Samsung-SonoAce-R7-Ultrasound-Service-manual

[Page 1] ENGLISH Document No. CSD - SM E SAR 7 Revision 0 3 Copyright ⓒ SAMSUNG MEDISON Co., LTD.

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[Page 3] S S a a f f e e t t y y R R e e q q u u i i r r e e m m e e n n t t s s Classifications: - Type of protection against electrical shock: Class I - Degree of protection against electrical shock (Patient connection):Type BF equipment - Degree of protection against harmful ingress of water: Ordinary equipment - Degree of safety of application in the presence of a flammable anesthetic material with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. - Mode of operation: Continuous operation Electromechanical safety standards met: - IEC/EN 60601 - 1 Medical Electrical Equipment, Part 1General Req uirements for Safety. - IEC/EN 60601 - 1 - 1 Safety requirements for medical electrical systems. - IEC/EN 60601 - 1 - 2 Electromagnetic compatibility - Requirements and tests. - IEC/EN 60601 - 2 - 37 Particular requirements for the safety of ultrasonic medical diagnost ic and monitoring equipment. - IEC 61157 Declaration of acoustic output parameters. - ISO 10993 - 1 Biological evaluation of medical devices. - UL 60601 - 1 Medical Electrical Equipment, Part 1 General Requirements for Safety. - CSA 22.2, 601.1 Medical Electri cal Equipment, Part 1 General Requirements for Safety.

[Page 4] Declarations: This is CSA symbol for Canada and United States of America This is manufacturer’s declaration of product compliance with applicable EEC directive(s) and the Europ ean notified 0123 body. This is manufacturer’s declaration of product compliance with applicable EEC directive(s). This is GMP symbol for Good Manufacturing Practice of Korea quality system regulation. Certificate of Excellent Service Quality is to cer tify that the above company has served customers with excellent services by the Ministry of Knowledge Economy Republic of Korea.

[Page 5] R R E E A A D D T T H H I I S S F F I I R R S S T T How to Use Your Manual This manual addresses the reader who is familiar with ultrasound techniques . O nly me dical doctors or persons supervised by medical doctors should use this system. S onography training and clinical procedures are not included here. This manual is not intended to be used as training material for the principles of ultrasound, anatomy, scannin g techniques, or applications . You should be familiar with all of these areas before attempting to use this manual or your ultrasound system. This manual does not include diagnosis results or opinions also, check the measurement reference for each applica tion ’ s result measurement before the diagnosis . It is useless to make constant or complex adjustments to the equipment controls. The system has been preset at the factory to produce an optimum image in the majority of patients. User adjustments are not us ually required. If the user wishes to change image settings, the variables may be set as desired. Optimal images are obtained with little difficulty. We are not responsible for errors that occur when the system is run on a user ’ s PC. Non - Medison product n ames may be trademarks of their respective owners. Please keep this user guide close to the product as a reference when using the system. For safe use of this product, you should read ‘ Chapter1. Safety ’ and ‘ Chapter8. Maintenance ’ in this manual, prior to starting to use this system. ˙ ˙ ˙ ˙ ˙ ˙ D D ˙ A A ˙ N N ˙ G G ˙ E E ˙ R R ˙ Describes precautions necessary to prevent user hazards of great urgency. Ignoring a DANGER warning will risk life-threatening injury. Used to indicate the presence of a hazard that can cause serious personal injury, or substantial property damage. Indicates the presence of a hazard that can cause equipment damage. A piece of information useful for installing, operating and maintaining a system. Not related to any hazard.

[Page 6] Chapter1. General Information 1.1 Overview 1 - 1 1.2 Features and Advantages of SonoAceR7 1 - 2 1.3 Product Configuration 1 - 3 1.3.1 Console 1 - 3 1.3.2 LCD Monitor 1 - 4 1.3.3 Control Panel 1 - 5 1 .3.4 Probes 1 - 5 1.4 Specifications 1 - 6 Chapter2. Safety 2.1 Overview 2 - 1 2.2 Safety – Related Information 2 - 2 2.2.1 Safety Symbols 2 - 2 2.2.2 LABEL 2 - 4 2.3 Safety Symbols 2 - 5 2.3.1 Prevention Electric Shock 2 - 5 2.3.2 ESD ... 2 - 6 2.3.3 EMI 2 - 6 2.3.4 E MC .. 2 - 7 2.4 Mechanical Safety 2 - 1 2 2.4.1 Moving Equipment 2 - 1 2 2.4.2 Moving Equipment 2 - 1 3 2.5 Biological Safety 2 - 1 4 2.5.1 Biological Safety 2 - 1 4 2.6 Environmental Protection 2 - 25

[Page 7] Chapter 3. Install ing the Product 3.1 Overview 3 - 1 3.2 Transportation 3 - 3 3.2.1 Precautions for Transportation 3 - 3 3.2.2 Temperature and Humidity 3 - 3 3.3 Unpacking 3 - 4 3.3.1 Unpacking the Box ... 3 - 4 3.3.2 Checking Package contents 3 - 5 3.4 Condition of Ins tallation 3 - 6 3.4.1 Precautions for Installation 3 - 6 3.4.2 Installation Place 3 - 6 3.5 Installation Procedure 3 - 7 3.5.1 Installation Safety 3 - 7 3.5.2 Connecting the Power Cord 3 - 8 3.5.3 Connecting the Network Cable 3 - 9 3.5.4 Connecting the Probe 3 - 9 3.6 Starting the Product 3 - 10 3.7 Shutting down the Product 3 - 11 3.7.1 Power S/W 3 - 11 3.7.2 Power Breaker 3 - 11 3.8 Connecting the Peripherals 3 - 12 3.8.1 Internal Peripherals 3 - 12 3.8. 2 External Peripherals 3 - 12 3.9 System Setting 3 - 14 3.9.1 System - General 3 - 14 3.9.2 System - Display 3 - 17 3.10 Peripherals Setting 3 - 20 3.10.1 Peripherals 3 - 20 3.10.2 Foot Switch 3 - 20 3.10.3 Set / Exit key Setup 3 - 20 3.10.4 User key Setup 3 - 20 3.10.5 Print Setup 3 - 21 3.11 System Information 3 - 22 3.1 2 Se tting DICOM ( Optional ) 3 - 2 3 3.1 2 .1 DICOM Configuration 3 - 23 3.1 2 .2 DICOM Send Format 3 - 24 3.1 2 .3 DICOM Compression 3 - 24 3. 12 .4 Display compensation 3 - 24

[Page 8] 3.1 2 .5 Add DICOM Service 3 - 25 3.1 2 .6 DICOM Server Information 3 - 26 3.1 2 .7 Print Server I nformation 3 - 27 3.12.8 Worklist Information 3 - 29 3.12.9 PPS Information 3 - 30 3.12.10 SC Information 3 - 30 3.12.11 Storage SR Information 3 - 31 3.12.12 Add DICOM Service 3 - 31 3.12.13 DICOM Service Delete 3 - 31 3.12.14 DICOM Server Test 3 - 31 3.12.15 DIC OM Management 3 - 31 3.12.16 DICOM Log 3 - 33 3.12.17 Utility setting 3 - 34 3. 1 3 Option setting 3 - 37 3.13.1 Option 3 - 37 3.13.2 Auto Calc 3 - 38 3. 1 4 Measurement Setup 3 - 39 3. 1 4 .1 General setting 3 - 39 3. 1 4 .2 Packages 3 - 41 3. 1 4 .3 Report 3 - 45 3. 1 4 .4 Ob stetrics Measurement Setup 3 - 48 3.14.5 Cardiac Measurement Setup 3 - 54 3.14.6 Vascular Measurement Setup 3 - 55 3.14.7 Urology Measurement Setup 3 - 56 3.14.8 Fetal Echo Measurement Setup 3 - 57

[Page 9] Chpater4. Checking the Product 4.1 Overview 4 - 1 4.2 Starting the Product 4 - 2 4.3 Monitor 4 - 3 4.3.1 Monitor Display 4 - 3 4.4 Control Panel 4 - 5 4.4.1 Detail Control Panel . 4 - 5 4.4.2 Soft Menu 4 - 7 4.4.3 Keyboard s 4 - 7 4.4 .4 Adjust of Control Panel 4 - 8 4.5 Checking the Performance 4 - 9 4.5.1 Basic Check 4 - 9 4.5.2 Detail Check 4 - 10

[Page 10] Chapter5. Product Structure 5.1 Overvi ew 5 - 1 5.2 System Block Diagram 5 - 3 5.3 Basic Structure of SonoAce R 7 . 5 - 4 5.4 PSA 5 - 6 5.5 Beamformer Part 5 - 8 5.6 CW Part .. 5 - 1 1 5.7 Back End Part 5 - 1 5 5.8 PCI Part .. 5 - 1 9 5.9 Motor Control Part 5 - 20 5.12 PC Mother Board 5 - 2 1 5.1 3 Software DSC 5 - 2 2 5.1 6 Control Panel 5 - 2 3

[Page 11] Chapter6. Basic Maintenance 6.1 Overview 6 - 1 6.2 System Information 6 - 2 6.3 Windows Mode 6 - 3 6.3 .1 Entering Windows Mode 6 - 3 6.4 Upgrade . 6 - 4 6.4.1 Software Upgrade 6 - 4 6.4.2 Hardware Upgrade ... 6 - 4 6.5 Admin mode 6 - 5 6.5.1 Entering Admin Mode 6 - 5 6.5.2 Admin Mode Functions 6 - 6 6.6 Adding and Deleting Options 6 - 9 6.6.1 Option type 6 - 9 6.6.2 Registering Option .. 6 - 10 6.6. 3 Option Delte 6 - 12

[Page 12] Chapter7. Troubleshooting 7.1 Overview 7 - 1 7.2 Power 7 - 2 7.2.1 Power Failure 7 - 2 7.2.2 Power cannot turned off 7 - 2 7.2.3 Po wer is automatically turned off 7 - 2 7.3 Monitor 7 - 3 7.3.1 Blank Screen 7 - 3 7.3.2 Screen Color Abnormal 7 - 3 7.4 Error Messages 7 - 4 7.4.1 System hangs after an error during booting 7 - 4 7.4.2 System works even if error occurred 7 - 4 7.5 Image .. 7 - 5 7.5.1 No BW Mode Image Echo 7 - 5 7.5.2 No BW Mode Image Format 7 - 5 7.5.3 Noise Link Rain over the BW Mode Image (Noise) 7 - 5 7.5. 4 PW & CW & Color Doppler, M Mode Trouble 7 - 5

[Page 13] Chapter8. Disassembly and Reassembly 8.1 Overview 8 - 1 8.2 Body Cover Disassembly and Reassembly 8 - 3 8.2.1 Preparations 8 - 3 8.2.2 Body Front Cover 8 - 3 8.2.3 Body Back Cover 8 - 3 8.2.4 Cover Body Side Right & Left 8 - 4 8 .2.5 Handle AY 8 - 5 8.3 LCD & ARM & SPEAKER Disassembly and Reassembly 8 - 6 8. 3 .1 Preparations 8 - 6 8. 3 .2 LCD 8 - 6 8. 3 .3 SPEAKER 8 - 7 8. 3 . 4 ARM 8 - 9 8.4 Ultrasound System PCB Part Disassembly and Reassembly 8 - 11 8.4.1 Preparations 8 - 11 8.4.2 PSA ASS Y 8 - 11 8.4.3 CW Board, MAIN Board 8 - 12 8.5 PC Part Disassembly and Reassembly 8 - 13 8.5.1 Preparations 8 - 13 8.5.2 HDD & ODD 8 - 13 8.5.3 Rear Board 8 - 14 8.5.4 POWER 8 - 15 8.6 User Interface Part Disassembly and Reassembly 8 - 16 8.6.1 Preparations 8 - 16 8.6.2 Control Panel 8 - 16 8.6.3 Control Panel Board 8 - 17 8.6.4 Track Ball 8 - 18 8.6.5 Alpha - Numeric Keyboard 8 - 19 8.6.6 LCDIF CON Board . 8 - 20

[Page 14] Chapter9. Probe 9.1 O verview 9 - 1 9.2 Probe List 9 - 2 9.2.1 Probe Application and Preset 9 - 2 9.2.2 Function List 9 - 3 9.3 Thermal Index (TI Table) 9 - 5 9.4 Ultrasound Transmission Gel 9 - 6 9.5 Sheaths 9 - 7 9. 6 Probe Precautions 9 - 8 9.6.1 Use and Infection Control of the Pro be .. 9 - 8 9.6.2 Electric Shocks 9 - 9 9. 7 Cleaning and Disinfecting the Probe 9 - 10 9.7.1 Information of Detergent , Disinfectant and Ultrasound Gel 9 - 10 9.7.2 Cleaning 9 - 16 Chapter10. User Maintenance 10.1 Overview .. 10 - 1 10.2 System Maintenance 10 - 2 10 .2.1 Installation Maintenance 10 - 2 10.2.2 Cleaning and Disinfections 10 - 2 10.2.3 Fuse Replacement . 10 - 3 10.2.4 Administration of Air Filter 10 - 4 10.2. 4 Accuracy Check 10 - 5 10.3 Administration of Information ... 10 - 6 10.3.1 U ser Setting Back - up 10 - 6 10.3.2 Patient Information Restore 10 - 6 10.3.3 Software 10 - 6 Chapter11. Service Part List 11.1 Overview .. 11 - 1 11.2 Body Cover 11 - 2 11.3 Ultrasound System Part 11 - 4 11. 4 LCD & HINGE Part 11 - 5 11. 5 User Interface Part 11 - 6 11. 6 PC & Power Par t 11 - 8 11 . 7 E TC Part .. 11 - 9 11. 8 Options 11 - 1 2 11. 9 Probes 11 - 1 3

[Page 15] C C h h a a p p t t e e r r 1 1 . . G G e e n n e e r r a a l l I I n n f f o o r r m m a a t t i i o o n n 1.1 Overview Chapter 1 contains the information necessary to plan the Troubleshooting of SonoAceR7. The SonoAceR7 is a high-resolution color ultrasound scanner with high penetration and a variety of measurement functions. 1.1 Overview 1-1 1.2 Features and Advantages of SonoAceR7 1-2 1.3 Product Configuration 1-3 1.3.1 Console 1-3 1.3.2 LCD Monitor 1-4 1.3.3 Control Panel 1-5 1.3.4 Probes 1-5 1.4 Specifications 1-6 Chapter 1. General Information 1-1

[Page 16] 1.2 Features and Advantages of SonoAceR7  High-end Digital Beam forming : The SonoAceR7 utilizes the newly developed Digital Beam forming technology.  A variety of applications : The SonoAceR7 is optimized for use in a variety of ultrasound departments, cardiac, vascular, abdomen, Obstetrics, Urology, Gynecology.  Various diagnostic Modes : 2D Mode, M Mode, Color Doppler Mode, Power Doppler Mode, PW Spectral Doppler Mode, etc.  Measurement and Report Functions : Besides the basic distance, area, circumference and volume measurement functions, the SonoAceR7 also provides application-specific measurement functions. The report function collates measurement data.  Review of Scanned Images : The SonoAceR7 displays Cine images of 7084 frames and loop images of 8192 lines.  SonoView TM : This is a total ultrasound image management system, which allows a user to archive, view and exchange documents.  Digital Imaging and Communication in Medicine (DICOM) Function : This is used to archive, transmit and print DICOM images through a network.  Peripheral/Accessory Connection : A variety of peripheral devices including VCRs and printers can be easily connected to the SonoAceR7. Chapter 1. General Information 1-2

[Page 17] 1.3 Product Configuration This Product consists of the monitor, the control panel, the console and, the probes. 1.3.1 Console The console consists of two parts – the inner unit and the outer unit. The interior of the console mainly contains devices that produce ultrasound images. The outside of the console consists of various connection ports, probe holder, storage space, wheel and handles. LCD Monitor Handle Probe holder Wheel [Figure 1-1] Console of SonoAce R7 Chapter 1. General Information 1-3

[Page 18] Probe Connector [Figure 1-2] Front and Back of SonoAce R7 ※ Type of Probe port Mini DLP type of probe is used for SonoAce R7 v2.00.00. In lower version of product, the shape of the probe port can be different. <v2.xx.xx: Mini DLP Type PSA> <v1.xx.xx :156 Pin Type PSA> ※ 256 Pin is necessary for 3D probe. Chapter 1. General Information 1-4

[Page 19] 1.3.2 LCD Monitor The monitor of this system is a color VGA monitor, which displays ultrasound images and additional information. Monitor arm can control to be tilted to the optimal viewing angle. [Figure 1-3] LCD Monitor Chapter 1. General Information 1-5

[Page 20] 1.3.3 Control Panel The control panel can be used for controlling the system. Alpha-Numeric Button Dial Button Track Ball Slide Volume [Figure 1-4] Control Panel 1.3.4 Probe Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation. For more information, refer to ‘Chapter 9. Probes’. Chapter 1. General Information 1-6

[Page 21] 1.4 Specifications Height: 1340mm (with handle) Width: 450mm Physical Dimensions Depth: 700mm Weight: More than 61kg (With monitor) 2D imaging mode M imaging mode Color Doppler Imaging (CDI) mode Power Doppler Imaging (PDI) mode Directional Power Doppler Imaging (DPDI) mode Pulse Wave (PW) Spectral Doppler imaging mode Imaging modes Continuous Wave (CW) Spectral Doppler imaging mode Tissue Doppler Imaging (TDI) mode 3D imaging mode Dual modes Combined modes Simultaneous mode Zoom Gray Scale 256 (8 bits) Transmit focusing, maximum of eight points (four points Focusing simultaneously selectable) Digital dynamic receive focusing (continuous) Curved Linear Array : C2-8 Linear Array : HL5-12ED, L3-8, L5-12/50EP Probes Endocavity Curved Linear Array : ER4-9/10ED, EV4-9/10ED Phased Array : P2-4AH Volume Probe : 3D4-8ET, 3DC2-6 Probe connections 3 probe connectors Monitor 19 inch LCD monitor VHS and SVHS VCR left and right audio B/W printer video and remote control Rear Panel VGA monitor Input/Output Parallel port Connections USB LAN Maximum 7084 frames for CINE memory Image Storage Maximum 8192 Lines for LOOP memory Image filing system Obstetrics, Gynecology, Abdomen, Cardiac, Urology, Vascular, Application Small Parts, Musculoskeletal, TCD Chapter 1. General Information 1-7

[Page 22] Electrical Parameters 100-120V/200-240V, 250VA, 50/60Hz Obstetrics, Gynecology, Cardiac, Carotid, Fetal Echo, UE Automatic Calculation Artery, LE Artery, UE Vein, LE Vein, Urology, Radiology, TCD, and Quantification Thyroid, Breast, Testicle, Superficial, Pediatric Hips, MSK * Refer the Chapter 5 for additional information TGC control Mode-independent gain control Acoustic power control (adjustable) Signal processing Dynamic aperture (Pre-processing) Dynamic apodization Dynamic range control (adjustable) Image view area control M-mode sweep speed control Frame average Edge Enhancement / Blurring Signal processing Gamma-scale windowing (Post-processing) Image orientation (left/right and up/down, rotation) White on black/black on white Zoom Trackball operation of multiple cursors 2D mode: Linear measurements and area measurements using Measurement elliptical approximation or trace M mode: Continuous readout of distance, time, and slope rate Doppler mode: Velocity and trace VCR Video Page Printer Color Video Page Printer USB Video Printer USB Color Video Printer Auxiliary USB HDD USB Wireless LAN USB Foot Switch USB Flash Memory Media Monitor Microphone User Interface English, German, French, Spanish, Italian Operating: 700hPa to 1060hPa Pressure Limits Storage: 700hPa to 1060hPa Operating: 30% to 75% Humidity Limits Storage & Shipping: 20% to 90% O O Operating: 10 C ~ 35 C Temperature Limits O O Storage & Shipping: -25 C ~ 60 C Chapter 1. General Information 1-8

[Page 23] C C h h a a p p t t e e r r 2 2 . . S S a a f f e e t t y y 2.1 Overview Chapter 2 . contains the information necessary to Safety . Please read this chapter before using the SAMSUNG MEDISON ultrasound system. It is relevant to the ultrasound system, the probes, the recording devices, and any of the optional equipment. SonoAce R7 is intended for use by or by the order of, and under the supervision of a licensed physician who is directly qualified to use the medical device. 2.1 Overview 2 - 1 2.2 Safety – Related Information 2 - 2 2.2.1 Safety Symbols 2 - 2 2.2.2 LABEL 2 - 4 2.3 Electrical Safety 2 - 5 2.3.1 Prevention Electric Shock 2 - 5 2.3. 2 ECG 2 - 6 2.3.3 ESD 2 - 6 2.3. 4 EMI 2 - 6 2.3. 5 EMC 2 - 7 2.4 Mechanical Safety 2 - 1 2 2.4.1 Moving Equipment . 2 - 1 2 2.4.2 Safety Note 2 - 1 3 2.5 Biological Safety 2 - 1 4 2.5.1 ALARA Principle 2 - 1 4 2.6 Environmental Protection 2 - 2 6 Chapter 2. Safety 2-1

[Page 24] 2.2 Safety – Related Information 2.2.1 Safety Symbols The International Electro Technical Commission (IEC) has established a set of symbols for medical electronic equipment, which classifies a connection or warn of potential hazards. The classifications and symbols are shown below. Symbols Description Isolated patient connection(Type BF applied part) Power switch (Supplies/cuts the power for product). Indicates a caution for risk of electric shock. Indicates dangerous voltages over 1000V AC or over 1500V DC. Warning, Caution AC (alternating current) voltage source Print remote output Electrostatic discharge Network port Output port ( DVI, RGB, B/W, S - VHS, SOUND ) Protection against the effects of immersion. Protection against dripping water. Probe connector Consult Inst ructions for Use Mic port Chapter 2. Safety 2-2

[Page 25] USB port Power switch (Supplies/cuts the power for product) Power switch (Supplies/cuts power to the product) Identifies an equipotential ground. Data Output port Data Input port Data Input/Output port Foot switch connector ECG connector Chapter 2. Safety 2-3

[Page 26] 2.2.2 LABEL To protect the system, you may see ‘ Warning ’ or ‘ Caution ’ marked on the surface of the product [ Figure 2 - 1. Marked on the back sides of the product] [ Fig ure 2 - 2 . Marked below OUTLET ] [ Figure 2 - 3 . Prohibition of seating on Control panel ] Chapter 2. Safety 2-4

[Page 27] 2.3 Electrical Safety This equipment has been verified as a Class I device with Type BF applied parts. 2.3.1 P revention of Electric Shock In a hospital, dangerous currents are due to the potential differences between connected equipment and touchable conducting parts found in medical rooms. The solution to the problem is consistent equip p otential bonding. Medical equipment is connected with connecting leads made up of angled sockets to the equi p potential bonding network in medical rooms. [ Figure 2 - 4] Equip p otential bonding Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601 - 1 - 1 or clause 16 of the  Electric shock may exist result if this system, including and all of its externally mounted recording and monitoring devices, is not properly grounded.  Do not remove the covers on the system; hazardous voltages are present inside. Cabinet panels must be in place while the system is in use. All internal adjustments and replacements must be made by a qualified MEDISON Customer Service Department .  Check the face, housing, and cable before use. Do not use, if the face is cracked, chipped , or torn, the housing is damaged, or if the cable is abraded .  Always disconnect the system from the wall outlet prior to cleaning the system .  All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to application of a high voltage defibrillation pulse .  The use of flammable anesthetic gas or oxidizing gases (N 2 0) should be avoided .  The system has been designed for 100-120VAC and 200-240VAC; you should select the input Outlet voltage of monitor, printer and VCR. Prior to connecting an OEM power cord, verify that the voltage indicated on the power cord matches the voltage rating of the OEM device .  An isolation transformer protects the system from power surges. The isolation transformer continues to operate when the system is in standby .  Do not immerse the cable in liquids. Cables are not waterproof .  The operator does not contact the parts (SIP/SOP) and the patient simultaneously . Chapter 2. Safety 2-5

[Page 28] 2.3.2 ECG - Related Information  This device is not intended to provide a primary ECG monitoring function, and therefore does not have means of indic ating an inoperative electrocardiograph.  Do not use ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical equipment may result in 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 a 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. During low humidity conditions, electrical charges naturally build up on individuals, creating static electricity. An ESD occurs when an individual with an electrical energy build - up comes in contact with conducti ve objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals.  The level of electrical energy discharged from a system user or patie nt to an ultrasound system can be significant enough to cause damage to the system or probes.  Always perform the pre-ESD preventive procedures before using connectors marked with the ESD warning label . - Apply anti-static spray on 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 . 2.3. 4 EMI Although this system has been manufactured in compliance with existing EMI (Electromagnetic Interference) requirements, use of this system in the presence of an electromagnetic field can cause momentary degradation of the ultrasound image. If this occurs often, SAMSUNGMEDISON suggests a review of the environment in which 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. The existence of radios, TVs, or microwave transmission equipment nearby can also cause interference. In cases where EMI is causing disturbances, it may be necessary to relocate this system . Chapter 2. Safety 2-6

[Page 29] 2.3. 5 EMC The testing for EMC(Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC60601-1-2). This IEC standard was adopted in Europe as the European norm (EN60601-1-2). 2.3. 5 .1 Guidance and manufacturer ’ s declaration - electromagnetic emission This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment . Emission test Compliance Electromagnetic environment - guidance The Ultrasound System uses RF energy only for its internal function. Therefore, its RF RF Emission Group 1 emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment. RF Emission Class B CISPR 11 The Ultrasound System is suitable for use in all establishments, including domestic Harmonic Emission establishments and those directly connected to Class A the public low-voltage power supply network IEC 61000 - 3 - 2 that supplies building used for domestic Flicker Emission purpose. Complies IEC 61000 - 3 - 3 2.3. 5 . 2 Approved Cables, Transducers and Accessories for EMC 1) Approved Cable for Electromagnetic Compliance Cables connected to this product may affect its emissio ns; Use only the cable types and lengths listed below table. Cable Type Length VGA Shielded Normal Parallel Shielded Normal RS232C Shielded Normal USB Shielded Normal LAN(RJ45) Twisted pair Any S - Video Shielded Normal Foot Switch Shielded 2.5m B/ W Printer Unshielded Coaxial Normal MIC Unshielded Any Printer Remote Unshielded Any Audio R.L Shielded Normal VHS Shielded Normal ECG AUX input Shielded < 3m 2) Approved Transducer for Electromagnetic Compliance The probe listed in ‘ Chapter 9 . Prob es ’ when used with this product, have been tested to comply with the group1 class B emission as required by International Standard CISPR 11. Chapter 2. Safety 2-7

[Page 30] 3) Approved Accessories for Electromagnetic Compliance Accessories used with this product may effect its emissions When connecting other customer-supplied accessories to the system, such as a remote printer or VCR, it is the user ’ s responsibility to ensure the electromagnetic compatibility of the system. Use only CISPR 11 or CISPR 22, CLASS B compliant devices The use of cables, transducers, and accessories other than those specified may result increased emission or decreased Immunity of the Ultrasound System . IEC 60601 Electromagnetic environment – Immunity test Compliance level Test level guidance Floors should be wood, concrete Electrostatic ±6KV Contact ±6KV Contact or ceramic tile. If floors are discharge (ESD) covered with synthetic material, ±8KV air ±8K V air the relative humidity should be at IEC 61000 - 4 - 2 least 30%. Electrical fast ± 2KV for power Mains power quality should be that ±2KV for power supply of a typical commercial or hospital transient/burst lines supply lines environment. ±1KV for input/output ±1KV for input/ lines output lines IEC 61000 - 4 - 4 Surge ±1KV differential mode ±1KV differential mode Mains power qu ality should be that of a typical commercial or hospital IEC 61000 - 4 - 5 ±2KV common mode ±2KV common mode environment. Voltage dips, short <5% U т <5% U т Mains power quality should be that interruptions and (>95% dip in U т) (>95% dip in U т) of a typical commercial or hospital voltage variations for 0.5cycle for 0.5cycle environment. If the user of t his on power supply product requires continued input lines 40% U т 40% U т operation during power mains (60% dip in U т ) (60% dip in U т ) interruptions, it is recommended IEC 61000 - 4 - 11 for 5 cycle for 5 cycle that t his product be powered from an uninterruptible power supply or 70% U т 70% U т a battery. (30% dip in U т) (30% dip in U т) for 25 cycle for 25 cycle <5% U т <5% U т (<95% dip in U т ) (<95% dip in U т ) for 5 s for 5 s Power frequency Power frequency magnetic fields (50/60Hz) should be at levels characteristic m agnetic field 3 A/m 3 A/m of a typical location in a typical commercial or hospital IEC 61000 - 4 - 8 environment. Chapter 2. Safety 2-8

[Page 31] NOTE U т is the a.c. mains voltage prior to application of the test level. Conducted RF 3 Vrms 0.01V Portable and mobile RF communications equipment should be used no closer to any part IEC 61000 - 4 - 6 150 kHz to 80MHz of the Ultrasound System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80MHz to 800MHZ 800MHz to 2.5GHz Radiated RF 3 V/m 3 V/m Where P is the maximum output power rating of the transmitter in watts (W) according to the IEC 61000 - 4 - 3 80 MHz to 2.5GHz transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter - mined by an electromagnetic site survey, 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 guidel ines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and l and mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If th e measured field strength in the location in which the Ultrasound System is used exceeds the applicable RF compliance level above, the Ultrasound System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re - orienting or relocating the Ultrasound System or using a shielded location with a higher RF shielding effectiveness and filter attenuation. b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V 1 ] V /m. Chapter 2. Safety 2-9

[Page 32] 2.3. 5 . 3 Recommended separation distances between portable and mobile RF communications equipment and the SonoAce R7 This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help Prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as recommended below, according to the maximum output power of the communications equipment . Separation distance according to frequency of transmitter [m] 800MHz to Rated maximum 150kHz to 80MHz 80MHz to 800MHz 2.5GHz output power of transmitter [W] V 1 =0.01Vrms E 1 =3 V/m E 1 =3V/m 0.01 35.00 0.11 0.23 0.1 11 0.68 0.36 0.73 1 350.00 1.16 2.33 10 1106.80 3.68 7.37 100 3500.00 11.66 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 2.3. 5 . 4 Electromagnetic environment – guidance The Ultrasound System must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location. Field strengths outside the shielded location 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 assure that they meet the minimum specification . If the system is connected to other customer-supplied equipment, such as a local area network (LAN) or a remote printer, SAMSUNGMedison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic phenomena . Chapter 2. Safety 2-10

[Page 33] 2.3. 5 . 5 Avoiding Electromagnetic Interference Typical interference on Ultrasound Imaging Systems varies depending on Electromagnetic phenomena. Please refer to following table . Imaging Mode ESD RF Power Line Change of operating For sector imaging White dots, dashes, mode, system probes, white radial diagonal lines, or settings, or system bands or flashes in the diagonal lines near the reset. centerlines of the center of the image. Brief flashes in the image. 2D or 3D displayed or recorded For linear imaging image. probes, white vertical bands, sometimes more pronounced on the sides of the image. Increase in the 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, increase dashes, or changes in Color in background noise, or the color noise level. changes in color image. Horizontal lines in the Vertical lines in the spectral display or spectral display, popping Doppler tones, abnormal noise type noise in the audio, in the audio, or both. or both. ESD caused by discharging of electric charge build-up on insulated surfaces or persons. RF energy from RF transmitting equipment such as portable phones, hand-held radios, wireless devices, commercial radio and TV, and so on. 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. A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference. SamSungMedison Ultrasound System does not generate interference in excess of the referenced standards. An Ultrasound System is designed to receive signals at radio frequency and is therefore susceptible to interference generated by RF energy sources. Examples of other source of interference are medical device, 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 only with one transducers op erating at the same frequency or with several transducer?  Do two different transducer 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 reside with the system or the scanning environment. After you answer the question, contact your local SAMSUNG MEDISON Technical Support Group . Chapter 2. Safety 2-11

[Page 34] 2.4 Mechanical Safety 2.4.1 Moving the Equipment Always turn the power off and disconnect the cables before moving the product .  Before transporting the product, check that the brakes on the front wheels are  Always use the handles at the back of the console and move the product slowly.  This product is designed to resist shocks. However, excessive shock, for example if the product falls over, may cause serious damage.  If the system operates abn ormally after repositioning, please contact with the SAMSUNG MEDISON Technical Support Group . 2.4.1.1 The Brakes Brakes are mounted to the front wheels of the console only. To lock the brakes, press the top part of the brake with your foot. To unlock the m, press the part labeled Off at the bottom of the brake with your foot. You can use the brakes to control the movement of the product. We recommend that you lock the brakes when using the product. 2.4.1.2 Precautions on Ramps Always make sure that contr ol panel is facing the direction of movement  Be aware of the castors, especially when moving the system. SAMSUNG MEDISON recommends that you exercise caution when moving the product up or down ramps  When moving the product down a ramp or resting it temporarily on a ramp, the product may tilt over even with the brakes on depending on the direction of the product. Do not rest the product on ramps. Chapter 2. Safety 2-12

[Page 35] 2.4. 2 Safety Note  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 metal pieces, do not enter the system .  Do not block the ventilation slots .  To prevent damage to the power cord, be sure to grip the plug head – not the cord – when unplugging .  Excessive bending or twisting of cables on patient-applied parts may cause failure or intermittent operation of the system .  Incorrect cleaning or sterilization of a patient-applied part may cause permanent damage . Please refer to “ Chapter 8. Maintenance ” for detailed information on protecting, cleaning and disi nfecting the equipment . 2.4.2.1 Safety Note for Monitor When adjusting the height or position of the monitor, be careful of the space in the middle of the monitor arm. Having your fingers or other body parts caught in it may result in injury. [Figure 2 - 5 ] Safety Note for Monitor Chapter 2. Safety 2-13

[Page 36] 2. 5 Biological Safety Verify the alignment of the Probe before use. See the “ Chapter 9. Probes ” section of this manual . Ultrasound waves may have damaging effects on cells and, therefore, may be harmful to the patient. If there is no medical benefit, minimize the exposure time and maintain the ultrasound wave output level at low. Please refer to the ALARA principle. Do not use the system if an error message appears on the video display indicating that a hazardous condition exists. Note the error code, turn off the power to the system, and call your local MEDISON Customer Service Department . Do not use a system that exhibits erratic or inconsistent updating. 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 degree Celsius, and the ultrasonic waves output observes American FDA regulations . 2.5.1 ALARA Principle Guidance for the use of diagnostic ultrasound is defined by the “ as low as reasonably achievable ” (ALARA) principle. The decision as to what is reasonable has been left to t he judgment and insight of qualified personnel. No set of rules can be formulated that would be sufficiently complete to dictate the correct response for every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic imag es, users can minimize ultrasonic bio effects. Since the threshold for diagnostic ultrasound bio effects is undetermined, it is the sonographer ’ s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposu re time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, the ultrasound system provides controls that can be manipulated during the exam to optimize the results of the exam. 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 the applications of the technology, have resulted in the need for more and better information to guide the user. The output indices are designed to provide that important information There are a number of variables, which 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. The ability to limit the index values over time support the ALARA principle Chapter 2. Safety 2-14

[Page 37] 2. 5 . 1 . 1 Applying ALARA Guidance for the use of diagnostic ultrasound is defined by the “ as low as reasonably achievable ” (ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight of qualified personnel. No set of rules can be formulated that would be suffi ciently complete to dictate the correct response for every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bio effects. Since the threshold for diagnostic ultrasound bio effe cts is undetermined, it is the sonographer ’ s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, th e ultrasound system provides controls that can be manipulated during the exam to optimize the results of the exam. 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 the applications of the technology, have resulted in the need for more and better information to guide the user. The output indices are designed to provide that important information There are a number of variables, which 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. The ability to limit the index values over time support the ALARA principle. . 2. 5 . 1 . 2 Direct Controls Application selection and the output intensity control directly affect acoustic intensity. There are different ranges of allowable intensity or output based on your selection. Selecting the correct range of acoustic intensity for the application is one of the first things 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, while others require manual selection. Ultimately, the user bears the responsibility for proper clinical use. The SAMSUNG MEDISON system provides both automatic and user-definable settings. Output has direct impact on acoustic intensity. Once the application has been established, the output control can be used to increase or decrease the intensity output. The output control allows you to select intensity levels less than the defined maximum. Prudent use dictates that you select the lowest output intensity consistent with good image quality . 2. 5 . 1 . 3 Indire ct Controls The indirect controls are those that have 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 a scanning mode, Doppler is a stationary or unscanned mode. A Chapter 2. Safety 2-15

[Page 38] stationary ultrasound beam concentrates energy on a single location. A moving or scanned ultrasound beam disperses the energy over a wide area and the beam is only concentrated on a given area for a fraction of the time necessary in unscanned mode. 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. Several controls affect pulse repetition frequency: focal depth, display depth, sample volume depth, color sensitivity, number of focal zones, and sector width controls. Focus of the ultrasound beam affects the image resolution. To maintain or increase resolution at a different focus requires a variation in 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 the 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 or 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 a deeper depth. To scan deeper at the same output intensity, a lower probe frequency is required. Using more gain and output beyond a point, without corresponding increases in image quality, can mean that a lower frequency probe is needed . 2. 5 . 1 . 4 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. 2. 5 . 1 . 5 Additional Considerations Ensure that scanning time is kept to a minimum, and ensure that only medically required scanning is performed. Never compromise quality by rushing through an exam. A poor exam will require a follow-up, which ultimately increases the time. Diagnostic ultrasound is an important tool in medicine, and, like any tool, should be used efficiently and effectively . 2. 5 . 1 . 6 Output Display Features The system output display comprises two basic indices: a mechanical index and a thermal index. Chapter 2. Safety 2-16

[Page 39] The thermal index consists of the following indices: soft tissue (TIs) and bone (TIb). One of these three thermal indices will be displayed at all times. Which one depends upon the system preset or user choice, depending upon 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 the three indices, and only one of these is displayed at any one time. Each probe application has a default selection that is appropriate for that combination. 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 application-specific nature of the default setting is also an important factor of index behavior. A default setting is a system control state which is preset by the manufacturer or the operator. The system has default index settings for the probe application. The default settings are invoked automatically by the ultrasound system when power is turned on, new patient data is entered into the system database, or a change in application takes place. 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 a focus at or near bone. Some factors might create artificially high or low thermal index readings e.g. presence of fluid or bone, or the flow of blood. A highly attenuating tissue path, for example, will cause the potential for local zone heating to be less than the thermal index displays. Scanned modes versus unscanned modes of operation affect 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 ultrasound exposure time. Do not rush the exam. Ensure that the indices are kept to a minimum and that exposure time is limited without compromising diagnostic sensitivity . 1) Mechanical Index (MI) Display Mechanical bio effects 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 bio effects varies with peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bio effects occurring but 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 . Chapter 2. Safety 2-17

[Page 40] 2) Thermal Index (TI) Display The TI informs the user about the potential for temperature increase occuring 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 etc. The TI should be used as a guide for implementing the ALARA principle. The bone thermal index (TIb) informs the user about potential heating at or near the focus after the ultrasound beam has passed through soft tissue or fluid, for example, at or near second or third trimester fetal bone. The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near the surface, for example, cranial bone. The soft tissue thermal index (TIs) informs the user about the potential for heating within soft homogeneous tissue. You can select either TIs or TIb using the TIs/TIb selection on the Miscellaneous system setups. TIc is displayed when you select a trans-cranial application. 3) Mechanical and Thermal indices Display Precision and Accuracy 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 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 achieve the ALARA principle through prudent use of the system. The values should not be interpreted as actual physical values 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 for calculating 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 measured water tank values 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. Steady state temperature rise is assumed in the industry standard TI models, and the assumption is made that the ultrasound probe is held steady in one position long enough for steady state to be reached. A number of factors are considered when estimating the accuracy of display values: hardware variations, algorithm accuracy estimation and measurement variability. Variability among probes and systems is a significant factor. Probe Chapter 2. Safety 2-18

[Page 41] variability results from piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens focusing parameter variations. Differences in the 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. 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 calculation of the accuracy estimate displayed. Neither linear propagation, nor uniform attenuation at the 0.3dB/ cm-MHz rate, occur in water tank 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, and particularly in water tank 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 not based on errors in, or caused by measuring according to, the AIUM measurement standards. They are also independent of the effects of non-linear loss on the measured values. 2.5.1.7 Control Affecting the indices As various system controls are adjusted, the TI and MI values may change. This will be most apparent as the POWER control is adjusted; however, other system controls will affect the onscreen output values. 1) POWER Power controls the system acoustic output. Two real-time output values are on the screen: a TI and a MI. They change as the system responds to POWER adjustments. In combined modes, such as simultaneous Color, 2D-mode and pulsed Doppler, the individual modes each add to the total TI. One mode will be the dominant contributor to this total. The displayed MI will be from the mode with the largest peak pressure . 2.5.1.8 2D mode Controls 1) 2D mode size Narrowing the sector angle may increase the frame rate. This action will increase the TI. Pulse voltage may be automatically adjusted down with software controls to keep the TI below the system maximums. A decrease in pulse voltage will decrease MI . Chapter 2. Safety 2-19

[Page 42] 2) ZOOM Increasing the zoom magnification may increase frame rate. This action will increase the TI. The number of focal zones may also increase automatically to improve resolution. This action may change MI since the peak intensity can occur at a different depth . 3) Persistence A lower persistence will decrease the TI. Pulse voltage may be automatically increased. An increase in pulse voltage will increase MI. 4) Focal no. More focal zones may change both the TI and MI by changing frame rate or focal depth automatically. Lower frame rates decrease the TI. MI displayed will correspond to the zone with the largest peak intensity . 5) 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 transducer . 2.5.1.9 Color and Power Controls 1) Color Sensitivity Increasing the color sensitivity may increase the TI. More time is spent scanning for color images. Color pulses are the dominant pulse type in this mode . 2) Color Sector Width Narrower color sector width will increase color frame rate and the TI will increase. The system may automatically decrease pulse voltage to stay 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 dominant mode and the TI change will be small . 3) Color Sector Depth Deeper color sector depth may automatically decrease color frame rate or select a new 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. MI will correspond to the peak intensity of the dominant pulse type, which is a color pulse. However, if pulsed Doppler is also enabled then pulsed Doppler will remain the dominant mode and the TI change will be small. 4) SCALE Using the SCALE control to increase the color velocity range may increase the TI. The system will automatically adjust pulse voltage to stay below the system maximums. A decrease in pulse voltage will also decrease MI Chapter 2. Safety 2-20

[Page 43] 5) SEC WIDTH A narrower 2D-mode sector width in Color imaging will increase color frame rate. The TI will increase. MI will not change. If pulsed Doppler is also enabled, then pulsed Doppler will remain as the primary mode and the TI change will be small . 2. 5 . 1 . 10 M mode and Doppler Controls 1) Speed M-mode and Doppler sweep speed adjustments will not affect the MI. When M- mode sweep speed changes, TI changes 2) Simultaneous and Update Methods Use of combination modes affects both the TI and MI through the combination of pulse types. During simultaneous mode, the TI is additive. 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 . 3) 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 automatically decrease the pulse voltage to remain below the system maximum. A decrease in pulse voltage will decrease MI . 2. 5 . 1 . 11 Doppler, CW, M - m ode, and Color Imaging Controls When a new imaging mode is selected, both the TI and the MI will change to default settings. Each mode has a corresponding pulse repetition frequency and maximum intensity point. In combined or simultaneous modes, the TI is the sum of the contribution from the modes enabled and MI is the MI for the focal zone and mode with the largest derated intensity. If a mode is turned off and then reselected, the system will return to the previously selected settings . 1) Probe Each probe model available has unique specifications for contact area, beam shape, and center frequency. Defaults are initialized when you select a probe. SAMSUNG MEDISON factory defaults vary with probe, application, and selected mode. Defaults have been chosen below the FDA limits for intended use . 2) DEPTH An increase in 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 MI displayed is that of the zone with the largest peak intensity . Chapter 2. Safety 2-21

[Page 44] 3) Application Acoustic output defaults are set when you select an application. MEDISON factory defaults vary with probe, application, and mode. Defaults have been chosen below the FDA limits for intended use . 2. 5 . 1 . 12 Related Guidance Documents For more information about ultrasonic bio effects and related topics refer to the following; AIUM Report, January 28, 1993, “Bio effects and Safety of Diagnostic Ultrasound” Bio effects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound M ed., Sept. 1998: Vol. 7, No. 9 Supplement Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM, NEMA. 1998) Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998) Second Edition of the AIUM Output Disp lay Standard Brochure, Dated March 10, 1994. (A copy of this document is shipped with each system.) Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. FDA. September 1997. FDA. Standard for Real - Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA. 1998) WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non - Thermal Mechanisms for Bio logical Effects of Ultrasound, Ultrasound in Medicine and Biology, 1998: Vol. 24, Supplement1. 2. 5 . 1 . 13 Acoustic Output and Measurement Since the first usage of diagnostic ultrasound, the possible human biological effects (bio effects) of ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine(AIUM) Bio effects Committee ( Bio effects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Se pt. 1988: Vol.7, No.9 Supplement) sometimes referred to as the Stowe Report, which reviewed available data on possible effects of ultrasound exposure. Another report “ Bio effects and Safety of Diagnostic Ultrasound, ” dated January 28, 1993 provides more up to date information. The acoustic output for this system has been measured and calculated in accordance with the December 1985 “ 510(K) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices, ” except that the hydrophone m eets the requirements of “ Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment ” (NEMA UD 2 - 1992) Chapter 2. Safety 2-22

[Page 45] 2. 5 . 1 . 14 In Situ, Derated, and Water Value Intensities All intensity parameters are measured in water. Since water does not absorb acoustic energy, these water measurements represent a worst case value. Biological tissue does absorb acoustic energy. The true value of the 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 [ e ] where: In Situ = In Situ Intensity Value Water = Water Value Intensity e = 2.7183 a = Attenuation Factor Tissue a(dB/cm - MHz) Bra in .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. An attenuation factor of 0.3 is used for general reporting purpose; therefore, the In Situ value which is commonly reported uses the formula:  ( 0 . 069 lf ) In Situ (derated) = Water [ ] Since this value is not the true In Situ intensity, the term “ derated ” is used. The maximum derated and the maximum water values do not always occur at the same operating condition; therefore, the reported maximum water and derated values may not be related to the In Situ (derated) formula. Take for example a multi-zone array transducer that has maximum water value intensities in its deepest zone: the same transducer may have its largest derated intensity in one if its shallowest focal zones. 2. 5 . 1 . 15 Acoustic Output and Measurement The terms and symbols used in the acoustic output tables are defined in the following paragraphs . ISPTA.3 The derated spatial-peak temporal-average intensity (milliwatts per square centimeter). Chapter 2. Safety 2-23

[Page 46] ISPPA.3 The derated spatial-peak pulse-average intensity (watts per square centimeter). The value of IPA.3 at the position of global maximum MI ( IPA.3@MI ) may be reported instead of ISPPA.3 if the global maximum MI is reported. MI The Mechanical Index. The value of MI at the position of ISPPA.3, ( [email protected] ) may be reported instead of MI (global maximum value) if ISPPA.3 is 190W/cm 2 . Pr.3 The derated peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the reported MI value . WO The ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, WO is the total time-average power;. For operating conditions subject to reporting under ISPPA.3, WO is the ultrasonic power associated with the transmit pattern giving rise to the value reported under ISPPA.3 Fc The center frequency (MHz). For MI and ISPPA.3, Fc is the center frequency associated with the transmit pattern giving rise to the global maximum val ue of the respective parameter. For ISPTA.3, for combined modes involving beam types of unequal center frequency, Fc is defined as the overall range of center frequencies of the respective transmit patterns. ZSP The axial distance at which the reported parameter is measured (centimeters) . x - 6,y - 6 are respectively the in-plane (azimuth) and out-of-plane (elevation) -6 dimensions in the x-y plane where ZSP is found (centimeters). PD The pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of the respective parameter. PRF The pulse repetition frequency (Hz) associated with the transmit pattern giving rise to the reported value of the respective parameter . EBD The entrance beam dimensions for the azimuth and elevation planes (centimeters) . EDS The entrance dimensions of the scan for the azimuth and elevation planes (centimeters). 2. 5 . 1 . 16 Acoustic Measurement Precision and Uncertainty The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below . Quantity Precision Total Uncertainty PII.3 (derated pulse intensity integral) 3.2 % +21 % to - 24 % Wo (acoustic power) 6.2 % +/ - 19 % Pr.3 (derated rarefaction pressure) 5.4 % +/ - 15 % Fc (center frequency) < 1 % +/ - 4.5 % Chapter 2. Safety 2-24

[Page 47] 1) Systematic Uncertainties For the pulse intensity integral, derated 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 systematic uncertainties Acoustic power measurements using a Radiation Force are measured through the use of calibrated NIST acoustic power sources. We also refer to a September 1993 analysis done by a working group of the IEC technical committee 87 and prepared by K. Beissner, as a 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). Target imperfections. Absorbing (reflecting ) target geometry and finite target size. Target misalignment. Ult rasonic 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. Ef fects due to nonlinear propagation and saturation loss. The overall findings of the analysis give a rough Acoustic Power accuracy figure of +/ - 10% for the frequency range of 1 - 10 MHz. Chapter 2. Safety 2-25

[Page 48] 2.6 Environmental Protection  The console and peripherals could be sent back to manufacturers for recycling or proper disposal after their useful lives .  Disposal of waste shall be disposed in accordance with national laws .  The waste sheaths are to be disposed of safely and national regulations must be observed . Chapter 2. Safety 2-26

[Page 49] C C h h a a p p t t e e r r 3 3 . . I I n n s s t t a a l l l l i i n n g g t t h h e e P P r r o o d d u u c c t t 3.1 Overview Chapter 3 contains the information necessary to plan the installation of SonoAce R7 and install it. This chapter describes the requirements for the transportat ion and installation environment for the product, so that the product is installed in the best condition. Also included are product installation and set up procedures and electrical security check procedures. In addition, procedures for connecting probe s and external equipment are included. 3.1 Overview 3 - 1 3.2 Transportation . 3 - 3 3.2.1 Precautions for Transportation 3 - 3 3.2.2 Temperature and Humidity 3 - 3 3.3 Unpacking 3 - 4 3.3.1 Unpacking the Box 3 - 4 3.3.2 Checking Package contents 3 - 5 3.4 Condition of Installation 3 - 6 3.4.1 Precautions for Installation 3 - 6 3.4.2 Installation Place 3 - 6 3.5 Installation Procedure 3 - 7 3.5.1 Installation Safety 3 - 7 3.5.2 Connecting the Power Cord 3 - 8 3. 5.3 Connecting the Network Cable 3 - 9 3.5. 4 Connecting the Probe ... 3 - 9 3.6 Starting the Product 3 - 1 0 3.7 Shutting down the Product 3 - 1 1 3.7.1 Power S/W 3 - 11 3.7.2 Power Breaker 3 - 11 3.8 Connecting the Peripherals 3 - 1 2 3.8.1 Internal Peripherals 3 - 12 3.8.1 External Peripherals 3 - 1 2 3.9 System Setting . 3 - 1 4 3. 9.1 System - General 3 - 1 4 3.9.2 System - Display 3 - 1 7 Chapter 3. Installing the Product 3-1

[Page 50] 3. 10 Peripherals Setting 3 - 20 3. 10.1 Peripherals 3 - 20 3. 10.2 Foot Switch 3 - 20 3. 10.3 Set / Exit Key Setup 3 - 20 3. 10.4 User Key Setup 3 - 2 0 3. 10.5 Print Setup 3 - 21 3. 1 1 System Information 3 - 2 2 3.12 Setting DICOM ( Optional ) 3 - 23 3. 12 .1 DICOM Configuration ... 3 - 23 3. 1 2 .2 DICOM Send Format 3 - 24 3. 1 2 .3 DICOM Compression ... 3 - 24 3. 12 .4 Display Compensation .. 3 - 24 3. 1 2 .5 Add DICOM Service 3 - 25 3. 1 2 .6 DICOM Server Info r mation 3 - 26 3. 1 2 .7 Print Server Info r mation 3 - 27 3. 12.8 Worklist Info r mation 3 - 29 3. 12.9 PPS Info r mation 3 - 30 3. 12.10 SC Info r mation 3 - 30 3.12.11 Storage SR Info r mation 3 - 31 3.12.12 Add DICOM Service 3 - 31 3.12.13 DICOM Service Delete . 3 - 31 3.12.14 DICOM Server Test 3 - 31 3.12.15 DICOM Management ... 3 - 31 3.12.16 DICOM Log 3 - 33 3.12.17 Utility setting 3 - 34 3. 1 3 Option setting 3 - 37 3.13.1 Option 3 - 37 3.13.2 Auto Calc 3 - 38 3.1 4 Measurement Setup 3 - 39 3.1 4 .1 Ge neral setting 3 - 39 3.1 4 .2 Packages 3 - 41 3.14.3 Report 3 - 45 3.14.4 Obstetrics Measurement Setup 3 - 48 3.14.5 Cardiac Measurement Setup 3 - 54 3.14.6 Vascular Measurement Setup 3 - 55 3.14.7 Urology Measurement Setup 3 - 56 3.14.8 Fetal Echo Measureme nt Setup 3 - 57 Chapter 3. Installing the Product 3-2

[Page 51] 3.2 Transportation SonoAce R7 is a sensitive piece of electronic medical equipment. Take care when moving it. 3.2.1 Precautions for Transportation 1) The box packaging is designed to diminish the effec ts of any impact to the product. However, take care not to subject the product to any external impact. . 2) If the box is subjected to an impact or is dropped, the shock sensor as illustrated below will indicate that a shock has occurred. In this case, cont act the customer service Team of SAMSUNG MEDISON Co., Ltd. or an authorized engineer immediately . 3.2.2 Temperature and Humidity The following [Table 3 - 1], “Temperature and Humidity Requirements” shows the required temperature and humidity for the trans portation, care and operation of the product . Type Temperature [ C ] Humidity [%] Transportation - 25 ~ 60 20 ~ 90 Care - 10 ~ 50 20 ~ 90 Operation 10 ~ 35 30 ~ 75 [Table 3 - 1] Temperature and Humidity Requirements Chapter 3. Installing the Product 3-3

[Page 52] 3.3 Unpacking the Box 3.3.1 Unpacking the Box 1) Remove the box strap . 2) Lift the top side of the box up and remove it . 3) Lift the box body up and remove it. 4) Remove the protective plastic packaging . 5) Take the probe and accessory boxes out and put them in a safe place . 6) Unlock the wheel. 7) Hold the rear handle and move the product to its installation location, pulling it gently by the handle. 8) It is recommended to use two pe rsons when wheeling the product . [Figu re 3 - 1 ] Unpacking the Box When moving the product up a steep incline or over a long distance, there is a danger of injury. Chapter 3. Installing the Product 3-4

[Page 53] 3.3.2 Checking Package Contents Un pack the product’s packaging and check the package contents . If there are any missing parts, contact your dealer . [Figure 3 - 2 ] Contents of Package Chapter 3. Installing the Product 3-5

[Page 54] 3.4 Precautions for Installation 3.4.1 Precauti ons . Please follow the precautions below . 1) Avoid installing the product where water may get into it . 2) Avoid installing the product in direct sunlight . 3) Avoid installing the product in places where there are high temperature fluctuations . O O 4) Temperat ures of 10 C ~ 35 C and a humidity of 30% ~ 75% ar e required for normal operation . 5) Avoid installing the product near a heater. . 6) Avoid installing the product in a dusty location, or where there is a lack of ventilation . 7) Avoid installing the produ ct in a location subject to vibration . 8) Avoid installing the product where there are chemicals or gas .  If you use the product near a generator, X - Ray equipment, or a broadcasting transmission cable, the screen may not work normally due to interference .  In addition, sharing the same wall outlet with other electric equipment may cause noise . 3.4.2 Installation Location 1) The width of the door must be at least 70cm for the product to pass through . 2) The distance between the wall and the product must be at least 30cm . 3) The wall outlet, grounding terminal and LAN connector (Ethernet Connector or LAN Connector) should be within 1m of the product . 4) The illumination should be capab le of being brightened or dimmed . 5) There must be sufficient ventilation in the room. . Vent Power Connector LAN Connector GN [ Figure 3 - 3 ] Installation location Chapter 3. Installing the Product 3-6

[Page 55] 3.5 Installation Procedure 3 . 5 . 1 Installation Safety ˙ ˙ ˙ ˙ ˙ ˙ D D ˙ A A ˙ N N ˙ G G ˙ E E ˙ R R ˙  If you use the product near a generator, X - Ray equipment, or a broadcasting transmission cable, the screen may not work normally due to interference.  In addition, sharing the same wall outlet with other electric equipment may cause noise.  When moving or storing the product for a long time, you should check the temperature and humidity of the environment.  Turn the power on after referring to the information in the following [Table 3 - 2] “ Product Operation Temperature ” .  Sudden temperature change causes dew and may generate problems in the product. Temperature - 20 - 15 - 10 - 5 0 5 10 ~ 35 45 50 55 60 Waiting Time 16 10 8 6 4 2 Immediate 2 4 6 10 [Table 3 - 2] Product Operation Temperature Chapter 3. Installing the Product 3-7

[Page 56] 3 . 5 . 2 Connecting the Power Cord Make sure to check t he output voltage of the wall outlet in the installation location. For the stable operation of SonoAce R7 , use it within the voltage range specified in the following [Table 3 - 3] “Product Voltage”. Connect the power cord to the power port on the rear panel of SonoAce R7 . The product and the power cord may be connected before shipping Connect the Power Cord [ Figure 3 - 4 ] Product Power Allowable Voltage Voltage Curr ent Frequency Range 100 - 120VAC +/ - 10% 10A 50~60Hz 200 - 240VAC +/ - 10% 10A 50~60Hz [Table 3 - 3] Product Voltage Chapter 3. Installing the Product 3-8

[Page 57] 3.5.3 Connecting the Network Cable Connect the network cable to the LAN port on the rear panel of SonoAce R7 Connect the network (LAN) [ Figure 3 - 5 ] Network Cable Connection 3.5. 4 Connecting the Probe SonoAce R7 provides 3 probe connections on its front panel. Place a probe in the probe holder and connect it up  Do not connect with excessive force, to prevent damage to the probe connection pin and the connector PCB. 1) Connect probes when the probe handle is unlocked (when the knob is turned counterclockwise). 2) Turn the probe handle clockwise until i t is fixed at the opposite direction of the cable. Probe Connection [ Figure 3 - 6] Probe Connections Although you can connect a probe when the power is on , do not connect or disconnect a probe during the booting sequence of the product. Chapter 3. Installing the Product 3-9

[Page 58] 3.6 Starting the Product 1) Check again if the power capacity is compliant with SonoAce R7 and connect the power cord to the wall outlet . 2) Check if the SonoAce R7 power cord is properly connected and switch on the cut - off switc h for the AC power. [Figure 3 - 7 ] Cut - Off Switch [Figure 3 - 7 ] AC Power  The product should be turned on abou t 10 seconds after the AC power switch at the back of the product is turned on.  During booting the system, do not press any key of the alphanumeric keyboard. It may cause malfunction. 3 ) To start SonoAce R7 , press the On/Off switch at the center of the c ontrol panel (keyboard). Power Switch [Figure 3 - 8] Power Switch ① The booting sequence is displayed on the LCD monitor. As the Windows XP logo disappears, the SonoAce R 7 logo and loading bar appear . ② The loading bar fills with color. This represents data b eing copied to the Front End and Back End of system by the PC software . ③ When software data copying is completed, the ultrasound picture appears and the system becomes ready . Chapter 3. Installing the Product 3-10

[Page 59] 3.7 Shutting down the Product You can shut down So noAce R7 by either turning the system off or switching off the cut - off switch. 3.7.1 Power Switch Press the On/Off switch at the center of the control panel (keyboard). Press and hold down the button for 2 seconds to turn the product On Power Switch [ Figu re 3 - 9 ] Power Switch  Pressing the On/Off button over five seconds turn off the power forcibly. It can cause hard disk damage .  If this problem repeats, contact the customer service Team of SAMSUNG M EDISON Co., Ltd. or an authorized engineer . 3.7.2 Cut - off Switch 1) Switching off the cut - off switch : You can cut off the power by switching off the cut - off switch after turning the system off . 2) Cut the power off in the event of storing the product fo r a long period of time, or when repairing the product. Cut - Off Switch [ Figure 3 - 10] AC Power Chapter 3. Installing the Product 3-11

[Page 60] 3.8 Connecting the Peripherals SonoAce R7 provides various connectors so that various external devices can be connected. Peripherals can include a mono printer, color printer, line printer, USB storage device, and VCR . These are peripheral devices that can be connected for use when needed and are connected via the USB port located at the rear panel . Refer to the operation manual of peripheral device about its operating . When using a peripheral device from a USB port, always turn the power off before connecting/disconnecting the d evice. Connection / disconnection of USB devices during power - on may lead to malfunction of the system and USB devices .  When remove the removable disk, use Utility > Storage manager .  The USB port is located on the console side panels and rear panel of the unit .  We recommend that you connect USB storage devices (MO drive, flash memory media, etc.) to the ports on the front panel and other USB peripheral devices to the rear panel for added convenien ce . 3.8. 1 Internal Peripheral Devices 3.8.1.1 DVD - Multi DVD - RW, DVD - RAM, DVD - R, DVD+R, DVD - ROM, CD - R, CD - RW, CD - ROM 3.8.1.2 Hard Disc Drive 50 0Gbytes . 3.8.2 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 from a USB port, always turn the power off before connecting/disconnecting the device. Connection / disconnection of USB devices dur ing power - on may lead to malfunction of the system and USB devices .  When remove the removable disk, use Utility > Storage manager .  The USB port is located on the console side panels and rear panel of the unit .  We recommend that you co nnect USB storage devices (MO drive, flash memory media, etc.) to the ports on the front panel and other USB peripheral devices to the rear panel for added convenience Chapter 3. Installing the Product 3-12

[Page 61] 3.8.2.1 Video Cassette Recorder (VCR) Analog : Panasonic MD835 Digital : Sony DVO - 1000 MD, JVC BDX201 3.8.2.2 Video Page Printer Color : SONY UP - 20 Black and White : Mitsubishi P93WM, SONY UP - 897MD 3.8.2.3 USB Video Printer Color : Mitsubishi CP - 30DW , SONY UP - D2 3 MD, Black and White : Mitsubishi P93DW, SONY UP - D897 TM  You must install a Microsoft Windows XP or above (English) compatible printer and driver. Contact SAMSUNG MEDISON customer service Team for inquiries about printer driver installation.  When c onnecting the printer, ensure that the printer is configured under Microsoft Windows TM or system setup and has been chosen as the default printer.  Please check the port used in printer before connecting. Printers should be connected to the Printer port wh ile the USB printer connected to the USB port . 3.8.2. 4 USB RS - 232C Serial Cable USB to Serial (RS-232C) Converter with FTDI Chipset (FTDI FT232BM Compatible) 3.8.2.5 Others Flash Memory media  If you use the USB 1.1 flash memory, the system cannot recognize it. In the case of this,delete the flash memory from the console and quip again .  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 a Flash Memory . Chapter 3. Installing the Product 3-13

[Page 62] 3.9 System Settings This mode is used for system settings. It does not affect image output. The setup may be modif ied depending on specific needs or preferences . 1. Press the Utility key, Setup, on the keyboard . 2. The Setup screen will appear. Select a tab that has items to specify . 3. Specify settings for each item . 4. The setting is completed when you press the [6] Close dial-button . Or you may press the Exit button on the control panel. ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ s s ˙ ! ! ˙ – – ˙ S S ˙ e e ˙ l l ˙ e e ˙ c c ˙ t t ˙ i i ˙ n n ˙ g g ˙ a a ˙ t t ˙ a a ˙ b b ˙ You can select a tab in either of two ways as desired . - Use the Trackball and the Set button to select a tab . - T urning Dial the [MENU] button to select the desired tab . 3.9.1 General System Setup Select the General tab in the Setting screen. You can specify general settings such as title settings [ Figure 3 - 11 ] Setup - General 3.9.1.1 Institution Enter the name of the hospital/institution where the product is installed. T he current date is displayed. To change the date, press You cannot input following characters; # [ “ ; : ? | ￦ Chapter 3. Installing the Product 3-14

[Page 63] 3.9.1. 2 Date The current date is displayed. To change the date, press  You cannot change the date and time when a patient ID is registered. To change the date and time, you should finish the current diagnosis by pressing End Exam on the control panel .  You can select the year from 2006 to 2027 . ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ s s ˙ ! ! ˙ – – ˙ H H ˙ o o ˙ w w ˙ t t ˙ o o ˙ s s ˙ e e ˙ t t ˙ t t ˙ h h ˙ e e ˙ d d ˙ a a ˙ t t ˙ e e ˙ a a ˙ n n ˙ d d ˙ t t ˙ i i ˙ m m ˙ e e ˙ 1. Press in the Date (or Time) button. 2. Set the date and time by using the Trackball and the Se t button on the control panel. 3. If it is properly set, press Apply to apply changes. Press OK to close the Date & Time window. To cancel, press Cancel or the Exit button on the control panel. [ Figure 3 - 12 ] Date & Time 3.9.1. 3 Date Format Specify the date format. Select a desired date format by pressing the combo button. The date format that you specify will be applied to various date fields in Patient Information. 3.9.1. 4 Time The current time is displayed . 3.9.1.5 Time Format Specify the time forma t. Select a desired time format by pressing the combo button . 3.9.1.6 Clip Store Method Specify the method and range in which an image is acquired and saved . You can select ECG Beat, Time or Manual. Note that ECG Beat can be selected . Chapter 3. Installing the Product 3-15

[Page 64] ECG Beat : Specify the heart beat as 1 – 8 beats . Time : Specify it as 1 – 50 seconds . Manual : After you press the Store Clip button, the images are automatically saved until 8 sec 3.9.1.7 Prospective When the Store Clip button is pressed during scanning, the subsequent ima ges are saved . 3.9.1.8 Retrospective When the Store Clip button is pressed during scanning, the previous images are saved .  To use Store Clip, set Utility > Setup > Peripherals > User Key Setup .  When you select ECG Beat and turn ECG off, a video is taken for about 4 seconds . 3.9.1.9 Simultaneous Mode This determines whether to enable simultaneou s mode in Spectral Doppler Mode . Off : Select this if you do not wish to use simultaneous mode . Allow B/PW : Sel ect this if you do not wish to use simultaneous mode in 2D/C/PW modes but do wish to use it in 2D/PW mode . Allow B/C/PW : Select this if you wish to use simultaneous mode for both 2D/PW and for 2D/C/PW . Doppler Axis : Select the axis sca le unit in Spectral Doppler Mode . Velocity : Specify the Doppler axis scale unit in cm/s (mm/s) . Frequency : Specify the Doppler axis scale unit in kHz . 3.9.1.11 Dual Operation Specify whether the selected area is activated in Dual or Quad mode. If ‘Auto Unfreeze’ is selected, the selected area will be activated in Dual or Quad mode all the time. 3.9.1.12 Track Ball Speed for Scan Mode Specify the Trackball speed as Slow, Normal or Fast 3.9.1.13 Track Ball Speed for Management Specify the Trackball speed as Slow, Normal or Fast. Slower speed allows more precise Chapter 3. Installing the Product 3-16

[Page 65] [Figure 3 - 13] Setup - General 3.9.2 Display Set up Select the Display tab in the Setup screen. Specify display-related options . [ Figure 3 - 14] Setup - Display Chapter 3. Installing the Product 3-17

[Page 66] 3.9.2.1 Option You can specify more than one item. Use the Trackball and the Set button to select a desired item and check or uncheck it . Auto Freeze : If the product is unused for 5 minutes, the scan mode will be automatic ally stopped . In Live 3D Mode, if the product is unused for 20 minutes, the Auto Freeze function is applied . TGC Line : This sets whether to display the TGC line . VCR Counter : This sets whether to show the VCR Counter on the screen when a VCR is connected to a serial port. When the counter interferes with an image and is turned off, it will appear during recording only . Image Info : This sets whether to display image information. When the image inform ation interferes with an image and is turned off, it will not be displayed Name + Age : This sets whether to display the patient ID, name and age . ‘ Name +Age ’ and ‘ Name + Birth ’ Canot be used simultaneously . 3.9.2.2 Freeze Action Select a function to execute when the Freeze button on the control panel is pressed. Available options are Bodymark, Caliper, Measure and None . 3.9.2.3 2D/C Live Select the location of Color Doppler Mode in 2D/C Live Mode. In the 2D menu, you can select from Up/Down if Horizontal Dual is on, or from Left/Right if it is off . Left/Up : Color Doppler Mode is located in the left or upper part . Right/Down : Color Doppler Mode is located in the right or lower part . Disable H orizontal Format : Turn off the Horizontal Dual function in 2D/C Live mode . 3.9.2. 4 LMP / GA / EDD Display Specify how the LMP, GA and EDD that are entered in the Patient Information screen are displayed on the monitor screen. Select two from LMP , GA and E DD . Information Bar (Replace ID) : display at the ID position of the title area . Information Bar (Replace Name) : display at the Name position of the title area . Information Bar (Replace App) : Replaces application in the information bar . Measure Result : display along with measurements . None : No display on the screen . Chapter 3. Installing the Product 3-18

[Page 67] 3.9.2. 5 Font Select the font to use in . Select one of the Document Font) and (Measure Result Font ) . 3.9.2.6 Font Name Select the font type to use . 3.9.2. 7 Font Size Select the font si ze to use . 3.9.2. 8 Font Color Select the font color to use . 3.9.2. 9 Preview Preview window displays the font you selected . 3.9.2. 10 Default Go back to the default setting like below . Document Font Measure Result Font Font Name Helvetica Verdana Font Size 11 11 Font Color White Yellow Certain fonts may not appear correctly on the screen . Chapter 3. Installing the Product 3-19

[Page 68] 3. 10 Peripherals Set up Select the Peripherals tab in the Setup screen. You can configure keys, buttons and the peripheral devices connected to the product . 3.10.1 Peripherals 3.10.1.1 VCR Model Select the type of VCR Model from Panasonic MD 835, Sony DVO - 1000MD, JVC BD - X201 3.10.1.2 Com Configure a device to connect to a serial port. Available devices are VCR and Open Line Transfer. If you select Reserve, the COM port will not be used . 3.10.2 Foot Switch Sets the functions of the buttons on the left and right side of the trackball on the control panel . Foot Switch Freeze Print Update Store Record Volume Start 3.10.3 Set / Exit Key Setup Set the location of the Exit and Set buttons on the control panel. Select the checkbox to make the SET / EXIT button on the left work as Set and the button on the right work as Exit . 3.10.4 User Key Setup Set the function of the User Key 1 button on the control panel. You can select one of the following functions for each button . User Key None RL Application Change Store Clip APTD M - Line EFW Measure TTD 2D / C Live EFW Resul t FTA Biopsy Document GS Change Window BPD CRL HC TDI AC Probe Change Chapter 3. Installing the Product 3-20

[Page 69] 3.10.5 Print Setup 3.10.5.1 Printer Orientation This option is available only for an Echo printer that uses roll paper . Set the type and page orientation of the Echo printer . Printer : Select a printer by using the combo button . Portrait: When printed, the long part of the page is vertical . Landscape: When printed, the long part of the page is horizontal .. 3.10.5.2 Print Key Set the functionality of the Print buttons on the control panel . Select from Analog Printer, Digital Printer or Record . Also set a printer or VCR to use when each button is pressed . 3.10.5.3 Measure Report Print Select the printer used to print measurement reports . Even though an Echo printer is selected, measurement reports are printed in the current report format . 3.10.5.4 Local Printing Area Set the area that will be printed . Full Screen ( 1280 * 1024 ) : Print the full monitor screen . Video Out ( 1024 * 768 ) : Print part of the monitor screen containing the image area . Image Only : Print only the image area . 3.10.5.5. Printing Image Adjustment Adjust the print quality of images. Select the image type and adjust gamma, brightness, contrast . [ Figure 3 - 15] Setup – Peripherals Chapter 3. Installing the Product 3-21

[Page 70] 3.1 1 System Information Click Detail to view more detailed information on the product version . Version2.00.00.0000 [ Figure 3 - 16] Setup – Information The S/W version of your system may be different from that in the figure above . Chapter 3. Installing the Product 3-22

[Page 71] 3.12 DICOM Setup ( Option ) Select the DICOM. You can configure the DICOM (Digital Imaging a nd Communication in Medicine) operation and the DICOM server . For more information, please refer to the user manual for the server equipment or the DICOM Conformance Statement . [ Figure 3 - 17] Setup – DICOM 3.12.1 DICOM Configuration The information on the DICOM server used by the system is displayed. You can change the information, or add or delete a server. The server information is used to identify DICOM for t he system in a network. It is also used to transfer data between other DICOM servers . ‘ Please consult your network administrator to set IP Address, AE Title and Port No . 3.12.1.1 AE Title Enter the name o f the DICOM AE (Application Entity). The title is used to identify devices that use DICOM in a network. (E.g. US1, US2, etc.) Chapter 3. Installing the Product 3-23

[Page 72] 3.12.1.2 Station Name Enter the name of the DICOM AE (Application Entity). The title is used to identify devices that use DICOM in a network . ( E.g. V201, V202, etc ) 3.12.1.3 Prot No Enter the port number of the server being used . 3.12.2 DICOM Send Format Specify the storage format for the 2D or Color mode images for which the DICOM services will be used. Select either Color or Gray by using the combo button If you select Gray, images are saved only in grayscale format . The DICOM Send Format settings are applied at the time when an image is saved. For example, when set to Gray, an i mage is saved as a grayscale image 3.12.3 DICOM Compression Specify whether to compress the still (Cine) images for which DICOM services will be used. Select either Uncompressed or JPEG Baseline by using the combo button. When Uncompressed is selected, images are saved without being compressed . The DICOM Compression setting is applied at the time an image is saved. For example, when set to JPEG Baseline, an image is compressed when it is saved . 3.12.4 Disp lay Compensation Configure the post curve settings for the images for which DICOM services will be used. Click this button to display the Display Compensation window. Adjust gamma, brightness, and contrast by using the slider for each option. Click Default to revert to the system defaults . ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ ! ! ˙ P P ˙ o o ˙ s s ˙ t t ˙ C C ˙ u u ˙ r r ˙ v v ˙ e e ˙ Adjusting the post curve settings for images allows other monitors to display them as close as possible to the original images, which is convenient in diagnosis . [ Figure 3 - 18] Display Compensation Chapter 3. Installing the Product 3-24

[Page 73] 3.12.5 Adding DICOM Service Click Add on the screen. The system is switched to a screen where you can enter a DICOM service to add. After adding a service, click Save to save the information. Click Cancel to cancel . 3.12.5.1 Services Select the type of service to use via DICOM. The supported DICOM servers are Storage, Print, Worklist, PPS, SC and Storage SR . 3.12.5.2 Alias Enter the name of the DICOM server . 3.12.5.3 AE Title Enter the AE title of the DICOM server. Consult your network administrator befo re specifying this option . 3.12.5.4 Transfer Mode Select a transfer method . • Batch : Send all saved images when you click the End Exam button . • Send As You Go : Send an image whenever you press the Save button to save it . • Manual : Send the specified image i n Exam List or SonoView . 3.12.5.5 Connect Timeout Specify how long the system will wait until it receives a response from the DICOM server. You can specify it in seconds . 3.12.5.6 IP Address Enter the IP address of the server being used. Consult your net work administrator before specifying this option . 3.12.5.7 Port No. Enter the port number of the server being used. Consult your network administrator before specifying this option . 3.12.5.8 Retry Interval Specify how long the system will wait before it retries when transmission fails. You can specify it in seconds . 3.12.5.9 Maximum Retries Specify how many times the system will retry when transmission fails . Chapter 3. Installing the Product 3-25

[Page 74] 3.12.6 Storage Server Information Select STORAGE under Services. Configure the Image Storage Se rvice using DICOM . 3.12.6.1 Include 3D Volume Specify whether to transfer the 3D volume data when transferring a 3D image . Check this checkbox only when a Storage service supporting MEDISON 3D volume data is used . 3.12.6.2 VOI LUT Setup Configure 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 that has 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 b e used only wh en it is supported by the Storage service . • Window Width : Enter a value for the DICOM Tag (0028, 1051) setting. The setting value indicates the brightness of an image that is displayed by the Storage service. Relative to 256, higher values result in lower contrast. Note that this function is avail able only when it is supported by the Storage service . [ Figure 3 - 19] DICOM Configuration - Storage Chapter 3. Installing the Product 3-26

[Page 75] 3.12.7 Print Server Information Select PRINT under Services. Configur e the Print Service using DICOM .  You can configure a printer connected to the DICOM network only .  Depending on the printer, some of the following functions may not be available. Before configuring a printe r service, please refer to the user manual for the printer or the DICO Conformance Statement . 3.12.7.1 Color Specify whether to use colors. Select Grayscale or RGB 3.12.7.2 Format Specify the paper layout. Select from 1 ⅹ 1, 1 ⅹ 2, 2 ⅹ 2, 2 ⅹ 3, 3 ⅹ 3, 3 ⅹ 4, 3 ⅹ 5, 4 ⅹ 4, 4 ⅹ 5 and 4 ⅹ 6 . 3.12.7.3 Orientation Specify the paper orientation. Select Landscape or Portrait 3.12.7.4 Magnification When resizing an image to print, specify the interpolation. Select from Replicate, Bilinear, Cubic and None . 3.12.7.5 Border Density Specify the border density of an image to print. Select Black or White . 3.12.7.6 Empty Density Specify the background color of an image to print. Select Black or White . 3.12.7.7 Min Density Specify the minimum brightness of an image to print. If this optio n is not specified, the default value is applied . 3.12.7.8 Max Density Specify the maximum brightness of an image to print. If this option is not specified, the default value is applied . 3.12.7.9 Medium Type Specify the paper type. Select from Paper, Clear Film, Blue Film, Mammo Clear Film and Mammo Blue Film . 3.12.7.10 Film Size Specify the paper size . Select from 8 inch ⅹ 10 inch, 5 inch ⅹ 11 inch, 10 inch ⅹ 12 inch, 10 inch ⅹ 14 inch, 11 inch ⅹ 14 inch, 11 inch ⅹ 17 inch, 14 inch ⅹ 14 inch, 14 inch ⅹ 17 inch, 24cm ⅹ 24cm, 24cm ⅹ 30cm, A4 and A3 . 3.12.7.11 Destination Specify the paper pathway. Select Magazine or Processor . Chapter 3. Installing the Product 3-27

[Page 76] 3.12.7.12 Smoothing Type This option is available only when Magnification is set to CUBIC. Enter a value specified in the DICOM Conformance Statement fo r the printer . 3.12.7.13 Priority Specify a priority for the print command. Select from High, Med and Low . 3.12.7.14 Copies Enter the number of copies between 1 and 99 . 3.12.7.15 Configuration Info Specify the unique value for a printer. Please refer to the DICOM Conformance Statement for the printer . [ Figure 3 - 20] DICOM Configuration – Print Chapter 3. Installing the Product 3-28

[Page 77] 3.12.8 Worklist Server Information Select WORKLIST under Services. Configure the Modality Worklist Service using DICOM . 3.12.8.1 Update Method Specify the update method for Worklist . • Only on User Request : Update only when asked by the user . • On Startup and Every : Update automatically at a specified interval after the system boots and Worklist is upda ted . ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ ! ! ˙ W W ˙ o o ˙ r r ˙ k k ˙ l l ˙ i i ˙ s s ˙ t t ˙ U U ˙ p p ˙ d d ˙ a a ˙ t t ˙ e e ˙ To update a worklist, in the Search tab on the Patient Information screen, select Worklist for Search Source and press Search . 3.12.8.2 Scheduled Station AE Title Specify the range of AE Title to retrieve from the Worklist serve r in a hospital . • Any : Retrieve the patient list stored in all AE Titles in the server . • This System : Retrieve the patient list specified under the DICOM tab . • Another : Retrieve the patient list stored in the AE Title specified by the user . This option is available only when the Worklist server is enabled . 3.12.8.3 Start Date Specify the range of dates to search • Today : Retrieve the patient list for the current date . • Range : the patient list for n days before and n days after the current date . • Past Week : Retrieve the patient list for 7 days before the current date . • Past Month : Retrieve the patient list for a month before the current date . • Custom Date : Specify a certain date and retrieve the patient list for that date . [ Figure 3 - 21] DICOM Configuration – Worklist Chapter 3. Installing the Product 3-29

[Page 78] 3.12.9 PPS Server Information Select PPS (Performed Procedure Step) under Services. Configure the Modality Performed Procedure Step Service using DICOM . It can be configured in the same way as for the Storage server . [ Figure 3 - 22] DICOM Configuration – PPS 3.12.10 SC Server Information Select SC (Storage Commitment) under Services. 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 transferred [ F igure 3 - 23] DICOM Configuration – SC Chapter 3. Installing the Product 3-30

[Page 79] 3.12.11 Storage SR Server Information Select Storage SR (Storage Structured Report) under Services. Configu re the Report Storage Service using DICOM . [ Figure 3 - 24] DICOM Configuration – Storage SR 3.12.12 Changing DICOM Information Select a service and press Edit on the screen . The information on the selected service will appear . Press t he Save button to save modified information . A nd Press the Cancel button to save. 3.12.13 Deleting DICOM Service Select a service and press Delete on the screen. A message appears asking whether to [Ok] delete it. Press Ok to delete the selected service . Press Cancel to cancel . 3.12.14 Testing DICOM Server Select a service and press Test on the screen. The connection with the selected service is tested and the results are shown under the Ping and Verify items. If the result is Normal, it indicates that the connection is normal . 3.12.15 Managing DICOM Click Queue on the screen to switch to the DICOM Job Status screen. You can review the current job status using the Job ID, Patient ID, etc . Chapter 3. Installing the Product 3-31

[Page 80] The following describes the elements of the DICOM Job Status screen . 1) Job ID : Display the job ID . 2) Patient ID : Display the patient ID . 3) Alias : Display the alias set in the DICOM Configuration screen . 4) Type : Display the job type. The available job types are Storage, Print, Storage SR, MPPS Start, MPPS End, and Storag e CMT . 5) Instances : Display the number of instances. What this denotes differs depending on the job type. For ‘Storage’ and ‘Print’, it means the number of images. For ‘Storage SR’, it means the amount of measurement data. For MPPS Start, it is al ways displayed as 0 . 6) Date/Time : Display the date and time when the job was created . 7) Status : Display the current status of the job . Status Description Fail The job failed Transfer The job is in progress Imperfect The job has been stopped during execution. It will be switched to the Ready state immediately Wait The job is waiting for execution . Wait Resp The job is waiting for a response . Hold The job is waiting for a retry. This occurs when the job has failed but the maximum retry count is not yet reached . Ready The job is waiting for execution. This occurs when the network is not connected . Not Ready The Ready state is not completed. This occurs when MPPS (Modality Performed Procedure Step) End occurs before MPPS Start is completed or the case that a Storage or Print batch job is not completed . 3.12.15.1 Network Status Display the network connection status. When connected, ‘Connected’ is displayed. When disconnected, ‘Disconnected’ is displayed . 3.12.15.2 Number of Jobs Display the number of jobs listed in the DICOM Job Status screen . 3.12.15.3 Log Display the DICOM Log window . 3.12.15.4 Retry Perform the selected job again. This button is enabled only when the status of the selected job is Fail or Wait Resp . Chapter 3. Installing the Product 3-32

[Page 81] 3.12.15.5 Retry All Retry all jobs for which the status is Fail . 3.12.15.6 Delete Delete the selected job. This button is enabled only when the status of the selected job is Fail,Imperfect, Wait Resp, or Not Ready . 3.12.15.7 Clear Delete all jobs . 3.12.16 DICOM Log Click Log on the DICOM Job Status window to display the DICOM Log window. This is used to manage the history of all DICOM services performed on this product . 3.12.16.1 DICOM Log Display a list of log files with their information . • Select All: Select all log files . • Delete Selected Fi les: Delete the selected log file . • Copy Selected Files: Copy the selected log file to an external storage media . • View Selected File : Display the details of the selected log file on the screen . • Refresh : Update the information of a log file. . [ Figure 3 - 25] DICOM Log Chapter 3. Installing the Product 3-33

[Page 82] 3.12.17 Utilities Setup Select the Utility. You can configure settings for e - mail, text and network status . 3.12 .1 7.1 E - mail You can specify a server through which you will send and rece ive e - mails . 1) Mail (SMTP) Server Specify the e - mail server . 2) Port No. Enter a port number . 3) ID Enter an ID for the e - mail server . 4) Password Enter a password for the e - mail server . 3.12 . 17.2 Buzzer Control Generate a buzzer sound wh en a button or dial - button is used . Buzzer Sound If Buzzer On is selected, the buzzer sound is turned on. A buzzer sound is generated whenever a button or dial - button is used . 3.12 . 1 7.3 Body Marker Body Marker Auto Active : 'If 'BodyMarker Auto Active' is selected, the system automatically enters the BodyMarker input mode when the Freeze button is pressed . 3.12 . 1 7. 4 Text Setup You can specify whether to use Autotext or Quick Text. . 1) Auto text Setup If an abbreviation is entered, the system retrieves and ent ers a full word automatically. When this option is selected, you can enter text more easily and quickly. For example, to enter the text ‘Abdominal Circumference’, you only need to enter ‘AC’ and the system will search the full word from the abbreviation l ist and automatically enter it. . To enable Autotext, check the Autotext checkbox with the Trackball. Otherwise, uncheck the checkbox . If this option is selected, the abbreviation list appears on the screen when text is entered . [ Figure 3 - 26] Abbreviation list The system has a built - in abbreviation list for this function. You can add a new abbreviation or edit the existing abbreviation as desired . Chapter 3. Installing the Product 3-34

[Page 83] ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ ! ! ˙ E E ˙ d d ˙ i i ˙ t t ˙ i i ˙ n n ˙ g g ˙ A A ˙ b b ˙ b b ˙ r r ˙ e e ˙ v v ˙ i i ˙ a a ˙ t t ˙ i i ˙ o o ˙ n n ˙ L L ˙ i i ˙ s s ˙ t t ˙ To enable the abbreviation list sto red in the system, press the Autotext Edit button. The system w ill switch to the Autotext Edit screen.To save the changes and finish editing, press the [ Close ] button . 1) Modify Word Use the Trackball and the Set button to select a word to modify in the list. An abbreviation for the selected word and its full word are displayed under the Abbreviation and Full Word fields at the bottom of the screen . Modify words in the Abbreviation and Full Word fields. The abbreviation list is updated in real time . 2) Add W ord Press the New button . Enter words to add in the Abbreviation and Full Word fields at the bottom of the screen. The entered words are added to the abbreviation list . 3) Delete Word Use the Trackball and the Set button to select a word to delete from the li st. An abbreviation for the selected word and its full word are displayed under Abbreviation and Full Word at the bottom of the screen . Press the Delete button, and the following warning message will appear . Press the Delete button, and the following warni ng message will appear . 4) Specify Word Input Delays Specify the time taken by the system to convert an abbreviation to a full word and enter it. In the Autotext Delay Time field at the bottom of the screen, enter the input delay time in seconds . [ Figure 3 - 27] Auto text Edit Chapter 3. Installing the Product 3-35

[Page 84] 5) Quick Text If the checkbox is selected, the Quick Text function is enabled. Quick Text switches the system to the text input mode immediately after a character key in the Alphanumeric Key board is pressed .  The Quick Text checkbox is checked by default .  You can still enter text if this option is not enabled. I f this is the case, press the F 3 key in the Alphanumeric Keyboard to switch to the text mode . 6) Auto Text Erase If this checkbox is checked, whole texts are deleted at once when pressing Freeze button after input texts . 7) Boot up Caps Lock Status If this checkbox is checked, Boot up Caps Lock Status is turned on. When text is entered, it i s entered in capital letters . [ Figure 3 - 28] Utility Chapter 3. Installing the Product 3-36

[Page 85] 3.13 Option Setup Select the Option. You can enable or disable optional software and hardware . [ Figure 3 - 29] Setup - Options 3.13 .1 Options The list of optional software is displayed on the screen . To purchase optional software, please contact the distributor for the software . 3.13 .1.1 Options Sh ows the types of optional software that can be installed on the product. The following table shows the list of optional software that is available with SONOACE R7 . TM 4D 3D XI CW Function Cardiac Measurement DICOM Auto IMT Spatial Compound DMR DMR+ Chapter 3. Installing the Product 3-37

[Page 86] 3.13 .1.2 Status • Shows the current status of optional software . • Lock_Not Installed : No hardware is connected . • Lock_Unregistered : The software is not registered . • Lock_Installed : Hardware is installed but not registered . • Unlock_Permanent: Ready for use without any time limitation . • Unlock_Restricted: Ready for use for a certain period . 3.13 .1.3 HW Configuration The list of optional hardware is displayed on the screen . Currently, only ECG is supported . Check the checkbox for hardware that will be used. Reb oot the system to finish settings . 3.13 .2 Auto Calc Select the AutoCalc tab in the Setup screen . Auto Calc. Auto Calc. f unction calculates specified measurement items automatically with measurement data and is supported in Spectral Doppler Mode . . The specified items will appear on the screen only when the [ 3 ] Auto Calc dial - button on the softmenu is pressed in Spectral Doppler Mode . [ Figure 3 - 30] Setup - Auto Ca lc 3.13 .2.1 AutoCalc. Setting Enable or disable the following items for automatic calculation by checking their checkbox and choose up to . Peak Systolic Velocity / Time Averaged Mean Velocity End Diastolic Velocity Diastole / Systole Ratio / Time Averag ed Peak Velocity / Max Pressure Gradient Resistive Index Mean Pressure Gradient / Pulsatility Index Velocity Time Integral Systole / Diastole Ratio / Peak A When the Peak Systolic Velocity and End Diastolic Velocity values are 0, not all results for the items will be displayed o n the screen . In addition, the result value for Timed Averaged Mean Velocity is displayed only when Mean Trace is ‘On’ . Chapter 3. Installing the Product 3-38

[Page 87] 3.14 Measure Setup Specify various setup options for measurement. The setup may be modified depending o n specific needs or preferences . • Control panel [Utility] button, then menu [Measure Setup] to select . • When the Measure Setup screen appears, select a tab that has items to configure . • Specify settings for each item . • Press the [6] Close dial - button on the so ftmenu to finish setting. Or, p ress the Exit button on the control panel to cancel . ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ ! ! ˙ S S ˙ e e ˙ l l ˙ e e ˙ c c ˙ t t ˙ i i ˙ n n ˙ g g ˙ a a ˙ t t ˙ a a ˙ b b ˙ You can select a tab in either of two ways as desired .  Use the t rackball and the Set button to select a tab .  Rotate the [1] Page Change dial - button on the soft menu to select a tab . 3.14 .1 General Select the General tab at the Measure Setup screen. You can specify basic measurement options . [ Figure 3 - 31] General - General 3.14 .1.1 Line Marker Type Specify the shape of the caliper cursor displayed on the screen. Either Cross Hai r or Arrow Head can be selected. . Chapter 3. Installing the Product 3-39

[Page 88] 3.14 .1.2 Circ. A nd area method Specify the method for measuring circumference and area. Either Ellipse or Trace can be selected . By default, the selected method appears when the Caliper button is pressed. Therefore, you c an start measurement more easily by specifying the most commonly used measurement method. For more information on Ellipse and Trace, please refer to the “Circumference and Area Measurement” section in Chapter 5 “Measurement.” . 3.14 .1.3 Line Type From the following three options, select the line pattern to use when measuring a distance . 1) Dotted Line Display with dotted line . 2) Hidden Dotted Line Display start and end point of the line . 3) Hidden Dotted line after Set Display with dotted line during making line. After set the line with Set button, dotted line will be disappeared . ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ ! ! ˙ S S ˙ e e ˙ l l ˙ e e ˙ c c ˙ t t ˙ i i ˙ n n ˙ f f ˙ L L ˙ i i ˙ n n ˙ e e ˙ T T ˙ y y ˙ p p ˙ e e ˙ If you select Hidden Dotted Line or Hidden Dotted Line after Set, you can keep images from being interfered with by a measur ement line . 3.14 .1.4 Display Specify items to display during measurement by checking their checkbox . 1) Display the Doppler Guideline Specify whether to display cross lines while items are measured in frozen spectrum. This option can be useful when approximate values are estimated . 2) Display the M - Mode Guideline Specify whether to display cross lines while items are measured in the frozen state in M Mode. This option can be useful when approximate values are estimated. 3) Show Mea sured Value in Menu Select whether or not to display the measured value in the menu. 4) Num of Measure Result Box Specify the number of lines for measurement results that are displayed on the screen. This setting is applied to all applications and basic measurement results except obstetrics, cardiac, vascular, urology and fetal echo measurements. To specify the Num of Measure Results Boxes setting for OB, cardiac, vascular, urology and fetal echo measurements, use the Setting tab for each application . 5) Clear Measure 2D Mode Result On Unfreeze Specify whether to clear measurement results from the screen in the Live status using the Freeze button after performing measurements in 2D mode . Chapter 3. Installing the Product 3-40

[Page 89] 6) Clear Measure M/D Mode Result On Unfreeze Specify whether to clear measurement results from the screen in Live status using the Freeze button after performing measurements in M mode and Doppler mode . 7) Measure Unit Specify the measurement unit. For a small object, it is more convenient to use ‘mm’ in Dist When blood flow is fast, it is better to use ‘m/s’ in Vel . • Dist : Select either a cm- or mm-scale for the unit of distance, area and volume . • Vel : Select either cm/s or m/s for the unit of velocity . Changing measurement units deletes all existing measurement data . 3.14 .2 Packages Select the Calc Menu tab under the General tab . Specify the measurement packages that will be used and the order in which they will appear on the screen when the Calculat or button is pressed . [ Figure 3 - 32] General - Package 3.14 .2.1 Menu Type Specify the type of menu that will be displ ayed on the monitor screen . 1) Full Menu Display the menu that contains all measurement items provided by this product . 2) Custom Menu Display the custom menu you configured using [ Menu Customize ] . 3.14 .2.2 Calc. Package(s) Order Chapter 3. Installing the Product 3-41

[Page 90] The right list displays t he calculation packages supported by this product. The left list displays the calculation packages that will be used . 1) Adding a Calculation Package to Use Select a calculation package you want to use from the right list and then click on the screen. The selected package will be moved to the left list . 2) Removing a Calculation Package to Use Select a calculation package you don’t want to use from the left list and then click O n the screen. The selected pack age will be moved to the right list . 3) Changing the Order of Calculation Packages Select the calculation package for which you want to change the order from the left list and Then click or on the screen. The topmost package i n the left list appears first when you press the Calculation button . 4) All Calc. Package List Checking this checkbox displays all calculation packages that can be used in this product in the left lis t . 5) Link with application If this checkbox is checked, measurement menu items are linked with probe presets. As a result, the measurement menu items that are related with the currently selected probe preset appear first when the Calculator button is pressed . The table below shows the probe presets and measurement menu items that are linked with each other . Probe Application Measure Application Fetal Heart st 1 Trimester OB nd rd 2 / 3 Trimester Uterus Gynecology Adnexa GB General Abdomen Renal Aorta Thyroid Breast Small Parts Testicle Bowel Aortic arch Cardiac Chapter 3. Installing the Product 3-42

[Page 91] Adult Echo Pediatric Echo Prostate Urology Carotid Arterial Vascular Venous General TCD Shoulder/ Knee Musculoskeletal Hand/ Foot Elbow/ Wrist 6) Menu Customize Click this button to switch to the Custom Menu screen. In the Custom Menu screen, you can set the menu items that appear when performing an application - specific measurement according to your preferences . 3.14 .2.3 Custom Menu The Custom Menu screen appears when you click Menu Customize. Specify which measurement items will appear on the custom menu according to your preferences .  To use custom menu, set it from Utility > Measure Setup > General > Package > Menu Type  Y ou can create up to four new tab menus .  You cannot delete or change the default tab menus provided by the product . The following describes custom menu screen . 1) Package List The calculation packages set in the Package screen appear in this list. If you sele ct a calculation package, it is outlined in orange . 2) Tab List Display the tab menus that belong to the list of calculation packages selected in Package List. The selected tab menu appears outlined in orange . 3) User Menu List Display the measurement items tha t belong to the list of tab menus selected in Tab List . 4) Available Menu List Display all calculation packages supported by this product. If you select an item with the “+” symbol to the left of it, its sub items are also selected . Chapter 3. Installing the Product 3-43

[Page 92] ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ ! ! ˙ M M ˙ o o ˙ d d ˙ i i ˙ f f ˙ y y ˙ i i ˙ n n ˙ g g ˙ t t ˙ h h ˙ e e ˙ P P ˙ a a ˙ c c ˙ k k ˙ a a ˙ g g ˙ e e ˙ L L ˙ i i ˙ s s ˙ t t ˙ Click Package Order at the bottom of the screen to return to the Package screen. Settings on the Package screen will apply to custom menu . [ Figure 3 - 33] Custom Menu The f ollowing describes how to set a custom menu . 1) In Package List, select an application . 2) In Tab List, select a tab menu. The measurement items that belong to the selected tab menu appear in User Menu List . 3) Configure a list of the tab menus . • Changing the orde r of tab menus : Select the tab menu and use or located • to the right of the list . • Setting whether to use a tab menu : Select the checkbox of the tab menu you want to use. • You should select at least one • Creating a new tab men : To create a ne w tab menu, click New. If you want to create a new tab menu by copying an existing tab menu, select it from Tab List and then click Copy . • Deleting a tab menu : Select the tab menu and click Delete . • Resetting tab menus : click Reset. Tab menu settings are re set . 4) Configure a list of the measurement items . • Changing the order of measurement items: Select the measurement item and click • O r located to the right of the User Menu List . • Adding a measurement item : Select the measurement it em from Available Menu List • and click • Deleting a measurement item : Select the measurement item and tap . ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ ! ! ˙ M M ˙ o o ˙ d d ˙ i i ˙ f f ˙ y y ˙ i i ˙ n n ˙ g g ˙ t t ˙ h h ˙ e e ˙ P P ˙ a a ˙ c c ˙ k k ˙ a a ˙ g g ˙ e e ˙ L L ˙ i i ˙ s s ˙ t t ˙ In the Available Menu List, if you select an item with the “+” symbol to the left of it, its sub items are also selected. However you cannot add whole measurement package . Chapter 3. Installing the Product 3-44

[Page 93] 3.14 .3 Report Select the sub tab Report under the General tab. You can specify options for measureme nt reports and printing . [ Figure 3 - 34] General - Report 1) Use SonoReport Select whether or not to use SonoReport. If you select this check box, the Sonoultra SonoReport appears when the Report button is pressed in the control panel . This feature can be used only when the SonoReport dongle is connected to the USB port . 3.14 .3.1 Report Header Specify header options for reports. You can specify more than one item and the specified items appear in all measurement reports . 1) Hospital Info. Shows information on the hospital where the product is installed . 2 ) Patient Info. Shows patient information . 3) Others Shows other information . Chapter 3. Installing the Product 3-45

[Page 94] 3.14 .3.2 Print Format Set a report page to print . • Only Current Page : Prints only the page currently displayed on the monitor . • All pages (1 X 1 ) : 1 graph is printed on a page . • All pages (3 X2 ) : 6 graphs are printed on a page . 3.14 .3.3 Measure Result Specify the measurement results output format for reports . • Average : Shows the average of t he last three measurement value . • Last : Shows the last measurement value . • Max : Shows the largest measurement value . • Min : Shows the smallest measurement value . 3.14 .3.4 OB / FH Header Layout Specify item(s) to display under the header of obstetrics or fe tal echo measurement reports. You can specify more than one item 3.14 .3.5 Print Enter additional information for the header, title and footer to display when printing measurements . 3.14 .3.6 Data Transfer Select the sub tab Transfer under the General tab. S pecify the data transfer method . 1) Save to file Specify the file format in which files will be saved. You can select from a text format and an XML format . 2) Serial Transfer Specify the data format in which data will be transferred. You can select from a text format and an XML format. This product uses an RS - 232C USB serial cable to transfer data. Select the XML format to transfer data with reporting tools such as Astraia, Sonoultra and Viewpoint. Before setting, make sure that COM is set to Open Line Transfer under the Peripherals tab in the Setup screen . 3) Measurement Data When the Write to file checkbox is selected, the Write to file button is created in the report screen. The Write to file function allows you to convert a measurement report to a file and save it in a storage media Chapter 3. Installing the Product 3-46

[Page 95] 4) User Table Backup & Restore Back up a user - defined table or restore the backed - up table to the system . [Backup] Click BackUp or Restore and specify desired op tions [ Figure 3 - 35] General - Data Transfer 3.14 .3.7 Caliper Select the Caliper sub - tab under the General tab . Specify whether additional information will be shown along with basic measurement values when basic measure ments are taken by pressing the Caliper button on the control panel. If this option is selected, the additional information will be also saved and output along with measurement results . Before setting, mak e sure that COM is set to Open Line Transfer under the Peripherals tab in the Setup screen . [ Figure 3 - 36] General - Caliper Chapter 3. Installing the Product 3-47

[Page 96] 3.14 .3.8 Display 1) N um of 2D Mode Result Box Specify the number of lines for 2D Mode results that are displayed on the screen . 2) Num of M/D Mode Result Box Specify the number of lines for M/D Mode results that are displayed on the screen . 3.14 .4 Obstetrics Measurement Setup Select the OB tab in the Measure Setup screen. You can specify obstetrics options 3.14 . 4.1 General Settings Select the sub tab General under the OB tab. You can specify basic options for obstetrics [ Figure 3 - 37] OB - General 3.14 . 4 . 2 Percentile Info. 1) Show Percentil e Info. Specify whether to use Percentile Info. by using this checkbox . 2) Percentile Criteria Select a value that will be used for percentile calculation . • GA by LMP : GA is calculated based on the maternal LMP . • Estab. Due Date : GA is calcula ted based on the Estab. Due Date that is entered in the Patient Information . • Average US GA : GA is calculated using the average value of several ultrasound measurements . Chapter 3. Installing the Product 3-48

[Page 97] 3) Rank Info. Method Specify how the growth range information will be displayed . The gro wth range information can be used to observe fetal development and abnormality, if any • Standard Deviation : International standard deviation is used to indicate the fetal development . Fetal development and abnormality are observed on the basis of SD = 0 i ndicating the standard development • Pctl. : Fetal development is indicated in percentile. Fetal development and abnormality are observed on the basis of 50% indicating the standard development . • Bar (Graph) : The percentile is shown in a bar graph. This opti on is available with OB reports only. The green color indicates normal development range, while the red color indicates abnormal development range . 3.14 . 4 . 3 Fetal Weight Unit Specify the unit for fetal weight measurement. You can select up to 2 units from grams [g], ounces [oz] and pounds [lb]. The primary and secondary units can be combined to show measurements in various units. The primary unit can be either ‘Gram [g]’ or ‘lb +oz’ on the left. The secondary unit can be selected from the units on the right , and can be any unit other than the one selected as the primary unit . ‘ lb +oz’ is a unit combining pounds and ounces, ‘ None ’ and ‘None’ indicates that no unit is used. 3.14 . 4 . 4 Display Num of Measure Result Box Specify the number of lines for OB measureme nt results that are displayed on the screen . 3.14 . 4.5 Table Settings Select the sub tab Tables under the OB tab. You can specify references such as reference tables and equations that will be used by each measurement item . [ Figure 3 - 38] OB - Tables Chapter 3. Installing the Product 3-49

[Page 98] 1) EFW Sequential Measurement These settings are needed when User Key 1 is set to EFW Measure in Utility > Setup > Peripherals > User Key Setup. The settings are applied w hen measuring EFW using the User Key 1 button . Specify the order of measurement items when measuring EFW using the User Key 1 button. Select the measurement item using trackball and the Set button and Change the order of measurement item using arrow butto ns . 2) Items This setting is intended for measurement of the gestational age (GA) and fetal size (Growth). Select items in the following order . • Select a measurement item in the list on the left . • Select a reference type from the GA table and Growth table . • Sele ct a reference in the list on the right . 3) Fetal Weight This setting is intended for measurement of the estimated fetal weight (EFW). Select items in the following order . 4) Add Reference  Observe the followi ng directions when adding a table reference . If these conditions are not met, a warning message appears and the reference is not saved .  Input at least three types of data .  If there are no Min and Max values, select Value Only for “ Table Type ” . • Press . The User Reference window will appear [ Figure 3 - 39] User Reference • Enter a name and description for a new reference. . • Specify the reference type as Table or Equation. . • Press OK to go to the next ste p. The system will switch to the Editor screen . Press Cancel to cance l • Press OK to finish. Press Cancel to cancel . Chapter 3. Installing the Product 3-50

[Page 99] EFW Equation can set only Equation and EFW Growth can set only Table as the reference ty pe . ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ A A ˙ d d ˙ d d ˙ R R ˙ e e ˙ f f ˙ e e ˙ r r ˙ e e ˙ n n ˙ c c ˙ e e ˙ T T ˙ a a ˙ b b ˙ l l ˙ e e ˙ Selection A preset for the selected measurement reference is displayed. The name and type of the reference is displayed on the right. Press the question mark button to show the source for the reference. Press it again to hid e it . [ Figure 3 - 40] User Table Table Enter a reference table . • You should make over two rows; use [+] or [ - ] button to add or delete a row . • Press the Tab or Enter key on the Alphanumeric keyboard to save the cur rent state and move to next item . Unit Information The various units for the selected reference (Input, Output, SD) are displayed . Table Type Specify the table type and SD (Standard Deviation) for the selected reference. For Growth Table, SD (Standard Devi ation) is displayed . • Range Type: The Min and Max values for the selected reference are shown in a table. The SD value varies depending on the range specified by the user . • Value Type: Only measurements entered by the user ar e shown, regardless of Min, Max or SD . Chapter 3. Installing the Product 3-51

[Page 100] ETC • Show In Days: When the checkbox is selected, the table unit is changed from wd (Week - day) to d (day) . • Cursor Movement for [Enter] key: Specify the direction of cursor movement when the Enter key on the alphanumeric keyboard is pressed while a table is being edited. Select from Right, Down and Edit ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ A A ˙ d d ˙ d d ˙ R R ˙ e e ˙ f f ˙ e e ˙ r r ˙ e e ˙ n n ˙ c c ˙ e e ˙ E E ˙ q q ˙ u u ˙ a a ˙ t t ˙ i i ˙ o o ˙ n n ˙ If a reference appears in an equation, the follo wing should be entered . Equation Enter a reference equation. Use the measurement calculator shown in the lower right corner . Input Value Ranges Enter the minimum (Low) and maximum (High) ranges for the selected reference . Tolerance Information Select the t olerance from w, d and % . [ Figure 3 - 41] User Equation 5) D e lete Reference • Under Selection, select a preset to delete . • Press . confirmation message appears asking whether to delete it . • Press OK to delete. Press Cancel to cancel . 6) View & Modify Reference • Under Selection, select a preset to delete . • Press . and the Editor screen will appear . • View or modify a reference . Chapter 3. Installing the Product 3-52

[Page 101] 3.14 .4.6 Calc & Graph Select the sub tab Calc & Graph under the OB tab. You can sp ecify settings for calculation and graphs . [ Figure 3 - 42] Calc & Graph 1) Auto Calculations Specify an item that will be calculated automatically. For example, if the MAD checkbox is selected as shown below, when APD and TAD are measured, the measurements are used to calculate MAD automatically and display the result on the screen. The results of automatic calculation may affect GA and EDD information . 2) Ratio Calculations Specify a measurement item for which a rati o will be calculated. For example, if the FL/BPD checkbox is selected, when FL and BPD are measured, the ratio between them is calculated and displayed on the screen. This ratio also appears in a report . 3) Fetal Doppler Trend Graph Specify whether to includ e PI and RI graphs for MCA (Mid Cerebral Artery) and UA (Umbilical Artery) in an obstetrics report. Press and the Editor screen for the selected graph will appear . 4) Trend Graph Specify whether to include a graph for a certain item or ratio in an obst etrics report. Press and the Editor screen for the selected graph will appear Chapter 3. Installing the Product 3-53

[Page 102] 3.14 .5 Cardiac Measurement Setup Select the Cardiac tab in the Measure Setup screen. You c an specify settings for cardiac 3.14 .5.1 Cursor & Method 1) Circ a nd Area Method Specify how a circumference and area is measured in a 2D cardiac image. Either Ellipse or Trace can be selected . 2) LV Volume Method Specify how the volume of the left ventricle is measured. Teichholz, Cubed or Gibson can be selected . 3.14.5. 2 Display Num of Measure Result Box : Specify the number of lines for Cardiac measurement results that are displayed on the screen . [ Figure 3 - 43] Cardiac Setup Chapter 3. Installing the Product 3-54

[Page 103] 3.14 .6 vascul ar measurements Select the Vascular tab in the Measure Setup screen. You can specify settings for vascular 3.14 .6.1 A/B Ratio Specify each individual peak velocity for which a ratio between A and B will be calculated . 3.14.6.2 ICA/CCA Ratio Sp ecify each individual measurement item that will be used for the ICA/CCA ratio . 3.14.6.3 Display Specify the number of lines for Vascular measurement results that are displayed on the screen . [ Figure 3 - 44] Vascular Setup Chapter 3. Installing the Product 3-55

[Page 104] 3.14.7 Urology measurements Select the Urology tab in the Measure Setup screen. You can specify settings for urology [ Figure 3 - 45] Urology Setup 3.14.7.1 Volume Method Specify an equation that will be used for volume calculation . • 3 Distance: The volume is calculated using three diameters in the longitudinal and transverse planes (4 / 3 x π x A/2 x B/2 x C/2) • 3 Distance x Factor: he volume is calculated using three diameters in the longitudinal and transversal planes, and a factor (F) value entered by the user (A x B x C x Factor) • Ellipsoid: The volume is calculated using t he length of the Main and Beside axes (4 / 3 x π x Main / 2 x (Beside / 2)2) • Main / 2 x (Beside / 2)2) Sum of 20 Disks: The volume is calculated by summing the areas in the 20 parallel planes (d /20 x (A1 + A2 + ... A20), d : the sum of the distances between disks) Chapter 3. Installing the Product 3-56

[Page 105] 3 Distances: A = 1st Dia. ; B = 2nd Dia. ; C = 3rd Dia. The factor value is set to “0.523” by default. When the value needs to be changed, a value between 0 and 1 (0 < factor <= 1) is recommended . 3. 14.7.2 Predicted PSA correction factor Specify the predicted PSA correction factor for measurement of volume of the WG and T - Zone. The default value is 0.12 . 3.14.7.3 Display Num of Measure Result Box Specify the number of lines for Urology measurement res ults that are displayed on the screen . 3.14.8 Fetal Echo Measurement Setup Select the Fetal Echo tab in the Measure Setup screen. You can specify settings for fetal echo 3.14 .8.1 Cursor & Method 1) Circ and Area Method Specify how a circumferenc e and area is measured in a 2D fetal cardiac image. Either Ellipse or Trace can be selected . 2) LV Volume Method Specify how the volume of the left ventricle is measured. For more information on calculation formulae, please refer to reference manual . 3.14.8.2 Display Num of Measure Result Box Specify the number of lines for Fetal Echo measurement results that are displayed on the screen . [ Figure 3 - 46] Fetal Echo Setup Chapter 3. Installing the Product 3-57

[Page 106] C C h h a a p p t t e e r r 4 4 . . C C h h e e c c k k i i n n g g t t h h e e P P r r o o d d u u c c t t 4 .1 Overview Chapter 4 describes how to check SonoAce R7 and how to check if its major functions and the power supply are working properly. 4.1 Overview 4 - 1 4.2 Starting the Product 4 - 2 4.3 Monitor 4 - 3 4.3.1 Monitor Display 4 - 3 4.4 Control Panel 4 - 5 4.4.1 Detail Control Panel 4 - 5 4.4.2 Soft Menu 4 - 7 4.4.3 Keyboard s 4 - 7 4.4.4 Adjust of Control Pan el 4 - 8 4.5 Checking the Performance 4 - 9 4.5.1 Basic Check 4 - 9 4.5.2 Detail Check 4 - 10 Chapter 4. Checking the Product 4-1

[Page 107] 4 . 2 Starting the Product 1) Check again if the power capacity is compliant with SonoAce R 7 and connect the pow er cord to the wall outlet. 2) Check if the SonoAce R 7 power cord is proper ly connected and switch on the power button for the control panel. [Figure 4 - 1] breaker S/W [Figure 4-1] AC power  After turning on the re ar of the AC power , 10 seconds has elapsed turn on the product .  During booting the system, do not press any key of the alphanumeric keyboard It may cause malfunction. 3) To start SonoAce R 7, press the On/Off switch at the center of the control pan el . Power S/W [Figure 4-2] Power S/W ① booting sequence is displayed on the LCD monitor. As the Windows XP logo disappears, the S ono Ace R 7 logo and loading bar appear ② The loading bar fills with color. This represents data being copied to the Front End and Back End of system by the PC softwa re . ③ When software data copying is completed, the ultrasound picture appears and the system becomes ready Chapter 4. Checking the Product 4-2

[Page 108] 4 . 3 Monitor The monitor of this system is a color VGA monitor, which displays ultrasound images and additional information. This monitor is connected to the main body through a central pivot, allowing it to be tilted to the optimal viewing angle 4 . 3 .1 Monitor Display The monitor displays ultrasound images, operation menus and a variety of other information. The screen is divided into six sections: ① Title, ② Menu, ③ Image, ④ Thumbnail, ⑤ User Information, and ⑥ Softmenu sections [Figure4-3] Monitor Display ① Title Area . Displays patient name, hospital name, application, frame rate and depth, probe information, acoustic output information, and date and time ② Measurement Menu Area Displays the selected thumbnail image. During measurement, displays the measurement menus. ③ Image Area Displays ultrasound images. Image information, annotation, and measurement information Chapter 4. Checking the Product 4-3

[Page 109] are also displayed. ④ Thumbnails Area The images saved by pressing the Acquire button are displayed. Click a thumbnail to enlarge. Up to 9 images are displayed. In BodyMarker mode, body markers are displayed ⑤ User Information Area The user information area provides a variety of information necessary for system use e.g. current system status, image information, selectable items, etc ⑥ Soft menu Different items are displayed in the menu, depending on the current status of the system. To set or change the items in the Soft Menu, use the dial-button for the corresponding number on the control panel. ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ ! ! ˙ D D ˙ i i ˙ s s ˙ p p ˙ l l ˙ a a ˙ y y ˙ i i ˙ n n ˙ g g ˙ t t ˙ h h ˙ e e ˙ c c ˙ u u ˙ r r ˙ r r ˙ e e ˙ n n ˙ t t ˙ s s ˙ t t ˙ a a ˙ t t ˙ u u ˙ s s ˙ o o ˙ f f ˙ t t ˙ h h ˙ e e ˙ s s ˙ y y ˙ s s ˙ t t ˙ e e ˙ m m ˙  : Indicates whether Lan is connected.  : : Indicates whether a removable disk is connected. If you double - click this icon, the Storage Manager screen will be displayed.  : Shows the amount of the total & available disk space in the system.  : Displays the status of Caps Lock On.. Chapter 4. Checking the Product 4-4

[Page 110] 4.4 Control panel The control panel can be used for controlling the system. [Figure 4-3] Control Panel The dial-button can be used both as a dial and a button. 4 . 4 . 1 Detail Control Panel The control panel can be used for controlling the system. On/Off Turns the system on/off. Displays the Patient Information screen for patient selection and Patient information entry . Displays the Probe Selection screen to select or change probes and Probe applications. Finishes the exam of the currently selected patient and resets the End Exam related data. Displays the Report screen that shows the measurement results of the Report current application and other information. User1 Pre - set to perform the functions . SONOVIEW Runs SONOVIEW TM which is the image filing program. Freq Press the button to change frequency for the probe. Focus Use this switch to adjust the focus position. Depth Use this switch to adjust the scanning depth for the selected image Dual Use this button to enable Dual Mode. M Use this button to enable/disable M Mode. PD Use this button to enable/disable Power Doppler Mode C Use this button to enable/disable Color Doppler Mode. 2D Use this button to enable 2D Mode. PW Use this button to enable/disable PW Spectral Dopp ler Mode. CW Use this button to enab le/disable C W Spectral Doppler Mode. Chapter 4. Checking the Product 4-5

[Page 111]  Q Scan : Press this dial - button to enable Quick Scan. If Quick Scan is enabled, ‘ Q Scan ’ is shown in the right hand side of the screen Q Scan  Gain : Rotate this dial - but ton to adjust Gain in each mode. In 3D View, it / Gain can be used to move the reference image / PS  PS : Rotate Dial button in 3D View , Reference Slice parallel to the left or right to move  PS = Parallel Shift. 3D / 4D This is used to start or finish the 3D/4D Mode. Use this button to freeze the image that is being scanned. Press it again Freeze to return to scan mode. Print Use this button to print the image on the screen via a printer. SAVE Use this button to save the selected image or report in a database  Menu : Press dial button to activate the available menu item of current scan mode.  Angle : Rotate the dial - button to adjust the angle. In Spectral Doppler Menu Mode, the angle of the sample volume can be adjusted by 1 ° . In 2D Mode / Angle and Sector Width is not 100%, rotate the 2D image left or right side . Use this button to adjust the probe cursor or the indicator angle in BodyMaker or Indicator Mode respectively. Deletes text, Indicator, body marker, and measurement result, etc. Clear displayed on an image Active Mode Changes the menu or soft menu on the screen. Set Use this option to select an item or value. Exit Use this option to exit the current mode and return to the previous setting. Use this button to take basic measurements such as d istance, volume, Caliper circumference and area. Press it again to exit the basic measurement mode. Calculator Use this button to take measurements for the selected application. Change Use this button to change the function of the trackball. Use this bu tton to display the selected image in panning mode. Update If it is pressed in PW Spectral Doppler Mode, the system switch to D Only Mode. Press this button to show an arrow - shaped pointer in scan mode. Press it again Pointer to hide it. Use the trackball to move the cursor on the screen. It can also be used Trackball to search through Cine or Loop images when Freeze is enabled. Adjusts TGC values for each depth using 8 slides. TGC stands for Time TGC Gain compensation Too large a difference in the gain value settings of adjacent TGC slides may lead to the generation of stripes in an image . Chapter 4. Checking the Product 4-6

[Page 112] 4. 4 . 2 Soft menu (1~5) Use the Soft Menu that appears on the screen. Available menu items may vary depending on the current system state. ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ s s ˙ ! ! ˙ U U ˙ s s ˙ i i ˙ n n ˙ g g ˙ S S ˙ o o ˙ f f ˙ t t ˙ M M ˙ e e ˙ n n ˙ u u ˙ d d ˙ i i ˙ a a ˙ l l ˙ - - ˙ b b ˙ u u ˙ t t ˙ t t ˙ o o ˙ n n ˙ s s ˙ The Soft Menu is divided into top and bottom sections as below. ▶ Top Menu ( ① ): Rotate a dial - button to select an item. ▶ Sub Menu ( ② ): Press a dial - button to select an item. [Figure 4-5] Soft Menu ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ s s ˙ ! ! ˙ S S ˙ o o ˙ f f ˙ t t ˙ M M ˙ e e ˙ n n ˙ u u ˙ d d ˙ i i ˙ a a ˙ l l ˙ - - ˙ b b ˙ u u ˙ t t ˙ t t ˙ o o ˙ n n ˙ [ [ ˙ 4 4 ˙ ] ] ˙ ~ ~ ˙ [ [ ˙ 6 6 ˙ ] ] ˙ Dial soft menu - button [4] [6] in the 3D View to the following features . ▶ Soft Menu dial - button [4] : X - axis to rotate image . ▶ Soft Menu dial - button [5] : Y - axis to rotate image . ▶ Soft Menu dial - button [6] : Z - axis to rotate image . 4. 4 . 3 Keyboard This is used to type in text or performs some functions. [Figure 4-5] Keyboards F1 Help Displays ‘ Help Menu ’ on the screen. F2 Indicator This is used to start or finish the indicator Mode. Starts Text mode. But if the check box is selected in Setup> F3 Text Utility > Quick Text, you can enter text without pressing this button . . Chapter 4. Checking the Product 4-7

[Page 113] F4 Body Marker Starts Body Marker mode . F5 Utility Displays the Utility menu on the Soft Menu s creen. F8 BPD Starts BPD measurement . F9 AC Starts AC measurement. F10 FL Starts FL measurement. F11 CRL Starts CRL measurement. F12 GS Starts GS measurement. Each time it is pressed, on - screen information disappears in the order of Space Bar Space Bar image Data  Gray Scale Bar/ Color Bar  TGC . After they have disappeared, all three sets of data are displayed again if it is pressed. Brightness Allows you to adjust the monitor brightness. Sound Allows you to adjust volume in Spectral Doppler Mode. ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ˙ ※ ※ ˙ T T ˙ i i ˙ p p ˙ s s ˙ ! ! ˙ A A ˙ d d ˙ j j ˙ u u ˙ s s ˙ t t ˙ t t ˙ h h ˙ e e ˙ b b ˙ r r ˙ i i ˙ g g ˙ h h ˙ t t ˙ n n ˙ e e ˙ s s ˙ s s ˙ o o ˙ f f ˙ t t ˙ h h ˙ e e ˙ k k ˙ e e ˙ y y ˙ b b ˙ o o ˙ a a ˙ r r ˙ d d ˙ While holding down the Fn key, press the 1 key to increase the brightness of the back light. To decrease the brightness, press the 2 key with the same way. 4. 4 . 4 Adjusting the Control Panel Press the lever on the handle of the control panel and move it carefully up or down. Do not move the control panel to excessive . Chapter 4. Checking the Product 4-8

[Page 114] 4.5 Checking the Performance Chapter 4 SONOACE R7 after the installation of power and operating normally critical functions and to check whether the information is used to describe. 4. 5 . 1 Basic Check 1) Monitor Check the screen color, focus, dots, residual image, spot, blurring, etc. Check the screen status when a shock is applied to the monitor and check the signal when you shake the cable. 2) Control Panel and LED Status Press on control panel key and check if the corresponding character is displayed on the screen. Check if the Key board LED is turned on. 3) Body Mark Key Check if the Body Mark [Body Mark Key] is properly displayed and if the key works properly. 4) Indicator Key Check if the trackball works properly by moving it up, down, left and right. 5) Clear Key Check if TEXT and measurement data is erased properly when this key is pressed 6) Zoom Operation Examination Check that the Zoom works properly. 7) Sonoview Examination Save an IMAGE and CINE INAGE in each mode. Check if the images are properly saved. Check if Backup & Restore works properly 8) Measure Check if DISTANCE, CALIPER and CALC works properly. 9) Patient Enter information in PATIENT and check if the entered contents appear in the report or Sonoview. 10) End Exam Measure for a New Patient and check if the measured data is cleared when End Exam is selected. 11) Probe Key Check if it works properly when the probe is changed. Chapter 4. Checking the Product 4-9

[Page 115] 4. 5 . 2 Detail Check 1) B Mode ① Check if there is any missing line in an image by doing a Knife Test. ② Check if the image is displayed properly thr ough Phantom. ③ Check if Freeze Cine ( Broken Image, Auto run, Auto run Speed and Track ball Cine) and its related functions work properly. ④ Check if there is an image brightness change when the Gain is adjusted. ⑤ Check if there is an image brightness c hange when the TGC Gain is adjusted. ⑥ Check if the image is flipped horizontally or vertically and left or right when the Left/Right Flip, Up/Down Direction and Rotation keys are pressed. ⑦ Check if the image select menus (EE, DR, View Area, Tissue, Frame Rate) work properly. ⑧ Check if the f requency (Phantom, Res, Pen, Gen) is normal. ⑨ Check if the image changes according to Depth change. ⑩ Check if the image changes according to Depth change when the focus is changed. ⑪ Check if the image compensation modes (FSI, Harmonic, DMR, SRF, Quick Scan, Spatial Compound Imaging) work properly. 2) Dual Mode ① Check if the image is displayed properly through Phantom. ② Check if the image is flipped horizontally or vertically and left or right when the Left/Right Flip, Up/Down Direction and Rotation keys are pressed. ③ Check if the image select menus (EE, DR, View Area, Tissue, Frame Rate, sane angle, Power) work properly. ④ Check if the frequency( Phantom, Res, Pen, Gen) is normal. ⑤ Check if the image changes ac cording to Depth change. ⑥ Check if the image changes according to Depth change when the focus is changed. ⑦ Check if the left or right image Cine (number of pages, Auto run, Auto run Speed and Track ball Cine) and its related functions work properly. 3) M Mode ① Check if the image is displayed properly through Phantom. ② Check if the information on M Line is displayed in the Image area. ③ Check if there is an image brightness change when the GAIN is adjusted. ④ Check if the image is flipped horizontally or vertically and left or right when the Left/Right Flip, Up/Down Direction and Rotation keys are pressed. ⑤ Check if the image select menus (EE, DR, View Area, Tissue, Frame Rate, sane angle, Power) work properly. ⑥ Check if the image changes according to Depth change. ⑦ Check if image changes acco r ding to Depth change when the focus is changed. Chapter 4. Checking the Product 4-10

[Page 116] ⑧ Check if the speed change and information is correct according to the SPEED conversion step. ⑨ Check if an image is reversed when Negative operates. ⑩ Check if t he Top Down Format and Side by Side Format Image are correct when Loop Format is selected ⑪ Check if Format B - Mode and M Line Size are changed . ⑫ Check if the Freeze Cine (Broken Image, Auto run, Auto run Speed and Track ball Cine) and its related function s work properly. 4) C Mode & PD Mode ① Check if the image is displayed properly through Phantom ② Check if the image select menus ( Balance, Sensitivity, Color Mode, Display ) work properly ③ Check if the image changes according to Depth change. ④ Check if Freeze Cine ( Broken Image, Auto run, Auto run Speed and Track ball Cine) and its related functions work properly. ⑤ Check if there is image brightness change when the Color Gain is adjusted. ⑥ Check if an image is broken or if there is noise (B or C M ode Noise) When ROI Box is moved . ⑦ Check if an image is broken or if there is noise (B or C Mode Noise) When ROI Box is adjusted size ⑧ Adjust the Scale up and down and check if the frequency is converted and blood flow speed range is controlled . (Check w ith directly scan) ⑨ Operate the filter and check if small signals are removed by step . ⑩ Check if the Color Bar is reserved when the Invert key is pressed . ⑪ Move the Baseline up and down and check if the blood flow range moves to + or - part . 5) D Mode ① Check if the image is displayed properly through Phantom. ② Check if the Doppler PRF value changes as the Simultaneous is turned on or off . ③ Check if the Doppler spectrum works properly . ④ Change the Scale and check the speed range change . ⑤ Move the B aseline up and down and check if the blood flow range moves to ( + ) or ( – ) part. ⑥ Operate the filter and check if small signals in the spectrum are removed . ⑦ Operate the Invert and check if the Doppler waveform is reversed. ⑧ Operate the Angle . ⑨ Move t he SV or Size and check if it works properly . ⑩ Change the Spectrum Type and check if the spectrum video changes. ⑪ Check if Sound Volume works properly. Chapter 4. Checking the Product 4-11

[Page 117] ⑫ Check if the line when appears when Auto Calc runs is continuous and if the subsequent calculations are automatically done correctly. ⑬ Check if the Top Down Format and Side by Side Format Image are correct when LOOP FORMAT is selected. ⑭ Check if the CINE/LOOP (Broken Image, Auto run, Auto run Speed and Track ball Cine) and its related functions work pr operly. 6) 3D Mode ① Check if the loading is normal when Free Hand 3D Scan runs and it is skipped by Freeze, check if the image is fragmented and if there is any noise during the operation . ② Check if the loading is normal when Static 3D Scan runs, check if the image is fragmented and if there is ant noise during the operation. Check if the probe and motor sounds are normal. ③ Check if the loading is normal when Live 3D Scan runs, check if the image is fragmented and if there is any noise during the oper ation. Check if the probe and motor sounds are normal. ④ Check if the ROI 3D, ABC 3D, and Full images are normal. ⑤ Check a 3D image changes according to the selected angle. ⑥ Check if the contrast of 3D images changes according to the selected value. ⑦ Ch eck if images are displayed properly according to image size changes. ⑧ Check if the Display Format Image is normal. (ACB, Volume CT Image) ⑨ Select Step Angle, Rotation Angle, Rot, Axis and check if Cine Loading is done according to the settings made duri ng Cine operation. Check if images are properly displayed during the Cine operation. Chapter 4. Checking the Product 4-12

[Page 118] C C h h a a p p t t e e r r 5 5 . . P P r r o o d d u u c c t t S S t t r r u u c c t t u u r r e e 5.1 Overview Chapter 5 describes the internal structure and operation mechanism of SONOACER7 . This chapter must be read for the product maintenance and upgrade. SONOACER7 is Softw are DSC - applied ultrasound system. It not only adopted 1 7 inch LCD monitor and provides high resolution ultrasound Image, but also provides the premium grade system functions. To improve the processing speed, SAMSUNG MEDISON Co., Ltd. developed new interfac e to connect a latest PC and the ultrasound system with its proprietary technology. The enhancement of processor speed makes the system operations faster and reduces diagnosis time. SONOACER7 can use up to 12 8 Element probes and adopted Digital Beamforming of TX 128 Channels. Ultrasound image is displayed on the LCD through the Front End Part and Back End Part (including PC Part). The resolution of the LCD monitor is 1280 X 1024 pixels and various image formats are provided. The wide view angle of the LCD p anel provides convenient work environment for diagnosis. In addition, the arm - type monitor controller enables users to control the monitor easily. The DVD RW drive and USB port are placed on the front panel of the system for easier image backup and softwar e service. Since this system supports various external storage devices such as USB MO, USB Flash Memory and external - type USB HDD, upgrade becomes more easier. SONOACER7 consists of the following major components.  Ultrasound System Part : PSA, Main Board , CW Board, DC to DC Power Module  User Interface Part : LCD Monitor, Control Panel, Track Ball, Alpha numeric Keyboard Chapter 5. Product structure 5-1

[Page 119] 5.1 Overview 5 - 1 5.2 System Block Diagram 5 - 3 5.3 Basic Structure of SONOACER7 5 - 4 5.4 PSA 5 - 6 5.5 Beamformer Part 5 - 8 5.6 CW Part .. 5 - 1 1 5.7 Back End Part 5 - 1 5 5.8 PCI Part .. 5 - 1 9 5.9 Motor Control Part 5 - 20 5.12 PC Mother Board 5 - 2 1 5.1 3 Software DSC 5 - 2 2 5.1 6 Control Panel 5 - 2 3 Chapter 5. Product structure 5-2

[Page 120] 5.2 System Block Diagram LCD 19” Monitor [Figure 5 - 1] System Block Diagram Chapter 5. Product structure 5-3

[Page 121] 5.3 Basic Structure of SONOACER7 5.3.1 Overview SONOACER7 consists of Ultrasound System Part, PC Part, User Interface Part and Power Part. However, i t consists of Front End Part, Back End Part, User Interface Part, and Power Part from the electronical view point. The following is the description of electronical structure of SONOACER7 . Front End Part refers to the CW (Continuous Wave) Board, PSA (Probe Select Assembly), and BF (Beamformer) Board of the Ultrasound System Part. The Front End Part delivers High Voltage Pulser to the probe so that ultrasound is generated, amplifies the returned echo signal and processes Digital Beamforming. The RF signal gen erated here is delivered to the Back End Part. Back End Part refers to the BE(Back End) Board and PC of the Ultrasound System Part. The RF signal generated in the BF(Beamformer) Board is processed to diagnosis image such as BW, Color Doppler, PW Doppler, C W Doppler, and Power Doppler and displayed on the monitor so that users can see it. User Interface Part refers to th e LCD monitor and control panel . 5.3.2 Ultrasound System Part The major function implements the ultrasound data before the prior step of the Scan Converter. It plays the roles of the Front End Part and Back End Part (including some). It recognizes probes and delivers system and application information depending on the user environment to each board. Based on the information, TX Focusing and RX Focusing are done. When high - voltage Pulser is delivered to probe along through the TX Focusing, ultrasound is generated and the echo signal returned from human body is amplified by the amplifier circuit and then is processed by Digital Beamforming. Th e RF signal generated here is delivered to the PC Part to process it to provide diagnosis image such as BW, Color Doppler, PW Doppler, CW Doppler, and Power Doppler and display it on the monitor. DC - DC Power module supplies power to the power of Ultrasoun d System Part. Ultrasound System Part consists of the components.  CW(Continuous Wave Board)  PSA(Probe Select Assembly)  BF(Beamformer Board) X 2ea  BE(Back End Board)  DDM (DC to DC Power Module) Chapter 5. Product structure 5-4

[Page 122] 5.3. 3 User Interface Part User Interface Part enables use rs to view ultrasound image on the LCD monitor and control SONOACER7 through the control panel and touch panel. The image output from the PC Part is transferred to the LCD monitor and external device. Image output interface includes VHS, S - VHS, Composite, and DVI. In addition, and Image input use VGA, S - VHS. the control panel enables users to easily operate the system through various interfaces. The User Interface Part consists of the following components.  LCD Monitor (LCD Inverter Board, LCD Control Volum e)  Control Panel Board  Track Ball  Alphanumeric Keyboard Chapter 5. Product structure 5-5

[Page 123] 5.4 PSA 5.4.1 Major Function PSA (Probe Select Assembly) connects the system and probe. It has 3 Mini DLP Probe Connector and 1 Static CW Static P robe Connector. The pins of Probe Connector are defined for Probe ID and HV - MUX control functions and consist of Relay circuit to select one of 3 Array Probes. In addition, High Voltage Switching is applied so that the BF (Beamformer Board)’s 64 Channel Si gnal and Probe’s 12 8 Element are switched. 5.4.2 Block Diagram [Figure 5 - 2] PSA Diagram Chapter 5. Product structure 5-6

[Page 124] 5.4.3 Specification  64 Channel BF Board Support  32 Channel CW Board Support  260 Pin Mini DLP Probe Connector 3 ea  Static CW Probe Connec tor 1ea  High Voltage Switching ( 64 Channel : 12 8 Element)  Probe Switching (from CW)  Probe ID Reader (to CW)  Board Version Reader 5.4.4 Operation Mechanism 5.4.4.1 High Voltage Switching Process SONOACER7 supports 64 Channels and 12 8 Elements Probes. Si nce the BF(Beamformer Board)’s Pulser and Receiver circuit consists of 64 Channels only, additional Element Selection is necessary. Element Selection uses High Voltage Switches and switches based on the Control Signal output from the BF(Beamformer Board)’s Control Logic(CPLD). Control Signal is connected through the Mother Board Connector. High Voltage Switch consists of the Shift Register and High Voltage FET. 5.4.4.2 Probe Switching It consists of circuit to select one of 4 probes. It can select a probe selected by the user by using Latched type relay. It drives the Relay with the Probe Select signal transmitted from the CW(Continuous Wave Board)’s Control Logic(CPLD). The Probe Select signal is connected through Mother Board Connector. 5.4.4.3 CW Prob e Switching Since Steered CW and Static CW are not done by BF(Beamformer Board) and CW(Continuous Wave Board) constructs Pulser and Receiver circuit, do Selecting by constructing an additional circuit when Steered CW and Static CW are used. Chapter 5. Product structure 5-7

[Page 125] 5.5 Beam former Part 5.5.1 Major Function Beamformer Board (hereafter, BF Board) delivers High Voltage Pulser to a probe, generates ultrasound, amplifies the returned echo signal and does Digital Beamforming. Active aperture is in charge of 64 Channel and supports up to 12 8 Element Probe. It consists of TX Pulser circuit, Receiving circuit and 8 Beamformer ASIC(MCB 1 24) to construct the Active aperture 64 Channels and does the Dynamic Apodization, Multi Beam Receiving, and TGC fu nctions to enhance ultrasound image. 5.5.2 Block Diagram [Figure 5 - 3] Beamformer Board Diagram Chapter 5. Product structure 5-8

[Page 126] 5.5.3 Specification  TX Pulser  Limiter  TGC Amp  AD converter  BF ASIC (MCB 1 24)  RX Dynamic Aperture Function  RX Apodization Function  Board Version Reader  BFIC Operation Control Support  PSA Probe Selecting Function  Synthetic Aperture Support  Trapezoidal Imaging Support  Multi - Line Receiving Support  TX Focal Point Support 5.5.4 Operation Mechanism 5.5.4.1 TX Pulser The Exciting pul se data provided by BF ASIC(MCB 1 24) is applied to TX Pulser via TX Pulse Buffer. TX Pulser generates Bipolar Pulser using the Exciting pulse data and the High Voltage from the Power Module. Bipolar Pulser is sent to the Probe element by using the PSA (Probe S elect Assembly) to generate ultrasound. TX Pulser is a Hybrid IC. It developed by SAMSUNG MEDISON Co., Ltd. is used as TX Pulser. 8 Blocks are applied in total. Since Active aperture 64 Channels provide up to 12 8 Elements, additional Element Selection is ne cessary. For this purpose, High Voltage Switch is used. High Voltage Switch is constructed in PSA (Probe Select Assembly). 5.5.4.2 Receive Channel Receive Channel amplifies echo that is penetrated through the medium of human body and the reflected, and d oes the role of Analog Digital Converter so that Beamforming can be conducted. It consists of Limiter and Pre - Amp, TGC - Amp, Low - Pass Filter and A/D Converter. 1) Limiter It removes unnecessary signal from the Echo returned through the PSA (Probe Select Ass embly)’s High Voltage Switch. Up to 180 Vpp Tx Pulses and a few mV Echo signals are mixed. Since actually necessary RX data is the echo signal of a few mV, Tx Pulse should be removed before the signal to the Pre - Amp. Limiter removes signal of higher than a pproximately 0.6V and transfers the echo signal to the Pre - Amp. Chapter 5. Product structure 5-9

[Page 127] 2) Pre - Amp Pre - Amp amplifies echo signal of a few mV that is not processed. 3) TGC - Amp Each TGC(Time Gain Compensation) Amp consists of 4 channels. Since the echo signal that is penetrated an d reflected by medium diminishes as it traverses, it compensates the attenuation of the signal. 4) Low Pass Filter(Anti - aliasing) Low - Pass Filter filters noise in Stop Band that is out of ultrasound band. In addition, it does the role of Anti - aliasing Fil ter that minimizes the Aliasing Effect that may appear in a high frequency probe such as 7.5MHz probe. The Aliasing of high frequency probe occurs due to the limitation of the Sampling Clock in the BF ASIC. 5) A/D Converter It converts the digital signal to be used in the Digital Beamforming into analog. 5.5.4.3 Digital Beamforming The ultrasound generated by a probe takes channel mode that uses a number of elements for TX Focusing. The ultrasound generated by channel is penetrated through medium and ref lected as echo signal. However, since echo signals do not return to Probe Element simultaneously, but they return with delay variation. Therefore, a countermeasure against the delays is necessary for RX Focusing and it is very important to construct ultras ound image. Digital Beamforming samples the echo signal returned to Probe Element and save the sampled data into the memory. The data saved in the memory when the sampling is complete means that time compensation is complete. The time compensation is done by the Sampling Clock itself. RX Focusing becomes complete, just by reading the data saved in memory and adding the data. Since this method requires different Sampling Clock for each element, VSCG(Variable Sampling Clock Generator) is necessary. VSCG(Vari able Sampling Clock Generator) uses 61.6Mhz that is the same as A/D Sampling Clock and generates data necessary for BF ASIC(MCB 1 24A). Chapter 5. Product structure 5-10

[Page 128] 5.6 CW Board ( Option) 5.6.1 Major Function CW(Continuous Wave Board) i s classified into CW Board that includes Continuous Wave Doppler function and Non CW Board that includes no Continuous Wave Doppler function. Continuous Wave Doppler function is optional. A product equipped with Non - CW should be replaced. 5.6.2 Block Diagram Fo COS Fo SIN To PSA Pulser(1CH) Fo COS Demodulation Wall/Thump Buffer Band Pass filter Mixer Driver & Filter Static CW I, Q Driver I, Q From PSA Pre- Selector amp(1CH) I, Q (Static CW To PSA Pulser(29CH) TX Focus Steered CW) Steered CW I, Q Variable Gain Anti Alias Filter CW I/Q CW Data To BE Board Pre- RX Focus ADC Data interface From PSA amp(29CH) I, Q I, Q [Figure 5 - 4] CW Board Diagram 5.6.3 Specification • Static CW Doppler circuit (TX/RX 1Channel) • Steered CW Doppler circuit (TX/RX 29 Channel) • CW Sensing - Beamformer High Voltage(+/ - ) & Current(+/ - ) Sense • CW TX Control - Control the volt age for TX Pulser • CW Option 5.6.4. Continuous Wave Doppler Continuous Wave Doppler processes TX and RX continuously and detects Doppler signal that cannot be detected by Pulse Wave Doppler. SONOACER7 does this function in the CW(Continuous Wave Board) and constructs Static CW and Steered CW circuit. 1) Static CW Doppler Circuit (TX/RX 1Channel) ① CW Pulser that drives Transducer Chapter 5. Product structure 5-11

[Page 129] ② RF Pre - Amplifier for signal reception ③ Mixer to convert RF signal into vertical phase (0 degree, 90 degree) base band signal of 50KHz bandwidth ④ Thump Filter ⑤ Variabl e Wall Filter ⑥ Variable Gain ⑦ Variable Low Pass Filter ⑧ 16bit Analog - To - Digital Converters 2) Steered CW Doppler Circuit (TX/RX 29 Channel) ⑨ 29 Channel CW Pulser that drives Transducer. ⑩ 29 Channel RF Pre - Amplifier for signal reception ⑪ TX/RX Beamformer for TX and RX Focusing ⑫ Mixer to convert RF signal into vertical phase (0 degree, 90 degree) baseband signal of 50KHz bandwidth ⑬ Thump Filter / Variable Wall Filter ⑭ Variable Gain / Variable Low Pass Filter / 16bit Analog to Digital Converters 5.6. 5 CW Sensing I t controls the TX voltage and current of CW(Continuous Wave). 1) CW TX Voltage Sense If the voltage of the TX Pulser used by CW(Continuous Wave) fails to satisfy the specification, the system stops with an error message. 2) CW TX Current Sense If the curre nt of the TX Pulser used by CW(Continuous Wave) fails to satisfy the specification, the system stops with an error message. 5.6. 6 CW TX Control Controls the voltage of the CW(Continuous Wave)’s TX Pulser. Chapter 5. Product structure 5-12

[Page 130] 5.7 Back End Part 5.7.1 Major Function Back End Part consists of DSP(Digital Signal Processing) Part, DMA & RTC Part, and Analog Sound Part. DSP Part receives RF Data and CW I/Q Data from the BF Board and CW Board respectively, processes the dat a and outputs the data as image data such as BW Image, PW Doppler, CW Doppler, Color Doppler, and Power Doppler. The image data pass through the Frame Average of the BE Board’s DMA & RTC Part, are sent to the PC Part through the PCI BUS and are processed b y the Software DSC. Analog Sound Part processes the Doppler Sound Data from the DSP Part, with the Digital Analog Converter, amplifies the signal and sends it to the speaker. BE Part consists of AISIC (MCB 028 A), FPGA Analog Sound Part . 5.7.2 Block Diagra m [Figure 5 - 5] Back End Board Block Diagram Chapter 5. Product structure 5-13

[Page 131] 5.7.3 Specification  BW mode (B - mode) Image Data Processing  Motion mode (M - mode) Image Data Processing  Color Flow Mapping mode (CFM - mode) Image Data Processing  Directional Power Doppler Image Data Processing  Pulsed wave (PW) spectral Doppler Image Data Processing  Multi frequency Doppler Image Data Processing  Spatial Compound Imaging (SCI) Support  Tissue Harmonic Imaging Support  Pulse Inversion Harmonic Imaging Support  Power Pulse Inversion Har monic Imaging Support  Trapezoidal Imaging Support  Synthetic Aperture Support  Tissue Doppler Imaging Support  Extreme High Dynamic Range (170db)  Full Spectrum Imaging (FSI) Support  High Pulse Repetition Frequency (HPRF) Support  Interface between Ultrasound System Part and PC Part  Frame Average Function  Real Time Controller (RTC) Function  ECG Interface 5.7.4 DSP Part Operation Mechanism 5.7.4.1 BW Mode and M Mode Image Data Processing RF data generated in the BF Board in Input to the FPGA. The input RF data in converted into RF data, which can be processed by the FPGA , and Input to the ASIC (MCB 028 A). The ASIC (MCB 028 A) generate BW mode image data (hereafter, BW Data) and send the data to the FPGA. The ASIC (MCB 028 A) are used to implement FSI(Full Spect rum Image) function that has 3 bands. The final processing of FSI(Full Spectrum Image) function is done in the FPGA. ASIC (MCB 028 ) not only generate BW data but also do the functions of FSI(Full Spectrum Image), Spatial Compound Imaging (SCI), Trapezoidal I maging, and Synthetic Aperture. Especially, BW data is generated using the received RF data and through the DTGC(Digital Time Gain Compensation), Decimation, Quadrature mixer, Envelope detection, Log compression and various filters. The BW data generated by ASIC (MCB 028 A) as described above are input to the FPGA again. The data are processed by FSI(Full Spectrum Image) and Lateral filter, which is used to remove Multibeam artifact, and sent to the DMA & RTC Part. Chapter 5. Product structure 5-14

[Page 132] For your reference, BW data can also be us ed as Motion Mode Image Data. 5.7.4.2 Doppler Image Data Processing The RF data generated in the BF Board is input to the FPGA. The input RF data is converted into RF data that can be processed by the FPGA and input to the ASIC (MCB 028 A). ASIC (MCB 028 A) receives RF data and does the DTGC (Digital Time Gain Compensation), Decimation, and Quadrature mixer processing for the RF data . The RF data becomes I/Q data (In - phase & Quadrature Data). I/Q data are input to the FPGA again. I/Q data are processed by th e FPGA and Doppler DSP and become Doppler Data and are sent to the DMA & RTC Part. Detailed descriptions are given below. The DSP FPGA that received the I/Q Data, sends the data to the Doppler DSP via filtering. At this time, the CW I/Q Data from the CW Bo ard also sends final Doppler Data to the DMA & RTC Part through the same process as above. Since both PW and CW data cannot be processed simultaneously, all commands follow internal control process. I/Q Data passes through the Clutter Filter in the Doppler DSP to remove the Wall (blood vessel wall) Noise after the data are filtered by the DSP FPGA. After that, the Doppler Sound is generated through the Hilbert transform that separates sound directions. The data are input to the DSP FPGA again and is sent to the Analog Sound Part of the BE Board. In addition, I/Q Data are sent to the FFT (Fast Fourier Transform) circuit to generate the Doppler Spectrum, after passing through the Clutter Filter. By extracting the basic Doppler components of Power, Velocity, a nd Variance components, the Doppler Data are generated. The data are input to the DSP FPGA again and is sent to the DMA & RTC Part of the BE Board. 5.7.4.3 Color Image Data Processing RF Data generated in the BF Board are input to the DSP FPGA. The inpu t RF data is converted into RF data that can be processed by the FPGA and input to the ASIC (MCB028A). ASIC (MCB 028 A) receives RF data and does the DTGC(Digital Time Gain Compensation), Decimation, and Quadrature mixer processing for the RF data . The RF d ata becomes I/Q data (In - phase & Quadrature Data). I/Q data are input to the DSP FPGA again. I/Q Data generates Color Data through the processing in the Color Processor (MCB02 8 A) and the data are sent to the DMA & RTC Part. Detailed descriptions are given below. The DSP FPGA receives the I/Q Data, sends the data to the Color Processor (MCB02 8 A) to extract color components. However, since the color component include Wall (blood vessel wall) Noise, the data are sent to the DSP FPGA again and passes through th e Rejection, Smooth Filter, and Post Filter. Color Data are completed in the process and sent to the DMA & RTC Part of the BE Board. Chapter 5. Product structure 5-15

[Page 133] 5.7.5 Analog Sound Part Operation Mechanism Processes the Doppler Sound and outputs to the speaker. Doppler Sound is ge nerated in the Doppler Part and is sent to the Analog Sound Part. Doppler Sound passes through Audio Digital Analog Converter because the speaker requires analog signal. In addition, the control of the Audio Digital Analog Converter is supported by the DMA & RTC Part. After that, the noise is removed and Doppler Sound is amplified and sent to the speaker via the LCD IF Board. 5.7.6 DMA & RTC Part Operation Mechanism The DMA Part of the DMA & RTC Part (Direct Memory Access & Real Time Controller Part) tem porarily saves the Image Data (BW, Doppler, Color) that is signal - processed in the DSP Part and the ECG Data from the ECG Module and sends Image Data to the PC Part through PCI Bus according to the purpose of the data. The RTC Part also determines base sig nal and operation sequence of all Image Modes, and controls the Audio Digital Analog Converter. 5.7.6.1 DMA Part DMA (Direct Memory Access) consists of FA(Frame Average), DMA and ECG In/Out Part. FA (Frame Average) processes the BW, Doppler, Color Data w ith the average of the current Frame’s Scan line Data and the previous Frame’s Scan line Data. DMA temporarily saves the Frame - Averaged BW, Doppler, and Color Data and send them through the PCI BUS upon request of the PC Part. In addition, ECG Data are al so saved and transferred in the same way as above. Since DMA processes data using the DMA path with the PC Part, it plays key role to improve the product performance. 5.7.6.2 RTC Part RTC(Real Time Controller) generates base signal necessary for entire system operation in real - time and controls the system operations. It generates and controls the PRF (Pulse Repeat Frequency), OF(One Frame), RP(Rate Pulse), Line Type, and Scan Line signals necessary for the BF Board and BE Board’s DSP Part. In addition, it internally controls the data flow in the DMA FPGA. 5.7. 7 Non CW function 5. 7 . 7 .1 Master Clock It provides 61.6Mhz Master Clock of the Ultrasound System Part to the CW(Continuous Wave Board), BF(Beamformer Board), and BE(Back End Board) so that the boards can be synchronized. 5. 7 . 7 .2 Beamformer Sensing Beamformer Sensing controls the TX voltage and current of is BF(Beamforming Part ) . Chapter 5. Product structure 5-16

[Page 134] This function is executed in CPLD. 1) Beamformer High Voltage(+) Sense and Beamformer High Voltage( - ) Sense If the voltage of the TX Pulser used by BF(Beamformer Board) fails to satisfy the specification, the system stops with an error message. 2) Beamfo rmer High Current(+) Sense and Beamformer High Current( - )Sense If the current of the TX Pulser used by BF(Beamformer Board) fails to satisfy the specification, the system stops with an error message. 5. 7 . 7 .3 Beamformer TX Control It controls the voltage of the TX Pulser of the BF(Beamformer Board). This function is executed in CPLD. Chapter 5. Product structure 5-17

[Page 135] 5.8 PCI Part 5.8.1 Major Function Peripheral Component Interconnect Part interconnects the Ultrasound System Part and the PC Part. It is used as a D MA path to control and initilize the Ultrasound System Part and to handle the BW, Color, Doppler Data using the Software DSC (Software Digital Scan conversion). Chapter 5. Product structure 5-18

[Page 136] 5. 8 Motor Control Part 5.8.1 Major Function This Motor Control Part (MTR Part) is the Motor Driver to drive the 3D Probe. 5.7.2 Block Diagram [Figure 5 - 7] Motor Board Block Diagram 5. 7 .3 Specification  3D Probe Motor Drive  Voltage & Current Control Controller  Null Position Signal Sensing  D C Voltage Supply (+12V, - 12V, +3.3V, +5V) 5. 7 .4 Operation Mechanism 3D Probe implements 3D Mode by driving the Stepping Motor. The Motor Part does Feedback Control by using the SIN and COS waveform that has 90 phase difference from the 3D Probe. 3D Pr obe provides Null Position signal to the Motor Board and the Motor Board provides One Frame signal that is used as basis for 3D image acquisition to the DMA. Chapter 5. Product structure 5-19

[Page 137] 5 .1 0 PC Mother Board 5.12.1 Major Function SONOACER7 ad opted commercial PC Mother Board as the PC Mother Board. The conventional Hardware DSC Board and Video Manager Board have been implemented in the PC Part. Since the BE Part is implemented as software, the performance of the PC Mother Board is critical. We have designed the system considering further upgrade of the PC Mother Board with a commercial one. However, the performance of the system is not guaranteed if a PC Mother Board other than the board supplied by SAMSUNG MEDISON Co., Ltd. PC Mother Board ha s the following specifications. 1) CPU : Intel Core2 Duo E 740 0 2. 8 GHz 2) Main Chip set : Mother Board Intel DP35DP 3) RAM : DDR2 PC5300 667MHz 2GB Memory 4) PCI Slot : DVI Board, PCI Board, VCRIN Board 5) PCI Express x16 Slot : VGA Card 6) Back Panel Con nector : User can use it at will. 7) HDD : ST3250310AS (S - ATA) 8) DVD : TSH - 652J (S - ATA) 9) POWER : micro ATX 250W Chapter 5. Product structure 5-20

[Page 138] 5.1 1 Software DSC 5.1 1 .1 Major Function SONOACER7 does the role of conventional Hardware D SC with Software DSC. Video signal generated in the BE Board is directly copied to the PC Memory through DMA, processed by Software DSC and ultrasound image processing software, and displayed on the monitor through the VGA Card and DVI Board. 5.1 1 .4 Ope ration Mechanism The image data generated in the BE Board’s DMA Part are directly copied to the PC Memory in DMA mode through the 100 Pin Cable connecting the Mother Board and the PCI Board. The data are saved in the Cine Memory through the UC Agency Buffe r and processed by the Software DSC and the Image Save. The Software DSC does all the functions can be done by the Hardware DSC. Processes the DSC by the Filter and Rendering and transfers data to the VGA Card. In addition, the delay problem when saving th e image into the HDD has been resolved. Chapter 5. Product structure 5-21

[Page 139] 5.1 2 Control Panel 5.1 2 .1 Major function It plays the role of the interface between the user and the system. Key Matrix Board, Alphanumeric Keyboard, and Track Ball do the role of User Interface. 5.1 2 .2 Block Diagram To LCD IF Board Control Panel USB HUB Board 1:4 MCU ADC TGC Alpha numeric Control Panel Track Key board Key board Ball [Figure 5 - 7 ] Control Panel Block Diagram 5.1 2 .4 Operation Mechanism It is connected with the Key Matrix Board, Alpha Numeric Board, and Track Ball through the USB HUB and operate accord ing to the user's commands. Control is simply connected with the Key Matrix Board through a switch, detailed description will be given in the Operation Mechanism of the Power Module. Chapter 5. Product structure 5-22

[Page 140] Chapter6. Basic Maintenance 6.1 Overview Chapter 6 describes basic SonoAce 7 maintenance procedures. How to upgrade and how to use Admin Mode (Service Mode) are described. 6.1 Overview 6 - 1 6.2 System Information 6 - 2 6.3 Windows Mode 6 - 3 6.3 .1 Entering Windows Mode 6 - 3 6.4 Upgrade . 6 - 4 6.4.1 Software Upgrade 6 - 4 6.4.2 Hardware Upgrade ... 6 - 4 6.5 Admin Mode 6 - 5 6.5.1 Entering A dmin Mode 6 - 5 6.5.2 Admin Mode Functions 6 - 6 6.6 Adding and Deleting Options 6 - 9 6.6 .1 Option type 6 - 9 6.6 .2 Registering Option .. 6 - 1 0 6.6.3 Option Del e te 6 - 12

[Page 141] 6.2 System Information To view system information, select the [Information] tab in the Setting screen. The software version of the system will be displayed. Press [Detail] to view the detailed version information of the product. Version : 2.00.00 [ Figure 6 - 1] Setup - Information The software version number in the above figure may differ from the actual software version of the system Chapter 6. Basic Maintenance 6-2

[Page 142] 6.3 Windows Mode Windows Mode is a mode that switches the ultrasound system to the normal Windows XP Desktop screen and is necessary for software upgrade . 6.3.1 Entering Windows Mode 1) You have to enter a password with a combination from the alphanumeric keyboar d in order to enter Windows Mode . 2) Press the [***] + [***] + [***] key combination by using the keypad of the keyboard . 3) When the Windows Password window appears, type “**********” and then press Enter. . . 3) When the system successfully enters the Wi ndows mode, the Start button appears at the bottom of the screen

[Page 143] 6.4 Upgrade You can upgrade the sof tware and hardware of SONOACE R7 . Upgrade includes the addition and improvement of functions and improves system performance . . • The installed software should be compatible with the hardware. If the installed software and hardware are not compatible, a prob lem may occur in functions or operations. • A compatibility table is additionally provided by the customer service department of SAMSUNG MEDISON Co., Ltd. 6.4.1 Software Upgrade Follow these instructions to software upgrade the system . 1) Prepare a software file provided by the customer service department of SAMSUNG MEDISON . 2) Turn on SonoAce R 7 . 3) When system booting is complete, enter admin mode referring to “ 6.3.1 . Entering Window Mode ” . 4) Insert a CD/DVD into the CD/DVD - ROM drive or inert a Fresh Mem ory or MO into the USB port . 5) Select the Explorer in Windows Mode 6) Click the version up file in Explorer 6.4.2 Hardware Upgrade This means the replacement or addition of hardware . For information on hardware upgrade, refer to the “ Chapter 8 Disassembly and Reassembly ” Of the Service Manual. Chapter 6. Basic Maintenance 6-4

[Page 144] 6. 5 Admin Mode Admin Mode is also called Service Mode. Admin Mode functio ns are described below. Admin Mode is necessary for critical settings and to add or delete options . 6.5.1 Entering Admin Mode 1) Enter [***] in keybo a rd . 2) Enter the password “ ********* ” . 3) If the entered password is correct, the “Admin Mode” tab app ears in the Setup Mode . 4) “ If you select “Admin Mode” you can enter Ad min Mode as shown by [Figure 6 - 2] . [ Figure 6 - 2] Admin mode

[Page 145] 6.5.2 Admin Mode Functions 6.5.2.1 Language You can select a language to be used for the system thro ugh filter. Supported languages are English, German, French, Spanish, and Italian . 6.5.2.2 Test Pattern You can test the monitor characteristics. Select [Test Pattern]. Each time you press the [Set] button of the keyboard, one of the 3 test patterns shown by [Figure 6 - 2] is displayed on the screen in turn . [ Figure 6 - 3] Test Pattern 6.5.2.3 Restore Using this function, you can restore settings with the backed - up user setting values. You can use this function in Admin Mode only . 1) If you press [Resto re], the ultrasound program is terminated and the Restore function runs. If a message appears asking whether to exit the ultrasound program before running the Restore function, click [OK]. 2) In the [Restore] screen, you can select the User Setting Item and B ackup Media . 3) If you press [Next], the Restore function is executed . 4) When the restoration is complete, the system will restart . [ Figure 6 - 4] Restore Chapter 6. Basic Maintenance 6-6

[Page 146] [ Figure 6 - 5] Execution of Restore Function 6.5.2.4 Backup Using this function, you can back up your user settings onto external media. This function is available only in the Admin Mode 1) If you press [Backup], the ultrasound program is terminated and the Backup function runs. If a message appears asking whether to exit the ultrasoun d program before running the Backup function, click [OK]. 2) [ In the [Backup] screen, you can select the User Setting Item and Backup Media . 3) If you press [Next], the Backup function is executed . 4) When the backup is complete, the system will restart . [ Figure 6 - 6] Backup

[Page 147] [ Figure 6 - 7] Execution of Backup Function 6.5.2.5 VGA 1) Video Out Format You can select the scan type for Video Out through filter. Supported scan types are NTSC and PAL . 2) Set Graphic Card when VGA Card setting is changed Defa u lt condition, Press the [Set Graphic Card] button will to . automatically VGA Setting. 6.5.2.6 Network Configuration The Windows XP Network Configuration screen appears . You can set up Network Settings such as DICOM, etc . [ Figure 6 - 8] Network Configuration Chapter 6. Basic Maintenance 6-8

[Page 148] 6.5.2.7 Control Panel + Serial Port Setting When the Control Panel or the HDD replace , Press the [Run] button . [ Figure 6 - 9] Control Panel + Serial Port Setting

[Page 149] 6. 6 Adding and Deleting Option s This section describes how to add and delete options from SonoAce R7 Adding and Deleting Options consist of Unlock / Lock types. Unlock means a state in which an option is available, while Lock means a state in which an op tion is unavailable. Options are classified into software and hardware type. You can view the contents of an option in the Setup Mode . 6.6 .1 Option Types SonoAce R7 options become available by entering an Option Password or installing hardware . For o ption types and registration methods, refer to the following table . 4D 3DXI CW Function Cardiac Measurement Dynamic MR DICOM Spatial Compound Evaluation AutoIMT Status: Shows the current status of optional software . • Lock_Not Installed: No hardware i s connected . • Lock_ Unregistered: The software is not registered . • Lock_Installed: Hardware is installed but not registered . • Unlock_ Permanent: Ready for use without any time limitation . • UnlLock_ Restricted: Ready for use for a certain period [ Fi gure 6 - 10 ] Option Tab Chapter 6. Basic Maintenance 6-10

[Page 150] 6.6 .2 Registering Options 6.6 .2.1 Entering Option Password Procedures to register (Unlock) an option by entering a password will be described below . 1) Switch to the Admin Mode r eferring to “6. 3 .1 Entering Admin Mode” . 2) The key - sha ped button at the top right of the Option tab is activated. When this button is activated, you can enter an Option Password . 3) Select an option to be added, click the key - shaped button and enter the password . 4) If the entered password is correct, press t he [OK] button and restart the system [ Figure 6 - 11 ] Entering Option Password 6.6.2.2 Registering Option Password after Replacing the HDD SONOACE R7 is designed so that the Option Password is maintained even after replacing the HDD . Procedu res to enter the Option Password after replacing the HDD are described below . 1) Switch to the Admin Mode referring to “6.5.1 Entering Admin Mode” . 2) The [Change HDD] button appears in the center of the Option tab . 3) Click the [Change HDD] button. Then the Option Password of the product is entered (Unlock) . 4) Confirm the Option Unlock and restart the system .

[Page 151] [ Figure 6 - 12 ] Change HDD 6.6.3 Deleting Options Procedures to delete options are described below . 1) Switch to the Admin Mode referring to “6 .5.1 Entering Admin Mode” . 2) The key - shaped button at the top right of the Option tab is activated. When this button is activated, you can delete an Option Password . 3) Select an option to be deleted, click the key - shaped button and then delete the password . 4) If you have deleted a password, click the [OK] button and then restart the system . Chapter 6. Basic Maintenance 6-12

[Page 152] C C h h a a p p t t e e r r 7 7 . . T T r r o o u u b b l l e e s s h h o o o o t t i i n n g g 7. 1 Overview Chapter 7 describes basic troubleshooting procedures . Procedures for troubleshooting expected problems are described. Unexpected situations may occur . Procedures for troubleshooting normal problems are described . 7.1 Overview 7 - 1 7.2 Power 7 - 2 7.2.1 Power Failure 7 - 2 7.2.2 Power cannot turned off 7 - 2 7.2.3 Power is automatic ally turned off 7 - 2 7.3 Monitor 7 - 3 7.3.1 Blank Screen 7 - 3 7.3.2 Screen Color Abnormal 7 - 3 7.4 Error Messages 7 - 4 7.4.1 System hangs after an error during booting 7 - 4 7.4.2 System works even if error occurred 7 - 4 7.5 Image 7 - 5 7.5.1 No BW Mode Image E cho 7 - 5 7.5.2 No BW Mode Image Format 7 - 5 7.5.3 Noise Link Rain over the BW Mode Image (Noise) 7 - 5 7.5.4 PW & CW & Color Doppler, M Mode Trouble 7 - 5 Chapter 7. Troubleshooting 7-1

[Page 153] 7. 2 Power 7.2.1 Power Failure This may occur if the power cord is not properly connected or the Power Supply is not working . 1) Check if the power cord is properly connected and if the cut-off switch of the ADM is turned on. 2) Check the fuse status . 3) Connect another device to the wall outlet and check if it works . If the device works, there is a Po wer Supply problem . If the device does not work, the problem is down to the wall outlet . 4) Check if the system fan works . If the fan works, the problem is not a power supply problem . If the fan does not work, a PC Power problem is likely . 5) C heck if the ADM of Alarm LED turn on NOR . If LED of NOR turn on, DDM is normal . If OVP,OLP,OTP of LED turn on, DDM problem is likely 6) Please connect again after 1 - 2 minutes separat ing a power cord perfectly . When you try to turn ON / OFF of power switch several times, Check if the power supply normally does work or not. 7) Check Out voltage of ADM 8) Check DDM (DC to DC Power Module) and AC power cable. 7.2.2 Power cannot be turned off A software error or PC Motherboard or Main Board problem is likely. 1) The power is automat ically turned off when the Power Switch is pressed for more than 3 seconds. If software such as printer software is running or an operating system error occurs, the power is not turned off. 2) If you cannot turn the power off after completing the procedures in 1), a PC Motherboard or Main Board problem is likely . 7.2.3 Power is automatically turned off Power cord, PC Mother Board, Main Board trouble is expected . 1) Check if the power cord is properly connected. 2) Check the fuse status. 3) Connect another device to the wall outlet and check if it works. If the device works, it is due to Power Supply problem. If the device does not work, it is due to wall outlet problem. 4) If the power is automatically turned off after completing the procedures of “1), 2), and 3)”,PC Mother Board, Main Board trouble is expected. Chapter 7. Troubleshooting 7-2

[Page 154] 7.3 Monitor 7.3.1 Blank Screen DVI Cable, Monitor or Main Board trouble is expected. 1) Try to print to check the product status . If printing is normal, monitor or PC Pa rt trouble is expected . 2) Check the cable is properly connected with the monitor . 3) Check the DVI Cable of LCD Monitor properly connected with the Main Board. 4) If no problem has been found in the above “1) and 2)”, monitor and PC Part trouble is expected. 7.3 .2 Screen Color is Abnormal Data Cable of the monitor or PC Part is improperly connected or monitor or PC Part trouble Is expected. 1) Check the monitor connection cable status. Check the DVI Cable of LCD Monitor properly connected with the Main Boar d. 2) If no problem has been found in the above “1)”, monitor and PC Part trouble is expected Chapter 7. Troubleshooting 7-3

[Page 155] 7.4 Error Messages 7.4.1 System hangs after an error during booting Temporary software error or product trouble is expected . 1) Turn the power off by force and then turn it on again after 1 to 2 minutes . 2) If the symptom continues after completing “1)”, check when the error message appears If the error message appears while SonoAce R5 logo appe ars, system software or ultrasound system part trouble is expected. 7.4.2 System works even if an error occurred Temporary software error or product trouble is expected . 1) Turn the power off by force and then turn it on again after 1 to 2 minutes . 2) If the symptom continues after completing “1)”, check when the error message appears If the error m essage appears while SonoAce R5 lo go appears, system software or ultrasound system part trouble is expected . Chapter 7. Troubleshooting 7-4

[Page 156] 7.5 Image 7.5.1 No BW Mode Image Echo Probe and the system connection, Main Board or Power trouble is expected . 1) Check the connection between the probe and the system . 2) Check if probe oscillation sound is heard . If oscillation sound is h eard, the problem may be DDM trouble . 3) Check if the ADM of Alarm LED turn on NOR . If LED of NOR turn on, DDM is normal . If OVP ,OLP ,OTP of LED turn on, DDM problem is likely . 4) If no problem has been found in the above “1), 2) ,3) Main Board trouble is expecte d . 7.5.2 No BW Mode Image Format Probe and the system connection, Ultrasound System Part or PC Part trouble is expected . 1) Check the connection between the probe and the system . 2) Check if probe oscillation sound is heard . 3) Check if the ADM of Alarm LED turn on NOR . If LED of NOR turn on, DDM is normal . If OVP ,OLP ,OTP of LED turn on, DDM problem is likely . 4) If no problem has been found in the above “1), 2) ,3) Main Board trouble is expected . 7.5.3 Noise Like Rain over the BW Mode Image (Noise) Power noise or M ain Board trouble is expected. 1) Check if the system shares the wall outlet with another device . If the system shares the wall outlet with a device that uses electric motor or consumes high power, noise may be generated . 2) If the symptom continues when you con nect the system to the wall outlet of another room, the problem is power noise. 3) If no problem has been found in the above “1) and 2)”, Main Board trouble is expected . 7.5.4 PW & CW & Color Doppler, M Mode Trouble Main Board trouble is expected. Chapter 7. Troubleshooting 7-5

[Page 157] C C h h a a p p t t e e r r 8 8 . . D D i i s s a a s s s s e e m m b b l l y y a a n n d d R R e e a a s s s s e e m m b b l l y y 8 .1 Overview Chapter 8 describes how to disassemble SonoAce R 7. Refer to this chapter when you upgrade or repair the hardware .  The system contains dangerous high voltage. Never disassemble the system. There is a risk of electric shock and injury.  The repair of the system and the replacement of parts must be carried out by an authorize d engineer or the customer service department of SAM MEDISON Co., Ltd .  The company is not responsible for any injury and damage caused by not following this wa rning .  When working with the system on, do not wear a static electricity protective wristband. Th ere is a risk of electric shock and injury .  When disassembling or reassembling the system, wear static electricity protective gloves and a wristband .  These will prevent any accidents due to carelessness, and damage to the system due to static electricity . [ Figure 8 - 1] Static Electricity Protective Gloves and Wristband C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-1

[Page 158] 8.1 Overview 8 - 1 8.2 B ody Cover Disassembly and Reassembly 8 - 3 8.2.1 Preparations 8 - 3 8.2.2 Body Front Cover 8 - 3 8.2.3 Body Back Cover 8 - 3 8.2.4 Cover Body Side Right & Left 8 - 4 8.2.5 Handle AY 8 - 5 8.3 LCD & ARM & SPEAKER Disassembly and Reassembly 8 - 6 8. 3 .1 Prepara tions 8 - 6 8. 3 .2 LCD 8 - 6 8. 3 .3 SPEAKER 8 - 7 8. 3 . 4 ARM 8 - 9 8.4 Ultrasound System PCB Part Disassembly and Reassembly 8 - 11 8.4.1 Preparations 8 - 11 8.4.2 PSA ASSY 8 - 11 8.4.3 CW Board, MAIN Board 8 - 12 8.5 PC Part Disassembly and Reassembly 8 - 13 8.5. 1 Preparations 8 - 13 8.5.2 HDD & ODD 8 - 13 8.5.3 Rear Board 8 - 14 8.5.4 POWER 8 - 15 8.6 User Interface Part Disassembly and Reassembly 8 - 16 8.6.1 Preparations 8 - 16 8.6.2 Control Panel 8 - 16 8.6.3 Control Panel Board 8 - 17 8.6.4 Track Ball 8 - 18 8. 6.5 Alpha - Numeric Keyboard 8 - 19 8.6.6 LCDIF CON Board . 8 - 20 C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-2

[Page 159] 8.2 Body Cover Disassembly and Reassembly 8. 2 .1 Preparations 1) Prepare a (+) screwdriver and static electricity protective gloves . 2) Shut down the system referring to “3.7 Syste m Shutdown (Power Shut Down)” 8.2 .2 Body Front Cover 1) Remove the 2 screws of the Body Front Cover using the (+) screwdriver . 2) Hold and pull the Body Front Cover to separate it 2 Sc rews [ Figure 8 - 2 ] Body Front Cover 8. 2 . 3 Body Back Cover 1) Remove the 5 screws of the Body Rear Cover using the (+) screwdriver . 2 ) Hold and pull the Body Back Cover to separate it . 2 ) 5 Screws [ Figure 8 - 3 ] Body Back Cover C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-3

[Page 160] 8. 2.4 Cover Body Side Right & Left 1) Disassemble the Body Front Cover referring to “ 8.2. 2 Body Front Cover ” 2 ) Disassemble the Body Back Cover referring to “ 8.2. 3 Body Back Cover ” . 3) Remove the each 6 screws of the Body Side Right Cover and Left Cover using the (+) screwdrive r 4) Remove the each 6 screws of the Body Side Right Cover and Left Cover using the (+) screwdriver 3 Screws 3 Screws C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-4

[Page 161] 4 ) 3 Screws 3 Screws [ Figure 8 - 4 ] Cover Body Side Right & Left 8. 2.5 Handle AY 1) Remove the 4 screws of the Handle AY using the (+) screwdriver . [ Figure 8 - 5 ] Handle AY C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-5

[Page 162] 8.3 Disassembly and Reassembly of the LCD & ARM 8. 3 .1 Preparations 1) Prepare a (+) screwdriver and static electricity protective gloves . 8.3 .2 LCD 1) Remove the 4 screws from the Back LCD Cover using the (+) screwdriver and separate it. 2) Remove the 2 screws from the Monitor Bracket Cover using the (+) screwdriver and separate it . 3) Hold and pull the Monitor Bracket Cover and Monitor Back Cover to separate it 4) Remove the 4 screws from Monitor HINGE using the (+) screwdriver and separate it . 5) Separate the cable from the LCD. Monitor Back Cover Monitor Bracket Cover 3) C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-6

[Page 163] 4) [ Figure 8 - 6 ] LCD 8.3 . 3 SPEAKER 1) Remove the 4 screws from the CP Bottom Cover using the (+) screwdriver and separate it . 2) Hold and pull the LCD Monitor to separate it . . 3) Separate the monitor and speaker cable connected to the Speaker . 4 ) Remove the each 4 screws of the Speaker using the (+) screwdriver and disassemble it . 1) 8 Screws 2) C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-7

[Page 164] 3) 4) [ Figure 8 - 7 ] SPEAKER C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-8

[Page 165] 8.3 . 4 ARM 1) Disassembl e the LCD referring to “8 . 3 .2 LCD” . 2) Disassemble the Speaker referring to “8 . 3.3 Speaker ” . 3 ) Remove the 4 screws from the Cover SWIVEL< 215 - M - 333B >using the (+) screwdriver and separate it . 4 ) Hold and pull the Cover SWIVEL < 215 - M - 333B > to separate i t . 5 ) Remove the 4 screws from the Cover SWIVEL< 215 - M - 333B >using the (+) screwdriver and separate it . 6 ) Hold and pull the Cover SWIVEL < 215 - M - 333B > to separate it . 7 ) Remove the 4 screws from the LCD ARM using the (+) screwdriver and separate it . 1) 2) 3) 4) C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-9

[Page 166] 5) 2 Screws 6) 7) [ Figure 8 - 8 ] ARM C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-10

[Page 167] 8. 4 Disassembly and Reassembly of the US PCB Part 8. 4 .1 Preparations 1) Prepare a (+) screwdriver and static electricity protective gloves . 8. 4 .2 P SA ASSY 1) Disassemble the Body Front Cover referring to “ 8.2. 2 Body Front Cover ” . 2) Remove the 10 screws form the PSA ASSY using the (+) screwdriver . 3 ) Hold the PSA ASSY with both hands and pull it to disassemble it . 10 Screws [ Figure 8 - 9 ] P SA ASSY C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-11

[Page 168] 8. 4 .3 CW Board, MAIN Board 1) Disassemble the Body Front Cover referring to “8.2.2 Body Front Cover” . 2) Disassemble the PSA ASSY referring to “8.3.2 PSA ASSY”. 3) Hold the handle of the CW Board with both hands and pull it to separate it . 4) Hold the handle of the Main Board with both hands and pull it to separate it . 3 ) CW Board 4 ) MAIN Board [ Figure 8 - 11 ] CW Board, MAIN Board C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-12

[Page 169] 8. 5 Disassembly and Reassembly of the PC Part 8. 5 .1 Preparations 1) Prepare a (+) screwdriver an d static electricity protective gloves. 8.5 .2 HDD & ODD 1) Disassemble the Body Back Cover referring to “ 8.2. 3 Body Back Cover ” . 2) Remove the 4 screws of the HDD & ODD using the (+) screwdriver . 3 ) Hold the handle of the HDD & ODD and pull it to separate it . 4) Remove the 8 screws of the HDD & ODD using the (+) screwdriver . 12 Screws HDD ODD [ Figure 8 - 12 ] HDD & ODD C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-13

[Page 170] 8.5 . 3 Rear Board 1) Disassemble the Body Back Cover referring to “ 8.2. 3 Body Back Cover ” . 2) Remove the 12 screws of the HDD & ODD using the (+) screwdriver . 3) Hold the handle of the Rear ASSY and pull it to separate it . 3 ) 12 Screws [ Figu re 8 - 13 ] Rear Board C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-14

[Page 171] 8.5 . 4 POWER 1) Disassemble the Body Rear Back referring to “ 8.2. 3 Body Back Cover ” . 2) Remove the 12 screws of the HDD & ODD using the (+) screwdriver . 3) Separate all cables connected to the PC Power . 4 ) Hold the handle of the PC Power and pull it to separate it . . [ Figure 8 - 14 ] POWER C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-15

[Page 172] 8. 6 Disassembly and Reassembly of the User Interface Part 8. 6 .1 Preparations 1) Prepare a (+) screwdriver and static electricity protective gloves . 8. 6 .2 Control Panel 1 ) Remove the 16 screws of the Control Panel using the (+) screwdriver 2 ) Separate all cables connected to the Control Panel Board . 3) Separate the upper board of the Control Panel . 16 Scr ews [ Figure 8 - 15 ] Cont rol Panel C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-16

[Page 173] 8. 6 . 3 Control Panel Board 1) Disassemble the Control Panel referring to "8.6.2 Control Panel ". 2) Take the Button Cap off the Control Panel . 3 ) Separate all cables connected to the Control Panel . 4 ) Remove the 14 screws of the Control Panel using the (+) screwdriver and separate it . 25 Screws [ Figure 8 - 16 ] Control Panel Board C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-17

[Page 174] 8. 6 . 4 Track Ball 1) Disassemble the Control Panel referring to "8.6.2 Control Panel ". . 2) Separate all cables connected to the Track Ball . 3 ) Remove the 2 screws of the Track Ball using the (+) screwdriver and separate it . 2 ) Track Ball 2 Screws [ Figure 8 - 17 ] Track Ball C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-18

[Page 175] 8. 6 . 5 Alpha - Numeric Keyboard 1) Disassemble the Control Panel referring to "8.6.2 Control Panel ". . 2) Separate all cables connected to the Alpha - Numeric Keyboard . 3) Remove the 5 screws of the Alpha - Numeric Keyboard using the (+) screwdriver and separate it . 5 Screws [ Figure 8 - 18 ] Alpha - Numeric Keyboard C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-19

[Page 176] 8. 6 . 6 LCDIF CON Board 1) Disassemble the SPEAKER referring to "8.3.3 SPEAKER " . 2) Disassemble the Control Panel referring to "8.6.2 Control Panel . 3 ) Separate all cables connected to the LCD IF CON Board. 5) Remove the 8 screws of the LCD IF CON Board using the (+) screwdriver and separate it . 6) Remove the 4 screws of the LCD IF Board using the (+) screwdriver and separate it . 8 Screws C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-20

[Page 177] 5 ) [ Figure 8 - 19 ] LCD IF CON Board C HAPTER 8. D ISASSEMBLY AND R EASSEMBLY 8-21

[Page 178] C C h h a a p p t t e e r r 9 9 . . P P r r o o b b e e 9.1 Overview The probe is a device that sends and receives ultrasound for acquiring image data. It is also called a Transducer or Scan head. The system limits patient contact tempe rature 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. Validation of the power protection fuse circuit is performed under normal system operation. For invasive probes, additional protections are design ed to keep patient contact surface temperature under 43 ℃ degrees Celsius in the event of a single fault failure. 9.1 Overview 9 - 1 9.2 Probe List 9 - 2 9.2.1 Probe Application and Preset 9 - 2 9.2.2 Function List 9 - 3 9. 3 Thermal Index (TI Table) 9 - 5 9.4 Ultrasound Transmission Gel . 9 - 6 9.5 Sheaths 9 - 7 9. 6 Probe Precautions 9 - 8 9.6.1 Use and Infection Control of the Probe .. 9 - 8 9.6.2 Electric Shocks 9 - 9 9. 7 Cleaning and Disinfecting the Probe 9 - 10 9.7.1 Information of Det ergent, Disinfectant and Ultrasound Gel 9 - 10 9.7.2 Cleaning 9 - 16 Chapter 9. Probe 9-1

[Page 179] 9.2 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 9.2.1 Probe Application and Preset Probes, applications and settings available for this product are as follows. Probe Application Preset Abdomen General, Renal, Aorta st nd rd C2 - 8 OB Fetal heart, 1 Trimester, 2 / 3 Trimester Gynecology Uterus Small Parts Thyroid, Breast, Testicle, Bowel HL5 - 12ED Vascular Caro tid, Arterial, Venous Musculoskeletal Shoulder/Knee, Hand/Foot, Elbow/Wrist Small Parts Thyroid, Breast, Testicle, Bowel L3 - 8 Vascular Carotid, Arterial, venous Abdomen GB, General Small Parts Thyroid, Breast, Testicle, Bowel L5 - 12/50EP Vascular Carotid, Arterial, Venous Musculoskeletal Shoulder/Knee, hand/Foot, Elbow/Wrist st OB 1 Trimester ER4 - 9/10ED Gynecology Uterus, Adnexa Urology Prostate st OB 1 Trimester EV4 - 9/10ED Gynecology Uterus, Adnexa Urology Prostate Abdomen Genera l, Renal, Aorta P2 - 4AH Cardiac Aortic arch, Adult Echo, Pediatric Echo TCD General Abdomen G eneral, Renal, Aorta st nd rd 3DC2 - 6 OB Fetal Heart, 1 Trimester, 2 / 3 Trimester Gynecology Uterus Abdomen General, Renal, Aorta st nd rd 3D4 - 8ET OB Fetal Heart, 1 Trim ester, 2 / 3 Trimester Gynecology Uterus Chapter 9. Probe 9-2

[Page 180] • Besides, user can have or select own preset between User 1 - 5. • Refer to ‘Chapter 3. Starting Diagnosis’ for how to set probe and its preset. 9.2.2 Function List The modes and fu n ctions that can be used according to the probes and applications in the SonoAce R7 are as follows . H P S D P M Q Probe Application A P C M ECG I R Scan R I I R Abdomen O O X X X O O Off C2 - 8 OB O O X X O O O Off Gynecology O O X X O O O Off Small Parts O X X O X O O Off Vascular Off HL5 - 12ED O X X O X O O ( Except Carotid) Musculoskeletal O X X O X O O Off Small Parts O X X O X O O Off Vascular Off L3 - 8 O X X O X O O (Except Carotid) Abdome n O X X O X O O Off Small Parts O X X O X O O Off Vascular Off L5 - 12/50EP O X X O X O O (Except Carotid) Musculoskeletal O X X O X O O Off OB X X X X O O O Off ER4 - 9/10ED Gynecology X X X X O O O Off Urology X X X X O O O Off OB O X X X O O O Off EV4 - 9/10ED Gynecology O X X X O O O Off Urology O X X X O O O Off Abdomen O O X X X O O Off P2 - 4AH Cardiac O O X X X O O Off TCD O O X X X O O Off Abdomen O O X X X O O Off 3DC2 - 6 OB O O X X O O O Off Gynecology O O X X O O O Off Chapter 9. Probe 9-3

[Page 181] A bdomen O O X X X O O Off 3D4 - 8ET OB O O X X O O O Off Gynecology O O X X O O O Off Probe Application C/M TDI PD DPDI TDW CW Biopsy Abdomen X X O O X X O OB X C2 - 8 X O O X X O (Except Fetal Heart) Gynecology X X O O X X O Small Parts X X O O X X O HL5 - 12ED Vascular X X O O X X O Musculoskeletal X X O O X X O Small Parts X X O O X X O L3 - 8 Vascular X X O O X X O Abdomen X X O O X X O Small Parts X X O O X X O L5 - 12/50EP Vascular X X O O X X O Musculoskeletal X X O O X X O OB X X O O X X O ER4 - 9/10ED Gynecology X X O O X X O Urology X X O O X X O OB X X O O X X O EV4 - 9/10ED Gynecology X X O O X X O Urology X X O O X X O Abdomen X X O O X O X P2 - 4AH Cardiac O O X X O O X TCD X X O O X O X Abdomen X X O O X X O OB X 3DC2 - 6 X O O X X O (Exc ept Fetal Heart) Gynecology X X O O X X O Abdomen X X O O X X O OB X 3D4 - 8ET X O O X X O (Except Fetal Heart) Gynecology X X O O X X O Chapter 9. Probe 9-4

[Page 182] 9.3 Thermal Index (TI Table) Tables TI (TI ; Thermal Index) values displayed on the screen title bar can change depending on probes and applications. R7 decides automatically which TI value will be displayed out of TIs (TI ; Thermal Index System), TIb (TI ;Thermal Index Bone), and Tic (TI ;Thermal Index Cranium). The TI values are as follows . Application Probe TCD Cardiac Urology Vascular Obstetrics Abdomen Small Parts Gynecology Musculoskeletal C2 - 8 TIb TIs TIs HL5 - 12ED TIs TIs TIs L3 - 8 TIs TIs TIs L5 - 12/50EP TIs TIs TIs ER4 - 9/10ED TIb TIs TIs EV4 - 9/10ED TIb TIs TIs P2 - 4AH TIs TIs 3DC2 - 6 TIb TIs TIs TIc 3D4 - 8ET TIb TIs TIs Chapter 9. Probe 9-5

[Page 183] 9.4 Ultrasound Transmission Gel Using an inappropriate ultrasound gel may damage the probe. For proper transmission of the acous tic beam, only use ultrasound transmission gel only approved by SAMUNG MEDISON. • Do not use mineral oil, O il - based solutions, or other non - approved material as they m ay cause damage to the probe. • Do not use gels that contain any of the following agents: - Acetone - Methanol - Denatured Ethyl Alcohol - Mineral Oil - Iodine - Lanolin - Any lotions or gels containing perfume Chapter 9. Probe 9-6

[Page 184] 9.5 Sheaths Sheaths are recommended for clinical applications of an i nvasive nature, including intraoprative, transrectal, and biopsy procedures. SAMSUNG MEDISON does not sully sheaths so that you should purchase appropriate ones on your own. • Always keep s heath s in a sterile state . • Sheath s are disposable . Do not reuse them. • If sheaths are torn or soiled after use. C lean and disinfect the probe. • In neurosurgical applications. a di sinfected probe must be used with sterile gel and a sterile pyro . gen - free sheath. • If the sterile sheath becomes compromised during neurosurgical applications involving a patient with Creutzfeldt - Jakob disease . R he probe cannot be successfully sterilized by any disinfection method. • Some sheaths contain natural rubber latex and talc. W hich can cause allergic reactions in some individuals. Please refer to the FDA Medical Alert released on March 29.1991. 1. Put on sterile gloves. Unpack the sheath and fill it with acoustic coupling gel. 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 is no air bubble within the ultrasound gel. If necessary, secure the sheath to the probe and the probe cable. 4. Dispose of the sheath after use. Chapter 9. Probe 9-7

[Page 185] 9. 6 Probe Precautions The probe can easily be damaged by improper use or by contacting 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 for cracks, broken parts, leaks and sharp edges. If there is any damage, immediately stop using the probe and contact the MEDISON Customer Support Department. Using damaged probes may result in electric shocks and other hazards to the patients and/or users • 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 chlori de and hydrogen peroxide . • Do not expose the probe to temperatures of 50°C or higher . 9. 6 .1 Use and Infection Control of the Probe The ultrasonographic image scanner uses ultrasound, and it 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 surgery. The most effective method to prevent 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, protective devices such as sheaths must be used, and the safety instructions must be followed carefully in order to minimize the risk of infection among patients . • No neurosurgical treatments or examinations should be carried out on a patient with Creutzfeldt - Jakob disease (critical brain disease caused by virus). If the p robe has been used on such a patient, it cannot be sterilized by any method whatsoever . • Sufficient washing and disinfecting must be carried out for preventing infecti on. This is the responsibility of the user who manages and maintains the disinfection procedures for the equipment. Always use legally approved detergents and sheaths . Chapter 9. Probe 9-8

[Page 186] 9. 6 .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 . • Regularly receive short - circuit examination from the SAMSUNG MEDISON Service Department . • Do not i mmerse the probe into liquid . • Do not drop the probe or apply mechanical shocks . • Inspect the housing, stra i n 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 ben d the probe cable. It may result in a short circuit . • 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 o rder 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 . Chapter 9. Probe 9-9

[Page 187] 9. 7 Cleaning and Disinfecting the Probe Using an inappropriate detergent or disinfectant may damage the probe Always use prot ective eyewear and gloves when cleaning and disinfecting. 9.7 .1 Information of Detergent, Disinfectant and Ultrasound Gel Use an appropriate one with following tables. The information is also listed on the SAMSUNG M EDISON web site. (http://www.medison.com ) . Disinfectants II II Blu Cloth Active Wipes Spray - 2% Wipes Name Bac - - Wipes Spray Cloth HB - - Spray - - - Cloth Plus Cloth idex T T - Caviwipes Metriwipes C Setptiwipes Cloth Germicidal Sani Sani Ster Incidin Foam - Asepti Asepti Sani Clieanisept Trasneptic Super Sani Sani Type S S W W W W W L S S W W W W W W L Active Alkyl) IPA NA Ingredient - (N Quaternary Ammonium C2 - 8 • • HL5 - 12ED • • L3 - 8 • • • L5 - 12/50EP • • ER4 - 9/10ED • • • EV4 - 9/10 ED • • • P2 - 4AH • ★ • 3D4 - 8ET • • ◐ Chapter 9. Probe 9-10

[Page 188] Disinfectants Names FG2 - 01 3) Cidex OPA 2,3) Cidex Plus 2) Metricide 2) Omnicide (28) Omnicide 14NS Omnicide Nuclean Wavicide Sekusept Extr Salvanios pH 7 Salvanios pH10 Steranios 2% Surfaces Hautes Sekusept Plus Milton Virkon Sporox Sporox Type L L L L L L L L L L L L S L L L L L Active Glutaraldehyde Ingredient Hypochlorite Nonionic surfactant Sodium NA Hydrogen Peroxide • • • • • • HL5 - 12ED • • • ◐ • ◐ • • • • • • • L5 - 12/50EP ◐ • • • • • • • • • • • • • • • • • • ★ • • • • • • • ◐ Chapter 9. Probe 9-11

[Page 189] Disinfectants Cleaner Names Gigasept Gigasept AF 3) Gigasept FF PeraSave Enzol Alkazyme Cidezyme Klenzyme Isopropyl alcohol (705) Isopropyl alcohol(80%) Metrizyme KcKesson Type L L L P L L L L L L uccindialdehyde, Active Ingredient S formaldehyde Bersteinsaure Peracetic Acid Dodecylphenolethoxylate, Sodium Xylene Sulfonate NA Proteolytic Enzymes Proteolytic Enzymes Alcohol Alcohol Propylene Glycol PCMX (Chloroxylenol) • • HL5 - 12ED ◐ • • • • • • • • • L5 - 12/50EP ◐ • • • • • • • • • • Chapter 9. Probe 9-12

[Page 190] Gel Names endall Natural Image Aquasonics 100 3) GE Ultrasound Contact Gel Clear Image K Scan Wavelength Sonogel Type G G G G G G G G Active Ingredient NA Ammonium Chlorides HL5 - 12ED L5 - 12/50EP • • • • Chapter 9. Probe 9-13

[Page 191] ※ Symbols Following is information about Symbols (1) Compatible but no EPA Registration (2) FDA 510(k) qualified (3) Has CE mark (4) Discontinued (5) Under Development S Spray W Wipe L Liquid P Powder G Gel 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 longer than 5 minutes. ◐ Must not be used longer than 10 minutes. ▲ Must not be used longer than 15 minutes. ◆ Must not be used longer than 20 minutes. ◇ Must not be used longer than 25 minutes. ◎ Must not be used longer than 30 minutes. ▣ Must not be used longer than 50minutes. Blank Untested (DO NOT USE) Chapter 9. Probe 9-14

[Page 192] Following is information about manufacturer (or Distributor) of Detergent, Disinfectant, and Ultrasound Gel Product Manufacturer or Distributor Telephone number Aquasonics Parker Co. +1-800-631-8888(USA) +1-800-445-6741(USA) Cidex CIVCO Co. +1-319-656-4447(Worldwide) +1-800-445-6741(USA) Enzol CIVCO Co. +1-319-656-4447(Worldwide) GIgasept AF S&M(Schulke&mayr) Co. +44-114-254-3500(UK) Gigasept FF S&M(Schulke&mayr) Co. +44-114-254-3500(UK) Isoproppyl alcohol Local drugstore None (70%) Klenzyme Steris Co. +1-800-548-4873(USA) +1-800-445-6741(USA) Metricide CIVCO Co. +1-319-656-4447(Worldwide) Metrizyme Metrex Research Corp. +1-800-841-1428(USA) Product & Gamble Australia Milton +61 - 1800 - 028 - 280(Australia) Pty. Ltd. +1 - 800 - 526 - 3867(USA) Nuclean Nation Diagonostics Co. +44(0) - 148 - 264 - 6020(UK) Omnic ide Cottrell Ltd. +1 - 800 - THE - EDGE(USA) Sani - cloth PDI Nice/Pak Products Co. +1 - 914 - 365 - 1602(USA) Sekusept Extra Henkel Hygiene GmbH. +49 - 0211 - 797 - 0 (Germany) Sporox II Sultan Chemist Inc. +1 - 800 - 637 - 8582(USA) +1 - 800 - 445 - 6741(USA) T - Spray CIVCO Co. +1 - 31 9 - 656 - 4447(Worldwide) Virkon Antec International LTD. +1 - 403 - 286 - 1771(USA) Wavicide Wave Energy System Inc. +1 - 800 - 252 - 1125(USA) Chapter 9. Probe 9-15

[Page 193] 9.7 .2 Cleaning • Do not use a su rgical brush when cleaning probes. The use of even 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 . This will help pre v ent liquid from entering non - liq uid - tight areas of the probe . 1) Disconnect the probe from the system . 2) Remove any biopsy adapters or biopsy needle guides . (Biopsy adapters are reusable and can be disinfected) 3) Discard sheaths. (Sheaths are single - use items). 4) Use a soft cloth lightly dampened with mild soap or compatible cleaning solution to remove any particulate matter and body fluid that remain on the probe or cable. 5) To remove remaining particulates, rinse with water up to the immersion point. 6) wipe with a dr y cloth. 7) If necessary, wipe first with a water - dampened clothe to remove soap residue. • 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 and will void the probe warranty . • Do not immerse probes for longer than one hour, unless they are sterilizable . Only sterilize probes using liquid solutions. Avoid using autoclave, gas (EtO) or other non - MEDISON - approved methods. 1) Follow the instructions on the disinfectant label for storage, use and disposition of the disinfectant . 2) Mix the disinf ectant compatible with your probe according to lavel instructions for solution strength . 3) Immerse the instructions on the disinfectant, rinse the probe after the immersion process is complete . 4) Using the instructions on the disinfectant, rinse the prob e after the immersion process is complete . 5) Air dry the probe or towel it dry with a clean cloth . Chapter 9. Probe 9-16

[Page 194] [ Figure 9 - 1] Disinfection Chapter 9. Probe 9-17

[Page 195] C C h h a a p p t t e e r r 1 1 0 0 . . U U s s e e r r M M a a i i n n t t e e n n a a n n c c e e 10.1 Overview Chapter 10 describes how to extend the life of SonoAce R7. It includes are how to maintain the product and how to backup information. Make sure to read this cha pter for proper maintenance of the product . 10.1 Overview ... 10 - 1 10.2 System Maintenance 10 - 2 10.2.1 Installation Maintenance 10 - 2 10.2.2 Cleaning and Disinfections 10 - 2 10.2.3 Fuse R eplacement 10 - 3 10.2.4 Administration of Air Filter 10 - 4 10.2. 4 Accuracy Check 10 - 5 10.3 Administration of Information 10 - 6 10.3.1 U ser Setting Back - up 10 - 6 10.3.2 Patient Information Restore 10 - 6 10.3.3 Software 10 - 6 Chapter 10. User Maintenance 10-1

[Page 196] 10.2 System Maintenance 10.2. 1 Installation Requirements When installing: . - Avoid humidity - Avoid direct sunlight. . - Avoid places with extreme temperature variations . - Optimal conditions for the system are temperatures of 10 ℃ ~ 35 ℃ and humidity of 30% ~ 75% . - Avoid heat sources - Avoid dusty and unventilated areas . - Avoid places where the system is likely to be exposed to vibration or impacts . - Avoid place whe n the system is likely to be exposed to chem ical substances or gases . Placing the system near generators, X - Ray machines, or broadcast cables may result in screen noise and abnormal visual images. Using the pow er source with other electric devices may also induce noise. 10.2.2 Cleaning and disinfections Using inappropriate detergent or disinfectant may damage the product. Please read the following carefully.  Turn off the system and disconnect the system power cord from the wall outlet . Otherwise, it may result in electric shock or fire.  Always use protective eyewear and gloves when cleaning and disinfecting the equipment . 10.2.2.1 Cleaning 1) Console : Use a soft cloth lightly dampened in a mild soap or detergent solution to clean exterior surfaces on the system. 2) Cleaning Monitor : Wipe the LCD surface with a soft dry cloth. When the LCD panel has dirt on it, wipe it 2 – 3 times or more in one direction system . Chapter 10. User Maintenance 10-2

[Page 197]  Do not use a spray directly on the product exterior. It may cause cracks in the appliance, or the color to deterio rate.  Do not use chemical substances such as wax, benzene, alcohol, thinner, mosquito repellant, deodorant, lubricant or detergent. For information on cleaning and di sinfection of the probe & biopsy kit, please refer to Chapter 9 “ Probes. ” I n User Manual 10.2.2.2 Disinfections Use only recommended disinfectants on system sur faces. A disinfectant qualified by the FDA 510(k) process is recommended. The following disinfectants are recommended because of both their biological effectiveness (as qualified through the FDA 510(k) process) and their chemical compatibility with SAMSUNG MEDISON ultrasound products . Active Solutions Country Type FDA 510(k) ingredient Cidex USA Liquid Gluteraldehyde K934434 Cidex Plus USA Liquid Gluteraldehyde K923744 [ Table 10 - 1] Solutions 1) Turn off the system and disconnect the system power cord fro m the wall outlet . 2) Mix the disinfection solution compatible with your system according to label instructions for solution strength 3) Wipe the system surfaces with the disinfectant solution, following the disinfectant label instruction for wipe durations, so lution strength and disinfectant contact duration . 4) Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label . Chapter 10. User Maintenance 10-3

[Page 198] 10.2.3 Fuse Replacement The power protection fuse protects the product from excess current. If the pow er monitoring protection circuit detects excess current, it shuts off the current to the equipment in order to prevent overheating and to restrict the ultrasound power output. If the fuse blows, replace it as shown below. ˙ ˙ ˙ ˙ ˙ ˙ D D ˙ A A ˙ N N ˙ G G ˙ E E ˙ R R ˙ To avoid risk of electric shock, always disconnect the plug from the system prior to fuse replacement . [ Figure 10 - 2] Fuse Replacement 1) Turn off the system and disconnect the system power cord f rom the wall ou t let. 2) Press the fuse holder in the direction of the arrow and pull it out. 3) Remove the old fuse and replace it with a new one. 4) After installing the new fuse, connect the plug to the system. Input Ratings Fuse Ratings Maker Order No. 100 - 120 VAC 10AH/250V Orisel 55T210000 200 - 240VAC 10A/H250V Orisel 55T210000 [ Table 10 - 2] Fuse Information Chapter 10. User Maintenance 10-4

[Page 199] 10.2.4 Cleaning The Air Filters The air filters minimize inflow of dust. Cleaned the air filter does not cause the system to overheat and reduce the noise and the system performance. It is recommended the air filters be cleaned once every three months. 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 ] The location of the air filters 1) Pull the filter under the front of the conso le to away from the product . 2) Shake the filter to remove the dust and wa sh in a mild soapy solution . 3) Rinse and air dry or dry with a cloth . 4) Slide the filter back into the product . Allow the wet filter to dry thoroughly before installing. The wet filter can cause the malfu n ction . Chapter 10. User Maintenance 10-5

[Page 200] 10.2. 5 Accuracy Check The product's maintenance status may affect the measurements obtained using the product. The product should be maintained in an optimal state to ensure reliable measurements. To ensure opt imal operation of the product, perform an accuracy check every year. The equations and table related to measurement accuracy are included in Chapter 5 "Measurements" in User manual Allow the wet filter to dry thoroughly before installing. The wet filter can cause the malfunction. Chapter 10. User Maintenance 10-6

[Page 201] 10.3 Administration of Information You may lose information files on user settings or patients, because of shock on the product or internal error. Thus, back - up on a regular basis . 10.3.1 User Setting Back - up Always keep a separate backup copy of the all information related to the user settin gs in case of data loss. Clients cannot back - up the user settings of the product. Please contact the MEDISON Service Department to attain support for back - up . 10.3.2 Patient Information Back - up The SonoView program can be used for backing up patients’ bas ic information and scanned images. The user can choose to save the data by himself/herself, and the data is also saved in the system by default. If the system needs to be reinstalled due to product failure, etc., the MEDISON customer support staff will res tore the patients’ basic information and scanned images that are saved in the system . 10.3 . 3 Software The product software may be updated to enhance performance. The user cannot make any changes to the software by himself/herself.. Please contact the SAMS UNG MEDISON customer s ervice for help in software changes . Minor software updates may be carried out without the prior notice from the manufacturer . Should errors occu r in the operating system and should you desire to upgrade the operating system, please follow the instructions of the operating system manufacturer . Chapter 10. User Maintenance 10-7

[Page 202] C C h h a a p p t t e e r r 1 1 1 1 . . S S e e r r v v i i c c e e P P a a r r t t L L i i s s t t 11.1 Overview This chapter 11 contains information on the SonoAce R7 Service Part. Please refer to the SonoAce R7 Part Catalogue to Check the replacement parts and their software versions for each system configuration. 11.1 Overview 11-1 11.2 Body Cover 11-2 11.3 Ultrasound System Part 11-4 11.4 LCD & HINGE 11-5 11.5 User Interface Part 11-6 11.6 PC & Power Part 11-8 11.7 ETC Part 11-9 11.8 Option 11-12 11.9 Probes 11-13 [Figure 11-1] SonoAce R7 Views Chapter 11. Service Part List 11-1

[Page 203] 11.2 Body Cover 6 5 8 2 9 1 [Figure 11-2] Body Cover Chapter 11. Service Part List 11-2

[Page 204] PART NAME PART NUMBER DESCRIPTION 1 Body Front Cover A215-328A Body Foot Cover R7 2 Body Side R Cover 215-M-583A Body Side R Cover R7 3 Body Top Cover 215-M-582A Body Top Cover R7 4 Cover CP Bottom AY A215-330A Cover CP Bottom AY R7 5 Cover CP Top AY A215-331A Cover CP Top AY R7 6 Cover Speaker 215-M-587A Cover Speaker R7 7 Handle CP 252-D-037A Handle CP R7 8 Body Rear Cover AY A215-329A Body Rear Cover AY R7 9 Body Side L Cover 215-M-584A Body Side L Cover R7 [Table 11-1] SonoAce R7 Cover Chapter 11. Service Part List 11-3

[Page 205] 11.3 Ultrasound System PCB Part 4 5 [Figure 11-3] Ultrasound System Part 1 PSA Board BD-355-PSA PSA Board SonoAce R7 2 Rear Board BD-355-REAR Rear Board SonoAce R7 3 Back PLANE Board BD-355-BP Back PLANE Board SonoAce R7 4 Main Board BD-355-MAIN Main Board SonoAce R7 5 CW BD BD-355-CW CW Board SonoAce R7 [Table 11-2] Ultrasound System Part Chapter 11. Service Part List 11-4

[Page 206] 11.4 LCD & HINGE Part 4 5 6 7 [Figure 11-4] LCD & HINGE Part 1 Monitor Hinge AY A373-025A ASSY MONITOR UNIT;SAR7,LCD,19" 2 MNT Front Cover 215-M-495C-1 COVER FRONT-LCD19;R7 V3.00,ABS 342T,3,44 3 MNT Rear Cover 215-M-A019A COVER;SAR7,215-M-A019A,MONITOR REAR LCD1 4 MNT Bracket Cover 215-M-A016A COVER MONITOR REAR B LCD19 R7 5 Hinge Mechanism AY A257-025A ASSY HINGE;SAR7,LCD19,A257-025A,MECHANIS 6 Hinge Rear Cover 215-M-A014A COVER HINGE;SAR7,215-M-A014A,HINGE REAR 7 Hinge Front Cover 215-M-A013A COVER HINGE;SAR7,215-M-A013A,HINGE FRONT [Table 11-3] LCD & HINGE Part Chapter 11. Service Part List 11-5

[Page 207] 11.5 User Interface Part 4 5 6 7 8 9 10 [Figure 11-5] User Interface Part Chapter 11. Service Part List 11-6

[Page 208] 1 Control Panel Board BD-355-CP Control Panel Board SonoAce R7 2 LCD Interface Con Board BD-355-LCDIF-CON LCD Interface Con Board SonoAce R7 3 Power SW Board BD-355-PWRSW Power SW Board SonoAce R7 4 Left Rubber Button 311-R-267A Left Rubber Button SonoAce R7 5 Center Rubber Button 311-R-266A Center Rubber Button SonoAce R7 6 Right Rubber Button 311-R-268A Right Rubber Button SonoAce R7 7 Backlit KBD ASSY A260-170A Backlit KBD ASSY SonoAce R7 8 Case Speaker AY A213-104A Case Speaker AY SonoAce R7 9 ORACOM T/B Copper Unit 58mm AY-TB06A-C ORACOM T/B Copper Unit 58mm R7 10 RUBBER POWER BUTTON 311-R-269A RUBBER POWER BUTTON R7 [Table 11-4] User Interface Part Chapter 11. Service Part List 11-7

[Page 209] 11.6 PC & Power Part 1 2 [Figure 11-6] PC & Power Part 1 SEAGATE 500G HDD HDD-500G-ST3500312CS-00 SEAGATE 500G HDD R7 2 POWER AY DC-DC MODULE AY-355-PWR-DDM POWER AY DC-DC MODULE R7 [Table 11-5] PC & Power Part Chapter 11. Service Part List 11-8

[Page 210] 11 . 7 ETC Part 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Chapter 11. Service Part List 11-9

[Page 211] 24 25 26 27 28 29 30 31 [ Figure 11 - 7 ] ETC Part No PART NAME PART NUM BER DESCRIPTION 1 HANDLE CP 252 - D - 037A HANDLE CP R7 2 KNOB ENCODER CIR S(NUM) 267 - M - 099A KNOB ENCODER CIR S(NUM) R 7 3 KNOB ENCODER CIR S(Q SCAN) 267 - M - 099B KNOB ENCODER CIR S(Q SCAN) R7 4 KNOB ENCODER MENU 267 - M - 055B KNOB ENCODER MENU R7 5 CAP KEY P OWER 269 - M - 523A CAP KEY POWER R 7 6 CAP KEY PRINT 269 - M - 534A CAP KEY PRINT R7 7 CAP KEY DUAL 269 - M - 647A CAP KEY DUAL R7 8 CAP KEY SAVE 269 - M - 654A CAP KEY SAVE R7 9 CAP KEY PW 269 - M - 651A CAP KEY PW R7 10 CAP KEY M 269 - M - 648A CAP KEY M R7 11 CAP KEY PD 269 - M - 649A CAP KEY PD R7 12 CAP KEY C 269 - M - 650A CAP KEY C R7 13 CAP KEY CW 269 - M - 652A CAP KEY CW R7 Chapter 11. Service Part List 11-10

[Page 212] 14 CAP KEY 3D4D 269 - M - 653A CAP KEY 3D4D R7 15 CAP KEY 2D 269 - M - 655A CAP KEY 2D R7 16 CAP KEY END EXAM 269 - M - 527A CAP KEY END EXAM R7 17 CAP KEY PATI ENT 269 - M - 524A CAP KEY PATIENT R7 18 CAP KEY PROBE 269 - M - 525A CAP KEY PROBE R7 19 CAP KEY CLEAR 269 - M - 645A CAP KEY CLEAR R7 20 CAP KEY USER1 269 - M - 644A CAP KEY USER1 R7 21 CAP KEY SONOVIEW 269 - M - 643A CAP KEY SONOVIEW R7 22 CAP KEY REPORT 269 - M - 642A CA P KEY REPORT R7 23 CAP KEY ACTIVE MODE 269 - M - 646A CAP KEY ACTIVE MODE R7 24 CAP KEY SET 269 - M - 658A CAP KEY SET R7 25 CAP KEY EXIT 269 - M - 659A CAP KEY EXIT R7 26 CAP KEY CHANGE 269 - M - 657A CAP KEY CHANGE R7 27 CAP KEY FREEZE 269 - M - 656A CAP KEY FREEZE R7 28 CAP KEY CALIPER 269 - M - 663A CAP KEY CALIPER R7 29 CAP KEY CALC 269 - M - 662A CAP KEY CALC R7 30 CAP KEY UPDATE 269 - M - 660A CAP KEY UPDATE R7 31 CAP KEY POINTER 269 - M - 661A CAP KEY POINTER R7 [ Table 11 - 6 ] ETC Part Chapter 11. Service Part List 11-11

[Page 213] 11. 8 Options 1 4D OPT - 355 - 4D SAR7 4D OPTION 2 3DXI OPT - 355 - 3DXI SAR7 4D OPTION 3 Cardiac Measurement OPT - 35 5 - CARDIAC SAR7 CARDIAC MEAS OPTION 4 Spatial Compound OPT - 35 5 - SCI SAR7 SPATIAL COMPOUND IM AGING 5 DICOM OPT - 35 5 - DICOM SAR7 DICOM OPTION 6 Auto IMT OPT - 35 5 - AUTOIMT SAR7 AUTO IMT OPTION 7 CW Function OPT - 355 - CW SAR7 CW FUNCTION OPTION 8 DynamicMR OPT - DMR - USB DYNAMIC MR OPTION (USB) 9 DynamicMR + OPT - DMR - PLUS DYNAMIC MR PLUS OPTION(USB) [ Tab le 11 - 7 ] Options Chapter 11. Service Part List 11-12

[Page 214] 1 1. 9 Probes No PART NAME PART NUMBER PICTURE 1 Curved Linear Array PB - KC2 - 8 - N 2 Linear Array PB - KHL5 - 12ED - N 3 Linear Array PB - KL5 - 12/50EP - N 4 Linear Array PB - KL3 - 8 - N 5 Phased Array PB - KP2 - 4AH - N Endocavity Curved 6 PB - KER4 - 9/10ED - N Linear Array Endocavity Curved 7 PB - KEV4 - 9/10ED - N Linear Array 8 Volume Probe PB - K3DC2 - 6 9 Volume Probe PB - K3DC4 - 8ET [ Table 11 - 8 ] Probes Chapter 11. Service Part List 11-13

[Page 215] SERVICE MANUAL Publisher SAMSUNGMEDISON Co., Ltd. Address SAMSUNGMEDISON Bldg., 42 Teheran-ro 108-gil, Gangnam-gu, Seoul 135-280, Korea. Homepage http://www.samsungmedison.com