Sonoace X6

[Page 1] SAMSUNG MEDISON DIAGNOSTIC ULTRASOUND SYSTEM Volume 1

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[Page 5] SAMSUNG MEDISON DIAGNOSTIC ULTRASOUND SYSTEM Version 1.04 English MI68-03116A

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[Page 7] PROPRIETRAY INFORMATION AND SOFTWARE LICENSE The Customer shall keep confidential all proprietary information furnished or disclosed to the Customer by Samsung Medison, unless such information has become part of the public domain through no fault of the Customer. The Customer shall not use such proprietary information, without the prior written consent of Samsung Medison, for any purpose other than the maintenance, repair or operation of the goods. Samsung Medison’s systems contain Samsung Medison’s proprietary software in machine- readable form. Samsung Medison retains all its rights, title and interest in the software except that purchase of this product includes a license to use the machine-readable software contained in it. The Customer shall not copy, trace, disassemble or modify the software. Transfer of this product by the Customer shall constitute a transfer of this license that shall not be otherwise transferable. Upon cancellation or termination of this contract or return of the goods for reasons other than repair or modification, the Customer shall return to Samsung Medison all such proprietary information.

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[Page 9] Safety Requirements ■ Classification: – 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: – Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance [IEC 60601-1:2005/A1:2012] – Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Compatibility - Requirements and Tests [IEC 60601-1-2:2007] – Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability [IEC 60601-1-6:2010] – Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2007] – Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601- 1:1988 with A1:1991 and A2:1995] – Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standard: safety Requirement for Medical Electrical Systems [IEC 60601-1-1:2000] – Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001, A1:2004] – Medical Electrical Equipment, Part 1-4 : General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999] – Medical Electrical Equipment, Part 2-37: Particular Requirements for Safety - Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37: 2001 with A1:2004, A2:2005] – Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]

[Page 10] – Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601- 1:2003] – Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance [CAN/CSA-C22.2 No. 60601-1:14] – Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance [ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND A2:2010(R)2012] – Biological Evaluation of Medical Devices, Part 1:Evaluation and Testing within a risk management process [ISO 10993-1:2009] – Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment [IEC 61157:2007] ■ Declarations: CSA mark with the indicators “C” and “US” means that the product is certified for both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards. This is manufacturer’s declaration of product compliance with applicable EEC directive(s) and the European notified body. This is manufacturer’s declaration of product compliance with applicable EEC directive(s). This is the GMP symbol for Korean Good Manufacturing Practice quality system regulation.

[Page 11] Precautions for Use Before attempting to use the product, be sure to read this manual thoroughly to familiarize yourself with the operation of the product and the relevant safety information. ■ Keep this manual near the product and refer to it when using the product. ■ Please familiarize yourself with the safety precautions in 'Chapter 1. Safety' and 'Chapter 7. Maintenance’ in particular. ■ This user manual does not contain clinical opinions or diagnoses. Also, please consult the reference for each study area before evaluating the measurement result of an application. ■ This product is an ultrasound diagnostic system, and cannot be used on your personal computer. If you use this product in such an environment, we cannot be held responsible for any resulting problems. ■ This product must be used by a person who possesses clinical pathology training and/or certification; use by unqualified persons is prohibited. ■ The manufacturer is not responsible for any damage to this product caused by user carelessness and/or neglect. ■ Please note that orders are based on the individually agreed specifications and may not contain all features listed in the user manual. ■ It might be possible that some features, options or probes are NOT available in some countries. ■ All references to standards / regulations and their revisions are valid for the time of publication of the user manual. ■ The figures in the user manual for illustrational purposes only and may be different from what you see on the screen or device. ■ The content and specifications contained in this manual are subject to change without prior notice. ■ Products that are not manufactured by Samsung Medison are indicated with the trademarks of their respective owners. ■ The following terms are used to highlight safety precautions that the user must be aware of:

[Page 12] Disregarding this instruction may result in death, serious injury, or other DANGER dangerous situations. WARNING Follow these instructions to prevent a serious accident or damage to property. CAUTION Follow these instructions to prevent a minor accident or damage to property. The accompanying information covers installation, operation, and maintenance NOTE procedures that require careful attention from the user, but have little chance of leading directly to a dangerous situation.

[Page 13] Revision History VERSION DATE NOTE v1.04.02-00 2014.11.20 Initial Release System Upgrades and Manual Set Updates Samsung Medison Ultrasound is committed to innovation and continued improvement. Upgrades may be announced that consist of hardware or software improvements. Updated manuals will accompany those system upgrades. Verify that Check if this version of the manual is correct for the system version. If not, please contact the Customer Service Department. If You Need Assistance If you need any assistance with the equipment, like the service manual, please contact the Samsung Medison Customer Service Department or one of their worldwide customer service representatives, immediately.

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[Page 15] Revision History VERSION DATE NOTE v1.04.02-00 2014.11.20 Initial Release System Upgrades and Manual Set Updates Samsung Medison Ultrasound is committed to innovation and continued improvement. Upgrades may be announced that consist of hardware or software improvements. Updated manuals will accompany those system upgrades. Verify that Check if this version of the manual is correct for the system version. If not, please contact the Customer Service Department. If You Need Assistance If you need any assistance with the equipment, like the service manual, please contact the Samsung Medison Customer Service Department or one of their worldwide customer service representatives, immediately.

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[Page 17] Table of Contents 1 Table of Contents – Volume 1 Chapter 1 – Safety Purpose of Use 3 Contraindications 3 Safety Signs 4 Safety Symbols 4 Symbols 7 Labels 7 Electrical Safety 8 Prevention of Electric Shock 8 ECG-Related Information 10 ESD 11 EMI 11 EMC 12 Mechanical Safety 19 Moving the Equipment 19 Safety Note 20 Biological Safety 21 ALARA Principle 21 Environmental Protection 35 Correct Disposal of This Product 35 Chapter 2 – Introduction and Installation Introduction 3 And Installation 3 What is SONOACE X6? 3 Features and Advantages of SONOACE X6 3 Specifications 4 Product Configuration and Installation 7 Monitor 7 Control Panel 10 Console 16 Peripheral Devices 19

[Page 18] 2 SONOACE X6 User Manual Probe 22 Accessory 23 Options 23 Chapter 3 – Setting Selecting Probe / Application 3 Probe /Application Selection 3 Application Change 4 Probe Setting Change 4 Editing Bodymarker 5 Calc Sequence 7 Entering Patient Data 8 Registering a New Patient 8 Finding Patient Information 9 Modifying Patient Information 11 Setting System 12 General 12 Display 15 Misc. 17 Setting Measurements 19 General 19 Obstetrics Measurement Setup 24 Fetal Echo Measurement Setup 28 Cardiac Measurement Setup 29 Urology Measurement Setup 30 Vascular Measurement Setup 31 Setting DICOM (Optional) 32 Setting DICOM Information 32 Network Setup 33 Adding or Changing the DICOM Server 33 Editing the DICOM Server Information 39 Deleting DICOM Server 39 Testing DICOM Server 39 DICOM Log 39 Setting Option 41

[Page 19] Table of Contents 3 Setting Peripheral Devices 42 Information 43 Utilities 44 Biopsy 44 ECG 46 Monitor Calibration 48 Preset 48 Miscellaneous 49 Chapter 4 – Diagnosis modes Diagnosis Mode Types and Control 3 Diagnosis Mode Types 3 Basic Use 4 Basic Modes 8 2D Mode 8 M Mode 12 Color Doppler Mode 14 Power Doppler Mode 18 Spectral Doppler Mode 20 Combined Modes 26 2D/C/PW Mode 26 2D/PD/PW Mode 27 2D/C/CW Mode 28 2D/PD/CW Mode 29 2D/C/M Mode 30 Multi-Image Mode 31 Dual-2D Mode 31 Dual-2D/C Mode 32 Dual-2D/PD Mode 33 3D Mode 34 3D 34 Acquiring a 3D Image 35 3D View 36

[Page 20] 4 SONOACE X6 User Manual Chapter 5 – Measurements and Calculations Measurement Accuracy 3 Causes of Measurement Errors 3 Optimization of Measurement Accuracy 5 Measurement Accuracy Table 7 Basic Measurements 9 Distance Measurement 11 Circumference and Area Measurement 17 Volume Measurement 19 Calculations by Application 21 Things to note 21 Common Measurement Methods 23 OB Calculations 28 GYN Calculations 35 Cardiac Calculations 37 Vascular Calculations 49 Urology Calculations 52 Fetal Echo Calculations 57 Report 62 Viewing Report 63 Editing Report 63 Comment 63 Printing out Report 63 Exporting Report 63 Graph Function 65 ** Reference Manual Samsung Medison is providing an additional SONOACE X6 Reference Manual. GA tables and references for each application are included in the Reference Manual.

[Page 21] Chapter 1 Safety Purpose of Use 3 Contraindications 3 Safety Signs 4 Safety Symbols 4 Symbols 7 Labels 7 Electrical Safety 8 Prevention of Electric Shock 8 ECG-Related Information 10 ESD 11 EMI 11 EMC 12 Mechanical Safety 19 Moving the Equipment 19 Safety Note 20 Biological Safety 21 ALARA Principle 21 Environmental Protection 35 Correct Disposal of This Product 35

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[Page 23] 1 - 3 SONOACE X6 User manual Purpose of Use The SONOACE X6 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel For detailed information on applications and presets, please refer to ‘Chapter 2. Introduction’ and ‘Chapter 8. Probes’ in this user manual Contraindications This product must not be used for ophthalmological applications, or any other use that involves the ultrasound beam passing through the eyeball.  Federal law restricts this device to sale by or on the order of a physician.  The method of application or use of the device is described in the manual 'Chapter 3. Setting' and 'Chapter 4. Diagnosis Modes'.

[Page 24] 1 - 4 SONOACE X6 User manual Safety Signs Please read this chapter before using the ultrasound system. It is relevant to the ultrasound system, the probes, the recording devices, and any of the optional equipment. SONOACE X6 is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of the medical device. Safety Symbols The International Electro Technical Commission (IEC) has established a set of symbols for medical electronic equipment, which classify a connection or warn of potential hazards. The classifications and symbols are shown below. WARNING: The accompanying information must be followed to prevent serious accidents and/or damage to property. CAUTION: The accompanying information helps to prevent minor accidents and/or damage to property. Refer to the user manual. Follow the user manual. CAUTION: Risk of electric shock Type BF applied part (Classification based on degree of protection against electric hazard) Defibrillation-proof type CF applied part (Classification based on degree of protection against electric hazard) Power on/off Power on

[Page 25] Chapter 1. Safety 1 - 5 Power off Power ON for part of the product Power Off for part of the product Alternating current voltage source V~ (Direct current voltage source Dangerous voltage (Indicates dangerous voltages over 1000V AC or 1500V DC) Protective earth (ground) Equipotentiality Data output port Data input port Data Input/Output port Input port Output port Print remote output Foot Switch Port

[Page 26] 1 - 6 SONOACE X6 User manual ECG port USB port Network port Microphone Port Probe port IPX 1 Protected against vertically falling water drops IPX 7 Protected against the effects of temporary immersion in water IPX 8 Protected against the effects of continuous immersion in water CAUTION: Electrostatic sensitive devices (ESD) Do not sit on the product. Do not push the product. Do not lean against the product.

[Page 27] Chapter 1. Safety 1 - 7 Be mindful of the space. Do not place a finger, and or any part of your body in the space. Symbols Authorized Representative In The European Community Manufacturer Labels Phrases containing the words ‘warning’ and/or ‘caution’ are displayed on the product's surface in order to protect it.

[Page 28] 1 - 8 SONOACE X6 User manual Electrical Safety This equipment is categorized as a Class I device with Type BF applied parts.  As for US requirement, the LEAKAGE CURRENT might be measured from a center-tapped circuit when the equipment connects in the United States to 240V supply system.  To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded power outlet. Prevention 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 equipotential bonding. Medical equipment is connected with connecting leads made up of angled sockets to the equipotential bonding network in medical rooms. [Figure 1-1. Equipotential 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 3 Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above-mentioned requirements. If in doubt, consult your local representative or the technical service department.

[Page 29] Chapter 1. Safety 1 - 9  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 Samsung Medison Customer Service Department.  Check the face, housing, and cable before use. Do not use and disconnect the power source, 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 (N2O) should be avoided.  Avoid places where the system is likely to be difficult to operate the disconnection device.  Do not use together with HF surgical equipment. HF surgical equipment may be damaged, which may result in fire.  The System must only be connected to a mains supply with protective earth to avoid risk of electric shock.  The system has been designed for 100-120VAC and 200-240VAC; you should select the input voltage of printer and VCR. Prior to connecting a peripheral power cord, verify that the voltage indicated on the power cord matches the voltage rating of the peripheral device.  An isolation transformer protects the system from power surges. The CAUTION isolation transformer continues to operate when the system is in standby.  Do not immerse the cable in liquids. Cables are not waterproof.  Make sure that the inside of the system is not exposed to or flooded with liquids. In such cases, fire, electric shock, injury, or damage to the product may occur.

[Page 30] 1 - 10 SONOACE X6 User manual  The auxiliary socket outlets installed on this system are rated 100- 120VAC and 200-240VAC with maximum total load of 150VA. Use these outlets only for supplying power to equipment that is intended to be part of the ultrasound system. Do not connect additional multiple-socket outlets or extension cords to the system.  Do not connect any peripheral devices that are not listed in this manual to the auxiliary socket outlet of the system. It may cause an electrical hazard.  Do not touch SIP/SOP and the patient simultaneously. There is a risk of electric shock from leakage current. ECG-Related Information  This device is not intended to provide a primary ECG monitoring function, and therefore does not have means of indicating an inoperative electrocardiograph.  Do not use ECG electrodes of HF surgical equipment. Any malfunctions WARNING 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.

[Page 31] Chapter 1. Safety 1 - 11 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 conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals. The static shock or ESD is a discharge of the electrical energy build-up from a charged individual to a lesser or non-charged individual or object.  The level of electrical energy discharged from a system user or patient 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. CAUTION - 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. 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, Samsung Medison 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.

[Page 32] 1 - 12 SONOACE X6 User manual 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). ▌ 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 RF Emission internal function. Therefore, its RF emissions are very low Group 1 and are not likely to cause any interference in nearby CISPR 11 electronic equipment. RF Emission The Ultrasound System is suitable for use in all Class A establishments other than domestic, and may be used in CISPR 11 domestic establishments and those directly connected to the public low-voltage power supply network that supplies Harmonic Emission Class A buildings used for domestic purposes, provided the IEC 61000-3-2 following warning is heeded: Warning: This system is intended for use by healthcare professionals only. This system may cause radio Flicker Emission interference or may disrupt the operation of nearby Complies IEC 61000-3-3 equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Ultrasound System or shielding the location.

[Page 33] Chapter 1. Safety 1 - 13 ▌ Approved Cables, Probes and Peripherals for EMC ■ Cables Cables connected to this product may affect its emissions; 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 2.99m 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 ■ Probes The image probe used with this product may affect its emission. The probe listed in ‘Chapter 8. Probes’ when used with this product, have been tested to comply with the group1 Class A emission as required by International Standard CISPR 11. ■ Peripherals Peripherals used with this product may effect its emissions. When connecting other customer-supplied accessories to the system, it is the user’s responsibility to ensure the electromagnetic compatibility of the system. The use of cables, probes, and peripherals other than those specified, may WARNING result in increased emissions or decreased immunity of the Ultrasound System.

[Page 34] 1 - 14 SONOACE X6 User manual Electromagnetic Immunity test IEC 60601 Test level Compliance level environment -guidance Floors should be wood, Electrotatic concrete or ceramic tile. ± 6KV Contact ± 6KV Contact discharge (ESD) If floors are covered with synthetic material, the relat- ± 8KV air ± 8KV air ive humidity should be at IEC 61000-4-2 least 30%. ± 2KV ± 2KV Electrical fast transient/burst for power supply lines for power supply lines Mains power quality should be that of a typical commer- ± 1KV ± 1KV cial or hospital environment. IEC 61000-4-4 for input/output lines for input/output lines Surge ± 1KV differential mode ± 1KV differential mode Mains power quality should be that of a typical commer- cial or hospital environment. IEC 61000-4-5 ± 2KV common mode ± 2KV common mode <5% U т for 0.5 cycles <5% U т for 0.5 cycles (>95% dip in U т ) (>95% dip in U т ) Mains power quality should Voltage dips, be that of a typical commer- short interruptions 40% U т for 5 cycles 40% U т for 5 cycles cial or hospital environment. and voltage (60% dip in U т ) (60% dip in U т ) If the user of this product variations on requires continued operation power supply during power mains interrup- input lines 70% U т for 25 cycles 70% U т for 25 cycles tions, it is recommended that this product be powered from (30% dip in U т ) (30% dip in U т ) an uninterruptible power IEC 61000-4-11 supply or a battery. <5% U т for 5 s <5% U т for 5 s (<95% dip in U т ) (<95% dip in U т ) Power frequency Power frequency magnetic (50/60Hz) fields should be at levels magnetic field 3 A/m 3 A/m characteristic of a typical location in a typical commer- cial or hospital environment. IEC 61000-4-8 NOTE U т is the a.c. mains voltage prior to application of the test level.

[Page 35] Chapter 1. Safety 1 - 15 IEC 60601 Compliance Electromagnetic Immunity test Test level level environment - guidance Conducted RF 3 Vrms 3V Portable and mobile RF communications equipment should be used no closer to any part IEC 61000-4-6 150 kHz of the Ultrasound System, including cables, to 80MHz than the recommended separation distance. This is calculated using the equation applicable to the frequency of the transmitter. Recommended separation distance 80MHz to 800MHz 800MHz to 2.5GHz Radiated RF 3 V/m 3V/m Where P is the transmitter’s maximum output power rating in watts (W) according to the IEC 61000-4-3 80 MHz transmitter’s manufacturer, and d is the to 2.5GHz recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Ultrasound System is used exceeds the applicable RF compliance level above, the Ultrasound System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Ultrasound System or using a shielded location with a higher RF shielding effectiveness and filter attenuation. Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

[Page 36] 1 - 16 SONOACE X6 User manual ▌ Recommended separation distances between portable and mobile RF communications equipment and the SONOACE X6 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. Rated maximum Separation distance, according to frequency of transmitter [m] output power of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz [W] 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at 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’s manufacturer. NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. ▌ Electromagnetic environment – guidance It is recommended to use ultrasound systems in shielded locations offering RF shielding effectiveness, with shielded cables. 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, Samsung Medison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic phenomena.

[Page 37] Chapter 1. Safety 1 - 17 ▌ Avoiding Electromagnetic Interference Typical interference on Ultrasound Imaging Systems varies depending on Electromagnetic phenomena. Please refer to following table: 1 2 3 Imaging Mode ESD RF Power Line 2D or 3D Change of operating For sector imaging probes, White dots, dashes, mode, system settings, white radial bands or diagonal lines, or diagonal or system reset. flashes in the centerlines of lines near the center of the the image. image. Brief flashes in the displayed or recorded For linear imaging probes, image. white vertical bands, sometimes more pronounced on the sides of the image. M Increase in the image White dots, dashes, background noise or white diagonal lines, or increase M mode lines. in image background noise Color Color flashes, radial or Color flashes, dots, vertical bands, increase in dashes, or changes in the background noise, or color noise level. changes in color image. Doppler Horizontal lines in the Vertical lines in the spectral display or tones, spectral display, popping abnormal noise in the type noise in the audio, or audio, or both. both. 1. ESD caused by discharging of electric charge build-up on insulated surfaces or persons. 2. RF energy from RF transmitting equipment such as portable phones, hand-held radios, wireless devices, commercial radio and TV, and so on. 3. Conducted interference on powerlines or connected cables caused by other equipment, such as switching power supplies, electrical controls, and natural phenomena such as lightning.

[Page 38] 1 - 18 SONOACE X6 User manual A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference. Samsung Medison Ultrasound System do 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 operating 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 customer service department.

[Page 39] Chapter 1. Safety 1 - 19 Mechanical Safety Moving the Equipment Only the front wheels of the system can be used for steering. Therefore to maneuver the system in tight spaces, use repeated back-and-forth movements to position the system into the desired space. If the system operates abnormally after repositioning, please contact the Samsung Medison Customer Service Department. On rare occasions a component may become disconnected inside the system. The components are installed securely and can withstand considerable shock, but excessive shock may cause system failure. The system has a brake for the front wheels. Press down on brake with your foot to lock it and lift up to release. Release the brake when moving the system.  The system can weigh approximately 60kg, depending upon configuration, and could cause injury should it topple over. WARNING  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. The monitor can be separated and easily removed from the unit if necessary.

[Page 40] 1 - 20 SONOACE X6 User manual Safety Note  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.  Improper cleaning or sterilization of a patient-applied part may cause permanent damage.  Servicing the product, including repairs and replacement of parts, must be done by qualified Samsung Medison service personnel. Assuming that the product is used in accordance with the guidelines contained in this manual and maintained by qualified service personnel, the expected lifespan of the product is approximately 7 years. Please refer to “Chapter 7. Maintenance” for detailed information on protecting, cleaning and disinfecting the equipment.

[Page 41] Chapter 1. Safety 1 - 21 Biological Safety For more safety information on probes and biopsy, please refer to Chapter 8 'Probes.'  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 Samsung 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. ALARA Principle Guidance for the use of diagnostic ultrasound is defined by the “as low as reasonably achievable” (ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight of qualified personnel. No set of rules 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 images, users can minimize ultrasonic bioeffects. Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposure 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.

[Page 42] 1 - 22 SONOACE X6 User manual ▌ Applying ALARA The system-imaging mode used depends upon the information needed. 2D-mode and M- mode imaging provide anatomical information, while Doppler, Power, and Color imaging provide information about blood flow. Scanned modes, like 2D-mode, Power, or Color, disperse or scatter the ultrasonic energy over an area, while an unscanned mode, like M- mode or Doppler, concentrates ultrasonic energy. Understanding the nature of the imaging mode being used allows the sonographer to apply the ALARA principle with informed judgment. The probe frequency, system set-up values, scanning techniques, and operator experience aid the sonographer in meeting the definition of the ALARA principle. The decision as to the amount of acoustic output is, in the final analysis, up to the system operator. This decision must be based on the following factors: type of patient, type of exam, patient history, ease or difficulty of obtaining diagnostically useful information, and the potential localized heating of the patient due to probe surface temperatures. Prudent use of the system occurs when patient exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve acceptable diagnostic results. Although a high index reading does not mean that a bioeffect is actually occurring, a high index reading should be taken seriously. Every effort should be made to reduce the possible effects of a high index reading. Limiting exposure time is an effective way to accomplish this goal. There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA. These controls can be divided into three categories: direct, indirect, and receiver control. ▌ 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.

[Page 43] Chapter 1. Safety 1 - 23 ▌ Indirect 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 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. ▌ Receiver Controls Receiver controls are used by the operator to improve image quality. These controls have no effect on output. Receiver controls only affect how the ultrasound echo is received. These controls include gain, TGC, dynamic range, and image processing. The important thing to remember, relative to output, is that receiver controls should be optimized before increasing output. For example; before increasing output, optimize gain to improve image quality.

[Page 44] 1 - 24 SONOACE X6 User manual ▌ 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. ▌ Output Display Features The system output display comprises two basic indices: a mechanical index and a thermal index. 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.

[Page 45] Chapter 1. Safety 1 - 25 ▌ Mechanical Index (MI) Display Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The potential for mechanical bioeffects 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 bioeffects 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. ▌ 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. ▌ 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:

[Page 46] 1 - 26 SONOACE X6 User manual 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 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. ▌ Control Effects - 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 on-screen output values. ■ 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.

[Page 47] Chapter 1. Safety 1 - 27 ▌ 2D-mode Controls ■ 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. ■ 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. ■ Persistence A lower persistence will decrease the TI. Pulse voltage may be automatically increased. An increase in pulse voltage will increase MI. ■ 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. ■ 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. ▌ Color and Power Controls ■ 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. ■ 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.

[Page 48] 1 - 28 SONOACE X6 User manual ▌ 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. ▌ 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. ■ 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. ▌ M-mode and Doppler Controls ■ Speed M-mode and Doppler sweep speed adjustments will not affect the MI. When M-mode sweep speed changes, TI changes. ■ 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. ■ 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.

[Page 49] Chapter 1. Safety 1 - 29 ▌ Doppler, M-mode, 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. ■ 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. ■ 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. ■ Application Acoustic output defaults are set when you select an application. Samsung Medison factory defaults vary with probe, application, and mode. Defaults have been chosen below the FDA limits for intended use. ▌ Related Guidance Documents For more information about ultrasonic bioeffects and related topics refer to the following; - AIUM Report, January 28, 1993, “Bioeffects and Safety of Diagnostic Ultrasound” - Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med ., Sept. 1998: Vol. 7, No. 9 Supplement - Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM, NEMA. 1998) - Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998) - Second Edition of the AIUM Output Display Standard Brochure, Dated March 10, 1994. (A copy of this document is shipped with each system.) - Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. FDA. September 1997. FDA.

[Page 50] 1 - 30 SONOACE X6 User manual - Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA. 1998) WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non-Thermal Mechanisms for Biological Effects of Ultrasound, Ultrasound in Medicine and Biology , 1998: Vol. 24, Supplement1. ▌ Acoustic Output and Measurement Since the first usage of diagnostic ultrasound, the possible human biological effects (bioeffects) of ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine(AIUM) ratified a report prepared by its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement), sometimes referred to as the Stowe Report, which reviewed available data on possible effects of ultrasound exposure. Another report “Bioeffects 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 meets the requirements of “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD 2-1992) ▌ 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) Brain 0.53 Heart 0.66 Kidney 0.79 Liver 0.43 Muscle 0.55 l = skin line to measurement depth (cm)

[Page 51] Chapter 1. Safety 1 - 31 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 [ e ] 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. ▌ 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). 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 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 value 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).

[Page 52] 1 - 32 SONOACE X6 User manual 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). ▌ 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 3.2% +21 % to -24% integral) Wo (acoustic power) 6.2% ± 19% Pr.3 (derated rarefaction pressure) 5.4% ± 15% Fc (center frequency) < 1% ± 4.5% ▌ 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.

[Page 53] Chapter 1. Safety 1 - 33 ‒ 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. ‒ Ultrasonic transducer misalignment. ‒ Water temperature. ‒ Ultrasonic attenuation and acoustic streaming. ‒ Coupling or shielding foil properties. ‒ Plane-wave assumption. ‒ Environmental influences. ‒ Excitation voltage measurement. ‒ Ultrasonic transducer temperature. ‒ Effects due to nonlinear propagation and saturation loss. The overall findings of the analysis give a rough Acoustic Power accuracy figure of +/- 10% for the frequency range of 1 - 10 MHz.

[Page 54] 1 - 34 SONOACE X6 User manual ▌ Training The users of this ultrasound system must familiarize themselves with the ultrasound system to optimize the performance of the device and to detect possible malfunctions. It is recommended that all users receive proper training before using the device. You can receive training on the use of the product from the Samsung Medison service department, or any of the customer support centers worldwide.

[Page 55] Chapter 1. Safety 1 - 35 Environmental Protection  The console and peripherals could be sent back to manufacturers for recycling or proper disposal after their useful lives. CAUTION  Disposal of waste shall be disposed in accordance with national laws.  The lithium ion battery used in the product must be replaced by a Samsung Medison service engineer or an authorized dealer. Correct Disposal of This Product (Waste Electrical & Electronic Equipment) Applicable in countries with separate collection systems This marking on the product, accessories or literature indicates that the product and its electronic accessories (e.g. charger, headset, USB cable) should not be disposed of with other household waste at the end of their working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources. Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can take these items for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchase contract. This product and its electronic accessories should not be mixed with other commercial wastes for disposal. State of California Proposition 65 Warning (US only) This product contains chemicals known to the State of California to cause cancer and reproductive toxicity.

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[Page 57] Chapter 2 Introduction And Installation Introduction 3 And Installation 3 What is SONOACE X6? 3 Features and Advantages of SONOACE X6 3 Specifications 4 Product Configuration and Installation 7 Monitor 7 Control Panel 10 Console 16 Peripheral Devices 19 Probe 22 Accessory 23 Options 23

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[Page 59] Chapter2. Introduction And Installation 2 - 3 What is SONOACE X6? The SONOACE X6 is a high-resolution color ultrasound scanner with high penetration and a variety of measurement functions. Features and Advantages of SONOACE X6 ■ High-end Digital Beam Forming – The SONOACE X6 utilizes the newly developed Digital Beam forming technology. ■ A variety of applications – The SONOACE X6 is optimized for use in a variety of ultrasound departments, including abdomen, obstetrics, gynecology, vascular, cardiac and urology applications. ■ Various diagnostic Modes - 2D Mode, M Mode, Color Doppler Mode, Power Doppler Mode, PW Spectral Doppler Mode, CW Spectral Doppler Mode(optional) etc. ■ 3D images can be obtained. ■ Measurement and Report Functions – Besides the basic distance, area, circumference and volume measurement functions, the SONOACE X6 also provides application-specific measurement functions. The report function collates measurement data. ■ Review of Scanned Images – The SONOACE X6 displays Cine images of 512 frames and loop images of 4096 lines. ■ SonoView - This is a total ultrasound image management system, which allows a user to archive, view and exchange documents. ■ DICOM (Digital Imaging and Communication in Medicine) 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 SONOACE X6.

[Page 60] 2 - 4 SONOACE X6 User manual Specifications Height: 1378mm (with monitor) Width: 483mm Physical Dimensions Depth: 691mm Weight: More than 60.75kg Weight: Approx. 75kg (with Safe Working Load) 2D real-time Dual 2D real-time 2D/M-mode Color Doppler Imaging modes Pulsed-wave Doppler Continuous-wave Doppler (Optional) Power Doppler 3D-mode (Freehand) Simultaneous Gray Scale 256 (8 bits) Dynamic transmit focusing, maximum of eight points (four points simultaneously selectable) Focusing Digital dynamic receive focusing (continuous) Curved Linear Array C2-5, C2-5EP, C2-8, C2-4ES, C3-7EP, C4-9ED Linear Array HL5-12ED, L3-8, L5-12/50, L5-12EP, L5-12/50EP, LN5-12 Endocavity Curved Linear Array Probes (Type BF / IPX7) ER4-9/10ED, EV4-9/10ED, NER4-9ES, NEV4-9ES, BCC4-9 Phased Array P2-4AH, P3-7AC, SP3-8 CW CW2.0, CW4.0 Three probe connectors Probe connections Four probe connectors for option ※ Including one CW probe connector. 15 inch LCD monitor (LED Backlight unit) called "LCD monitor" henceforth ECG Type BF

[Page 61] Chapter2. Introduction And Installation 2 - 5 VHS and S-VHS VCR left and right audio ECG Microphone Rear Panel Input Patient monitor video and 9V dc power Connections B/W printer video and remote control VGA monitor Parallel port USB Maximum 512 frames for CINE memory Image Storage Maximum 4096 Lines for LOOP memory Image filing system General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Application Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal Electrical Parameters 100-120V/200-240VAC, 8/5A, 50/60Hz Obstetrics Gynecology Cardiology Automatic Calculation and Fetal Echo Quantification Vascular Urology * Refer the Chapter 5 for additional information TGC control Mode-independent gain control Acoustic power control (adjustable) Dynamic aperture Signal processing Dynamic apodization (Pre-processing) Dynamic range control (adjustable) Image view area control M-mode sweep speed control HD zoom Frame average Signal processing Gamma-scale windowing (Post-processing) Image orientation (left/right and up/down) White on black/black on white Trackball operation of multiple cursors 2D: Linear measurements and area measurements using elliptical Measurement approximation or trace M-mode: Continuous readout of distance, time, and slope rate

[Page 62] 2 - 6 SONOACE X6 User manual Doppler: Velocity and trace Black-and white printer Color printer Auxiliary VCR Foot switch (IPX1) User Interface English, German, French, Spanish, Italian, Russian, Chinese 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

[Page 63] Chapter2. Introduction And Installation 2 - 7 Product Configuration and Installation The SONOACE X6 consists of the monitor, the control panel, the console, the peripheral devices, and the probes. When the system powers on, the monitor screen becomes white for 1 or 2 NOTE seconds. This is the effect of the residual power and does not affect the use of the equipment. 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. ▌ 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 Feedback, and ⑥ Flexible Soft Menu sections. [Figure 2.1 Monitor Display]

[Page 64] 2 - 8 SONOACE X6 User manual ■ Title This section displays the Logo, Patient Name, Hospital Name, Application, Frame Rate & Depth, Probe Information, Acoustic Output Information and Date & Time. ■ Menu The menu is divided into 3 kinds: Image adjustment menu, Measurement menu, and Utility menu. Use Menu dial-button to select an item from the menu. ■ Image Area The ultrasound image, image information, annotation, and measurement information are displayed in the image area. ■ Thumbnails Area Saved images, by pressing the Save button on the control panel, are displayed in the thumbnails area. This area shows up to four images. Thumbnails are showed when you check ‘on’ in Setup> System > Misc. Click a thumbnail with a pointer to enlarge. NOTE Refer to ‘Chapter 3. Settings’ for detail. ■ Feedback Area This feedback area provides a variety of information necessary for system use e.g. current system status and Body Markers. ■ Flexible Soft Menu The Flexible Soft Menu is displayed on the screen at all times. The items shown on the monitor vary, depending on the status of the system.

[Page 65] Chapter2. Introduction And Installation 2 - 9 ※ Principles of Operation of the Diagnostic Ultrasound System Medical ultrasound images are created when the computer's digital memory converts the high-frequency wave signals that are transmitted and received by the probe. As ultrasound waves propagate through the human body, they generate reflected signals whenever they encounter a change in density. For example, reflected signals are generated when signals pass from fatty tissues to muscle tissues. Reflected signals return to the probe where they are converted into electronic signals. The reflected signals are amplified and processed by analog and digital circuits that have filters for various frequencies and response time options. Then they are again converted into high-frequency electronic signals, and saved as a series of digital image signals. The monitor displays the image signals stored on the storage device in real time. The entire process of transmitting, receiving, and processing signals is controlled by the computer

[Page 66] 2 - 10 SONOACE X6 User manual Control Panel The control panel can be used for controlling the system. [Figure 2.2 Control Panel] The user can manipulate the control panel using ① Up/Down Switch, ② Dial-Button, ③ Dial, ④ Slide, ⑤ Button, and ⑥ Trackball. The dial-button can be used both as a dial and a button. ▌ Control Panel Map The following are descriptions and instructions for the controls on the control panel. For more information on the buttons with multiple functions, see Chapter 3 and later of this manual. ■ Power On/Off This is used toTurn the system on/off. Press the button for about 1 second to turn the product On for use, and On/Off press and hold down the button for 2 seconds to turn the product Off after use. Once turned Off, the system needs a 5-second interval before restarting by pressing the button.

[Page 67] Chapter2. Introduction And Installation 2 - 11 ■ Starting and Finishing Exam This is used to change another probe. Probe If you use Two-probe connector (optional), this is used to appear a window to select/change probes and applicati-ons. This is used to appear a window for patient selection and information Patient entry. This is used to finish the exam of the currently selected patient and reset End Exam the related data. ■ Selecting Diagnosis mode and Gain Control For further information on each Mode, refer to ‘Chapter 4. Diagnosis Modes’. This is used to view two-dimensional anatomy images in the direction of scanning in real time. Pressing this button while in 2D mode does not turn 2D it off. However, pressing the 2D button will return the system to 2D Mode from other image modes. This is used to turn M Mode on. The M Mode is used to observe the M motion patterns of objects occurring over time along a single vector. Press this button again to turn M Mode off. This is used to turn Color Doppler Mode on. Color Doppler Mode shows C the pattern of blood flow on 2D image in real time. Press C button again to turn Color Doppler Mode off. This is used to turn Power Doppler Mode on. Power Doppler Mode PD displays the color intensity of blood flow within the ROI in the 2D image. Press PD button again to turn Power Doppler Mode off. This is used to turn PW Spectral Doppler Mode on. This mode is used to PW show vascular or cardiac blood flow. 2D Mode can be used (Optional) simultaneously. Press this button again to turn PW Spectral Doppler Mode off. This is used to turn CW Spectral Doppler Mode on. CW Spectral Doppler CW Mode gives information on the speed/direction of blood flow in the form of (Optional) a spectral trace and audio signal. This is used to turn Dual Mode on. Dual Mode is used to compare two 2D Dual images. Use the Set button Dual button or Update button to change the activated image in Dual Mode. Press 2D button to turn Dual Mode off. This is used to turn Harmonic Imaging on. Press this button again to turn Harmonic the mode off. This button is only activated with the specific probe.

[Page 68] 2 - 12 SONOACE X6 User manual This adjusts 2D Gain, 2D Post Gain or activates the Freeze function. - 2D Gain function – Use the dial in 2D mode to adjust Gain. - Freeze function – Press the button while scanning to stop the video Gain/Freeze/PGC scanning. LED of this button in frozen state is displayed as blue and Cine, Save, Echo Print, and Measurements are available. Press this button again, LED is displayed as green. - 2D PGC(Post Gain Control) function - Changes the post curve in the frozen state to provide effects similar to changing Gain, TGC, DR, etc. Gain/PGC This adjusts Gain or Post Gain. ■ Image Adjustment This switch is used to focus on the area of interest. Raise/ lower the switch Focus to raise/lower the focusing point. This switch is used to adjust the scanning depth of the image. Raise/ Depth lower the switch to decrease/ increase the scanning depth of an image. Raising this switch causes a Zoom box to appear. Modify the size of Zoom box with the Change button and Trackball , and press Set button to apply it to the image. HD Zoom Press Exit button or adjust Depth switch to exit. The position of the magnified area can be adjusted with the Trackball . This is used to perform the Read Zoom function. Adjust the size/position of a 2D image with Change button and the Trackball . Roll the Trackball Zoom upwards to view the lower portion of the image, and vice versa. To observe the right/left portion of the image, move the Trackball to the left/right. Press Exit button or Zoom button to exit Zoom mode. This is used to adjust Gain, TGC, etc. automatically to optimize Contrast and Brightness. Quick Scan The ‘Q’ mark is displayed on the top of the image. Press this button again to exit. Menu function - Press dial button to activate the available menu item of current scan mode. Rotate the dial button to the right/left to move up/down a menu. Menu/ Angle Angle function - Adjust the angle of sample volume in PW Spectral Doppler Mode. It is also used to adjust the Indicator angle or the Probe angle of Body Marker.

[Page 69] Chapter2. Introduction And Installation 2 - 13 ■ TGC (Time Gain Control) TGC Eight slides are used to adjust TGC (Time Gain Compensation) values. Care should be taken when adjusting TGC values. Too large CAUTION difference in the gain value settings of two adjacent slides may lead to inaccurate image generation. ■ Measurement and Annotation This is used to measure distance, volume, circum-ference, and area. Caliper Press the button repeatedly to cycle through all the available measurement methods. This is used to appear a different measurement menu, depending on the examination subject and diagnosis mode. The examination subject Calculator changes each time the button is pressed. Select an appropriate item to perform the measurement. This button is used to appear an arrow marker. It points the parts of the Indicator displayed image. This button is used to erase the text, Indicator, Body Marker, and Clear measurement data from the displayed image. Body Marker This button is used to appear a Body Marker list. For more information about Measurement, refer to ‘Chapter 5 Measurements NOTE and Calculations’. For more information about annotation, refer to ‘Chapter 6 Image Managements’. ■ Trackball and its related control This is used to move the cursor on the display and to scroll through CINE Trackball images. This is used to change the current Trackball function. It is used during Change measurements to alter the position of the last point. It is also used to adjust the position of the text cursor. There are two buttons on each side of the Trackball. SET; This is used in conjunction with the Trackball to set a specific item or value. In Spectral Doppler Mode and 3D mode, it is also used as update function. It shows as green color. Set / Exit EXIT; This is used to exit the current mode and return to initial settings. It shows as blue color. The function of each button can be set in Utility > Setup > Peripherals > Key Setup.

[Page 70] 2 - 14 SONOACE X6 User manual ■ SonoView and Report When this is pressed on the keyboard, SonoView, the Image Filing SonoView program, is activated. When this is pressed on the keyboard, a report program containing Report measurement results from the current diagnosis mode appears. For more information about SonoView, refer to ‘Chapter 6 Image NOTE Managements’ and for more information about Report, refer to ‘Chapter 5 Measurements and Calculations’. ■ Save and Print This is used to save a currently displayed image or measurement report in Save the system database. The user can manage the saved image and report with SonoView. Echo Print This is used to print out the current image via an Echo printer. ■ Alphanumeric Keyboard [Figure 2.3 Alphanumeric keyboards] The alphanumeric keyboards are used to type in text. Some function keys are related to measurement. Press this button in HD Zoom mode to hide the Zoom Navigation Box. Z Key Press it again to show the box.

[Page 71] Chapter2. Introduction And Installation 2 - 15 ■ Flexible Soft Buttons These buttons activate the corresponding Flexible Soft Menu at the bottom of the screen. ■ Function Buttons [F1] This is used to input text. Text [F2] This is used to display M line or hide. M Line [F3] This is used to start the biopsy. Biopsy [F4] This button is used to display information of image on the upper right side of screen or hide. Data on / off [F5] This is used to start 3D Mode. 3D [F7] This button is used to appear the Storage Manager window, where saving, transmission, backup and other functions are available. Storage Manager [F8] This button is used to appear the Setup window for setting system parameters. Setup [F9] This button is used to appear the utility menu. Utility [F10] This is used to appear a window to select/change probes and applications. Application

[Page 72] 2 - 16 SONOACE X6 User manual Console The console consists of two parts – the inner unit and the outer unit. The inner section is responsible for ultrasound image generation. The outer section is designed to support the use of other devices and includes monitor and probe connection sockets, the probe holder, storage devices like HDDs, storage space for peripheral devices and the system power switch. [Figure 2.4 Console]

[Page 73] Chapter2. Introduction And Installation 2 - 17 ▌ Rear Panel A monitor, printer, VCR, etc. are connected via the rear panel at the back of the system. VGA (Output) The VGA signal is sent to the monitor. LAN (Input/Output) DICOM can be connected via the LAN port. Patient information is transferred to another server via the DICOM network. Audio (Output) The input/output of Audio signals is possible. VHS (Output) Connect the VCR using the VHS method. Printer (Output) Echo printer connection. Printer Remote (Output) Remote Echo printer connection. ECG Connector ECG Module connection. [Figure 2.5 Rear Panel] ▌ Main Power On/Off Switch The main power on/off switch locates under the rear panel. Powers the product On/Off.

[Page 74] 2 - 18 SONOACE X6 User manual [Figure 2.6 Main Power On/Off Switch] ▌ Probe Holder A probe holder is mounted at the right/left side of the control panel.

[Page 75] Chapter2. Introduction And Installation 2 - 19 Peripheral Devices  When using a peripheral device from a USB port, always turn the power off before connecting/disconnecting the device. Connection/discon-nection of USB devices during power-on may lead to malfunction of the system and USB devices. CAUTION  Do not install a peripheral device that is not listed in this user manual in the patient environment. If you install an unlisted device in the patient environment, it may cause an electrical hazard.  Do not connect additional Peripheral Devices to the auxiliary socket outlets. When connecting, the level of safety may be reduced. [Figure 2.7 The patient environment] NOTE Refer to the user manual of peripheral device about its operating. ▌ Internal Peripheral Devices These are peripheral devices mounted in the system. ■ DVD-Multi DVD-RW, DVD-RAM, DVD-R, DVD+R, DVD-ROM, CD-R, CD-RW, CD-ROM

[Page 76] 2 - 20 SONOACE X6 User manual ■ Hard Disc Drive More than 80Gbytes. ▌ 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 remove the removable disk, use Storage manager.  USB ports are located both on the front panel and the rear panel of the NOTE console. 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 convenience. The following products are recommended: ■ Video Cassette Recorder (VCR) ■ Video Page printer – Black and White : SONY UP-897MD, Mitsubishi P91W, Mitsubishi P93W – Color : SONY UP-20, SONY UP-21MD ■ Inkjet Printer Contact Samsung Medison’s customer service department about abailable printers. Contact Samsung Medison’s customer service department for inquiries about printer driver installation. ■ USB Magnetic Optical (MO) Disk Drive 1 Fujitsu DynaMO 1300U2B or later version The USB MO Drive should not be used with other USB storage devices simultaneously. ■ USB to RS-232C Serial Cable USB to Serial (RS-232C) Converter with FTDI Chipset (FTDI FT232BM Compatible)

[Page 77] Chapter2. Introduction And Installation 2 - 21 For more information about the Open Line Transfer, refer to ‘Chapter 5. Measurements and Calculations’. ■ Foot Switch Set the function of the foot switch in Setup > Peripherals > Foot Switch; Dual, Freeze, Update, or Store. ■ Flash Memory Media Imation iFLASH USB 2.0 1GB, Imation USB Swing Blue 1G  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.  USB ports are located both on the front panel and the rear panel of the console. We recommend that you connect USB storage NOTE 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.  Do not use flash memory media which contain anti-virus programs or are defective. Otherwise, the product may fail to work properly

[Page 78] 2 - 22 SONOACE X6 User manual Probe Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation. NOTE For more information, refer to ‘Chapter 8 Probes’. ▌ Connecting probes Be sure to connect or disconnect probes when the power is off to ensure the safety of the system and the probes. 1. Connect probes to the probe ports on the front panel of the system. A maximum of three probes (four probes optional) can be connected at one time. Connect the Biplane and CW probes to their respective dedicated connectors. 2. Turn the connector-locking handle clockwise after inserting the probe into the probe port. When the system is powered on, the probe last in use is automatically activated. [Figure 2.8 Probe Connector]

[Page 79] Chapter2. Introduction And Installation 2 - 23 Accessory This system provides a box including accessories. Main cord set, separately certified according to the relevant standards, is to be used when supplied to EU and USA/CAN. [Figure 2.9 Accessories] NOTE Accessories can be different according to the country. Options The SONOACE X6 has the following optional functions: ■ Image filing-SONOVIEW ■ DICOM ■ Freehand 3D ■ Pulse wave Doppler ■ Color Doppler ■ Cardiac S/W Package

[Page 80]

[Page 81] Chapter 3 Setting Selecting Probe / Application 3 Probe /Application Selection 3 Application Change 4 Probe Setting Change 4 Editing Bodymarker 5 Calc Sequence 7 Entering Patient Data 8 Registering a New Patient 8 Finding Patient Information 9 Modifying Patient Information 11 Setting System 12 General 12 Display 15 Misc. 17 Setting Measurements 19 General 19 Obstetrics Measurement Setup 24 Fetal Echo Measurement Setup 28 Cardiac Measurement Setup 29 Urology Measurement Setup 30 Vascular Measurement Setup 31 Setting DICOM (Optional) 32 Setting DICOM Information 32 Network Setup 33 Adding or Changing the DICOM Server 33 Editing the DICOM Server Information 39 Deleting DICOM Server 39 Testing DICOM Server 39 DICOM Log 39 Setting Option 41

[Page 82] 3 - 2 SONOACE X6 User manual Setting Peripheral Devices 42 Information 43 Utilities 44 Biopsy 44 ECG 46 Monitor Calibration 48 Preset 48 Miscellaneous 49

[Page 83] Chapter3. Setting 3 - 3 Selecting Probe / Application Before scanning, select a probe and an application. Refer to `Chapter 8 Probes’ for more information about the probes available for this system. On the control panel, press the [F10] Application button to bring up the Application window on the screen. This window can be used to select or change applications and probes, and to edit probe preset. To switch to another probe without using Application window, press Probe button on the control panel. [Figure 3.1 Application] Probe /Application Selection 1. Select a probe and an application using the Trackball and Set button. 2. After selecting them, click Ok in the Application Window. To cancel the selection, press Cancel .

[Page 84] 3 - 4 SONOACE X6 User manual Application Change 1. After checking the currently selected probe, select an application using the Trackball and Set button. 2. After selecting it, click Ok in the Application Window. To cancel the selection, press Cancel . Probe Setting Change While the probe settings are preset with the optimal values for each application, the user may change the preset values using the following method. 1. After checking the currently selected probe/application, change the probe setting using the Trackball and Set button. Click Save to save the changed values. 2. Click Ok in the Application Window. To cancel the selection, press Cancel . 3. Change the names of the user-definable settings other than ‘Default’ values using the Rename . To change the probe setting values, see ‘Utility’.

[Page 85] Chapter3. Setting 3 - 5 Editing Bodymarker Press Edit Bodymarker in the Application window to bring up the Bodymarker manager . Select some bodymarkers to use in the system or change the order of bodymarkers. [Figure 3.2 Bodymarker Manager] ‘Group’ shows system supporting bodymarkers with the application. Use Prev or Next to display Bodymarkers of other applications. ‘User defined Bodymarker preset’ shows selected bodymarekrs. ▌ Add Bodymarkers Select a bodymarker on ‘Group’ using the Trackball . Press Set button to add to the ‘User defined Bodymarker preset’. ▌ Delete Bodymarkers Select a bodymarker on ‘User defined Bodymarker preset’ using the Trackball . Press Set button to delete.

[Page 86] 3 - 6 SONOACE X6 User manual ▌ Change the order of Bodymarkers Select a bodymarker on ‘User defined Bodymarker preset’ using the Trackball . Press Set button to delete. With pressing the Exit button on the control panel, move the position using the Trackball . Release the Exit button to finish changing the order. ▌ Back to default Bodymarker Press the Default on ‘User defined Bodymarker preset’ to back to default Bodymarker. ▌ Delete all Bodymarkers Press the Delete on ‘User defined Bodymarker preset’ to delete all bodymarkers. It deletes bodymarkers only in ‘User defined Bodymarker preset’. ▌ Save Bodymarkers Press the Save on ‘User defined Bodymarker preset’ to save current setting. When you press the Bodymarker button on the control panel during using the system, this setting will be displayed. Refer to ‘Chapter 6 Image managements’ for more information about displaying Bodymarker.

[Page 87] Chapter3. Setting 3 - 7 Calc Sequence To change the order and content of the Calculation Package of each application, click the Calc Sequence . If you want to return to the initial settings, click Default in the window. [Figure 3.3 Calc Package Sequence Change]

[Page 88] 3 - 8 SONOACE X6 User manual Entering Patient Data Be sure that the patient information has been correctly entered before scanning. The patient information includes basic information such as patient ID, patient name, birth date, gender as well as other application specific data. Patient ID and name are mandatory information when registering a new patient. All patient data are classified according to the patient ID. If the ID is not entered, the Ok is not activated. (Extra information can be entered when needed.) Press Patient on the control panel, and the Patient Information window shown below appears. You can register and modify patient information. [Figure 3.4 the Patient Information] Registering a New Patient 1. After clicking the New , enter the patient name, ID and other information using the Trackball , Set button and keyboard. – While Auto ID Creation is checked, click the New . A new Patient ID is automatically provided by the system. – When an existing ID is entered, the ID field icon changes to . 2. After entering patient information correctly, click Ok . Or click Cancel or X to cancel.

[Page 89] Chapter3. Setting 3 - 9 Finding Patient Information ▌ Finding Patient Information using ID Enter the Patient ID to change his or her information. ▌ Finding Patient Information using the Search Function 1. Click Search in the Patient Information window, and the Search window shown below appears. [Figure 3.5 Patient Search] 2. Type in patient ID or name, and the list of registered patients appears. – If there is no ID or name that satisfies the search key, the Select and Ok are not activated. – To display all registered ID, click Show All . To select all ID on the list, click Select All . – To delete the ID and its all information, select the patient and click Delete . 3. After selecting ID, press Select or Ok to display information of the selected patient. To stop the search or close the current search dialog box, click Cancel or X . WARNING If a patient ID is deleted, all data and images stored in SonoView are erased.

[Page 90] 3 - 10 SONOACE X6 User manual ▌ Finding Patient Information using Worklist The system connects to the hospital’s DICOM Modality Worklist server and obtains information on scheduled patients and examinations. Searching a patient by Worklist allows you to enter the patient information automatically. Use the DICOM tab in the Settings screen to select the Worklist server. For more information, see “DICOM Settings.” 1. Press Worklist in the Patient Information screen and the Modality Worklist window will appear. (If “Open MWL on Patient Key” is selected under the DICOM server settings, pressing the Patient button opens the Modality Worklist window first.) 2. Select Worklist Server, enter one or more search conditions in “Search Criteria”, and then press Search button. A list of scheduled patients that match the search conditions will appear. 3. Select a patient and press OK . The patient information will appear. 4. Press the X button on the window to quit searching patients and close the Modality Worklist window. If you wish to enter patient information directly without using Worklist data, press Manual Entry . ID, Name, Accession #, Birth, Age, or Gender cannot be changed when entering patient information by using Worklist. [Figure 3.6 Modality Worklist]

[Page 91] Chapter3. Setting 3 - 11 Modifying Patient Information To modify information in the Patient Information window: 1. Modify the information using the Trackball , Set button and keyboard. 2. After modifying patient information correctly, click Ok . To cancel editing, click Cancel or X . For more details on patient backup, see the ‘Information Management’ section in ‘Chapter 6. Image Managements’.

[Page 92] 3 - 12 SONOACE X6 User manual Setting System This mode is used for system settings. It does not affect image output. The setup may be modified depending on specific needs or preferences. 1. Press the [F8] SetUp button on the keyboard. Setup window is appeared. 2. Select System in the Setup menu. 3. Set the specific system values according to each item on the screen. 4. Press Ok to finish the setup. To close the screen, press Cancel or X. General Select the General tab in the System menu. [Figure 3.7 System Setup – General] ■ Institution Enter the name of the hospital/institution.

[Page 93] Chapter3. Setting 3 - 13 ■ Language This sets the language to be used. English, Deutsch, Français, Italiano, Español, Russian, and Simplified Chinese are available. To display the screen in the selected language, reboot the system after completing setup. The input setup of key button is automatically updated. ■ Date Set the date and its format. ■ Time Set the time and its format. ※ How to set the date and time. [Figure 3.8 System Setup – Date/Time] 1. Click Set in the Title tab of System menu. 2. Set the Date/Time using the Trackball and Set button. 3. After finishing setup correctly, click Ok . To cancel setup, click Cancel .

[Page 94] 3 - 14 SONOACE X6 User manual ■ Boot up caps lock status This menu sets the initial status of Caps Lock after system boot-up. Its default value is ‘Off’. This Caps Lock enables capital letter entry without the need to press the Shift key. ■ Autotext Set Select Autotext Set to use the Autotext text function. Its default value is ‘Off’. Using the Autotext text function allows fast and easy input of text statements. For example, to enter the text ‘Tumor’, you only need to enter ‘Tu’ and the system will search the word from the abbreviation list and automatically enter the word ‘Tumor’. ※ How to edit the Autotext Set. Press the Edit button on the screen. The Autotext Table Edit table window will be appeared. To add a new abbreviation, click New, and to completely delete an existing abbreviation, click the entry to be deleted and then click Delete. ‘Delay(msec)’ sets seconds to input the full word after enter the abbreviation. The unit value is msec, and 1000msec is 1second. [Figure 3.9 Autotext Set Edit]

[Page 95] Chapter3. Setting 3 - 15 Display To set the information about images and related data, select the Display tab in the System menu. ■ Auto Freeze After the preset time span (Minute) of inactivity, the scan mode is automatically frozen. ■ Screen Saver After the preset time span (Minute) of inactivity, the screen saver is automatically started. ■ Post Map This sets the display of the Post Map in the Feedback section at the bottom of the screen. ■ TGC Line This sets whether or not the TGC line is displayed. If ‘Off’ is selected, the TGC Line is not shown. If ‘Off after 3 seconds’ is selected, the TGC value appears when a TGC value is adjusted, but disappears after 3 seconds. If ‘On’ is selected, the TGC Line is always shown. ■ TI (Thermal Index) Display The system sets TI values automatically. However, this menu allows the user to choose manually from one of the three TI parameters as desired: Default, TIs or TIb. ■ HPRF Enable or disable High Pulse Repetition Frequency (HPRF) supported in the PW Spectral Doppler mode. If it is set to ‘On,’ HPRF is supported by default. ■ Bodymarker After Freeze Determine whether the system will automatically switch to the Body Marker mode when the Freeze button is pressed. If it is set to ‘On,’ a Body Marker appears when the Freeze button is pressed during scanning. If it is set to ‘Off,’ a Body Marker appear only when BodyMarker is pressed during scanning. ■ 2D Image Size The Image size can be set to 100%, 95% or 90%.

[Page 96] 3 - 16 SONOACE X6 User manual ■ Display Gender This sets whether or not the gender of the patient is displayed. If ‘On’ is selected, the patient’s gender is shown. ■ Simultaneous Mode This menu determines whether or not simultaneous mode is enabled in PW Spectral Doppler Mode. – ‘Off’: Select this if you do not wish use simultaneous mode. – ‘Allow 2D/PW: Select this if you wish to use simultaneous mode in 2D/PW mode. – ‘Allow 2D/C/PW: Select this if you wish to use simultaneous mode in 2D/C/PW mode. [Figure 3.10 System Setup – Display]

[Page 97] Chapter3. Setting 3 - 17 Misc. Select the Misc. tab in the System menu. [Figure 3.11 System Setup – Misc.] ■ OB Measure Shortcut Key You can use this feature to start a desired obstetrics measurement instantly while scanning. ■ Shortcut Key Setup Assign commonly used obstetrics measurement items to number keys in the alphanumeric keyboard. ■ Hibernation To booting speed up, set this item as ‘On’. th The system turns off with normal shutdown after 30 booting NOTE with ‘Hibernation On’. However the system will start with ‘Hibernation On’ on the next booting.

[Page 98] 3 - 18 SONOACE X6 User manual ■ Thumbnail To use thumbnail list, set this item as ‘On’. Thumbnails of saved images are showed up on the right side of the screen. ■ Set/Exit Key Setup Set the position of the Set and Exit buttons. ■ Active Plane NOTE This option is available only if the Biplane probe is used. Select which of the two elements in the Biplane probe will be used as the default element. In Single mode, images scanned with the selected element are displayed. For detailed information on the Biplane probe, please refer to “Chapter 8 Probes".

[Page 99] Chapter3. Setting 3 - 19 Setting Measurements Select Measure in the Setup menu to set up measurement functions. 1. Press the [F8] SetUp button on the keyboard. Setup window is appeared. 2. Select Measure in the Setup menu. 3. Set the specific system values according to each item on the screen. 4. Press Ok to finish the setup. To close the screen, press Cancel or X . General Select the General tab in the Measure menu to set general measurement settings. [Figure 3.12 Measurement Settings- General]

[Page 100] 3 - 20 SONOACE X6 User manual ▌ General Select General tab. ■ Measure Item Display Count Select the number of measurement items to be between 1 and 4. If you select ‘Hide’, measurement items are not displayed. NOTE If you select ‘4’, reboot the system after completing setup ■ Circ/Area Method Select either the ‘Ellipse’ or ‘Trace’ caliper to be the default tool for measurement. ■ Default Volume Method Select either the ‘3 Distance’, ‘1 Distance’ or ‘Distance + Ellipse’ items to be used as the default tool in volume measurement. ■ Distance Method Set either ‘Line’ or ‘Trace’ as the distance measurement method. ■ Caliper Display Unit Set either ‘cm’ (centimeter) or ‘mm’ (millimeter) as the caliper display unit. ■ Trackball Speed Set the Trackball speed to either ‘Fast’, ‘Medium’ or ‘Slow’. ■ Result Display Set the output format of measurement results in the report. When ‘Average Value’ is selected, the report shows the average value of the last three measurement results. When ‘Last Measured Value’ is selected, the last measurement value is shown.

[Page 101] Chapter3. Setting 3 - 21 ▌ Doppler Select the Doppler tab in the General tab. [Figure 3.13 Measurement Settings - Doppler] ■ Y-Axis Unit This sets the vertical (Y) axis unit in Spectral Doppler Mode. ■ Trace Direction When Auto Trace and Limited Trace functions are used in Spectral Doppler Mode, this sets the range of the measurement values. ■ Control Threshold The trace threshold can be adjusted by rotating the Menu dial-button when tracing is not finished after Auto trace / Limited trace. ■ Mean Trace This menu specifies the use of Mean Trace Line on the screen for Auto trace / Limited trace.

[Page 102] 3 - 22 SONOACE X6 User manual ※ How to change Doppler setting during measurement Press the space bar after pressing the Calculator button to bring up the Setting Measure Method window shown below. [Figure 3.14 Setting Measure method]

[Page 103] Chapter3. Setting 3 - 23 ▌ Report Select the Report tab in the General tab. Select items to mark the header on the report. The header will be shown only the item has its data. [Figure 3.15 Report Setting]

[Page 104] 3 - 24 SONOACE X6 User manual Obstetrics Measurement Setup To set up obstetrics related measurement, select the OB tab in the Measure menu. [Figure 3.16 Measurement Settings – Obstetrics] ■ Display SD Value This menu sets whether SD (Standard Deviation) is displayed or not. If ‘Yes’ is selected, the SD value is shown on the screen and on the report. If ‘No’ is selected, it is not shown and its range value appears on the report. ■ HC Auto Calc This menu is used to set the HC Auto Calculation. ‘Yes’ shows the HC value on the screen and in the report using the result of OFD and BPD calculation. ‘No’ will not show the HC value on the screen. ■ Fetal Weight This menu is used to set the measurement items used for fetal examination. In the fetal weight and fetal weight growth fields, more measurement items can be added. – Unit: This sets the unit of fetal weight measurement. You can choose from grams [g], ounces [oz], and pounds [lb]. – Auxiliary Unit: This sets the auxiliary unit of fetal weight measurement. Unit sets the

[Page 105] Chapter3. Setting 3 - 25 available auxiliary unit. For instance, set the unit as Gram [g], available units are None, oz, lb, or lb+oz. If you select lb+oz as an auxiliary unit, the value will be shown like as xx lb yy oz. – Display SD: This menu sets the SD information shown in the result display section: No, SD or Percentile. Both SD and Percentile appear in the report. ■ Preset Measurement items used during exams are set. Set a specific preset in the Name field. If ‘General’ is selected, all items can be used. If ‘Fetal Biometry’ is selected, only Fetal Biometry-related items can be used. – User Preset If the beside the Name field is selected, a user can set a new preset. Enter a title in the Preset Name field and a Autotext explanation in the Description field. Press Ok . [Figure 3.17 New Preset window] After a new preset is made, register items in the right-hand list to use in obstetrics measurement. When is clicked, the items in the right list are moved to the left list to be used with the user preset. To delete the items from the left list, select them and click . To delete a user preset, select it and click . Because `General and Fetal Biometry’ are system presets, cannot be deleted. – Table and Equation The measurement items used in the Preset menu are GA and Fetal Growth. The measurement values of GA and Fetal Growth are shown in table or equation form. When is clicked, the contents of the GA or Fetal Growth’s table and equation contents are shown. When is clicked, a user can set a specific value, and when is clicked, the table and equation set by the user are erased. However, the default values provided by the system are not erased. For more information about each table and equation, refer to the Reference Manual.

[Page 106] 3 - 26 SONOACE X6 User manual ■ Graph The user can select graphs to mark on the OB report or print. Press Graph button and select items. After selecting/deselecting a specific item, click Close . [Figure 3.18 Graph window] – MCA/UA Graph Set MCA/UA graph and reference. Selected graphs will be included in the OB report. – HC/AC Graph Include HC/AC ratio in the graph. – Report Graph Select graph to include in the report. ‘All’ displays all graphs, and ‘Data Exist’ displays only the graph has its data. – Print Graph Select graph to print. ‘All Graph in Report’ prints all graphs of the report, and ‘Data Exist’ prints only the graph has its data. ‘Current Page’ prints the current page of report.

[Page 107] Chapter3. Setting 3 - 27 ■ Backup / Restore – Backup If you want to back up a new user preset to Mo Media, Flash Memory or a HDD, press Backup/Restore on the screen. When the setting window is displayed, select the disk and directory. Directories can be created or deleted using the New Dir. or Remove Dir. Take care when deleting directories or files. Once a file or directory is erased, it cannot be restored. During user-preset backup, all user reference tables/equations are backed up. Separate tables/equations backup is therefore not necessary. – Restore To bring up the backed up user preset, click Backup/Restore . When the Backup/Restore screen appears, select the disk and directory which the user preset is to be restored to. [Figure 3.19 Measurement Settings - Backup/Restore]

[Page 108] 3 - 28 SONOACE X6 User manual Fetal Echo Measurement Setup [Figure 3.20 Measurement Setting - Fetal Echo] During obstetric measurement, Fetal volume can be measured in M Mode. The calculation method is set in the ‘LV Volume Calculation’.The options are the same as those in the cardiac package (Teichholz, Cubed, or Gibson).

[Page 109] Chapter3. Setting 3 - 29 Cardiac Measurement Setup To set up cardiac measurement, select the Cardiac tab in the Measure menu. ■ 2D Circumference and Area Method Select either the ‘Ellipse’ or ‘Trace’ caliper to be the default tool for area measurement. ■ LV Volume Calculation The LV Volume Calculation method is set with this menu. [Figure 3.21 Measurement Setting window – Cardiac]

[Page 110] 3 - 30 SONOACE X6 User manual Urology Measurement Setup To set up urology measurement, select the Urology tab in the Measure menu. This menu sets the formula used to calculate volume values during urology measurement. [Figure 3.22 Measurement Setting window – Urology] ■ Volume Method ‒ 3 Distance: The volume value is calculated using three diameters in the longitudinal and transverse planes. (4 / 3 x 3.14 x A x B x C / 8) ‒ 3 Distance x Factor: The volume value is calculated using three diameters from the longitudinal plane and transversal plane and a factor (F) value entered by a user. ( A x B x C x F) ‒ Ellipsoid: The volume value is calculated using the lengths of the Main axis and the beside axis. (4 / 3 x 3.14 x Main / 2 x (Beside / 2) ) ‒ Sum of 20 Disks: The volume value is calculated by summing the areas in the 20- parallel planes. (d / 20 x (A1 + A2 + ... A20), d : the sum of distances between disks) st nd rd 3 Distances: A = 1 Dia. ; B = 2 Dia. ; C = 3 Dia. The default factor value (F) is ‘0.5’. If it is changed, a value between 0 and 100 (0 < factor <= 100) is recommended. ■ Predicted PSA Correction Factor The Predicted PSA Correction Factor can be changed. The default value is 0.12.

[Page 111] Chapter3. Setting 3 - 31 Vascular Measurement Setup Select the Vascular tab in the Measure menu. You can set the peak velocity used in the calculation of the ‘A/B Ratio’ and ‘ICA/CCA Ratio’. [Figure 3.23 Measurement Setting window – Vascular]

[Page 112] 3 - 32 SONOACE X6 User manual Setting DICOM (Optional) Select the DICOM tab in the Setup menu. This function is used to set up the DICOM server and other DICOM-related functions. For more information, refer to the user manual of the corresponding server and the DICOM Conformance Statement. [Figure 3.24 Setting DICOM] Setting DICOM Information Enter the DICOM information for the product in use. For automatic DICOM transmission, select ‘Acquisition in Progress’ after completing the fields. For automatic print out, select ‘Print After Each image’. Enter the DICOM Application Entity title of the ultrasound system. This title uses to distinguish the ultrasound system in the network. (Ex. US, US2) ■ Station Name Enter a name to differentiate pieces of ultrasound system. (Ex. SONOACE1, SONOACE2)

[Page 113] Chapter3. Setting 3 - 33 ■ Port Enter the Port Number of the server being used. ■ Network Status Display the current status of the network. Network Setup To set the network like IP address, press System Network Settings. To set the IP value automatically, press ‘Using Dynamic IP Configuration’. If you enter the wrong IP address, the network will not run. To finish the network setup, press the Apply . To cancel setup, press the Close . Adding or Changing the DICOM Server Press Add to enter the information related to the DICOM Server. ■ Service Select the kind of server to use; Store, Print, Worklist. ■ Alias Enter the name of the server being used. Enter the AE title of the server being used. ■ IP Address Enter the IP address of the server being used. ■ Port Enter the Port Number of the server being used.

[Page 114] 3 - 34 SONOACE X6 User manual ▌ Store Server Information Select STORE under Services . Configure the Image Storage Service using DICOM ■ Service Select the kind of server to use. ■ Alias Enter the name of the server being used. Enter the AE title of the server being used. ■ Transfer Mode Select any one of the three image transfer methods. – Batch: send all images when you click the End Exam . – Send As You Go: send the image whenever you press the Save button. – Manual: send the image manually only in the SonoView. ■ Connect Timeout Set how many seconds the system will wait until get response. ■ IP Address Enter the IP address of the server being used. ■ Port Enter the Port Number of the server being used. ■ Retry Interval Set how many seconds the system will wait if the transmission fails. ■ Maximum Retries Set how many times the system will retry.

[Page 115] Chapter3. Setting 3 - 35 [Figure 3.25 DICOM Configuration-Store] ▌ Print Server Information Select PRINT under Services . Configure the Print Service using DICOM.  You can configure a printer connected to the DICOM network only. NOTE  Depending on the printer, some of the following functions may not be available. Before configuring a printer service, please refer to the user manual for the printer or the DICOM Conformance Statement. ■ Color Specify whether to use colors. Select Grayscale or RGB . ■ 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. ■ Orientation Specify the paper orientation. Select Landscape or Portrait. ■ Magnification When resizing an image to print, specify the interpolation. Select from Replicate, Bilinear, Cubic and None. ■ Border Density Specify the border density of an image to print. Select Black or White. ■ Empty Density Specify the background color of an image to print. Select Black or White.

[Page 116] 3 - 36 SONOACE X6 User manual ■ Min Density Specify the minimum brightness of an image to print. If this option is not specified, the default value is applied. ■ Max Density Specify the maximum brightness of an image to print. If this option is not specified, the default value is applied. ■ Medium Type Specify the paper type. Select from Paper, Clear Film, Blue Film, Mammo Clear Film and Mammo Blue Film. ■ 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. ■ Destination Specify the paper pathway. Select Magazine or Processor. ■ Smoothing Type This option is available only when Magnification is set to CUBIC . Enter a value specified in the DICOM Conformance Statement for the printer. ■ Priority Specify a priority for the print command. Select from High, Med and Low. ■ Copies Enter the number of copies between 1 and 99. ■ Configuration Info Specify the unique value for a printer. Please refer to the DICOM Conformance Statement for the printer.

[Page 117] Chapter3. Setting 3 - 37 [Figure 3.26 DICOM Configuration - Print] ▌ Worklist Server Settings ■ Open MWL on Patient key Sets the screen that appears when pressing the Patient button on the control panel. If this function is selected, pressing the Patient button opens the Modality Worklist window. If not selected, pressing the Patient button opens the Patient Information screen. ■ Update Method Sets the method for updating Worklist. – Only on user Request: Update only when asked by the user. ※ Tip! To update a worklist, in the Search tab on the Patient Information screen, select Worklist for Search Source and press Search . – On Startup and Every_ Min.: Worklist is updated at the system boot-up and then updated continually at a set interval. Note that Worklist is not updated while the Modality Worklist window is open. ■ Scheduled Station AE Title Sets the range of AE Title to fetch from the hospital’s Worklist server. – All: Obtains the list of patients saved under all AE Titles within the server. – This System: Obtains the list of patients for the AE Titles set under the DICOM tab. – Another: Obtains the list of patients for the AE Title directly entered by the user.

[Page 118] 3 - 38 SONOACE X6 User manual NOTE This function is available only if when the Worklist server is configured. ■ Start Date Set the range of dates to search. – Today: Obtains the list of patients for the current date. – Prior_days, Next_days: Obtains the list of patients for dates between n days prior to the current date and n days after the current date. – Period From Date: Enter a date and the system obtains the list of patients starting from the date entered up until the current date. To Date: Enter a date and the system obtains the list of patients starting from the current date up until the date entered. From Date To Date: Enter two separate dates and the system obtains the list of patients between the two dates entered. [Figure 3.27 DICOM Configuration – Worklist]

[Page 119] Chapter3. Setting 3 - 39 Editing the DICOM Server Information Press Edit in the setting DICOM window to edit the server information already entered. Deleting DICOM Server Press the Delete in the setting DICOM window to erase the current server information. Testing DICOM Server Press the Test in the setting DICOM window to check the connection between the system and the DICOM server. DICOM Log Press the Log in the setting DICOM window, and the screen will be changed. Set or copy the current DICOM log file. DICOM log file is the history of all DICOM services performed so far on the product. Press the Close to finish the DICOM log. ■ Log Settings Set the DICOM Log. – Delete archived log file after: set the number of days to wait before deleting the archived history. After that period, the log file will be deleted. However there is only one log file, it will not be deleted. – Log File Maximum Size: set the maximum size of each history file archived. Set the unit as Kbytes. ■ Explanation View the log setting.

[Page 120] 3 - 40 SONOACE X6 User manual ■ DICOM Log View, copy, or delete the DICOM log files. – View Selected File: Select the log file from ‘Select log files to copy’ and press the View selected file . – Copy Selected Files: 1. Select the log files and set the storage file format on the ‘Copy to’. 2. Set the ‘Delete files after copy’ whether to delete the log files saved in the hard disk of the system. 3. Press the Copy selected files. – Delete Selected Files: Select the log file and press the Delete Selected Files .

[Page 121] Chapter3. Setting 3 - 41 Setting Option The S/W serial No information of the system is shown in this window. You can select/cancel S/W options. A user cannot modify options. Select the Option tab in the Setup menu. If the password you enter is not correct, the options are not activated. If the password is not correct, click Cancel . [Figure 3.28 Setting Option]

[Page 122] 3 - 42 SONOACE X6 User manual Setting Peripheral Devices The following describes how to set up the video output type, video input type, printer, foot switch and network. Select the Peripherals tab in the Setup menu. [Figure 3.29 Peripherals Setting] ■ Video Input Type Set the video input type as VHS or S-VHS. ■ Foot Switch Assign functions to the left and right pedals of the foot switch. Four options are available: Dual, Store, Freeze and Update. ■ Printer Select a printer to use. After connecting a USB printer to the USB port of the system, select the printer type on the screen and click Ok . The printer can then be used immediately. The USB printer can only be used to print out Report and SonoView screens. ‒ HP DeskJet 5650 ‒ HP DeskJet 6980 ‒ HP Color LaserJet 3600 ‒ HP DeskJet 5940 ‒ HP LaserJet 1320 ‒ HP OfficeJet J5780 ‒ HP DeskJet 6540 ‒ HP LaserJet 2420 ‒ HP OfficeJetProK550 ‒ HP DeskJet 6940 ‒ HP LaserJet P2015

[Page 123] Chapter3. Setting 3 - 43 Information The information menu displays information about the system S/W version. Select the Information tab in the Setup menu. Press the Detail Info. to view more detailed information. Click License Info. to display license information [Figure 3.30 Information] * The S/W version of your system may be different from that in the figure above.

[Page 124] 3 - 44 SONOACE X6 User manual Utilities Press [F9] Utility button on the keyboard. The Utility menu appears at the left side of the screen. You can select a menu with the Menu dial-button on the control panel. [Figure 3.31 Utility menu] Biopsy The Biopsy function is designed to obtain cells of abnormal tissue via the Biopsy Needle. To change Biopsy Guideline settings, press Utility button on the control panel. If Biopsy Guideline is disabled you cannot mark guidelines on the screen. NOTE Prior to use Biopsy, edit the biopsy guideline first. ▌ Editing Biopsy guide line  Note that the Biopsy Guide Line cannot be edited when the Trapezoidal function is in use for the Linear Probe.  If the system is rebooted, the Biopsy Guide Line settings are restored to the default. 1. Select Edit in the Biopsy menu. The warning message will appear. 2. If you press the Ok , the Biopsy Edit screen appears. Press the Cancel to escape from the Biopsy menu. 3. After the Biopsy Edit screen appears, you can adjust the Biopsy Guide Line with the soft menu on the keyboard.

[Page 125] Chapter3. Setting 3 - 45 – Flexible soft button [1] Start : Move the Trackball up and down to designate the starting point of the Biopsy Guide Line. – Flexible soft button [2] Angle : Move the Trackball right and left to decide the direction of Biopsy Guide Line movement. 4. Press Flexible soft button [4] Save to setting. The confirmation message will appear before saving settings. 5. Press the OK button on the message to apply the changed Biopsy Guide Line. Press Flexible soft button [5] Cancel to cancel saving. [Figure 3.32 Biopsy Edit] ▌ Starting and Finishing Biopsy Before performing biopsy, make sure that the Biopsy Guide Line is adjusted. 1. Select On in the Biopsy menu. The message below appears. The warning message will appear. 2. Press OK , and the Biopsy Guide Line will appear on the screen. 3. Insert a needle along the Guide Line. And then perform biopsy as desired. 4. To finish the biopsy, select Off in the Biopsy menu.

[Page 126] 3 - 46 SONOACE X6 User manual ECG The ECG (echocardiogram) function allows viewing of the cardiac pulsation. To turn on ECG, select ECG in the pop-up menu. The ECG setting menu appears. ▌ Starting ECG and terminating Use the Flexible Soft dial-button [1] to turn on or off the ECG. [Figure 3.33 ECG] ▌ ECG Setup ■ Size Set the size of ECG. ‘Large’, ‘Normal’, or ‘Small’ is available. ■ Position Set the position of ECG from 0 to 300. When its number is large, ECG will be displayed in upper side of screen. ■ Trigger Set the Trigger interval or Off. ■ Trigger Time Set the Trigger time. CAUTION If the ECG is less then 30Hz, the Heart Rate (HR) is not displayed.

[Page 127] Chapter3. Setting 3 - 47 ▌ Dual ECG Compare two cardiac images. Press Dual button on the control panel. Use the Set button or Dual button to change the activated image in Dual Mode.

[Page 128] 3 - 48 SONOACE X6 User manual Monitor Calibration Select Monitor Calibration in Utility menu. ■ Gamma: Set up contrast and brightness. ■ Brightness: Set up brightness. ■ Contrast: Set up contrast. ■ R Gain: Set the red color proportion. ■ G Gain: Set the green color proportion. ■ B Gain: Set the blue color proportion. ■ Default: Go back to default setting. ■ Save: Save the setting. Preset Preset allows the user to adjust Image Settings and select a Setting to apply to the system. Select Preset in the utility menu. [Figure 3.34 Preset] ■ Setting: Use the Menu dial-button to make your selection. You can use the default Image Setting or choose from the User1 ~ User5 slots. If you select the value from User1 to User5, you can setup the image setting. ■ Load: Select the desired Setting value and press Load to apply the value to the current screen. ■ Save: After Image Setting, select the desired Setting value and press the Save .

[Page 129] Chapter3. Setting 3 - 49 Miscellaneous Select Miscellaneous in the utility menu. [Figure 3.35 Miscellaneous] ▌ Histogram Shows the brightness level of the selected area in a histogram. 1. Press Histogram in the Miscellaneous menu. 2. Specify an area that a histogram is to cover. Use the Trackball and the Set button to specify area 1, 2 and 3. – Press the Change button to change the shape of the selected area into an ellipse. 3. Histogram 1, 2 and 3 will appear on the screen. [Figure 3.36 Histogram]

[Page 130] 3 - 50 SONOACE X6 User manual ▌ Demo Images Select Demo Image in the menu. This function displays DEMO images obtained from this system. To adjust the display time, use the Flexible Soft button [1] Slower and [2] Faster . To change to the previous or next one, use the Flexible Soft button [3] Prev , or Flexible Soft button [4] Next . Press the Flexible Soft button [5] Play/Pause to pause the image cycle; press it again to resume the cycle. To end the Demo function, press Exit button on the control panel or Esc key on the keyboard.

[Page 131] Chapter 4 Diagnosis Modes Diagnosis Mode Types and Control 3 Diagnosis Mode Types 3 Basic Use 4 Basic Modes 8 2D Mode 8 M Mode 12 Color Doppler Mode 14 Power Doppler Mode 18 Spectral Doppler Mode 20 Combined Modes 26 2D/C/PW Mode 26 2D/PD/PW Mode 27 2D/C/CW Mode 28 2D/PD/CW Mode 29 2D/C/M Mode 30 Multi-Image Mode 31 Dual-2D Mode 31 Dual-2D/C Mode 32 Dual-2D/PD Mode 33 3D Mode 34 3D 34 Acquiring a 3D Image 35 3D View 36

[Page 132]

[Page 133] Chapter4. Diagnosis Modes 4 - 3 Diagnosis Mode Types and Control Diagnosis Mode Types This product supports a variety of diagnosis modes including Basic Mode, Combined Mode, Multi-Image Mode, and 3D Mode. ■ Basic Mode: Consists of different modes, each of which has a specific usage and function. By default, 2D Mode is applied together with other mode. ■ Combined Mode: For an image, two or three Basic Modes are applied at the same time. By default, 2D Mode is applied together with other mode. An image is viewed in a single screen. ■ Multi-Image Mode: The screen is divided into two (dual) sub screens, each of which is used to view an image. Since each sub screen can display a different image, it can be a very useful feature, allowing multilateral views of an organ. ■ 3D Mode: Freehand 3D images can be obtained. The types of diagnosis mode that are available with the product are shown below: Mode Type 2D Mode Color Doppler Mode Power Doppler Mode Basic Mode M Mode PW Spectral Doppler Mode CW Spectral Doppler Mode 2D/C/PW Mode 2D/PD/PW Mode Combined Mode 2D/C/CW Mode 2D/PD/CW Mode 2D/C/M Mode Multi-Image Mode Dual Mode 3D Mode Freehand 3D Mode NOTE The functionalities for each mode may be restricted by the selected probe.

[Page 134] 4 - 4 SONOACE X6 User manual Basic Use The items that can be used commonly in each diagnosis mode are shown below: ■ Gain Use the Gain dial-button on the control panel. You can adjust the brightness of an image. If you rotate the Gain dial-button clockwise, its value increases. ■ TGC (Time Gain Compensation) Use the TGC slide on the control panel. In general, ultrasound penetration gets weaker with depth. TGC can be used to compensate for this effect. The product provides eight TGC slides for varying depths, allowing you to adjust Gain by area. Among the eight slides, the top slide represents the shallowest area, while the lower slides represent the deeper ones. Move the slide to the right (+) to increase Gain, brightening the image. Too large a difference in the gain value settings of two adjacent slides may lead to inaccurate image generation. ■ Focus Use the Focus switch on the control panel. Raise/lower the Focus switch raise/lower the focusing point. ■ Depth Use the Depth switch on the control panel. Raise/lower the Depth switch to decrease/increase the scanning depth of an image. The allowable range for adjustment varies with the selected probe. ■ HD Zoom This function allows you to magnify and scan an image in real time. 1. Use the HD Zoom switch on the control panel to start Write Zoom mode. The Write Zoom box will appear on the screen. 2. Use the Change button to move and resize the Zoom box. Each time you press the Change button, the current state of the Zoom box is displayed in the lower left of the screen. – Zm Pos.: You can move the Zoom box. Use the Trackball to move the Zoom box and press the Set button to specify its position.

[Page 135] Chapter4. Diagnosis Modes 4 - 5 – Zm Size: You can resize the Zoom box. Use the Trackball to resize the Zoom box and press the Set button to specify its size. 3. Press the Set button to start the Write Zoom function. Magnify an image and scan it. 4. Press the Exit button to exit Zoom Mode. Changing the depth also exits Zoom Mode automatically. ※ Tip! Zoom Navigation Box You can view the position of the magnified area through the Zoom Navigation Box on the screen. In HD Zoom mode, press the Z key on the keyboard to make the Zoom Navigation Box disappear and Zoom Position deactivate. Press Z key again, and the Zoom Navigation Box is shown again. ■ Zoom This function allows you to zoom an image saved in a hard disk. In HD Zoom mode, it is available to press the Zoom button on the control panel to start the Read Zoom mode. However, in Read Zoom mode, you cannot enter the HD Zoom mode with the Zoom button. 1. Press the Zoom button on the control panel to start Read Zoom mode. The Read Zoom box will appear on the screen. 2. Use the Trackball to move the Zoom box. You can locate the Zoom box in an image with the Zoom Navigation box on the left side of the screen. 3. View the magnified image. If you rotate the dial-button clockwise, the image is magnified. 4. Press the Exit or Zoom button to exit Zoom Mode. Changing the depth also exits Zoom Mode automatically. ■ QuickScan Use the Quick Scan button on the control panel. The ‘Q Scan’ mark will appear at the top of an image. In 2D Mode, it is used to optimize the contrast and brightness of an image by adjusting Gain and TGC automatically. In PW Spectral Doppler Mode, it is used to optimize the spectrum by adjusting Scale and Baseline automatically. Press the Exit button to quit the Quick Scan Mode. ■ Harmonic Press the Harmonic button on the control panel. ‘HGen’, ‘HRes’, ‘HPen’ mark is displayed in the image information area. This product provides the OHI (Optimal Harmonic Imaging) function that optimizes an image with high frequencies.

[Page 136] 4 - 6 SONOACE X6 User manual NOTE The Harmonic function is available with specific probes only. ■ Post Map Settings Use the Menu/Angle dial-button on the control panel and press 2D Post , M Post , PW Post , or CW Post on the menu to bring up the sub-menu. On this sub-menu, select an appropriate map from Type1~5, User1~3. When select User , you can make your own Map. Select Return to escape this status. ※ User Post Map Edit 1. Press Edit in the menu. The User Post Map image and its Flexible Soft Menu appear on the screen. [Figure 4.1 The Flexible soft menu of Post map] – Add : Add a new point between the currently selected point and the adjacent point. – Delete : Delete the currently selected point . – Save : Save the map. – Cancel : Cancel Map editing and return to the original map. – Apply : Apply the Map setting to the image. 2. Each map point is selected with the Change button on the control panel, and you can set the shape of the map with the Trackball and Set button. ■ Chroma Settings Use the Menu/Angle dial-button on the control panel to press Chroma on the menu, and then select On or Off. If you change the color, select Color on the menu and choose the color.

[Page 137] Chapter4. Diagnosis Modes 4 - 7 ■ Gamma Settings Use the Menu/Angle dial-button on the control panel to press Gamma on the menu, and then select Off, Weak, Medium or Hard. Adjusts the contrast. – Weak: make the image brightly. – Medium: make the image medium bright. – Hard: make the image darkly. ■ M Line Press the [F2] M Line key on the keyboards. It shows M Line on the image.

[Page 138] 4 - 8 SONOACE X6 User manual Basic Modes 2D Mode This basic mode, also referred to as B Mode (Brightness mode), shows anatomy scan planes. [Figure 4.2 2D Mode] ▌ 2D Mode Selection Press the 2D button on the control panel. 2D Mode is the default mode and the 2D button is not a toggle button. Instead, it is used to return to basic 2D Mode when in other image modes.

[Page 139] Chapter4. Diagnosis Modes 4 - 9 ▌ Changing 2D Image Format ■ Changing Image Direction – Changing Left/ Right Orientation (Horizontal Orientation Direction) Press the Flexible Soft button [1] Direction. – Changing Up/down Orientation (Vertical Orientation. Apex) Select Apex in the 2D menu using the Menu/Angle dial-button. ■ Changing View Area Select View Area in the menu using the Menu/Angle dial-button on the control panel. You can adjust View Area using the Flexible soft button [3] Size + and [4] Size – buttons in the Flexible Soft Menu. Widening / narrowing the View Area, decreases/increases the frame rate (FPS). If you want to view other unseen parts, press the Pos.L and Pos.R buttons in Flexible Soft Menu to move the View Area to the right or left. To apply changed view area and go to scan mode, press the Flexible Soft button [5] Return . During using a linear probe, flexible soft button [1] Pos.L, and [2] Pos.R are not available. ▌ 2D Image Optimization ■ Extended Resolution (Ext. Res.) Use the Flexible soft button [2] Ext. Res . Increases the resolution by increasing the number of channels. Note that the frame rate falls in proportion to the number of channels. ■ Frequency Use the Flexible soft button [3] Frequency . Use the button to change the frequency of the current probe. Select from Res , Pen and Gen . – Res (Resolution): Low frequency – Gen (General): General frequency

[Page 140] 4 - 10 SONOACE X6 User manual – Pen (Penetration): High frequency The selected frequency is displayed in the title area, allowing you to determine the state of the current frequency easily. ■ Density Press Flexible soft button [4] Density . Use the dial-button to select the scan line density. If it is set to High, the number of scan lines increases, enhancing the image resolution. However, the frame rate is reduced. ■ Frame Average Control Use the Menu/Angle dial-button on the control panel to press FA in the menu. Select a value between 0~9. The Frame Average function is used to average frames together on the screen, thereby reducing the speckles, which make diagnosis difficult. Setting the Frame Average value as high makes the display movements smoother but slower. (Though the actual frame rate doesn’t drop.) Turn the function off in OB and cardiac examination where organs are highly active. ■ Dynamic Range Control Use the Menu/Angle dial-button on the control panel to press DR in the left menu. Select a value between 40~180. This function is used to change the range of contrast by adjusting the ratio of minimum/maximum input signal value ratio. Increase/decrease Dynamic Range to smooth/roughen the image. ■ Edge Enhance Control Use the Menu/Angle dial-button on the control panel to press EE in the menu. Select a value between 0~9. This function is used to view more accurate images of organ or tissue boundaries. Increase the Edge Enhance value to obtain clearer pictures of boundaries. ■ Reject Level Control Use the Menu/Angle dial-button on the control panel to press Reject in the left menu. Select a value between 1~32 This function is used to eliminate noise or low level echoes for clearer signals. ■ Focus Number Control Press the Flexible Soft button [5] Focus No. Use [3] Focus + or [4] Focus - to set the focus number.

[Page 141] Chapter4. Diagnosis Modes 4 - 11 ■ Frame Rate Control Use the Menu/Angle dial-button on the control panel to press Frame Rate in the left menu. Select Fast, Normal, or Slow. The Frame Rate is the number of images generated per second. The Frame Rate should be set to Fast when viewing fast moving organs. ■ Tissue Property Control Use the Menu/Angle dial-button on the control panel to select Tissue in the menu. Select the desired ultrasound speed according to the patient’s tissue type. The Tissue menu consists of Cystic, Adipose, Normal, and Solid. ■ Trapezoid Function This function is used to view the trapezoid-shaped 2D image when using the Linear probe. Use the Menu/Angle dial-button on the control panel to select Trapezoid in the menu. When adjusting image depth, some depth values do not support the Trapezoid function. Using HD Zoom switch makes the Trapezoid function off. ■ FSI (Full Spectrum Imaging) Use the Menu/Angle dial-button on the control panel to select FSI in the menu. This function synthesizes images with data obtained with frequencies of different characteristics. Therefore, shallow observation depths yield higher resolution and deep observation depths yield higher penetration. Select a value between 1 – 3. ■ Format NOTE This item is displayed only in 2D menu under dual model. Use the Menu dial-button on the control panel to select Format in the menu. ‘Hor’ means Top Down Format, in dual mode image, and ‘Ver’ means Side by Side Format, in which the two images are set side-by-side. ■ 2D Post Use the Menu dial-button on the control panel to select 2D Post in the menu. Select Loop Format in the menu using the Menu dial-button on the control panel. ‘Hor’ means Top Down Format, in which 2D image is set above the PW Spectral Doppler image, and ‘Ver’ means Side by Side Format, in which the two images are set side-by- side.

[Page 142] 4 - 12 SONOACE X6 User manual M Mode In M Mode, you can observe the motion patterns of an area of anatomy - along a 2D image reference line (M Line). This mode is especially useful for cardio-valvular observation. [Figure 4.3 M Mode] ▌ M Mode Selection Press the M button on the control panel. Press M button again. M Mode turns off and 2D Mode turns on. ▌ Changing M Mode Format ■ Image Direction Change Press the Flexible soft button [1] Direction to change the direction of the image.

[Page 143] Chapter4. Diagnosis Modes 4 - 13 ■ M Line Control Move the M Line to change the observation location. The M Line can be moved left and right by using the Trackball on the control panel. ■ M Image Size Change To adjust the size (Large, Normal or Small) of the 2D image and the M image, select an M Mode image size with the Flexible Soft button [5] M Size . ■ Sweep Speed Control Choose from 120Hz, 180Hz, 240Hz or 300Hz with the Flexible soft button [2] Speed button on the control panel. ■ Loop Format Change Select Top Down Format or Side-by-Side Format using the Flexible Soft button [3] Loop Format . Top Down Format sets the 2D image and M image at the top and bottom of the screen. Side-by-Side Format sets the images side by side. ■ M Post Use the Menu dial-button on the control panel to select M Post in the menu. NOTE Refer to ‘2D Mode’ for more information about other items in the menu.

[Page 144] 4 - 14 SONOACE X6 User manual Color Doppler Mode This mode displays the colored blood flow pattern of the ROI (Region of Interest) within the 2D image. It is appropriate for examining the presence of the blood flow, its average speed and direction. The 2D Mode image is also shown allowing the marking and adjustment of the ROI within the entire image. [Figure 4.4 Color Doppler Mode] ▌ Entering & Exiting C Mode Press the Color button on the control panel. Press the button again, and C Mode will be terminated and the mode switched to 2D.

[Page 145] Chapter4. Diagnosis Modes 4 - 15 ▌ Changing Color Image Format ■ Controlling Color Bar Baseline Control The colors above the baseline represent the direction/speed of blood flow moving toward the probe, and the colors below the baseline represent the direction/speed of blood flow away from the probe. Use the Flexible soft button [2] Baseline switch on the control panel. Baseline can be adjusted only when the Color Doppler Mode value is set to Velocity. ■ Color Bar Invert Use the Menu dial-button on the control panel to select Invert in the menu. ■ Changing Color Display Information Select Color Mode in C-Menu using the Menu dial-button on the control panel. Use the Menu dial-button to cycle through the available settings - Velocity, Power, Variance, and Vel + Var. ▌ Color Image Optimization ■ Changing ROI Box Position The ROI is the area within the 2D image where color (blood flow) information is displayed in Color Doppler Mode. Use the Trackball to change the ROI Box position. ■ Changing ROI Box Size Enter the ROI Box Size Control Mode by rotating the Menu dial-button without opening the pop-up menu or pressing the Change button on the control panel. Adjust the ROI Box size with the Trackball . To return to the ROI Box Position Change Mode, rotate the Menu dial-button without opening the pop-up menu or press Change button again. ■ Scale (PRF) Control Use the Flexible soft button [1] Scale on the control panel. If you raise/lower the switch, PRF (Pulse Repetition Frequency) increases/decreases so that the speed range of blood flow is widened/narrowed.

[Page 146] 4 - 16 SONOACE X6 User manual ■ Wall Filter Control Wall filter is an electrical filter used to eliminate low-frequency Doppler signals caused by the motions of vessel walls. Eliminate Doppler signals whose frequencies are lower than the Cutoff Frequency by adjusting the Cutoff Frequency. Use the Flexible soft button [3] Filter on the control panel. If you raise the Filter switch, the Cutoff Frequency of the Wall Filter decreases, and vice versa. ■ Sensitivity Control Select Sensitivity in C-Menu using the Menu dial-button on the control panel. Select the value (8~31). To increase/decrease Sensitivity , raise/lower the Sensitivity value. Increasing the Color Sensitivity decreases the frame rate, and vice versa. ■ Balance Control This function is used to adjust the range of the color image displayed by comparing the gray level of the 2D image with the Doppler signal value of the color image. If the Balance value increases, the color image is seen even where the 2D image signal is strong (bright), thereby increasing the color image range. Select Balance using the Menu dial-button on the control panel and adjust the value (1~16). ■ Steer Function When Linear probe is selected, this function adjusts the ultrasound beam angle to prevent the loss of color information caused by the ultrasound beam angle. Pressing the Steer button on the control panel steers the ROI to the left, center and right - in that order. ■ Display Function Color Doppler Mode supports Color + B/W Image, Color Only, and B/W Only display. Select Display in the menu using the Menu dial-button on the control panel. In Freeze, use the Flexible Soft Button [5] to select the function.

[Page 147] Chapter4. Diagnosis Modes 4 - 17 ■ TDI (Tissue Doppler Image) Function This function is used to show the movements of the cardiac tissues. To use the TDI function, use the Menu dial-button on the control panel to select Tissue Doppler from the menu on the left-hand side of the screen. It uses the color information of Color Doppler Mode or Power Doppler Mode. It also uses the change of cardiac tissue of PW Spectral Doppler Mode as time goes by. It is only used in the specific application (General, Cardiac, Pediatric) of Phased Array probe. ■ C Post Select C Post in the menu. You can select Color Map. ■ Capture Select Capture in the menu. You can select Capture on or off and Frame value. ■ Color Tag Select Color Tag in C-Menu using the Menu dial-button on the control panel. NOTE For further information about other items in the menu, refer to ‘2D Mode’.

[Page 148] 4 - 18 SONOACE X6 User manual Power Doppler Mode This mode displays the color intensity of blood flow within the ROI in the 2D image. It is appropriate for examining the presence and amount of blood flow. The 2D Mode image is also shown, allowing the marking and adjustment of the ROI within the entire image. Following applications of Phased array probes are not available in power Doppler mode; General, Cardiac, Pediatric. [Figure 4.5 Power Doppler Mode] ▌ Power Doppler Mode Selection Press the PD button on the control panel. Pressing PD button again turns PD Mode off, and 2D Mode on.

[Page 149] Chapter4. Diagnosis Modes 4 - 19 ▌ PD Mode Screen ■ Color Bar Colors show the existence and amount of blood flow in PD Mode. The top of the color bar is the brightest section, where the amount of blood flow is at its highest. ▌ Power Doppler Image Optimization ■ Display Select Display in the Menu using the Menu dial-button on the control panel. You can select BW+PD, PD Only, or BW Only. ■ Multi Freq (Multi Frequency) Select Multi Freq in the Menu using the Menu dial-button on the control panel. This controls the frequency in the ROI box. Select Pen or Gen . ■ PD Post Select PD Post in the menu. You can select PD Map. For further information about other PD Image optimization, refer to ‘Color Doppler Mode’.

[Page 150] 4 - 20 SONOACE X6 User manual Spectral Doppler Mode Spectral Doppler Mode gives information on the speed/direction of blood flow at a specific site in the form of a spectral trace and audio signal. It is divided into PW (Pulsed Wave) Spectral Doppler Mode and CW (Continuous Wave) Spectral Doppler Mode. ▌ PW Spectral Doppler Mode PW Spectral Doppler Mode gives information on the speed of blood flow at a specific site in the form of a spectral trace and audio signal. Since the pulse is transmitted being divided according to time, distance (depth) information can be obtained. The mode is suitable for measuring relatively slow blood flow such as that in abdominal and peripheral vessels. The 2D Mode image is shown simultaneously allowing the marking and adjustment of specific sites within blood vessels. Press the PW button on the control panel. Press PW button again to enter 2D Mode. [Figure 4.6 PW Spectral Doppler Mode]

[Page 151] Chapter4. Diagnosis Modes 4 - 21 ▌ CW Spectral Doppler Mode (Optional) CW Spectral Doppler Mode gives information on the speed/direction of blood flow in the form of a spectral trace and audio signal. The 2D Mode image is shown simultaneously allowing the marking and adjustment of specific sites within blood vessels. Press the CW button on the control panel. Press CW button again to enter 2D Mode. [Figure 4.7 CW Spectral Doppler Mode]

[Page 152] 4 - 22 SONOACE X6 User manual ▌ Spectral Doppler Mode Screen On the Spectral Doppler Mode image, the horizontal axis represents time, and the vertical axis represents speed (or frequency). ■ Sample Volume When Sample Volume is on the blood flow of 2D image, it represents Doppler Spectrum. Its position is moved with the Trackball and displayed in the [email protected] mm format. The format means that the Sample Volume of ‘xx.x’ mm size is located at a depth of ‘yy.y’ mm. For example, [email protected] mm means that the Sample Volume of 2.0mm size is located at a depth of 16.7mm. NOTE Sample Volume is available only in PW Spectral Doppler Mode. ▌ Spectral Doppler Mode Format Change ■ Changing PW Spectral Doppler Image Size To adjust the image position, the 2D image is shown together. The size of the 2D image and PW Spectral Doppler image can be changed. Select PW Size in the menu using the Menu dial-button on the control panel. Select the size (Large, Normal, or Small). This function is activated in Simultaneous mode is on. ■ Activating Simultaneous Function The PW Spectral Doppler image and 2D image can be displayed simultaneously or separately. This function is not available in Steered CW Spectral Doppler Mode. Select Simultaneous in the menu using the Menu dial-button on the control panel. If Simultaneous is selected again when this mode is already on, the mode is deactivated. Activate the Simultaneous function option by setting Simultaneous function as ‘Allow 2D/PW’ or ‘Allow 2D/C/PW’in the Misc. tab in the Setup window. NB. Simultaneous function decreases Doppler PRF, thus decreasing the measurable speed range. ■ Doppler Baseline Control Press the Flexible Soft Button [2] Baseline on the control panel to raise/lower the Baseline.

[Page 153] Chapter4. Diagnosis Modes 4 - 23 ■ Doppler Axis Invert Press the Flexible Soft Button [4] Invert on the control panel. The ‘+ velocity value’ and ‘- velocity value’, shown at the Doppler axis, change positions. ■ Loop Format Change Select Loop Format in the menu using the Menu dial-button on the control panel. ‘Hor’ means Top Down Format, in which 2D image is set above the PW Spectral Doppler image, and ‘Ver’ means Side by Side Format, in which the two images are set side-by- side. ▌ Spectral Doppler Image Optimization ■ Sample Volume Position Control Use the Trackball on the control panel. ■ Sample Volume Size Control Adjust the Sample Volume size by pressing the Change button and using the Trackball on the control panel. Press Change button again to return to the Sample Volume Position Control screen. The icon showing the two Trackball functions (SV Pos/SV Size) is shown for a second and disappears. ■ Sample Volume Angle Control Press the Flexible Soft Button [5] Angle for accurate measurement of speed. ■ Doppler Sound Volume Control Use the Audio Slide Volume control on the control panel. ■ Average Control The Average Control is used to increase spectrum quality. Select Average in the menu using the Menu dial-button on the control panel. Select the Average value (Low, Middle or High). ■ Spectrum Enhancement The Spectrum Enhancement is used to compensate the signal of low gain Spectral Doppler Spectrum. This function is available in Loop Only Mode or Simultaneous Function and is not available in TDI function. Select Spectrum Ehc. In the menu using the Menu dial-button on the control panel. Select the value from 1 to 8.

[Page 154] 4 - 24 SONOACE X6 User manual ■ HPRF (High PRF) Function This function measures blood flow whose speed exceeds specified limits at a specified depth. It doubles the original scale. This function is available only in PW Spectral Doppler Mode. NOTE To use HPRF function, select ‘On’ in the Seup > System > Display tab. – HPRF Activation To activate HPRF, increase the Scale values at the required depth. The Phantom Gate appears over the sample volume in D Line. Once HPRF is activated, the PRF doesn’t increase even if the scale values are raised. [Figure 4.8 HPRF]

[Page 155] Chapter4. Diagnosis Modes 4 - 25 – HPRF Exit To exit HPRF, decrease Scale values by one notch while HPRF is activated. The maximum PRF values in PW Spectral Doppler Mode are shown. – Sample Volume Position Control To move the Sample Volume position in the PW Only status, the system calculates PRF values and the Phantom Gate position, and updates them on the PW Spectral Doppler image. Exit HPRF when HPRF cannot be activated. When Sample Volume is moved in the 2D Only status, the PRF values don’t change. In PW Only status, the PRF values and Phantom Gate position are calculated and updated on the PW Spectral Doppler image. HPRF is not activated in Simultaneous Mode. It is also not activated if [PRF*2] exceeds 23KHz.  The Phantom Gate position can be located outside the 2D image area in Zoom Mode. CAUTION  Ensure that the Sample Volume and Phantom Gate are not positioned over the area to be measured. If more than two SVs are located in the vessels, all Doppler components will appear in the spectrum, causing noise. For further information about Wall Filter, Dynamic Range and Steer Control, refer to ‘2D Mode’ and ‘Color Doppler Mode’.

[Page 156] 4 - 26 SONOACE X6 User manual Combined Modes 2D/C/PW Mode Color Doppler Mode and PW Spectral Doppler Mode are displayed simultaneously. Press the PW button on the control panel in Color Doppler Mode. In PW Spectral Doppler Mode press the Color button. [Figure 4.9 2D/C/PW Mode]

[Page 157] Chapter4. Diagnosis Modes 4 - 27 2D/PD/PW Mode PD Mode and PW Spectral Doppler Mode are displayed simultaneously. Press the PW button on the control panel in PD Mode. In PW Spectral Doppler Mode press the PD button. [Figure 4.10 2D/PD/PW Mode]

[Page 158] 4 - 28 SONOACE X6 User manual 2D/C/CW Mode Color Doppler Mode and CW Spectral Doppler Mode are displayed simultaneously. Press the CW button on the control panel in Color Doppler Mode. In CW Spectral Doppler Mode press the Color button. [Figure 4.11 2D/C/CW Mode]

[Page 159] Chapter4. Diagnosis Modes 4 - 29 2D/PD/CW Mode PD Mode and CW Spectral Doppler Mode are displayed simultaneously. Press the CW button on the control panel in PD Mode. In CW Spectral Doppler Mode press the PD button. Following applications of Phased array probes are not available in 2D/PD/CW mode; General, Cardiac, Pediatric. [Figure 4.12 2D/PD/CW Mode]

[Page 160] 4 - 30 SONOACE X6 User manual 2D/C/M Mode Color Doppler Mode and M Mode are displayed simultaneously. Press the M button on the control panel in Color Doppler Mode, or press the Color button on the control panel in M Mode. (Only available in Cardiac related application of specific probe) [Figure 4.13 B/C/M Mode]

[Page 161] Chapter4. Diagnosis Modes 4 - 31 Multi-Image Mode The multi-image viewing function is only available when the images and conditions on both sides are identical. Dual-2D Mode This mode allows you to compare 2D images side by side. Press the Dual button on the control panel in 2D Mode, M Mode and PW Spectral Doppler Mode. Press the 2D button to exit Dual-2D Mode and return to the basic 2D Mode. To change the active image, press the Update, Dual, or Set button. [Figure 4.14 Dual-2D Mode]

[Page 162] 4 - 32 SONOACE X6 User manual Dual-2D/C Mode This mode allows you to compare Color Doppler Mode images side by side. Press the Dual button on the control panel in Color Doppler Mode. In Dual-2D Mode press the Color . [Figure 4.15 Dual-2D/Color Doppler Mode]

[Page 163] Chapter4. Diagnosis Modes 4 - 33 Dual-2D/PD Mode This mode allows you to compare PD Mode images side by side. Press the Dual button on the control panel in PD Mode. In Dual-2D mode press the PD button. [Figure 4.16 Dual-2D/PD Mode]

[Page 164] 4 - 34 SONOACE X6 User manual 3D Mode 3D The 3D Mode displays tissues or objects in the human body as three-dimensional images inste- ad of two-dimensional images. The 3D mode uses the Volume data acquired by the probe as continuous 2D images for ren- dering, producing three-dimensional volume data displays of objects that can better assist in the diagnosis process. Volume rendering refers to the calculation process used in formulating a 3D volume structure from 2D scans. Using the gray value of the light path through each pixel of the 2D image, the corresponding voxel, or volume element, of the 3D image is calculated. The rendering algorithm determines the way the way the 3D structure is visualized. Surface rendering is employed in the SONOACE X6. ▌ How to Improve 3D Image Quality  Consider the direction, division and size of the viewpoint, as well as the visibility of an object.  Before 3D scanning, adjust the contrast of the specific textures in 2D Mode.  The ROI box determines the contents of the image box to be rendered. The images outside the ROI box, except for the ultrasound data, are not included in the rendering process and are cut out.  The bigger the ROI box, the slower the rendering speed. Therefore, set an appropriate ROI box size.  To determine surface contour, the surfaces of objects should be insulated with hypo- echoic textures - such as amniotic fluid - which don’t generate echos.  To obtain a high quality 3D surface, adjust the low-threshold value.  In order to acquire a clear image from the ROI box start boundary to the specific surface, noise can be eliminated if the gray scale value is smaller than the surface value.  High-threshold is generally set at the maximum value of 255. If the Surface Rendering Algorithm is higher than the threshold value, it marks the boundaries of the surface. The boundary can be adjusted with the threshold-high slider.

[Page 165] Chapter4. Diagnosis Modes 4 - 35 Acquiring a 3D Image The following explains how to acquire a 3D image. 1. Press the [F5] 3D button on the keyboard. 2. The ROI box appears. Set the required area using the Trackball , and press the Set button. The position and size of the area can be changed by pressing the Change button before pressing Set button. 3. Pressing Set button starts the 3D scanning of the area. A maximum of 200 frames can be scanned at one time. A bar, indicating the scanning progress, appears at the bottom of the screen. 4. To scan the specific frame and finish scanning, press Set button again. To cancel the scanning during the process, press the Exit button. 5. Once scanning is completed, ‘3D View Mode’ is turned on.  To see the 3D scan of a fetus in a frontal view, position the fetal head in the direction of “Direction Mark”, putting it in the coronal plane. Then scan the fetus from back to abdomen.  The 3D image of the fetal face is more easily found in the coronal plane than in the sagittal plane.

[Page 166] 4 - 36 SONOACE X6 User manual 3D View 3D images can be seen through the 3D View application. [Figure 4.17 3D View] ▌ Viewing a 3D Image  Select the menus using the Trackball and the Set button.  To return to the initial screen of 3D View, press the Init 3D button.  The Preview function allows the operator to check changes in the values of Rotation , Magnification , and Position in advance. To obtain a clearer image in the Preview screen, press the Set button.  To close 3D View Mode, press the X on the screen. All scanned data and 3D images will be lost if 3D View Mode is closed before saving data. Therefore, ensure that all the necessary images are saved using the Save button on the control panel prior to pressing the X .

[Page 167] Chapter4. Diagnosis Modes 4 - 37 ▌ 3D Image Optimization ■ Threshold (Low, High) Adjustment Adjust the slide bar of the threshold using the Trackball and the Set button. If the slide bar is moved to the left, cyst components – and not bone components – are shown. If the slide bar is moved to the right, bone components – and not cyst components – are shown. ■ Gamma Adjustment Adjust the ‘Bias’ and ‘Pos’ slide bars on the right side of the screen using the Trackball and Set button. – Pos (Position): Designates the bending start point of the Gamma Curve. – Bias: Sets the brightness and contrast by adjusting the curve bend. The changed values are applied to the Gamma curve and 3D image. ■ Changing ROI Size Adjust the ROI control slide bar using the Trackball and the Set button. Changed values can be checked in the Preview screen. ■ Initialization To return to the initial status in 3D View Mode, press the Init 3D button or the Flexible Soft button [5] INIT 3D in Rotation , Position , or Magnification Modes. ■ Rotation After entering Rotation mode by pressing the Rotation button, the 3D image can be rotated using the Trackball . Moving the Trackball right or left rotates the 3D image about the X axis, and moving it up or down rotates the image about the Y axis. Moving it while pressing the Set button rotates the image about the Z axis. The rotated 3D image is shown in the Preview screen. After checking the changed values, apply them to the entire screen by pressing the Flexible Soft button [4] Apply . Pressing the Exit applies the changes to the 3D image and exits Rotation mode. To activate Position , Magnification or Cut Mode functions while rotating the image, press the Flexible Soft Menu of the corresponding function. To return to the initial image, press the Flexible Soft button [5] INIT 3D .

[Page 168] 4 - 38 SONOACE X6 User manual [Figure 4.18 Flexible Soft Menu - Rotation Mode] ※ Other ways to rotate the image 1. The ROT slide bar at the bottom of the screen can be adjusted using the Trackball and the Set in the 3D View initial screen. 2. Use the Flexible Soft Menu in the initial 3D View screen. Use the Flexible Soft button [1] ~ [3] to rotate the 3D image 90 ° degrees about each axis. [Figure 4.19 Flexible Soft Menu – 3D Mode] ■ Position The 3D image position can be adjusted with the Trackball after entering Position mode. After checking changed values in the Preview screen, apply the changes to the entire screen by pressing the Flexible Soft button [4] Apply . Pressing the Exit applies the changes to the 3D image and exits Position mode. To activate the Rotation , Magnification or Cut Mode functions while adjusting the image position, press the corresponding Flexible Soft Menu of each function. To return to the initial image, press the Flexible Soft button [5] INIT 3D . [Figure 4.20 Flexible Soft Menu – Position Mode] ※ Other ways to move the image Use the Flexible Soft Menu in the 3D View initial screen. To move the 3D image right or left, use the Flexible Soft button [4] Shift Left or [5] Shift Right . [Figure 4.21 Flexible Soft Menu – 3D Mode]

[Page 169] Chapter4. Diagnosis Modes 4 - 39 ■ Magnification To magnify or reduce the image size, enter Magnification mode by pressing the Magnification button, and move the Trackball right or left. After checking changed values in the Preview screen, apply the changes to the entire screen by pressing the Flexible Soft button [4] Apply . Pressing the Exit button applies the changes to the 3D image and exits the Magnification mode. To activate the Rotation , Position or Cut Mode function while adjusting the image size, press the corresponding Flexible Soft Menu of each function. To return to the initial image, press the Flexible Soft button [5] INIT 3D . [Figure 4.22 Flexible Soft Menu – Magnification Mode] ■ Cut Mode Press the Cut Mode button on the left side of the screen to enter Cut mode. Determine the area to cut using the Trackball , and press the Set button. Then, the "+" cursor appears. After contouring the area to cut, press Set button again, and the cutting is finished. To cancel the cutting area, press the Exit button. Press the Flexible Soft button [1] Inside Contour to outline an area to be cut. The Flexible Soft button [2] Point Eraser function is used to cut a portion of the image. The default setting is Inside Contour. To cancel cutting, press the Flexible Soft button [3] Undo . To redo the cancelled job, press the Flexible Soft button [4] Redo . To cancel all cuttings and return to the initial 3D screen, press the Flexible Soft button [5] Undo All . [Figure 4.23 Flexible Soft Menu – Cut Mode] ■ Multi-planar View Press Multiplanar , and 3D multiplanar screen appears. Shows volume data in cross- section images of Coronal Section, Sagittal Section, and Axial Section.

[Page 170] 4 - 40 SONOACE X6 User manual [Figure 4.24 Multi-planar view] ■ Reference Plane Select the reference plane on the Multi Planar window: – A plane: Coronal Section – B plane: Sagittal Section – C plane: Axial Section Multi Planar has its standard coordinates system and rotates/moves along that system. However the reference plane rotates/moves along the own coordinates system of reference plane. If you select a reference plane, it rotates/moves along the coordinates system of reference plane. The other planes are rotate/move along its standard coordinates system.

[Page 171] Chapter4. Diagnosis Modes 4 - 41 Use X/Y/Z slide on the screen to rotate reference plane. [Figure 4.25 The standard coordinates systems of Multi-planar] [Figure 4.26 The coordinates system of the reference plane] To init all setting, press Init on the screen. To finish the 3D Multiplanar and go back to 3D View, press X . Refer to ‘3D Image Optimization’ for more information like Gamma Curve setting.

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[Page 173] Chapter 5 Measurements And Calculations Measurement Accuracy 3 Causes of Measurement Errors 3 Optimization of Measurement Accuracy 5 Measurement Accuracy Table 7 Basic Measurements 9 Distance Measurement 11 Circumference and Area Measurement 17 Volume Measurement 19 Calculations by Application 21 Things to note 21 Common Measurement Methods 23 OB Calculations 28 GYN Calculations 35 Cardiac Calculations 37 Vascular Calculations 49 Urology Calculations 52 Fetal Echo Calculations 57 Report 62 Viewing Report 63 Editing Report 63 Comment 63 Printing out Report 63 Exporting Report 63 Graph Function 65

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[Page 175] Chapter 5.Measurements and Calculations 5 - 3 Measurement Accuracy Measurement values can vary, depending on the nature of the ultrasound, the body’s response to ultrasound, the measurement tools, algorithms, product settings, probe type and user operation. Before using this product, make sure to read and understand the following information regarding the causes of measurement errors, and measurement optimization. Causes of Measurement Errors ▌ Image Resolution The resolution of ultrasound images may be limited by the available space. – Errors due to a signal range may be minimized by adjusting focus settings. Optimizing focus settings increases the resolution of the measurement area. – In general, lateral resolution is lower than axial resolution. Therefore, measurements should be performed along the axis of the ultrasound beam to obtain accurate values. – Gain has a direct impact on resolution. Gain can be adjusted by using the Gain button for each mode. – In general, increasing the frequency of ultrasound enhances resolution. ▌ Pixel Size – An ultrasound images in the product consist of pixels. – Since a single pixel represents the basic unit of an image, a measurement error may result in the displacement of approximately ±1 pixel when compared to the original image size. – However, this error becomes significant only when a narrow area in an image is measured.

[Page 176] 5 - 4 SONOACE X6 User manual ▌ Ultrasound Velocity – The velocity of ultrasound used during measurement is usually 1,540 m/s on average. – The velocity of ultrasound may vary depending on the cell type. – The possible range of error is between approximately 2-5% depending on the structure of cells (about 2% for typical cells and about 5% for fatty cells). ▌ Doppler Signal Adjustment – During velocity measurement, an error may occur depending on the cosine angle between the blood flow and the ultrasound beam. – For Doppler velocity measurements, the most accurate results can be ensured when the ultrasound beam is aligned in parallel with the blood flow. – If that is not possible, the angle between them should be adjusted by using the Angle option. ▌ Aliasing – PW Spectral Doppler Mode uses a signal sampling technique to calculate the frequency (or velocity) spectrum. – Adjust the baseline or the velocity scale to minimize aliasing. A lower frequency probe can also be used to reduce aliasing. – Aliasing is dramatically reduced in CW Spectral Doppler Mode. ▌ Calculation Equation – Some of the calculation equations used for clinical purposes originate from hypotheses and approximation. – All calculation equations are based on medical reports and articles. ▌ Human Error – Human error may occur due to inappropriate use or lack of experience. – This can be minimized through compliance with and thorough understanding of the manuals.

[Page 177] Chapter 5.Measurements and Calculations 5 - 5 Optimization of Measurement Accuracy ▌ 2D Mode – Resolution is in proportion to the frequency of the probe. – Penetration is in inverse proportion to the frequency of the probe. – The highest resolution can be obtained at the focus of the probe where the ultrasound beam is narrowest. – The most accurate measurements can be obtained at the focus depth. The accuracy decreases as the distance from the focus increases, widening the beam width. – Using the zoom function or minimizing the depth display makes distance or area measurements more accurate. ▌ M Mode – The accuracy of time measurements can be increased when the sweep velocity and the display format are set to high values. – The accuracy of distance measurements can be increased when the display format is set to higher values. ▌ Doppler Mode – It is recommended to use lower frequency ultrasound for measurement of faster blood flows. – The size of the sample volume is limited by the axial direction of the ultrasound. – Using lower frequency ultrasound increases penetration. – The accuracy of time measurements can be increased when the sweep velocity is increased. – The accuracy of velocity measurements can be increased when the vertical scale is set to smaller values. – It is most important to use an optimal Doppler angle to enhance the accuracy of velocity measurements.

[Page 178] 5 - 6 SONOACE X6 User manual ▌ Color/Power Doppler Mode – A protocol is not specified for images in Color Doppler Mode or Power Doppler Mode. Therefore, the same limitations imposed when measurements are taken in B/W images apply to the accuracy of the measurements taken in these modes. – It is not recommended to use images in Color/Power Doppler Mode for measurement of accurate blood flow velocity. – The amount of blood flow is calculated based on the average velocity rather than the peak velocity. – In all applications, the amount of blood flow is measured in PW/CW Spectral Doppler Mode. ▌ Cursor Position – All measurements are affected by input data. – To ensure accurate positioning of the cursor: Adjust the images on the screen so that they are displayed at maximum granularity. Use the front edge or boundary point of a probe to make the start and end points of a measurement object more distinct. Make sure that the probe direction is always aligned during measurement.

[Page 179] Chapter 5.Measurements and Calculations 5 - 7 Measurement Accuracy Table The following tables show the accuracy of the measurements available using the product. Ensure that the results of measurement accuracy checks are kept within the ranges specified in the table. Except for certain applications or probes, the following accuracy ranges should be maintained for measurement of a straight distance. To ensure accurate measurements, an accuracy check should be performed NOTE at least once per year. If the measurement accuracy falls outside the ranges specified in the following table, contact Samsung Medison Customer Service. ▌ Modes Performance (1) Specification Modes Test Accuracy Description performance Methodology Based on Frequency Depth Linear <± 2MHz <± 10cm Phased Array <± 4MHz <± 8cm Penetration Probe Phantom Acquisition Endo-Cavity <± 5.5MHz <± 5cm Convex <± 7.5MHz <± 3cm Mode db M <75 Sensitivity M , PW , CW Phantom Acquisition PW <90 CW <90 (1) Displays the depth with ‘cm’, (2) Based on center frequency of each probe.

[Page 180] 5 - 8 SONOACE X6 User manual ▌ 2D Mode (1) System Tolerance Test Accuracy (2) Measurements Range (Whichever is greater) Methodology Based on Axial Distance: < ± 4% or 2mm Phantom Acquisition 0.01 – 25 cm Lateral Distance: < ± 4% or 2mm Phantom Acquisition 0.01 – 35 cm Axial Resolution: < ± 4% or 3mm Phantom Acquisition 0.01 – 25 cm Lateral Resolution < ± 4% or 3mm Phantom Acquisition 0.01 – 35 cm (1) Measurement accuracy depends on the table and human errors. (2) Distance is displayed with ‘cm’ and with the second digit. ▌ M Mode (1) System Tolerance Test Accuracy (2) Measurements Range (whichever is greater) Methodology Based on Depth : < ± 5% or 3 mm Phantom Phantom 1 – 25 cm Time: < ± 5% Signal generator Phantom 0.01 – 11.3 sec (1) Measurement accuracy depends on the table and human errors. (2) Distance is displayed with ‘cm’ and with the second digit. Velocity is displayed with ‘cm/s’ and with the second digit. ▌ Spectral Doppler Mode Doppler System Tolerance (2) Methodology Range Measurement (whichever is greater) PW: 0.1cm/s – 8.8 m/s Velocity < ± 15% Phantom CW: 0.1cm/s - 19.3 m/s Time: < +/- 5%. Signal generator 0.01 - 11.3 sec (1) Measurement accuracy depends on the table and human errors. (2) Distance is displayed with ‘cm’ and with the second digit. Velocity is displayed with ‘cm/s’ and with the second digit.

[Page 181] Chapter 5.Measurements and Calculations 5 - 9 Basic Measurements Press the Caliper button on the control panel. Take basic measurements of distance and area regardless of the application. NOTE For information on measurements for each application, please refer to “Measurements by Application” in this chapter. The available measurement methods vary depending on the current diagnosis mode. Please refer to the following table: Diagnosis Measurements Measurement Methods Mode 2D Distance 2D 2D Line Trace 2D Hip Joint Distance M M Distance Doppler Velocity CW, PW Doppler Velocity (A/B) Doppler Trace 2D Ellipse Circumference & Area 2D 2D Trace 3 Distance Volume 2D 1 Distance Distance + Ellipse [Table 5.1 Basic Measurement]

[Page 182] 5 - 10 SONOACE X6 User manual ▌ Basic Measurement Operations The following is the information on common button operations for basic measurements: ■ Select/Change Measurement Method Use the Flexible Soft dial-button on the control panel. The Flexible Soft menu items displayed vary depending on the diagnosis mode. The selected measurement method is displayed in the user information area. ■ Delete Measurement Result Press the Clear button on the control panel. ■ Print Measurement Result Press the Print button on the control panel. ■ Finish Basic Measurements Press the Exit button on the control panel. To change various settings such as measurement units, press [F8] Setup NOTE on the control panel and select Measure > General > General . For more information, please refer to Chapter 3 “Setting.”

[Page 183] Chapter 5.Measurements and Calculations 5 - 11 Distance Measurement ▌ 2D Distance (Line) This is a basic measurement that is available in all diagnosis modes. You can specify two points in a 2D image and measure the straight distance between them. You can measure up to 4 distances. When taking more than one measurement, use 1. Select the Flexible Soft button [1] Distance . “2D Distance” is displayed in the user 2. Use the Trackball and the Set button on the control panel to specify both end points of the measurement area. ※ Tip! Repositioning Point Pressing the Change button before pressing the Set button to complete positioning resets the position of a point just set. 3. If you specify both end points, the distance between them will be automatically calculated. measurement cursor. The ratio (+/x, #/*) and average for each measurement data is calculated and displayed as a percentage. 5. A new measurement cursor appears. When more than 4 measurements are taken,

[Page 184] 5 - 12 SONOACE X6 User manual ▌ 2D Distance (Trace) It is a basic measurement that is available in all diagnosis modes. You can specify a point in a 2D image and trace a curve from that point to measure the distance between them. You can measure up to 4 distances. When taking more than one measurement, use 1. Select the Flexible Soft button [1] Line Trace . “2D Line Trace” is displayed in the user 2. Use the Trackball and the Set button on the control panel to specify the start point of the measurement area. 3. With the Trackball , draw a desired curve and press the Set button to specify the end point. ※ Tip! Editing Curve Before pressing the Set button to specify the end point, you can rotate the Flexible Soft dial-button [5] Delete (trace) to delete a part of the curve being traced. 4. If you specify both end points, the length of the curve will be automatically calculated. 5. When the measurement is finished, its result is shown on the screen. measurement cursor. The ratio (+/x, #/*) and average for each measurement data is calculated and displayed as a percentage. 6. A new measurement cursor appears. When more than 4 measurements are taken,

[Page 185] Chapter 5.Measurements and Calculations 5 - 13 ▌ 2D Hip Joint angle of two straight lines to a straight line in a 2D image. This measurement is commonly used in the obstetrics application. 1. Select the Flexible Soft button [4] Hip Joint . “2D Hip Joint” is displayed in the user 2. Use the Trackball and the Set button on the control panel to specify the first straight line. ※ Tip! Repositioning Point Pressing the Change button before pressing the Set button to complete positioning resets the position of a point just set. 3. Repeat the above process to specify two other straight lines. 4. The angle between them will be calculated automatically. – α : The angle between the first and second straight lines. – β : The angle between the first and third straight lines. 5. When the measurement is finished, its result is shown on the screen. The angles α and β, and the Hip Joint Type are displayed on the screen. 6. A new measurement cursor appears. When more than 3 straight lines are specified, the Please refer to the table below for Hip Joint Type information: Type α β 1a 60 ≤ α ＜ 90 0 ＜ β ＜ 55 1b 60 ≤ α ＜ 90 55 ≤ β ＜ 90 2a/b 50 ≤ α ＜ 60 0 ＜ β ＜ 90 2c 43 ≤ α ＜ 50 77 ≤ β ＜ 90 d 43 ≤ α ＜ 50 0 ＜ β ＜ 77 3/4 0 ＜ α ＜ 43 [Table 5.2 Hip Joint Type Table]

[Page 186] 5 - 14 SONOACE X6 User manual ▌ M Distance This is a basic measurement that is available in M Mode only. You can specify two points in an M image and measure the distance, elapsed time and velocity between them. 1. Select the Flexible Soft button [1] M Distance . “M Distance” is displayed in the user 2. Specify two points and measure the straight distance between them. The method for measuring a line is the same as in “2D Distance.” measurement cursor. – The elapsed time (Time) and velocity (Slope) are also displayed. 4. A new measurement cursor appears. When more than 4 measurements are taken, ▌ Doppler Velocity two points in a Spectral Doppler image and measure the distance between them, and the velocity at each point to calculate the velocity change, time change and acceleration. In a Spectral Doppler image, the X- and Y-axes represent time and velocity, respectively. You can measure acceleration for up to two segments and differentiate the points of segments into Point 1 and 2. 1. Select the Flexible Soft menu [1] D Velocity . “D Velocity” is displayed in the user 2. Specify two points and measure the straight distance between them. The method for measuring a line is the same as in “2D Distance.” – Vel. 1: Velocity at Point 1 – Time: Time Change – Vel. 2: Velocity at Point 2 – Acc : Acceleration – PGmax – RI: Resistivity Index – V2-V1: Velocity Change – S/D: Systolic to Diastolic Ratio 4. A new measurement cursor appears. When more than 2 measurements are taken,

[Page 187] Chapter 5.Measurements and Calculations 5 - 15 The equations used for D Velocity measurement are as follows: V 1 − V 2 – RI = V 1 – dV = V − V 2 1 ( V 2 − V 1 ) dV – Accelerati on = = ( T 2 − T 1 ) dT ▌ Doppler Velocity (A/B) two points in a Spectral Doppler image and measure the velocity at each point to calculate the ratio of the velocity between them. You can calculate up to 4 sets of velocity ratios. The points representing each set are differentiated into Point A and B. 1. Select the Flexible Soft button [1] D A/B . “D A/B” is displayed in the user information area. 2. Specify two points to measure velocity for. – Vel. A: Velocity at Point A – PGmax – Vel. B: Velocity at Point B – A/B: Velocity Ratio 4. A new measurement cursor appears. When more than 4 sets are measured,

[Page 188] 5 - 16 SONOACE X6 User manual ▌ Doppler Trace a point in a Spectral Doppler image and trace a curve from that point to calculate the velocity, integral value and average velocity of blood flow. 1. Select the Flexible Soft button [1] D Trace . “D Trace” is displayed in the user 2. Trace a curve. The method for measuring a curve is the same as in “2D Line Trace.” – Vmax: Max. Velocity – PGmean – Vmean: Average Velocity – VTI: VTI (Velocity Time Integral) – PGmax – Time: Time Change 4. A new measurement cursor appears. The equations used for D Trace measurement are as follows: – dT = T − T 2 1 – VTI = v × dt , ( VTI : Velocity Time Integral ) VTI – V mean = Duration of flow

[Page 189] Chapter 5.Measurements and Calculations 5 - 17 Circumference and Area Measurement ▌ 2D Ellipse circumference and area of a circular (elliptical) object in a 2D image. You can measure up to 4 distances. When taking more than one measurement, use 1. Select the Flexible Soft button [2] Ellipse . “2D Ellipse” is displayed in the user 2. Use the Trackball and the Set button on the control panel to specify the diameter (axis) of the measurement area. ※ Tip! Repositioning Point Pressing the Change button before pressing the Set button to complete positioning resets the position of a point just set. 3. Specify the size of the circle (ellipse). – Adjust the size using the Trackball , and press the Set button. – Circ.: Circumference of Object – Avg.(C): Average Circumference – Area: Area of Object – Avg.(A): Average Area 5. A new measurement cursor appears. When more than 4 straight lines are specified, the The equations used for ellipse measurement are as follows: 2 2   1   A   B   – Circ = 2 π ⋅ ⋅    +    , (A: Long axis, B: Short axis) 2   2   2     – Area = π × a × b , (a, b: Axis)

[Page 190] 5 - 18 SONOACE X6 User manual ▌ 2D Trace circumference and area of an irregular object in a 2D image. You can measure up to 4 distances. When taking more than one measurement, use 1. Select the Flexible Soft button [2] Trace . “2D Trace” is displayed in the user information area. 2. Use the Trackball and the Set button on the control panel to specify the start point for tracing over the contour of the measurement area. 3. Trace the curve so that the measurement cursor returns to the start point, and then press the Set button. Trace lines must be closed. If you press the Set button before tracing NOTE is complete, tracing may be done over a straight line between the current point and the start point, resulting in a significant error. – Circ.: Circumference of Object – Avg.(C): Average Circumference – Area: Area of Object – Avg.(A): Average Area 5. A new measurement cursor appears. When more than 4 straight lines are specified, the The equations used for Trace measurement are as follows: 2 2 – Circ = sum { X ( ) n − X ( n − 1 ) } + { Y ( ) n − Y ( n − 1 ) } , (N = 1,2… last point) – Area = sum [ X ( n − 1 ) × Y ( n ) − X ( n ) × Y ( n − 1 ) ] , (N = 1,2… last point)

[Page 191] Chapter 5.Measurements and Calculations 5 - 19 Volume Measurement ▌ 3 Distance volume of an object in a 2D image by using 3 straight lines. 1. Select the Flexible Soft button [3] 3 Distance . “3 Distance” is displayed in the user 2. Specify two points and measure the straight distance between them. The method for measuring a line is the same as in “2D Distance.” 3. Measure the length of the remaining two straight lines as in the above. Measure other two distance using the same method with 2. 4. When the measurement is finished, its result is shown on the screen. The volume of the object along with the length of each straight line are calculated. 5. A new measurement cursor appears. When more than 3 straight lines are specified, the The equations used for 3 Distance measurement are as follows: 4 D 1 D 2 D 3 – Vol = π ⋅ ⋅ ⋅ , (D: distance) 3 2 2 2 ▌ 1 Distance volume of an object in a 2D image by using only one straight line. You can measure up to 4 sets of volumes. When measuring more than one set, use 1. Select the Flexible Soft button [3] 1 Distance . “1 Distance” is displayed in the user 2. Specify two points and measure the straight distance between them. The method for measuring a line is the same as in “2D Distance.” 3. When the measurement is finished, its result is shown on the screen. The volume of the object along with the length of the straight line are calculated. 4. A new measurement cursor appears. When more than 4 straight lines are specified, the The equations used for 1 Distance measurement are as follows:

[Page 192] 5 - 20 SONOACE X6 User manual 4  D  – Vol = π ⋅   , (D: distance) 3  2  ▌ Distance + Ellipse volume of an object in a 2D image by using one straight line and one circle (ellipse). You can measure up to 2 sets of volumes. When measuring more than one set, use measurement cursors with different shapes (+, X) to differentiate them. 1. Select the Flexible Soft button [3] Distance + Ellipse . “Distance + Ellipse” is displayed in the user information area. 2. Specify two points and measure the straight distance between them. The method for measuring a line is the same as in “2D Distance.” 3. Specify the size of the circle (ellipse). The method for measuring a circle (ellipse) is the same as in “2D Ellipse.” – Dia.: Length of Straight Line – A: Length of A-axis in Ellipse – B: Length of B-axis in Ellipse 5. A new measurement cursor appears. When more than 2 sets are measured, The equations used for Distance + Ellipse measurement are as follows: – Vol = × a × b × d , ( a : Short axis , b : Long axis , d : Distance ) Since Dual Mode simultaneously displays two images on the screen, you don't have to return to the diagnosis mode to measure volume in Dual Mode.

[Page 193] Chapter 5.Measurements and Calculations 5 - 21 Calculations by Application Press the Calculator button on the control panel. Things to note ▌ Before Taking Measurements  Please ensure that the information for the current patient is correct. When the patient is not registered, press the Patient button on the control panel to register the patient.  Ensure that the probe and application displayed in the title area are the ones that you want to use. If needed, press the Probe button to change the probe, application or preset. ▌ Measurement Operations The following gives information on the common button operations for measurements: ■ Select/Change Application Use the Calculator button on the control panel. Each time the Calculator button is pressed, the application toggles in the order determined under Measure Setup . The order in which applications appear can be specified at [F10] Application > Calc Sequence . ■ Menu A / Menu B When there are a lot of measurement items (menus), they are divided into two menu groups. Select them using the Flexible Soft button [1] or the Change button on the control panel. ■ Select Measurement Item After moving the cursor by using the Trackball or the Menu / Angle dial-button on the control panel, press the Set button or the Menu / Angle dial-button.

[Page 194] 5 - 22 SONOACE X6 User manual ■ Change Method This menu can be selected by pressing the Flexible Soft button [1] Chg Method or the Change button on the control panel. Once the measurement is started, the selected measurement method cannot be changed. In case of measuring distance, choose a measurement method from Line or Trace. When circumference and area are measured, choose a measurement method from Ellipse and Trace. ■ Delete Measurement Result Press the Flexible Soft Button [2] Rm Data or the Clear button on the control panel. It erases all the measurement data. The measurement results are deleted from the screen but still shown on the report for the corresponding application. ■ Cancel/Undo Press the Flexible Soft button [3] Cancel/Undo to cancel the latest measurement. ■ Measurement Result Display Settings Press the Flexible Soft button [4] Rslt Disp Cnt . Select number of the measurement result to display. The information related to the item number is displayed in the screen for about a second. ■ Return to Parent Menu After placing the cursor under Return in the Measurement menu, press the Set button or the Menu / Angle dial-button. ■ Print Measurement Result Press the Print button on the control panel. ■ Exit Measurement Press the Exit button on the control panel. ■ End Diagnosis Press the End Exam button on the control panel. The diagnosis for the current patient ends and all measurement results are saved. For information on settings for each application, please refer to Chapter 3 “Setting”.

[Page 195] Chapter 5.Measurements and Calculations 5 - 23 Common Measurement Methods This section provides information on the common measurement methods used for applications. ▌ Measurements in Spectral Doppler Mode In general, if you trace a Doppler spectrum, you can obtain results for various measurement items automatically. There are 3 ways to trace a Doppler spectrum. SONOACE X6 also allows you to select a specific item under the Measurement menu and take measurements individually without tracing a Doppler spectrum. ■ Auto Trace A spectrum is traced automatically. It is enabled in the Measurement menu in Spectral Doppler Mode. 1. Press Auto Trace in the Measurement menu. 2. The system traces a spectrum automatically. 3. When Trace is complete, the measurement results are displayed on the screen. ※ Things to consider for Doppler Spectrum Auto Trace The state of a Doppler spectrum may affect measurement results. Please see the following: Causes for Trace Failure – If Gain is changed for a Doppler image in the Freeze state, Contour Trace and Peak Trace will not work. – If there is little or no noise in an image without a spectrum, Contour Trace will not work. – If there is severe noise in an image, Contour Trace will not work. – If the Clutter filter is set too high, Auto Trace or Limited Trace may not work. Causes for Inaccurate Peak Trace – If PRF (Pulse Repetition Frequency) is lower than the velocity of the observation area, aliasing may occur. If the original signals are separated from aliasing, Trace can be done but the peak measurement may not be accurate. – If the peak of a spectral waveform is not clear or occurs intermittently, Trace can be done but the peak measurement may not be accurate. – If the Doppler Gain is set to high or low, it becomes difficult to distinguish

[Page 196] 5 - 24 SONOACE X6 User manual spectrums. This may result in measurement error(s). – If the Wall Filter is set too high, only part of the spectrum is displayed. In this case, Trace can be done but Peak measurement may not be accurate. – If abnormal noise or artifact occurs, Trace can be done but Peak measurement may not be accurate. Misc. – Use of the CW Probe may result in measurement error(s). – Limited Trace is supported only for two-peak spectrums such as Mitral Valve Inflow and Tricuspid Valve Inflow in the cardiology application. ■ Limited Trace If you specify a measurement range, a spectrum is traced automatically. It is enabled in the menu in Spectral Doppler Mode. 1. Press Limited Trace in the Measurement menu. A bar appears allowing you to specify a measurement area. 2. Specify the measurement range. – Place the bar at a desired position with the Trackball , and press the Set button. 3. The system traces spectrums within the specified range automatically. 4. When Trace is complete, the measurement results are displayed on the screen. ■ Manual Trace A spectrum is traced manually. It is enabled in the menu in Spectral Doppler Mode. 1. Press Manual Trace in the Measurement menu. A measurement cursor appears over a spectrum. 2. Trace the spectrum. The measuring method is the same as in “D Trace.” 3. When Trace is complete, the measurement results are displayed on the screen.

[Page 197] Chapter 5.Measurements and Calculations 5 - 25 ■ Itemized Measurement In the Measurement menu, select an individual item and take a measurement. 1. Press the Calculator button on the control panel after obtaining a desired image. 2. Select a desired item in the Measurement menu. The “+” cursor appears over a spectral waveform. 3. Position the “+” cursor and press the Set button. 4. The measurement results for the selected item are displayed on the screen. Measurement items for Doppler Spectrum are as follows: Item Type Unit Equation PSV (Peak Systolic Velocity) Velocity cm/s or m/s EDV (End Diastolic Velocity) Velocity cm/s or m/s TAMV (Time Average Mean Velocity) Velocity cm/s or m/s TAPV (Time Average Peak Velocity) Velocity cm/s or m/s PGmean (Mean Pressure Gradient) Calculation None Pgmax (Max Pressure Gradient), Calculation None 4 x PSV S/D (Ratio of PSV to EDV) Calculation Ratio (PSV / EDV) D/S (Ratio of EDV to PSV) Calculation Ratio EDV /PSV RI (Resistivity Index) Calculation Ratio (PSV – EDV) / PSV PI (Pulsatility Index) Calculation Ratio (PSV – EDV) / Vmean

[Page 198] 5 - 26 SONOACE X6 User manual ▌ Volume Flow Measurement Select Volume Flow in the Measurement menu. Volume Flow allows you to measure and calculate an area or distance. For information on distance or area measurements, please refer to “Basic Measurements.” The TAMV (Time Avg. Mean Velocity) value is automatically measured. ■ Vesl. Area (Vessel Area) Measure the area of a blood vessel and calculate TAMV and Volume Flow. VolumeFlow ( A ) = Area × TAMV × 60 ■ Vesl. Dist. (Vessel Distance) Measure the width of a blood vessel and calculate TAMV and Volume Flow. π × d VolumeFlow ( D ) = × TAMV × 60 ▌ Stenosis Measurement You can measure the stenosis of each blood vessel system by measuring and calculating an area or distance. ■ %StA (Stenosis Area) Measure the area of the inner and outer walls of a blood vessel. 1. Select the %StA menu and the first cursor will appear in 2D Mode. 2. Measure the area of the vessel’s outer wall using the Circ/Area measurement method. 3. When the second cursor appears, measure the area of the vessel’s inner wall under stenosis. %Stenosis Area. = (Outer Area – Inner Area) / Outer Area × 100

[Page 199] Chapter 5.Measurements and Calculations 5 - 27 ■ %StD (Stenosis Distance) Measure the diameter of a blood vessel. 1. Select the %StD menu and the first cursor will appear in 2D Mode. 2. Measure the total diameter of a blood vessel using the Distance measurement method. 3. When the second cursor appears, measure the diameter of the vessel’s inner wall under stenosis. %Stenosis Dist. = (Outer Distance – Inner Distance) / Outer Distance × 100 ▌ Heart Rate Measurement ■ HR (Heart Rate) You can calculate heart rates for a certain period of time. 1. Select HR in the Measurement menu. A bar appears allowing you to specify a measurement area. 2. Specify the measurement range. – Place the bar at a desired position with the Trackball , and press the Set button. 3. The system measures the heart rate within the specified range automatically. The measurement results are displayed on the screen.

[Page 200] 5 - 28 SONOACE X6 User manual OB Calculations ▌ Before Obtaining OB Calculations ■ OB Basic Information Type the information needed for OB diagnosis in the patient information window. Enter LMP, then EDD (Estimated Delivery Date) and GA (Gestational Age) are automatically calculated. LMP is required for the calculation of values such as EDD and SD. – EDD (LMP) = LMP + 280days – GA (LMP) = Current System Date - LMP A maximum of four fetuses can be input in the Gestations item. The default item value is ‘1’. In the case of twins, enter ‘2’. For further information about patient information menus and how to input patient information, refer to ‘Entering Patient Data’ in ‘Chapter 3 Settings’. ■ OB Measurement Menu Setup Set GA Equation, GA Table and OB Measurement menus. The user can manually write, back up and restore the GA Table. For more information on GA Equation and Table, refer to the Reference Manual. For more information about other measurement menus and setup, refer to ‘Setting Measurements’ in ‘Chapter 3. Settings’. For twins, distinguish fetuses by specifying them as Fetus A and Fetus NOTE B in the Measurement menu. Press the Change button on the control panel to change a fetus to measure.

[Page 201] Chapter 5.Measurements and Calculations 5 - 29 ▌ Measurement Menu The measurement menu items are arranged in the order in which they are used most during obstetrics diagnosis. When the measurements for the selected items are complete, the measurements and gestational age are displayed on the screen. The measurement method for each item is the same as for basic measurement. Measured items are automatically recorded in a report. [Figure 5.1 OB Measurement Menu]  For information on basic measurements, please refer to “Basic Measurements” in this chapter.  For references on measurement items, please refer to “Reference Manual – Part 1.”

[Page 202] 5 - 30 SONOACE X6 User manual ▌ Pregnancy Calculation 1. Press the Calculator button on the control panel to select the OB menu . 2. Select a measurement item, and a cursor appears on the screen. 3. Make a measurement using the Trackball and Set button. Distance measurement is most important in Fetal Biometry and Fetal Long Bones. The items that measure circumference are HC, AC, etc. The items that measure area are FTA, etc. ■ How to Measure a Distance Measurement Item – BPD: Measure the maximum transverse diameter value when symmetrical thalamus appears on the midline. – OFD: Measure the distance from the front of the head to the back in the same way as in BPD. – CRL: Measure the distance from head to rump of embryo. – FL: Femur length measurement. Measure the length of the femur that is closer to the probe. – MAD : Calculate the average value of the transverse and anterior-posterior lengths of the fetal abdomen. MAD = (APD + TAD) / 2 ■ How to Measure a Circumference Measurement Item HC: Calculate head circumference in the same way as in BPD. If the user measures BPD and OFD, HC is automatically calculated. 2 2 HC = π * ( BPD + OFD ) / 2 2 2 Exception: when you use Merz reference, HC = 2 . 325 × BPD + OFD AC: Calculate abdominal circumference on the fetal transverse image when DV (ductus venosus) is shown clearly. If the user measures APD and TAD, AC is automatically calculated. At that time, position the cursor on the outside including the skin. 2 2 AC = π * ( APD + TAD ) / 2 Exception: when you use Merz reference, AC = π × ( APD + TAD ) / 2 FTA: This is the measurement of the fetal trunk area (chest or abdomen). Draw a circle using the trace or ellipse, and the value is automatically calculated. FTA = AC / 4 / π

[Page 203] Chapter 5.Measurements and Calculations 5 - 31 NOTE For more information, refer to ‘Basic Measurements’. ■ Measurement Item Position (Measurement points) BPD, OFD, HC –fetal head BPD HC OFD APD, TAD, APTD, TTD – fetal abdomen or fetal trunk TTD, AC TAD APTD, APD FTA –fetal trunk FL – fetal femur

[Page 204] 5 - 32 SONOACE X6 User manual LV – fetal Vertebrae In a report, a maximum of three mean average of new GA values and recently measured values are recorded automatically. (If an item is measured less than three times, the value may not be accurate.) The average values are used for GA and EDD calculation, and displayed on a graph. ▌ Calculating Fetal Weight (EFW) Measuring one set of the following table and estimated fetal weight will be calculated automatically. . Refer to ‘Estimated Fetal Weight Formula’ in the Reference Manual. – BPD. AC – AC, FL – BPD, FL, FTA – BPD, AC, FL – BPD, APTD, TTD, FL – HC, AC, FL – BPD, APTD, TTD, SL – BPD, HC, AC, FL – BPD, TTD – AC For reference, Osaka University /Tokyo University methods are mainly used NOTE in Asia, Merz method in Europe, and Shepard/ Hadlock methods on the American continent.

[Page 205] Chapter 5.Measurements and Calculations 5 - 33 ▌ AFI Calculation Method The AFI is calculated by adding up the values of four measurements (Q1, Q2, Q3, Q4). 1. Measurements are performed by dividing the pregnant woman’s abdomen into four parts. The distance between the fetus and the farthest point of each area is measured. 2. Select and measure each quadrant. Or select and measure all quadrants by selecting the All menu. 3. To obtain the specific image from each quadrant plane, press the Freeze button to go to the diagnosis mode. After obtaining the image, press Freeze button again to return to the measurement mode. 4. The measurement values taken from each plane are added and displayed on the screen. ▌ Measurements in Spectral Doppler Mode Trace – Auto, Limited, Manual Doppler Waveform Trace PSV Velocity EDV Velocity Volume Flow %StA Calculation %StD Calculation Vessel Area Area Vessel Distance Distance Umbilical Artery Same as above Same as above MCA(Mid Cereb Artery) Same as above Same as above Rt. / Lt. Uterine Artery Same as above Same as above Placenta Artery Same as above Same as above Rt. / Lt. Fetal Carotids Same as above Same as above Fetal Aorta Same as above Same as above Ductus Venous Same as above Same as above The measurement items in Spectral Doppler Mode are measured using the same method. The Volume Flow and Stenosis can be obtained. For more information, refer to ‘Volume Flow Measurement Method’.

[Page 206] 5 - 34 SONOACE X6 User manual ▌ Fetal HR Calculation Fetal HR Fetal Heart Rate Time interval & no. of beats

[Page 207] Chapter 5.Measurements and Calculations 5 - 35 GYN Calculations ▌ Before Obtaining GYN Calculations Patient information needed for GYN diagnosis can be inputted in the patient information window. Gynecology Basic Information are GRAVIDA, PARA, ABORTA, Exp. Ovul., and Day of Cycle. ▌ Measurement Items The measurement menu items are arranged in the order in which they are used most during gynecology diagnosis. The measurement method for each item is the same as for basic measurement. Measured items are automatically recorded in a report. [Figure 5.2 GYN Measurement Menu]  For information on basic measurements, please refer to “Basic Measurements” in this chapter.  For references on measurement items, please refer to “Reference Manual – Part 1.”

[Page 208] 5 - 36 SONOACE X6 User manual ▌ GYN Measurements in 2D Mode Uterus Length Distance Uterus Height Distance Uterus Width Distance Uterus Endo. Thickness Distance Cervix Length Distance Cervix Height Distance Cervix Width Distance Length Distance Right / Left Ovary Height Distance Width Distance Cyst / Mass Same as above Same as above Right / Left Follicle Required for 1 to 12 Follicles Distance When the Long axis image and Transverse axis image of the uterus are needed for measuring volume, press the Freeze button to return to the scan mode. ▌ GYN Measurements in Spectral Doppler Mode Trace – Auto, Limited, Manual Doppler Waveform Trace Right / Left Ovarian Artery Peak E Velocity Peak A Velocity The user can obtain the values such as PSV, EDV, Vmean, Gmean, Gpeak, S/D, TAM, PI and RI from the spectral waveform in Spectral Doppler Mode. For more information, refer to ‘Doppler Spectrum Measurement Method’.

[Page 209] Chapter 5.Measurements and Calculations 5 - 37 Cardiac Calculations NOTE Since the cardiac blood flow is fast, m/s is used as a velocity unit. ▌ Before Obtaining Cardiac Calculations ■ Cardiac Basic Information Enter the patient information required for cardiology diagnosis in the Patient Information window. The basic information for cardiology includes Height, Weight, HR (Heart Rate), RAP (Right Arterial Pressure) and BP (Blood Pressure). When the patient's height and weight are entered, BSA (Body Surface Area) is automatically calculated and displayed. For more information about patient information menus and how to enter information, please refer to “Entering Patient Data” in Chapter 3 “Setting.” ■ Cardiac Measurement Menu Setup Set the related menus for convenient measurement. You can specify how an area and volume can be calculated. Please refer to the “Setting Measurements” section in Chapter 3 “Setting” for more information on measurement menus and settings.

[Page 210] 5 - 38 SONOACE X6 User manual ▌ Measurement Items The measurement menu items are arranged in the order in which they are used most during cardiology diagnosis. The measurement method for each item is the same as for basic measurement. Measured items are automatically recorded in a report.  For information on basic measurements, please refer to “Basic Measurements” in this chapter.  For references on measurement items, please refer to “Reference Manual – Part 2.” [Figure 5.3 Cardiac Measurement Menu]

[Page 211] Chapter 5.Measurements and Calculations 5 - 39 ▌ Cardiac Measurements in 2D Mode A4C Diastole 20 Diameter & Length A4C Systole 20 Diameter & Length Simpson A2C Diastole 20 Diameter & Length A2C Systole 20 Diameter & Length Vol. A/L LV Vol. Diastole Area & Length (Volume Area/Length) LV Vol. Systole Area & Length All Distance (Thickness) IVSd (Inter Ventricular Septal thickness Diastolic) Distance (Thickness) IVSs (Inter Ventricular Septal thickness Systolic) Distance (Thickness) LVDd (Left Ventricle Diameter Diastolic) Distance (Thickness) 2D Measure LVDs(Left Ventricle Diameter Systolic) Distance (Thickness) LVPWd (Left Ventricle Posterior Wall Dimension Distance (Thickness) Diastolic) LVPWs (Left Ventricle Posterior Wall Dimension Distance (Thickness) Systolic) Epi. Area (Epicardial) Area LV (Left Ventricle) Endo. Area (Endocardial) Area Mass LV Length (Left Ventricle Length) Distance LVOT Dia (Left Venticle Outflow Tract Diameter) Length Ao/LA (Aorta/Left Ao Root Dia (Aorta Root Diameter) Length Atrium) LA Dia (Left Atrium Dimension) Length ■ Simpson and Vol. A/L Measure the cardiac circumference and axis. – 20 Diameter & Length: A cursor to trace the area appears. After the area measurement, a new cursor to measure length appears. After drawing an axis within the area, calculate the area by dividing it equally into 20 sections with the axis as a standard.

[Page 212] 5 - 40 SONOACE X6 User manual ■ 20 Measure Make the measurements of the sub-menus of 2D Measure . – All measures six items of 2D Measure (IVSd, IVSs, LVDd, LVDs, LVPWd, LVPWs) at once using the Rotational Guide Line. Move the Guide Line using the Trackball and adjust angle using Menu dial button. After pressing Set button to fix Guide Line, set the measure point with the Trackball. Six items are measured at once. – IVSd and IVSs measure the AIVS and PIVS at the heart diastole and heart systolic phases. – LVDd and LVDs measure ENDO at the heart diastole and heart systolic phases. – LVPWd and LVPWs measure EPI at the heart diastole and heart systolic phases. – AIVS: Anterior Interventricular Septum PIVS: Posterior Interventricular Septum ENDO: Endocardial Surface of Left Ventricular Wall EPI: Epicardial Surface of Left Ventricular Wall ■ LV Mass When measuring LV Mass , the user can obtain the images at different angles needed for the sub-menus by using the Freeze button on the control panel. In Dual 2D Mode, simultaneous images are activated, and the image doesn’t have to be scanned during the measurement. – LV (Left Ventricle) is used only when measuring mass. It can be measured only in the case of the diastole of Left Ventricle. – Myocardial thickness = SQRT(Dia.A / Pi) – SQRT(Sys.A / Pi) ■ Ao/LA The sub-menus of Ao/LA are measured as shown below. – Ao-LA measures Aorta and Left Atrium in sequence. – LVOT Dia measures the point of Aortic Valve Annulus. – Ao Root Dia measures the distance from Anterior Aortic Wall to Posterior Aortic Wall. – LA Dia measures the distance from Posterior Aortic Wall to Left Arterial Wall.

[Page 213] Chapter 5.Measurements and Calculations 5 - 41 ▌ Cardiac Measurements in M Mode IVSd (Inter Ventricular Septal thickness Diastolic) Distance (Thickness) LVDd (Left Ventricle Diameter Diastolic) Distance (Thickness) LVPWd (Left Ventricle Posterior Wall Dimension Distance (Thickness) Diastolic) IVSs (Inter Ventricular Septal thickness Systolic) Distance (Thickness) Lt. Ventricle LVDs (Left Ventricle Diameter Systolic) Distance (Thickness) LVPWs (Left Ventricle Posterior Wall Dimension Systolic) Distance (Thickness) RVDd (Right Ventricle Diameter Diastolic) Distance (Thickness) All (IVSd, LVDd, LVPWd, IVSs, LVDs, LVPWs) Same as above Ao Root Dia (Aortic Root Dimension) Distance AoV Cusp Sep. (Aortic Valve Cusp Separation) Distance LA Dia (Left Atrial Dimension) Distance Ao/LA (Aorta/Left LV PET (Left Ventricle Pre Eject Time) Time Atrium) LV ET (Left Ventricle Eject Time) Time All (Ao Root Dia, AoV Cusp Sep., LA Dia, LV PET, LV Same as above ET) A-C Interval Time interval D-E (D – E Excursion) Distance MV (Mitral E-F Slope Slope (Velocity) Valve) EPSS (E Point Septal Separation) Distance (Thickness) All Points (D-E Excursion, E-F slope, A-C Interval, Same as above E Point Septal Separation) Heart Rate Heart Rate Time interval & no. of beats

[Page 214] 5 - 42 SONOACE X6 User manual ■ Lt. Ventricle – The sub-menus of Lt. Ventricle are measured in the same way as in 2D Measure . – RVDd is measured in the same way as in LVDd. ■ Ao/LA The sub-menus of Ao/LA are measured as shown below. – Ao Root Dia measures the distance between the Anterior Aortic Wall and Posterior Aortic Wall. – AoV Cusp Sep. measures the distance between the Coronary Cusp and Non Coronary Cusp. – LA Dia measures the distance between the Posterior Aortic Wall and Left Arterial Wall. – LV PET measures the distance between the ECG’s Q Wave and Aortic Valve Opening. – LV ET measures the distance between the Aortic Valve Opening and Aortic Valve Closing. ■ MV The sub-menus of MV are measured as shown below. – A-C Interval calculates the time duration by measuring the distance between the A point and C point in the Mitral Valve measurement screen . – D-E measures the distance between the E point of the Anterior Mitral Valve and the D point of the Mitral Valve Opening. – E-F Slope calculates the velocity by measuring the distance between the E point and F point in the Mitral Valve measurement screen . – EPSS measures the distance between the E point in the Mitral Valve and Posterior Interventricular Septum. The user can measure only in the upper direction of the E point, and only in the lower direction in Apex. ■ Heart Rate Select Heart Rate , and heart rate is calculated. – Set the start and end points of the spectral waveform with a bar. – Rotate the Menu / Angle dial-button to select ‘Number of Beats’. Calculate the average mean of the Fetal HR.

[Page 215] Chapter 5.Measurements and Calculations 5 - 43 ▌ Cardiac Measurements in Color Doppler Mode PISA(Proximal Isovelocity Surface Area) Radius Distance MV (Mitral Valve) Regurg PISA-Alias Vel. Velocity PISA-Radius Distance AoV (Aortic Valve) Regurg PISA-Alias Vel. Velocity PISA Radius Distance TV (Tricuspid Valve) Regurg PISA-Alias Vel. Velocity PISA Radius Distance PV (Pulmonary Valve) Regurg PISA-Alias Vel. Velocity ■ PISA-Radius Measure the distance between Valve and First Isovelocity. ■ PISA-Alias Vel. Multiply the result value of PISA-Radius by the color bar’s regurgitant peak velocity. – PISA: Proximal Isovelocity Surface Area The velocity value is needed to measure the items above. So select Velocity or Vel + Var as the color display. For more information, refer to ‘Color Image Format Change’ in the ‘Color Doppler Mode’ section.

[Page 216] 5 - 44 SONOACE X6 User manual ▌ Cardiac Measurements in Spectral Doppler Mode Trace –Limited, Manual Doppler Waveform Trace E-DT-A Velocity & Time Peak E Velocity Peak A Velocity MV (Mitral Valve) Inflow PHT (Pressure Half Time) Time or Calculated from Trace IVRT (IsoVolumic Relaxation Time) Time R-R Interval (Rate-Rate Interval) Time Interval & No. of beats Trace – Auto, Limited, Manual Doppler Waveform Trace MV (Mitral Valve) Peak V (Velocity) Velocity Regurg VTI (Velocity Time Integral) Calculated Trace – Auto, Limited, Manual Doppler Waveform Trace LVOT (Left Peak V (Velocity) Velocity Ventricular Outflow Tract) VTI (Velocity Time Integral) Calculated Doppler Dia (Diameter) Distance Trace – Auto, Limited, Manual Doppler Waveform Trace Peak V (Velocity) Velocity VTI (Velocity Time Integral) Calculated AoV (Aortic Valve) Systolic Ejection (Ejection Time) Time R-R Interval (Rate-Rate Interval) Time Interval & No. of beats Trace –Limited, Manual Doppler Waveform Trace AoV (Aortic Valve) Regurg Peak V (Velocity) Velocity

[Page 217] Chapter 5.Measurements and Calculations 5 - 45 VTI (Velocity Time Integral) Calculated PHT (Pressure Half Time) Time or Calculated from Trace Trace –Limited, Manual Doppler Waveform Trace E-DT-A Velocity & Time Peak E Velocity Peak A Velocity TV (Tricuspid Valve) Inflow PHT (Pressure Half Time) Time or Calculated from Trace R-R Interval (Rate-Rate Interval) Time Interval & No. of beats Trace – Auto, Limited, Manual Doppler Waveform Trace TV (Tricuspid Peak V (Velocity) Velocity Valve) Regurg VTI (Velocity Time Integral) Calculated Trace – Auto, Limited, Manual Doppler Waveform Trace Peak V (Velocity) Velocity PV Systolic R-R Interval (Rate-Rate Interval) Time Interval & no. of beats Trace – Auto, Limited, Manual Doppler Waveform Trace Peak V (Velocity) Velocity PV Regurg VTI (Velocity Time Integral) Calculated PHT (Pressure Half Time) Time or Calculated from Trace Dias Vel. (Diastolic Velocity) Velocity Sys Vel. (Systolic Velocity) Velocity Plum. Veins (Pulmonary Veins) A. Rev Vel. (Artery Reversal Velocity) Velocity A. Rev Dur. (Artery Reversal Duration) Time Tissue Doppler E-DT-A Velocity & Time

[Page 218] 5 - 46 SONOACE X6 User manual Peak E’ Velocity Peak A’ Velocity Peak S Velocity IVCT (IsoVolume Contraction Time) Time or Calculated from Trace IVRT (IsoVolume Relaxation Time) Time or Calculated from Trace Sys. VTI ([Systemic] Flow Area Trace) Calculated Sys. HR ([Systemic] Heart Rate) Heart Rate Sys. Dia ([Systemic] Outflow Tract Diameter) Diameter Qp:Qs Pulm. VTI ([Pulmonic] Flow Area Trace) Calculated Pulm. HR ([Pulmonic] Heart Rate) Heart Rate Pulm. Dia ([Pulmonic] Outflow Tract Diameter Diameter) Heart Rate Heart Rate Time interval & no. of beats All N/A Dias Vel. (Diastolic Velocity) Velocity Hepatic Vein Sys Vel. (Systolic Velocity) Velocity Rev Vel. (Reversal Velocity) Velocity For more information, refer to ‘Doppler Spectrum Measurement Method’. NOTE The Auto Trace function is not provided in MV Inflow and TV Inflow.

[Page 219] Chapter 5.Measurements and Calculations 5 - 47  The values of Peak, Acc Time, Dec Time. Ejection Time, VTI, PHT, R-R Interval, etc. are automatically measured by tracing the Spectral Doppler image. Each item can also be selectively measured. – Peak V: Measures the higher velocity value. – Peak E: Measures the Ventricular Systolic peak. – Peak A: Measures the Atrial Systolic peak. – Acc: Measures the time duration when blood flow is accelerated. Dec Measures the time duration when blood flow is decelerated. – [E-DT-A]: Measure Peak E,Dec. , and Peak A in order. – Ejection: Measures the time duration by measuring the distance between the Aortic Valve Opening and Aortic Valve Closing. – VTI: Calculates the value using the formula of VTI = Sum of Vi × ∆ t after tracing the Spectral Doppler image. – PHT: Calculates Half-Time using the Pressure gradient value obtained between the E point of Valve and the baseline. – R-R Interval: Measures the distance between consecutive R waves on the ECG.  LVOT Doppler Measure Left Ventricular Outflow. Its sub-menu Dia . measures the Aortic Valve Annulus point in the 2D image.  The sub-menus of Plum. Veins are measured as shown below. – Dias Vel. and Sys Vel. measure the velocity at the diastole and systolic phases. – A. Rev Vel. measures the Peak Velocity at Atrial Reversal. – A. Rev Dur. measures the time duration by measuring the distance between the Mitral Valve Closing and the heart diastole phase.  In the sub-menu of Tissue Doppler, Peak S measures the systolic peak, and IVCT and IVRT measure Isovolumic Contraction and Isovolumic Relaxation phases, respectively.  The sub-menus of Qp:Qs are measured as shown below. – Sys. VTI and Pulm. VTI measure the VTI by tracing LVOT Flow and RVOT Flow respectively. – Sys. HR and Pulm. HR measure the heart rate by measuring diastole phase and systolic phase respectively in LVOT Flow and RVOT Flow. – Sys. Dia and Pulm. Dia measures the distance of Outflow Tract in the 2D images of LVOT Flow and RVOT Flow, respectively.

[Page 220] 5 - 48 SONOACE X6 User manual  Select Heart Rate to calculate the heart rate. – Select and measure the start and end points of the spectral waveform. – Measure the average value of the heart rate by selecting ‘Number of Beats’ with the Menu / Angle dial-button .  Select Hepatic Vein to measure Hepatic Vein. – Dias Vel. measures the Peak Velocity at diastole. – Systolic Vel. measures the Peak Velocity at systole. – Reversal Vel. measures the Peak Velocity at reversal.

[Page 221] Chapter 5.Measurements and Calculations 5 - 49 Vascular Calculations ▌ Before Obtaining Vascular Calculations Set the related menus for convenient measurement. The user can also set the Peak Velocity used to calculate ‘A/B Ratio’ and ‘ICA/CCA Ratio’. For more information, refer to ‘Setting Measurements’ in ‘Chapter 3. Settings’. ▌ Measurement Items The measurement menu items are arranged in the order in which they are used most during vascular diagnosis. The measurement method for each item is the same as for basic measurement. Measured items are automatically recorded in a report.  All vascular systems are measured using the same method. For information on basic measurements, please refer to “Basic Measurements” in this chapter. NOTE  It is convenient to calculate each measurement value on the Spectral Doppler image.  For references on measurement items, please refer to “Reference Manual – Part 2.” [Figure 5.4 Vascular Measurement Menu]

[Page 222] 5 - 50 SONOACE X6 User manual ▌ Vascular Measurements Trace – Auto, Limited, Manual Doppler Waveform Trace PSV Velocity EDV Velocity Rt./ Lt. Subclavian %StA Calculation %StD Calculation Vessel Area Area Vessel Distance Distance (Proximal Common Carotid Artery) Rt./Lt. Prox CCA Same as above Same as above Rt./Lt. Mid CCA Same as above Same as above Rt./Lt. Distal CCA Same as above Same as above Rt./Lt. Bulb Same as above Same as above (Proximal Internal Carotid Artery) Rt./Lt. Prox ICA Same as above Same as above Rt./Lt. Mid ICA Same as above Same as above Rt./Lt. Distal ICA Same as above Same as above (External Carotid Artery) Rt./Lt. ECA Same as above Same as above Rt./Lt. Vertebral Same as above Same as above General Same as above Same as above  The values such as PSV, EDV, Vmean, Gmean, Gpeak, S/D, PI, RI, etc. can be obtained from the spectral waveform in Spectral Doppler Mode. There are four measurement methods: Auto Trace, limited Trace, Manual Trace, and Measurement Each Item One by One. For more information, refer to ‘Doppler Spectrum Measurement Method’.  Stenosis % Calculation: There are two ways to obtain the Stenosis % of each vascular system: %StA using the area and %StD using the distance. Refer to ‘Volume Flow Measurement’ for more information.  Vessel Area Measurement: There are two ways to obtain Vessel Area: Vesl. Area using the circumference and Vesl. Dist using the distance.  The user can obtain the Volume Flow values using the TAM (Time Average Mean Velocity) value obtained from the spectral waveform and the Vessel Area value obtained using Vesl. Area or Vesl. Dist.

[Page 223] Chapter 5.Measurements and Calculations 5 - 51 ▌ Volume Flow Measurements The Volume Flow menu is shown below. For more information, refer to ‘Volume Flow Measurement Method’. Auto Trace Doppler Waveform Trace Volume Flow Vessel Distance Distance ▌ Heart Rate Calculations Select Heart Rate to calculate the heart rate. – Select and measure the start and end points of the spectral waveform. – Calculate the average value of the heart rate by selecting ‘Number of Beats’ with the Menu / Angle dial-button . Heart Rate Heart Rate Time interval & no. of beats

[Page 224] 5 - 52 SONOACE X6 User manual Urology Calculations ▌ Before Obtaining Urology Calculations For more convenient measurement, set the related menus. The user can select the Volume Method. There are four types of Volume Method. The factor value can be set manually for the formulas that need it. For more information, refer to ‘Settings Measurements’ in ‘Chapter 3. Settings’. ▌ Measurement Items The measurement menu items are arranged in the order in which they are used most during urology diagnosis. The measurement method for each item is the same as for basic measurement. Measured items are automatically recorded in a report.  For information on basic measurements, please refer to “Basic Measurements” in this chapter.  For references on measurement items, please refer to “Reference Manual – Part 2.” [Figure 5.5 Urology Measurement Menu]

[Page 225] Chapter 5.Measurements and Calculations 5 - 53 ▌ Volume Measurements 1. Select the Urology menu by pressing the Calculator button on the control panel. 2. Select the required measurement item and menu, and a cursor appears on the screen. 3. Perform the measurement using the Trackball and the Set button on the control panel. – The measurement of Transitional Zone Prostate Volume, Bladder Volume, Left Kidney Volume, and Right Kidney Volume is the same as in Prostate Volume. – There are two ways to measure in each menu: one is measuring the item values from one image, and the other is measuring the item values from several images. The measurement methods of each menu vary with the Volume Method set in the Setup menu. – If 3Distance or 3Distance * Factor is set in Setup, three diameter values can be obtained in order. st 1 Dia. (Diameter) Distance Bladder Volume nd 2 Dia. (Diameter) Distance rd 3 Dia. (Diameter) Distance st 1 Dia. (Diameter) Distance nd 2 Dia. (Diameter) Distance rd 3 Dia. (Diameter) Distance Pre All st Pre 1 Dia. (Diameter) Distance nd Pre 2 Dia. (Diameter) Distance rd Residual Volume Pre 3 Dia. (Diameter) Distance Post All st Post 1 Dia. (Diameter) Distance nd Post 2 Dia. (Diameter) Distance

[Page 226] 5 - 54 SONOACE X6 User manual rd Post 3 Dia. (Diameter) Distance st 1 Dia. (Diameter) Distance Prostate Volume nd 2 Dia. (Diameter) Distance rd 3 Dia. (Diameter) Distance st 1 Dia. (Diameter) Distance Left (Right) Kidney nd 2 Dia. (Diameter) Distance rd 3 Dia. (Diameter) Distance

[Page 227] Chapter 5.Measurements and Calculations 5 - 55 – If Ellipsoid is set in Setup, Main Diameter and Beside Diameter values can be obtained in order. Bladder Volume Main Dia. (Diameter) Distance Beside Dia. (Diameter) Distance Prostate Volume Main Dia. (Diameter) Distance Beside Dia (Diameter) Distance Pre All Pre Main Dia. (Diameter) Distance Pre Beside Dia. (Diameter) Distance Residual Volume Post All Post Main Dia. (Diameter) Distance Post Beside Dia. (Diameter) Distance Main Dia. (Diameter) Distance Beside Dia. (Diameter) Distance Main Dia. (Diameter) Distance Left (Right) Kidney Beside Dia. (Diameter) Distance

[Page 228] 5 - 56 SONOACE X6 User manual – If Sum of 20 Disks is set in Setup, the user can calculate the measurement value by measuring the prostate circumference and prostate axis using the Trackball and the Set button. Bladder Volume Bladder Vol. 20 Diameter & Area Prostate Volume Prostate Vol. 20 Diameter & Area Pre Vol. 20 Diameter & Area Residual Volume Post Vol. 20 Diameter & Area Transitional Zone Prostate Vol. 20 Diameter & Area Left (Right) Kidney Vol. 20 Diameter & Area Left (Right) Kidney ▌ Volume Flow Measurements The Volume Flow menu is shown below. For more information, refer to ‘Volume Flow Measurement Method’. Trace – Auto, Limited, Manual Doppler Waveform Trace PSV Velocity EDV Velocity Volume Flow %StA Calculation %StD Calculation Vessel Area Area Vessel Distance Distance

[Page 229] Chapter 5.Measurements and Calculations 5 - 57 Fetal Echo Calculations ▌ Before Obtaining Fetal Echo Calculations Set the related menus for convenient measurement. The user can also set the measurement method to calculate volume. Refer to the ‘Setting Measurements’ section in “Chapter 3. Settings” for more information. ▌ Measurement Items The measurement menu items are arranged in the order in which they are used most during fetal echo diagnosis. The measurement method for each item is the same as for basic measurement. In addition, measurement items are similar to those for cardiac calculation. Measured items are automatically recorded in a report.  For information on basic measurements, please refer to “Basic Measurements” in this chapter.  For references on measurement items, please refer to “Reference Manual – Part 2.” [Figure 5.6 Fetal Echo Measurement Menu]

[Page 230] 5 - 58 SONOACE X6 User manual ▌ Fetal Echo Measurements in 2D Mode Asc. Aorta (Ascending Aorta) Distance MPA (Main Pulmonary Artery) Distance Duct. Art (Ductus Arteriosus) Distance Left Atrium Distance Right Atrium Distance Right Ventricle Distance 2D Echo Inter Ventricular Septum Distance Lt. Ventricle Dia.(Diastole) Distance Lt. Ventricle Sys.(Systole) Distance LVPW (Left Ventricle Posterior Wall) Distance Heart Circ. (Circumference) Circ/Area Thoracic Circ. (Circumference) Circ/Area Thorax AP (Anteroposterior) Diameter (ThAPD) Distance Thorax Transverse Diameter (ThTD) Distance CTAR (Cardio-Thorax Area Ratio) Heart AP Diameter (HAPD) Distance Heart Transverse Diameter (HTD) Distance  Use the Distance measurement method to measure Asc. Aorta (Ascending Aorta), MPA (Main Pulmonary Artery), Duct. Art (Ductus Arteriosus), Lt. Atrium (Left Atrium), Rt. Atrium(Right Atrium), Rt. Ventricle(Right Ventricle), IVS (Inter Ventricular Septum), LVDd (Left Ventricle Diameter Diastole), LVDs (Left Ventricle Diameter Systole), and LVPW (Left Ventricle Posterior Wall).  Use the Circ/Area calculation method to measure Heart Circ. (Heart Circumference), and Thora Circ. (Thoracic Circumference).  The CTAR menu measures and compares the size of the fetal chest and heart. You can obtain the value by comparing ThAPD, ThTD, HAPD, and HTD values. HAPD × HTD CTAR = × 100 ThAPD × ThTD

[Page 231] Chapter 5.Measurements and Calculations 5 - 59 ▌ Fetal Echo Measurements in M Mode IVSd (Inter Ventricular Septal Thickness Diastolic) Distance (Thickness) LVDd (Left Ventricle Diameter Diastolic) Distance (Thickness) LVPWd (Left Ventricle Posterior Wall Dimension Distance (Thickness) Diastolic) IVSs (Inter Ventricular Septal Thickness Systolic) Distance (Thickness) Fetal M Mode LVDs (Left Ventricle Diameter Systolic) Distance (Thickness) LVPWs (Left Ventricle Posterior Wall Dimension Distance (Thickness) Systolic) RVDd (Right Ventricle Diameter Diastolic) Distance (Thickness) All (IVSd, LVDd, LVPWd, IVSs, LVDs, LVPWs) Same as above Fetal HR Fetal Heart Rate Time interval & no. of beats  Measure the sub menus of Fetal M Mode as shown below. – IVSd and IVSs measure AIVS and PIVS at the diastolic and systolic phases respectively. – LVDd and LVDs measure ENDO at the diastolic and systolic phases respectively. – LVPWd and LVPWs measure EPI at the diastolic and systolic phases respectively. – AIVS: Anterior Interventricular Septum PIVS: Posterior Interventricular Septum ENDO: End cardinal Surface of Left Ventricular Wall EPI: Epicardial Surface of Left Ventricular Wall – RVDd is measured in the same way as in LVDd .  Select Fetal HR to calculate the fetal heart rate. – Select and measure the start and end points of the spectral waveform. – Calculate the average value of the heart rate by selecting ‘Number of Beats’ with the Menu / Angle dial-button . – This links up with the Fetal HR in Obstetrics.

[Page 232] 5 - 60 SONOACE X6 User manual ▌ Fetal Echo Measurements in Spectral Doppler Mode Trace – Auto, Limited, Manual Doppler Waveform Trace MPA (Main Pulmonary PSV Velocity Artery) EDV Velocity Ductua Arteriosus Same as above Same as above Inferior Vena Cava Same as above Same as above Ductus Venosus Same as above Same as above Ascending Aorta Same as above Same as above Descending Aorta Same as above Same as above Peak E Velocity MV (Mitral Valve) Inflow Peak A Velocity MV (Mitral Valve) Velocity Velocity Regurgitation Peak E Velocity Tricuspid Valve Inflow Peak A Velocity Tricuspid Valve Velocity Velocity Regurgitation Systolic Flow Velocity PLI (PreLoad Index) Diastolic Flow Velocity Atrial Reversal Flow Velocity Fetal HR Fetal Heart Rate Time interval & no. of beats

[Page 233] Chapter 5.Measurements and Calculations 5 - 61  Select Auto Trace . The image is automatically traced and the measurement values calculated.  Select Limited Trace , and the baseline appears on the image. Set the start and end points of the spectral waveform using the baseline, and the measurement value is automatically calculated. The user can reposition the baseline by pressing the Change button.  Select Manual Trace , and a cursor appears on the image. Trace the Doppler waveform, and the measurement value is automatically calculated.  The user can select and measure each item manually. – PSV measures the Peak Systolic velocity. – EDV measures the End Diastolic velocity. – Peak E measures the Ventricular Systolic peak. – Peak A measures the Atrial Systolic peak.  Select Fetal HR to calculate the fetal heart rate. – Select and measure the start and end points of the spectral waveform. – Measure the average value of the heart rate by selecting ‘Number of Beats’ with the Menu / Angle dial-button. – This links up with the Fetal HR in obstetrics.

[Page 234] 5 - 62 SONOACE X6 User manual Report Check the measurement and calculation results in the report of each application.  Press the Report button on the keyboard to check the report of the specific application.  The applications not yet measured are not shown.  The deviated data from the valid range will be displayed with Invalid mark(*).  To return to the diagnosis mode, press the X on the report screen, or press the Exit button on the control panel or the Report button on the keyboard. [Figure 5.7 Report Screen – Example]

[Page 235] Chapter 5.Measurements and Calculations 5 - 63 Viewing Report  The measurement and calculation items and their values are displayed.  When the report screen has more than two pages, use the left/right arrow button on the report screen. To search and check the reports of other applications, use the Next Package to move to the specific package. Editing Report Press the Edit to edit the specific information. After editing, press the Ok at the top of the screen to return to the original report screen, and the edited values are shown in the [ ] bracket in the report. Comment Press the Comment . Press the Ok at the top of the screen after entering some comment to return to the original report screen. Printing out Report Press the Print in the report screen. If there is no connection with a printer, this button will not be displayed. Exporting Report  Press the Export on the screen to save the report as MO Disk or Flash Memory. The Export Report window appears on the screen to designate File Name and File Format as shown below.  The Export is not activated if the drive is not connected.  The file name is automatically given, but the file name can also be inputted manually. The user can choose a file format of either Excel or Text.

[Page 236] 5 - 64 SONOACE X6 User manual ▌ Open Line Transfer Transfer the report to another computer or printer. Press the Open Line Transfer on the Export Report window.  Connect the USB to RS-232C serial cable to the USB port of the rear panel prior to use this function.  If the operating system of the PC connected to this system via the USB TM to RS-232C Serial Cable is Windows XP , errors may be caused during report transferring. Set the computer or printer, connects to this system, like following; – 9,600 Baud – 8-bit data – No parity – 1 stop bit

[Page 237] Chapter 5.Measurements and Calculations 5 - 65 Graph Function  This function is used to display the GA values such as BPD, HC, AC and FL, allowing the user to diagnose fetal growth.  The function can be used only in the OB report. Press Graph on the screen.  The graph is created using ID, LMP, and measurement date as standards.  To change to the report screen, press Report on the screen.  To return to the diagnosis mode, press the X on the graph screen, or press the Exit button on the control panel. Only after the patient name, ID and LMP are entered, the graph and report are automatically saved in the HDD. ▌ Viewing Graph  The graph of the recently measured values is drawn according to the gestation period (week) and fetal size (mm).  The G.A. values, including the fetal weight, are displayed at the bottom of the screen. Select a specific item on the combo box using the Trackball and the Set button, and a graph appears. ▌ Viewing History  To view the history information, press the History on the OB report screen. To return to the graph screen, press the button again.  Select Fetus and Date Display Type to study.

[Page 238]

[Page 239] User Manual Volume 2

[Page 240]

[Page 241] Version 1.04 User Manual English MI68-03116A

[Page 242]

[Page 243] Table of Contents 1 Table of Contents – Volume 2 Chapter 6 – Image Managements Image Managements 3 Reviewing Images (CINE / LOOP) 3 Annotating Images 5 Text 5 Body Marker 7 Indicator 9 Saving and Transferring Images 11 Saving Images 11 Transferring Images 11 Printing and Recording Images 12 Printing Images 12 Recording Images 12 SONOVIEW 13 Starting SONOVIEW 13 Exam View 15 Exam Review 20 Chapter 7 – Maintenance System Maintenance 3 Installation Requirements 3 Cleaning and disinfections 4 Fuse Replacement 6 Cleaning The Air Filters 7 Accuracy Check 8 Administration of Information 9 User Setting Back up 9 Patient information Back-up 9 Software 9

[Page 244] 2 SONOACE X6 User Manual Chapter 8 – Probes Probes 3 Ultrasound transmission Gel 6 Sheaths 7 Probe Precautions 8 Cleaning and Disinfecting the Probe 9 Biplane Probe 22 Biopsy 24 Biopsy KIT Components 24 Using the Biopsy Kit 25 Cleaning and Disinfecting Biopsy Kit 27 Assembling the Biopsy Kit 29 ** Reference Manual Samsung Medison is providing an additional SONOACE X6 Reference Manual. GA tables and references for each application are included in the Reference Manual.

[Page 245] Chapter 6 Image Managements Image Managements 3 Reviewing Images (CINE / LOOP) 3 Annotating Images 5 Text 5 Body Marker 7 Indicator 9 Saving and Transferring Images 11 Saving Images 11 Transferring Images 11 Printing and Recording Images 12 Printing Images 12 Recording Images 12 SONOVIEW 13 Starting SONOVIEW 13 Exam View 15 Exam Review 20

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[Page 247] Chapter 6. Image Managements 6 - 3 Reviewing Images (CINE / LOOP) Images are automatically saved in the memory during scanning. The saved images can be useful when a patient is diagnosed and reviewed. The saved images can be in CINE or LOOP depending on the diagnosis mode. – CINE: Images that are saved in all modes other than M Mode and Spectral Mode. – LOOP: Images that are saved in M Mode and Spectral Mode. [Figure 6.1 Reviewing Images] ▌ Starting and Finishing Image Review During scanning, press the Freeze button on the control panel. The scanning is stopped and the system switches to the image review mode screen. Press the Freeze button again to return to the scan mode.

[Page 248] 6 - 4 SONOACE X6 User manual ▌ How to Review Images Use the Trackball on the control panel. You can search for saved images in chronological order by rotating the Trackball to the left or right. The number of images saved so far and the number of the image currently under review are displayed in the user information area. The Flexible Soft menu is changed when images are reviewed.  [1] Auto Run Use the Flexible Soft button [1] . CINE Mode or LOOP Mode is automatically played and repeated. To stop Auto Run, press this button again.  [2] CINE/LOOP Use the Flexible Soft button [2] . This option appears only when both CINE and LOOP are available, as in M Mode or Spectral Doppler Mode. You can select an image to play in CINE and LOOP by pressing the dial-button. The selection is displayed in the left side of the user information area.  [3] Cine Edit Use the Flexible Soft button [3] . Set the range of the Cine mode. When you press this button, the Flexible Soft button [3]~[5] is changed; – Set Cine start point: press the Flexible Soft button [3] Frame Start and set the start point using the Set button. – Set Cine end point: press the Flexible Soft button [4] Frame End and set the start point using the Set button. – Finish setting: press the Flexible soft button [5] Cine Save to save the start and the end point. ※ Tip! Set using the Change button Set the start point using the Set button and press the Change button to set the end point  [4] Cine Save Use the Flexible Soft button [4] . Save the Cine whole Cine images.  [5] Speed (%) Use the Flexible Soft button [5] . Change the speed of Auto Run. When you press this button repeatedly, it changes as 10%, 40%, 70% and 100%. ▌ Reviewing Images in Multi-Image Mode Only images in an active area can be reviewed in multi-image mode. To review images in another area, change the active area by using the Set or the Dual button on the control panel.

[Page 249] Chapter 6. Image Managements 6 - 5 Annotating Images Text You can enter comments or text over an image. This function can be useful when the diagnosis area is differentiated or displayed. ▌ Starting Text Input Mode Press the [F1] Text button in the Alphanumeric Keyboard. The system will switch to text input mode. [Figure 6.2 Text Input Mode]

[Page 250] 6 - 6 SONOACE X6 User manual ▌ Typing Text 1. Move the cursor by using the Trackball on the keyboard. 2. Enter text by using the Alphanumeric Keyboard. While entering text, the keys in Alphanumeric Keyboards have the specific functions shown below. Move the cursor position up by one row on the same column of the [↑] Key current cursor. Move the cursor position down by one row on the same column of the [↓] Key current cursor. Move the cursor position to the left by one column on the same row [←] Key of the current cursor. Move the cursor position to the right by one column on the same row [→] Key of the current cursor. ▌ Autotext This function allows you to enter text automatically by using an abbreviation. In this way, you can enter text easily and quickly. When Autotext is enabled, the autotext list appears on the screen. [Figure 6.3 The Autotext List] NOTE Select [8] Setup > System > General > Autotext Set ▌ Deleting Text Press the Clear button on the control panel. All the text entered on the screen will be deleted. ▌ Exiting Text Input Mode Press Exit on the control panel or the [F1] Text key on the keyboard.

[Page 251] Chapter 6. Image Managements 6 - 7 Body Marker You can place a Body Marker over an image. This function can be useful when the diagnosis area is differentiated or displayed. [Figure 6.4 Body Marker]

[Page 252] 6 - 8 SONOACE X6 User manual ▌ Starting Body Marker Input Mode Press the Body Marker button on the control panel. The system will switch to Body Marker input mode and Body Markers will appear in the user information area. ▌ Entering Body Marker 1. Body markers will appear on the Flexible Soft menu. – The types of Body Marker shown in the Flexible Soft Menu vary with the diagnosis mode. – A maximum of 5 body markers are displayed on the screen at any one time. When there are more Body Markers than this, press the Body Marker button repeatedly to move to other pages. 2. Press the Flexible Soft button for the Body Marker that you want. The Body Marker will appear in the image. 3. Position the probe cursor on the Body Marker using the Trackball . 4. Use the Angle dial on the control panel to adjust the angle of the probe cursor. 5. Press the Set button to finish. Press the Exit button to cancel. ▌ Changing Body Marker Position 1. Press the Change button on the control panel. 2. Move the Body Marker to a desired position by using the Trackball . 3. Press the Change button on the control panel again to confirm the new position. ▌ Deleting Body Marker Press the Clear button on the control panel. ▌ Exiting Body Marker Input Mode Press the Exit button on the control panel. Select ‘On’ in Setup> System >Display > Bodymarker After Freeze to NOTE start Bodymarker input mode automatically when pressing the Freeze button.

[Page 253] Chapter 6. Image Managements 6 - 9 Indicator You can place an Indicator over an image. This function can be useful when the diagnosis area is differentiated or displayed. You can place one or more Indicators on specific positions. [Figure 6.5 Indicator Display]

[Page 254] 6 - 10 SONOACE X6 User manual ▌ Starting Indicator Input Mode Press the Indicator button on the control panel. The system will switch to the Indicator input mode. ▌ Entering Indicator 1. Press the Indicator button on the control panel and an Indicator will appear on the screen. 2. Move the Indicator to a desired position by using the Trackball . 3. Adjust the Indicator direction by using the Angle dial on the control panel. 4. Press the Set button to finish. Press the Exit button to cancel. ▌ Deleting Indicator Press the Clear button on the control panel and all Indicators displayed on the screen will be deleted. Press the Flexible Soft dial-button [1] Undo to delete the last entered indicator only.

[Page 255] Chapter 6. Image Managements 6 - 11 Saving and Transferring Images Saving Images Press the Save button on the control panel. Images are stored and managed according to patients. Therefore, if the Save button is pressed without entering basic patient information, a window to enter patient information appears. General images, 3D images, etc. can be saved, TM and then edited and managed with SONOVIEW . Ensure a patient ID is entered, since images are saved according to the ID. If WARNING not, an image can be lost, and serious errors can occur in the previously saved images. ▌ Saving an Image with Text NOTE It’s convenient to save an image with description for later search. For more information about entering text, refer to ‘Annotating Images’ in this chapter. Transferring Images Send images using DICOM. For more information on the DICOM server settings and DICOM operation, see the section on “Setting DICOM” in ‘Chapter 3. Settings’. ▌ Transferring Images in Real Scan Mode There are two methods of sending images: sending one scanned image at a time immediately after each scan, and sending selected images after the scanning process is complete. For more information about transferring images, see the section on “Transfer Mode” in ‘Chapter 3. Settings’. ▌ Transferring Images in SONOVIEW Select an exam in the Exam View screen to transfer all images in the exam, or select and transfer images one by one in the Exam Review screen. For more information, see the TM section on “SONOVIEW ” in this chapter.

[Page 256] 6 - 12 SONOACE X6 User manual Printing and Recording Images Printing Images Press the Echo Print button on the control panel to print out a scanned image using an echo- printer. For details on how to set-up a printer, refer to ‘Chapter 3. Settings’. Recording Images To record an image with the VCR during scanning, press the recording button of the connected standard VCR.

[Page 257] Chapter 6. Image Managements 6 - 13 SONOVIEW SONOVIEW used in the SONOACE X6 is an integrated image management system. The Personal Computer or Embedded PC loaded into the product supports the system. A variety of functions are provided in SONOVIEW: Saving/Filing of specific images, image viewing, deleting images one by one, and exporting documents with a standard PC. The file types used in this system follow the international standard DICOM (Digital Imaging and Communication in Medicine). As a result, the PACS (Picture Archiving Communication System) can be implemented in the SONOACE X6 without any additional costs, and it’s easy to exchange documents with other hospitals or equipment. (cf. DICOM and PACS are well established in advanced countries, but not yet in Korea.) This system supports the Bitmap file format (ie. *. BMP), which is most commonly used on standard office PCs. It is therefore easy to exchange data on images. Thanks to these functions, SONOVIEW has enabled systematic management and research of patient medical history. Starting SONOVIEW Press the SONOVIEW button on the control panel. If the ID has already been entered, the images saved during the current examination will be displayed on the Review screen. [Figure 6.6 SONOVIEW - Review]

[Page 258] 6 - 14 SONOACE X6 User manual  If the ID has not yet been entered, the patient information window will be displayed prior to saving the images. Please enter the ID in the patient TM information window before saving the images or using SONOVIEW .  Each patient’s data is identified by the patient’s unique ID. For efficient management of IDs, we recommend the use of the patients’ chart numbers or the last 6 digits of patients’ social security numbers.

[Page 259] Chapter 6. Image Managements 6 - 15 Exam View If you select an icon on the Exam View screen, the name of icon will be displayed. ▌ Starting Exam View Press Exam Search on the Review screen. The Exam View screen appears. [Figure 6.7 Exam View Screen] In the center of the Exam View screen is the exam list with information on the patients’ IDs, names, age, genders, examination dates, and the number of images saved. On the top right- hand corner of the screen are the total number of examinations, number of selected examinations, number of selected images and the size of selected images. ▌ Selecting Exam Use the trackball and the Set button to select an examination. To cancel the exam selection, press the Set button once again. Press Select All to select all examinations at once, or press Deselect All to deselect all exams. To view exams saved in a storage devices, select Hard drive, MO drive, FLASH, or ODD from Source on the screen. Selecting a source brings up information on the used space and total space for the source.

[Page 260] 6 - 16 SONOACE X6 User manual ▌ Searching Exam Enter the patient’s ID, name, and exam date, and press Search to bring up an exam list with examinations that are identical or similar to the search conditions. You can search exams using as little as a single character or number for your search string. ■ Search i ng by Period Select a period from the combo box at the top of the exam List. Today, 1Week, 1Mon, 3Mon, and 1Year show the exams for the respective periods dating back from the current date, and All Exams shows all examinations. ■ Showing All Exam Select Show All at the top of the exam list. All exam lists saved in the selected source will be displayed. ▌ View Exam Use the trackball and the Set button to select an exam to view, and then press Review Exam at the top of the screen. The screen will switch to the Review screen and show images for the selected exam. ▌ Deleting Exam Use the trackball and the Set button to select an exam to delete, and then press Delete Exam at the bottom of the screen or press the Del key on the keyboard. To select multiple images, select images while holding down the Ctrl button on the keyboard. ▌ Exam Export Multiple exams can be selected and exported simultaneously. 1. Select exam(s) and press Export to bring up the Export window. 2. Select MO drive, Flash Memory, or ODD as the destination drive for the export. Current directories and files in the selected drive will be displayed on the screen. 3. Select BMP, JPEG, TIFF, or DICOM as the file format. 4. Specify the file name. Exams and images share the same file name: if there are multiple images in the exam, each file name will end with a serial number. 5. Specify the directory name. After entering the directory name, press Make Directory to create a folder in the destination medium. The new folder will be reflected as a directory in the selected drive. To delete the directory, press Remove Directory .

[Page 261] Chapter 6. Image Managements 6 - 17 When you use the ODD, Make Directory and Delete Directory are not available. 6. Once all fields have been entered, press Export . To cancel, press X at the top right-hand corner of the screen. [Figure 6.8 Exam Export] ▌ Exam Backup MO, ODD, and Flash Memory can be used. 1. Install the target medium for backup. – MO or ODD: Insert the medium in the drive and wait until the LED light goes out. – If using Flash Memory, connect it to the USB port on the front or rear panel of the product. 2. Select exam(s) and press Backup Exams 3. At the medium selection window, select MO, ODD or Flash and then press OK . Once the backup process is complete, you will be prompted whether to delete the exam(s) saved in the hard disk. Select your response for whether to delete or keep the exam(s). If you select “delete,” all backed up exam(s) will be deleted from the hard disk completely.

[Page 262] 6 - 18 SONOACE X6 User manual ▌ Exam Restore MO, ODD, and Flash Memory can be used. 1. Connect the MO, ODD, or Flash Memory with exam backup information to the product and wait until the LED light goes out. 2. Use Source at the top left-hand corner of the screen to select the connected medium. 3. When the saved exam list appears, select appropriate exam(s) and perform Review, Delete, DICOM Send and other necessary functions. Note that the Delete function cannot be performed when using ODD. To move exam(s) to the system hard disk, select the exam(s) and press Restore . ■ Using USB MO Drive USB MO drives can be connected to the USB port on the rear panel. Only one MO drive can be used at a time, and if two or more drives are connected, only one will be recognized. When you have finished using the drive, you must use the Eject function from Storage Manager to remove the MO disk or disconnect the drive after turning the product off. If you are using a new MO disk for the first time, use the ‘MO Format’ function from Storage Manager to format the disk first. ■ Using USB Flash Memory USB flash memory can be connected to the USB port on the rear panel. Only one flash memory can be used at a time. You do not need to format new USB flash memory. If you need to format the USB flash memory, ensure that the file system type used is ‘FAT’ or ‘FAT32.’ To disconnect the USB flash memory from the product, use the ‘Unplug’ function from Storage Manager to remove it from the product. ■ Using ODD Only one ODD drive can be used at a time. After using the ODD, use the Eject function from Storage Manager to eject the medium. If using a re-writable ODD, you can erase all recorded data using the Format function from Storage Manager.

[Page 263] Chapter 6. Image Managements 6 - 19 ▌ Sending Exam This function uses the DICOM network. The DICOM Send button will not work if the DICOM function is not configured. 1. Select exam(s) and press Send at the bottom of the screen. – If you want to add a new server after selecting exam(s), select Add from the DICOM Send window, enter the necessary information, and then press Ok. – Press Modify to view or edit the server information after selecting exam(s). – Select Delete to delete the server after selecting exam(s), or select Test to check the DICOM connection to the server. 2. When all steps are complete, press Send to send the selected exam(s) to the selected server. ▌ Printing Exam This function uses printer(s) on the DICOM network. DICOM Print will not work if the DICOM function is not configured. 1. Select exam(s) and press DI COM Print. 2. Steps for printing exams are the same as for sending exams.

[Page 264] 6 - 20 SONOACE X6 User manual Exam Review Saved images can be managed using measurement, printing, sending and many other functions. [Figure 6.9 Exam Review] If you select an icon on the Exam View screen, the name of icon will be displayed. ▌ Exam Information Patient names, IDs, and exam dates are displayed in the left-hand center of the Exam Review screen. ▌ Opened Exams This displays the list of exams currently in progress or exams selected from Exam View. If multiple exams are selected from Exam View, you can use the trackball and the Set button to quickly browse through the exams. For example, after selecting multiple exams from Exam View, press Review Exam to switch to the Review screen and bring up the list of selected exams in Opened Exams.

[Page 265] Chapter 6. Image Managements 6 - 21 ▌ Close Exam Closes the current exam(s). ▌ Exam Search The Exam View screen appears. You can browse through exams to select, change, save, send, or backup. For more information, see ‘Exam View.’ ■ Single Exam This displays all the images for selected exams in the order they are saved. Use the trackball over the Preview window at the bottom of the screen to select image(s) to show on the screen. Images will be numbered according to their order. ■ Compare Exams This function is useful for comparing multiple images. 1. Select images in the Preview window at the bottom of the screen. The border of selected images will go bright. 2. Place the cursor over the image display window and press the Set button on the control panel to display the image at the selected location. A maximum of 4 images can be compared at the same time. ▌ Selecting imaages and Full Screen Image View ■ Selecting Images Use the trackball on the control panel to move the cursor over an image and press the Set button. To select multiple images, use the trackball and the Set button while holding down the Ctrl key on the keyboard. ■ Full Screen Image View This displays a full screen view of one selected image. Place the cursor over the image and press the Set button on the control panel twice. To return to the Review screen, press the Exit button or press Close on the screen. When in full screen image view, use the arrows on the screen to navigate to the previous or next images.

[Page 266] 6 - 22 SONOACE X6 User manual ▌ Using Preview This function previews selected exam(s). Images displayed on the current screen are indicated with white borders. You can use the arrow buttons on the right to browse through the images if there are 4 or more images. ▌ Printing This function prints images or simple reports. 1. Press Print from the Exam Review screen. 2. Select settings from the Print window. – Column : sets the number of column of image – Row : sets the number of row of image – Portrait : sets the paper horizontally – Landscape : sets the paper vertically – Image Only : prints only images – Report Only : prints only report – Images and Report : prints both images and report 3. Press Ok and Print screen will be displayed. Select printer and paper. 4. Click Print to start printing. Press Cancel to cancel. ▌ Report You can query the report for the selected exam or enter new information in it. 1. Press Add Comments from the Exam Review screen. 2. Enter details in the Report window. 3. Press Ok to save the information. Press Cancel to cancel.

[Page 267] Chapter 6. Image Managements 6 - 23 ▌ DICOM Send (Optional) This function uses DICOM to send selected images. This button is deactivated for products that do not support the DICOM option. 1. Select image(s) and press DICOM Send on the Exam Review screen. 2. The number of selected images will be displayed on the screen. Press Ok to bring up the DICOM window. 3. After confirming the settings, press Send to send the image(s). Press Cancel to cancel. ▌ DICOM Printing (Optional) This function uses DICOM to print selected images. This button is deactivated for products that do not support the DICOM option. 1. Select image(s) and press DICOM Print on the Exam Review screen. 2. The number of selected images will be displayed on the screen. Press Ok to bring up the DICOM window. 3. After confirming the settings, press Print to print the image(s). Press Cancel to cancel. For more information on DICOM printers, please refer to the printer manual or the DICOM Conformance Statement. ▌ E-mail This function sends e-mails with image attachments. 1. Select image(s) and press E-mail on the Exam Review screen. 2. Enter the user’s name, e-mail address, the recipient’s e-mail address, subject and message. Please note that server names and e-mail addresses are case-sensitive. 3. Press Send to send the e-mail. Press Cancel to cancel. In order to use the E-mail function, you must specify the e-mail (SMTP) server and you must own an e-mail account on the mail server. You can specify the Outgoing Mail Server on the E-mail Setup screen. If e-mails cannot be sent even though the mail server is functional, check that NOTE the ICMP (ping) is open for the mail server. If the ICMP (ping) is closed, the e-mail function may not work properly.

[Page 268] 6 - 24 SONOACE X6 User manual ▌ Magnification This function magnifies a part of the image displayed on the screen. 1. Press Magnifier on the Exam Review screen. The mouse cursor changes to a magnifying glass shape. 2. Place the magnifying glass over an area and press the Set button. ▌ Delete Select image(s) and press Delete Image on the Exam Review screen. To delete many images at once, use Trackball and Set button during pressing Ctrl key on the keyboard. Current exam cannot be deleted. The deleted exams are not be recovered. ▌ Export This function saves the images in BMP, JPEG, TIFF or DICOM file formats. 1. Press Export on the Exam Review screen. The mouse cursor changes to a floppy diskette shape. 2. Place the floppy diskette shape over an area and press the Set button. The Export window will be displayed. 3. Enter the directory and file names for the image file(s) and press Export to save the images in the selected file format. Do not use blank spaces in file names or directory names. The Export NOTE function will not work for file names or directory names containing blank spaces. ▌ Text Use this function to insert text into the image. 1. Press Add Text on the Exam Review screen. 2. Place the cursor over the image and press the Set button. The image will be displayed in full screen view. 3. Move the cursor to a desired location and insert the text. To change the font size or color, press Font Style .

[Page 269] Chapter 6. Image Managements 6 - 25 ▌ Distance This function measures the distance between any two points on 2D images. 1. Press Distance on the Exam Review screen. 2. Place the cursor over the image and press the Set button. The image will be displayed in full screen view. 3. Move the cursor to a desired location and press the Set button to set the start point. 4. Use the trackball to move the cursor to another location and press the Set button to set the end point. Press the Change button before assigning the end point to change the position of the start point. The distance between the two points will be displayed on the screen. You can use the same method to take multiple measurements. Note that the measurement results are not saved with the image. To finish measurement, press the Exit button on the control panel or Close on the screen. ▌ Ellipse Use this function to draw an ellipse over the 2D image, and then measure the perimeter and area of the ellipse. 1. Press Ellipse on the Exam Review screen. 2. Place the cursor over the image and press the Set button. The image will be displayed in full screen view. 3. Move the cursor to a desired location and press the Set button to set the start point. 4. Use the trackball to move the cursor to another location and press the Set button to set the end point. Press the Change button before assigning the end point to change the position of the start point. 5. After adjusting the size of the ellipse, press the Set button to confirm the size of the ellipse. The perimeter and area of the ellipse will be displayed on the screen. You can use the same method to take multiple measurements. Note that the measurement results are not saved with the image. To finish measurement, press the Exit button on the control panel or Close on the screen.

[Page 270] 6 - 26 SONOACE X6 User manual ▌ Image Selection Window (Layout) Use this function to configure the number of images to show on the Exam Review screen. On the Exam Review screen, press Layout and select items from 1*1 to 3*3 in the Image Layout window. ▌ Closing SONOVIEW Press the X button on the screen. Alternatively, you can press the SonoView button or the Exit button on the control panel to close SonoView.

[Page 271] Chapter 7 Maintenance System Maintenance 3 Installation Requirements 3 Cleaning and disinfections 4 Fuse Replacement 6 Cleaning The Air Filters 7 Accuracy Check 8 Administration of Information 9 User Setting Back up 9 Patient information Back-up 9 Software 9

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[Page 273] Chapter 7. Maintenance 7 - 3 System Maintenance  The user must ensure that the safety inspections are performed every 2 years according to the requirements of safety standard EN 60601-1. Only trained persons are allowed to perform the safety inspections mentioned above.  The expected service life of this equipment is 7 years. Installation Requirements When installing:  Optimal conditions for the system are temperatures of 10 ° ~ 35 ° C and humidity of 30% ~ 75%.  Avoid humidity.  Avoid direct sunlight.  Avoid places with extreme temperature variations.  Avoid heat sources.  Avoid dusty and unventilated areas.  Avoid places where the system is likely to be exposed to vibration or impacts.  Avoid places where the system is likely to be exposed to chemical substances or gases. Placing the system near generators, X-Ray machines, or broadcast cables may CAUTION result in screen noise and abnormal visual images. Using the power source with other electric devices may also induce noise.

[Page 274] 7 - 4 SONOACE X6 User manual 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. ▌ Cleaning  Do not use a spray directly on the product exterior. It may cause cracks in the appliance, or the color to deteriorate.  Do not use chemical substances such as wax, benzene, alcohol, paint thinner, insecticide, aerosol deodorant, lubricant. ■ Console Use a soft cloth lightly dampened with a mild soap to clean the exterior surfaces of the system. ■ Cleaning Monitor Gently wipe the LCD surface with a soft, dry cloth. For information on cleaning and disinfection of the probe & biopsy kit, please refer to Chapter 8 “Probes.”

[Page 275] Chapter 7. Maintenance 7 - 5 ▌ Disinfection CAUTION Use only recommended disinfectants on system surfaces. 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. Solutions Country Type Active ingredient FDA 510(k) Cidex USA Liquid Gluteraldehyde K934434 Cidex Plus USA Liquid Gluteraldehyde K923744 1. Turn off the system and disconnect the system power cord from 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 instructions for wipe durations, solution strength, and disinfectant contact duration. 4. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label.

[Page 276] 7 - 6 SONOACE X6 User manual Fuse Replacement The power protection fuse protects the product from excess current. If the power 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. To avoid risk of electric shock, always disconnect the plug from the system DANGER prior to fuse replacement. [Figure 7.1 Fuse replacement] 1. Disconnect the power cord from the system. (See ① ) 2. Take the fuse out by pressing the middle of fuse. (See ② ) 3. Insert the fuse holder into the appliance inlet. 4. After installing the new fuse, connect the power cord to the system. Fuse information is shown in the following table. Input Ratings Fuse Ratings Company Order No. 100-120VAC T8A/250V Schurter 0001.2515 200-240VAC T5AL/250V Orisel 50T2505A

[Page 277] Chapter 7. Maintenance 7 - 7 Cleaning The Air Filters The air filters minimize the indraft of dust. Clean the air filter to ensure that a clogged 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. 1. Pull the filter under the front of the console to away from the product. 2. Shake the filter to remove the dust and wash in a mild soapy solution. 3. Rinse and air dry or dry with a cloth. 4. Slide the filter back into the product. [Figure 7.2 The location of the air filters] Allow the wet filter to dry thoroughly before installing. The wet filter can cause the malfunction.

[Page 278] 7 - 8 SONOACE X6 User manual 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 optimal operation of the product, perform an accuracy check every year. The equati- ons and table related to measurement accuracy are included in “Chapter 5 Measurements” in this manual.

[Page 279] Chapter 7. Maintenance 7 - 9 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. User Setting Back up Always keep a backup copy of all information related to the user settings in case of data loss. Clients cannot back-up the user settings of the product. Contact the Samsung Medison Customer Service Department to attain support for back-up. However, clients may back up the user setting on GA Table used in obstetrics diagnosis. For further information please refer to ‘Chapter 3. Settings’. Patient information Back-up The SonoView program can be used for backing up patients’ basic information and scanned images. The user can choose to save the data, and the data is also saved in the system by default. If the system needs to be reinstalled due to product failure, etc., the Samsung Medison customer support staff will restore the patients’ basic information and scanned images that are saved in the system. For more information on this, see ‘Chapter 6. Image Managements’. Software The product software may be updated to enhance performance. The user cannot make any changes to the software. Please contact the Samsung Medison customer service representative for help in software changes. Minor software updates may be carried out without the prior notice from the manufacturer. Should errors occur in the operating system (Linux), and should you desire to upgrade the operating system, please follow the instructions of the operating system manufacturer. This product uses the Windows firewall to prevent any hacker or malicious software from accessing the system through the internet or network.

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[Page 281] Chapter 8 Probes Probes 3 Ultrasound transmission Gel 6 Sheaths 7 Probe Precautions 8 Cleaning and Disinfecting the Probe 9 Biplane Probe 22 Biopsy 24 Biopsy KIT Components 24 Using the Biopsy Kit 25 Cleaning and Disinfecting Biopsy Kit 27 Assembling the Biopsy Kit 29

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[Page 283] Chapter 8. Probes 8 - 3 Probes The probe is a device that sends and receives ultrasound for acquiring image data. It is also called a Transducer or Scanhead.The ultrasonographic image scanner uses the image data received by the probe to display the images of each organ on the screen. For best quality images, select the appropriate probe for the each application. The system limits patient contact temperature to 43 degrees Celsius, and acoustic power 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 designed to keep patient contact surface temperature under 43 degrees Celsius in the event of a single fault failure. ▌ Probe List The ultrasound image scanner uses probes to obtain graphic data of the human body and then displays it on the screen. Always use application-specific probes in order to obtain the best quality images. It is also important to configure the probe with the best settings for the particular organ being scanned. ■ Probe Application and Preset Probes, applications and settings available for this product are as follows: Product Applications C2-5 General, OB, Gynecology, Abdomen, Fetal Heart, Renal C2-5EP General, OB, Gynecology, Abdomen, Fetal Heart, Renal C2-4ES General, Abdomen C2-8 General, OB, Gynecology, Abdomen, Fetal Heart, Renal C3-7EP General, OB, Gynecology, Abdomen, Fetal Heart, Renal C4-9ED General, Pediatric, Vascular, Neonatal HL5-12ED General, Breast, Small Parts, Vascular, Musculoskeletal L3-8 General, Small Parts, Vascular L5-12EP General, Breast, Small Parts, Vascular, Musculoskeletal L5-12/50 General, Breast, Small Parts, Vascular, Musculoskeletal

[Page 284] 8 - 4 SONOACE X6 User manual Product Applications L5-12/50EP General, Breast, Small Parts, Vascular, Musculoskeletal LN5-12 General, Breast, Small Parts, Vascular, Musculoskeletal ER4-9/10ED General, OB, Gynecology, Urology EV4-9/10ED General, OB, Gynecology, Urology NER4-9ES General, OB, Gynecology, Urology NEV4-9ES General, OB, Gynecology, Urology BCC4-9 General, Urology P2-4AH General, Abdomen, Cardiac, Pediatric, TCD P3-7AC General, Cardiac, Pediatric SP3-8 General, Cardiac, Pediatric CW2.0 General, Cardiac CW4.0 General, Pediatric, Cardiac  Besides, user can have or select own preset between User1-5.  Refer to ‘Chapter3. Setting’ for how to set probe and its preset.

[Page 285] Chapter 8. Probes 8 - 5 ▌ TI Table TI (Thermal Index) is displayed on the title of the screen and shows the estimate of the temperature increase in specific body tissues. The thermal index consists of the following indices: soft tissue (TIs), bone (TIb), and cranial bone (Tic). This product will show the TI automatically by the probe and application. See the following table. Application Probe Renal TCD General OB Early Cardiac Breast Vascular Urology Neonatal Pediatric Obstetrics Abdomen Fetal Heart Small Parts Gynecology Musculoskeletal C2-5 TIs TIb TIs TIs TIs TIb TIs C2-5EP TIs TIb TIs TIs TIs TIb TIs C2-4ES TIs TIs C2-8 TIs TIb TIs TIs TIs TIb TIs C3-7EP TIs TIb TIs TIs TIs TIb TIs C4-9ED TIs TIs TIc TIs HL5-12ED TIs TIs TIs TIs TIs L3-8 TIs TIs TIs L5-12EP TIs TIs TIs TIs TIs L5-12/50EP TIs TIs TIs TIs TIs L5-12/50 TIs TIs TIs TIs TIs LN5-12 TIs TIs TIs TIs TIs ER4-9/10ED TIs TIb TIs TIs EV4-9/10ED TIs TIb TIs TIs NER4-9ES TIs TIb TIs TIs NEV4-9ES TIs TIb TIs TIs BCC4-9 TIs TIs

[Page 286] 8 - 6 SONOACE X6 User manual Application Probe Renal TCD General OB Early Cardiac Breast Vascular Urology Neonatal Pediatric Obstetrics Abdomen Fetal Heart Small Parts Gynecology Musculoskeletal P2-4AH TIs TIs TIs TIs TIs P3-7AC TIs TIs TIs SP3-8 TIs TIs TIs CW2.0 TIs TIs CW4.0 TIs TIs TIs Ultrasound transmission Gel Using an inappropriate ultrasound gel may damage the probe. For proper transmission of the acoustic beam, only use ultrasound transmission gel only approved by Samsung Medison. Refer to the table of ‘Cleaning and Disinfecting the Probe’ section in ‘Appendix A Maintenance’ for detail.  The use of inappropriate ultrasound gels could result in damages in the probe. Using damaged probe could cause injuries such as electric shock in users or patients.  Do not use ultrasound gels or contact media that contain the following contents. – Oils such as mineral oil, cooking oil, gasoline, solvents, rust inhibitors, lanolin, paraffin-based grease, ester and excessive silicon-based release agent. – Alcohols such as acetone, methanol, plasticizer (dioctylphtalate) or denatured alcohols. – Glacial acetic acid and iodine.  All types of lotions or gels that contain aromatic substances.

[Page 287] Chapter 8. Probes 8 - 7 Sheaths Sheaths are recommended for clinical applications of an invasive nature, including intraoperative, transrectal, transvaginal, and biopsy procedures. Samsung Medison does not supply sheaths so that you should purchase appropriate ones on your own.  Always keep sheaths in a sterile state.  Sheaths are disposable. Do not reuse them.  If sheaths are torn or soiled after use, wash and disinfect the probe.  In neurosurgical applications, a disinfected probe must be used with sterile gel and a sterile pyrogen-free sheath.  If the sterile sheath becomes compromised during neurosurgical applications involving a patient with Creutzfeldt-Jakob disease, the probe cannot be successfully sterilized by any disinfection method.  Some sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Please refer to the FDA Medical Alert released on March 29, 1991. ▌ Installing the Sheath 1. Use sterile gloves. 2. Unpack the sheath and fill it with acoustic coupling gel. 3. Insert the probe into the sheath and pull the latex tip to cover the probe completely. If possible, cover the probe cable as well. 4. Ensure that there is no air bubble within the ultrasound gel. 5. If necessary, secure the sheath to the probe and the probe cable. 6. Dispose of the sheath after use.

[Page 288] 8 - 8 SONOACE X6 User manual 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 Samsung 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 chloride, and hydrogen peroxide.  Do not expose the probe to temperatures of +50 ° C or higher. ▌ Use and Infection Control of the Probe No neurosurgical treatments or examinations should be carried out on a patient with Creutzfeldt-Jakob disease (critical brain disease caused by virus). If the probe has been used on such a patient, it cannot be sterilized by any method whatsoever. Sufficient washing and disinfecting must be carried out for preventing infection. This is the responsibility of the user who manages and maintains the disinfection procedures for the equipment. Always use legally approved detergents and sheaths. 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 re-used 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.

[Page 289] Chapter 8. Probes 8 - 9 ▌ 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 Customer Support Department.Do not immerse the probe into liquid.  Do not immerse the probe into liquid  Do not drop the probe or apply mechanical shocks.  Inspect the housing, strain relief, lens and seal for damage, and check for any functional problem before and after each use. WARNING  Do not apply excessive force to twist, pull or bend 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 order to prevent the probe surface from overheating and to restrict the ultrasound power output.  The temperature of the product for making contact with patients is limited under 43°C. The ultrasound power output (AP&I) is in compliance with US FDA standards. Cleaning and Disinfecting the Probe  Always use protective eyewear and gloves when cleaning and disinfecting probes.  Inspect the housing, strain relief, lens and seal for damage, and check for any functional problem after cleaning and disinfecting the probe. Using an inappropriate detergent or disinfectant may damage the probe. Only use the disinfect and disinfectants approved by the country ’ s government in Canada.

[Page 290] 8 - 10 SONOACE X6 User manual ▌ Information of Detergent, Disinfectant, and Ultrasound Gel Use an appropriate one with following tables. All probes are under tested in IPX 7 Criteria. 7) T-Spray T-Spray II Cidex 2% Setptiwipes Ster-Bac Blu CaviWipes MetriWipes Sani-Cloth HB Sani-Cloth Plus Incidin Foam Asepti-Wipes Asepti-Wipes II Sani-Cloth Active Clieanisept Wipes Trasneptic Spray Super Sani-Cloth Sani-Cloth Germicidal Type S S W W W W W L S S W W W W W W L IPA NA (N-Alkyl) Quaternary Ammonium C2-5 ● ● ● C2-5EP ● C2-4ES ● ● ● C2-8 ● ● C3-7EP ● ● C4-9ED ● ● HL5-12ED ● ● L3-8 ● ● ● L5-12EP ● L5-12/50 ● ● L5-12/50EP ● ● LN5-12 ● ● ● ER4-9/10ED ● ● ● EV4-9/10ED ● ● ●

[Page 291] Chapter 8. Probes 8 - 11 7) T-Spray T-Spray II Cidex 2% Setptiwipes Ster-Bac Blu CaviWipes MetriWipes Sani-Cloth HB Sani-Cloth Plus Incidin Foam Asepti-Wipes Asepti-Wipes II Sani-Cloth Active Clieanisept Wipes Trasneptic Spray Super Sani-Cloth Sani-Cloth Germicidal Type S S W W W W W L S S W W W W W W L IPA NA (N-Alkyl) Quaternary Ammonium NER4-9ES ● ● ● NEV4-9ES ● ● ● BCC4-9 ◆ ◆ ◎ ▣ ▲ ▣ P2-4AH ● ★ ● P3-7AC ● ● ● SP3-8 ● ● ● CW2.0 ● ● ● CW4.0 ●

[Page 292] 8 - 12 SONOACE X6 User manual 3) 2, 7) 2, 7) 2, 3, 6, 7) Milton Nuclean Metricide Cidex Plus Omnicide (28) Omnicide 14NS Omnicide - FG2 Wavicide-01 Sekusept Extra Salvanios pH 7 Steranios 2% Sekusept Plus Bleach 5.25% Salvanios pH10 Cidex OPA Surfaces Hautes Type L L L L L L L L L L L L S L L L Glutaraldehyde Nonionic surfactant Ortho-phthalaldehyde Sodium Hypochlorite C2-5 ● ● ● C2-5EP ● ● ● C2-4ES ★ ● ● ● C2-8 ● ● ● ● ● C3-7EP ● ● ● ● C4-9ED ● ● ● ● ● HL5-12ED ● ● ● x ● L3-8 ● ● ● ● ● ● L5-12EP ● ● ● L5-12/50 ● ● ● ● ● ● L5-12/50EP ● ● ● ● LN5-12 ● ● ● ● ● ● ER4-9/10ED ● ● ● ● ● ● EV4-9/10ED ● ● ● ● ● ● NER4-9ES ● ● NEV4-9ES ● ●

[Page 293] Chapter 8. Probes 8 - 13 3) 2, 7) 2, 7) 2, 3, 6, 7) Milton Nuclean Metricide Cidex Plus Omnicide (28) Omnicide 14NS Omnicide - FG2 Wavicide-01 Sekusept Extra Salvanios pH 7 Steranios 2% Sekusept Plus Bleach 5.25% Salvanios pH10 Cidex OPA Surfaces Hautes Type L L L L L L L L L L L L S L L L Glutaraldehyde Nonionic surfactant Ortho-phthalaldehyde Sodium Hypochlorite BCC4-9 ▲ ◇ ▣ ▣ P2-4AH ● ● ● ● P3-7AC ★ x ● ● ★ ● ★ SP3-8 CW2.0 ★ ● ● ● CW4.0 ● ● ●

[Page 294] 8 - 14 SONOACE X6 User manual Disinfectants Cleaner 3) Virkon Sporox Enzol Hibitane Sporox Gigasept PeraSave Alkazyme Cidezyme Klenzyme Isopropyl Isopropyl Gigasept FF Gigasept AF alcohol(70%) alcohol(80%) Type L L L L L L L P L L L L NA NA solution Alcohol formaldehyde Bersteinsaure Peracetic Acid Hydrogen Peroxide Succindialdehyde, Proteolytic Enzymes Chlorhexidine gluconate Sodium Xylene Sulfonate Dodecylphenolethoxylate, C2-5 ● ● ● ● C2-5EP ● ● ● C2-4ES ● x x ● ● ● x C2-8 ● ● C3-7EP x ● ● C4-9ED x ● ● x HL5-12ED x ● ● x L3-8 ● ● ● ● L5-12EP x ● ● L5-12/50 ● ● ● ● L5-12/50EP x ● ● x LN5-12 ● ● ● ● ER4-9/10ED ● ● ● EV4-9/10ED ● ● ● NER4-9ES ●

[Page 295] Chapter 8. Probes 8 - 15 Disinfectants Cleaner 3) Virkon Sporox Enzol Hibitane Sporox Gigasept PeraSave Alkazyme Cidezyme Klenzyme Isopropyl Isopropyl Gigasept FF Gigasept AF alcohol(70%) alcohol(80%) Type L L L L L L L P L L L L NA NA solution Alcohol formaldehyde Bersteinsaure Peracetic Acid Hydrogen Peroxide Succindialdehyde, Proteolytic Enzymes Chlorhexidine gluconate Sodium Xylene Sulfonate Dodecylphenolethoxylate, NEV4-9ES ● BCC4-9 ◎ ◎ ◎ ▲ P2-4AH ★ ● ● P3-7AC x x x ★ ● ● x SP3-8 CW2.0 ● x x ● ● ● x CW4.0 ● ●

[Page 296] 8 - 16 SONOACE X6 User manual Cleaner Gel 3) Scan Kendall Sonogel Metrizyme McKesson Ethanol 75% Natural Image Contact Gel Clear Image Wavelength GE Ultrasound Aquasonics 100 Type L L L G G G G G G G G NA PCMX Alcohol (Chloroxylenol) Propylene Glycol Ammonium Chlorides C2-5 ● ● C2-5EP ● C2-4ES ● ● C2-8 ● ● C3-7EP ● ● ● C4-9ED ● ● HL5-12ED ● ● L3-8 ● ● ● L5-12EP ● ● L5-12/50 ● ● ● L5-12/50EP ● ● ● LN5-12 ● ● ● ER4-9/10ED ● ● ● EV4-9/10ED ● ● ● NER4-9ES ● NEV4-9ES ●

[Page 297] Chapter 8. Probes 8 - 17 Cleaner Gel 3) Scan Kendall Sonogel Metrizyme McKesson Ethanol 75% Natural Image Contact Gel Clear Image Wavelength GE Ultrasound Aquasonics 100 Type L L L G G G G G G G G NA PCMX Alcohol (Chloroxylenol) Propylene Glycol Ammonium Chlorides BCC4-9 ● ● ● P2-4AH ● ● ● P3-7AC ● ● SP3-8 ● ● CW2.0 ● ● CW4.0 ●

[Page 298] 8 - 18 SONOACE X6 User manual ※ Symbols (1) Compatible but no EPA Registration (2) FDA 510(k) cleared (3) Has CE mark (4) Discontinued (5) Under Development (6) ANVISA Registered Health Canada Approved; (7) CaviWipes (DIN: 02242209), Cidex OPA (DIN: 02239732), Cidex Plus (DIN: 02158396), Metricide (DIN: 01963996) 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 a e 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)

[Page 299] Chapter 8. Probes 8 - 19 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) Isopropyl alcohol (70%) Local drugstore None 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) Milton Product & Gamble Australia Pty. Ltd. +61-1800-028-280(Australia) +1-800-526-3867(USA) Nuclean Nation Diagonostics Co. +44(0)-148-264-6020(UK) Omnicide Cottrell Ltd. +1-800-843-3343 (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. +1-319-656-4447(Worldwide) Virkon Antec International LTD. +1-403-286-1771(USA) Wavicide Wave Energy System Inc. +1-800-252-1125(USA)

[Page 300] 8 - 20 SONOACE X6 User manual ▌ Cleaning Cleaning is an important procedure that is carried out before disinfecting the probe. The probe must be cleaned after each use.  Do not use a surgical brush when cleaning probes. 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 prevent liquid from entering non-liquid-tight areas of the probe. 1. Disconnect the probe from the system. 2. Remove any biopsy adapters or biopsy needle guides. (Biopsy adapters are re-usable 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 dry cloth. 7. If necessary, wipe first with a water-dampened clothe to remove soap residue. ▌ Disinfection -6 Only disinfect vaginal and rectal probes. A 10 reduction in pathogens should be reached following the disinfection procedures in this Manual and using the following Samsung Medison recommended solutions.  If a pre-mixed solution is used, be sure to observe the solution expiration date.  The type of tissue it will contact during use dictates the level of disinfection required for a device. Ensure that the solution strength and duration of contact are appropriate for disinfection.

[Page 301] Chapter 8. Probes 8 - 21  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-Samsung Medison -approved methods. 1. Follow the instructions on the disinfectant label for storage, use and disposition of the disinfectant. 2. Mix the disinfectant compatible with your probe according to label instructions for solution strength. 3. Immerse the probe into the disinfectant as shown in the illustration below. 4. Using the instructions on the disinfectant, rinse the probe after the immersion process is complete. 5. Air dry the probe or towel it dry with a clean cloth. [Figure 8.1 Disinfection]

[Page 302] 8 - 22 SONOACE X6 User manual Biplane Probe The Biplane probe allows you to scan two objects simultaneously using two elements. It is mainly used in urology. ▌ Configuration The following illustration shows the Biplane probe with its two elements. ① Horizontal element ② Vertical element [Figure 8.2 Biplane Probe] NOTE The biopsy function is only available using the vertical element.

[Page 303] Chapter 8. Probes 8 - 23 ▌ Connecting and Removing The Biplane probe is connected using a probe connector and a dedicated Biplane probe connector. ① Main connector ② Sub connector [Figure 8.3 Connecting Biplane Probe] You must observe the following instructions for connecting and removing the probe. Otherwise, you may cause serious damage to the probe. ■ Connecting the Probe First, connect the sub connector ( ② ) and then connect the main connector ( ① ). ■ Removing the Probe First remove the main connector, and then remove the sub connector.

[Page 304] 8 - 24 SONOACE X6 User manual Biopsy A biopsy is an examination method that surgically extracts tissue from the patient for examination. The probe and the biopsy kit are used together when conducting a biopsy with the ultrasonographic image scanner. The ultrasound system shows the needle, which penetrates through the skin surface and veins, along with the examination location, minimizing the risk to the patient. Biopsy KIT Components The biopsy kit consists of the adapter, needle guide and needle. The components vary depending on the probe type. [Figure 8.4 Biopsy Kit Components] ‒ Adaptor: Secures the needle guide to the probe tightly. ‒ Needle Guide: Guides the angle (direction) of the needle so that it can reach the examination location accurately. It also secures the needle so that the needle is not loose. ‒ Needle: This is the needle that is inserted into the patient’s body. The biopsy kit supplied by Samsung Medison does not contain a needle. ‒ Sheath: Prevents the probe and adaptor from getting soiled by any unwanted substances during the examination (blood and other body fluids). ‒ Ultrasound Gel: The space between the probe and the sheath is filled with the ultrasound gel to obtain images of the best quality.

[Page 305] Chapter 8. Probes 8 - 25 Using the Biopsy Kit  Verify the condition of the biopsy needle before use. Do not use a bent biopsy needle.  The biopsy needle may bend during tissue penetration. The precise location of the needle must be checked by monitoring the echo generated WARNING from the needle.  Never use the biopsy kit to biopsy prostate tissue.  Verify the condition of the biopsy needle before use. Do not use a bent biopsy needle. ▌ Before Using Biopsy Kit Ultrasonographic scanning using the biopsy kit must be conducted by medical doctors or experienced medical staff with appropriate qualifications. Always, without fail, verify all safety prevention procedures and disinfection. Use only Samsung Medison -approved biopsy kits. Other bands may not properly fit Samsung Medison probes. Improper installation may result in patient discomfort. Inspect all components. Ensure that the biopsy kit you are using is the correct one for the probe, the system, and system software.  Do not attempt to use the biopsy until you read the instructions for installing the sheath and verifying alignment of the needle guide. WARNING  Always ensure that the probe and the needle guide are secured on both the left and the right.  Do not use in IVF, CVS, or PUBS procedures. ▌ Biopsy Procedure The system generates a needle guideline though the displayed real-time ultrasound images to indicate the anticipated path of the needle. You can use this guideline to ensure that the needle or instrument is following the correct path. 1. Ready the patient according to the procedure appropriate for the examination objectives. 2. Install the sheath and the biopsy kit. 3. Set the system controls for the biopsy procedure.If necessary, apply acoustic gel to the patient. 4. Begin scanning the patient. Adjust the patient so that the location for examination fits into the needle guideline on the screen. 5. Insert the needle into the needle guide. Perform the puncture by sliding the needle

[Page 306] 8 - 26 SONOACE X6 User manual through the groove in the guide until the needle intercepts the target. To keep the needle securely in the needle guide, press down on the top of the biopsy adapter with your index finger. 6. When the examination location is reached, take the needle out of the needle guide. 7. Detach the needle guide, adapter and sheath from the probe. 8. Dispose of the components that are not designed for reuse. ▌ Needle Guide Alignment Alignment of the needle guide displayed on the system is for the purpose of verifying whether the needle and the needle guide are properly installed. This must be done prior to the biopsy examination. Do not use the needle guide if the needle is not following the intended path. Contact Samsung Medison Customer Service Department for service. Reverberation or other tissue artifacts may produce false needle images which can cause confusion. Ensure the needle path is along the guideline, and that you are not using a false needle image to locate the needle.  The needle used for this alignment verification must not be used for the actual procedure. Always use a new, sterile needle for each biopsy procedure.  To assist in accurate projection of the needle, use a straight, new needle for each alignment procedure. 1. Attach the biopsy kit. 2. Set the system depth for the procedure to be performed and select the Biopsy menu. 3. Immerse the probe into the water bath, and insert the needle into the needle guide. 4. Confirm that the needle image is on the needle guidelines. If so, the needle guide is properly aligned. 5. If the needle image is out of the needle guideline, check the needle guide or the probe adapter.

[Page 307] Chapter 8. Probes 8 - 27 Cleaning and Disinfecting Biopsy Kit -6 Wash and disinfect the biopsy kit to reduce pathogens to the level of 10 . Some components of the biopsy kit may be disposable. Please read the biopsy kit user manual carefully before use. Refer to the table of ‘Cleaning and Disinfecting the Probe’ section in this chapter for detail. Always use protective eyewear and gloves when cleaning and disinfecting biopsy kit. ▌ Cleaning and disinfection of stainless steel biopsy kit ■ Cleaning 1. After use, remove the biopsy kit from the probe. 2. Disassemble the biopsy kit into its component parts, if applicable. 3. Using a small brush and water, scrub each part to remove trapped material from the biopsy kit. 4. Rinse with water to remove remaining particulates. ■ Disinfection 1. Disinfect the adapter by autoclaving (Steam) or using gas (Ethylene Oxide). 2. After disinfection, follow the proper post-disinfection procedure for the disinfection method used. (Please refer to the disinfection user manual, etc.) 3. Inspect the biopsy kit for damage such as cracks, rust or breakage. If damage is evident, discontinue use of the biopsy kit and contact Samsung Medison Customer Service Department. ▌ Cleaning and Disinfection of plastic biopsy kit ■ Cleaning 1. After use, remove the biopsy kit from the probe. 2. Disassemble the biopsy kit into its component parts, if applicable. Discard the single- use parts. These parts cannot be disinfected. 3. Using a small brush and water, scrub each part to remove trapped material from the reusable components. 4. Rinse with water to remove remaining particulates.

[Page 308] 8 - 28 SONOACE X6 User manual ■ Disinfection Plastic biopsy kits can only be disinfected using a chemically compatible cold-disinfectant. Disinfection by autoclaving or by using gas or radiation will cause damage to these parts. Please refer to the user manual of the disinfectant for storage, use, and disposition of the disinfectant. 1. Check the disinfection duration (generally 10 hours) and temperature of the disinfectant. 2. After disinfection, follow the proper post-disinfection procedure for the disinfection method used. 3. Inspect the components for damage such as cracks, rust or breakage. If damage is evident, discontinue use of the biopsy kit and contact Samsung Medison Customer Service Department. ■ Sterilization  If the material of the biopsy needle guide is plastic, only single use is possible.  Do not gas sterilize or autoclave biopsy adapter. Plastic biopsy adapter is reusable. Refer to the user instructions of the biopsy kit for details of sterilization.

[Page 309] Chapter 8. Probes 8 - 29 Assembling the Biopsy Kit ▌ C2-5 Biopsy Guide (Plastic) Model name BP-KIT-045 Biopsy Bracket 1 EA Needle Guide(16G) 6 EA Component Needle Guide(18G) 6 EA Needle Guide(20G) 6 EA Needle Guide(22G) 6 EA Material Acetal Copolymer Available Gauges 16G, 18G, 20G, 22G

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[Page 311] Chapter 8. Probes 8 - 31 ▌ C2-5Biopsy Guide (Metal) Model name BP-KIT-042 Biopsy Bracket 1 EA Needle Guide(16G) 6 EA Component Needle Guide(18G) 6 EA Needle Guide(20G) 6 EA Needle Guide(22G) 6 EA Material Stainless Steel Available Gauges 16G, 18G, 20G, 22G

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[Page 313] Chapter 8. Probes 8 - 33 ▌ C2-5EP Biopsy Guide Model name BP-KIT-021 Needle Guide 8 EA Material Polyurethane 1. Mount the Biopsy Adapter onto the probe.

[Page 314] 8 - 34 SONOACE X6 User manual 4. Choose a needle guide of the desired gauge and secure it to the adapter. 5. Insert the needle into the needle guide for use.

[Page 315] Chapter 8. Probes 8 - 35 ▌ C2-8Biopsy Guide Model name BP-KIT-035 Biopsy Bracket 1 EA Needle Guide 24 EA Material Acetal Copolymer

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[Page 317] Chapter 8. Probes 8 - 37 ▌ C3-7EP Biopsy guide Model name BP-KIT-025 Bracket 1EA Needle Guide 2EA Material Acetal Copolymer

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[Page 319] Chapter 8. Probes 8 - 39 ▌ BCC4-9 Biopsy Guide The biopsy function is only available using the vertical element. Model name BP-KIT-031 Component Adapter 1EA Material ABS Available Gauges 16 ~ 18G 1. Fill the sheath with the ultrasound gel and place the sheath all the way down to the probe. 2. Mount the adapter onto the probe. 3. Place the sheath all the way down to the probe and adapter.

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[Page 321] Chapter 8. Probes 8 - 41 ▌ HL5-12ED Biopsy guide Model name BP-KIT-022 Adapter 1EA Needle Guide Kit (Odd & Even Gauge Clip) 3EA/Each Body: Acetal Copolymer Material Screw: 303 Stainless ※ You can buy a pack of Adapter or needle guide kit. One pack is consisted of 24ea per each gauge. 1. Mount the Adapter onto the probe. 2. Insert gel into probe cover. And cover it.

[Page 322] 8 - 42 SONOACE X6 User manual 3. Install the needle guide onto the Adapter. 4. Lock the needle guide like (a), and do like (b). (a) (b) (c) 5. Press the needle guide like (c), and install the needle into the needle guide.

[Page 323] Chapter 8. Probes 8 - 43 ▌ L3-8 Biopsy Guide Model name BP-KIT-036 Adapter 1EA Needle Guide 24EA Material Acetal Copolymer

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[Page 325] Chapter 8. Probes 8 - 45 ▌ L5-12/50 Biopsy Guide (Plastic) Model name BP-KIT-047 Component Adapter , Needle Guide Material Plastic Available Gauges 16G, 18G, 20G, 22G Multi Angle 4 angle (20mm, 30mm, 40mm, 50mm)

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[Page 327] Chapter 8. Probes 8 - 47 ▌ L5-12/50 Biopsy Guide (Metal) Model name BP-KIT-048 Component Adapter , Needle Guide Material Stainless Steel Available Gauges 16G, 18G, 20G, 22G Multi Angle 4 angle (20mm, 30mm, 40mm, 50mm)

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[Page 329] Chapter 8. Probes 8 - 49 ▌ L5-12EP Biopsy Guide BP-KIT-023 Model name Needle Guide 8 EA Material Polyurethane adapter.

[Page 330] 8 - 50 SONOACE X6 User manual 4. Choose a needle guide of the desired gauge and secure it to the adapter. 5. Insert the needle into the needle guide for use.

[Page 331] Chapter 8. Probes 8 - 51 ▌ L5-12/50EP Biopsy Guide NOTE To purchase this biopsy kit, please contact the local office. Model name BP-KIT-020 Biopsy Adapter 1EA Needle Guide 8EA Material Polyurethane Available Gauges 16G, 18G, 20G 1. Insert gel into the cover for the Kit and cover the adapter completely. 2. Mount the needle guide for the desired gauge onto the adapter.

[Page 332] 8 - 52 SONOACE X6 User manual 3. Lock the needle guide.

[Page 333] Chapter 8. Probes 8 - 53 ▌ LN5-12 Biopsy Guide  Specification Model name BP-KIT-040 16Ga disposable needle guide/probe cover KIT 8EA 18Ga disposable needle guide/probe cover KIT 8EA 22Ga disposable needle guide/probe cover KIT 8EA Material Acetal Copolymer  Installation

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[Page 335] Chapter 8. Probes 8 - 55 ▌ EV4-9/10ED, ER4-9/10ED Biopsy Guide Model name BP-KIT-024 Sheath 2 EA Material Stainless 1. Fill the sheath with the ultrasound gel and place the sheath all the way down to the Adapter. And then tie with rubber band. 2. Mount the adapter onto the probe 3. Place the sheath again and tie with the rubber band again. Tie the lower part than 1.

[Page 336] 8 - 56 SONOACE X6 User manual ▌ NER4-9ES, NEV4-9ES Biopsy guide (Disposable Type) Model name BP-KIT-018 Package 24 EA Component Biopsy Adapter 1 EA Sheath 2 EA Material Plastic 1. Fill the sheath with ultrasound gel and insert the probe. 2. Mount the Adapter onto the probe. 3. Place the thin sheath on the adapter again and insert the needle into the needle guide for use.

[Page 337] Chapter 8. Probes 8 - 57 ▌ NER4-9ES, NEV4-9ES Biopsy guide (Reusable Type) Model name BP-KIT-019 Cleaning Brush 5 EA Material Stainless 1. Fill the sheath with ultrasound gel and insert the probe. 2. Mount the adapter to the probe and insert the needle.

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[Page 341] Diagnostic Ultrasound System Reference Manual Version 1.04 English

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