Samsung HS50A, HS60A Service manual

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HS50A/HS60A
Service Manual
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(Empty page)
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Version 1.00
HS50A/HS60A
Service Manual
English
SM-HS50A/HS60A-ENG-01
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(Empty page)
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Safety Classifications

Classification

– Type of protection against electric shock: Class I
– Degree of protection against electric shock (when the patient is in physical contact): Type
BF or type CF applied part
– Degree of protection against harmful ingress of water: Ordinary equipment
– Degree of safety of use in the presence of flammable anesthetic agent mixed with air,
oxygen, or nitrous oxide: Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
– Mode of operation: Continuous operation

Electromechanical safety standards met

– Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and
Essential Performance [IEC 60601-1:2005/A1:2012]
– Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and
Essential Performance - Collateral Standards: Electromagnetic Compatibility ­Requirements and Tests [IEC 60601-1-2:2007]
– Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and
Essential Performance - Collateral Standards: Usability [IEC 60601-1-6:2010]
– Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety
and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2007]
– Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-
1:1988, A1:1991, A2:1995]
– Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral
Standards: General Requirements for Medical Electrical Systems [IEC 60601-1-1:2000]
– Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral
Standards: Electromagnetic Compatibility - Requirements and Tests [IEC 60601-1-2:2001, A1:2004]
– Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral
Standards: Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999]
– Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety
and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
[IEC 60601-2-37:2001, A1:2004, A2:2005]
– Medical Devices - Application of Risk Management [ISO 14971:2007]
– Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-1:2003]
– Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and
Essential Performance[CAN/CSA C22.2 No. 60601-1:14]
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– Medical electrical equipment - part 1: General Requirements for Basic Safety and
Essential Performance [ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND A2:2010(R)2012]
– Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing [ISO 10993-1:
2009]
– Standard Means for Reporting the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment [IEC 61157:2007]

Declarations

CSA mark with the indicators “C” and “US” means that the product is certified for both US and Canadian markets according to the applicable US and Canadian standards.
This mark certifies that the product conforms to applicable EEC standards, and that it has been certified by the European certification agency.
This is the manufacturer’s declaration of product compliance with the applicable EEC directive(s).
This is the GMP symbol for Korean Good Manufacturing Practice quality system regulation.
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Precautions for Use
Be sure to read this Service Manual thoroughly to familiarize yourself with the operation of the product and the relevant safety information before attempting to use the product.
Keep this service manual near the product and refer to it when using the product.
Be sure to familiarize yourself with the safety information contained in 'Chapter 2. Safety' and
'Chapter 10. Maintenance and Storage' in particular.
This service manual does not include diagnosis results or opinions. In addition, please consult the reference for each study area before evaluating the measurement result of an application.
This product is an ultrasound diagnostic system and cannot be used with your personal computer. If you use this product in such an environment, we cannot be held responsible for any resulting problems.
This product must be used by a person who possesses clinical pathology training and/or certification. Use by unqualified persons is prohibited.
The manufacturer is not liable for any problems with the system caused by careless operation and/or improper control by the operator.
Product orders are based on individually agreed-upon specifications and may not include all functions specified in this service manual.
Some functions or options, probes, and the like may not be used in certain countries.
All reference materials on standards, regulations, and related revisions are valid at the time
of publication of this service manual.
Screen images in this service manual are examples only (may differ from the actual screen or system).
The content of this service manual is subject to change without prior notice.
Products that are not manufactured by Samsung Medison are indicated with the trademarks
of their respective owners.
The following terms are used to highlight the safety precautions that the user must be aware of:
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DANGER
Disregarding this instruction may result in death, serious situations.
WARNING
Follow these instructions to prevent serious accidents or damage to property.
CAUTION
Follow these instructions to prevent minor accidents or damage to property.
A piece of information related to any hazard.
injury, or other dangerous
useful for installing, operating, and maintaining a system; not
NOTE
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Revision History
The revision history of this service manual is as follows:
Versi o n D AT E REASON FOR CHANGE
1.00.00 2016.07.15 Initial Release

If You Need Assistance

If you need a service manual or any assistance with the product, please contact the Samsung Medison customer service department or your local vendor.
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Patient Privacy Policy

Treatment of Patients' Personal Information

One of Samsung's social responsibilities is to recognize the importance of patient privacy and handle and protect the personal information provided by patients in an appropriate manner.
Patient information stored in repaired and demo products should be handled as follows:
Patient Information: IDs, names, DOBs, and images are information used to identify patients.
Patient Information Management: Personal information provided by patients must be
protected during repairs and demonstrations. Do not use, distribute, or lose patient information to third parties.

Management of Patient Information on Demo and Trade Products

Patient information stored on a product during the course of its use must be handled as the patient desires. (delete or backup)
When any demo or trade product is collected, patient information must be deleted if requested by the patient to prevent its unintended distribution.

Management of Patient Information on Repaired Hospital Products

Before removing the product from hospital premises for repairs, all patient information should be backed up to an external HDD or a memory device.
Before removing the product from hospital premises, each patient should sign the patient privacy agreement.
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Request for Repairs and Patient Privacy Agreement
Customer Information
Hospital
Handler
Product Information
Product name
Software version
S/N
Symptom
Date: MM/DD/YY
Stored item
Outsourced product
Administration
Handling date MM/DD/YY
Customer service representative
Please sign inside the box below if you agree to the following:
□ Data saved on memory devices -- for example, hard disks -- may be lost during tests and
repairs.
□ Data saved on a product being repaired must be backed up by the customer.
□ Samsung will not be held responsible for any loss of data that are not backed up.
□ Samsung neither uses nor modifies patient information nor provides it to third parties.
Customer Signature
None Main unit HDD DVD/CD USB Photo □ Other ( )
None Provide details if applicable ( )
I entrust my product to ( ) for repair and agree to the policies above.
Date: MM/DD/YY Name: (Signature)
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Table of Contents 1
Table of Contents
Chapter 1. Introduction 1
1.1. Product Specifications ........................................................................................................ 2
1.2. Product Configuration ........................................................................................................ 5
1.2.1. Monitor .....................................................................................................................7
1.2.2. Control Panel ...........................................................................................................9
1.2.3. Console ................................................................................................................. 16
1.2.4. Peripheral Devices ................................................................................................ 19
1.2.5. Probes ................................................................................................................... 21
1.2.6. Accessories ........................................................................................................... 23
1.2.7. Optional Functions ................................................................................................ 24
Chapter 2. Safety 1
2.1. Purpose of Use .................................................................................................................... 2
2.1.1. Restrictions ..............................................................................................................2
2.2. Safety Information ............................................................................................................... 3
2.2.1. Safety Symbols ........................................................................................................3
2.2.2. LABEL ......................................................................................................................6
2.3. Electrical Safety ................................................................................................................... 7
2.3.1. Prevention of Electric Shock ....................................................................................7
2.3.2. Related Information ..................................................................................................9
2.3.3. ESD ..........................................................................................................................9
2.3.4. EMI ........................................................................................................................ 10
2.3.5. EMC ...................................................................................................................... 10
2.4. Mechanical Safety ............................................................................................................. 17
2.4.1. Moving the Equipment .......................................................................................... 17
2.4.2. Safety Notes .......................................................................................................... 18
2.5. Biological Safety ................................................................................................................ 20
2.5.1. ALARA Principle .................................................................................................... 20
2.6. Protecting the Environment ............................................................................................. 34
Chapter 3. Installing Product 1
3.1. Transporting......................................................................................................................... 2
3.1.1. Caution on Transporting...........................................................................................2
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2 HS50/HS60 Service Manual
3.1.2. Brake ....................................................................................................................... 2
3.1.3. Precautions on Ramps ............................................................................................ 2
3.1.4. Humidity and Temperature ...................................................................................... 3
3.2. Unpacking the Product ....................................................................................................... 4
3.2.1. Dismantling the Product Box ................................................................................... 4
3.2.2. Accessories ............................................................................................................. 5
3.2.3. Release of the Locking Mechanism ......................................................................... 5
3.3. Installation Environment .................................................................................................... 6
3.3.1. Caution .................................................................................................................... 6
3.4. Installing the Product ......................................................................................................... 7
3.4.1. Installation Safety .................................................................................................... 7
3.4.2. Connecting Peripherals ........................................................................................... 9
3.5. System Power .................................................................................................................... 12
3.5.1. Turning the Power On............................................................................................ 12
3.5.2. Shutting down the System ..................................................................................... 12
3.6. System Settings ................................................................................................................ 13
3.6.1. ECG Setup ............................................................................................................. 14
3.6.2. General System Settings ....................................................................................... 16
3.6.3. Customize .............................................................................................................. 24
3.6.4. Peripherals ............................................................................................................. 26
3.6.5. Connectivity ........................................................................................................... 28
3.6.6. Service ................................................................................................................... 41
3.6.7. Help........................................................................................................................ 41
Chapter 4. Product Inspection 1
4.1. Inspecting the Functions .................................................................................................... 2
4.1.1. Basic Inspections ..................................................................................................... 2
4.1.2. Detailed Inspections ................................................................................................ 3
Chapter 5. Product Structure 1
5.1. Overview .............................................................................................................................. 3
5.2. System Block Diagram ....................................................................................................... 5
5.2.1. System Block Diagram ............................................................................................ 5
5.2.2. System Rack Design ............................................................................................... 6
5.3. Basic Structure of the Product .......................................................................................... 7
5.3.1. Electronic Structure ................................................................................................. 7
5.3.2. Ultrasound System Part ........................................................................................... 7
5.3.3. PC Part .................................................................................................................... 8
5.3.4. User Interface Part ................................................................................................... 8
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Table of Contents 3
5.3.5. Power Part ...............................................................................................................8
5.4. Ultrasound System Part ...................................................................................................... 9
5.4.1. Main Functions of the PSA (Probe Select Assembly) ..............................................9
5.4.2. Beam Former Board .............................................................................................. 11
5.4.3. Back End Board .................................................................................................... 15
5.5. PC Part ................................................................................................................................ 19
5.5.1. PC Module ............................................................................................................ 19
5.5.2. Rear IO Board ....................................................................................................... 20
5.5.3. Software DSC ....................................................................................................... 21
5.6. User Interface Part ............................................................................................................. 23
5.6.1. Control Panel ........................................................................................................ 23
5.6.2. Main Monitor ......................................................................................................... 25
5.6.3. Touch-Screen ........................................................................................................ 26
5.6.4. Display Layout ....................................................................................................... 27
5.7. Power Part .......................................................................................................................... 28
5.7.1. ADM ...................................................................................................................... 28
5.7.2. Power Block Diagram ............................................................................................ 29
5.8. Interconnect Diagram ........................................................................................................ 30
5.8.1. HS50/HS60 Interconnect Diagram 1/2 .................................................................. 30
5.8.2. HS50/HS60 Interconnect Diagram 2/2 .................................................................. 31
5.8.3. Cable Description .................................................................................................. 32
Chapter 6. Service Mode 1
6.1. Service Mode........................................................................................................................ 3
6.1.1. How to Shift to Service Mode ...................................................................................3
6.2. Service Information ............................................................................................................. 4
6.3. Configuration ....................................................................................................................... 5
6.3.1. Clock ........................................................................................................................5
6.3.2. Keyboard/Region .....................................................................................................5
6.3.3. TCP/IP ......................................................................................................................6
6.3.4. Option .......................................................................................................................7
6.3.5. User Account and User Account Management ........................................................8
6.3.6. Printer .......................................................................................................................9
6.4. System ................................................................................................................................ 10
6.4.1. Upgrade Software ................................................................................................. 10
6.4.2. System Serial Number .......................................................................................... 11
6.4.3. Window Explorer ................................................................................................... 12
6.4.4. Install Recovery System........................................................................................ 13
6.5. Diagnostics ........................................................................................................................ 14
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4 HS50/HS60 Service Manual
6.5.1. Control Panel Test ................................................................................................. 14
6.5.2. Keyboard Test ....................................................................................................... 14
6.5.3. Power On Self Test................................................................................................ 14
6.5.4. Built in Self Test ..................................................................................................... 14
6.5.5. Monitor Test ........................................................................................................... 14
6.6. Backup and Restore ......................................................................................................... 15
6.6.1. Backup ................................................................................................................... 15
6.6.2. Restore .................................................................................................................. 15
6.6.3. Log Backup ............................................................................................................ 15
6.7. Report ................................................................................................................................. 16
6.7.1. Report .................................................................................................................... 16
6.8. Demo Play .......................................................................................................................... 17
6.8.1. Demo Play ............................................................................................................. 17
6.9. Entering the Installation Key............................................................................................ 18
Chapter 7. Troubleshooting 1
7.1. Power Issues ....................................................................................................................... 2
7.1.1. Power Does Not Turn on ......................................................................................... 2
7.1.2. Power Does Not Turn off ......................................................................................... 2
7.1.3. Power Turns off by Itself .......................................................................................... 2
7.2. Monitor ................................................................................................................................. 3
7.2.1. Nothing Is Displayed on the Screen ........................................................................ 3
7.2.2. Screen is Discolored ................................................................................................ 3
7.3. Error Messages ................................................................................................................... 4
7.3.1. Error Occurs During Booting ................................................................................... 4
7.4. Image .................................................................................................................................... 4
7.4.1. 2D Mode: There is No IMAGE ECHO or IMAGE FORMAT .................................... 4
7.4.2. Lines (Noise) Appear in 2D Mode Image ................................................................ 4
7.4.3. M, C, PW, CW Mode Trouble .................................................................................. 4
7.5. USD Device Detection Failure ............................................................................................ 5
7.5.1. Failed to recognize the USB (Removable device) device ....................................... 5
7.6. Trouble Shooting Tree ........................................................................................................ 6
Chapter 8. Disassembly and Assembly 1
8.1. Power Issues ....................................................................................................................... 2
8.1.1. Preparation .............................................................................................................. 2
8.2. Disassembling the Product ................................................................................................ 3
8.2.1. Rear Side Disassembly ........................................................................................... 3
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Table of Contents 5
8.2.2. HDD Disassembly ....................................................................................................5
8.2.3. Front End Disassembly ............................................................................................6
8.2.4. Control Panel Disassembly ......................................................................................7
8.2.5. Touch Panel Disassembly........................................................................................8
8.2.6. Dust Filter and Fan Disassembly .............................................................................9
8.2.7. ODD Disassembly ................................................................................................. 10
8.2.8. Monitor Disassembly ............................................................................................. 11
Chapter 9. Probes 1
9.1. Probes ................................................................................................................................... 2
9.1.1. Probe List .................................................................................................................2
9.1.2. Ultrasound Transmission Gel ................................................................................ 18
9.1.3. Sheaths ................................................................................................................. 19
9.1.4. Probe Safety Precautions ..................................................................................... 19
9.1.5. Cleaning and Disinfecting the Probe ..................................................................... 21
9.2. Biopsy ................................................................................................................................. 37
9.2.1. Biopsy Kit Components ......................................................................................... 37
9.2.2. Using the Biopsy Kit .............................................................................................. 38
9.2.3. Assembling the Biopsy Kit..................................................................................... 40
9.2.4. Cleaning and Disinfecting the Biopsy Kit .............................................................. 43
Chapter 10. Maintenance 1
10.1. Operational Environment .................................................................................................... 2
10.2. Product Maintenance .......................................................................................................... 3
10.2.1. Cleaning and Disinfecting ........................................................................................3
10.2.2. Cleaning Air Filters ...................................................................................................6
10.2.3. Accuracy Checks .....................................................................................................7
10.3. Data Maintenance ................................................................................................................ 8
10.3.1. User Settings Backup ...............................................................................................8
10.3.2. Backing Up Patient Information ...............................................................................8
10.3.3. Software ...................................................................................................................8
Chapter 11. Service Parts List 1
11.1. Body Cover Parts ................................................................................................................ 2
11.2. Control Panel Parts ............................................................................................................. 9
11.3. Monitor & Arm Parts .......................................................................................................... 17
11.4. System Parts ...................................................................................................................... 21
11.5. System Cable Parts ........................................................................................................... 24
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Chapter 1
1. Introduction Chapter 1. Introduction

Introduction

1.1. Product Specifications ....................................................................................................... 2
1.2. Product Configuration ........................................................................................................ 5
1.2.1. Monitor .................................................................................................................... 7
1.2.2. Control Panel .......................................................................................................... 9
1.2.3. Console................................................................................................................. 16
1.2.4. Peripheral Devices ............................................................................................... 19
1.2.5. Probes .................................................................................................................. 21
1.2.6. Accessories .......................................................................................................... 23
1.2.7. Optional Functions ................................................................................................ 24
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1.1. Product Specifications

Height: 1344 mm (with Monitor)
Physical
Dimensions
Imaging Modes
Width: 529 mm
Depth: 767 mm (with Keyboard)
Weight: 79.8kg (without accessories) Weight: Approx. 98kg (with Safe Working Load)
2D Mode
M Mode
Color M Mode
Anatomical Mode
Color Doppler Mode
Pulsed Wave (PW) Spectral Doppler Mode
Continuous Wave (CW) Doppler Mode
Tissue Doppler Imaging (TDI) Mode
Tissue Doppler Wave (TDW) Mode
Power Doppler (PD) Mode
ElastoScan Mode
3D/4D/XI STIC imaging Mode
Dual Mode
Quad Mode
Combined Mode
Simultaneous Mode
Zoom Mode
Gray Scale
Focusing
Probes
(Type BF/IPX7)
256 (8 bits)
Transmit focusing, maximum of eight points (four points simultaneously selectable)
Digital dynamic receive focusing (continuous)
Linear Array
LA3-14AD, LA2-9A, LA3-16AI, LA4-18BD, LA3-16A
Curved Array
CA1-7AD, CA2-9AD, CA2-6BM, CF4-9
Endo Cavity
ER4-9, EA2-11B
Phased Array
PA1-5A, PA3-8B, PE2-4
3D
CV1-8AD, V5-9
CW
CW6.0, DP2B
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Probe
Connections
Monitor
Chapter 1. Introduction 1 - 3
HS50 does not support LA2-9A and LA3-16AI, EA2-11B, LA4-18BD, PA1-5A.
NOTE
3 Probe Connectors, 4 Probe Connectors for option
NOTE
CW Probe Connector
Main Monitor
Number of Pixel: 1920 x 1080
21.5 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD monitor”)
Touch Screen Monitor
Number of Pixel: 1280 x 800
10.1 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD monitor”)
HS60 does not support PE2-4 and ER4-9.
HS50 HS60
3 PORT O X
4 PORT O (Option) O
ECG
Rear Panel Input/Output Connections
Image Storage
Application
Electrical
Parameters
Measurement
Packages
USB Type (Type CF)
Audio Output Port (Right/Left) VGA monitor
LAN
USB Port
HDMI output
Maximum 45,000 frames for Cine memory
Maximum 14,000 Lines for Loop memory
Image filing system
Obstetrics, Gynecology, Urology, Abdomen, Cardiac, Vascular, Small Parts, TCD, MSK, Pediatric
100-240VAC, 800VA, 50/60Hz
Abdomen, Obstetrics, Gynecology, MSK, Pediatric, Small Parts, Urology, Vascular, Cardiac, Fetal Heart
* For additional information, refer to the ‘Chapter 8. Measurements and Calculations’ in the user manual.
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Signal
Processing
(Pre-
processing)
Signal
Processing
(Post-
processing)
Measurement
Acoustic Power Control Dynamic Aperture Control
Dynamic Apodization Control
Dynamic LPF Control
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)
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
User Interface
Pressure Limits
Humidity Limits
Temperature
Limits
DVD Multi-Drive
Digital B/W Video Printer
Digital Color Video Printer
USB Printer DVD Recorder
Foot switch (IPX8)
USB Flash Memory Media
USB HDD
USB ECG
Monitor
English, German, French, Spanish, Italian, Portuguese
Operating: 700 – 1060hPa Storage: 700 – 1060hPa
Operating: 30 – 75%
Storage & Shipping: 20 – 90%
Operating: 10 – 35°C
Storage & Shipping: -25 – 60°C
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Chapter 1. Introduction 1 - 5

1.2. Product Configuration

This product consists of monitor, control panel, console, peripheral devices and probes.
Monitor
Monitor arm
Keyboard
Control panel
Lift
Probe holder
DVD drive
USB port
Speaker
Probe port
Wheel
[Figure 1.1 Front of the Product]
Location of ID Label
Brake
Gel warmer
Internal peripheral devices
outlet
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1 - 6 HS50/HS60 Service Manual
Handle
Storage compartments
Ventilation
Rear panel
Power connection part
ID label
[Figure 1.2 Back of the Product]
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Chapter 1. Introduction 1 - 7
1.2.1. Monitor
Ultrasound images and other information are displayed on the color LCD monitor.
1.2.1.1. Screen Layout
The monitor displays ultrasound images, operation menus and a variety of other information.
[Figure 1.3 Monitor Display]
Title Area
Displays patient information, hospital name, application, frame rate, depth, probe information, acoustic output information, and the current date and time.
Image Area
Displays ultrasound images. Image information, annotation, and measurement information are also displayed.
Thumbnail Area
Images saved by pressing the preset Store button are shown in the thumbnails. When you save Single screens, up to 4 images are shown in a list; for Quad screens, up to 12 images are shown. Click it with the pointer to enlarge the preview image.
User Information and Status Information Area
Information that is useful to the user, such as current system status, image information, selectable items, etc., is displayed.
User Key (User Defined Key) Area
Settings for User Defined Keys, including the positions of Set and Exit buttons, are displayed. You can change the setting of each button in Setup > Customize > Buttons.
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For information on User Key Setup, please refer to manual.
NOTE
‘Chapter 3. Utilities’ in the user
TIP
Principles of Operation of the Diagnostic Ultrasound System
Medical ultrasound images are created by digital memory and computer when they convert the high-frequency wave signals that are transmitted and received by the probe.
As ultrasound waves propagate through the human body, they generate reflected signals whenever they encounter a change in density. For example, reflected signals are generated when signals pass from fatty tissues to muscle tissues. Reflected signals return to the probe, where they are converted into electronic signals. The reflected signals are amplified and processed by analog and digital circuits that have filters for various frequencies and response time options. Then they are again converted into high-frequency electronic signals, and saved as a series of digital image signals. The monitor displays the image signals stored on the storage device in real time. The entire process of transmitting, receiving, and processing signals is controlled by the computer.
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1.2.2. Control Panel
The system can be controlled by using the control panel.
Chapter 1. Introduction 1 - 9
[Figure 1.4 Control Panel]
The control panel consists of a keyboard, soft menus, buttons, dials, dial-buttons, a slider, and a trackball.
The dial-button can be used both as a dial and a button.
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1.2.2.1. Functions of the Control Panel
The following are the descriptions and instructions for the controls on the control panel. For more information on controls with multiple functions, see ‘Chapter 3. Utilities’ and later in the user manual.
Button Turns the system on/off.
On/Off
End Exam
SonoView
Report
Button
Finishes the exam of the currently selected patient and resets the related data.
Button Displays the screen for viewing and managing stored images.
Button
Displays the Report screen that shows the measurement results of the current application and other information.
When you press the dial-button, the menu items that are
Dial-
button
available in the current scan mode are shown on screen. Rotating the Menu dial-button to the right selects the menu one row above the current menu selected, and rotating it to the left selects the menu one row below.
Dial-
button
– Marker: Allows the user to enter a BodyMarker over an
image.
– Ref: Moves the reference slice horizontally in 3D View.
Dial-
button
Adjusts the angle of the sample volume in Spectral Doppler mode. It is also used to adjust the Arrow’s angle or the probe angle for a BodyMarker.
Button In this mode, only the image is displayed on the screen.
Button Compares four independent images.
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Chapter 1. Introduction 1 - 11
Button
Button
Compares two independent images. The active image mode is on the left.
Compares two independent images. The active image mode is on the right.
Switch Adjusts the scanning depth of the image.
Switch Moves the focus to the target area for observation.
Dial-
button
Makes the Zoom Box appear.
In order to close the Zoom mode, press the Exit button.
Press this button to turn the Quick Scan function on. The ‘Q
Button
scan’ mark will appear at the top of an image. It can be used in applications of all probes.
Button Pauses/resumes scanning.
Stands for User Key; functions can be assigned to these
Button
Dial-
button
buttons as desired. The function for each button can be assigned in Setup > Customize > Buttons > User Key.
Start or end M Mode. Rotate this dial-button to adjust Gain.
Also, turning this dial-button when in 3D View rotates the image along the x-axis.
Press this button to start/stop PW Spectral Doppler mode.
Dial-
button
Rotate this dial-button to adjust Gain.
Also, turning this dial-button, when in 3D View rotates the image along the y-axis.
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Press this button to start/stop Color Doppler mode. Rotate this
Dial-
button
Button Press this button to start/stop Power Doppler mode.
dial-button to adjust Gain.
Also, turning this dial-button when in 3D View rotates the image along the z-axis.
Set/Exit
Clear
Pointer
Button
Dial-
button
Press this button to start/stop CW Spectral Doppler mode.
Available only with the phased array probe.
Press this button to start 2D mode. Rotate this dial-button to adjust Gain.
Button Press this button to turn 3D/4D Mode on/off.
Set or Exit function may be assigned to this button. The function for each button can be assigned in Setup > Customize > Set/Exit Key.
Button
– Set: Select an item or value using the trackball. Also used
to change the function of the trackball.
– Exit: Exits the function currently being used and returns to
the previous state.
Button
Button
Deletes text, Arrow, BodyMarker, measurement results, etc. displayed on an image.
When this is pressed, an arrow marker appears to point to parts of the displayed image.
Change
Calculator
Trackball
Button Changes the current trackball function.
Button Allows the user to place text on an image.
Button Starts measurements by application.
Trackball
Moves the cursor on the screen. Also scrolls through Cine images.
Page 29
Keyboard
The keyboard is used to type in text.
Help Displays the Help Manual on the screen.
Chapter 1. Introduction 1 - 13
[Figure 1.5 Keyboard]
Patient Displays the General Information on the screen.
Patient info. Shows or hides the patient information on the screen.
Image Info. Shows or hides the Image Parameters on the screen.
DICOM Spooler Displays the DICOM Spooler on the screen.
Arrow Initiates Arrow mode.
Home Moves the cursor to the Home position in Annotation mode.
Set Home Specifies the Home position in Annotation mode.
Delete Word Deletes the last text entered in Annotation mode.
Delete All Deletes all the text that has been entered in Annotation mode.
Setup This displays the Setup screen.
Insert Select an input method.
Delete Deletes text.
Turns up the speaker volume.
Turns down the speaker volume.
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1.2.2.2. Touch Screen
The touch screen is an operating tool that can be touched by the user to input data. The functions that are available in the current mode are shown in the form of buttons or a dial­button.
Touch Screen Layout
[Figure 1.6 Touch Screen Display]
These buttons are always displayed on the touch screen. Buttons that are in use are
shown in blue and buttons that cannot be used are deactivated.
Patient
Probe
Quick
Preset 1–4
Setup
The Patient Information screen will appear, where you can select a Patient ID in the list or enter new patient information.
It displays the Probe Selection screen where you can select and modify the probe and application.
It shows up to 4 Preset buttons configured at Setup.
The general system settings that do not have a direct bearing on imaging are explained below.
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Chapter 1. Introduction 1 - 15
NOTE
For further details about setting up Quick Preset, please refer to ‘Setup > System > Quick Preset’ in ‘Chapter 3
CAUTION
Too great a difference in the gain value settings of adjacent TGC sliders may cause stripes in an image.
CAUTION
. Utilities’ in the user manual.
Displays the mode that is currently used.
This is the TGC area. Adjust TGC Slide when TGC Curve is activated on the touch
screen. Move the slider to the right to increase Gain and brighten the image. TGC stands for Time Gain Compensation.
Menu Area: The menu items that are available in the current input mode are shown in the
form of buttons. The user can access the desired menu item by pressing the corresponding button. The menu currently in use is shown in blue. To change the values in the menu, use the ◁ and ▷ buttons.
Soft Menu Area: The Soft Menu items that are available in the current input mode are
shown. Press or rotate the dial-buttons right below each menu.
TIP
When there are Two Soft Menus
When there are two menus available - upper and lower, both menus can be adjusted with the corresponding dial-button. Or tap the button for the menu you want to use on the touch screen and then use the dial-button.
1.2.2.3. Adjusting the Control Panel
Do not apply excessive force to the control panel.
Use the handle at the back of the product when moving it.
Adjusting to the Right and Left
Hold the control panel handle and move it carefully to the right or left.
Adjusting the Height
Press the lever on the handle of the control panel and move it carefully up or down.
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1.2.3. Console
The console consists of two parts - the inner and outer units. The interior of the console mainly contains devices that produce ultrasound images. On the exterior of the console are various connectors, probe holders, storage compartments, handles, and wheels, etc.
1.2.3.1. Rear Panel
A monitor and other peripheral devices, like a printer, are connected via the rear panel at the back of the system.
HDMI port (Output): Outputs digital signals to the
monitor. (Input: Not supported.)
USB port: Used to connect to peripheral USB
devices.
Audio Port (Output): Outputs audio signal. (Input:
Not supported.)
Network port: Connect to a network. You can
transfer patient information to another server via DICOM network.
R.G.B Port (Output): Provides analog signal
output to be displayed on the monitor.
[Figure 1.7 Rear Panel]
S-VHS Port (Output): Provides an S-VHS
connection for a VCR.
Microphone port (Input): Connects a microphone.
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Chapter 1. Introduction 1 - 17
1.2.3.2. Power Connection Part
The power connection part is located at the bottom on the rear panel.
Power switch/breaker: Turns on the
power of the product, and cuts off power if overcurrent or overvoltage occurs.
Power inlet: Accepts the power cord,
which connects to an external power supply.
Equipotential Terminal: This should be
connected to the equipotential connection part in the exam room.
[Figure 1.8 Power Connection Part]
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1.2.3.3. Probe Holder
Probe holders are mounted at the left and right-hand sides of the control panel.
The holder can be separated for easy cleaning.
The six probe holders on the control panel can be attached and removed.
Hold the marked area at the top of the holder
Pull the holder up th detach it. and pull it in the direction shown by the arrow.
[Figure 1.9 Removing the Probe Holder]
TIP
Hockey Stick Probe Holder
Insert the Hockey stick probe holder into the probe holder to mount. It is provided as an option.
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Chapter 1. Introduction 1 - 19
CAUTION
Refer to the user manual of the peripheral device for its operating information.
1.2.4. Peripheral Devices
Peripheral devices can be connected to their corresponding ports on the left/right or rear sides of the console, as needed.
Do not install peripheral devices that are not listed in the user manual in the patient environment. If you install an unlisted device in the patient environment, it may cause an electrical hazard.
Do not connect additional external peripheral devices to the auxiliary socket outlet. Doing so may decrease safety level.
[Figure 1.10 Patient Environment]
NOTE
1.2.4.1. Internal Peripheral Devices
These are peripheral devices mounted in the system.
DVD-Multi
DVD±R, DVD±RW, DVD-RAM, CD-R, CD-RW
Solid State Device
Min. 64Gbytes SATA SSD
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CAUTION
When using a peripheral device via a USB port, always turn the power off before connecting/disconnecting the device. Connection/disconnection of USB devices while the power is on
1.2.4.2. External Peripheral Devices
These are peripheral devices that can be connected for use when needed and are connected via the USB port located at the rear panel.
may lead to malfunction of the system and the USB devices.
TIP
The console’s USB ports are located on the rear panels of both the control panel and the console.
We recommend that you connect USB storage devices (flash memory media, etc.) to the ports on the control panel, and other USB peripheral devices to the rear panel for convenience.
The following products are recommended:
Digital Video Printer
– Black and White: Sony UP-D897 (UP-897MD, UP-X898MD, UP-D898MD), Mitsubishi
P95DE (P95DW, P95D, P95DE)
– Color: Sony UP-D25MD, Mitsubishi CP30DW
USB Printer
HP Officejet 4500, Samsung CLP-620NDK
DVD Recorder
Sony DVO-1000MD
You must install a printer and drivers that are compatible with Microsoft Windows 7 (English version). Contact Samsung Medison customer support division for inquiries about printer driver installation.
When connecting the printer, ensure that the printer is configured under Microsoft
CAUTION
Windows or system setup and has been chosen as the default printer.
Please check the port that the printer uses before connecting. Printers should be connected to the printer port while the USB printer should be connected to the USB port.
Foot Switch
– 3 Pedals HID Type
To configure the foot switch function, go to Setup > Customize > Buttons > Foot Switch. You can select Exit, Freeze, U1, U2, U3, U4, U5, U6, Update, Single, or Quad.
Misc.
Flash Memory Media
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Chapter 1. Introduction 1 - 21
• The system cannot recognize USB 1.1 flash memory. Remove the flash memory from
For information on probes, refer to ‘Chapter
the console and equip again with an appropriate device.
Regarding file formats that are not ordinarily saved: Please check first to see if it is possible to save the file format on a desktop PC before trying to save the file on flash
NOTE
memory.
Do not use flash memory media which contain anti-virus programs or are defective. Otherwise, the product may fail to work properly.
1.2.5. Probes
Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation.
9. Probes’ and the Reference Manual.
NOTE
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If the probe does not connect properly, try reconnecting it after removing any foreign objects.
1.2.5.1. Connecting Probes
Be sure to connect or disconnect probes when the power is off to ensure the safety of the system and the probes.
Connect probes to the probe connectors on the front panel of the system. Up to four (options
inclusive) (five including CW) probes may be connected.
Turn the connector-locking handle clockwise.
NOTE
[Figure 1.11 Probe Connector]
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Chapter 1. Introduction 1 - 23
Accessories can be different according to the country.
1.2.6. Accessories
An accessory box containing the items below is supplied with the product.
NOTE
[Figure 1.12 Accessories]
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1.2.7. Optional Functions
HS50 and HS60 products have the following options based on the version:
Option HS50 HS60
4D O O
3D XI O O
DICOM O O
Ez Exam+ O O
MultiVision O Basic option
5D NT O O
CW Function O O
Cardiac Measurement O O
Strain+ X O
Auto IMT+ O O
ElastoScan O O
E-Strain X O
Panoramic O O
XI STIC O O
SEE Stream (RU region only) O O
Needle Mate+ O O
CEUS+ X O
Realistic Vue O O
HDVI X O
Mobile Export O O
5D Follicle O O
For further information about optional functions, please refer to the relevant chapters in this manual.
Page 41
Chapter 2

2. Safety

Chapter 2. Safety

Safety

2.1. Purpose of Use ........................................................................................... 2
2.1.1. Restrictions ............................................................................................................... 2
2.2. Safety Information ...................................................................................... 3
2.2.1. Safety Symbols ......................................................................................................... 3
2.2.2. LABEL ....................................................................................................................... 6
2.3. Electrical Safety ......................................................................................... 7
2.3.1. Prevention of Electric Shock ..................................................................................... 7
2.3.2. Related Information................................................................................................... 9
2.3.3. ESD ........................................................................................................................... 9
2.3.4. EMI .......................................................................................................................... 10
2.3.5. EMC ........................................................................................................................ 10
2.4. Mechanical Safety .................................................................................... 17
2.4.1. Moving the Equipment ............................................................................................ 17
2.4.2. Safety Notes ........................................................................................................... 18
2.5. Biological Safety ...................................................................................... 20
2.5.1. ALARA Principle ...................................................................................................... 20
2.6. Protecting the Environment .................................................................... 34
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2 - 2 HS50/HS60 Service Manual
For detailed information on applications and presets, refer to “Chapter and “Chapter
CAUTION
For information on the use or cl Starting Diagnosis” and “Chapter 7. Diagnosis Mode” in

2.1. Purpose of Use

Ultrasound diagnostic system and probes were designed for obtaining ultrasound images and analyzing human blood. Below are the clinical applications:
1. Introduction”
9. Probes” in this manual.
NOTE
2.1.1. Restrictions
This product must not be used for ophthalmological application or any other use that involves the ultrasound beam passing through the eyeball.
inical application of this product, refer to “Chapter 6.
the user manual.
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Chapter 2. Safety 2 - 3

2.2. Safety Information

Read the following safety information before using this product: This provides an explanation about the ultrasound system, probes, recording devices, and any of the optional equipment.
This product is intended for use by, or by the order of, and under the supervision of a licensed physician who is qualified to use medical devices directly.
Prolonged use of three-dimensional ultrasound (3D, 4D) by an unqualified individual, such as to produce commemorative photograph or video of the fetus, may have an adverse effect on the fetus.
Use the 3D ultrasound diagnostic imaging system for appropriate purposes only; using it for non-diagnostic purposes such as recording videos of the fetus may adversely affect the fetus.
2.2.1. Safety Symbols
The International Electro Technical Commission (IEC) has established a set of symbols for medical electronic equipment, which classify a connection or warn of potential hazards. The classifications and symbols are shown below.
Symbols Description
Warning: Follow these instructions to prevent serious accidents or damage to property.
Caution: Follow these instructions to prevent minor accidents or damage to property.
Refer to the user manual.
Follow the user manual.
Caution: Risk of electric shock
Type BF applied part (Classification based on degree of protection against electric hazard)
Defibrillation-proof type CF applied part (Classification based on degree of protection against electric hazard)
Power on/off
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Symbols Description
Power on
Power off
V~
Product is partially powered on
Power off for part of the product
AC (alternating current) voltage source
DC (direct current) voltage source
Dangerous voltage (over 1000V AC or 1500V DC)
Protective earth (ground)
Equipotential terminal
Data output port
Data input port
Data input/output port
Input port
Output port
Print remote output
Page 45
Symbols Description
Foot switch port
Chapter 2. Safety 2 - 5
Electrocardiograph (ECG) port
USB port
Network port
Microphone port
Probe port
IPX 1 Dripping-proof device: Protected against vertically falling water
IPX 7
IPX 8
Immersion-proof device: Protected against the effects of non­continuous immersion in water
Submersion-proof device: Protected against the effects of continuous immersion in water
Caution: The device is sensitive to electrostatic discharge (ESD)
Do not sit on the product.
Do not push the product.
Do not lean against the product.
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Symbols Description
Mind the space. Do not place a hand, a finger, or any other part of the body in the empty space.
2.2.2. LABEL
Phrases containing the words 'Warning' and/or 'Caution' are displayed on the product’s surface in order to protect the product.
Page 47
Chapter 2. Safety 2 - 7

2.3. Electrical Safety

This equipment is categorized as Class I device with Type BF or Type CF (ECG) applied parts.
2.3.1. Prevention of Electric Shock
In a hospital environment, dangerous electric current may occur as a result of the potential difference between a contactable conductive part and the connected equipment in treatment rooms. The solution to the problem is consistent equipotential bonding. The equipotential terminal of an item of medical equipment must be connected to the equipotential bonding network in a treatment room, as shown in the figure below.
[Figure 2.1 Equipotential Bonding]
Additional equipment connected to medical electrical equipment must comply with the pertinent IEC standards (e.g., IEC 60950/EN 60950 for data processing equipment, IEC 60601-1/EN 60601-1 for medical devices). Furthermore, all components of the product shall comply with the requirements for medical electrical systems IEC 60601-1-1/EN 60601-1-1. Any person connecting additional equipment to the signal input and output ports of medical electrical equipment must verify that the equipment complies with IEC 60601-1-1/EN 60601-1-1.
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WARNING
• All patient contact devices, such as probes and ECG leads, must be removed from the
uct in the presence of flammable anesthetic gas or oxidizing gases
• Avoid installing the system where it is difficult for the operator to disconnect it from the
Electric shock may occur if this system, including all of its externally mounted
recording and monitoring devices, is not properly grounded.
Never open the cover of the product. The interior of this product contains dangerous
high-voltage electricity. All internal component repairs and part replacements must be performed by Samsung Medison’s customer service department.
Always check the product's housing, cables, cords, and plugs before using the
product. Disconnect the power source and do not use the equipment if the housing is damaged (for example, cracked or chipped) or if the cable is worn.
Always disconnect the system from the wall outlet prior to cleaning it.
patient prior to the application of a high-voltage defibrillation pulse.
Never use the prod
(N2O). Doing so may cause an explosion.
power source.
Do not use HF surgical equipment with the system. Any malfunctions in the HF
surgical equipment may cause burns to the patient.
The system must be connected to a power supply with protective earth to prevent
electric shock.
CAUTION
The system has been designed for 100-240VAC; you should select the input voltage
of any connected printer and VCR. Prior to connecting a peripheral power cord, verify that the voltage indicated on the power cord matches the voltage rating of the peripheral device.
An isolation transformer protects the system from power surges. This continues to
operate even when the system is on standby.
Do not immerse the power cable in any liquid. Cables are not waterproof.
Make sure that the inside of the system is not exposed to or immersed in any liquid.
Otherwise, fire, electric shock, injury, or damage to the product may occur.
The auxiliary socket outlets installed on this system are rated 100-240VAC, with
maximum total load of 150VA. Use these outlets only for supplying power to equipment that is intended to be part of the ultrasound system. Do not connect additional multiple-socket outlets or extension cords to the system.
Do not connect peripheral devices other than those listed in this manual to the
auxiliary socket outlets of the system. It may pose an electrical hazard.
Do not touch the SIP/SOP and the patient simultaneously. There is risk of electric
shock from leaking current.
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Chapter 2. Safety 2 - 9
ESD preventive procedures before using connectors marked with
2.3.2. Related Information
This product does not support ECG monitoring. Therefore, it will not recognize
incompatible ECG signals.
Do not use the ECG electrodes of HF surgical equipment. Any malfunctions in the HF
WARNING
surgical equipment may cause burns to the patient.
Do not use ECG electrodes during cardiac pacemaker procedures or other electrical
stimulators.
Do not use ECG leads and electrodes in an operating room.
2.3.3. ESD
Electrostatic discharge (ESD), commonly referred to as static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. Static shock, or ESD, is a discharge of the electrical energy buildup from a charged individual to a lesser or an uncharged individual or object. ESD occurs when an individual with electrical energy build-up comes in contact with conductive objects such as metal doorknobs, filing cabinets, computer equipment, and even other individuals.
CAUTION
The level of electrical energy discharged from a system user or a patient to an
ultrasound system can be significant enough to cause damage to the system or probes.
Always perform anti-
the ESD warning label.
– Apply anti-static spray to carpets or linoleum.
– Use anti-static mats.
– Ground the product to the patient table or bed.
It is highly recommended that the user be given training on ESD-related warning
symbols and preventive procedures.
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CAUTION
In cases wherein EMI is system.
2.3.4. EMI
This product complies with EMI (Electromagnetic Interference) standards. Note, however, that using the system inside an electromagnetic field can lower the quality of ultrasound images and even damage the product.
If this occurs often, Samsung Medison suggests a review of the environment where the system is being used to identify possible sources of radiated emissions. These emissions could be from other electrical devices used within the same room or an adjacent room. Communication devices such as cellular phones and pagers can cause these emissions. Nearby radios, TVs, or microwave transmission equipment can also cause interference.
causing disturbances, it may be necessary to relocate the
2.3.5. EMC
Testing of the EMC (Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC 60601-1-2). This IEC standard was adopted in Europe as the European norm (EN 60601-1-2).
2.3.5.1. Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should make sure that it is used in such an environment.
Emission Test Compliance Electromagnetic Environment Guidance
The Ultrasound System uses RF energy only for its
RF Emission
CISPR 11
RF Emission
CISPR 11
Harmonic Emission
IEC 61000-3-2
Flicker Emission
IEC 61000-3-3
Group 1
Class A
Class A
Compliant
internal function. Therefore, its RF emissions are very low and are not likely to cause any interference to nearby electronic equipment.
The Ultrasound System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that powers buildings used for domestic purposes.
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Chapter 2. Safety 2 - 11
CAUTION
When connecting other customer responsibility to ensure the electromagnetic compatibility of the system.
WARNING
The use of cables, probes, and peripherals other than those specified may result in increased emissions or decreased immunity
2.3.5.2. Approved Cables, Probes, and Peripherals for EMC
Cables
Cables connected to this product may affect its electromagnetic emissions. Therefore, use only the appropriate cable of the types and lengths listed below.
Cables Type Length
VGA Shielded Normal
USB Shielded Normal
LAN(RJ45) Twisted pair Any
S-Video Shielded Normal
Foot Switch Shielded 2.99m
Audio R.L Shielded Normal
Parallel Shielded Normal
HDMI Shielded Normal
MIC Non-shielded Any
ECG 3-lead Shielded Normal
Probe
The image probe used with this product may affect its electromagnetic emission. The probes listed in ‘Chapter 9. Probes’ of this manual have been tested to comply with the Group 1, Class A requirements of the CISPR 11 standard.
Peripherals
Peripherals used with this product may affect its electromagnetic emissions.
-supplied accessories to the system, it is the user’s
of the Ultrasound System.
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Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions, and voltage variations on power supply input lines
IEC 61000-4-11
IEC 60601
Test Level
±6KV contact
±8KV air
±2KV
for power supply lines
±1KV
for input/output lines
±1KV differential mode
±2KV common mode
5%Uт for 0.5 cycles (>95% dip in Uт)
40%Uт for 5 cycles (60% dip in Uт)
70%Uт for 25 cycles (30% dip in Uт)
5%Uт for 5 seconds (<95% dip in Uт)
Compliance Level
±6KV contact
±8KV air
±2KV
for power supply lines
±1KV
for input/output lines
±1KV differential mode
±2KV common mode
5%Uт for 0.5 cycles (>95% dip in Uт)
40%Uт for 5 cycles (60% dip in Uт)
70%Uт for 25 cycles (30% dip in Uт)
5%Uт for 5 seconds (<95% dip in Uт)
Electromagnetic
Environment Guidance
Floors should be wood, concrete, or ceramic tile.
If floors are covered with synthetic material, the relative humidity should be at least 30%.
The quality of the power mains should be that of a typical commercial or hospital environment.
The quality of the power mains should be that of a typical commercial or hospital environment.
The quality of the power mains should be that of a typical commercial or hospital environment. If the user of this product requires continued operation during interruptions in the power mains, it is recommended that this product be powered by an uninterruptible power supply or a battery.
Power frequency magnetic field (50/60Hz)
IEC 61000-4-8
Note: Uт is the AC main voltage, prior to application of the test level.
3A/m 3A/m
Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.
Page 53
Chapter 2. Safety 2 - 13
𝑑 = 1.2√P
𝑑 = 2.3P
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601 Test Level
3Vrms
150kHz ~ 80MHz
3V/m
80MHz ~
2.5GHz
Compliance
Level
Electromagnetic environment guidance
3V 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. This distance is calculated using the equation applicable to the frequency of the transmitter.
Recommended separation distance
𝑑 = 1.2√P
80MHz to 800MHZ
800MHz to 2.5GHz
3V/m
Where P is the transmitter’s maximum output power rating in watts (W) according to the transmitter’s manufacturer and d is the recommended separation distance in meters (m).
a
Field strengths
from fixed RF transmitters, as determined by an electromagnetic site survey, 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.
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 broadcasts, and TV broadcasts cannot be predicted accurately. 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 where 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 reorienting or relocating the Ultrasound System or using a shielded location with higher RF shielding effectiveness and filter attenuation.
b
Beyond the frequency range from 150kHz to 80MHz, field strengths should be less than 3 V/m.
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= . √
= . √
= . √
CAUTION
If the system is connected to other customer network (LAN), Samsung Medison cannot guarantee that the remote equipment will work correctly in the presence of electromagn
2.3.5.3. Recommended Separation Distances between This Product and RF
Communications Equipment
This product is intended for use in an electromagnetic environment wherein radiated RF disturbances are controlled. The customer or the user of this product can help prevent electromagnetic interference by maintaining the minimum distance between portable and mobile RF communications equipment (transmitters) and this product. These distances are recommended below, according to the maximum output power of the communications equipment.
Rated maximum
Separation distance according to the frequency of transmitter [m]
output power of
transmitter
[W]
150kHz – 80MHz
80MHz – 800MHz
800MHz – 2.5GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at 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’s 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.
2.3.5.4. Electromagnetic environment guidance
It is recommended to use ultrasound systems in shielded locations offering RF shielding effectiveness, with shielded cables. Field strengths outside the location shielded from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m.
It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to ensure that they meet the minimum specification.
-supplied equipment, such as local area
etic phenomena.
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Chapter 2. Safety 2 - 15
2.3.5.5. Avoiding Electromagnetic Interference
Typical interference on ultrasound imaging systems varies depending on electromagnetic phenomena. Refer to the following table:
Imaging mode ESD1 RF2 Power Line3
2D
M
Color
Doppler
When changing the operating mode or system settings or resetting the system, brief flashes appear in the displayed or recorded image.
For sector imaging probes, white radial bands or flashes in the centerlines of the image.
For linear imaging probes, white vertical bands that are sometimes more pronounced on the sides of the image.
Increase in image background noise or white M mode lines.
Color flashes, radial or vertical bands, increase in background noise, or changes in color image.
Horizontal lines in the spectral display or tones, abnormal noise in the audio, or both.
White dots, dashes, diagonal lines, or diagonal lines near the center of the image.
White dots, dashes, diagonal lines, or increase in image background noise.
Color flashes, dots, dashes, or changes in color noise level.
Vertical lines in the spectral display, popping-type noises in the audio, or both.
1. ESD caused by the discharging of electric charge build-up on insulated surfaces or
persons.
2. RF energy from RF transmitting equipment such as portable phones, hand-held radios,
wireless devices, commercial radio and TV, and so on.
3. Conducted interference on power lines or connected cables caused by other equipment,
such as switching power supplies, electrical controls, and natural phenomena such as lightning.
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A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference.
Samsung Medison’s ultrasound systems do not generate electromagnetic interference in excess of the referenced standards.
The Ultrasound System is designed to receive signals at radio frequency; therefore, it is susceptible to interference generated by RF energy sources. Examples of other sources of interference are medical devices, information technology products, and radio and television transmission towers. Tracing the source of radiated interference can be a difficult task. Customers should consider the following in an attempt to locate the source:
Is the interference intermittent or constant?
Does the interference show up with only one probe operating at the same frequency or with
several probes?
Do two different probes operating at the same frequency have the same problem?
Is the interference present if the system is moved to a different location in the facility?
The answers to these questions will help determine if the problem lies with the system or the scanning environment. Answer each of the questions and contact Samsung Medison's customer service department.
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WARNING
Special caution should be taken during movement. Careless transportation of the product may result in product damage or personal injury.
WARNING
Mind the castors, especially when moving the system. Samsung Medison recommends exercising caution when moving the product up or down ramps.

2.4. Mechanical Safety

2.4.1. Moving the Equipment
Before transporting the product, check whether the wheel brakes are unlocked. In addition, be sure to retract the monitor arm completely so that it is secured in a stationary position.
Always use the handles at the back of the console and move the product slowly.
This product is designed to resist shock. Note, however, that excessive shock -- for example, if the product falls over -- may cause serious damage.
If the product does not work properly after transfer, contact Samsung Medison's Service Department.
2.4.1.1. Brake
Brakes are mounted to the wheels of the console. To lock the brakes, press the bottom part of the brake with your foot. To unlock them, press the part labeled OFF at the top of the brake with your foot.
You can use the brakes to control the movement of the product. We recommend locking the brakes when using the product.
2.4.1.2. Precautions on Ramps
Always make sure that the control panel is facing the direction of movement.
If you leave the product on an incline, the product may fall over even if the brakes are engaged. Do not leave the product on ramps.
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2.4.2. Safety Notes
Do not press the control panel excessively.
Never attempt to modify the product in any way.
Check the operational safety when using the product after a prolonged break in
CAUTION
Refer to ‘Chapter 10. Maintenance and Storage’ for detailed information on protecting, cleaning, and disinfecting the equipment.
service.
Make sure that other objects, such as pieces of metal, do not enter the system.
Do not block the ventilation slots.
Do not pull the power cord to unplug it. Doing so can damage the cord and cause
short-circuit and cord snapping. Always unplug by pulling the plug itself.
Excessive bending or twisting of cables or parts that are applied to the patient may
cause failure or intermittent operation of the system.
Improper cleaning or sterilization of parts applied to the patient may cause permanent
damage.
Servicing the product, including repairs and replacement of parts, must be done by
qualified Samsung Medison service personnel. Assuming that the product is used in accordance with the guidelines contained in this manual and maintained by qualified service personnel, the expected service life of the product is approximately 7 years.
2.4.2.1. Monitor Safety Caution
When adjusting the height or position of the monitor, mind the space in the middle of the monitor arm. Getting your fingers or other body parts caught in it may result in injury.
[Figure 2.2 Monitor Safety Caution]
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CAUTION
2.4.2.2. Control Panel Caution
Do not press on the control panel with excessive force or lean against it.
Do not sit on the control panel or apply too much pressure to it.
When adjusting the control panel’s height or position, mind the space between the panel and the lift. Getting your fingers or other body parts caught in it may result in injury.
[Figure 2.3 Control Panel Caution]
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WARNING

2.5. Biological Safety

For safety information on the probe and biopsy, refer to ‘Chapter 9. Probes.’
Ultrasound waves may have damaging effects on cells and consequently harm the
patient. If there is no medical benefit, minimize the exposure time and maintain the ultrasound wave output at low levels. Refer to the ALARA principle.
Do not use the system if an error message appears on the video display indicating
that a hazardous condition exists. Take note of the error code, turn off power to the system, and call Samsung Medison's customer service department.
Do not use a system that exhibits erratic or inconsistent functioning. Discontinuities in
the scanning sequence are indicative of a hardware failure that should be corrected before use.
The system limits the maximum contact temperature to 43 degrees Celsius; the
ultrasonic wave output observes the American FDA regulations.
2.5.1. ALARA Principle
Guidance for the use of diagnostic ultrasound is defined by the '(As Low As Reasonably Achievable)' (ALARA) principle. The decision as to what is reasonable has been left to the
judgment and insight of qualified personnel. No set of rules that would be sufficiently complete to dictate the correct response to every circumstance can be formulated. By keeping ultrasound exposure as low as possible while obtaining diagnostic images, users can minimize the ultrasonic bioeffects.
Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile the exposure time with the diagnostic image quality. To ensure diagnostic image quality and limit the exposure time, the Ultrasound System provides controls that can be manipulated during the exam to optimize the results.
The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound, not only in the technology but also in its applications, have given rise to the need for increased and improved information to guide the user. Based on a variety of ultrasound output data, the output indices are designed to provide important information for executing the ALARA principle.
There are a number of variables that affect the way in which the output display indices can be used to implement the ALARA principle. These variables include mass, body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because the user controls it. Unlike other variables, exposure time is entirely controlled by the operator of the ultrasound system.
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2.5.1.1. Applying ALARA
The system-imaging mode used depends on the information needed. 2D-mode and M-mode imaging provide anatomical information, whereas Doppler, Power, and Color imaging provide information about blood flow. Scanned modes, like 2D-mode, Power, or Color, disperse or scatter the ultrasonic energy over an area, whereas an unscanned mode like M-mode or Doppler concentrates ultrasonic energy. Understanding the nature of the imaging mode being used allows the sonographer to apply the ALARA principle with informed judgment. The probe frequency, system setup values, scanning techniques, and operator experience aid the sonographer in adhering to the ALARA principle. The decision as to the amount of acoustic output is, in the final analysis, up to the system operator. This decision must be based on the following factors: type of patient, type of exam, patient history, ease or difficulty of obtaining diagnostically useful information, and potential localized heating of the patient due to probe surface temperatures. Prudent use of the system is secured when patient exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve acceptable diagnostic results.
Although a high index reading does not mean that a biological effect is actually occurring, it should be taken seriously. Every effort should be made to reduce the possible effects of a high index reading. Limiting the exposure time is an effective way of accomplishing this goal.
There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA and can be divided into three categories: direct, indirect, and receiver control.
2.5.1.2. Direct Controls
Application selection and output intensity control directly affect acoustic intensity. There are different ranges of allowable intensity or output depending on your selection. Selecting the correct range of acoustic intensity for the application is one of the priorities required during any exam. For example, peripheral vascular intensity levels are not recommended for fetal exams. Some systems automatically select the proper range for a particular procedure, whereas others require manual selection. Ultimately, the user bears the responsibility for proper clinical use. Samsung Medison's systems provide both automatic and user-definable settings.
Output has direct impact on acoustic intensity. Once the application has been established, output control can be used to increase or decrease the output intensity. Output control lets you select intensity levels that are lower than the defined maximum. Prudent use ensures good image quality while employing the lowest output intensity.
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2.5.1.3. Indirect Controls
Indirect controls are those with an indirect effect on acoustic intensity. These controls affect imaging mode, pulse repetition frequency, focus depth, pulse length, and probe selection.
The choice of imaging mode determines the nature of the ultrasound beam. 2D-mode is scanned mode; Doppler is stationary or unscanned mode. A stationary ultrasound beam concentrates energy on a single location. Moving or scanned ultrasound beam disperses the energy over a wide area, with the beam concentrated only on a given area for a fraction of time necessary in unscanned mode.
The pulse repetition frequency or rate refers to the number of ultrasound bursts of energy over a specific period of time. The higher the pulse repetition frequency, the more pulses of energy in a given period of time. Pulse repetition frequency is affected by several controls such as focal depth, display depth, sample volume depth, color sensitivity, number of focal zones, and sector width controls.
The focus of the ultrasound beam affects the image resolution. Maintaining or increasing resolution at a different focus requires a variation of output over the focal zone. This variation of output is a function of system optimization. Different exams require different focal depths. Setting the focus to the proper depth improves the resolution of the structure of interest.
Pulse length is the time during which ultrasonic burst is turned on. The longer the pulse, the greater the time-average intensity value. The greater the time-average intensity, the greater the likelihood of temperature increase and cavitations. Pulse length, burst length, or pulse duration is the output pulse duration in pulsed Doppler. Increasing the Doppler sample volume increases the pulse length.
Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The higher the probe operating frequency, the greater the attenuation of the ultrasonic energy. Higher probe operating frequencies require higher output intensity to scan at an increased depth. To scan deeper at the same output intensity, lower probe frequency is required. Using more gain and output beyond a point without corresponding increases in image quality can mean that lower frequency probe is needed.
Receiver Controls
Receiver controls are used by the operator to improve image quality. These controls have no effect on output. Receiver controls only affect how the ultrasound echo is received. These controls include gain, TGC, dynamic range, and image processing. The important thing to remember, relative to output, is that receiver controls should be optimized before increasing output. For example; before increasing output, optimize gain to improve image quality.
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2.5.1.4. Additional Considerations
Ensure that scanning time is kept to a minimum, and that only medically required scanning is performed. Never compromise quality by rushing an exam. A poor exam will require follow-up, which ultimately increases the scanning time. Diagnostic ultrasound is an important tool in medicine and, like any tool, should be used efficiently and effectively.
2.5.1.5. Output Display Features
The system output display consists of two basic indices: mechanical index and thermal index. The thermal index consists of the following indices: soft tissue (TIs), bone (TIb), and cranial bone (TIc). One of these three thermal indices will be displayed at all times. Which one is determined by the system preset or user choice, depending on the application at hand.
The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of
0.1. The thermal index consists of three indices, and only one of these is displayed at all times.
Each diagnostic probe application has a default selection. The TIb or TIs is continuously displayed over the range of 0.0 to maximum output, based on the probe and application, in increments of 0.1.
The default setting of the application-specific nature is also an important factor of index selection. A default setting is a system control state that is preset by the manufacturer or the operator. The system has default index settings for the probe application. The default settings are applied automatically by the ultrasound system when power is turned on, new patient data is entered into the system database, or change of application occurs.
The decision as to which of the three thermal indices to display should be based on the following criteria:
Appropriate index for the application: TIs is used for imaging soft tissue, and TIb, for focus at or near a bone. Elements such as fluid, bone, and blood flow may act as elements that increase or decrease TI. A highly attenuating tissue path, for example, may cause the potential for local zone heating to be lower than the thermal index displays.
The selection of scanned modes or unscanned modes of operation also affects the thermal index. For scanned modes, heating tends to be near the surface; for unscanned modes, the potential for heating tends to be deeper in the focal zone.
Always limit the ultrasound exposure time. Do not rush the exam. Make sure that the indices are kept to a minimum, and that exposure time is limited without compromising diagnostic sensitivity.
Mechanical Index (MI) Display
Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The potential for mechanical biological effects varies with peak pressure and ultrasound frequency. MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. Note, however, that there is no specific MI value that means that a mechanical effect will actually occur. The MI should be used as a guide for implementing the ALARA principle.
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Thermal Index (TI) Display
The TI informs the user of the potential for temperature increase occurring at the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, and mode of operation. The TI should be used as a guide for implementing the ALARA principle.
The bone thermal index (TIb) informs the user of potential heating at or near the focus after the ultrasound beam has passed through soft tissue or fluid, such as the skeletal structure of a 2-3-month-old fetus. The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near the surface -- for example, the cranial bone. The soft tissue thermal index (TIs) informs the user about the potential for heating within soft homogeneous tissue. TIc is displayed when you select a trans-cranial application.
Go to Setup > Imaging > Application/Preset > Thermal Index Type to select TI for display.
Precision and Accuracy of Mechanical and Thermal Indices Displays
The Mechanical and Thermal Indices on the system are precise to 0.1 units.
The MI and TI display accuracy estimates for the system are given in the Acoustic Output Tables section of this manual. These accuracy estimates are based on the variability range of probes and systems, inherent acoustic output modeling errors, and measurement variability as described below.
The displayed values should be interpreted as relative information to help the system operator adhere to the ALARA principle through prudent use of the system. The values should not be interpreted as actual physical values of investigated tissue or organs. The initial data that is used to support the output display is derived from laboratory measurements based on the AIUM measurement standard. The measurements are then put into algorithms to calculate the displayed output values.
Many of the assumptions used in the process of measurement and calculation are conservative in nature. Over-estimation of actual in situ exposure, for the vast majority of tissue paths, is built into the measurement and calculation process. For example, the acoustic output values measured underwater are de-rated using a conservative, industry­standard, attenuation coefficient of 0.3dB/cm-MHz.
Conservative values for tissue characteristics were selected for use in the TI models. Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat capacity, and tissue thermal conductivity were selected.
A ste ad y-state temperature rise is assumed in the industry-standard TI models, and the ultrasound probe is assumed to be held steadily in one position long enough for a steady state to be reached.
A number of factors that are considered when estimating the accuracy of display values include hardware variations, algorithm accuracy estimation, and measurement variability. Deviation among probes and systems in particular is an important factor. Probe deviation results from piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens focusing on parameter variations. Differences in system pulse voltage control and efficiencies are also a contributor to variability. There are inherent uncertainties in the algorithms used for estimating acoustic output values over the range of possible system operating conditions and pulse voltages. Inaccuracies in laboratory measurements are related to differences in hydrophone calibration and performance, positioning, alignment and digitization tolerances, and variability among test operators.
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The conservative assumptions of the output estimation algorithms of linear propagation, at all depths, through a 0.3dB/cm-MHz attenuated medium are not taken into account in the calculation of the accuracy estimate displayed. Neither linear propagation nor uniform attenuation at the 0.3dB/cm-MHz rate occurs in underwater measurements or in most tissue paths in the body. In the body, different tissues and organs have dissimilar attenuation characteristics. In water, there is almost no attenuation. In the body, particularly in underwater measurements, non-linear propagation and saturation losses occur as pulse voltages increase.
The display accuracy estimates take into account the variability ranges of probes and systems, inherent acoustic output modeling errors, and measurement variability. Display accuracy estimates are measured according to AIUM measurement standards but not based on errors caused during measurement or inherent errors. They are also independent of the effects of non-linear loss on the measured values.
2.5.1.6. Control Effect- Controls Affecting the Indices
Since various system controls are adjusted, the TI and MI values may change. This will be most apparent as the Power control is adjusted; note, however, that other system controls will also affect the on-screen output values.
Power
Power controls the system’s acoustic output. Two real-time output values are on the screen: TI and MI. They change as the system responds to POWER adjustments.
In combined modes, such as simultaneous Color, 2D-mode, and pulsed Doppler, the total TI is the sum of TIs of the individual modes. Each mode will be a dominant contributor to this total; the displayed MI will be from the mode with the largest peak pressure.
2.5.1.7. 2D Mode Controls
2D Mode Size
Narrowing the sector angle may increase the frame rate. This will increase the TI. The pulse voltage may be automatically lowered by the software controls to keep the TI below the system maximum. A decrease in pulse voltage will decrease the MI.
Zoom
Increasing the zoom magnification may increase the frame rate. This will increase the TI. The number of focal zones may also increase automatically to improve the resolution. This action may change the MI, since the peak intensity can occur at a different depth.
Number of Focal Zones
Increasing the number of focal zones may change both TI and MI by changing the frame rate or focal depth automatically. Lower frame rates decrease the TI. The displayed MI will correspond to the focal zone with the largest peak intensity.
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Focus
Changing the focal depth will change the MI. Generally, higher MI values will occur when the focal depth is near the natural focus of the probe (transducer).
2.5.1.8. Color and Power Controls
Color Sensitivity
Increasing the color sensitivity increases the TI and the time spent on scanning color images. Color pulses are the dominant pulse type in this mode.
Color Sector Width
Narrower color sector width will increase the color frame rate; the TI will also increase. The system may automatically decrease the pulse voltage to below the system maximum. A decrease in pulse voltage will decrease the MI. If pulsed Doppler is also enabled, then pulsed Doppler will remain the primary mode, and the TI change will be small.
Color Sector Depth
Deeper color sector depth may automatically decrease the color frame rate or change the color focal zone or color pulse length. The TI will change due to the combination of these effects. Generally, the TI will decrease with increased color sector depth. The MI will correspond to the peak intensity of the dominant pulse type, which is a color pulse. If pulsed Doppler is also enabled, however, then pulsed Doppler will remain the primary mode, and the TI change will be small.
Scale
Using the SCALE control to increase the color velocity range may increase the TI. The system will automatically adjust the pulse voltage to below the system maximum. A decrease in pulse voltage will also decrease the MI.
2D Mode Size
A narrower 2D-mode sector width in Color imaging will increase the color frame rate. The TI will increase, but the MI will not change. If pulsed Doppler is also enabled, then pulsed Doppler will remain the primary mode, and the TI change will be small.
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2.5.1.9. M Mode and Doppler Controls
Simultaneous and Update Methods
Use of combination modes affects both TI and MI through the combination of pulse types. During Simultaneous mode, the TI is an ancillary element. During Auto-update and Duplex, the TI will display the dominant pulse type. The displayed MI will be from the mode with the largest peak pressure.
Sample Volume Depth
When Doppler sample volume depth is increased, the Doppler PRF may automatically decrease. A decrease in PRF will decrease the TI. The system may also decrease the pulse voltage to below the system maximum. A decrease in pulse voltage will decrease the MI.
2.5.1.10. Others
2D, Color, M-Mode, PW, and CW Modes
When a new imaging mode is selected, both TI and MI will change to default settings. Each mode has a corresponding pulse repetition frequency and a maximum intensity point. In combined or simultaneous modes, the TI is the sum of the contribution from the modes enabled, and the MI is the value for the focal zone of the mode with the largest de-rated intensity. If a mode is turned off and then reselected, the system will return to the previously selected settings.
Probes
Each probe model available has unique specifications for contact area, beam shape, and center frequency. Settings are initialized when you select a probe. Samsung Medison's factory defaults vary according to the probe, application, and mode. Defaults have been chosen below the FDA limits for intended use.
Depth
An increase in the 2D-mode depth will automatically decrease the 2D-mode frame rate. This would decrease the TI. The system may also automatically choose a deeper 2D-mode focal depth. A change of focal depth may change the MI. The displayed MI is that of the zone with the largest peak intensity.
Application
Acoustic output defaults are set when you select an application. Samsung Medison's factory defaults vary with probe, application, and mode. Defaults have been chosen below the FDA limits for intended use.
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2.5.1.11. Related Guidance Documents
For more information on ultrasonic bioeffects and related topics, refer to the following:
Medical Ultrasound Safety (AIUM, 2014).
AIUM Consensus Report on Potential Bioeffects of Diagnostic Ultrasound: Executive
Summary, J. Ultrasound in Medicine, 2008, Vol. 27, Num. 4.
WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non-thermal Mechanisms for Biological Effects. Ultrasound in Med. & Biol; 1998, 24: Supplement 1.
Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993)
Guidelines for the safe use of diagnostic ultrasound equipment. (BMUS, 2009)
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers (U.S. FDA – 2008)
Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (IEC, 2007)
Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 2008)
Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment. (IEC, 2007)
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (AIUM / NEMA, 2004)
Ultrasonics - Field characterization -Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC, 2005)
Measurement and Characterization of Medical Ultrasonic Fields up to 40 MHz. (IEC, 2007)
Ultrasonics-Power Measurements- Radiation Force Balances and Performance
Requirements. (IEC, 2006)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM / NEMA, 2004)
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)23
.0(
alf
e
)069
.0( lf
e
2.5.1.12. Acoustic Output and Measurement
Since the first use of diagnostic ultrasound, the possible human biological effects (bioeffects) of ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its Bioeffects Committee (Bioeffect Considerations for the Safety of Diagnostic Ultrasound, J. Ultrasound Med., Sept. 1988: Vol.7, No. 9 Supplement), sometimes referred to as the Stowe Report, which reviewed available data on the possible effects of ultrasound exposure. Another report, “Bioeffects and Safety of Diagnostic Ultrasound” dated January 28, 1993, provides more up-to-date information. In addition, periodically updated reports on biological effects, results, and guidelines on safe use have been published by groups such as WFUMB (World Federation of Ultrasound in Medicine and Biology), AIUM, and BMUS.
The Acoustic output for this system has been measured and calculated in accordance with the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM / NEMA, 2004) and the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (AIUM / NEMA, 2004)
2.5.1.13. In Situ, De-rated, and Water Value Intensities
All intensity parameters are measured in water. Since water does not absorb acoustic energy, these water measurements represent the largest possible value. Biological tissue absorbs acoustic energy. The true value of intensity at any point depends on the amount and type of tissue and the frequency of the ultrasound that passes through the tissue. The intensity value in the tissue In Situ has been estimated using the following formula:
In Situ = Water [ ]
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 to measurement depth (cm)
f = Center frequency of the transducer/system/mode combination (MHz)
Since the ultrasonic path during an examination is likely to pass through varying lengths and types of tissue, it is difficult to estimate the true in situ intensity. A 0.3 de-rating factor is used for general reporting purposes. Therefore, the in situ value is commonly reported using the following formula:
In Situ (derated) = Water [ ]
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Since this value is not the true in situ intensity, the term “de-rated” is used. The maximum de­rated and maximum water values do not always occur under the same operating conditions. Therefore, the reported maximum water and de-rated values may not be related to the In Situ (de-rated) formula. For example, a multi-zone array transducer has the greatest water value intensities in its deepest zone. The same transducer may have its largest de-rated intensity in one of its shallowest focal zones.
2.5.1.14. Terms and Symbols Related to Acoustic Output and Measurement
The terms and symbols used in the acoustic output tables are defined in the following paragraphs:
A
-12dB OUTPUT BEAM AREA, ultrasonic beam area induced by -12dB
aprt
output beam size (unit: cm
d
at max. Ipi EQUIVALENT BEAM DIAMETER, the acoustic beam's diameter at the
eq
location where the PULSE-INTENSITY INTEGRAL is maximal, expressed as an equivalent beam area (unit: cm)
EQUIVALENT BEAM DIAMETER, the acoustic beam's diameter at Zb
d
eq(zb)
location, expressed as an equivalent beam area (unit: cm
2
)
2
)
Dim of Aaprt -12dB OUTPUT BEAM DIMENSIONS, the dimensions of an ultrasound
beam (whose pulse beam width is -12dB) from a specific direction that is perpendicular to the transducer output plane and the beam alignment axis (unit: cm)
ACOUSTIC WORKING FREQUENCY, the arithmetic average of f1 and f2
f
awf
that are farthest from each other among the frequencies of the pressure spectrum of the acoustic signal whose amplitudes are lower than the peak amplitude, i.e., maximum amplitude, by 3dB (unit: MHz)
Focal Length The focal length in a direction parallel to the beam alignment axis in the
defined operational state of the ultrasound system (unit: cm)
at max. MI
I
pa,α
(z)
I
ta, α
The average attenuated pulse strength at the location with maximum Mechanical Index (MI) (unit: W/cm
Attenuated average strength over time at a specific focal length (z) (unit: mW/cm
2
)
2
)
MI MECHANICAL INDEX, a variable representing potential cavitations within
the human body (unit: N/A)
P OUTPUT POWER, time average power of an ultrasonic transducer's
emissions into a free field through specified media such as water (unit: mW)
P
(z) ATTENUATED OUTPUT POWER, the power of ultrasonic output
α
calculated at a specific distance from the transducer after attenuation occurs (unit: mW)
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P
ATTENUATED PEAK-RAREFACTIONAL ACOUSTIC PRESSURE, the
r,α
peak rarefactional acoustic pressure calculated at a specific distance after attenuation occurs (unit: MPa)
at max. I
P
r
pi
The peak rarefactional acoustic pressure at the location where PULSE­INTENSITY INTEGRAL is maximal (unit: MPa)
prr PULSE REPETITION RATE, the inverse number of the time interval
between two contiguous acoustic pulses (unit: Hz)
TIB BONE THERMAL INDEX, a thermal index for a focal zone formed near a
bone after the ultrasound beam passes through soft tissue, e.g. applied to a fetus (in the 2nd or 3rd trimester) or to the head of a neonate (through the fontanel) (unit: N/A)
TIC CRANIAL BONE THERMAL INDEX, a thermal index for an ultrasound
beam entering the body and passing through a bone, e.g. the skull of children or adults (unit: N/A)
Soft tissue thermal index in scanning mode (unit: N/A)
TIS
scan
TIS
t
PULSE DURATION (unit: us)
d
z_at_max_Ipi,
z
b
Soft tissue thermal index in non-scanning mode (unit: N/A)
non-scan
Location with maximum PULSE-INTENSITY INTEGRAL (unit: cm)
α
DEPTH FOR BONE THERMAL INDEX (unit: cm)
z
BREAK-POINT DEPTH, which is the EQUIVALENT APERTURE
bp
DIAMETER multiplied by 1.5 (unit: cm)
z
DEPTH FOR SOFT-TISSUE THERMAL INDEX, distance from a plane
s
where the product of minimum attenuated output power, ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY, and 1 cm at the distance range that is equal to or greater than the equivalent aperture diameter multiplied by 1.5, when the beam dimension of -12dB output is defined along the beam alignment axis (unit: cm)
2
maximum
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2.5.1.15. Acoustic Measurement Precision and Uncertainty
The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below.
Quantity Precision Total Uncertainty
Ipi,α (attenuated pulse intensity
integral)
3.2% +21% to -24%
P (acoustic power) 6.2% ±19%
P
(attenuated rarefaction pressure) 5.4% ±15%
r,α
f
(acoustic working frequency) < 1% ±4.5%
awf
Systematic Uncertainties
For the pulse intensity integral, de-rated rarefaction pressure (Pr.3), center frequency, and pulse duration, the analysis includes considerations of the effects on accuracy of:
Hydrophone calibration drift or errors.
Hydrophone / Amp frequency response.
Spatial averaging.
Alignment errors.
Voltage measurement accuracy, including.
– Oscilloscope vertical accuracy.
– Oscilloscope offset accuracy.
– Oscilloscope clock accuracy.
– Oscilloscope Digitization rates.
– Noise.
The acoustic power is measured using a Radiation Force for systematic uncertainties through the use of calibrated NIST acoustic power sources.
We also refer to a September 1993 analysis conducted by the working group of the IEC technical committee 87 and prepared by K. Beissner as the first supplement to IEC publication 1161.
The document includes analysis and discussion of the sources of error/measurement effects due to:
– 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).
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– Target imperfections.
– Absorbing (reflecting ) target geometry and finite target size.
– Target misalignment.
– Ultrasonic transducer misalignment.
– Water temperature.
– Ultrasonic attenuation and acoustic streaming.
– Coupling or shielding foil properties.
– Plane-wave assumption.
– Environmental influences.
– Excitation voltage measurement.
– Ultrasonic transducer temperature.
– Effects due to nonlinear propagation and saturation loss.
2.5.1.16. Training
The users of this ultrasound system must familiarize themselves with the ultrasound system to optimize the performance of the device and to detect possible malfunctions. It is recommended that all users receive proper training before using the device. You can receive training on the use of the product from Samsung Medison's service department or any of the customer support centers worldwide.
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2.6. Protecting the Environment

You must consult the manufacturer or follow a proper procedure for disposal to
dispose safely of the system and/or peripherals that have reached the end of their service life
You are responsible for complying with the relevant regulations for disposing of
CAUTION
wastes.
The lithium ion battery used in the product must be replaced by a Samsung Medison
service engineer or an authorized dealer.
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Chapter 3

3. Installing Product

Chapter 3. Installing Product

Installing Product

3.1. Transporting ............................................................................................... 2
3.1.1. Caution on Transporting ........................................................................................... 2
3.1.2. Brake ......................................................................................................................... 2
3.1.3. Precautions on Ramps ............................................................................................. 2
3.1.4. Humidity and Temperature ........................................................................................ 3
3.2. Unpacking the Product .............................................................................. 4
3.2.1. Dismantling the Product Box .................................................................................... 4
3.2.2. Accessories ............................................................................................................... 5
3.2.3. Release of the Locking Mechanism .......................................................................... 5
3.3. Installation Environment ........................................................................... 6
3.3.1. Caution ...................................................................................................................... 6
3.4. Installing the Product ................................................................................ 7
3.4.1. Installation Safety...................................................................................................... 7
3.4.2. Connecting Peripherals ............................................................................................ 9
3.5. System Power ........................................................................................... 12
3.5.1. Turning the Power On ............................................................................................. 12
3.5.2. Shutting down the System ...................................................................................... 12
3.6. System Settings ....................................................................................... 13
3.6.1. ECG Setup .............................................................................................................. 14
3.6.2. General System Settings ........................................................................................ 16
3.6.3. Customize ............................................................................................................... 24
3.6.4. Peripherals .............................................................................................................. 26
3.6.5. Connectivity ............................................................................................................ 28
3.6.6. Service .................................................................................................................... 41
3.6.7. Help ......................................................................................................................... 41
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WARNING
The product weighs more than 100kg. Be extra careful when transporting it. Careless trans
WARNING
Mind the castors especially when moving the system. Samsung Medison recommends exercising caution when moving the product up or down ramps.

3.1. Transporting

This product is a finely tuned piece of medical electronic equipment; careful attention is required when transporting it.
3.1.1. Caution on Transporting
This product and its package box are designed to protect the product from physical impacts. Note, however, that dropping and external impact may cause serious damage to the product.
Before transporting the product, check whether the wheel brakes are unlocked. In addition, be sure to retract the monitor arm completely so that it is secured in a stationary position.
Always use the handles at the back of the console and move the product slowly.
3.1.2. Brake
To control the movement of the product, you can use the brakes. The brakes are placed on the center of the console pedal; you can use the pedal to control the wheels simultaneously. To lock the brakes, press the front part of the brake with your foot. To unlock the brakes, press the back of the pedal.
We recommend locking the brakes when using the product.
3.1.3. Precautions on Ramps
Always make sure that the control panel is facing the direction of movement. If you leave the product on an incline, the product may fall over even if the brakes are engaged. Do not leave the product on ramps.
portation of the product may result in product damage or personal injury.
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Chapter 3. Installing Product 3 - 3
3.1.4. Humidity and Temperature
[Table 3-1. Product's Humidity and Temperature Tolerance] below presents the temperature and humidity ranges for transporting, storing, and operating the product.
Category Temperature °C Humidity %
Transporting -25 – 60 20 – 90
Storage -10 – 50 20 – 90
Operating 10 – 35 30 – 75
[Table 3.1. Product’s Humidity and Temperature Tolerance]
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3.2. Unpacking the Product

3.2.1. Dismantling the Product Box
1. Open the box.
2. Remove the protective cover.
3. Take out the probe box and accessory box and store them in a safe place.
4. Unlock the brakes on wheels.
5. Grab the rear handle on the product and move it to the installation site.
[Figure 3.1 Dismantling the Product Box]
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Chapter 3. Installing Product 3 - 5
3.2.2. Accessories
An accessory box containing the items below is supplied with the product. If it is not consistent with your order, contact Samsung Medison's customer service department or your local vendor.
3.2.3. Release of the Locking Mechanism
When this product is being transported, the monitor arm is secured in place with the locking mechanism to ensure safety. Release the locking mechanism based on the following procedure before using the product:
1. Pull down the locking mechanism on the center of the monitor arm to release the lock.
[Figure 3.2 Release of the Locking Mechanism]
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CAUTION
Placing the system near generators, X screen noise and abnormal visual images.
Sharing the power source with other electrical devices may also induce noise.

3.3. Installation Environment

3.3.1. Caution
When installing the product, pay attention to the following: For more information on use and setup, refer to the accompanying manual for this product.
-ray machines, or broadcast cables may result in
Optimal conditions for the system are temperature of 10-35° and humidity of 30-75%.
Avoid excess humidity.
Avoid direct sunlight.
Avoid excessive fluctuations in temperature.
Avoid installing the product near a heating appliance.
Avoid dusty and/or poorly ventilated locations.
Avoid locations that are subject to vibration.
Avoid locations where chemical substances or harmful gases are present.
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Chapter 3. Installing Product 3 - 7
The product may be shipped with the power cable connected to the console.
CAUTION

3.4. Installing the Product

3.4.1. Installation Safety
The power receptacle and equipotential terminal are located at the back of the product.
[Figure 3.3 Power Receptacle and Equipotential Terminal]
① Power inlet: Accepts the power cord, which connects to an external power supply.
Equipotential terminal: This should be connected to the equipotential connection part in the
exam room.
3.4.1.1. Power Cord Connection
Prior to connecting a power cord, verify that the voltage indicated on the power cord matches the voltage rating of the installation site.
NOTE
If the product needs to be transported or stored for an extended duration, the
temperature and humidity of the environment must be checked.
A sudden change in temperature may cause condensation and lead to product failure.
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Refer to “[Table 3-2. Operational Temperature of the Product]” before turning the product on.
Temperature °C -20 -15 -10 -5 0 5 10 – 35 45 50 55 60
Waiting time Hour
16 10 8 6 4 2
[Table 3.2 Operational Temperature of the Product]
Use
immediately
2 4 6 10
3.4.1.2. Connecting the Equipotential Terminal
In a hospital environment, dangerous electric current may occur as a result of the potential difference between a contactable conductive part and the connected equipment in treatment rooms. The solution to the problem is consistent equipotential bonding. The equipotential terminal of an item of medical equipment must be connected to the equipotential bonding network in a treatment room, as shown in the figure below.
3.4.1.3. Probe Connection
Be sure to turn off power before connecting or disconnecting a probe to ensure the safety of the system and the probes.
1. Connect probes to the probe connectors on the front panel of the system. Up to four (five including CW) probes may be connected. The CW probe should be connected only to its own connector.
2. To install, turn the connector turning handle clockwise.
[Figure 3.4 Probe Connector]
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For more information on the recommende Installing Product
3.4.2. Connecting Peripherals
Do not install peripheral devices other than those listed in this Service Manual within
the patient environment. Installing an unlisted device in the patient environment may pose an electrical hazard.
CAUTION
Do not connect additional external peripheral devices to the auxiliary socket outlet.
Doing so may decrease the safety level.
Chapter 3. Installing Product 3 - 9
[Figure 3.5 Patient Environment]
d peripheral devices, refer to ‘Chapter 3.
.’
NOTE
3.4.2.1. Internal Peripheral Devices
These are peripheral devices mounted in the system.
DVD-Multi
DVD-RW, DVD+RW, DVD-R, DVD+R, CD-R, CD-RW, CD-ROM
Solid State Device
Min. 64Gbytes SATA SSD
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CAUTION
When connecting/disconnecting the device. Connecting or disconnecting a USB device while power is turned on may cause the system and/or the USB device to malfunction.
• You must install a printer and a driver compatible with the English version of Microsoft
• Check the port used by the printer before connecting. Printers should be connected to
3.4.2.2. External Peripheral Devices
These are peripheral devices that can be connected for use when needed and are connected via the USB port located at the rear panel.
using a peripheral device via a USB port, always turn power off before
When removing the removable disk, use Utility > Storage manager.
USB ports are located on both the console and its rear panel.
We recommend that you connect USB storage devices (flash memory media, etc.) to
NOTE
USB Video Printer
The following products are recommended:
the ports on the console and other USB peripheral devices to the rear panel for convenience.
BW: Mitsubishi P-95DE (Japan: Mitsubishi P95D), Sony UP-D897, Sony UP-X898MD,
Samsung ML-2955DW, Sony UP-D898MD
Color: Mitsubishi CP-30DW, Sony UP-D25MD, Samsung CLP-615ND
Windows 7. Contact Samsung Medison's customer service department for inquiries about printer driver installation.
CAUTION
When connecting the printer, make sure that the printer is configured under Microsoft
Windows or system setup and has been chosen as the default printer.
the printer port; the USB printer should be connected to the USB port.
USB to RS-232C Serial Cable
Foot Switch
WLAN Card
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• The system cannot recognize USB 1.1 flash memory. Remove the flash memory from
virus programs or which are defective.
Others
Flash Memory Media
NOTE
Chapter 3. Installing Product 3 - 11
the console and mount again with an appropriate device.
When using a flash memory device that supports functions other than saving files,
check first if it is possible to save the file on a desktop PC.
Do not use flash memory media containing anti-
Otherwise, the product may fail to work properly.
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CAUTION
Be sure to connect the probes and peripheral devices that will be used before powering on the system. If you attempt to connect them during system use, it may lead to patient injury or
CAUTION
Before
button for five seconds or
• To ensure that electrical power is safely cut off, set the power switch at the rear of the

3.5. System Power

Boot up the system for use.
irreparable damage to the console.
3.5.1. Turning the Power On
Press the On/Off button when the power is off. Booting begins, and the product logo appears on the screen. When booting is completed, the 2D mode screen appears in End Exam state.
starting the diagnosis, you must register the patient information.
If the power switch near the power connection port on the rear panel of the product
has been switched off, wait for 10 seconds before turning on the product.
Do not press keyboard keys or buttons while booting is in progress. Doing so may
NOTE
cause the system to malfunction.
If you turn on power after turning it off abruptly, the system may turn on and off
momentarily. This is a feature of the built-in Intel PC Main Board of the product and is not a system error.
3.5.2. Shutting down the System
Press the On/Off button while using the system to initiate shutdown. Click Shut Down on the screen to shut down the system or Cancel to cancel.
When the system is not turned off, holding down the On/Off
longer forces the product to power off.
If the ultrasound system is unplugged while working or turned off by forcibly shutting
CAUTION
down, files may get corrupted, and such may result in system down or data loss.
product to Off position after using the product.
Press the On/Off button twice to turn off the system. The Select Next Operation
window appears when you press the On/Off button once. The system will turn off if you press it again.
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Chapter 3. Installing Product 3 - 13

3.6. System Settings

This mode is used for system settings. It does not affect image output. The setup may be modified depending on specific needs or preferences.
1. Tap the button on the touch screen or press the Setup button on the keyboard.
2. The Setup screen will appear on the monitor and the touch screen. Select a tab that contains items you want to specify.
TIP
3. Specify the settings for each item.
4. Save the settings and exit. Click Exit on the monitor screen, tap Exit on the touch screen, or
Selecting a tab
You can select a desired tab in one of two ways. Select the method that suits you.
Use the trackball and the Set button to select a tab.
Tap the corresponding button on the touch screen.
press the Exit button on the control panel to switch to Scan Mode.
[Figure 3.6 Setup – Touch Screen]
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You may show or hide the ECG on the screen for each Preset at Setup > Application/Preset > Preset Setting.
3.6.1. ECG Setup
If an ECG is installed, the ECG tab will be displayed on the touch screen. In Multi-Image Mode such as Dual or Quad, ECG Cine can be used for each image.
NOTE
3.6.1.1. Starting and Terminating an ECG
Tap the ECG button in the touch screen menu to turn the function on or off.
3.6.1.2. ECG Setup
Sweep Speed
Tap the Sweep Speed button in the touch screen menu to select the ECG display speed. You may select 15mm/s, 29mm/s, 44mm/s, 59mm/s, 88mm/s, or 117mm/s.
Invert
Tap the Invert button in the touch screen menu to turn ECG Invert on or off.
Gain
Adjust the amplitude of the ECG. Rotate the Soft Menu dial-button 1 to adjust the gain between 0-100.
Position
Rotating the Soft Menu dial-button 2 changes the display position of the ECG signal. You may select a position between 0-10; selecting a higher value will position the ECG higher on the screen.
Clip
Rotate the Soft Menu dial-button 3 to select the interval for saving the clip. You can select either Time or Beat.
Trigger
Tap the Trigger button on the touch screen menu to set up Trigger. You can rotate the Soft Menu dial-button 4 to select a number of ECG Triggers between 1 and 7.
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Chapter 3. Installing Product 3 - 15
CAUTION
• In CW Mode, when the ECG is active, the error ratio of the Heart Rate (HR) should be
Trig Delay
Select the time delay between the R-wave and the frame containing the trigger, which will be applied to the Trigger function. Rotate the dial-button 4 to select a value between 0 and 3,000msec.
Dual Trigger
Tap the Dual Trigger button in the touch screen menu to turn Dual Trigger on or off.
Dual Trig Delay
Select the time delay between the frame containing the first trigger and the frame containing the second trigger, which will be applied to the Dual Trigger function. Rotate the dial-button 4 to select a value between 6 and 3,000 msec.
If the ECG is less than 30Hz, the Heart Rate (HR) may not be displayed.
within 2%.
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3.6.2. General System Settings
On the Setup screen, select the System tab. Or, tap System on the touch screen. From this tab, you can configure the general system settings.
3.6.2.1. General
On the Setup screen, select the General tab in the System category.
[Figure 3.7 Setup - System - General]
1. Location
You can specify the information that is displayed in the title area on the screen.
Institute
Enter the name of the hospital/institution where the product is installed. Special characters can be entered.
Language
Select the system language. (Supported languages: English, German, French, Spanish, Italian, Russian, Simplified Chinese, Portuguese)
2. Date and Time
Set the date and time for use in the system.
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Chapter 3. Installing Product 3 - 17
• Make sure to set the date and time to the time zone in which the system is installed. If
End
Before starting diagnosis, confirm the time, date, and time zone and modify the
settings if necessary.
CAUTION
it is not set, the date and time can be automatically synchronized to the time zone of the country of the manufacturer.
You cannot change the date and time when a patient ID has been registered. To
change the date and time, you should finish the current diagnosis by pressing the
Exam button on the control panel.
NOTE
When the system time and date are changed, the change is not reflected on the time
and date indicated in previous diagnosis results.
Date Format
Specify the date format. Select a date format using the combo button. The date format that you specify will be applied to various date fields in Patient Information.
Time Format
Specify the time format. Press the combo button to select the preferred display format (12 Hour or 24 Hour).
Date and Time
Select settings for date and time. Press the button to display the Date and Time window.
Set the date and time by using the trackball and the Set button on the control panel.
Press Saveto apply the settings. Tap Cancel or press Exit button on the control panel
to cancel.
Time Zone
Specify the local time zone where the system is used. When you press this button, the Time Zone Settings window appears.
① Press Time Zone.
Specify the time zone by using the trackball and the Set button for the combo button.
Press OK to apply the settings. Click Cancel to cancel.
3. Trackball Speed
Scan Mode
Specify the trackball speed in Scanning Mode as Slow, Normal, or Fast.
Measurement
Used to specify the trackball’s speed during measurement. Select Slow, Normal, or Fast.
Slower speeds allow more precise measurements.
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4. Video
Format
Select either NTSC or PAL.
5. Beep Sound
Touch Screen
Set the sound level when using the touch screen. Set this to on or off using the trackball.
Control Panel
Set the sound level when using buttons and dial-buttons in the control panel. You can turn it on or off using the trackball.
In particular, for Set/Exit, Freeze, Save, and Other buttons and dial-buttons, you can turn it on or off.
6. Account
Register a user ID and a password.
User Log-in
Set the user account (login) function. If user login is set to on, it can be used for the following areas:
Screen Saver
– Accessing SonoView/Patient
Search window for Patient
User Account Manager
This is the exclusive administrator function for the approval and management of accounts. The Account List window will be enabled.
– Create: Fill out the User ID, Password, and Name fields. Then click the OK button to
create a new ID.
– Change Password: Change password.
– Delete: Delete the selected ID.
– Close: Close the settings.
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Log-in
Chapter 3. Installing Product 3 - 19
[Figure 3.8 Setup – User Account Manager]
You can set a User Account ID after logging in to the Admin account. Please contact the service engineer to learn how to reset user account information including the Admin account.
The Admin account can be configured when you run “User Account Manager” at
Setup for the first time.
The Admin account cannot be deleted.
NOTE
Once the user account function is activated, you cannot load exams without logging
in.
The password must be 8 to 16 characters and composed of at least three of the
following:
English alphabet upper case
English alphabet lower case
Numbers
Special characters
Log-out
Close the Admin account.
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3.6.2.2. Display
On the Setup screen, select the Display tab in the System category.
Configure the settings for displaying images.
[Figure 3.9 Setup – System – Display]
1. Display
System Logo
Choose SAMSUNG or HS60/ HS50.
Direction Marker
Set the Direction Marker. Among SAMSUNG HS60, HS60, and S Marker, select a desirable shape.
Screen Saver
Select the waiting time (in minutes) for the screen saver. Use the trackball to set it off or to 5, 10, 30, or 60 minutes.
System Power Button
– Ask me what to do: Set a message to recheck the Off status when it is shut down.
– Shut Down: Power will turn off.
Option
– Auto Freeze: Automatically switch to freeze state. Set the freeze time between 0 and
60 minutes.
– Prompt for Save on Exit: Use the checkbox to select whether to save or not.
– Check On: Set a message to recheck whether to save the changes when closing the
setup.
– Check Off: Set it to automatically save changes when closing the setup.
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Chapter 3. Installing Product 3 - 21
– Boot up Caps Lock On: When the checkbox is selected, Caps Lock is turned on after
completing system booting.
Touch Screen Brightness
By using the trackball, adjust the brightness of the touch screen between 0 and 100 in units of 10. Adjust it by pressing the - and + buttons.
3.6.2.3. Patient
On the Setup screen, select the Patient tab in the System category.
[Figure 3.10 Setup – System – Patient]
1. Patient Data
Name Display
– Last, First Middle: Display the name of the patient in order of last name, first name,
and then middle name.
– First Last Middle: Display the name of the patient in order of first name, last name, and
then middle name.
Title Display
Show or hide patient information in the Title area of the screen.
– None: Patient information is not displayed.
– Date of Birth: Displays the patient's date of birth.
– Age: Displays the patient's age.
– Gender: Select this checkbox to display the patient's gender.
Note that the patient's gender can only be displayed if the patient's date of birth or age is also displayed.
Title LMP/GA/EDD Display
– LMP/GA: The last menstruation date and estimated gestation weeks are shown on the
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screen.
– EDD/GA: The expected delivery date and estimated gestation weeks are shown on
the screen.
Save Patent Page as First Image
If On is checked, Patient information is saved as the first image.
Other ID
When a Patient record is created, a GUI for text input is displayed for you to enter the Other ID.
– Other ID Format: Any Numbers, Letters and Numbers, and NHS Numbers are
available. Except Any, inputs in each format type can only be entered as text.
2. User Defined List
You ca n enter information related to studies beforehand, so that you can assign the information easily when entering patient information. Use the Change, Delete All, Delete, Up, and Down buttons to add, edit, or delete information; you may create a list of up to 20 for each item.
• Operator: You can save the name of the operator who scans the patient.
• Diag. Physician: You can save the name of the physician who diagnosed the patient.
Ref. Physician: You can save the name of the referring physician.
Indication: You can save information on the patient's medical history.
• Description: You can save up to 20 diagnostic memos per application.
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Chapter 3. Installing Product 3 - 23
3.6.2.4. Quick Preset
On the Setup screen, select the Quick Preset tab in the System category.
[Figure 3.11 Setup – System – Quick Preset]
1. Quick Preset
After selecting the Probe, Application, and Preset connected to the port, save them to Quick Preset. Up to 4 sets can be saved. By using Preview, you can preview the saved preset.
In diagnosis mode, the saved Probe and Preset are shown as a button on the touch
screen.
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3.6.3. Customize
3.6.3.1. Buttons
On the Setup screen, select the Buttons tab in the Customize category. You can set the functions of the keys and buttons on the product.
[Figure 3.12 Setup – Customize – Buttons]
1. Set/Exit Key
Select the functions to assign to the buttons on the left and right sides of the trackball on the control panel.
– Set/Set: Both left and right buttons are set to the Set function.
– Set/Exit: The left button is set to Set, and the right button is set to Exit.
– Exit/Set: The left button is set to Exit, and the right button is set to Set.
2. Pointer
Select Pointer or Arrow.
3. End Exam
End Exam + Patient
Pressing the End Exam button on the control panel switches the screen to the Patient Information screen.
End Exam Only
Pressing the End Exam button on the control panel closes the exam and switches the screen to B mode Scan screen.
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Chapter 3. Installing Product 3 - 25
4. Clip Store Type
Retrospective
Click the Save button to save currently open images.
Prospective
When saving images, images that appear after the button is pressed are saved.
5. Clip Store Method
Clip Length (sec)
Specify the length of the image to save. Select one of 2, 4, 6, 8, 10, 20, 30, 60, 120, 240, and 360 seconds.
Number of heart cycles
Specify the number of Heart Cycles to be included in the image.
Time before heart cycle (ms)
Specify the time to be included before a Heart Cycle begins from 1 to 10 hours.
Time after heart cycle (ms)
Specify the time to be included before a Heart Cycle is completed.
6. Foot Switch
Assign functions to the Foot Switch's left, middle, and right pedals. The functions you can assign are as follows:
Exit, Freeze, U1, U2, U3, U4, U5, U6, Update, Single, and Quad.
7. User Key
• Assign functions to the U1, U2, U3, U4, U5, and U6 buttons on the control panel.
• The functions you can assign are as follows:
U1, U2, U3, U4, U5, U6
Patient Quad Arrow
Exit Dual Live Pointer
TGC Biopsy Probe Change
Q scan Simultaneous TDI
Harmonic EFW Measure TDW
Single EFW Result Store/Print
– When Store/Print is set, additional functions for Store (Single, Clip) and Print can be
set.
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A printing job can be canceled only if the image data to print has not been completely sent to the printer.
3.6.4. Peripherals
Select the Peripherals tab on the Setup screen. Or, tap Peripherals on the touch screen. You can configure keys, buttons, and peripheral devices connected to the product.
3.6.4.1. Peripherals
On the Setup screen, select the Peripherals tab in the Peripherals category.
You can configure the peripheral devices connected to the product.
[Figure 3.13 Setup – Peripherals – Peripherals]
1. Printer
Printer Settings
Select the printer to use by using the combo button. To remove a printer that is no longer used, select the printer and press the Remove button.
Clear Printer Queue
Choose whether to cancel a work of the printer while an image is being printed. Use the combo button to select a printer that is printing an image. Press the Clear Print Queue button to cancel the printing job.
– Select All Printers
Select this checkbox to cancel the printing jobs of all the connected printers.
NOTE
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