HS50-HS60-Service-Manual-English

[Page 1] HS50/HS60 Service Manual

[Page 2] (Empty page)

[Page 3] Version 1.00 HS50A/HS60A Service Manual English SM-HS50A/HS60A-KOR-01

[Page 4] (Empty page)

[Page 5] 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]

[Page 6] – 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.

[Page 7] 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:

[Page 8] Disregarding this instruction may result in death, serious injury, or other dangerous situations. DANGER Follow these instructions to prevent serious accidents or damage to property. Follow these instructions to prevent minor accidents or damage to property. A piece of information useful for installing, operating, and maintaining a system; not related to any hazard.

[Page 9] Revision History The revision history of this service manual is as follows: Version DATE 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.

[Page 10] 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.

[Page 11] Request for Repairs and Patient Privacy Agreement Date: MM/DD/YY 【 Customer Information 】 Hospital Handler 【 Product Information 】 Product name Software version S/N Symptom □ None □ Main unit □ HDD □ DVD/CD Stored item □ USB □ Photo □ Other ( ) □ None Outsourced product □ Provide details if applicable ( ) 【 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 】

[Page 12] I entrust my product to ( ) for repair and agree to the policies above. Date: MM/DD/YY Name: (Signature)

[Page 13] Table of Contents 1 Table of Contents 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 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 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

[Page 14] 2 HS50/HS60 Service Manual 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 4.1. Inspecting the Functions 2 4.1.1. Basic Inspections 2 4.1.2. Detailed Inspections 3 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 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

[Page 15] Table of Contents 3 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 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 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

[Page 16] 4 HS50/HS60 Service Manual 6.9. Entering the Installation Key 18 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 8.1. Power Issues 2 8.1.1. Preparation 2 8.2. Disassembling the Product 3 8.2.1. Rear Side Disassembly 3 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 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

[Page 17] Table of Contents 5 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 Maintena n ce 8 10.3.1. User Settings Backup 8 10.3.2. Backing Up Patient Information 8 10.3.3. Software 8 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

[Page 18] 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

[Page 19] 1 - 2 HS50/HS60 Service Manual 1.1. Product Specifications Height: 1344 mm (with Monitor) Width: 529 mm Physical Depth: 767 mm (with Keyboard) Dimensions 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 Imaging Modes 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 256 (8 bits) Transmit focusing, maximum of eight points (four points simultaneously Focusing 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 Probes ER4-9, EA2-11B (Type BF/IPX7) Phased Array PA1-5A, PA3-8B, PE2-4 3D CV1-8AD, V5-9 CW CW6.0, DP2B

[Page 20] Chapter 1. Introduction 1 - 3 • HS50 does not support LA2-9A and LA3-16AI, EA2-11B, LA4-18BD, PA1-5A. • HS60 does not support PE2-4 and ER4-9. 3 Probe Connectors, 4 Probe Connectors for option HS50 HS60 Probe 3 PORT O X Connections NOTE 4 PORT O (Option) O 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”) Monitor Touch Screen Monitor Number of Pixel: 1280 x 800 10.1 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD monitor”) ECG USB Type (Type CF) Audio Output Port (Right/Left) Rear Panel VGA monitor Input/Output LAN Connections USB Port HDMI output Maximum 45,000 frames for Cine memory Image Storage Maximum 14,000 Lines for Loop memory Image filing system Obstetrics, Gynecology, Urology, Abdomen, Cardiac, Vascular, Small Application Parts, TCD, MSK, Pediatric Electrical 100-240VAC, 800VA, 50/60Hz Parameters Abdomen, Obstetrics, Gynecology, MSK, Pediatric, Small Parts, Urology, Measurement Vascular, Cardiac, Fetal Heart Packages * For additional information, refer to the ‘Chapter 8. Measurements and Calculations’ in the user manual.

[Page 21] 1 - 4 HS50/HS60 Service Manual Acoustic Power Control Signal Processing Dynamic Aperture Control (Pre- Dynamic Apodization Control processing) Dynamic LPF Control Digital TGC Control Slider TGC Control Mode-Independent Gain Control Black Hole/Noise Spike Filtering Signal 1D Lateral/Axial Filtering Processing 2D Edge/Blurring Filtering (Post- processing) 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 Measurement approximation or trace M mode: Continuous readout of distance, time, and slope rate Doppler mode: Velocity and trace DVD Multi-Drive Digital B/W Video Printer Digital Color Video Printer USB Printer DVD Recorder Auxiliary Foot switch (IPX8) USB Flash Memory Media USB HDD USB ECG Monitor User Interface English, German, French, Spanish, Italian, Portuguese Operating: 700 – 1060hPa Pressure Limits Storage: 700 – 1060hPa Operating: 30 – 75% Humidity Limits Storage & Shipping: 20 – 90% Temperature Operating: 10 – 35°C Limits Storage & Shipping: -25 – 60°C

[Page 22] Chapter 1. Introduction 1 - 5 1.2. Product Configuration This product consists of monitor, control panel, console, peripheral devices and probes. ① Monitor ② Monitor arm ③ Keyboard ④ Control panel ⑤ Lift ⑥ Probe holder ⑦ DVD drive ⑧ USB port ⑨ Speaker ⑩ Probe port ⑪ Wheel ⑫ Location of ID Label ⑬ Brake ⑭ Gel warmer ⑮ Internal peripheral devices outlet [Figure 1.1 Front of the Product]

[Page 23] 1 - 6 HS50/HS60 Service Manual ① Handle ② Storage compartments ③ Ventilation ④ Rear panel ⑤ Power connection part ⑥ ID label [Figure 1.2 Back of the Product]

[Page 24] 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] ① Title Area Displays patient information, hospital name, application, frame rate, depth, probe information, acoustic output information, and the current date and time. ② Image Area Displays ultrasound images. Image information, annotation, and measurement information are also displayed. ③ 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. ④ 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. ⑤ 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.

[Page 25] 1 - 8 HS50/HS60 Service Manual For information on User Key Setup, please refer to ‘Chapter 3. Utilities’ in the user manual. 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.

[Page 26] Chapter 1. Introduction 1 - 9 1.2.2. Control Panel The system can be controlled by using the control panel. [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.

[Page 27] 1 - 10 HS50/HS60 Service Manual 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 Finishes the exam of the currently selected patient and resets the related data. End Exam Button Displays the screen for viewing and managing stored images. SonoView Displays the Report screen that shows the measurement results of the current application and other information. Report When you press the dial-button, the menu items that are available in the current scan mode are shown on screen. Dial- Rotating the Menu dial-button to the right selects the menu one button row above the current menu selected, and rotating it to the left selects the menu one row below. – Marker: Allows the user to enter a BodyMarker over an Dial- image. button – Ref: Moves the reference slice horizontally in 3D View. Adjusts the angle of the sample volume in Spectral Doppler Dial- mode. It is also used to adjust the Arrow’s angle or the probe button angle for a BodyMarker. Button In this mode, only the image is displayed on the screen. Button Compares four independent images.

[Page 28] Chapter 1. Introduction 1 - 11 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- Makes the Zoom Box appear. button 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 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. Dial- Also, turning this dial-button when in 3D View rotates the button image along the x-axis. Press this button to start/stop PW Spectral Doppler mode. Dial- Rotate this dial-button to adjust Gain. button Also, turning this dial-button, when in 3D View rotates the image along the y-axis.

[Page 29] 1 - 12 HS50/HS60 Service Manual Press this button to start/stop Color Doppler mode. Rotate this Dial- dial-button to adjust Gain. button Also, turning this dial-button when in 3D View rotates the image along the z-axis. Button Press this button to start/stop Power Doppler mode. Press this button to start/stop CW Spectral Doppler mode. Available only with the phased array probe. Dial- Press this button to start 2D mode. Rotate this dial-button to button 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 Set/Exit to change the function of the trackball. – Exit: Exits the function currently being used and returns to the previous state. Deletes text, Arrow, BodyMarker, measurement results, etc. displayed on an image. Clear When this is pressed, an arrow marker appears to point to parts of the displayed image. Pointer Button Changes the current trackball function. Change Button Allows the user to place text on an image. Button Starts measurements by application. Calculator Moves the cursor on the screen. Also scrolls through Cine Trackball images. Trackball

[Page 30] Chapter 1. Introduction 1 - 13 ■ Keyboard The keyboard is used to type in text. [Figure 1.5 Keyboard] Help Displays the Help Manual on the screen. 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.

[Page 31] 1 - 14 HS50/HS60 Service Manual 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 dial- button. ■ Touch Screen Layout [Figure 1.6 Touch Screen Display] ① 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. The Patient Information screen will appear, where you can select a Patient Patient ID in the list or enter new patient information. It displays the Probe Selection screen where you can select and Probe modify the probe and application. Quick It shows up to 4 Preset buttons configured at Setup. Preset 1–4 The general system settings that do not have a direct bearing on Setup imaging are explained below.

[Page 32] Chapter 1. Introduction 1 - 15 For further details about setting up Quick Preset, please refer to ‘Setup > System > Quick Preset’ in ‘Chapter 3. Utilities’ in the user manual. ② Displays the mode that is currently used. ③ 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. Too great a difference in the gain value settings of adjacent TGC sliders may cause stripes in an image. ④ 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. ⑤ 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.

[Page 33] 1 - 16 HS50/HS60 Service Manual 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. ① HDMI port (Output): Outputs digital signals to the monitor. (Input: Not supported.) ② USB port: Used to connect to peripheral USB devices. ③ Audio Port (Output): Outputs audio signal. (Input: Not supported.) ④ Network port: Connect to a network. You can transfer patient information to another server via DICOM network. ⑤ R.G.B Port (Output): Provides analog signal output to be displayed on the monitor. ⑥ S-VHS Port (Output): Provides an S-VHS connection for a VCR. [Figure 1.7 Rear Panel] ⑦ Microphone port (Input): Connects a microphone.

[Page 34] 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. ① Power switch/breaker: Turns on the power of the product, and cuts off power if overcurrent or overvoltage occurs. ② Power inlet: Accepts the power cord, which connects to an external power supply. ③ Equipotential Terminal: This should be connected to the equipotential connection part in the exam room. [Figure 1.8 Power Connection Part]

[Page 35] 1 - 18 HS50/HS60 Service Manual 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.

[Page 36] Chapter 1. Introduction 1 - 19 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. CAUTION Doing so may decrease safety level. [Figure 1.10 Patient Environment] Refer to the user manual of the peripheral device for its operating information. 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

[Page 37] 1 - 20 HS50/HS60 Service Manual 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. 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 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

[Page 38] Chapter 1. Introduction 1 - 21 • The system cannot recognize USB 1.1 flash memory. Remove the flash memory from 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. For information on probes, refer to ‘Chapter 9. Probes’ and the Reference Manual.

[Page 39] 1 - 22 HS50/HS60 Service Manual 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. If the probe does not connect properly, try reconnecting it after removing any foreign objects. [Figure 1.11 Probe Connector]

[Page 40] Chapter 1. Introduction 1 - 23 1.2.6. Accessories An accessory box containing the items below is supplied with the product. Accessories can be different according to the country. [Figure 1.12 Accessories]

[Page 41] 1 - 24 HS50/HS60 Service Manual 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 42] 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

[Page 43] 2 - 2 HS50/HS60 Service Manual 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: For detailed information on applications and presets, refer to “Chapter 1. Introduction” and “Chapter 9. Probes” in this manual. 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. For information on the use or clinical application of this product, refer to “Chapter 6. Starting Diagnosis” and “Chapter 7. Diagnosis Mode” in the user manual.

[Page 44] 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. 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

[Page 45] 2 - 4 HS50/HS60 Service Manual Power on Power off Product is partially powered on Power off for part of the product AC (alternating current) voltage source V~ 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 46] Chapter 2. Safety 2 - 5 Foot switch port Electrocardiograph (ECG) port USB port Network port Microphone port Probe port IPX 1 Dripping-proof device: Protected against vertically falling water Immersion-proof device: Protected against the effects of non- IPX 7 continuous immersion in water Submersion-proof device: Protected against the effects of continuous IPX 8 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.

[Page 47] 2 - 6 HS50/HS60 Service Manual 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 48] 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.

[Page 49] 2 - 8 HS50/HS60 Service Manual • 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 WARNING 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. • All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to the application of a high-voltage defibrillation pulse. • Never use the product in the presence of flammable anesthetic gas or oxidizing gases (N2O). Doing so may cause an explosion. • Avoid installing the system where it is difficult for the operator to disconnect it from the 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. • 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. CAUTION • 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.

[Page 50] Chapter 2. Safety 2 - 9 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 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. • 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-ESD preventive procedures before using connectors marked with CAUTION 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.

[Page 51] 2 - 10 HS50/HS60 Service Manual 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. In cases wherein EMI is causing disturbances, it may be necessary to relocate the system. 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 internal function. Therefore, its RF emissions are Group 1 CISPR 11 very low and are not likely to cause any interference to nearby electronic equipment. RF Emission Class A CISPR 11 The Ultrasound System is suitable for use in all establishments other than domestic and those Harmonic Emission Class A directly connected to the public low-voltage power IEC 61000-3-2 supply network that powers buildings used for domestic purposes. Flicker Emission Compliant IEC 61000-3-3

[Page 52] Chapter 2. Safety 2 - 11 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. When connecting other customer-supplied accessories to the system, it is the user’s responsibility to ensure the electromagnetic compatibility of the system. The use of cables, probes, and peripherals other than those specified may result in increased emissions or decreased immunity of the Ultrasound System.

[Page 53] 2 - 12 HS50/HS60 Service Manual IEC 60601 Electromagnetic Immunity Test Compliance Level Test Level Environment Guidance Floors should be wood, Electrostatic concrete, or ceramic tile. discharge ±6KV contact ±6KV contact (ESD) If floors are covered with synthetic material, the ±8KV air ±8KV air relative humidity should IEC 61000-4-2 be at least 30%. Electrical fast ±2KV ±2KV The quality of the power transient/burst for power supply lines for power supply lines mains should be that of a ±1KV ±1KV typical commercial or IEC 61000-4-4 for input/output lines for input/output lines hospital environment. ±1KV differential ±1KV differential Surge The quality of the power mode mode mains should be that of a typical commercial or IEC 61000-4-5 hospital environment. ±2KV common mode ±2KV common mode 5% U т 5% U т for 0.5 cycles (>95% for 0.5 cycles (>95% dip in U т) dip in U т) The quality of the power mains should be that of a Voltage dips, typical commercial or short 40% U т 40% U т hospital environment. If interruptions, for 5 cycles (60% dip for 5 cycles (60% dip the user of this product and voltage in U т) in U т) requires continued variations on operation during power supply 70% U т 70% U т interruptions in the power input lines for 25 cycles (30% dip for 25 cycles (30% dip mains, it is in U т) in U т) recommended that this IEC 61000-4-11 product be powered by an uninterruptible power 5% U т 5% U т supply or a battery. for 5 seconds (<95% for 5 seconds (<95% dip in U т) dip in U т) Power frequency Power frequency magnetic field magnetic fields should be (50/60Hz) 3A/m 3A/m at levels characteristic of a typical commercial or hospital environment. IEC 61000-4-8 Note: U т is the AC main voltage, prior to application of the test level.

[Page 54] Chapter 2. Safety 2 - 13 IEC 60601 Compliance Immunity Test Electromagnetic environment guidance Test Level Level Conducted RF 3Vrms 3V Portable and mobile RF communications IEC 61000-4-6 150kHz equipment should be used no closer to ~ 80MHz 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 𝑑 = 1.2 √ P 80MHz to 800MHZ 𝑑 = 2.3 √ P 800MHz to 2.5GHz Radiated RF 3V/m 3V/m Where P is the transmitter’s maximum IEC 61000-4-3 80MHz ~ output power rating in watts (W) according to the transmitter’s manufacturer and d is 2.5GHz the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range ( ). 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. 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. Beyond the frequency range from 150kHz to 80MHz, field strengths should be less than 3 V/m.

[Page 55] 2 - 14 HS50/HS60 Service Manual 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. Separation distance according to the frequency of transmitter [m] Rated maximum output power of transmitter 150kHz – 80MHz 80MHz – 800MHz 800MHz – 2.5GHz [W] 𝒅 = 𝟏 . 𝟐√𝐏 𝒅 = 𝟏 . 𝟐√𝐏 𝒅 = 𝟐 . 𝟑√𝐏 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. If the system is connected to other customer-supplied equipment, such as local area network (LAN), Samsung Medison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic phenomena.

[Page 56] 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: 1 2 3 Imaging mode ESD RF Power Line When changing the For sector imaging White dots, dashes, operating mode or probes, white radial diagonal lines, or system settings or bands or flashes in the diagonal lines near the resetting the system, centerlines of the center of the image. brief flashes appear image. 2D in the displayed or For linear imaging recorded image. probes, white vertical bands that are sometimes more pronounced on the sides of the image. Increase in image White dots, dashes, background noise or diagonal lines, or white M mode lines. increase in image background noise. Color flashes, radial or Color flashes, dots, vertical bands, dashes, or changes in increase in color noise level. Color background noise, or changes in color image. Horizontal lines in the Vertical lines in the spectral display or spectral display, Doppler tones, abnormal noise popping-type noises in in the audio, or both. 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.

[Page 57] 2 - 16 HS50/HS60 Service Manual 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.

[Page 58] Chapter 2. Safety 2 - 17 2.4. Mechanical Safety 2.4.1. Moving the Equipment Special caution should be taken during movement. Careless transportation of the product may result in product damage or personal injury. • 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. Mind the castors, especially when moving the system. Samsung Medison recommends exercising caution when moving the product up or down ramps. 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.

[Page 59] 2 - 18 HS50/HS60 Service Manual 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 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. Refer to ‘Chapter 10. Maintenance and Storage’ for detailed information on protecting, cleaning, and disinfecting the equipment. 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]

[Page 60] Chapter 2. Safety 2 - 19 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]

[Page 61] 2 - 20 HS50/HS60 Service Manual 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 WARNING 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 '( A s L ow A s R easonably A chievable)' (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.

[Page 62] Chapter 2. Safety 2 - 21 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.

[Page 63] 2 - 22 HS50/HS60 Service Manual 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.

[Page 64] Chapter 2. Safety 2 - 23 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.

[Page 65] 2 - 24 HS50/HS60 Service Manual ■ 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, industry- standard, 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 steady-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.

[Page 66] Chapter 2. Safety 2 - 25 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.

[Page 67] 2 - 26 HS50/HS60 Service Manual ■ 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.

[Page 68] Chapter 2. Safety 2 - 27 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.

[Page 69] 2 - 28 HS50/HS60 Service Manual 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)

[Page 70] Chapter 2. Safety 2 - 29 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: − ( 0 . 23 alf ) 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: − ( 0 . 069 lf ) In Situ (derated) = Water [ ]

[Page 71] 2 - 30 HS50/HS60 Service Manual Since this value is not the true in situ intensity, the term “de-rated” is used. The maximum de- rated 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 aprt -12dB OUTPUT BEAM AREA, ultrasonic beam area induced by -12dB output beam size (unit: cm ) d eq at max. I pi EQUIVALENT BEAM DIAMETER, the acoustic beam's diameter at the location where the PULSE-INTENSITY INTEGRAL is maximal, expressed as an equivalent beam area (unit: cm) d eq( z b) EQUIVALENT BEAM DIAMETER, the acoustic beam's diameter at Zb location, expressed as an equivalent beam area (unit: cm ) 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) f awf ACOUSTIC WORKING FREQUENCY, the arithmetic average of f1 and f2 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) I pa, α at max. MI The average attenuated pulse strength at the location with maximum Mechanical Index (MI) (unit: W/cm ) I ta, α (z) Attenuated average strength over time at a specific focal length (z) (unit: mW/cm ) 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 α (z) ATTENUATED OUTPUT POWER, the power of ultrasonic output calculated at a specific distance from the transducer after attenuation occurs (unit: mW)

[Page 72] Chapter 2. Safety 2 - 31 P r,α ATTENUATED PEAK-RAREFACTIONAL ACOUSTIC PRESSURE, the peak rarefactional acoustic pressure calculated at a specific distance after attenuation occurs (unit: MPa) P r at max. I pi The peak rarefactional acoustic pressure at the location where PULSE- INTENSITY 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) TIS scan Soft tissue thermal index in scanning mode (unit: N/A) TIS non-scan Soft tissue thermal index in non-scanning mode (unit: N/A) t d PULSE DURATION (unit: us) z_at_max_Ipi, α Location with maximum PULSE-INTENSITY INTEGRAL (unit: cm) z b DEPTH FOR BONE THERMAL INDEX (unit: cm) z bp BREAK-POINT DEPTH, which is the EQUIVALENT APERTURE DIAMETER multiplied by 1.5 (unit: cm) z s DEPTH FOR SOFT-TISSUE THERMAL INDEX, distance from a plane where the product of minimum attenuated output power, ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY, and 1 cm maximum 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)

[Page 73] 2 - 32 HS50/HS60 Service Manual 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 3.2% +21% to -24% integral) P (acoustic power) 6.2% ±19% P r,α (attenuated rarefaction pressure) 5.4% ±15% f awf (acoustic working frequency) < 1% ±4.5% ■ 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).

[Page 74] Chapter 2. Safety 2 - 33 – 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.

[Page 75] 2 - 34 HS50/HS60 Service Manual 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.

[Page 76] 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

[Page 77] Chapter 3. Installing Product 3 - 2 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. The product weighs more than 100kg. Be extra careful when transporting it. Careless transportation of the product may result in product damage or personal injury. Mind the castors especially when moving the system. Samsung Medison recommends exercising caution when moving the product up or down ramps.

[Page 78] 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]

[Page 79] 3 - 4 HS50/HS60 Service Manual 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]

[Page 80] 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]

[Page 81] 3 - 6 HS50/HS60 Service Manual 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. Placing the system near generators, X-ray machines, or broadcast cables may result in screen noise and abnormal visual images. Sharing the power source with other electrical devices may also induce noise. • 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.

[Page 82] Chapter 3. Installing Product 3 - 7 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. ② 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. The product may be shipped with the power cable connected to the console. • 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.

[Page 83] 3 - 8 HS50/HS60 Service Manual 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 Use Waiting time Hour 16 10 8 6 4 2 2 4 6 10 immediately [Table 3.2 Operational Temperature of the Product] 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]

[Page 84] Chapter 3. Installing Product 3 - 9 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. • Do not connect additional external peripheral devices to the auxiliary socket outlet. Doing so may decrease the safety level. [Figure 3.5 Patient Environment] For more information on the recommended peripheral devices, refer to ‘Chapter 3. Installing Product.’ 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

[Page 85] 3 - 10 HS50/HS60 Service Manual 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. When using a peripheral device via a USB port, always turn power off before 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. • 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 the ports on the console and other USB peripheral devices to the rear panel for NOTE convenience. ■ USB Video Printer The following products are recommended: • 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 • You must install a printer and a driver compatible with the English version of Microsoft Windows 7. Contact Samsung Medison's customer service department for inquiries about printer driver installation. • 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. • Check the port used by the printer before connecting. Printers should be connected to the printer port; the USB printer should be connected to the USB port. ■ USB to RS-232C Serial Cable ■ Foot Switch ■ WLAN Card

[Page 86] Chapter 3. Installing Product 3 - 11 ■ Others Flash Memory Media • The system cannot recognize USB 1.1 flash memory. Remove the flash memory from 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-virus programs or which are defective. Otherwise, the product may fail to work properly.

[Page 87] 3 - 12 HS50/HS60 Service Manual 3.5. System Power Boot up the system for use. 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 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. Before 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 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 button for five seconds or longer forces the product to power off. • If the ultrasound system is unplugged while working or turned off by forcibly shutting down, files may get corrupted, and such may result in system down or data loss. • To ensure that electrical power is safely cut off, set the power switch at the rear of the 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.

[Page 88] 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. Selecting a tab TIP 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. 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 press the Exit button on the control panel to switch to Scan Mode. [Figure 3.6 Setup – Touch Screen]

[Page 89] 3 - 14 HS50/HS60 Service Manual 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. You may show or hide the ECG on the screen for each Preset at Setup > Application/Preset > Preset Setting. 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.

[Page 90] Chapter 3. Installing Product 3 - 15 ■ 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. • In CW Mode, when the ECG is active, the error ratio of the Heart Rate (HR) should be within 2%.

[Page 91] 3 - 16 HS50/HS60 Service Manual 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.

[Page 92] Chapter 3. Installing Product 3 - 17 • Before starting diagnosis, confirm the time, date, and time zone and modify the settings if necessary. • Make sure to set the date and time to the time zone in which the system is installed. If 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 End Exam button on the control panel. • When the system time and date are changed, the change is not reflected on the time NOTE 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. ① Set the date and time by using the trackball and the Set button on the control panel. ② Press Save to 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 . ② Specify the time zone by using the trackball and the Set button for the combo button. ③ 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.

[Page 93] 3 - 18 HS50/HS60 Service Manual 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.

[Page 94] Chapter 3. Installing Product 3 - 19 [Figure 3.8 Setup – User Account Manager] • Log-in 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. • 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.

[Page 95] 3 - 20 HS50/HS60 Service Manual 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.

[Page 96] 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

[Page 97] 3 - 22 HS50/HS60 Service Manual 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 can 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.

[Page 98] 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.

[Page 99] 3 - 24 HS50/HS60 Service Manual 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.

[Page 100] 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.

[Page 101] 3 - 26 HS50/HS60 Service Manual 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. A printing job can be canceled only if the image data to print has not been completely sent to the printer.

[Page 102] Chapter 3. Installing Product 3 - 27 • Local Printing Area Select the area to be printed. – Full Screen: Prints everything shown on the monitor screen. – Video Out: Prints only a certain area of the screen, including the Image area. – Image Only: Prints the image area only. • Hide Patient Data Select whether or not to display the patient information. 3.6.4.2. Device On the Setup screen, select the Device tab in the Peripherals category. Press the Eject/Remove button to eject or remove the disk from the device. Press the Format Media button to erase the CD/DVD. [Figure 3.14 Setup – Peripherals – Device] 1. Map Network Drive Connect to a network. ① Press the Map Network Drive button. ② Select a Drive Name. ③ Enter a Network Folder path. ④ Enter the User ID and password, and then press the Connect button. ⑤ Select a Drive Name and press the Disconnect button to close it.

[Page 103] 3 - 28 HS50/HS60 Service Manual 3.6.5. Connectivity Tap Connectivity on the touch screen. You can perform DICOM administration tasks or manage DICOM server settings and network information for your system. 3.6.5.1. DICOM On the Setup screen, select the DICOM tab in the Connectivity category. Configure the DICOM (Digital Imaging and Communication in Medicine) operation and DICOM server. For more information, refer to the server’s user manual or the DICOM Conformance Statement. [Figure 3.15 Setup – Connectivity – DICOM] 1. System Configuration Shows information about the DICOM server that is being used by the system. You can change the information or add or delete a server. The server information is used to identify the DICOM for the system within a network. It is also used to transfer data to other DICOM servers. For the 'IP Address,' 'AE Title,' and 'Port No.' settings, contact your organization’s network administrator.

[Page 104] Chapter 3. Installing Product 3 - 29 • Station Name Enter the name of the system. Along with 'AE Title,' it is often used to identify the system in the DICOM network. • Port No. Enter the port number for the server being used. • AE Title Enter the name of the DICOM AE (Application Entity). Used for identifying the equipment that uses DICOM on the network. 2. General Configuration • SR Format Select a format to be used to save SR between General Report and Viewpoint. • Store SR at End of Exam Select whether or not to store the SR at the end of the exam. When you select this checkbox, the SR is automatically stored at the end of the exam. Otherwise, it is not stored. 3. Adding DICOM Services Click Add on the screen. A screen where you can enter a DICOM service to add is displayed. After adding a service, click Apply to save the information. Click Cancel to cancel. • DICOM Services Select the type of service to use via DICOM. The supported DICOM servers are Storage, SC, Worklist, Print, PPS, Storage SR, and QR. • Alias Enter the name of the DICOM server. • AE Title Enter the AE title of the DICOM server. Consult your network administrator before specifying this option. • HOST Enter the IP address of the server being used. Consult your network administrator before specifying this option. • Port No. Enter the port number for the server being used. Consult your network administrator before specifying this option. • Connect Timeout The connection will time out if there is no response from the DICOM server within the configured time period. You can specify this time period in seconds.

[Page 105] 3 - 30 HS50/HS60 Service Manual • Read Timeout Specify the Read Timeout time limit for the server you are adding. • Retry Interval Specify how many seconds the system will wait before it retries a failed transmission. You can specify this time period in seconds. • Maximum Retries Specify how many times a failed transmission will be retried. • Packet Size Specify the size of the transfer packet. 4. Storage Server Information Select 'STORAGE' as DICOM Service Options item. Configure the Image Storage Service using DICOM. [Figure 3.16 DICOM Configuration – Storage] • Transfer Mode Select a transfer method: – Send after acquisition: Sends an image whenever you press the Store button to save it. – Send on end exam: Sends all saved images when you press the End Exam button. – Send manually: Send an image selected by the user from the Exam List or in Review. • Transfer Types – Include Multi Frame: Select this checkbox to transfer Cine Loops. – Include 3D Volume: Select whether or not to send 3D volume data together with the 3D images.

[Page 106] Chapter 3. Installing Product 3 - 31 Select this option only if you use a storage service that supports the 3D volume data format used by Samsung Medison. • Convert to Gray scale Select the grayscale conversion type for the image for which the DICOM service will be used. – No Conversion: Send the original image without converting it. – All Images: Convert all images into grayscale before sending them. – B/W Image only: Only images that do not have color are converted into grayscale before being sent. • Support Include Pixel Spacing: In addition to the area information used in ultrasonography, the area information used in CT or radiography is also included. You can take measurements in a PACS system that does not support ultrasound area information. Note, however, that only 2D and 2D Color Mode images are supported. In Dual and Quad Modes, the depths of the included images must be identical. • DICOM Compression Select whether to compress the images for the DICOM service. Use the combo button to select the image type and compression type (Uncompressed or JPEG Baseline). When you select Uncompressed, the images are saved without compression. – Single Frame: Specify the compression type for still images. – Multi Frame: Specify the compression type for Cine images. – If the JPEG Baseline is selected, you need to select Low, Medium, or High. You can prioritize either the quality or the compression ratio. You can specify the compression type, compression ratio, and frame rate. You can select Full, 10, or 20 as the frame rate for Multi Frame. • VOI LUT Setup Configure the VOI LUT (Value Of Interest, Look Up Table). Adjust the brightness and contrast of a DICOM image when saving it. The saved image can be viewed with any PACS device with DICOM VOI LUT implemented. – Window Center: Enter a value for the DICOM Tag (0028, 1050) setting. The setting value indicates the brightness of an image that is displayed by the storage service. Relative to 128, a higher value results in a darker image. Note that this function can be used only when it is supported by the storage service.

[Page 107] 3 - 32 HS50/HS60 Service Manual – Window Width: Enter a value for the DICOM Tag (0028, 1051) setting. The setting value indicates the contrast of the image displayed by the storage service. Values set higher than 256 will result in lower contrast. Note that this function is available only when it is supported by the storage service. 5. SC Server Information Select 'SC' (Storage Commitment) as DICOM Service Options item. Configure the Storage Commitment Service using DICOM. The Storage Commitment Service is used after a diagnosis is finished and all saved images and reports are sent. [Figure 3.17 DICOM Service Options – SC] • Associated Storage Server Select an Image Storage server to connect to.

[Page 108] Chapter 3. Installing Product 3 - 33 6. Worklist Server Information Select 'WORKLIST' as DICOM Service Options item. Configure the Modality Worklist Service using DICOM. [Figure 3.18 DICOM Service Options – WORKLIST] • Query Setting – Select the type of Modality to retrieve when updating the worklist. – Modality: Select either ultrasound images (US) or all images (All). After setting up the Worklist service, press the Patient button on the control panel to go to TIP the Worklist page.

[Page 109] 3 - 34 HS50/HS60 Service Manual 7. Print Server Information Select 'PRINT' as DICOM Service Options item. Configure the Print Service using DICOM. [Figure 3.19 DICOM Configuration – Print] • You can configure only the printers connected to the DICOM network. • Depending on the printer, some of the following functions may not be available: Before configuring a printer, refer to the printer’s user manual or the DICOM Conformance Statement. • Transfer Mode Select a printing method: – Print after acquisition: Print an image whenever you press the Store button to save it. – Print on end exam: Prints all saved images when you press the End Exam button. – Print manually: Print an image selected by the user from the Exam List or in Review. • Layout Setting Specify the paper layout. Between 1 and 6 rows and 1 and 4 columns can be selected. • Printer Setup – Color: Specify whether to use colors. Select Grayscale or RGB. – Orientation: Specify the paper orientation. Select either Landscape or Portrait. – Magnification: Specify the interpolation when resizing an image to print. Select Replicate, Bilinear, Cubic, or None. – Border Density: Specify the border color of the image to be printed. Select Black or White. – Priority: Specify a priority for the print command. Select High, Med, or Low. – Destination: Specify the paper pathway. Select Magazine or Processor.

[Page 110] Chapter 3. Installing Product 3 - 35 – Medium Type: Specify the material type for the printout. Select Paper, Clear Film, Blue Film, Mammo Clear Film, or Mammo Blue Film. – Copies(1–99): Enter the number of copies between 1 and 99. – Film Size: Select a paper size from 8 x 10 inches, 8.5 x 11 inches, 10 x 12 inches, 10 x 14 inches, 11 x 14 inches, 11 x 17 inches, 14 x 14 inches, 14 x 17 inches, 24 x 24 cm, 24 x 30 cm, A4, and A3. – Smoothing Type: This option is available only when Magnification is set to CUBIC. Enter the value for the printer as specified in the DICOM Conformance Statement. – Empty Density: Specify the background color of an image to print. Select Black or White. – Min Density: Specify the minimum brightness of an image to print. If this option is not specified, the default value is applied. – Max Density: Specify the maximum brightness of an image to print. If this option is not specified, the default value is applied. – Configuration Info: Specify the unique value for a printer. Refer to the DICOM Conformance Statement for the printer. 8. PPS Server Information Select 'PPS' (Performed Procedure Step) as DICOM Service Options item. Configure the Modality Performed Procedure Step Service using DICOM. [Figure 3.20 DICOM Service Options – PPS] • Always complete exams When you check this checkbox, exams are always reported in complete condition. If you press the End Exam button without selecting a checkbox, the cancellation message that was selected after you selected the cancellation message for End Exam will be sent to the RIS server.

[Page 111] 3 - 36 HS50/HS60 Service Manual 9. Storage SRServer Information Select 'STORAGE SR' (Storage Structured Report) as DICOM Service Options item. Configure the Report Storage Service using DICOM. [Figure 3.21 DICOM Service Options – Storage SR] • Transfer Mode Select a printing method: – Send after acquisition : Whenever the Store button is pressed, the measurement data in the report will be sent as an SR. – Send on end exam : Whenever the End Exam button is pressed, the measurement data in the report will be sent. 10. QR Server Information Select 'QR' as DICOM Service Options item. The configuration options are the same as those for the storage server. 11. Modifying DICOM Information Select a service and click Modify on the screen. The information on the selected service will appear. After changing the information, click Apply to save the changes. Click Cancel to cancel. 12. Deleting DICOM Services Select a service and click Delete on the screen. 13. Testing DICOM Servers Select a service and click Verify on the screen. The connection with the selected service is tested, and the results are shown under Verify. If the result is Success, the connection is normal.

[Page 112] Chapter 3. Installing Product 3 - 37 3.6.5.2. HL7 Include the Measurement Data PDF in the HL7 Message and send it to the HL7 Repository server. Select the HL7 tab and click the HL7 Manager button on the screen. [Figure 3.22 DICOM HL7 – HL7 Manager] • Repository: Register, edit, and delete a report repository server to send reports to. – Add Repository: Add a repository to send an HL7 message. - Alias: Refers to a name of the HL7 repository server to send an HL7 message to. - IP Address: Enter an IP address for the HL7 repository server. - Port No: Enter the port number of the HL7 repository server (a value between 0 and 65535). - Connect Timeout: Select the time for transfer standby in seconds (a value between 120 and 300). - Read Timeout: Set the standby time for transmission in seconds (a value between 120 and 300).

[Page 113] 3 - 38 HS50/HS60 Service Manual [Figure 3.23 DICOM HL7 – HL7 Manager] – Edit Repository: Edit the repository server information. – Delete Repository: Delete the repository server information. – Active/Inactive Repository: Select whether or not to use the repository server by selecting the Active checkbox for the registered repository. • Show Job Status: Shows the information regarding the transfer of the HL7 report into an HL7 message. – Colums: The user can select the columns to check. – Retry: The user can retry a Failed job. – Delete: The user can delete a job, whether the status is “SUCCESS” or “FAIL.” – Show All: Shows all jobs. – Delete Archived Job Status after(days): Delete archived jobs for the selected dates.

[Page 114] Chapter 3. Installing Product 3 - 39 [Figure 3.24 DICOM HL7 – HL7 Manager] • HL7 Export If there is an Active repository server registered to the HL7 Manager, the user can export the report by selecting the “ HL7 ” button after taking at least one measurement on the Report screen. (Note, however, that there must be patient information; a warning message asking for a valid patient ID will appear if the information has not been entered.) [Figure 3.25 Report – HL7 Export]

[Page 115] 3 - 40 HS50/HS60 Service Manual 3.6.5.3. Network On the Setup screen, select the Network tab in the Connectivity category. Or, tap Connectivity on the touch screen. You can manage the network information for the current equipment. [Figure 3.26 Setup – Connectivity – Network] 1. Network Configuration Set up the network information for the current equipment. • Automatic Configuration (DHCP) If the checkbox is selected, the IP information will be configured automatically. • Static Configuration If the checkbox is empty (Automatic Configuration), you can enter a static IP address. Specify the IP Address, Subnet Mask, Gateway, and DNS information. • Revert Clear the currently entered information and restore the default settings. • Apply Use the currently entered information to set up the IP.

[Page 116] Chapter 3. Installing Product 3 - 41 3.6.6. Service • Users should not attempt to perform anything on their own. They must contact the customer service department of Samsung Medison who can perform this service for them. • Restores saved basic patient information and images or changes the software. • Enables or disables optional software or hardware. – Option: Shows the types of optional software that can be installed on the product. – Status: Show the current status of optional software. Registered means that the software can be used until the date specified by the Expiration Date is reached. Unregistered means that the software cannot be used now. • Displays the software version of the product. • It provides the built-in self-test function. 3.6.7. Help Press the Help button on the keyboard. The electronic manual will appear on the monitor screen. Pressing the button again causes it to disappear. The Help screen does not provide a Return key.

[Page 117] Chapter 4 4. Product Inspection Chapter 4. Product Inspection Product Inspection 4.1. Inspecting the Functions 2 4.1.1. Basic Inspections 2 4.1.2. Detailed Inspections 3

[Page 118] 4 - 2 HS50/HS60 Service Manual 4.1. Inspecting the Functions After installation, inspect the device and use the major functions to verify that the product works properly. 4.1.1. Basic Inspections 4.1.1.1. Monitor Check the screen for color, focus, dots, afterimage, stain, and blurriness. Check the screen while applying impact on the monitor and check the signal while shaking the cable to the left and right. ■ Control Panel and LED Status Press any keys on the control panel and see if text appears or breaks. Verify that the Keyboard LEDs turn on. ■ BodyMark Key Check if a BodyMarker image appears correctly and whether selection works properly. ■ Indicator Key Check whether the trackball works properly by rolling it up, down, left, and right. ■ Clear Key Check whether all texts and measurements are properly cleared. ■ Check Zoom Functioning Check the zoom function for proper action and make sure that there are no errors. ■ Check SonoView Save Images and Cine Images in each mode. Check for errors in saving images. Check whether Backup & Restore function properly. ■ Measure Check the operation of Distance, Caliper, Calc, etc.

[Page 119] Chapter 4. Inspecting the Product 4 - 3 ■ Patient Enter information in Patient and check whether the same Patient information is displayed in Report, SonoView, etc. ■ End Exam Make an arbitrary measurement in New Patient and see whether the measurement is erased when you press End Exam. ■ Probe Key Perform a Probe Change and check whether it functions correctly. 4.1.2. Detailed Inspections ■ 2D Mode 1. Perform a Knife Test to check whether part of the image is not displayed. 2. Perform a Phantom to check for errors in image. 3. Check the Freeze Cine actions (broken image, Auto Run, Auto Run Speed, Trackball 4. Check for changes in image brightness when you adjust Gain. 5. Check whether TGC Gain operates correctly by adjusting it and check for changes in image brightness in accordance with depth. 6. Perform Left/Right Flip, Up/Down Direction, and Rotation to check whether the image changes its orientation correctly. 7. Check whether the Select Image menus (EE, DR, View Area, Tissue, Frame Rate) work properly. 8. Check for errors in frequency (Phantom, Res, Pen, Gen). 9. Check for changes in image in accordance with the changes in depth. 10. Check for changes in image by depth when you change the focus. 11. Check whether or not Image Compensation Mode works.

[Page 120] 4 - 4 HS50/HS60 Service Manual ■ Dual Mode 1. Perform a Phantom to check for errors in image. 2. Perform Left/Right Flip, Up/Down Direction, and Rotation to check whether the image changes its orientation correctly. 3. Check the proper operation of Select Image menus (EE, DR, View Area, Tissue, Frame Rate, Power). 4. Check for errors in frequency (Phantom, Res, Pen, Gen). 5. Check for changes in image in accordance with the changes in depth. 6. Check for changes in image by depth when you change the focus. 7. Check for errors in operations related to left and right image Cine (number of pages, Cine progression order, broken image, Auto Run, Auto Run Speed, Track Ball Cine). ■ M Mode 1. Perform a Phantom to check for errors in image. 2. Check whether the M-Line’s information is displayed in the Image area. 3. Check for changes in image brightness when you adjust Gain. 4. Perform Left/Right Flip, Up/Down Direction, and Rotation to check whether the image changes its orientation correctly. 5. Check whether the Select Image menus (EE, DR, View Area, Tissue, Frame Rate, Same Angle, Power) operate correctly. 6. Check for changes in image in accordance with the changes in depth. 7. Check for changes in image by depth when you change the focus. 8. Check for changes in speed when you change Speed gradually and for errors in the information. 9. Check whether the image becomes inverted when Negative is performed. 10. Check for errors in Top Down Format and Side by Side Format images when Loop Format is selected. 11. Check for changes in Format B-Mode and M Line area sizes. 12. Check the Freeze Cine actions (broken image, Auto Run, Auto Run Speed, Trackball

[Page 121] Chapter 4. Inspecting the Product 4 - 5 ■ Color Doppler/Power Doppler Mode 1. Perform a Phantom to check for errors in image. 2. Check the operations related to the Select Image menus (Balance, Sensitivity, Color Mode, Display, CFR). 3. Check for changes in image in accordance with the changes in depth. 4. Check the Freeze Cine actions (broken image, Auto Run, Auto Run Speed, Trackball 5. Check for changes in image brightness when you adjust Color Gain. 6. Check for noises and breaks in image (B or C Mode Noise) when you move the ROI Box. 7. Check for noises and breaks in image (B or C Mode Noise) when you resize the ROI Box. 8. Adjust the Scale up and down to check whether or not the frequency changes and if the speed range of blood flow is adjusted. (Check by actually performing a scan.) 9. Operate Filter to check whether small signals are removed by stage. 10. Check whether or not Color Bar is inverted when you operate the Invert key. 11. Move the Baseline up and down to check whether the speed range of blood flow moves to the “+” or “-” position. ■ PW Spectral Doppler Mode 1. Perform a Phantom to check for errors in image. 2. Check whether Doppler’s PRF value changes when you set Simultaneous to on/off. 3. Check for errors in the Doppler spectrum. 4. Change the Scale to check the change in velocity range. 5. Move the Baseline up and down to check whether the spectrum range moves to the “+” or “-” position. 6. Check whether changing Filter removes low signals from the Spectrum. 7. Check whether the Doppler wave form is inverted when you operate Invert. 8. Perform Angle action. 9. Change the position and size of SV, and then check for errors. 10. Check whether Spectrum’s image changes when you change Spectrum’s Type. 11. Check for errors in Sound Volume. 12. Perform Auto Calc and check whether the line is displayed without breaks; check whether the calculated results are carried out automatically. 13. Check for errors in Top Down Format and Side by Side Format images when Loop Format is selected. 14. Check the Cine/Loop (broken image, Auto run, Auto run speed, Trackball Cine) operations.

[Page 122] 4 - 6 HS50/HS60 Service Manual ■ 3D/4D Mode 1. Check whether loading is performed correctly when you proceed with Free Hand 3D SCAN and when you skip to Freeze; check for broken images and noise while proceeding. 2. Check whether loading is performed correctly when you proceed with Static 3D Scan; check for broken images and noise while proceeding. Check the probe for noise and whether the probe’s motor works normally. 3. Check whether loading is performed correctly when you proceed with Live 3D Scan; check for broken images and noise while proceeding. Check the probe for noise and whether the probe’s motor works normally. 4. Check for errors in ROI 3D, ABC 3D, and Full images. 5. Check whether the 3D image changes to the selected angle. 6. Check whether the 3D image’s contrast changes to the selected value. 7. Check for errors in the image when you change the size of the image. 8. Check the Display Format Image (ACB, Volume CT Image) 9. Step Angle, Rotation Angle, Rot. Axis, and then proceed with Cine; check whether Cine Loading works in accordance with the Setting items and check for breaks and errors in the image.

[Page 123] Chapter 5 5. Product Structure Chapter 5. Product Structure Product Structure 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 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

[Page 124] 5 - 2 HS50/HS60 Service Manual 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

[Page 125] Chapter 5. Product Structure 5 - 3 5.1. Overview This is an ultrasound diagnostic imaging system utilizing software DSC. It features a 21.5-inch Full HD Wide LED monitor and a 10.1-inch LED touch screen monitor, provides high-resolution ultrasound images, and includes premium-grade features. Samsung Medison’s new proprietary technology is incorporated into the latest spec PC and ultrasound system interface to enhance processing speed. Enhanced processor speed means faster processing speed of the product, which in turn reduces exam time. The major specifications are as follows: • Main Monitor 21.5 inch LCD monitor (LED Backlight unit, hereafter referred to as “LCD monitor”) Monitor • Touch Screen Monitor 10.1 inch LCD monitor (LED Backlight unit, hereafter referred to as “LCD monitor”) PC Advantech, COM Express Module CPU Intel Haswell (4th core) I3-4100E Memory DDR3 SDRAM 8GB OS 64bit Windows 7 Embedded Standard Storage SSD 512GB • HS60 (External VGA): GTX 750TI VGA • HS50 (Internal VGA): Intel HD Graphics 4600 Chanel TX 128 CH Probe port 4-Probe Port (with 1-port Dummy probe port) 3D Driver BE B/D Moving CP Up/Down, Swivel CP using Handle and Gas Spring

[Page 126] 5 - 4 HS50/HS60 Service Manual The major structure of this product includes the following: • PSA(Probe Select Assembly) 4 Ports • BF(Beamformer Board) 1ea 128ch • BE(Back End Board) Ultrasound System Part • USB ECG Module • USB Foot Switch • Gel Warmer • FAN Module • 21.5 inch LCD for main monitor • 10.1 inch LCD for touch panel User Interface Part • Key Matrix Board • Up/Down, Swivel, CP • 1.2” Track Ball • PC Module: Advantech , Com Express Module CPU: Intel Haswell(4th core) I3-4100E • RAM: DDR3 SDRAM 8GB PC Part • Storage: SSD 512GB • VGA: HS50 Intel HD Graphics 4600 HS60 GTX 750TI Power Module ADM

[Page 127] Chapter 5. Product Structure 5 - 5 5.2. System Block Diagram 5.2.1. System Block Diagram [Figure 5.1 System Block Diagram ]

[Page 128] 5 - 6 HS50/HS60 Service Manual 5.2.2. System Rack Design Power CP BF BE Rack PSA BP Frame Name Full Name PSA Probe Select Assembly CP Control Panel BF Beamformer BE Back End BP Back Plane [Figure 5.2 System Rack Design ]

[Page 129] Chapter 5. Product Structure 5 - 7 5.3. Basic Structure of the Product This product consists of the Ultrasound System Part and the User Interface Part. In the aspect of electronic structure, it consists of a Front End Part, a Back End Part, a User Interface Part, and a Power Part. The electronic structure of HS50/HS60 can be explained as follows: 5.3.1. Electronic Structure • Front End Part It consists of the PSA (Probe Select Assembly) and the BF (Beamformer). The Front End Part delivers High-Voltage Pulser to the probe to generate ultrasonic waves and amplifies the returning echo signal to process Digital Beamforming. The RF signal generated here is sent to the Back End Part. • Back End Part It consists of the BE (Back End) of the Ultrasound System Part as well as the PC Module. Raw data required to make diagnostic images (e.g., BW, Color Doppler, PW Doppler, and CW Doppler) from the RF signal generated by the BF (Beamformer) go through image processing in the form of DMA Packet by BE (Back End) and get transferred to the PC Module. Then, the data are displayed on screen via several steps of post-processing at the PC Module. New technologies such as MultiVision and ClearVision are adopted to show the image more clearly. • User Interface Part It consists of LED monitor, control panel, and touch screen. • Power Part It takes AC voltage and supplies AC power to the ADM and AUX Output via the circuit breaker. The ADM converts AC power into DC power, so it can supply voltage to the boards of the Ultrasound System as well as the PC module. 5.3.2. Ultrasound System Part It processes ultrasound data up to the stage before SW Post-Image Processing. This detects probes and performs TX Focusing and RX Focusing based on system and application information from the host in accordance with the user environment. When high-voltage Pulser is sent to the probe according to TX Focusing, ultrasonic waves are generated. Echo signals returning from the body due to the ultrasonic waves go through amplification and ADC to process Digital Beamforming. The RF signal obtained here goes through various filtering and processing to generate I/Q signals such as BW, Color Doppler, PW Doppler, CW Doppler, and Power Doppler, which are sent to the PC Part to generate image signals via SW Post-Image Processing. The AC to DC Power Module supplies power to the Ultrasound System Part. The Ultrasound System Part consists of the following: • PSA(Probe Select Assembly) Board • BF(Beamformer) Board • BE(Back End) Board • ADM (AC to DC Power Module)

[Page 130] 5 - 8 HS50/HS60 Service Manual 5.3.3. PC Part This displays the ultrasound information generated by the Ultrasound System Part. It consists of the Scan Converter and image output circuits. It also performs control panel and interface functions. The ADM supplies power to the PC Part. The PC Part consists of the following: • PC Module: Advantech , Com Express Module • CPU: Intel Haswell(4th core) I3-4100E • RAM: DDR3 SDRAM 8GB • Storage: SSD 512GB • VGA Card: HS60: GTX 750TI / HS50: Intel HD Graphics 4600 5.3.4. User Interface Part It consists of LED monitor, control panel, and touch screen, so that users can view and control ultrasound images. Images are sent by the Ultrasound Part to the LED monitor and peripherals. Image output includes VHS, S-VHS, Composite, and HDMI. In addition, the User Interface Part provides a function of setting the customized status through the control panel and touch screen. The User Interface Part consists of the following: • Monitor: 21.5” Full-HD Wide LED Backlight Panel (1920*1080) • Touch Screen: 10.1” LED Backlight Panel (1280*800) • Control Panel Board • Trackball • Key Matrix Board • Alphanumeric K/B 5.3.5. Power Part It converts external 110/230V AC voltage into DC voltage that should be supplied as required to each part of the Ultrasound System. The ADM supplies power to the PC Part as well. The ADM switch also works as a power circuit breaker and prevents any possible troubles due to overcurrent. • ADM

[Page 131] Chapter 5. Product Structure 5 - 9 5.4. Ultrasound System Part 5.4.1. Main Functions of the PSA (Probe Select Assembly) The PSA connects the system to the probes. This product is equipped with four probe connectors (408-pin) and one CW-probe. It has 3D Probe Drive Path, Probe Insert Path, Port Select Path, and CW Path as well as the Relay circuit to select one out of four probes. [Figure 5.3 PSA Board Location Image] Port SEL A SEL B SEL C PORT # A 0 0 0 PORT # B 1 0 0 PORT # C 1 1 0 PORT # D 1 1 1 [Figure 5.4 PSA Board Block Diagram]

[Page 132] 5 - 10 HS50/HS60 Service Manual 5.4.1.1. Specification • 4 Probe Port Support • CW Pencil Probe Port Support • Probe Insert Check, ID read, Port selection • Motor driving signal path for 3D probe 5.4.1.2. Description ■ Probe Selection It consists of circuits to choose one of four probes. It can use the relay of the latched type to select a probe chosen by the user. The relay is operated by the probe select signal transmitted from the control logic (CPLD) of the CW (Continuous Wave Board). Probe Select signals are connected via the Back Plan Connector. ■ CW Pencil Probe Connection The Static CW Probe uses the coax-pin LEMO Connector. The LEMO Connector is located on a separate Connector Board and is connected to the PSA via cable. This connector consists of 2 coax-pins and 6 pins. 2 coax-pins are used for the TX/RX of Static CW, and 6 pins are used for the personality of Static Probe.

[Page 133] Chapter 5. Product Structure 5 - 11 5.4.2. Beam Former Board The Beamformer board is located between the PSA and Back End; it sends an ultrasound signal focused on a specific position of the body and amplifies the received signal to convert it into a Digital signal. Then, it beamforms the signal and relays the Focused data to the Back End for Mid-processing. The BF Board consists of Pulser, TR Switch, AFE, TX FPGA, ADC, and BF FPGA. [Figure 5.5 BF Board Image ] • Pulser: It consists of one 128-channel board and operates 192 element probes. The Pulser amplifies the entered firing signal into High-Voltage Pulse. • TR Switch: It adjusts the High Voltage from probes so that it cannot flow to the AFE • AFE: This amplifies the entered echo signal to a sufficient level, and then compensates the signal to a certain level. Finally, it converts the compensated signal into digital signal for RX Focusing. • BF FPGA: The BF FPGA covers 64 TX Channels per unit and outputs the TX Wave Data focused on TX. Moreover, it performs RX Focusing for 64 channels of RX echo signal per unit. Finally, it sums 128 channels of RX Focusing Data and sends them to the BE Part.

[Page 134] 5 - 12 HS50/HS60 Service Manual [Figure 5.6 BF Block Diagram] [Figure 5.7 PCB Layout]

[Page 135] Chapter 5. Product Structure 5 - 13 [Figure 5.8 BF Signal Flow] 5.4.2.1. Spectification • TX Pulser + TR Switch 16 ea(HDL6M5585, 8CH) – Pulser applied with built-in Limiter • Limiter 64CH • ALL IN ONE AFE 16 ea (MAX2079, 8CH), LNA+VGA(TGC)+ADC +CW I,Q • BF FPGA (XC7K325T-2FFG900, 2 ea) – RX Dynamic Aperture – RX Apodization – Synthetic Aperture – Trapezoidal imaging – Multi-line receiving – TX Focal point • CWD processing

[Page 136] 5 - 14 HS50/HS60 Service Manual 5.4.2.2. Description ■ Transmit Channel Transmit Channel performs a function of applying high-voltage signal to the probe element, thereby generating ultrasound waves. It generates high-voltage pulse to transmit arbitrary waveforms from the BF FPGA. The Transmit Part consists of the BF FPGA and Pulser. ① BF FPGA The BF FPGA uses RTC signal to calculate the delay time for TX focusing and outputs a firing pulse to each TX channel. ② Pulser The Pulser amplifies the entered Firing Pulse signal into a high-voltage signal that is outputted to each element of probes. As a result, the probes vibrate to generate ultrasound waves. ■ Receive Channel Receive Channel amplifies the echo reflected from the medium in the human body. This signal is converted from analog into digital for beamforming at the BF FPGA. The BF FPGA sums the focused signal of each channel and sends the signals to the BE Board. The Receive Part consists of TR Switch, AFE, and BF FPGA. ① TR Switch Each element of the probes is connected in parallel to the TX Channel and RX Channel. Up to 180 Vpp Tx Pulse and mV-range Echo signals are mixed with each other. The RX data actually required is the echo signal in the mV range, which is a very weak signal. The TR Switch prohibits the high-voltage Tx Pulse from flowing into AFE input and permits low-level echo signals to pass. ② AFE HS50/HS60 uses the all-in-one type of AFE. One AFE performs the roles of LNA, TGC, and ADC for existing equipment. The AFE amplifies the mV-range echo signal input and performs gain compensation over time. It also transmits digitized RX Data to the BF FPGA. ③ BFX FPGA The BF FPGA performs RX focusing for each RX Channel data received from the AFE and sums the whole channel data. It then transmits the summed data to the BE Board.

[Page 137] Chapter 5. Product Structure 5 - 15 5.4.3. Back End Board The Back End Board (Below BE Board) includes three key features as follows: • RTC (Real Time Controller) / Host Interface • DMA (Direct Memory Access) Control • IQ Digital Signal Processing The RTC generates the control signals of the system and goes through the RF data entered in the BF board, and then transfers the DMA through the path. Digital Signal Processing implements some functions of the Mid Processor that is present in previous systems and transfers data to the SW DSC via DMA. Data reconfiguration for image implementation is handled by the FPGA, and image implementation is handled by the SW DSC . [Figure 5.9 Back End Board Top Side]

[Page 138] 5 - 16 HS50/HS60 Service Manual [Figure 5.10 Back End Board Block Diagram] [Figure 5.11 Back End Layout and Signal Flow]

[Page 139] Chapter 5. Product Structure 5 - 17 5.4.3.1. Specification • Focused RF Data Interface • BW Data Processing • Color Doppler Data Processing • IQ + Digital Signal Processing • Digital Signal Processing (Pre Processing, Post Processing) • CW IQ data Interface(CWD) • Direct Memory Access • 3D Probe Motor Driver • Diagnostic Signal Processing • RTC(Real Time Controller) • PCI-express Interface 5.4.3.2. Digital Signal Processing (DSP) Part The Back End Board's MID FPGA (KINTEX325T) comprises the Digital Signal Processing Part, which transforms the Focused RF Data inputted by the BF Board into Base-Band IQ Data. The inputted RF Data goes through Gain Control, High-Pass Filtering, Quadrature Demodulation, and Decimation processes, and then gets sent to the DMA FPGA so that the Base-Band IQ Data can be transmitted to the PC SW Module.

[Page 140] 5 - 18 HS50/HS60 Service Manual 5.4.3.3. Host Interface & RTC Part ■ Host Interface The Host Interface integrated into the MID FPGA (KINTEX325T) is connected to the PC on PCI-Express 1Lane through PCI-Express Switch. The Host Interface converts the Host Command from the PC into Local Bus, so it provides an interface with each board of the Ultrasound System. ■ RTC Part The RTC (Real Time Controller), which is integrated into the MID FPGA, controls the operation of the system by generating the standard signals needed for the operation of the entire system in real time. It generates PRF (Pulse Repeat Frequency), OF (One Frame), RP (Rate Pulse), Linotype, and Scan Line, which are required for the BF Board and DSP Part of the BE Board. 5.4.3.4. DMA Part The Direct Memory Access (DMA) Part, which is integrated into the Back End Board's MID FPGA (KINTEX325T), consists of PCI-Express Gen1 1Lane to transfer large-capacity Base- Band IQ Data at high rate and performs the function of PCI-Express Interface within the FPGA. It has DDR3 SODIMM (4Gbyte) external memory in order to save large-capacity Base-Band IQ Data by frame.

[Page 141] Chapter 5. Product Structure 5 - 19 5.5. PC Part 5.5.1. PC Module Certain functions of Digital Signal Processing, which were previously handled by hardware, are implemented by the Software Program. This module provides various peripheral ports for connecting the 1 Lane and user interface for controlling the Ultrasound System and receiving Base-Band IQ Data. This module consists of Dual Port VGA Card for the output of the Main Monitor and Touch Panel as well as Rear Module for the output of various external images. 5.5.1.1. Specification • PC Module: Advantech, Com Express Module • CPU: Intel Haswell(4th core) I3-4100E • RAM: DDR3 SDRAM 8GB • Storage: SSD 512GB • OS: Windows 7 64bit • Monitor: 21.5 Inch Full-HD(1924 x 1080) LED Display • VGA: – HS50: Intel HD Graphics 4600 – HS60 GTX 750TI [Figure 5.12 PC Module & Storage & VGA (HS60 only)]

[Page 142] 5 - 20 HS50/HS60 Service Manual 5.5.2. Rear IO Board It serves as In/Out Interface with external devices and as data interface with the control panel. This board handles image output on screen display and touch screen. It provides VHS, S-VHS, and DVI Port to support a variety of external image storages. [Figure 5.13 Rear IO Board & Layout] [Figure 5.14 Rear IO Block Diagram]

[Page 143] Chapter 5. Product Structure 5 - 21 5.5.2.1. Specification • Internal Port – HDD – Speaker L/R – ODD • External Port – Monitor VGA Out – S-Video Out – Audio L/R Out – MIC In 5.5.3. Software DSC The image data generated by the BE board is transferred to the PC Memory. The DSC Part processes image data inputted in various forms of video image and outputs them to the VGA card. [Figure 5.15 DSC Block Diagram]

[Page 144] 5 - 22 HS50/HS60 Service Manual 5.5.3.1. Specification • Cine for 5,140 frame • Loop Review for 8,192 lines • Zoom • Edge Enhancement • Multi-Slice View • Dynamic MR (Optional) • Quick Scan • Real-Time Auto Calculation time Doppler Auto Trace • Free Angle M-Mode • Post measurement • Post image optimizing process Arbitrary M mode • Help function

[Page 145] Chapter 5. Product Structure 5 - 23 5.6. User Interface Part 5.6.1. Control Panel It serves as the interface between the user and the system. It connects to the Key Matrix Board, Touch Screen, Trackball, and more via USB hub and operates as commanded by the user. 5.6.1.1. Control Panel Module [Figure 5.16 Control Panel Module] [Figure 5.17 Control Panel Block Diagram]

[Page 146] 5 - 24 HS50/HS60 Service Manual 5.6.1.2. Specification • Input part Consists of Key Switch, Encoder, and Trackball • Control part ① ATMEGA640(8bit Microcontroller) Processes input data and relays it to CP_USB B/D. ② MAX II EPM1270 (Altera CPLD) – Touch Panel power on/off Control – LED outputs / Knob control – Trackball power on/off control ③ PIC18F14K50 (USB Mouse Controller) Track ball interface • CP_USB Part User USB 2 Port

[Page 147] Chapter 5. Product Structure 5 - 25 5.6.2. Main Monitor 21.5-Inch Samsung Full-HD Wide LED Panel is applied. [Figure 5.18 Main Monitor] 5.6.2.1. Specification ITEM SPECIFICATION UNIT Display area 21.5 Inch Samsung Display Inch Number of Pixels 1920 x 1080 RGB stripe arrangement Pixels Pixel Pitch 0.2475 (H) x 0.2475 (V) mm Electrical Interface LCD Panel Input: HDMI Display colors 16.7M colors (Hi-FRC) Viewing angle 89°/89°/89°/89° (CR≥10) Display mode Normally Black

[Page 148] 5 - 26 HS50/HS60 Service Manual 5.6.3. Touch-Screen 10.1-Inch Samsung Panel is applied. [Figure 5.19 Touch Screen] 5.6.3.1. Specification ITEM SPECIFICATION UNIT Display Size 10.1 Inch Samsung Panel mm Display colors 16.2M colors Number of pixel 1280 x 800 (16:9) pixel Pixel arrangements RGB vertical stripe Pixel pitch 0.1695 (H) x 0.1695 (V) mm Display Mode Normally Black Surface treatment Hardness (3H)

[Page 149] Chapter 5. Product Structure 5 - 27 5.6.4. Display Layout [Figure 5.20 Display Layout]

[Page 150] 5 - 28 HS50/HS60 Service Manual 5.7. Power Part 5.7.1. ADM [Figure 5.21 ADM Image] [Figure 5.22 ADM Connector Pin]

[Page 151] Chapter 5. Product Structure 5 - 29 [Figure 5.23 ADM Layout] 5.7.2. Power Block Diagram [Figure 5.24 HS50/HS60 ADM Block Diagram]

[Page 152] 5 - 30 HS50/HS60 Service Manual 5.8. Interconnect Diagram 5.8.1. HS50/HS60 Interconnect Diagram 1/2 [Figure 5.25 Interconnect Diagram 1/2]

[Page 153] Chapter 5. Product Structure 5 - 31 5.8.2. HS50/HS60 Interconnect Diagram 2/2 [Figure 5.26 Interconnect Diagram 2/2]

[Page 154] 5 - 32 HS50/HS60 Service Manual 5.8.3. Cable Description 5.8.3.1. Power cable [Figure 5.27 Power cable list] 5.8.3.2. Signal Cable [Figure 5.28 Power cable]

[Page 155] Chapter 6 6. Service Mode Chapter 6. Service Mode Service Mode 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 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

[Page 156] 6 - 2 HS50/HS60 Service Manual 6.7.1. Report 16 6.8. Demo Play 17 6.8.1. Demo Play 17 6.9. Entering the Installation Key 18

[Page 157] Chapter 6. Service Mode 6 - 3 6.1. Service Mode Chapter 6 describes the Service Mode for servicing HS50/HS60. This chapter explains how to update the version, back up the system, and shift to Service Mode as well as how to add options and perform diagnostics. 6.1.1. How to Shift to Service Mode 1. Press the Setup button on the alphanumeric keyboard. 2. Click the Service Mode on the lower left. 3. Make sure that Select User Level is set to Service Engineer. 4. Enter “**********” in the password box. 5. If the password is correct, you can go to Service Mode. [Figure 6.1 Service Mode screen]

[Page 158] 6 - 4 HS50/HS60 Service Manual 6.2. Service Information Service Information shows details about the hardware and software version of the product as well as the version information of each board. [Figure 6.2 Service Information screen] • Workstation: Displays information on the system, hardware, and software version of the workstation. • License Information: Displays information on the license used in software. • Atom Information: Displays information about Atom.

[Page 159] Chapter 6. Service Mode 6 - 5 6.3. Configuration 6.3.1. Clock Here, you can change the date, time, and time zone of the Windows System. [Figure 6.3 Clock screen] 6.3.2. Keyboard/Region • Keyboard Type: international, French, German... * Caution: System restart is required when changing the type. • Region: Select a region (WW, US, CN, RU...) • Apply button: Apply the region you select.

[Page 160] 6 - 6 HS50/HS60 Service Manual 6.3.3. TCP/IP • Commands: Check the PC's IP Config information on the Result screen on the right. • LAN: Set the properties of wired network connection. • WLAN: Set the properties of wireless network connection. • Support: Add a new device, install drivers, and run Device Manager. [Figure 6.4 TCP/IP screen]

[Page 161] Chapter 6. Service Mode 6 - 7 6.3.4. Option • This is a menu for managing licensed applications. • Unlock All Options: Disable all the options displayed in the sublist. • Install: Install the option you select. • Uninstall: Disable the option installed. [Figure 6.5 Option screen]

[Page 162] 6 - 8 HS50/HS60 Service Manual 6.3.5. User Account and User Account Management • Reset: Reset all the user accounts managed by the User Account Manager. • User Account Manager: Setup  System  Account • If User Login status is enabled, the user is automatically logged out. [Figure 6.6 User Account screen]

[Page 163] Chapter 6. Service Mode 6 - 9 6.3.6. Printer • Printer: Apply the default printer settings. • Properties: Apply the default printing settings of the printer you select. • Add Printer: Install a new printer driver. • System restart is required to install the new printer driver. [Figure 6.7 Printer screen]

[Page 164] 6 - 10 HS50/HS60 Service Manual 6.4. System 6.4.1. Upgrade Software Install ultrasound software and check its patch version. [Figure 6.8 Upgrade Software screen]

[Page 165] Chapter 6. Service Mode 6 - 11 6.4.2. System Serial Number Change the System Serial Number of ultrasound software. [Figure 6.9 System Serial Number screen]

[Page 166] 6 - 12 HS50/HS60 Service Manual 6.4.3. Window Explorer • Displays the Windows Explorer, so you can check the information of Windows Local Directory. • In case of System, only E: (DATA) drive gets enabled. [Figure 6.10 Windows Explorer screen]

[Page 167] Chapter 6. Service Mode 6 - 13 6.4.4. Install Recovery System • Reboot the system. • Enter the OS environment for software recovery. [Figure 6.11 Install Recovery System screen]

[Page 168] 6 - 14 HS50/HS60 Service Manual 6.5. Diagnostics 6.5.1. Control Panel Test Testing each button of the Control Panel 6.5.2. Keyboard Test Testing each button of the Keyboard 6.5.3. Power On Self Test Testing the self-diagnosis of the PIST System 6.5.4. Built in Self Test Testing the self-diagnosis of the BIST System 6.5.5. Monitor Test Testing the color sense and brightness of monitor [Figure 6.12 Monitor screen]

[Page 169] Chapter 6. Service Mode 6 - 15 6.6. Backup and Restore 6.6.1. Backup • Backs up the user data files you select. • External storages like USB or CD are required. 6.6.2. Restore • Restores the user data files you select. • Previously stored backup data are required. 6.6.3. Log Backup • Using this menu, any log and DB file stored at the system can be copied to a storage. • Storage media like USB are required before starting the system. [Figure 6.13 Log Backup screen]

[Page 170] 6 - 16 HS50/HS60 Service Manual 6.7. Report 6.7.1. Report Shows the log information stored in the system regarding State, Temperature, Diagnostic SW, POST, BIST, and Connectivity. [Figure 6.14 Report screen]

[Page 171] Chapter 6. Service Mode 6 - 17 6.8. Demo Play 6.8.1. Demo Play • Play: Plays the image already stored in the system. • Import: Saves the image from USB or CD to a specified storage. • Delete: Deletes any image stored. • Interval: Adjusts the time interval between the images being played. [Figure 6.15 Demo Play screen]

[Page 172] 6 - 18 HS50/HS60 Service Manual 6.9. Entering the Installation Key Register the system after installing the software. 1. Once the system reboots after installation, the System Installation screen will be displayed. [Figure 6.16 System Installation input window] 2. Enter the Installation Key. The Installation Key can be acquired from Samsung Remote Service.

[Page 173] Chapter 6. Service Mode 6 - 19 TIP Samsung Remote Service Samsung Remote Service is used to issue the installation keys required for product authentication. Please enter the required information, such as product name, user, and distributor. URL: http://www.samsungremoteservice.com/rm/identity/anonymous/ussInstKey.html 1. Enter product name, user, and distributor information. – Serial No: Enter the product serial number. The serial number is located on the label on the exterior of the product. – Code: Enter the code shown on the System Installation screen. – Enter the name of the hospital and your vendor information in the Hospital Info and Distributor field. 2. Press Install key Generate to acquire your installation key. [Figure 6.17 Samsung Remote Service] 3. Press Authentication to complete the authentication process.

[Page 174] Chapter 7 7. Troubleshooting Chapter 7. Troubleshooting Troubleshooting 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

[Page 175] 7 - 2 HS50/HS60 Service Manual 7.1. Power Issues 7.1.1. Power Does Not Turn on The power cord may be unplugged, the ADM may have failed to output the necessary voltage, or the power receptacle may have failed. 1. Make sure the power cord is properly plugged and the power switch is on. 2. Connect a different appliance to the power outlet to see whether it works. – If the appliance works, the power connection part has failed. – If the appliance does not work, the power outlet has failed. 3. Check if the system fan works. – If the fan works, the problem is likely to have been caused by reasons other than the power connection part. – If the fan does not work, it is likely that the PC Power has failed. 4. Check the output voltage of the ADM. 5. Check the PC Power and DDM. 7.1.2. Power Does Not Turn off A software error may have occurred, or the PC Motherboard and/or Main Board may have failed. 1. Press and hold the Power button for at least 3 seconds, and power will turn off automatically. Note, however, that power will not turn off if hardware such as the printer has not yet stopped working or if an OS error has occurred. 2. If power does not turn off even by the method in paragraph 1 above, it is likely that the PC board and/or BE board have (has) failed. 7.1.3. Power Turns off by Itself It is likely that the Power Cord, PC Mother, Main Board, Cable & Connector Pin (shorted), AIM, and ADM PSU have failed. 1. Make sure the power cord is properly plugged and the power switch is on. 2. Connect a different appliance to the power outlet to see whether it works. – If the appliance works, the power connection part has failed. – If the appliance does not work, the power outlet has failed. 3. Check the LED status of the ADM. 4. If the problem is not solved by the methods in paragraphs 1 and 2 above, it is likely that the PC Motherboard, PCI Board, DVI Board, LCD IF Board, AIM, and/or ADM have (has) failed.

[Page 176] Chapter 7. Troubleshooting 7 - 3 7.2. Monitor 7.2.1. Nothing Is Displayed on the Screen The DVI Cable and/or VGA Cable may have failed, or the Monitor and/or PC part may have failed. 1. Check the status of the product with the printer output. 2. Check the status of the monitor connection cable. 3. If the problem is not solved by the method in paragraphs 1 and 2 above, it is likely that the Monitor and/or PC Part have (has) failed. Check the DVI board and VGA card of the PC Part. 7.2.2. Screen is Discolored The Monitor and DVI cable may have failed, or the Monitor and/or PC Part may have failed. 1. Check the status of the monitor connection cable. 2. If the problem is not solved by the method in paragraph 1 above, it is likely that the Monitor and/or PC Part have (has) failed. Check the DVI board and VGA card of the PC Part.

[Page 177] 7 - 4 HS50/HS60 Service Manual 7.3. Error Messages 7.3.1. Error Occurs During Booting This may be a temporary software error, or it may indicate product failure. 1. Turn power off, and then turn it back on in 1-2 minutes. 2. If the problem is not solved even by the method in paragraph 1 above, determine when the error message is shown. If the error occurs while WINDOWS is initiating, it is likely that the OS and/or PC part have (has) failed. If the error occurs after the logo is displayed, it is likely that the System Software or Ultrasound System part has failed. 7.4. Image 7.4.1. 2D Mode: There is No IMAGE ECHO or IMAGE FORMAT Contact between the probe and the product may be poor, or the Main Board or DDM may have failed. 1. Check whether the contact between the probe and the system is poor. 2. Check the probe for vibrating sound. If you can hear the sound, it is likely that the DDM has failed. 3. If the problem is not solved even by the methods in paragraphs 1 and 2 above, it is likely that the Main Board has failed. 7.4.2. Lines (Noise) Appear in 2D Mode Image Power noise and/or Main Board failure may have occurred. 1. Check whether the product is sharing the power outlet with another appliance. 2. Sharing a power outlet with a motor or other appliance that consumes large amount of power may cause noise. 3. Check whether the symptom persists when you plug the system into an outlet in a different room. 4. If the noise occurs, it is caused by power noise. 5. If the problem is not solved even by the methods in paragraphs 1 and 2 above, it is likely that the Main B Board has failed. 7.4.3. M, C, PW, CW Mode Trouble It is likely that the Main Board has failed.

[Page 178] Chapter 7. Troubleshooting 7 - 5 7.5. USD Device Detection Failure 7.5.1. Failed to recognize the USB (Removable device) device It is related to Windows 7, and it may cause the storage volume of the removable device not to be recognized if such removable device has been shut down after connecting it to the device for the first time. This issue can be fixed by reinstalling the volume. 1. Launch Windows Explorer, type "devmgmt.msc," and then start Device Manager 2. Choose "Storage Volumes" from the device list 3. Choose "Unknown device" under "Storage Volumes" and uninstall it 4. Run "Scan for hardware changes" from Device Manager

[Page 179] 7 - 6 HS50/HS60 Service Manual 7.6. Trouble Shooting Tree • System power does not turn on. Is the power cord plugged NO properly into the power Plug the power cord into the power outlet? outlet Circuit breaker ON Does the circuit breaker NO turn on? Replace the power module NO Does the Status LED turn green? Replace the PC module NO Is the power cable Does the power button connected normally? LED turn ON? YES NO Reconnect the cable Does the CP LED color NO change from white to orange? NO Check the PC module and/or SSD Does the OCP LED System booting works normally blink? Replace the ADM Module

[Page 180] Chapter 7. Troubleshooting 7 - 7 • No image appears in the monitor. No image appears in the Main Monitor or Touch Monitor NO Replace the ADM or cable Are the monitor power YES Does the LED and HDMI signal Monitor failure Backlight turn on? working normally? Replace the Monitor

[Page 181] 7 - 8 HS50/HS60 Service Manual • Noise occurs in the image format. Noise appears in the image Is there any YES Use a different power from peripheral likely to the noise source or remove affect the system? the noise source NO Change the Probe to another port Check the BIST before testing report Passed all the Is any noise visible? Test the analog part in BIST tests? NO YES Check if the Probe PSA board Check failed

[Page 182] Chapter 7. Troubleshooting 7 - 9 • System power does not turn on. Track Ball does not work properly but deviates Clean the inside of the Track Ball NO Does it work Replace the Track Ball normally? Does it work Replace the Track Ball Use normally? Cable Use Does it work normally? Use Check the PC module

[Page 183] 7 - 10 HS50/HS60 Service Manual • System power does not turn off. Press the Power button of the CP. Suspected collision between Ultrasound Software → Reinstall the software NO Is Windows closed? Replace the PC and SSD if the system works at abnormally slow rate or system booting takes an abnormally long time Is the system running NO Is the system NO Does any blue the shutdown deactivated in the screen symptom process? course of shutdown? appear? YES YES YES Turn off the system Reinstall the system software Check the power module Second, SSD, VGA card, RAM connection Check

[Page 184] Chapter 8 8. Disassembly and Assembly Chapter 8. Disassembly and Assembly Disassembly and Assembly 8.1. Power Issues 2 8.1.1. Preparation 2 8.2. Disassembling the Product 3 8.2.1. Rear Side Disassembly 3 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

[Page 185] 8 - 2 HS50/HS60 Service Manual 8.1. Power Issues This chapter describes the procedure for disassembling the HS50/HS60 system. Refer to this chapter when upgrading or servicing the system’s hardware. • Samsung Medison's customer service department or authorized engineers are allowed to repair or replace the parts of the products. • The interior of this product contains dangerous high-voltage electricity. Do not disassemble the product. Otherwise, short-circuit may occur. • Do not wear an antistatic wrist strap while working with the product in powered on state. Otherwise, you may sustain electrical injury. 8.1.1. Preparation You will need the following items: Phillips (+) screwdriver, antistatic gloves, and antistatic wrist strap. Turn off the power of the product and disconnect the battery. Wear antistatic gloves and wrist strap when disassembling or reassembling the product. They help prevent accidents for the engineer and product failure caused by static electricity. [Figure 8.1 Antistatic Gloves and Wrist Strap]

[Page 186] Chapter 8. Disassembly and Assembly 8 - 3 8.2. Disassembling the Product 8.2.1. Rear Side Disassembly 1. First, disconnect the Power Cord. Remove 8 screws and detach the rear cover. Next, remove 5 screws and detach the Cable Protection Cover. 2. Disconnect 7 cable connectors. At this time, make sure that the connectors are disconnected while holding down their locking mechanism. Remove 6 screws and detach the Shield Cover.

[Page 187] 8 - 4 HS50/HS60 Service Manual 3. Remove 2 screws and detach both BE module and BF board. 4. Remove 5 connectors and 4 screws and detach the ADM Module.

[Page 188] Chapter 8. Disassembly and Assembly 8 - 5 8.2.2. HDD Disassembly 1. First, disconnect the Power Cord. Remove 8 screws and detach the rear cover. Next, remove 5 screws and detach the Cable Protection Cover. 2. Remove 2 HDD mounting screws and detach the HDD.

[Page 189] 8 - 6 HS50/HS60 Service Manual 8.2.3. Front End Disassembly 1. First, remove 2 screws on the bottom of the Foot Cover and detach the Foot Cover. As shown in the figure below, use your hands to pull the Front Cover forward and detach it. (no screw used) 2. Remove 10 screws and pull up the handles mounted on the PSA Board. Use your hands to pull the handles forward to detach the PSA.

[Page 190] Chapter 8. Disassembly and Assembly 8 - 7 8.2.4. Control Panel Disassembly 1. First, remove 14 screws on the bottom of the CP Panel and carefully lift the upper plate of the CP Panel. Then, remove 6 connectors and detach the upper plate of the CP Panel. 2. Remove 2 screws and 1 connector of the Track Ball and detach the Track Ball.

[Page 191] 8 - 8 HS50/HS60 Service Manual 8.2.5. Touch Panel Disassembly Remove 4 screws on the bottom of the CP Panel and detach 2 connectors. Take care when detaching the CP Panel and Touch Panel so that the surface of the Touch Panel is not scratched.

[Page 192] Chapter 8. Disassembly and Assembly 8 - 9 8.2.6. Dust Filter and Fan Disassembly First, pull out the Dust Filter on the bottom of the system to the left. Detach the Foot Cover and the Front Cover. On the bottom of the PSA, remove 2 screws and detach the Fan Power Connector. Finally, detach the FAN Module.

[Page 193] 8 - 10 HS50/HS60 Service Manual 8.2.7. ODD Disassembly 1. First, detach the Rear Cover of the system. As shown in the figure below, remove 2 screws and open the Case right and left to detach it. 2. Remove 8 screws and lift the upper plate to detach it. 3. Remove 2 screws and 1 connector and pull out the ODD forward.

[Page 194] Chapter 8. Disassembly and Assembly 8 - 11 8.2.8. Monitor Disassembly 1. First, remove 2 screws on the rear bottom of the Monitor.

[Page 195] Chapter 9 9. Probes Chapter 9. Probes Probes 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

[Page 196] 9 - 2 HS50/HS60 User Manual 9.1. Probes The probe is a device that sends and receives ultrasound for acquiring image data. It is also called a Transducer or Scanhead. The system limits patient contact temperature to 43 degrees Celsius, and acoustic output values to their respective U.S. FDA limits. A power protection fuse circuit protects against over-current conditions. If the power monitor protection circuit senses an over-current condition, then the drive current to the probe is shut off immediately, preventing overheating of the probe surfaces and limiting acoustic output. 9.1.1. Probe List The ultrasound image scanner uses probes to obtain graphic data of the human body and then displays it on the screen. Always use application-specific probes in order to obtain the best quality images. It is also important to configure the probe with the best settings for the particular organ being scanned. ■ Probe Application and Presets The types of probes, applications, and presets available with this product are as follows: Small Parts Breast, Thyroid, Testicle LA3-14AD Vascular Carotid, Arterial, Venous, TCD GYN Uterus, Adnexa Linear Small Parts Breast, Thyroid, Testicle LA2-9A Vascular Carotid, Arterial, Venous, TCD GYN Uterus, Adnexa LA3-16AI Abdomen Abdomen, Renal, Bowel, Aorta

[Page 197] Chapter 9. Probes 9 - 3 MSK General, Superficial, Deep Small Parts Breast, Thyroid, Testicle GYN Uterus, Adnexa Small Parts Breast, Thyroid, Testicle LA4-18BD Vascular Carotid, Arterial, Venous, TCD GYN Uterus, Adnexa Small Parts Breast, Thyroid, Testicle LA3-16A Vascular Carotid, Arterial, Venous, TCD GYN Uterus, Adnexa Curved CA1-7AD GYN Uterus, Adnexa

[Page 198] 9 - 4 HS50/HS60 User Manual Urology Prostate, Bladder CA2-9AD GYN Uterus, Adnexa Urology Prostate, Bladder CA2-6BM Abdomen Abdomen, Renal CF4-9 GYN Uterus, Adnexa Urology Prostate, Bladder Cardiac Adult Echo, Ped Echo, Aortic Arch PA1-5A Pediatric Ped Abd Phase Cardiac Adult Echo, Ped Echo, Aortic Arch PA3-8B Pediatric Ped Abd PE2-4 Cardiac Adult Echo, Ped Echo, Aortic Arch

[Page 199] Chapter 9. Probes 9 - 5 Pediatric Ped Abd EA2-11B GYN Uterus, Adnexa Urology Prostate, Bladder Endo Cavity ER4-9 GYN Uterus, Adnexa Urology Prostate, Bladder CV1-8AD GYN Uterus, Adnexa 3D Urology Prostate, Bladder V5-9 GYN Uterus, Adnexa Urology Prostate, Bladder Cardiac Adult Echo, Ped Echo DP2B Pencil Cardiac Adult Echo, Ped Echo CW6.0 • In addition to the standard presets, users can also create up to five of their own, which can be accessed by selecting User 1-8. • For information on the selection and setting of probes, refer to ‘Chapter 6. Starting NOTE Diagnosis’ in the user manual.

[Page 200] 9 - 6 HS50/HS60 User Manual ■ Function List The functions available in this product for various probes and applications are as follows: MSK O O O X X O O General (O) Small Parts O O Breast (O), O X X O O Thyroid (O) LA3-14AD GYN O O X O X X O O Small Parts O O X O X X O O LA2-9A Vascular O O X O X X O O GYN O O X O X X O O Small Parts O O X O X X O O LA3-16AI Vascular O O X O X X O O GYN O O X O X X O O LA4-18BD

[Page 201] Chapter 9. Probes 9 - 7 General (O) Small Parts O O Breast (O), O X X O O Thyroid (O) GYN O O X O X X O O MSK O O O X X O O General (O) Small Parts O O Breast (O), O X X O O Thyroid (O) LA3-16A GYN O O X O X X O O CA1-7AD GYN O O X O X X O O CA2-9AD GYN O O X O X X O O

[Page 202] 9 - 8 HS50/HS60 User Manual CA2-6BM Abdomen O O X O X X O O CF4-9 GYN O O X O X X O O Abdomen X O X O X X O O Cardiac X O X O O O X X PA1-5A Vascular X O X O X X O O Pediatric X O X O X X O O Abdomen X O X O X X O O Cardiac X O X O O O X X PA3-8B Vascular X O X O X X O O Pediatric X O X O X X O O Abdomen X O X O X X O O Cardiac X O X O O O X X PE2-4 Vascular X O X O X X O O Pediatric X O X O X X O O OB X O X O X X O O EA2-11B GYN X O O O X X O O Urology X O Prostate(O), O X X O O

[Page 203] Chapter 9. Probes 9 - 9 Bladder(X) OB X O X O X X O O GYN X O O O X X O O ER4-9 Prostate(O), Urology X O O X X O O Bladder(X) CV1-8AD GYN O O X O X X O O OB X O X O X X O O GYN X O O O X X O O V5-9 Prostate(O), Urology X O O X X O O Bladder(X) Cardiac X O X X X X X X DP2B Vascular X O X X X X X X Cardiac X O X X X X X X CW6.0 Vascular X O X X X X X X

[Page 204] 9 - 10 HS50/HS60 User Manual MSK O X X O O O O Small Parts O X X O O O O LA3-14AD Vascular O X X O O O O MSK O X X O O O O Small Parts O X X O O O O LA2-9A Vascular O X X O O O O Abdomen X X X O O O O MSK X X X O O O O Small Parts X X X O O O O LA3-16AI Vascular X X X O O O O OB X X X O O O O GYN X X X O O O O Pediatric X X X O O O O MSK O X X O O O O LA4-18BD Small Parts O X X O O O O

[Page 205] Chapter 9. Probes 9 - 11 MSK O X X O O O O Small Parts O X X O O O O LA3-16A Vascular O X X O O O O MSK O X X O O O O CA1-7AD GYN O X X O O O O MSK O X X O O O O CA2-9AD GYN O X X O O O O CA2-6BM Abdomen X X X O O O O Abdomen X X X O O X X CF4-9 MSK X X X O O X X

[Page 206] 9 - 12 HS50/HS60 User Manual OB X X X O O X X GYN X X X O O X X Pediatric X X X O O X X Vascular X X X O O X X Urology X X X O O X X Abdomen X X O X O O O Cardiac X O O X O O O PA1-5A Vascular X X O X O O O Pediatric X X O X O O O Abdomen X X O X O O O Cardiac X O O X O O O PA3-8B Vascular X X O X O O O Pediatric X X O X O O O Abdomen X X O X O O O Cardiac X O O X O O O PE2-4 Vascular X X O X O O O Pediatric X X O X O O O EA2-11B GYN O X X O O O O ER4-9 GYN O X X O O O O CV1-8AD MSK O X X O O O O

[Page 207] Chapter 9. Probes 9 - 13 V5-9 GYN O X X O O O O Cardiac X X O X X X X DP2B Vascular X X O X X X X Cardiac X X O X X X X CW6.0 Vascular X X O X X X X • The significance of each symbol is as follows: – Q Scan: Quick Scan – Har: Harmonic Imaging NOTE – S-Har: S-Harmonic Imaging – ECG: Electrocardiograph Imaging – CM: Color M – TDI: Tissue Doppler – PD: Power Doppler – S-Flow: Directional Power Doppler Imaging – TDW: Tissue Doppler Wave – CW: Continuous Wave • MultiVision is only available in 2D/C Mode.

[Page 208] 9 - 14 HS50/HS60 User Manual 9.1.1.1. Thermal Index (TI) Table The Thermal Index (TI) is displayed in the Title area of the screen, and represents the probability of temperature rise in a particular area of the body. The thermal index consists of the following indices: Soft tissue (TIs), bone (TIb), and cranial bone (TIc). This product automatically displays an appropriate thermal index for the current probe and application. Refer to the following table: Small Parts Breast, Thyroid,Testicle TIs LA3-14AD 1st Trimester, 2nd Trimester 3rd Trimester, Fetal Heart Small Parts Breast, Thyroid, Testicle TIs LA2-9A Vascular Carotid, Arterial, Venous, TCD TIs MSK General, Superficial, Deep TIs Small Parts Breast, Thyroid, Testicle TIs LA3-16AI

[Page 209] Chapter 9. Probes 9 - 15 Small Parts Breast, Thyroid, Testicle TIs LA4-18BD Vascular Carotid, Arterial, Venous, TCD TIs Small Parts Breast, Thyroid, Testicle TIs LA3-16A 1st Trimester, 2nd Trimester 3rd Trimester, Fetal Heart NT CA1-7AD CA2-9AD

[Page 210] 9 - 16 HS50/HS60 User Manual NT CA2-6BM Abdomen Abdomen, Renal TIs CF4-9 GYN Uterus, Adnexa TIs Cardiac Adult Echo, Ped Echo, Aortic Arch TIs PA1-5A Pediatric Ped Abd TIs Cardiac Adult Echo, Ped Echo, Aortic Arch TIs PA3-8B Pediatric Ped Abd TIs Cardiac Adult Echo, Ped Echo, Aortic Arch TIs PE2-4 Pediatric Ped Abd TIs

[Page 211] Chapter 9. Probes 9 - 17 EA2-11B GYN Uterus, Adnexa TIs ER4-9 GYN Uterus, Adnexa TIs NT CV1-8AD V5-9 GYN Uterus, Adnexa TIs Cardiac Adult Echo, Ped Echo TIs DP2B Cardiac Adult Echo, Ped Echo TIs CW6.0 • The default thermal index may vary, corresponding to the presets. • You can change the thermal index can in Setup > Imaging > Application/Preset > Preset Settings > Thermal Index Type.

[Page 212] 9 - 18 HS50/HS60 User Manual 9.1.2. Ultrasound Transmission Gel For proper transmission of the acoustic beam, only use ultrasound transmission gel approved by Samsung Medison. • The use of inappropriate ultrasound gels could result in damages in the probe. Using damaged probe could cause injuries such as electric shock in users or patients. • Do not use ultrasound gels or contact media that contain the following contents. – Oils such as mineral oil, cooking oil, gasoline, solvents, rust inhibitors, lanolin, paraffin-based grease, ester and excessive silicon-based release agent. – Alcohols such as acetone, methanol, plasticizer (dioctylphtalate) or denatured alcohols. – Glacial acetic acid and iodine. – All types of lotions or gels that contain aromatic substances. 9.1.2.1. Gel Warmer (Optional) The Gel Warmer keeps the ultrasound gel warm. Warming up ultrasound gel takes approximately 5 minutes. • Always turn the Gel Warmer off when it is not in use. • Do not put your hands inside the Gel Warmer, as it may burn your skin. • Do not use the Gel Warmer for purposes other than to control the temperature of ultrasound gel. • Do not place the probe or any other equipment inside the Gel Warmer. • Do not touch the power terminal of the Gel Warmer while you are examining a patient. There is a risk of electric shock from leakage current. • Do not apply excessive force to the Gel Warmer, or you may damage its support parts. [Figure 9.1 Gel Warmer Label – Example]

[Page 213] Chapter 9. Probes 9 - 19 9.1.3. Sheaths Sheaths are recommended for clinical applications of an invasive nature, including intraoperative, transrectal, transvaginal, and biopsy procedures. Using a sheath also prevents contamination from blood or other bodily fluids during operations or biopsy. Samsung Medison does not supply sheaths, so appropriate sheaths should be purchased independently. • Always keep sheaths in a sterile state. • Sheaths are disposable. Do not reuse them. • If sheaths are torn or soiled after use, clean and disinfect the probe. WARNING • In neurosurgical applications, a disinfected probe must be used with sterile gel and a sterile pyrogen-free sheath. • If the sterile sheath becomes compromised during neurosurgical applications involving a patient with Creutzfeldt-Jakob disease, the probe cannot be successfully sterilized by any disinfection method. • Some sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Please refer to the FDA Medical Alert released on March 29, 1991. 9.1.3.1. Installing the Sheath 1. Remove the sheath from the packaging, and fill it with ultrasound gel. Be sure to put on sterilized surgical gloves. 2. Insert the probe into the sheath and pull the latex tip to cover the probe completely. If possible, cover the probe cable as well. 3. Ensure that there are no air bubbles trapped within the ultrasound gel. If necessary, secure the sheath to the probe and the probe cable. 4. Dispose of the sheath after use. 9.1.4. Probe Safety Precautions • Do not apply mechanical shock to the probe. • Do not place the probe cable on the floor where the cable can be run over by equipment wheels, etc. Do not apply excessive force to bend or pull the cable. • Do not immerse the probe into any inappropriate substances such as alcohol, bleach, ammonium chloride, and hydrogen peroxide. • Do not expose the probe to temperatures of +50 ° C or higher. The probe can easily be damaged by improper use or by coming into contact with certain chemical substances. Always follow the instructions in the user manual to inspect the probe cable, case and lens before and after each use. Check the probe for cracks, broken parts, leaks and sharp edges. If there is any damage, stop using the probe immediately and contact the Samsung Medison Customer Support Department. Using damaged probes may result in electric shocks and other hazards to the patients and/or users.

[Page 214] 9 - 20 HS50/HS60 User Manual 9.1.4.1. Use and Infection Control of the Probe No neurosurgical treatments or examinations should be carried out on a patient with Creutzfeldt-Jakob disease. If the probe has been used on such a patient, it cannot be sterilized by any method whatsoever. Sufficient washing and disinfecting must be carried out to prevent infection. This is the responsibility of the user who manages and maintains the disinfection procedures for the equipment. Always use legally approved detergents. The ultrasonographic image scanner uses ultrasound, and makes direct contact with the patient when in use. Depending on the types of examinations, such contact can be made to a wide variety of locations, including the ordinary skin or the location of blood transfusion during a surgical procedure. The most effective method of preventing infection among patients is to use each probe only once. However, probes may need to be reused, as they are complex in design and expensive. Consequently, the safety instructions must be followed carefully in order to minimize the risk of infection among patients. 9.1.4.2. Electric Shocks The probe uses electrical energy. If it touches conductive materials, there are risks of electric shocks to the patient or the user. • The product should regularly be checked for electrical leakage by the Samsung Medison Customer Support Department. • Do not immerse the probe into liquid. • Do not drop the probe or apply mechanical shocks. • Inspect the housing, strain relief, lens, and seal for damage, and check for any functional problem before and after each use. • Do not apply excessive force to twist, pull or bend the probe cable. • The power protection fuse protects the probe and the product from excess current. If the power monitoring protection circuit detects excess current, it immediately shuts off the current to the probe in order to prevent the probe surface from overheating and to restrict the ultrasound power output. • The temperature of the product for making contact with patients is limited under 43°C. The ultrasound power output (AP&I) is in compliance with US FDA standards.

[Page 215] Chapter 9. Probes 9 - 21 9.1.5. Cleaning and Disinfecting the Probe Using an inappropriate cleaning or sterilizing agent may damage the probe. • Always use protective eyewear and gloves when cleaning and disinfecting probes. • Inspect the housing, strain relief, lens and seal for damage, and check for any functional problem after cleaning and disinfecting the probe. 9.1.5.1. Information of Detergent, Disinfectant, and Ultrasound Gel ■ Classification of Disinfectants To maintain the performance of ultrasound probes, proper maintenance is required. As ultrasound probes are classified into critical, semi-critical, or non-critical devices based on the standards of FDA guidance*, proper disinfection, cleaning or sterilization methods for that classification should be used. Classification Contact Area Application Probe Level Selection Criteria Non-critical Convex, Linear array, and Intact skin Low level disinfectant device sector transducers Semi-critical Mucous membrane and Endocavity High level disinfectant device damaged skin High level disinfectant or Critical device blood, sterile tissue, etc. Intraoperative, TEE sterilization *Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Appendix D

[Page 216] 9 - 22 HS50/HS60 User Manual An appropriate detergent, disinfectant or ultrasound gel should be selected based on the following tables. All probes are tested in accordance with IPX 7 Criteria. 7) 7) T-Spray Tristel Duo T-Spray II Septiwipes Ster-Bac Blu Sani-Cloth HB Incidin Foam Sani-Cloth Plus Sani-Cloth Active Cleanisept Wipes Transeptic Spray Super Sani-Cloth Tristel Sporicidal Wipe Cleanisept wipe forte Sani-Cloth Germicidal Sani-Cloth AF Germicidal Sani-Cloth AF3 Germicidal Sani-Cloth Bleach Germicidal Type S W S S W W W W W W W W L W S S W W H H L L L L L L L L L L L L L L L L (N-Alkyl) (N-Alkyl) Quaternary Ammonium Quaternary Ammonium Chlorine dioxide Ammonium Chlorides LA3-14AD ● ● ● ● ● ● ● ● LA2-9A ◆ ◆ ◎ ▣ ▲ LA3-16AI ● ● ● ● ● ● ● ● LA4-18BD LA3-16A ● ● ● CA1-7AD ● ● ● ● ● ● ● ● CA2-9AD ● ● ● ● ● ● ● ● ● CA2-6BM ● CF4-9 ◆ ◆ ◎ ◆ PA1-5A ● ● ● ● ● ● ● ● ● ● PA3-8B ● ● ● ● ● ● ●

[Page 217] Chapter 9. Probes 9 - 23 7) 7) T-Spray Tristel Duo T-Spray II Septiwipes Ster-Bac Blu Sani-Cloth HB Incidin Foam Sani-Cloth Plus Sani-Cloth Active Cleanisept Wipes Transeptic Spray Super Sani-Cloth Tristel Sporicidal Wipe Cleanisept wipe forte Sani-Cloth Germicidal Sani-Cloth AF Germicidal Sani-Cloth AF3 Germicidal Sani-Cloth Bleach Germicidal Type S W S S W W W W W W W W L W S S W W H H L L L L L L L L L L L L L L L L (N-Alkyl) (N-Alkyl) Quaternary Ammonium Quaternary Ammonium Chlorine dioxide Ammonium Chlorides PE2-4 ● ● ● ● ● ● ● EA2-11B ◆ ◆ ◎ ▣ ▲ ER4-9 ● ● CV1-8AD ● ● ● ● ● ● ● ● V5-9 ◆ ◆ ◎ ▲ ▲ ▲ ▲ ■ ▲ DP2B ◆ ◆ ◎ ▣ ▲ CW6.0 ◆ ◆ ◎ ▣ ▲

[Page 218] 9 - 24 HS50/HS60 User Manual 7) 7) 7) 2) 2,3,7) 2,7) Names 7) Cidex Cidex 2% MetriWipes Metricide Asepti-Wipes CaviWipes Cidex OPA Cidex Plus Metricide 14 Metricide 28 Metricide 30 Omnicide 28 Asepti-Wipes II Omnicide 14NS Omnicide - FG2 Metricide OPA Plus Type W W W W L L L L L L Soak Soak Soak L L L L L L L H H H H H H H H H H H H (N-Alkyl) Alcohol Glutaraldehyde Glutaraldehyde Glutaraldehyde Ortho-phthalaldehyde Quaternary Ammonium Ortho-Phthalaldehyde LA3-14AD ● ● ● ● ● LA2-9A ▣ ▲ ◇ ▣ LA3-16AI ● ● ● ● ● ● × ● LA4-18BD ● ● LA3-16A ● ● ● ● ● ● ● CA1-7AD ● ● ● ● ● CA2-9AD ● ● ● ● ● ● CF4-9 ▣ ▲ ◇ ▣ PA1-5A ● ● ● ● ● ● ● ● ● ● PA3-8B ● ● ● ● ● ● ● ● ● PE2-4 ● ● ● ● ● ● ● ● ● EA2-11B ▣ ▲ ◇ ▣ ER4-9 ● ● ● ●

[Page 219] Chapter 9. Probes 9 - 25 7) 7) 7) 2) 2,3,7) 2,7) Names 7) Cidex Cidex 2% MetriWipes Metricide Asepti-Wipes CaviWipes Cidex OPA Cidex Plus Metricide 14 Metricide 28 Metricide 30 Omnicide 28 Asepti-Wipes II Omnicide 14NS Omnicide - FG2 Metricide OPA Plus Type W W W W L L L L L L Soak Soak Soak L L L L L L L H H H H H H H H H H H H (N-Alkyl) Alcohol Glutaraldehyde Glutaraldehyde Glutaraldehyde Ortho-phthalaldehyde Quaternary Ammonium Ortho-Phthalaldehyde CV1-8AD ● ● ● ● ● V5-9 ● ● ▲ ◇ ● ● DP2B ● ▲ ◇ ● CW6.0 ▲ ▣ ◇ ▣

[Page 220] 9 - 26 HS50/HS60 User Manual 3) 3) 7) 7) Milton Nuclean Virkon Sporox Gigasept Sporox II Wavicide-01 Steranios 2% Sekusept Plus Bleach 5.25% Gigasept AF Sekusept Extra Salvanios pH 7 Salvanios pH 10 Surfaces Hautes Type L L L L L L S L L L L L L L L L H H H H H H H L L H H H H H Alcohol Potassium Quaternary Ammonium formaldehyde Glutaraldehyde Nonionic surfactant Sodium Hypochlorite peroxymonosulfate Hydrogen Peroxide Succindialdehyde, LA3-14AD ● ● ● ● LA2-9A ▣ ◎ LA3-16AI × × ● ● LA4-18BD ● ● LA3-16A ● ● ● × CA1-7AD ● ● ● ● CA2-9AD ● ● ● ● CF4-9 ▣ ◎ PA1-5A ● ● ● ● ● PA3-8B ● ● ● ● PE2-4 ● ● ● ● EA2-11B ▣ ◎ ER4-9 ● ● ● × CV1-8AD ● ● ● ●

[Page 221] Chapter 9. Probes 9 - 27 3) 3) 7) 7) Milton Nuclean Virkon Sporox Gigasept Sporox II Wavicide-01 Steranios 2% Sekusept Plus Bleach 5.25% Gigasept AF Sekusept Extra Salvanios pH 7 Salvanios pH 10 Surfaces Hautes Type L L L L L L S L L L L L L L L L H H H H H H H L L H H H H H Alcohol Potassium Quaternary Ammonium formaldehyde Glutaraldehyde Nonionic surfactant Sodium Hypochlorite peroxymonosulfate Hydrogen Peroxide Succindialdehyde, V5-9 ▣ ◎ ◎ DP2B ▣ ◎ CW6.0 ▣ ◎

[Page 222] 9 - 28 HS50/HS60 User Manual Disinfectants Cleaner 7) Enzol (70%) (80%) Hibitane PeraSafe Alkazyme Cidezyme Klenzyme Gigasept FF OX RESERT Ethanol 75% Anioxyde 1000 STERIS REVITAL Isopropyl alcohol Isopropyl alcohol Type L L P Soak L L L/W L L L L L H – H H H solution Peroxide Alcohol Citric Acid Bersteinsaure Peracetic Acid Proteolytic Enzymes Accelerated Hydrogen Chlorhexidine gluconate Sodium Xylene Sulfonate Dodecylphenolethoxylate, LA3-14AD × ● ● ● ● LA2-9A ◎ ◎ ▲ LA3-16AI ● ● ● ● LA4-18BD ● ● ● LA3-16A ● ● ● CA1-7AD ● ● ● ● ● CA2-9AD ● ● ● ● ● CF4-9 ◎ ◎ ▲ PA1-5A ● ● ● ● ● PA3-8B ● ● ● PE2-4 ● ● ● EA2-11B ◎ ◎ ▲ ER4-9 ● ● ●

[Page 223] Chapter 9. Probes 9 - 29 Disinfectants Cleaner 7) Enzol (70%) (80%) Hibitane PeraSafe Alkazyme Cidezyme Klenzyme Gigasept FF OX RESERT Ethanol 75% Anioxyde 1000 STERIS REVITAL Isopropyl alcohol Isopropyl alcohol Type L L P Soak L L L/W L L L L L H – H H H solution Peroxide Alcohol Citric Acid Bersteinsaure Peracetic Acid Proteolytic Enzymes Accelerated Hydrogen Chlorhexidine gluconate Sodium Xylene Sulfonate Dodecylphenolethoxylate, CV1-8AD ● ● ● ● ● V5-9 ▲ ◐ DP2B ◎ ◎ ▲ CW6.0 ◎ ◎ ▲

[Page 224] 9 - 30 HS50/HS60 User Manual Cleaner Gel 3) Antigermx Names Trophon S1 SCAN Kendall Sonogel Metrizyme McKesson Wavelength Contact Gel Clear Image Natural Image GE Ultrasound Aquasonics 100 Type L L G G G G G G G G NA PCMX (Chloroxylenol) Propylene Glycol Ammonium Chlorides LA3-14AD ● ● ● LA2-9A ● ● ● ● LA3-16AI ● ● ● LA4-18BD ● LA3-16A ● ● ● CA1-7AD ● ● ● ● CA2-9AD ● ● ● ● CF4-9 ● ● ● ● PA1-5A ● ● ● ● PA3-8B ● ● ● ● PE2-4 ● ● ● ● EA2-11B ● ● ● ER4-9 ● ● ●

[Page 225] Chapter 9. Probes 9 - 31 Cleaner Gel 3) Antigermx Names Trophon S1 SCAN Kendall Sonogel Metrizyme McKesson Wavelength Contact Gel Clear Image Natural Image GE Ultrasound Aquasonics 100 Type L L G G G G G G G G NA PCMX (Chloroxylenol) Propylene Glycol Ammonium Chlorides CV1-8AD ● ● ● ● V5-9 ● ● ● ● DP2B ● ● ● CW6.0 ● ● ●

[Page 226] 9 - 32 HS50/HS60 User Manual TIP Symbols The significance of each symbol is as follows: (1) Compatible but no EPA Registration (2) FDA 510(k) Cleared (3) Has CE mark (4) Discontinued (5) Under Development (6) ANVISA Registered (7) Health Canada Approved; Sani-Cloth Plus (DIN: 02242608), Sani-Cloth Bleach Germicidal (DIN: 02450410), CaviWipes (DIN: 02242209), Cidex (DIN: 02158418), Cidex OPA (DIN: 02239732), Metricide (DIN: 01963996), Metricide 28 (DIN: 01964461), Metricide 30 (DIN: 01964496), Virkon (DIN: 02125021), Sporox II (DIN: 02243075), Hibitane (DIN: 00053201) S Spray W Wipe L Liquid P Powder G Gel Soak Soak x Not compatible (DO NOT USE) ● Compatible ★ Staining may occur on housing parts; however, the acoustic performance and image quality are not affected. ■ Must not be used for longer than 5 minutes. ◐ Must not be used for longer than 10 minutes. ▲ Must not be used for longer than 15 minutes. ◆ Must not be used for longer than 20 minutes. ◇ Must not be used for longer than 25 minutes. ◎ Must not be used for longer than 30 minutes. ▣ Must not be used for longer than 50 minutes. Blank Untested (DO NOT USE)

[Page 227] Chapter 9. Probes 9 - 33 The following is information about the manufacturers (or Distributors) of detergents, disinfectants, and ultrasound gels. Alkazyme Alkapharm UK Ltd. Anioxyde 1000 Laboratoires Anios Aquasonics 100 Parker laboratories, inc. Asepti-Wipes Ecolab Asepti-Wipes II Ecolab Bleach 5.25% - CaviWipes Metrex Cidex Advanced Sterilization Products Cidex 2% Advanced Sterilization Products Cidex OPA Advanced Sterilization Products Cidex Plus Advanced Sterilization Products Cidezyme Johnson&Johnson Cleanisept Wipes Dr.Schumacher GmbH Clear Image NEXT Medical Products Enzol Johnson&Johnson Ethanol 75% - GE Ultrasound Contact Gel GE Accessories Gigasept Schulke & Mayr GmbH Gigasept AF Schulke & Mayr GmbH Gigasept FF Schulke & Mayr GmbH Hibitane Regent Medical Incidin Foam Ecolab Isopropyl alcohol (70%) - Isopropyl alcohol (80%) - Kendall Tyco/Healthcare Klenzyme Steris McKesson McKesson Medical-Surgical Inc. Metricide 14 Metrex Metricide 28 Metrex

[Page 228] 9 - 34 HS50/HS60 User Manual Metricide 30 Metrex Metricide OPA Plus Metrex Metricide Metrex MetriWipes Metrex Metrizyme Metrex Milton Procter & Gamble Natural Image Sonotech Inc. Nuclean Alkapharm Omnicide - FG2 Coventry Chemicals Limited Omnicide 14NS Coventry Chemicals Limited Omnicide 28 Coventry Chemicals Limited PeraSafe ANTEC International Limited Salvanios pH 7 Laboratoires Anios Salvanios pH 10 Laboratoires Anios Sani-Cloth Active PDI Sani-Cloth AF Germicidal PDI Sani-Cloth AF3 Germicidal PDI Sani-Cloth Bleach Germicidal PDI Sani-Cloth Germicidal PDI Sani-Cloth HB PDI Sani-Cloth Plus PDI Scan Parker laboratories, inc. Sekusept Extra Ecolab Sekusept Plus Ecolab Septiwipes Dr. Schumacher GmbH Sonogel Sonogel Vertriebs GmbH Sporox DSHealthcare Inc. Sporox II DSHealthcare Inc. Steranios 2% Laboratoires Anios Ster-Bac Blu Ecolab Super Sani-cloth PDI

[Page 229] Chapter 9. Probes 9 - 35 Surfaces Hautes Laboratoires Anios Transeptic spray Parker laboratories, inc. Tristel Duo Tristel Solutions Limited Tristel Sporicidal Wipe Tristel Solutions Limited Trophon Nanosonics Limited T-Spray Pharmaceutical Innovations, Inc. T-Spray II Pharmaceutical Innovations, Inc. Virkon DuPont Wavelength National Therapy Products Inc. Wavicide-01 National Therapy Products Inc. 9.1.5.2. Cleaning Cleaning is an important procedure that is carried out before disinfecting the probe. The probe must be cleaned after each use. • Do not use a surgical brush when cleaning probes. Even the use of soft brushes can damage the probe. • During cleaning and disinfection, keep the parts of the probe that must remain dry higher than the other parts during wetting until all parts are dry. 1. Disconnect the probe from the system. 2. Remove any biopsy adapters or needle guides. (Adapters may be reused after disinfection.) 3. Remove the sheath. (Sheaths are disposable.) 4. Use a soft cloth, lightly dampened with mild soap or compatible cleaning solution, to remove any particulate matter and bodily fluids that remain on the probe or cable. 5. To remove remaining particulates, rinse with water up to the immersion point. 6. Wipe with a dry cloth. 7. If necessary, wipe first with a water-dampened cloth to remove soap residue, and wipe with a dry cloth again.

[Page 230] 9 - 36 HS50/HS60 User Manual 9.1.5.3. Disinfecting -6 A 10 reduction in pathogens should be reached following the disinfection procedures in this manual and using the following Samsung Medison recommended solutions. • If a pre-mixed solution is used, be sure to observe the solution expiration date. • The type of tissue it will contact during use dictates the level of disinfection required for a device. Ensure that the solution strength and duration of contact are appropriate for disinfection. • Using a non-recommended disinfectant or not following the recommended disinfection method can damage and/or discolor the probe. This could also void the probe warranty. • Do not immerse probes for longer than one hour, unless they are sterilizable. • Only use liquid solutions to sterilize probes. Do not sterilize by autoclaving or using EtO gas. 1. Please refer to the user instructions of the disinfectant for details of proper storage, use, and disposal of the disinfectant. 2. Mix the disinfectant compatible with your probe according to the instructions for solution strength provided on its label. 3. Immerse the probe into the disinfectant as shown in the illustration below. 4. Follow the instructions on the disinfectant to complete the immersion procedure of the probe, and rinse the probe afterwards. 5. Air dry the probe or towel it dry with a clean cloth. [Figure 9.2 Disinfection]

[Page 231] Chapter 9. Probes 9 - 37 9.2. Biopsy A biopsy is an examination method that surgically extracts tissue from the patient for examination. The probe and the biopsy kit are used together when conducting a biopsy with the ultrasonographic image scanner. The ultrasound system shows the needle, which penetrates through the skin surface and veins, along with the examination location, minimizing the risk to the patient. 9.2.1. Biopsy Kit Components The biopsy kit consists of the adapter, needle guide and needle. The components vary depending on the probe type. [Figure 9.3 Biopsy Kit Components] • Adapter: Secures the needle guide to the probe tightly. • Needle Guide: Guides the angle (direction) of the needle so that it can reach the examination location accurately. It also secures the needle so that the needle is not loose. • Needle: This is the needle that is inserted into the patient’s body. The biopsy kit supplied by Samsung Medison does not contain a needle. • Sheath: Prevents the probe and adapter from getting soiled by any unwanted substances during the examination (blood and other bodily fluids). • Ultrasound Gel: The space between the probe and the sheath is filled with the ultrasound gel to obtain images of the best quality.

[Page 232] 9 - 38 HS50/HS60 User Manual 9.2.2. Using the Biopsy Kit • Only use the needles approved by the country’s government. • Verify the condition of the biopsy needle before use. Do not use a bent biopsy needle. • The biopsy needle may bend during tissue penetration. The precise location of the needle must be checked by monitoring the echo generated from the needle. • Never use the biopsy kit to biopsy prostate tissue. 9.2.2.1. Before Using Biopsy Kit • Do not attempt to use the biopsy kit until you have read the instructions for installing the sheath and verifying alignment of the needle guide. • Always ensure that the probe and the needle guide are secured on both the left and the right. • Do not use in IVF, CVS, or PUBS procedures. 1. Ultrasonographic scanning using the biopsy kit must be conducted by medical doctors or experienced medical staff with appropriate qualifications. Always, without fail, verify all safety procedures and disinfection. 2. Biopsy kits not supplied by Samsung Medison may fail to fit the probe properly. Always use biopsy kits supplied by Samsung Medison, since improper setup may adversely affect the patient. 3. Inspect all components. Ensure that the biopsy kit you are using is the correct one for the probe, the system, and system software. 9.2.2.2. Biopsy Procedure The system generates a needle guideline though the displayed real-time ultrasound images to indicate the anticipated path of the needle. You can use this guideline to ensure that the needle or instrument is following the correct path. 1. Ready the patient according to the procedure appropriate for the examination objectives. 2. Install the sheath and the biopsy kit. 3. Set the system controls for the biopsy procedure. If necessary, apply acoustic gel to the patient. 4. Scan the patient. Adjust the patient so that the location for examination fits into the needle guideline on the screen. 5. Insert the needle into the needle guide for use. Perform the puncture by sliding the needle through the groove in the guide until the needle intercepts the target. To keep the needle securely in the needle guide, press down on the top of the biopsy adapter with your index finger. 6. When the examination location is reached, take the needle out of the needle guide. 7. Detach the needle guide, adapter and sheath from the probe. 8. Discard all disposable items following use.

[Page 233] Chapter 9. Probes 9 - 39 9.2.2.3. Needle Guide Alignment • The needle used for this alignment verification must not be used for the actual procedure. Always use a new, sterile needle for each biopsy procedure. • To assist in accurate projection of the needle, use a straight, new needle for each alignment procedure. Alignment of the needle guide displayed on the system is for the purpose of verifying whether the needle and the needle guide are properly installed. This must be done prior to the biopsy examination. If the needle fails to follow the accurate path while verifying the alignment of needle guide, stop using the product and contact Samsung Medison Customer Support Department. Reverberation or other tissue artifacts may produce false needle images, which can cause confusion. Ensure the needle path is along the guideline, and that you are not using a false needle image to locate the needle. 1. Attach the biopsy kit. 2. Set the system depth for the procedure to be performed and select the Biopsy menu. 3. Immerse the probe into the water bath, and insert the needle into the needle guide. 4. Confirm that the needle image is on the needle guidelines. If it is, then the needle guide is properly aligned. 5. If the needle image is out of the needle guideline, check the needle guide or the probe adapter.

[Page 234] 9 - 40 HS50/HS60 User Manual 9.2.3. Assembling the Biopsy Kit 9.2.3.1. Stainless Steel Biopsy Kit 1. Place a Sheath up to the top of the probe’s handle. 2. Mount the biopsy adapter onto the probe. If the surface of probe is fluted, mount the adapter in accordance with it. 3. Install the needle into the needle guide and start the exam. 9.2.3.2. Plastic Biopsy Kit 1. Mount the biopsy adapter onto the probe. 2. Insert gel into the sheath. And cover the probe completely. 3. Install the needle guide onto the adapter.

[Page 235] Chapter 9. Probes 9 - 41 4. Installing the Needle Guide Clip if it is included in the components. 5. Install the needle into the needle guide and start the exam. TIP Using Multi Angle Use the angle adjuster.

[Page 236] 9 - 42 HS50/HS60 User Manual 9.2.3.3. Biopsy Specifications Biopsy Probe Adapter Reusable/ Needle Multi Angle Model Name Components Material Disposable Gauge Depth Biopsy Adapter Reusable 14, 15, 16, Acetal 17, 18, 20, 1.5, 2.5, 4 LA4-18BD BP-KIT-069 Utra-Pro II Copolymer 21, 22, 23, (cm) Needle Guides & Disposable 8.5FR CIV-Flex Cover Biopsy Adapter Reusable 14, 15, 16, Acetal 17, 18, 20, LA2-9A BP-KIT-043 Utra-Pro II 4, 5.5, 7 (cm) Copolymer 21, 22, 23, Needle Guides & Disposable 8.5FR CIV-Flex Cover BP-KIT-053 Biopsy Adapter Reusable Acetal 16, 18, 20, 0.591, 0.984, LA3-14AD [BP-KIT-053- Needle Guide & Copolymer 22 1.575 (in) Disposable NG] Probe Cover BP-KIT-068 Biopsy Adapter Reusable Acetal 16, 18, 20, 0.591, 0.984, [BP-KIT-068- Needle Guide & Copolymer 22 1.575 (in) Disposable NG] Probe Cover LA3-16A BP-KIT-055 Biopsy Adapter Reusable Acetal 16, 18, 20, 0.591, 0.984, [BP-KIT-055- Needle Guide & Copolymer 22 1.575 (in) Disposable NG] Probe Cover BP-KIT-058 Biopsy Adapter Reusable 1.969, 3.937, Acetal 14, 16, 18, CA1-7AD [BP-KIT-058- 5.906, 7.874 Needle Guide & Copolymer 20, 22, 25 Disposable NG] Probe Cover (in) BP-KIT-054 Biopsy Adapter Reusable Acetal 16, 18, 22, 2.362, 3.150, CA2-9AD [BP-KIT-054- Needle Guide & Copolymer 25 3.937 (in) Disposable NG] Probe Cover Single Angle BP-KIT-065 Needle Guide Stainless Reusable 16-18 2° EA2-11B Single Angle BP-KIT-066 Needle Guide Abs Disposable 16-18 2° Single Angle BP-KIT-024-3 Needle Guide Stainless Reusable 16 1° ER4-9 Single Angle BP-KIT-061 Needle Guide Abs Disposable 16-18 1° BP-KIT-059 Biopsy Adapter Reusable Acetal 14, 16, 18, 1.969, 3.937 CV1-8AD [BP-KIT-059- Needle Guide & Copolymer 20, 22, 25 (in) Disposable NG] Probe Cover BP-KIT-029 Needle Guide Stainless Reusable 18 – V5-9 Single Angle BP-KIT-060 Needle Guide ABS Disposable 16–18 1.8°

[Page 237] Chapter 9. Probes 9 - 43 9.2.4. Cleaning and Disinfecting the Biopsy Kit Always use protective eyewear and gloves when cleaning and disinfecting biopsy kit. -6 Wash and disinfect the biopsy kit to reduce pathogens to the level of 10 . Some components of the biopsy kit may be disposable. Please read the biopsy kit user manual carefully before use. 9.2.4.1. Cleaning and Disinfection of Stainless Steel Biopsy Kit ■ Cleaning 1. After use, remove the biopsy kit from the probe. 2. Disassemble the biopsy kit into its component parts, if applicable. 3. Using a small brush and water, scrub each part to remove trapped material from the biopsy kit. 4. Rinse with water to remove remaining particulates. ■ Disinfection 1. Disinfect the adapter by autoclaving (Steam) or using gas (Ethylene Oxide). 2. After disinfection, follow the proper post-disinfection procedure for the disinfection method used (refer to the instructions for the disinfecting equipment). 3. Inspect the components for damage such as cracks, rust or breakage. If damage is discovered, contact the Samsung Medison Customer Support Department.

[Page 238] 9 - 44 HS50/HS60 User Manual 9.2.4.2. Cleaning and Disinfecting, Sterilizing of Plastic Biopsy Kit ■ Cleaning 1. After use, remove the biopsy kit from the probe. 2. Disassemble the biopsy kit into its component parts, if applicable. Discard the single-use parts. These parts cannot be disinfected. 3. Using a small brush and water, scrub each part to remove trapped material from the reusable components. 4. Rinse with water to remove remaining particulates. ■ Disinfection Plastic biopsy kits can only be disinfected by using a chemically compatible cold- disinfectant. Disinfection by autoclaving, or by using gas or radiation, will cause damage to these parts. 1. Please refer to the user instructions of the disinfectant for details of proper storage, use, and disposal of the disinfectant. 2. Check the disinfection duration (generally 10 hours) and temperature of the disinfectant. 3. After disinfection, follow the proper post-disinfection procedure for the disinfection method used. 4. Inspect the components for damage such as cracks, rust or breakage. If damage is discovered, contact the Samsung Medison Customer Support Department. ■ Sterilization • The plastic biopsy adapter is reusable. • The plastic biopsy needle guide is disposable. • Do not sterilize with autoclave or gas. CAUTION • Please refer to the user manual in the biopsy kit.

[Page 239] Chapter 10 10. Chapter 10 Maintenance Chapter 10. Maintenance Maintenance 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

[Page 240] 10 - 2 HS50/HS60 User Manual 10.1. Operational Environment When installing the product, please pay attention to the following: Placing the system near generators, X-ray machines or broadcast cables may result in screen noise and abnormal visual images. Sharing the power source with other electrical devices may also induce noise. • Optimal conditions for the system are temperatures of 10–35 ° C and humidity of 30–75%. • Avoid excess humidity. • Avoid direct sunlight. • Avoid places with extreme temperature variations. • Avoid heat sources. • Avoid dusty and unventilated areas. • Avoid places where the system is likely to be exposed to vibration or impacts. • Avoid places where the system is likely to be exposed to chemical substances or gases.

[Page 241] Chapter 10. Maintenance 10 - 3 10.2. Product Maintenance 10.2.1. Cleaning and Disinfecting Using an inappropriate cleaning or sterilizing agent may damage the product. Pay attention to the following: • Turn off the system and disconnect the power cord from the wall outlet before cleaning and disinfecting, otherwise, there is a risk of electric shock or fire. • Always use protective eyewear and gloves when cleaning and disinfecting the product. 10.2.1.1. Cleaning • Do not spray detergent directly onto the product's exterior. Doing so may discolor or crack the surface. • Do not use chemical substances such as wax, benzene, alcohol, paint thinner, insecticide, aerosol deodorant, lubricant. ■ Console Use a soft cloth lightly dampened with a mild soap to clean the exterior surfaces of the system. ■ Cleaning Monitor Gently wipe the LCD surface with a soft, dry cloth. For information on cleaning and disinfecting the probe, please refer to ‘Chapter 9. Probes’. ■ Touch Screen Wipe the LCD surface with a soft dry cloth. Make sure that the touch screen is not contaminated by an electrically conductive substance. Contamination of the LCD screen by ultrasound gel or other substances may degrade the sensitivity of the touch screen and cause malfunctions. This phenomenon is caused by the contact between the capacitive touch screen and the conductive NOTE substance. If the screen is contaminated, clean it with a dry cloth and then reboot the system.

[Page 242] 10 - 4 HS50/HS60 User Manual ■ Trackball While cleaning the trackball, make sure that liquid and other substances do not enter the product. 1. Turn the trackball rim counterclockwise to remove it from the control panel. 2. Wipe the trackball with a soft cloth and turn the trackball rim clockwise to reattach. [Figure 10.1 Removing the Trackball] • For information on cleaning and disinfecting the probes, please refer to ‘Chapter 9. Probes’ in the user manual. • This image may differ from the actual system.

[Page 243] Chapter 10. Maintenance 10 - 5 10.2.1.2. Disinfection Use only disinfectants recommended by Samsung Medison on system surfaces. A disinfectant certified by the FDA 510(k) process is recommended. For more information, please refer to the information about detergents, disinfectants, and ultrasound gels in ‘Chapter 9. Probes’. 1. Turn off the system and disconnect the power cord from the wall outlet. 2. Mix the disinfectant solution that is compatible with your system to the solution strength specified on the instruction label. 3. Clean the exterior surface of the product in compliance with the instructions provided with the disinfectant. 4. Air dry or towel dry the surface with a sterile cloth according to the instructions on the disinfectant label.

[Page 244] 10 - 6 HS50/HS60 User Manual 10.2.2. Cleaning Air Filters The air filters minimize the intake of dust. When the air filter is clogged with dust, it may cause the product to overheat and generate noise; it may also reduce the reliability and the system performance. Clean the filter once every three months to maintain the system in optimal condition. Be sure to lock the brakes on the front wheels before cleaning the air filters to avoid injury by any unexpected movement of the product. [Figure 10.2 Disconnect Air Filter] 1. Pull out the filter under the front of the console and take it away from the product. 2. Shake the filter to remove the dust and wash it in a mild, soapy solution. 3. Afterwards, dry the filter with a cloth, then air dry it in the shade. 4. Slide the filter back into the product. Allow the wet filter to dry thoroughly before reinstalling it. A wet filter can cause the system to malfunction.

[Page 245] Chapter 10. Maintenance 10 - 7 10.2.3. Accuracy Checks Users may request safety inspections as required, but only trained persons are allowed to perform the safety inspection. The product’s maintenance status may affect the measurements obtained when using the product. The product should be maintained in an optimal state to ensure reliable measurements. To ensure optimal operation of the product, perform an accuracy check every year. The equations and table related to measurement accuracy are included in ‘Chapter 8. Measurements and Calculations’ in the user manual.

[Page 246] 10 - 8 HS50/HS60 User Manual 10.3. Data Maintena n ce You may lose information files on user settings or patients, because of physical shocks to the product or internal errors. Therefore, you should back-up on a regular basis. 10.3.1. User Settings Backup Always keep a backup copy of all information related to the user settings in case of data loss. Clients cannot back-up the user settings of the product. Please contact the servicing department to attain support for back-up. 10.3.2. Backing Up Patient Information The SonoView program can be used to backup patients’ basic information and scanned images. The data is saved in the system by default, and the user can also choose to save the data to a specific location. If the system needs to be reinstalled because of product failure, etc., Samsung Medison customer support staff will restore the patients’ basic information and scanned images that are saved in the system. For a more detailed description, see ‘Chapter 9. Image Managements’ in the user manual. 10.3.3. Software The software may be changed to improve the product’s performance. Software may not be altered by the user; any alterations to the software must be made with the help of a representative of Samsung Medison customer support department. Minor software updates may be carried out without prior notice from the manufacturer. If errors occur in the operating system (Windows 7), or you desire to upgrade the operating system, please follow the instructions of the operating system manufacturer. This product uses the Windows firewall to prevent any hacker or malicious software from accessing the system through the internet or network.

[Page 247] Chapter 11 11. Service Parts List Chapter 11. Service Parts List Service Parts List 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

[Page 248] 11 - 2 HS50/HS60 Service Manual 11.1. Body Cover Parts Body Cover Parts MI61-01658C HANGER-REAR CABLE Body Cover Parts MI61-01912A BUSH ROLLER-CLUTCH- Body Cover Parts MI61-03179A LEVER Body Cover Parts MI63-01657C COVER-CABLE FRONT

[Page 249] Chapter 11. Service Parts List 11 - 3 Body Cover Parts MI63-01658C COVER-CABLE COVER BASE- Body Cover Parts MI63-02241A LOWER_L COVER-MONITOR Body Cover Parts MI63-02446A CABLE COVER-SPEAKER Body Cover Parts MI63-02451A FRONT COVER-SPEAKER Body Cover Parts MI63-02452A REAR

[Page 250] 11 - 4 HS50/HS60 Service Manual COVER-SUPPORT Body Cover Parts MI63-02460A ARM Body Cover Parts MI63-02464A COVER-SIDE-R Body Cover Parts MI63-02465A COVER-SIDE-L Body Cover Parts MI63-02466A COVER-REAR BODY Body Cover Parts MI63-02468A COVER-LIFT TOP

[Page 251] Chapter 11. Service Parts List 11 - 5 Body Cover Parts MI63-02470A COVER-FOOT Body Cover Parts MI64-01766B HANDLE-CP BOTTOM Body Cover Parts MI64-01770B HANDLE-CP TOP Body Cover Parts MI64-02050A HANDLE-REAR Body Cover Parts MI66-01096B LEVER-LIFT

[Page 252] 11 - 6 HS50/HS60 Service Manual Body Cover Parts MI68-03436A LABEL-ID WR LABEL-SPEAKER Body Cover Parts MI68-03443A COVER Body Cover Parts MI68-03447A LABEL-MANUAL ICON Body Cover Parts MI68-03448A LABEL-CW ICON Body Cover Parts MI68-03449A LABEL-PROBE PORT 1

[Page 253] Chapter 11. Service Parts List 11 - 7 Body Cover Parts MI68-03450A LABEL-PROBE PORT 2 Body Cover Parts MI68-03451A LABEL-PROBE PORT 3 Body Cover Parts MI68-03452A LABEL-PROBE PORT 4 Body Cover Parts MI68-03453A LABEL-DUMMY ODD Body Cover Parts MI68-03454A LABEL-DUMMY PSA

[Page 254] 11 - 8 HS50/HS60 Service Manual ASSY COVER-BASE Body Cover Parts MI97-02866A LOWER-R Body Cover Parts MI97-03388A ASSY CASTER ASSY COVER-TOP Body Cover Parts MI97-03526A BODY Body Cover Parts MI97-03652A ASSY COVER-PSA 3P Body Cover Parts MI97-03653A ASSY COVER-PSA 4P

[Page 255] Chapter 11. Service Parts List 11 - 9 11.2. Control Panel Parts Control Panel CBF CABLE- MI39-02065A Parts CP_TRACKBALL MI59-01170A TRACK BALL MI61-04057A HOLDER-PROBE S MI61-04058A HOLDER-PROBE M MI61-04059A HOLDER-PROBE L

[Page 256] 11 - 10 HS50/HS60 Service Manual MI63-02450A COVER-CP BOTTOM MI63-02453A COVER-CP TOP MI63-02454A COVER-TOUCH REAR MI63-02459A COVER-USB RUBBER Control Panel COVER-LIGHT MI63-02491A Parts MARKER-REF MI63-02492A COVER-LIGHT ANGLE MI63-02493A COVER-LIGHT DEPTH

[Page 257] Chapter 11. Service Parts List 11 - 11 MI63-02494A COVER-LIGHT FOCUS MI63-02495A COVER-LIGHT ZOOM Control Panel COVER-LIGHT EZ MI63-02516A Parts EXAM MI64-01911C KNOB-ENCORDER Control Panel BUTTON-ENCORDER MI64-02014A Parts M Control Panel BUTTON-ENCORDER MI64-02015A Parts PW Control Panel BUTTON-ENCORDER MI64-02016A Parts COLOR Control Panel BUTTON-ENCORDER MI64-02017A Parts 2D Control Panel BUTTON-CAP KEY MI64-02019A Parts 3D/4D

[Page 258] 11 - 12 HS50/HS60 Service Manual MI64-02022A BUTTON-CAP KEY CW MI64-02023A BUTTON-CAP KEY PD Control Panel BUTTON-CAP KEY MI64-02029A Parts FREEZE MI64-02048A BUTTON-CP RUBBER MI64-02058A BUTTON-END EXAM MI64-02059A BUTTON-SONOVIEW MI64-02060A BUTTON-REPORT

[Page 259] Chapter 11. Service Parts List 11 - 13 MI64-02071A BUTTON-SINGLE MI64-02072A BUTTON-QAUD MI64-02086A BUTTON-U4 MI64-02087A BUTTON-U5 MI64-02088A BUTTON-U6 MI64-02089A BUTTON-QSCAN MI64-02090A BUTTON-L MI64-02091A BUTTON-R

[Page 260] 11 - 14 HS50/HS60 Service Manual MI64-02092A BUTTON-U1 MI64-02093A BUTTON-U2 MI64-02094A BUTTON-U3 Control Panel BUTTON-TRACKBALL MI64-02095A Parts SET L Control Panel BUTTON-TRACKBALL MI64-02096A Parts SET R Control Panel BUTTON-TRACKBALL MI64-02097A Parts POINTER Control Panel BUTTON-TRACKBALL MI64-02098A Parts TEXT Control Panel BUTTON-TRACKBALL MI64-02099A Parts CHANGE

[Page 261] Chapter 11. Service Parts List 11 - 15 Control Panel BUTTON-TRACKBALL MI64-02100A Parts MEASURE Control Panel BUTTON-TRACKBALL MI64-02101A Parts ERASER MI67-01109A RUBBER-CAP KEY MI68-02095B LABEL-CP DO NOT SIT MI68-03421A LABEL-CP TOP MI92-02438A ASSY BOARD-CP USB

[Page 262] 11 - 16 HS50/HS60 Service Manual MI92-02439A ASSY BOARD-CP Control Panel ASSY CAP KEY- MI95-01304A Parts POWER Control Panel ASSY CAP KEY- MI95-01310C Parts TOGGLE MI95-01311C ASSY CAP KEY-KNOB Control Panel ASSY ALPHA MI95-01499A Parts KEYBOARD

[Page 263] Chapter 11. Service Parts List 11 - 17 MI96-01392A ASSY TOUCH PANEL 11.3. Monitor & Arm Parts MI63-01634B Parts TOP ADD MI63-01635D Parts TOP MI63-01636D Parts BOTTOM

[Page 264] 11 - 18 HS50/HS60 Service Manual MI63-01637D Parts TOP ADD MI63-01638B Parts BACK TOP MI63-01639B Parts BACK BOTTOM MI63-01640B Parts TOP FRONT MI63-01641B Parts TOP BACK

[Page 265] Chapter 11. Service Parts List 11 - 19 MI63-01642B Parts TOP MI63-01643B Parts BOTTOM MI63-01646C COVER-ARM BUTTON Monitor&Arm COVER-ARM BUTTON MI63-01647B Parts GUIDE MI63-01661B Parts BOTTOM ADD

[Page 266] 11 - 20 HS50/HS60 Service Manual MI63-01662B Parts FRONT ADD MI63-01981A COVER-LINK FRONT R MI63-01982A COVER-LINK FRONT L MI68-01977A LABEL CAUTION MI68-02554A LABEL DO NOT PUSH

[Page 267] Chapter 11. Service Parts List 11 - 21 MI96-01394A ASSY MONITOR UNIT MI97-03500A ASSY ARM 11.4. System Parts System Parts 5903-005726 SSD System Parts MI68-03422A LABEL-I/O PORT ASSY BOARD BE System Parts MI82-02355A (WITHOUT PC MODULE, REAR IO BD)

[Page 268] 11 - 22 HS50/HS60 Service Manual System Parts MI92-02454A ASSY BOARD-BP System Parts MI92-02456A ASSY BOARD-BF System Parts MI92-02457A ASSY BOARD-REAR IO ASSY BOARD-PSA 4P System Parts MI92-02464A CW ASSY BOARD-PSA 3P System Parts MI92-02500A CW

[Page 269] Chapter 11. Service Parts List 11 - 23 System Parts MI92-02614A ASSY BOARD-PSA 3P System Parts MI92-02615A ASSY BOARD-PSA 4P System Parts MI96-01391A ASSY POWER ASSY PC MAIN System Parts MI96-01393A BOARD-PC MODULE System Parts MI96-01403A ASSY FAN-TOP

[Page 270] 11 - 24 HS50/HS60 Service Manual System Parts MI96-01404A ASSY FAN-INTAKE System Parts MI97-03498A ASSY LIFT 11.5. System Cable Parts MI39-01020B CBF CABLE MI39-01718A CBF CABLE-SPEAKER

[Page 271] Chapter 11. Service Parts List 11 - 25 MI39-02021A CBF CABLE-CP_USB_B MI39-02022A CBF CABLE-CP_USB_A MI39-02023A Parts MONITOR_POWER_B MI39-02024A Parts MONITOR_POWER_A MI39-02025A CBF CABLE-ECG_USB

[Page 272] 11 - 26 HS50/HS60 Service Manual MI39-02028A Parts BOTTOM_FAN_ASSY MI39-02029A Parts BOTTOM_FAN_EXT MI39-02030A Parts BW_PRINTER_USB MI39-02055A Parts COLOR_PRINTER_USB MI39-02056A Parts PRINTER_POWER

[Page 273] Chapter 11. Service Parts List 11 - 27 MI39-02057A Parts SATA_POWER MI39-02058A CBF CABLE-SATA MI39-02059A Parts MONITOR_HDMI_A MI39-02060A Parts TOUCH_HDMI MI39-02063A Parts CP_POWER

[Page 274] 11 - 28 HS50/HS60 Service Manual MI39-02064A Parts GEL_WARMER MI39-02066A Parts MONITOR_HDMI_B MI39-02067A CBF CABLE-SOUND System Cable CBF HARNESS- MI39-02071A Parts ALPHAKEY