tissues and organs have different attenuation features. Water, however, has almost no attenuation. In internal and water tank measurement, nonlinear transfer and saturation losses occurs when pulser voltages rises.
Accuracy estimation of display is based on probe, system, unique acoustic output
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modeling error and change range of measurement variability. Accuracy estimation of display is calculated by AIUM measurement standard, but it is not based on nonlinear loss effect about errors or measured value occurred by the measurement.
2.5.1.7 Control Affecting the indices
TI and MI value may change when various system controls are in operation. This happens the most when the power control is in operation, while other system controls affect on-screen output value.
1) POWER
Power controls the system acoustic output. 2 real-time output values of TI and MI are shown on the screen. These change when the system reacts to the power control.
Each mode is added to the integrated TI in combined mode such as simultaneous color, 2D mode and pulsed dopper. Each mode becomes the major factors of this integrated TI and displayed MI is shown from the mode with the biggest peak pressure.
2.5.1.8 2D mode Controls)
1) 2D mode size
The narrower the sector angle, the bigger the frame rate. This will also increase TI. Pulser voltage is automatically set low with the software control, maintaining TI below the value of system maximum. Decrease in pulser voltage also decreases MI.
2) ZOOM
Zooming the image will raise the frame rate. This will also increase TI. The number of focal zone will also automatically increase in order to enhance the resolution. This will bring changes in MI in case of maximum intensity happening at different depth.
3) Persistence
Lower persistence will decrease TI. Pulser voltage will automatically increase. Increase in pulser voltage will raise MI.
4) Focal no.
When there are numerous focal zones, frame depth and focal depth are automatically changed, which change both TI and MI. Lower frame rates will decrease TI. Displayed MI will react to the area of maximum intensity.
5) FOCUS
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MI changes if focal depth changes. Generally, MI value is high when the focal depth is close to the nature focus of transducer.
2.5.1.9 Color and Power Controls
1) Color Sensitivity
Increasing color sensitivity raises TI and it takes more time to scan color images. Color pulses are the major pulse type in this mode.
2) Color Sector Width
Narrowing color sector width increases color frame rate and TI. System automatically lowers the pulser voltage, maintaining it below the system maximum. Decreasing pulser voltage decrease MI. Pulsed doppler will maintain the major mode if pulsed doppler is also in operation, and change in TI will be small.
3) Color Sector Depth
If color sector depth deepens, color frame rates automatically decrease or it selects the new color focal range or color pulse length. TI varies by the combination of these effects. Generally, TI decreases with the raise in color sector depth. MI will react to the maximum intensity of major pulse type which is the color pulse. If pulsed doppler is also in operation, however, pulsed doppler will maintain the major mode and the change in Ti will be small.
4) Scale
TI can be increased when enlarging color velocity range using scale control. System will be automatically set to maintain pulsed voltage lower than the system maximum. Decrease in pulser voltage also decreases MI.
5) Sector Width
Narrowing 2D mode sector width in color image increases color frame rate. TI will increase and MI will have no change. If pulsed doppler is also in operation, pulsed doppler will maintain major mode and the change in TI will be small.
2.5.1.10 M mode and Doppler Controls
1) Speed
M mode or dopper sweep speed adjustments will have no effect on MI. TI varies when the operation speed of M mode changes.
2) Simultaneous and Update Methods
Using combination mode will have effect on both TI and MI through the combination of pulse type. During simultaneous feature, Ti becomes additive. During auto-update and duplex, TI will display major pulse type. Displayed MI will come from the mode with the highest pressure.
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3) Sample Volume Depth
Doppler PRF automatically decreases when doppler sample volume depth becomes larger. System automatically lowers the pulser voltage, maintaining it below the system maximum. Decrease in pulser voltage will decrease MI.
2.5.1.11 DOPPLER, CW, M Mode, and COLOR Imaging Controls
When new imaging mode is selected, TI and MI will change to its default. Each mode has its corresponding pulse repetition frequency and intensity point. In combined or simultaneous mode, TI becomes the sum of contribution from the operated mode, and MI, the MI about focal range, becomes the mode with high intensity in length reduction. When it is re-selected after it has been turned off, system should be rolled back to the previous mode.
1) Probe
Each valuable probe model has unique specifications on contact area, beam shape and center frequency. Default values are initiated when selecting probe. The factory default of Samsung Medison Co., Ltd. varies depending on probe, diagnostic subject and selected mode. Defaults are selected lower than the standard of FDA depending on the purpose of use.
2) Depth
Increase in depth of 2D mode automatically lowers 2D mode frame rate. This will also decrease TI. System automatically selects the deeper focal depth of 2D mode. Change of focal depth will have change on MI. displayed MI is the MI in the area with the highest intensity.
3) Application
Default of acoustic output is set when selecting the diagnostic subject. The factory default of Samsung Medison Co., Ltd varies depending on probe, diagnostic subject and selected mode. Defaults are selected lower than the standard of FDA depending on the purpose of use.
2.5.1.12 Related Guidance Documents
Refer to the following if you need more information about ultrasound biological effect or related subject;
AIUM 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
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
(AIUM, NEMA. 1998)
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)23.0( alf
e
Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment
(AIUM, 1998)
Second Edition of the AIUM 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, AIUM, 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.
2.5.1.13 Acoustic Output and Measurement
Since the first use of diagnostic ultrasound, in many science and medical laboratory, there has been many studies about human bioeffects which can be occurred from the exposure of ultrasound. In October 1987, the American Institute of Ultrasound in Medicine(AIUM) approved the report prepared by Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement), which is sometimes called Stowe Report, and this is a report of useful data about possible effects of ultrasound exposure. Another report, “Bioeffects and Safety of Diagnostic Ultrasound”, describes more recent data, written in January 1993. Acoustic output of this system is measured and calculated in accordance with December 1985 “510(K) Guided for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices. Only hydrophone is in compliance with the requirements of “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD 2-1992).
2.5.1.14 In Situ, Derated and Water Value Intensities
All intensity parameters are calculated underwater. Since water does not absorb acoustic energy, this water measurement shows the worst figure. Biological tissue does not absorb acoustic energy. In every respect, the true value of intensity varies depending on the amount and type of tissue and the frequency of ultrasound which penetrates the tissue. Intensity value and In Situ have been calculated with the following formula.
In Situ = Water [
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]
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)069.0( lf
e
where: In Situ = In Situ Intensity Value Water = Water Value Intensity e = 2.7183 a = Attenuation Factor Tissue a(dB/cm-MHz) Brain .53 Heart .66 Kidney .79 Liver .43 Muscle .55 l = skin line (cm) to the measurement depth f = major frequency (MHz) of converter/system/mode combination
During the experiment, it is difficult to estimate true In Situ intensity because ultrasound is easy to penetrate the tissues of which length and type varies. If the attenuation index is 0.3, it is used for general report purpose.
Therefore, reported In Situ values are calculated using the following formula. In Situ (derated) = Water [
] Since this value is not true In Situ intensity, the word "Derated" is used. Even with the identical condition, maximum derated or maximum water values
does not always occur. Therefore, reported maximum water value or derated values may not be associated with In Situ (Derated) formula. A good example is the multi-zone array transducer which has maximum water value intensities of the deepest area. Same converter may have the biggest derated intensity in one of the lightest focal area.
2.5.1.15 Acoustic Output and Measurement
Terminology and symbols used in acoustic output table are defined in the following paragraph.
ISPTA.3 Derated spatial-peak temporal-average intensity (Mill watts per square
centimeter).
ISPPA.3 The derated spartial-peak pulse-average intensity (Watts per square
centimeter). If Global maximum MI is reported, IPA3 value can be reported instead of ISSPPA.3 in the location of Global maximum MI(IPA.3@MI)
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Quantity
Precision
Total Uncertainty
PII.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 %
MI The Mechanical Index. If ISPPA.3 is 190W/cm2, the MI value
(MI@ISPPA.3) can be reported instead of MI(Global maximum value) in the location of ISPPA.3
Pr.3 Derated peak rarefactional pressure integrated with Transmit pattern,
the origin of value reported below MI (Megapascals).
WO Ultrasonic power (Milliwatts). About operating condition based on
ISPTA.3, WO is Time-average power; in operating condition where it is reported lower than ISPPA.3, WO is ultrasonic power integrated with Transmit pattern based on the reported value of ISPPA.3.
fc Center frequency (MHz). About MI and ISPPA.3, fc is the center
frequency, integrated with transmit pattern which is the origin of global maximum value of each parameter. About ISPTA.3 and about combined modes accompanied with other center frequency, fc is
defined as the whole range of center frequency of transmit pattern. ZSP Axis distance measured in reported parameter (Centimeters). x-6,y-6 In each X-Y plane where ZSP is found, In-plane (Azimuthal) and Out-
of-plane (Elevational) are -6 dimensions PD Pulse duration integrated with Transmit pattern, based on the reported
value of each parameter (microsecond). PRF Pulse repetition frequency integrated with Transmit pattern, based on
the reported value of each parameter (Hz). EBD Entrance beam dimensions (Centimeters) about Azimuthal and
Elevational Planes EDS Entrance beam dimensions (Centimeters) about Azimuthal and
Elevational Planes
2.5.1.16 Acoustic Measurement Precision and Uncertainty
Acoustic measurement precision and uncertainty are as follows.
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1) Systematic Uncertainties
Pulse intensity integral, Derated rarefaction pressure Pr.3, Center frequency Pulse duration 대해, effect screening about accuracy by the following categories is included in the analysis.
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.
Acoustic power measurements using Systematic uncertainty radiation force is measured with calibrated NIST acoustic power sources.
As the first supplement by IEC publication 1161, we recommend the analysis data of September 1993, prepared by K. Beissner and conducted by working group of IEC technical committee 87.
This document includes the analysis and discussion about source/measurement effect of error, and the causes are as following:
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.
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Environmental influences. Excitation voltage measurement. Ultrasonic transducer temperature. Effects due to nonlinear propagation and saturation loss.
In the overall findings of this analysis, the rough acoustic power accuracy figure is reported as +/- 10% for frequency range of 1 - 10 MHz .
2.5.1.17 Training
The user of this ultrasound system should be familiar with the ultrasound system in order to optimize the performance of the equipment and to detect the possible errors. All users are recommended to take appropriate training before making use of the equipment. The training can be provided from Samsung Medison global technical support group or any customer support center throughout the world.
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CAUTION
Depleted console and peripheral devices should be handled by the
manufacturer or properly and safely disposed with the appropriate disposal procedure.
Waste should be treated in compliance with the relevant laws and
regulations.
The battery of the product should be replaced by Samsung Medison
Co., Ltd. global technical support group or by the authorized dealer.
2.6 Protecting Environment
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3.1 Overview
Installing Product
3
3.2 Delivery
3.3 Unpacking
3.4 Installation Condition
3.5 How to Install
3.6 Turning on the Product
3.7 Turning off the Product
3.8 Connecting Peripheral Devices
3.9 Settings
3.10 Printer Installation
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3
Installing Products
3.1 Overview
Chapter 3 plans the installation of UGEO H60 and describes the information required for installation of UGEO H60.
It describes the information about delivery and installation environment for the installation in the best condition.
It includes the procedure and settings for the installation and inspection for the electrical safety. It also includes the method of connecting probe and other external peripheral devices.
Table of Contents
3.1 Overview ..................................................................................................................... 3-1
3.2 Delivery ........................................................................................................................ 3-3
3.2.1 Precautions when Delivering ......................................................................... 3-3
3.2.2 Temperature and Humidity ............................................................................. 3-3
3.3 Unpacking ................................................................................................................... 3-4
3.3.1 Disassembling Product Box ........................................................................... 3-4
3.4 Installation Condition ............................................................................................... 3-5
3.4.1 Precautions ...................................................................................................... 3-5
3.5 How to Install .............................................................................................................. 3-6
3.5.1 Installation Safety ............................................................................................ 3-6
3.5.2 Connecting the Power Cable ......................................................................... 3-6
3.5.3 Connecting Probe ........................................................................................... 3-7
3.6 Turning on the Product ............................................................................................ 3-8
3.7 Turning off the Product ............................................................................................ 3-9
3.8 Connecting Peripheral Devices ........................................................................... 3-10
3.9 Settings ..................................................................................................................... 3-11
3.9.1 System General Settings ............................................................................. 3-11
3.9.2 Monitor Display Settings .............................................................................. 3-16
3.9.3 Measurement related Settings .................................................................... 3-18
3.9.4 Report ............................................................................................................. 3-28
3.9.5 Annotation ...................................................................................................... 3-30
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3.9.6 Body Marker .................................................................................................. 3-33
3.9.7 Application ..................................................................................................... 3-36
3.9.8 Peripheral Devices Settings ......................................................................... 3-37
3.9.9 Connectivity ................................................................................................... 3-41
3.9.10 Service ........................................................................................................... 3-51
3.9.11 Help ................................................................................................................ 3-52
3.10 Printer Installation ................................................................................................... 3-53
3.10.1 BW Printer Installation .................................................................................. 3-53
3.10.2 Color Printer Installation ............................................................................... 3-60
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Division
Temperature [
O
C]
Humidity [%]
Delivering
-25 ~ 60
20 ~ 90
Storing
-10 ~ 50
20 ~ 90
Operating
10 ~ 35
30 ~ 75
3.2 Delivery
UGEO H60 is a fine electronic medical device which requires to be handled carefully when delivering
3.2.1 Precautions when Delivering
Packaging boxes are designed to reduce the shock. However, be careful not to deliver external shock to the product.
3.2.2 Temperature and Humidity
"[Table 3-1] Temperature and Humidity of Product" below describes the range of temperature and humidity when delivering, storing and operating the product.
[Table 3-1] Temperature and Humidity of Product
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3.3 Unpacking
3.3.1 Disassembling Product Box
1) Disassemble the box.
2) After taking out the product and component boxes, store them in a safe place.
[Figure 3-1] Disassembling Product Box
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3.4 Installation Condition
3.4.1 Precautions
Consider the following for the management.
1) Avoid wet places.
2) Avoid a place exposed to direct sunlight.
3) Avoid a place with drastic temperature change.
4) For normal operation, temperature of 10C ~ 35C and humidity of 30% ~ 75% should be maintained.
5) Avoid installing near heaters.
6) Avoid dusty or poorly ventilated places.
7) Avoid a place with frequent vibration.
8) Avoid chemicals or gases.
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DANGER
Using the product near generator, X-ray equipment, transmission device near a broadcasting station may cause irregular screen such as noise.
Sharing the power with other electronic devices may be a cause of noise phenomenon.
CAUTION
When delivering or storing the product for a long period, temperature and humidity of the environment should be checked beforehand.
Turn on the product by referring to "[Table 3-2] Usage Temperature of Product" below.
Drastic change of temperature may be the cause of product defect from the possibility of condensation.
Temperature
-20
-15
-10
-5 0 5
10 ~ 35
45
50
55
60
Waiting
Time
16
10 8 6 4 2
Ready-to-
use
2 4 6
10
NOTE
Product may be delivered with the power cable connected.
3.5 How to Install
3.5.1 Installation Safety
[Table 3-2] Usage Tempe Ready-to-use rature of Product
3.5.2 Connecting the Power Cable
You should measure the output voltage of the electrical outlet in the place of installation.
For safe usage of power outlet of H60, use the product within the range of “[Table 3-3] Usage Voltage of Product below.
Connect the power cable in the rear panel of H60.
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CAUTION
When connecting connector PCB and connecting pin of probe, do not use excessive force in order to prevent damage.
CAUTION
You can connect probe while it is turned on, but you should not connect or disconnect probe while the product is booting.
3.5.3 Connecting Probe
The connecting or disconnecting probe on probe connector should be conducted with the power turned off for the safety of the product.
[Figure 3-2] Connecting Power Cable
1) Connect probe to the probe port on the console.
2) Equip probe by turning the probe locking lever to the right.
[Figure 3-3] Connecting Probe
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Power Switch
3.6 Turning on the Product
Pressing On/Off switch on the left of the control panel (keyboard) of UGEO H60 turns on the product.
[Figure 3-4] Power Switch
1) The procedure of booting can be checked on the LCD monitor. With the logo
disappearing, UGEO H60 logo and loading bar appear.
2) The time that takes to fill the loading bar with color means the time that the
software moves data to the Front End Part and Back End Part.
3) When moving software data is completed, ultrasound image appears and
preparation of UGEO H60 is ready.
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NOTE
Pressing [On/Off] switch for more than 4 seconds forces the product to turn off, which is the reason for causing damage of hard disk of the product.
CAUTION
Try not to press keyboard or buttons while booting. This could
be a cause of system malfunction.
When forcibly turning off the product and turning it back on,
system may turn on and off instantly. This is one of the features of Intel
®
PC Main Board and is not a system error.
Power Switch
3.7 Turning of f the Product
Press the power switch on the left of control panel (keyboard) for 2 seconds.
[Figure 3-5] Power Switch
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CAUTION
For peripheral devices using USB port, you must turn off the product before connecting or disconnecting them to or from it. Malfunction of system or peripheral devices for USB may happen, when the power is not completely off.
NOTE
Refer to the manual of the corresponding product for using peripheral devices.
NOTE
When using USB 1.1 Flash Memory, system may not be able to
recognize the device. In this case, remove Flash Memory from the system and insert it again.
In order to remove USB storage device, use Utility > Storage
Manager.
For Flash Memory which supports features other than general
data storage, use it after checking if data storage feature works properly on desktop PC.
3.8 Connecting Peripheral Devices
UGEO H60 is composed of various types of connections which enable it to connect to external devices. It can be used depending on the users need, and the connection is usually made through the port on the rear panel.
Following products are recommended.
1) DVD-multi : DVD+R, DVD-R, DVD+RW, DVD-RW, CD-R, CD-RW
2) USB Video Printer
Color : Mitsubishi CP30DW, SONY UP-D23MD Black and White : Mitsubishi P93DW, SONY UP-D897
3) USB Magnetic Optical (MO) Disk Drive : 1.4G External USB Optical Drive
4) USB to Serial (RS-232C) converter : USB to Serial(RS-232C) Converter, using
FTDI Chipset (FTDI FT232BM Compatible)
5) Other : USB Flash Memory media
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Tips! – How to select tab
You can select the tab in the following two methods. Select the method to the user's taste.
Select the tab on the monitor screen using trackball and [Set] button. Press the button on touch screen.
3.9 Settings
This describes all settings of system which has no influence on video. It can be modified according to the user's need and taste.
1) Press [Setup] button on keyboard.
2) Setup screen appears on monitor and touch screen. Select the tab which you
wish to make changes in settings.
3) Make settings appropriate for each item.
4) Complete after saving the settings. Pressing [Exit] on monitor screen, [Exit] on
touch screen or [Exit] on control panel will switch to the scan mode.
[Figure 3-6] Setup - Touch Screen
3.9.1 System General Settings
Select [System] tab in Setup screen, or press [System] of touch screen. Make settings on overall system such as title.
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NOTE
Date and time cannot be changed when patient ID is registered. By pressing [End Exam] of control panel, exit the current diagnosis and make changes.
3.9.1.1 General
Select [General] tab in [System] category in Setup screen.
[Figure 3-7] Setup-System- General
1) Location
Change settings on Table of title area of screen.
Institute
Insert hospital/institution which the product is installed in.
Language
Select the system language. (Supporting language: English, German, French, Spanish, Italian, Russian,
Simplified Chinese)
2) Date and Time
Current weather is in table. Pressing will change the date.
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Tip! How to set the date (or time)
1. Press in date (or Time).
2. Press [Change date and time settings]. Set the date and time using [Set] button. Press [change time zone settings] to change the time zone.
3. If the settings are correct, apply the settings by pressing [Apply]. Pressing [Ok] will close all settings of date and time. Pressing [Cancel] or [Exit] of control panel will cancel settings.
[Figure 3-8] Date & Time
Date Format
Set the Table display for the date. By pressing combo button, select the Table display. Table display settings are applied in the various date input of Patient Information as well.
Time Format
Set the Table display for the time. By pressing combo button, select the Table display (12 Hour, 24 Hour).
3) Trackball Speed Scan Mode
Set the speed of trackball in scan mode (Slow, Normal, Fast).
Measurement
Set the trackball speed when measuring (Slow, Normal, Fast). If the speed is slow, it is a good use for precise measurement.
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4) Display Screen Saver
Set Wait (Min) time of Screen Saver.
System Power Button
- Select among Ask me what to do: Shut Down, Restart, Cancel.
- Shut Down: Turns the power off.
Option
- Auto Freeze (20min):Change to auto Freeze status after 20 minutes.
- Beeper Off: Set Beeper Off.
- Prompt for Save on Exit: Determine whether to save the settings using checkbox.
- Boot up Caps Lock On: Set whether to enter using uppercase using checkbox.
5) Video Settings Format
Select between NTSC, PAL.
3.9.1.2 Patient
Select [Patient] tab in [System] category in Setup screen.
[Figure 3-9] Setup-System-Patient
1) Patient Data Name Display
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- Last, First Middle: Setting in the order of patient's last name, first name and middle name.
- First Last Middle: Setting in the order of patient's first name, last name and middle name.
2) Operator List & Description List Operator List
It can add, modify, delete or change location of up to 20 names of sonographers who scan patients.
Description List
It saves up to 20 memos for diagnostic according to each diagnostic subject. Using the button on the right, add, modify, delete or change locations.
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3.9.2 Monitor Display Settings
Select [Imaging] tab in Setup screen or press [Imaging] on touch screen. Change settings for displaying video Table.
3.9.2.1 Display
[Figure 3-10] Setup - Imaging- Display
1) Common Setting
This commonly applies to all applications. You can select multiple items. Select an item using trackball and [Set] button, and
check or uncheck Table display.
Show Image Info
Sets weather to display Table of video information. When video information obstruct the video, turning off this feature will help.
Show Horizontal Scale Bar
Sets weather to display Table of Horizontal Scale Bar of Scan UI.
HPRF
Bloodstream exceeding the limit speed can be checked in depth acquiring Sample Volume when in PW spectral doppler mode.
Prefered Probe Port
When starting the system or when selecting probe, set Probe Port which is the major priority.
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Touch window Auto Close (sec)
When operating TGC Control Windows of Touch Screen, set the automatic shut­off time when there is no input. If you do not want this feature, select OFF.
TGC Curve Display
Set the time for Table display of TGC Curve in Scan UI (On: always display, Off: never display, Auto: displays for certain period and disappear).
Color Velocity Unit
Select the unit of speed in color mode.
Doppler Scale Unit
Select the scale unit of Axis in spectral doppler mode.
Biopsy Guideline Type
Change settings for Table display of Biopsy Guide Line.
Thermal Index Type
Change settings for displaying TI among TIs(Soft tissue thermal Index), TIb(Bone thermal index), TIc(Cranial bone thermal index)..
2) Application Setting
This applies only to the selected Application You can select multiple items. Select an item using trackball and [Set] button, and
check or uncheck Table display.
Application
Change settings for diagnostic subject.
Seamless Dual Mode
Change settings for Seamless Dual Mode in Dual Mode.
Enable Doppler Cursor Mode
Change settings for entering into Cursor Mode before Doppler Mode.
Enable M Cursor Mode
Change settings for entering into Cursor Mode before M mode.
Activated Mode When Image Is Frozen
Change settings for activation mode when in freeze. You can select among Cine, Measurement, Annotation, Body Marker.
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3.9.3 Measurement related Settings
Change settings for various items related with measurement. It can be changed according to the user's need or taste.
1. Press [Setup] in keyboard. Select [Measurement] tab when Setup screen is Table displayed.
2. When Measurement screen appears, select the tab for the designated settings.
3. Change settings according to each item.
4. Save the settings by pressing [Save ] button. Pressing [Exit] on monitor screen or [Exit] of touch screen will change to Scan mode from Setup screen.
3.9.3.1 General Settings
Select [General] tab in [Measurement] category in Setup screen. Change the basic settings for the measurement.
[Figure 3-11] Setup- Measurement- General
1) Menu
Direction: Select either left or right for Direction Type applying to the
measurement target in the initial system state.
Location: Select among Prox, Mid, Dist for Location Type applying to the
measurement target in the initial system state.
2) Cursor
Cursor Type
Select among (+), 'Cross' and 'X' for the default shape of Caliper Cursor which
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appears on the screen.
Cursor Size
Select among small, medium and large for the default size of Caliper Cursor which appears on the screen.
3) Display
2D Line Type
You can select the type of line (Solid: solid, Dot: dotted line, None: starting point and finishing point) for measurement in 2D mode.
Ellipse Cross Line
You can choose to display the Table (on) or not display (off) of long axis and short axis of ellipse when measuring ellipse.
Clear Measurement(s) On Unfreeze
When image switches to scan mode, you can choose to display the Table (on) or not display (off) by selecting 2D mode or M/D mode for displaying measurement result table.
4) Key
Set Measurement on Store
You can enable (on) or disable (off) the feature for completing the measurement when pressing [Store] of control panel while measuring.
Set Measurement on Unfreeze
You can enable (on) or disable (off) the feature for completing the measurement when image switches to scan mode while measuring.
5) Result
You can select the display method of measurement result Table.
Position On 2D:
In 2D mode, it changes the location of measurement result Table.
- Left-Top: Display the Table on the left-top of the screen.
- Left-Bottom: Display the Table on the left-bottom of the screen.
- Right-Bottom: Display the Table on the right- bottom of the screen.
- Right-Top: Display the Table on the right -top of the screen.
- Custom: Display the Table on the desired location of the screen.
Position On D/M
Move the Table display of measurement result.
- Left-Top: Move the Table to the left-top of the screen.
- Left-Bottom: Move the Table to the left-bottom of the screen.
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- Right-Bottom: Move the Table to the right- bottom of the screen.
- Right-Top: Move the Table to the right -top of the screen.
- Custom: Move the Table to the desired location of the screen.
Show Background
You can display measurement result Table with transparent setting (on) or opaque setting (off).
Font Size
You can choose the size of font when displaying Table.
3.9.3.2 Parameter1 (Tool & Calculation Settings)
Select [parameter1] tab in [Measurement] category in Setup screen.
[Figure 3-12] Setup- Measurement- Parameter1
1) Application
Choose the diagnostic subject.
2) Caliper
Default Tool
You can choose the Default Tool operating in measurement cursor state for each Image Mode.
- 2D Mode : Distance, Trace Length, Open Spline, Ellipse, Trace, Closed Spline, Angle, Distance Steno(D),Trace Steno(D), Ellipse Steno(A), Trace Steno(A), Spline Steno(A), 1 Dist Volume, 2 Dist Volume, 3 Dist Volume, Ellipse Volume, Ellipse+ Dist Vol
- D Mode : Velocity, Acc, Manual Trace, Limited Trace, HR, RI, Dist Vol.Flow(D), Trace
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Vol. Flow(D), Spline Vol. Flow(D), Ellipse Vol. Flow(A), Trace Vol. Flow(A), Spline Vol.Flow(A),Time
- M Mode : Distance(M),Slope, HR,Ti me(M)
Default Tool Category
You can choose Default Tool for each category of measurement value.
- Volume :1 Dist Volume, 2 Dist Volume, 3 Dist Volume, Ellipse Volume, Ellipse + Dist Vol
- Stenosis : %Stenosis(D), %Stenosis(A)
- Volume Flow : Volume Flow(D), Volume Flow(A)
- Doppler Trace : Manual Trace, Limited Trace
3) Doppler Display Absolute Value
Doppler measurement value is displayed as Table of absolute value.
RI Calculation Method
Determine to use either ED or MD when calculating RI value.
Doppler Auto Calc ulation Items
In measurement mode using Auto Doppler Trace Tool, you can choose which value would be measured and displayed on Table.
Heart Rate
- Cycle: Set the frequency of heart rate (HR)
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NOTE
You can make selections only when the diagnostic subject is OB.
3.9.3.3 Parameter2
Select [parameter2] tab in [Measurement] category in Setup screen.
[Figure 3-13] Setup- Measurement- Parameter2
1) Application
Select the diagnostic subject.
2) SD/Percentile Type
Select among None, SD and Percentile.
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3.9.3.4 Menu
Select [Menu] tab in [Measurement] category in Setup screen.
[Figure 3-14] Setup- Measurement- Menu
1) Available Menu List Application
You can select the diagnostic subject for desired Available Menu List. Available Menu List on the bottom of the screen changes.
Available Menu View
Available Menu View can display Label which can be measured in the selected diagnostic subject to the Table of Tree. You can add or delete Group, Measurement, Calculation using the [+] and [-] button on the bottom.
Add Item
After selecting Group or Item in Available Menu View, pressing [>] button will enter the selected Group or Item in the Available List Box on the right.
Entered Group or Item can be saved by pressing [Save] button on the left and displayed as Table on Menu.
- Entered on Label Menu and Touch Menu simultaneously. At this time, the added Group or Item are entered after the last Group or Item in the displayed Table.
Group View
Group View lists all the Groups in displayed Table of Menu. Enabling Group View can delete Groups in displayed Table and switch the location of Groups in displayed Table of Menu and Touch Menu.
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Item View
Item View lists all the Items in displayed Table of Menu. Enabling Item View can delete Items in displayed Table and switch the location of Items in displayed Table of Menu and Touch Menu. You can select among Average, Max and Min for each Item.
Package
You can select Package for each diagnostic subject.
Image Mode
You can check Menu and Touch Menu for each Image Mode.
Remove
You can delete Group or Item in Group View or Item View.
Edit Touch
You can place Group and Item displayed in Group View or Item View on Touch Screen.
- Clicking [Edit Touch] will display the dialog box displayed in Touch Button.
- Clear All: delete all Group and Item
- Add Page: add pages
- Remove Page: delete pages
- Clicking each Touch Button displays assigned Troup and Item.
- When you select Empty for displayed Group or Item, it deletes the assigned
Group or Item in the corresponding Touch Button.
- Deleted Group and Item in Touch is deleted in Group View and Item View when
exiting the dialog box by clicking [Save] button.
Auto Sequence
Checking Auto Sequence enables it. This supports the feature of sequentially operating items in Group. When measuring AFI and Volume of OB, this supports the feature of sequentially measuring.
Default Items
Selecting [OK] after pressing [Default Items] returns to the initial state.
3.9.3.5 Author1Setting
Select [Author1] tab in [Measurement] category in Setup screen.
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[Figure 3-15] Setup- Measurement- Author1
1) Fetal Age
Sets Fetal Age Author for each Label.
2) Fetal Growth
Sets Fetal Growth Authorfor each Label.
3) Estimated Fetal Weight
Sets EFW or EFW percentile Author.
4) Composite GA Author
Sets Author used for calculating Composit GA.
5) Set Authors To
Sets all authors to be the same for all Label.
3.9.3.6 Author2(Tables & Equations) Settings
Select [Author2] tab in [Measurement] category in Setup screen. Make query and modification on Table and Equation used in each measurement item of OB.
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NOTE
When selecting the Author data created by users, Copy button is disabled and cannot be selected.
NOTE
It can delete only the Author data created by users.
[Figure 3-16] Setup- Measurement- Author2
1) Selecting Category
When selecting among Fetal Age, Fetal Growth, EFW(Estimated Fetal Weight), you can make query or modification of Table in the corresponding category.
2) Selecting Label
When selecting Label in list box, Author List of corresponding Label is filled in combo box, and the first Author data is displayed on the screen.
3) Selecting Author
When selecting Author in combo box, corresponding Author data is displayed in screen.
4) New
It creates the new Author data.
5) Copy
It creates the new Author data by copying the currently selected Author data.
6) Delete
It deletes the currently selected Author data.
7) Author Name
It means the currently selected Author name. When creating a new Author data, you can enter Author name.
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NOTE
When creating a new Author data, you cannot save the data unless you enter the Author name.
NOTE
When creating a new Author data by using New button, you can change the Author data type. However, EFW cannot create Table­typed data.
8) Author Data Label
It means the Label which the currently selected Author data is in. When creating a new Author data, you can change the Label.
9) Author Data Type
It means the data type of currently selected Author data.
10) Age Unit
It means the Fetal Age unit of currently selected Author data. When creating a new Author data, you can change the Age Unit.
11) Valid GA Range
It means the effective Gestational Age (GA) range of currently selected Author data. When creating a new Author data, you can change the effective GA range.
12) Label Unit
It means the Label unit of currently selected Author data. When creating a new Author data, you can change Label Unit.
13) Valid Label Value Range
It means the effective Label value range of currently selected Author data. When creating a new Author data, you can change the effective Label value range.
14) Table Type
It means the Table deviation type of currently selected Fetal Age Author data. When creating a new Author data, you can change the Table deviation type.
15) SD Type
It means the Table deviation type of currently selected Fetal Growth Author data. When creating a new Author data, you can change the Table deviation type.
16) EFW Unit
It means the EFW Unit of currently selected EFW Author data. When creating a new Author data, you can change the EFW Unit.
17) Equation
It means the currently selected Author Equation data. When creating a new Author data, you can change the Equation by using Input Parameter list box or Calculator buttons.
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NOTE
When there is formula error in Equation, you cannot save the
data.
When entering Label not in the Input Parameter list box, you
cannot save the data.
NOTE
Minimum of 1 Row of data should be entered in Table, in order to save the data.
18) Table
It means the currently selected Author Table data. When creating a new Author data, you can change the Table by using Insert Row, Delete Row, Clear Table buttons.
3.9.3.7 Print Settings
Select [Print] tab in [Measurement] category in Setup screen. Change settings by selecting Printer.
[Figure 3-17] Setup- Measurement- Print
3.9.4 Report
Select [Report] tab in Setup screen or press [Report] in touch screen. Change settings of information related with video input.
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3.9.4.1 Anatomy
Select [Anatomy] tab in [Report] category in Setup screen.
[Figure 3-18] Setup- Report- Anatomy
You can add new items by pressing [Create Item] , edit items by pressing [Edit Item] and delete items by pressing [Delete Item]. Pressing [Reset Default] will return back to the initial settings.
1) Application: change settings for measurement diagnostic subject.
2) Group: change settings for preset of measurement diagnostic subject.
3) Available Items: it is the category or item list to be added on Anatomy page.
4) Selected Items: it is the category or item list added on Anatomy page.
5) Selection Menu: it is the sub-item list of selected items when selecting added
items in Anatomy page.
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3.9.4.2 Comments
Select [Comment] tab in [Report] category in Setup screen.
1) Select Application
Display all measured diagnostic subject and select the diagnostic subject for diaplaying in Report.
2) Comments
Users themselves can enter Comments.
3) Clear
Delete the saved Comments.
3.9.5 Annotation
Select [Annotation] tab in Setup screen or select [Annotation] of touch screen. Change settings for entering opnions.
3.9.5.1 Library
Select [Library] tab in [Annotation] category in Setup screen. You can create, modify or delete Annotation library.
[Figure 3-19] Setup- Report- Comments
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[Figure 3-20] Setup – Annotation- Library
1) Application Type
Select the diagnostic subject type.
2) User Defined Library
Users can create or delete the text.
Create
Create the text.
Delete
Delete the text.
Reset Default
Return back to the default setting.
3) Touch Screen Page1
Change settings for the Table display in the first page of touch screen.
4) Touch Screen Page2
Change settings for the Table display in the second page of touch screen.
5) Copy From Existing
You can change settings by selecting the Items provided by the system.
3.9.5.2 Annotation
Select [Annotation] tab in [Annotation] category in Setup screen. You can change the settings for deleting Annotation of screen when switching scan mode, probe or diagnostic subject.
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[Figure 3-21] Setup – Annotation- Annotation
1) Common
Erase When the Image is Unfrozen
Settings for deletion in image scan mode
Erase When the probe or application is changed
Settings for deletion when changing probe or diagnostic subject
2) Annotation
Text Font Size
Settings for the size of text
Text Color
Settings for the color of text
Arrow Size
Settings for the size of Arrow
Arrow Type
Settings for the shape of Arrow
Arrow angle
Settings for the angle of Arrow
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3.9.6 Body Marker
Select [Body Marker] tab in Setup screen or [Body Marker] of touch screen.
3.9.6.1 Library
Select [Library] tab in [Body Marker] category in Setup screen. You can create, modify or delete Body Marker library.
1. Selecting the desired location using the trackballs on Touch Screen Page1 or Touch Screen Page2 will Tabld display yellow.
2. Selecting Body Marker in copy From Existing will create Body Marker in yellow Table displayed location.
3. Selecting the Body Marker using the trackballs on Touch Screen Page1 or Touch Screen Page2 will Tabld display yellow and pressing [Erase Pattern] will erase Body Marker.
1) Library
Select the diagnostic subject.
2) User Defined Library
Users can create or delete the Library.
Create
Create a new Body Marker
Delete
[Figure 3-22] Setup – Bard Marker- Library
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Delete a Body Marker
Reset Defalut
Return to the default settings
3) Touch Screen Page1
Change settings for the Table display in the first page of touch screen.
4) Touch Screen Page2
Change settings for the Table display in the second page of touch screen.
5) Copy From Existing
Change settings by selecting Body Marker provided by the system.
3.9.6.2 Body Marker
Select [Body Marker] tab in [Body Marker] category in Setup screen.
[Figure 3-23] Setup – Body Marker- Body Marker
1) Common
Activate When Dual/Quad Mode On
Settings for displaying Table when enabling Dual or Quad Mode
Erase When the Preset Is Changed
Settings for deletion when changing Preset
Copy to Active Side When Dual/Quad Mode On
Settings for copying to the active area when in Dual or Quad Mode
2) e-Motion Marker
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