HS40-XH40-v1-05-00-00-en-us

[Page 1] SAMSUNG MEDISON DIAGNOSTIC ULTRASOUND SYSTEM Version 1.05 HS40/XH40 English Copyright © 2018 By SAMSUNG MEDISON CO., LTD. All rights reserved.

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[Page 3] PROPRIETARY 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 systems contain Samsung Medison 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.

[Page 4] Precautions for Use You should be familiar with all of these areas before attempting to use this manual or your ultrasound system. X Please refer to this user manual when using the system. X In particular, be sure to read the precautions for use, such as ‘Safety’ and ‘Maintenance’. X This manual does not include diagnosis results or opinions. Also, check the measurement reference for each application’s result measurement before making the final diagnosis. X Only medical doctors or persons supervised by medical doctors should use this system. Persons who are not qualified must not operate this product. X Samsung Medison is not responsible for any product issues caused by the user’s careless operation or negligence in maintenance. X Please note that orders are based on the individually agreed specifications and may not contain all features listed in the user manual. X Some ultrasound diagnosis systems, functions, options, or probes may not be available in certain countries. X All references to standards/regulations and their revisions are valid for the time of publication of the user manual. X The figures in the user manual for illustrational purposes only and may be different from what you see on the screen or device. X Information contained in this user manual is subject to change without prior notice. X Products that are not manufactured by Samsung Medison are marked with the trademark of their respective copyright holders. X Revised versions of this manual will be published to reflect any upgrades to the product. Please make sure that your operation manual is appropriate for your product version. X Please download the latest user manual from the company website at: http://www.samsunghealthcare.com 1. After signing up on the website, you can download the multilingual manual files by entering the Serial Number of the product, found on the ID Label on the back of the product purchased, in the Download section. 2. Product names and Revision numbers are indicated on the cover of all manuals. Please make sure that the manual you want matches the product’s Revision number before selecting your language.

[Page 5] Should you have questions regarding the product, please contact Samsung Medison’s Customer Service Department or your local vendor, or visit the following website. X Website: http://www.samsunghealthcare.com

[Page 6] Revision History VERSION DATE REASON FOR CHANGE v1.00.00-00 2017.03.01 Initial Release v1.00.04-00 2017.12.10 S/W Improvement v1.01.00-00 2017.10.30 S/W Improvement v1.01.03-00 2018.06.20 S/W Improvement v1.02.00-00 2019.01.16 S/W Improvement v1.02.01-00 2019.05.27 S/W Improvement v1.02.01-01 2019.06.28 S/W Improvement v1.03.00-00 2019.10.25 S/W Improvement v1.04.00-00 2021.01.31 S/W Improvement v1.05.00-00 2022.08.31 S/W Improvement

[Page 7] WARRANTY Samsung Medison provides the following warranty to the purchaser of this unit. This warranty covers all problems caused by faulty workmanship or faulty material. Samsung Medison will, as sole and exclusive remedy, replace any such defective unit returned to Samsung Medison within the designated warranty period. The warranty does not cover damages and loss caused by outside factors including, but not limited to, fire, flood, storm, tidal wave, lightning, earthquake, theft, abnormal conditions of operation, and intentional destruction of the equipment. Damage caused by equipment relocation is not covered. The warranty is void in cases where the equipment has been damaged as a result of an accident, misuse, abuse, dropping, or when attempts to modify or alter any part or assembly of the equipment have taken place. Parts with cosmetic defects or deterioration will not be replaced. Replacement of batteries, training materials, and supplies are not covered. Samsung Medison will not be responsible for incidental or consequential damages of any kind arising from or connected with the use of the equipment. Samsung Medison will not be responsible for any loss, damage, or injury resulting from a delay in services rendered under the warranty This limited warranty is in lieu of all other warranties expressed or implied, including warranties of merchant ability or fitness for any particular use. No representative or other person is authorized to represent or assume for Samsung Medison any warranty liability beyond that set forth herein. Defective equipment shipped from you to Samsung Medison must be packed in the replacement cartons. Shipping and insurance costs are the responsibility of the customer. To return defective material to Samsung Medison contact the Samsung Medison Customer Service Department. Samsung Medison or a local distributor will make available, upon request, circuit diagrams, a component parts list, descriptions, calibration instructions and other information which will assist your appropriately qualified technical personnel to repair those parts of the equipment which are designed by Samsung Medison as repairable. Subject to the applicable laws of the relevant territory, Samsung Medison reserves the right to accommodate service requests by (1) replacing the product presented for repair with a refurbished product of the same model or (2) repairing the product with refurbished parts. The refurbished products and parts shall be subject to the same inspection, quality control procedures as for new products and parts. CAUTION: United State federal law restricts this device to sale by or on the order of physicians. Manufacturer: SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA Customer Service Department: SAMSUNG MEDISON CO., LTD. Website: www.samsunghealthcare.com EC Representative: Samsung Electronics GmbH Am Kronberger Hang 6, 65824 Schwalbach am Taunus, GERMANY United States Agent: NEUROLOGICA CORPORATION 14 Electronics Avenue, Danvers, MA 01923 USA Service Center: +1 888-564-8561

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[Page 9] Safety Guidelines 1-3 Guidelines for Safe Usage 1-4 Safety Standards 1-5 Safety Symbols and Labels 1-7 Operational Environment Safety 1-10 Electrical Safety 1-11 Prevention of Electric Shocks 1-11 ECG-Related Information 1-13 ESD (ElectroStatic Discharge) 1-13 EMI (ElectroMagnetic Interference) 1-14 EMC (ElectroMagnetic Compatibility) 1-14 Electrical Safety Check 1-24 Accuracy Check 1-24 Mechanical Safety 1-25 Product Transfer and Brakes 1-25 Safety Precautions When Using the Product 1-26 Biological Safety 1-30 ALARA Principle 1-30 Maintenance 1-46 Cleaning and Frequency 1-46 Cleaning and Disinfection 1-47 Battery Pack Management 1-51 Replacing the Battery Pack 1-51 Recharging the Battery Pack 1-51 Disposing of the Battery Pack 1-52

[Page 10] Information Management 1-53 User Settings Backup 1-53 Patient Information Backup 1-53 Software 1-53 Network 1-54 Cybersecurity 1-56 Environmental Protection 1-57 Indications for Use 2-3 Contraindications 2-3 Product Specifications 2-4 Product Configuration 2-8 Monitor 2-10 Control Panel 2-12 Console 2-20 Peripheral Devices 2-22 Probes 2-27 Accessories 2-28 Optional Accessories 2-29 Optional Functions 2-30

[Page 11] Setup 3-3 System 3-3 Imaging 3-17 Application 3-24 Measurement 3-26 Report 3-43 Annotation 3-47 BodyMarker 3-51 Customize 3-55 Peripherals 3-60 Connectivity 3-67 Service 3-83 Help 3-83 Strain+ Image (Option) 3-84 Strain+ 3-85 Auto EF 3-92 TMAD 3-98 EzCompare™ 3-103 ECG (Option) 3-104 StressEcho (Option) 3-106 Setting up a Protocol 3-106 Starting a Protocol and Acquiring Images 3-111 Reviewing an Image 3-117 EzAssist™ (Option) 3-123

[Page 12] Probes 4-3 Ultrasound Transmission Gel 4-24 Using Sheaths 4-26 Probe Safety Precautions 4-27 Cleaning, Disinfecting, and Sterilizing the Probes 4-30 Biopsy 4-45 Biopsy Kit Components 4-46 Using Biopsy Kit 4-47 Assembling the Biopsy Kit 4-50 Cleaning and Disinfecting the Biopsy Kit 4-55 System Power 5-3 Powering On 5-4 Powering Off 5-5 Force Quit 5-6 Probes and Applications 5-7 Selecting Probes and Applications 5-8 Creating UserPreset 5-8 Modifying UserPreset 5-8 Deleting UserPreset 5-9 Patient Information 5-10 Searching Patient Information 5-18 Information 6-3 Types of Mode and Basic Usage 6-3 Basic Modes 6-6 2D Mode 6-6 S-Detect™ for Breast 6-29 M Mode 6-39

[Page 13] Color Doppler Mode 6-41 Power Doppler Mode 6-45 PW (Pulse Wave) Spectral Doppler Mode 6-47 CW (Continuous Wave) Spectral Doppler Mode 6-53 TDI (Tissue Doppler Imaging) Mode 6-55 TDW (Tissue Doppler Wave) Mode 6-56 ElastoScan™ Mode 6-57 Combined Modes 6-65 2D/C/PW Mode 6-65 2D/PD/PW Mode 6-65 2D/C/CW Mode 6-65 2D/PD/CW Mode 6-65 2D/C/M Mode 6-65 2D/TDI/TDW Mode 6-66 Dual Live Mode 6-66 Multi-Image Modes 6-67 Dual Mode 6-67 Quad Mode 6-68 3D/4D Mode 6-69 3D Mode 6-70 4D Mode 6-74 3D Stand By 6-76 3D View – MPR 6-78 5D Follicle™ 6-86 VOCAL (Virtual Organ Computer Aided Analysis) 6-89 3D XI 6-97 XI VOCAL 6-107 XI STIC (Spatio-Temporal Image Correlation) 6-114 3D Utility Menu 6-118

[Page 14] Measurement Accuracy 7-3 Causes of Measurement Errors 7-3 Optimization of Measurement Accuracy 7-5 Measurement Accuracy Table 7-7 Basic Measurements 7-9 Distance Measurement 7-12 Circumference and Area Measurement 7-21 Volume Measurement 7-24 Measurements by Application 7-27 Things to Note 7-27 Common Measurement Methods 7-30 OB Measurements 7-33 Fetal Heart Measurements 7-42 Gynecology Measurements 7-45 Cardiac Measurements 7-48 Abdomen Measurements 7-61 Pediatric Hips Measurements 7-63 Urology Measurements 7-65 Small Parts Measurements 7-66 MSK (Musculoskeletal) Measurements 7-70 Vascular Measurements 7-71 Report 7-81 View Reports 7-81 Report Preview 7-82 Editing Report (Worksheet) 7-84 Adding Comments 7-86 Printing Reports 7-86 Saving Reports 7-86 Store SR 7-86 Image 7-87 OB Graph 7-88 Description 7-92

[Page 15] Fetus Compare 7-93 Closing Reports 7-93 Cine 8-3 Annotating Images 8-5 Annotation 8-5 BodyMarker 8-8 Saving, Playing and Transferring Images 8-10 Saving Images 8-10 Playing Images 8-11 Transferring Images 8-12 Printing Images 8-13 Printing Images 8-13 SonoView Mode 8-14 Exam List 8-15 Review – Exam Mode 8-17 Review – Compare Mode 8-20 DICOM Q/R 8-24

[Page 16] Chapter 9 Appendix Technology and Design 9-3 ACE 9-3 CrystalLive™ 9-3 EC Transducer Holder 9-3 Gel warmer 9-3 Height-adjustable operating panel 9-3 HelloMom™ 9-3 Low noise 9-4 Measure Navigation 9-4 Monitor Arm 9-4 Solid State Drive (SSD) 9-4 Side storage 9-4 Reference Manual A Reference Manual (English) is supplied with this product.

[Page 17] Safety and Chapter 1 Maintenance ‹ Safety Guidelines 1-3 Guidelines for Safe Usage 1-4 Safety Standards 1-5 Safety Symbols and Labels 1-7 ‹ Operational Environment Safety 1-10 ‹ Electrical Safety 1-11 Prevention of Electric Shocks 1-11 ECG-Related Information 1-13 ESD (ElectroStatic Discharge) 1-13 EMI (ElectroMagnetic Interference) 1-14 EMC (ElectroMagnetic Compatibility) 1-14 Electrical Safety Check 1-24 Accuracy Check 1-24 ‹ Mechanical Safety 1-25 Product Transfer and Brakes 1-25 Safety Precautions When Using the Product ... 1-26 ‹ Biological Safety 1-30 ALARA Principle 1-30 ‹ Maintenance 1-46 Cleaning and Frequency 1-46 Cleaning and Disinfection 1-47

[Page 18] Chapter 1 ‹ Battery Pack Management 1-51 Replacing the Battery Pack 1-51 Recharging the Battery Pack 1-51 Disposing of the Battery Pack 1-52 ‹ Information Management 1-53 User Settings Backup 1-53 Patient Information Backup 1-53 Software 1-53 Network 1-54 Cybersecurity 1-56 ‹ Environmental Protection 1-57

[Page 19] Safety Guidelines The following terms are used to emphasize circumstances in which the user must take extra caution: DANGER: Disregarding this instruction may result in death, serious injury, or other dangerous situations. WARNING: Follow these warnings to prevent a serious accident or damage to property. CAUTION: Follow these instructions to prevent minor accidents and damage to property. NOTE: The accompanying information covers installation, operation, and maintenance procedures that require careful attention from the user, but have little chance of leading directly to a dangerous situation. 1-3

[Page 20] Guidelines for Safe Usage DANGER: X This product 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 medical devices. X This product must not be used for ophthalmological applications, or any other use that involves the ultrasound beam passing through the eyeball. X The manufacturer is not responsible for any injury or damage that may result from using the product for purposes not specified or not following the safety information. X Make sure that you use the three-dimensional ultrasound diagnostic imaging system for its intended purposes only, since using it for a long period of time for purposes other than diagnosing the fetus, such as keepsake images or videos, may have an adverse effect on the fetus. X According to the IEC 60601-2-37 Annex CC, when used for cardiac scanning, the lung surfaces may be exposed to ultrasonic beam; therefore, recommend minimizing the MI value. X Detergents or disinfectants may cause skin irritation. Avoid leaving residues on the product. 1-4

[Page 21] Safety Standards „ Classification X Type of protection against electric shocks: Class I or Internally powered ME equipment X Degree of protection against electric shocks (when the patient is in physical contact): Type BF applied part (Probes), Defibrillation-Proof Type CF applied part (ECG) X Degree of protection against the ingress of harmful liquids: Ordinary equipment (Ultrasound System), IPX7 (Probes), IPX8 (Foot Switch) X Degree of safety of use in the presence of flammable anesthetic agent mixed with air, oxygen, or nitrous oxide: Not suitable for use near flammable anesthetic agent mixed with air, oxygen, or nitrous oxide X Mode of operation: Continuous operation „ Safety Standards the Device Conforms to X Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance [IEC 60601-1] X Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance [ANSI/AAMI ES60601-1] X 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] X Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability [IEC 60601-1-6] X 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] X Medical Devices – Application of Risk Management to Medical Devices [ISO 14971] X Biological Safety Evaluation of Medical Devices – Part 1: Evaluation and Testing [ISO 10993-1] 1-5

[Page 22] „ Declarations The Nemko-CCL mark with “C” and “US” identifiers indicates that the product is compliant with and certified to the applicable U.S. and Canadian standards. This mark certifies that the product conforms to applicable EEC standards and has been certified by the European certification agency. This mark certifies that the product conforms to applicable EEC standards. The GMP symbol indicates the Good Manufacturing Practice in accordance with the Korean quality management regulations. 1-6

[Page 23] Safety Symbols and Labels These are safety and notice symbols for medical electronic equipment. The International Electrotechnical Commission (IEC) has established the part of the symbols. Symbols Description Symbols Description WARNING: Warnings to prevent a serious accident, or damage to USB port property CAUTION: Precautions to prevent a minor accident or damage to Network port property Refer to the user manual. Microphone port Follow the user manual. Probe port Dripping-proof device: Protected CAUTION: Risk of electric shock against vertically falling water drops Type BF applied part Immersion-proof device: (Classification based on degree Protected against the effects of of protection against electric non - continuous immersion in hazard) water Defibrillation-proof type CF Submersion-proof device: applied part (Classification based Protected against the effects of on degree of protection against continuous immersion in water electric hazard) CAUTION: Electrostatic sensitive Power on/off devices (ESD) Power on Do not sit on the product. Power off Do not push the product. DANGER: Do not place your Alternating current voltage fingers, hands, or any parts of source your body in the space. 1-7

[Page 24] Symbols Description Symbols Description Do not place objects heavier than Direct current voltage source the weight specified next to the symbol. Do not place heavy objects on the Protective grounding terminal monitor while the monitor mount is folded. Do not push down on the monitor Equipotential terminal while the monitor mount is folded. Data output port Do not stand on it. Federal law restricts this device Data input port to sale by or on the order of a physician. The Authorized European Data input/output port Representative’s address is provided. The Swiss Authorized Input port Representativeʼs address is provided. The manufacturer’s name and Output port address are provided. This equipment is a medical Print remote output device. Foot switch port Consult the latest information. Indicates the need for the user to consult electronic instructions for use. ECG port (You can access to it by pressing help on the product or download www.samsunghealthcare.com it from the website.) 1-8

[Page 25] „ Labels Phrases containing the words ‘WARNING’ and/or ‘CAUTION’ are displayed on the product’s surface in order to protect it. 1-9

[Page 26] Operational Environment Safety The user is responsible for the safety of everyone near the product. Please handle the product with caution even when it is not in use. The product must be installed by a professional technician. Please remember the following: X Using the system near generators, X-ray machines, or broadcast cables may result in noise and abnormal visual images. Sharing the power source with other electrical devices may also cause noise. X Do not install or use the product in the Magnetic Resonance (MR) Environment. Doing so may result in improper operation of the product due to powerful magnetic fields. X Optimal conditions for the normal operation of the system are a temperature of 10–35°C and a humidity of 30–75%. X Avoid areas where moisture, direct sunlight, or a heater is near the product; that are frequently exposed to vibration; that are too dusty or are not properly ventilated; or where chemicals or gases are present. X Avoid using this product close to or on top of another device, as this may cause malfunctions. WARNING: Do not block the vents on the system, peripheral devices, and accessories. „ Operational Environment for Normal Operation If the products, probes and peripherals have been in an environment outside of 10-35°C, allow them to reach room temperature before turning them on. 1-10

[Page 27] Electrical Safety This product is categorized as a Class I device. X 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. X To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded power outlet. Prevention of Electric Shocks In a hospital environment, hazardous current can form due to potential differences between exposed conductive parts and connected devices. The solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up of sockets which are angled to the equipotential bonding network in medical rooms. NOTE: For more information about an equipotential connection, please refer to ‘Introduction’ in this User Manual. All connected peripheral devices must comply with the relevant IEC standards (e.g., IEC 60950/ EN 60950 for data processing equipment, and IEC 60601 - 1/EN 60601 - 1/ANSI AAMI ES60601 - 1 for medical devices). Furthermore, all components of the product must comply with the requirements for medical electrical systems IEC 60601 - 1/EN 60601 - 1/ANSI AAMI ES60601 - 1. Anybody connecting additional equipment to signal input and output ports of medical electrical equipment must make sure that the peripherals comply with IEC 60601 - 1/EN 60601 - 1/ ANSI AAMI ES60601-1. 1-11

[Page 28] X Electric shocks may result if this system, including all of its externally mounted recording and monitoring devices, is not properly grounded. X Never open the cover of the product. The interior of this product contains dangerous high-voltage electricity. Any repairs to the product's internal components or replacement of parts must be performed by Samsung Medison. X Always check the product’s housing, cables, cords, and plugs before using the product. Disconnect the power source and do not use the equipment if the housing is damaged (for example cracked or chipped), or if the cable is worn. X Always disconnect the system from the wall outlet prior to cleaning the system. X All patient-contact devices, such as probes, must be detached from the patient prior to using a high-voltage defibrillator. X Never use the product in the presence of flammable or anesthetic gas. Doing so may cause an explosion. X Avoid installing the system in such a way that it is difficult for the operator to disconnect it from the power source. X Do not use together with HF surgical equipment. HF surgical equipment may be damaged, which may result in fire. X The product must be connected to a power supply with a protective earth to prevent electric shock. X The system has been designed for 100-240VAC; you should select the input voltage of any connected printer and VCR. Prior to connecting a peripheral power cord, verify that the voltage indicated on the power cord matches the voltage rating of the peripheral device. X An isolation transformer protects the system from power surges. The isolation transformer continues to operate when the system is in standby. X Do not immerse the cable in liquids. Cables are not waterproof. X 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. X The auxiliary socket outlets installed on this system are rated 100-240VAC with maximum total load of 150VA. Use these outlets only for supplying power to equipment that is intended to be part of the ultrasound system. Do not connect additional multiple-socket outlets or extension cords to the system. X Connecting any devices that are not listed in this User Manual to the auxiliary socket outlet of the system may cause an electrical hazard. X Do not touch SIP/SOP and the patient simultaneously. There is a risk of electric shock from leakage current. 1-12

[Page 29] ECG-Related Information X This device is not intended to provide a primary ECG monitoring function, and therefore does not have means of indicating an inoperative electrocardiograph. X Do not use ECG electrodes with HF surgical equipment. HF surgical equipment may be damaged, which may result in fire. X Do not use ECG leads and electrodes in an operating room. CAUTION: Using ECG electrodes with a cardiac pacemaker or an electrical stimulator at the same time may cause interference with the ECG signals. ESD (ElectroStatic Discharge) An ESD event is generally caused by static electricity that naturally occurs due to friction. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. The static shock or ESD is a discharge of the electrical energy build-up from a charged individual to a less or non-charged individual or object. An ESD occurs when an individual with an electrical energy build-up comes into contact with conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals. X 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. X Always perform the pre-ESD preventive procedures before using connectors marked with the ESD warning label. – Apply anti-static spray to carpets or linoleum. – Use anti-static mats. – Ground the product to the patient table or bed. X It is highly recommended that the user be given training on ESD-related warning symbols and preventive procedures. 1-13

[Page 30] EMI (ElectroMagnetic Interference) This product has passed the EMI compliance test. However, using the system where an electromagnetic field is being produced may lower the quality of ultrasound images and/or damage the product. 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. CAUTION: In cases where EMI is causing disturbances, it may be necessary to relocate this system. EMC (ElectroMagnetic Compatibility) EMC testing on this product has been performed according to the international EMC standard for medical devices, IEC 60601 - 1 - 2. This IEC standard was adopted in Europe as the European norm (EN 60601 - 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 ensure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment – Guidance The Ultrasound System uses RF energy only for its internal RF Emission functions. Therefore, its RF emissions are very low and are Group 1 CISPR 11 not likely to cause any interference in nearby electronic equipment. RF Emission Class A CISPR 11 The Ultrasound System is suitable for use in all Harmonic Emission establishments other than domestic and those directly Class A IEC 61000-3-2 connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Flicker Emission Complies IEC 61000-3-3 1-14

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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 in the table below. Cable Type Length VGA Shielded Normal USB Shielded Normal LAN (RJ45) Twisted pair Any S-Video Shielded Normal Foot Switch Shielded 2.99m Audio R.L Shielded Normal Parallel Shielded Normal HDMI Shielded Normal ECG 3-lead Shielded Normal „ Probes The image probe used with this product may affect its emission. The probe listed in ‘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 affect its emissions. CAUTION: When connecting other customer-supplied accessories to the system, it is the user’s responsibility to ensure the electromagnetic compatibility of the system. WARNING: The use of cables, probes, and peripherals other than those specified may result in increased emission or decreased Immunity of the Ultrasound System. 1-15

[Page 32] Electromagnetic Immunity Test IEC 60601 Test Level Compliance Level Environment – Guidance Floors should be wood, concrete, or ceramic tile. Electrostatic ±8 kV contact ±8 kV contact If floors are covered Discharge ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV, with synthetic material, (ESD) ±15 kV air ±15 kV air a relative humidity IEC 61000-4-2 of at least 30% is recommended. Electrical fast ±2 kV (for power supply ± 2 kV (for power supply Mains power quality transient/ lines) lines) should be that of a typical burst ±1 kV (for input/output ± 1 kV (for input/output commercial or hospital IEC 61000-4-4 lines) lines) environment. ±0.5 kV, ±1 kV ±0.5 kV, ±1 kV Mains power quality Surge differential mode differential mode should be that of a typical IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV ±0.5 kV, ±1 kV, ±2 kV commercial or hospital common mode common mode environment. Mains power quality should be that of a Voltage typical commercial or dips, short 0% Uт (100% dip in Uт) 0% Uт (100% dip in Uт) hospital environment. If interruptions, for 0.5/1 cycles for 0.5/1 cycles the user of this product and voltage 70% Uт (30% dip in Uт) 70% Uт (30% dip in Uт) requires continued variations on for 25/30 cycles a for 25/30 cycles a operation during power power supply mains interruptions, it is 0% Uт (100% dip in Uт) 0% Uт (100% dip in Uт) input lines a a recommended that this for 250/300 cycles for 250/300 cycles IEC 61000-4-11 product be powered from an uninterruptible power supply or a battery. Power Power frequency frequency magnetic fields should be magnetic field 30 A/m 30 A/m at levels characteristic of (50/60 Hz) a typical commercial or IEC 61000-4-8 hospital environment. NOTE: Uт is the main voltage (AC) prior to the application of the test level. a For example, 10/12 means 10 cycles at 50 Hz or 12 cycles at 60 Hz. 1-16

[Page 33] IEC 60601 Compliance Immunity Test Electromagnetic Environment – Guidance Test Level Level Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications IEC 61000-4-6 150 kHz – equipment should not be used closer to any part 80 MHz of the Ultrasound System, including cables, than the recommended separation distance. This is Outside ISM calculated using the equation applicable to the bands c frequency of the transmitter. 6 Vrms 6 Vrms Recommended Separation Distance 150 kHz – 1.2 80 MHz In ISM IEC 60601-1-2: 2007 bands c 1.2 80 MHz to 800 MHz 2.3 800 MHz to 2.5 GHz IEC 60601-1-2: 2014 2.0 80 MHz to 2.7 GHz Radiated RF 3 V/m 3 V/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 2.7 GHz recommended separation distance in meters (m). Field strengths from fixed RF transmitters a , as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range b . Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not be applicable in some situations. Electromagnetic propagation is affected by absorption and reflection of structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio, (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted 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 reorienting or relocating the Ultrasound System or using a shielded location with a higher RF shielding effectiveness and filter attenuation. b When the frequency range exceeds 150 kHz - 80 MHz, the electric field strength should be not higher than 3 V/m. c The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. 1-17

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Recommended Distance Between Wireless Communication Device and this Product 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. These distances are recommended below, according to the maximum output power of the communications equipment. Separation Distance in Relation to Frequency of Transmitter [m] Rated Maximum IEC 60601-1-2: 2007 IEC 60601-1-2: 2014 Output Power of Transmitter 150 kHz – 80 MHz – 800 MHz – 150 kHz – 80 MHz – [W] 80 MHz 800 MHz 2.5 GHz 80 MHz 2.7 GHz 1.2 1.2 2.3 1.2 2.0 0.01 0.12 0.12 0.23 0.12 0.20 0.1 0.38 0.38 0.73 0.38 0.63 1 1.2 1.2 2.3 1.2 2.0 10 3.8 3.8 7.3 3.8 6.3 100 12 12 23 12 20 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 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not be applicable in some situations. Electromagnetic propagation is affected by absorption and reflection of structures, objects, and people. 1-18

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Potrable RF communications equipments shoud be used no closer than 30cm (12 inches) to any parts of the product. Otherwise, the performance of this equipment could be degraded. Band a IEC 60601 Compliance Immunity Test Service a Modulation b (MHz) Test Level (V/m) Level (V/m) Proximity fields Pulse from RF wireless 380 – 390 TETRA 400 modulation b 27 27 communications 18 Hz equipment FM IEC 61000-4-3 GMRS 460 430 – 470 ±5 kHz deviation 28 28 FRS 460 1 kHz sine Pulse 704 – 787 LTE Band 13, 17 modulation 9 9 217 Hz GSM 800/900 TETRA 800 Pulse 800 – 960 iDEN 820 modulation 28 28 CDMA 850 18 Hz LTE Band 5 GSM 1800 CDMA 1900 Pulse 1700 – 1990 GSM 1900 modulation 28 28 DECT 217 Hz LTE Band 1, 3, 4, 25 UMTS Blue Tooth WLAN Pulse 2400 – 2570 802.11 b/g/n modulation 28 28 RFID 2450 217 Hz LTE Band 7 Pulse 5100 – 5800 WLAN 802.11 a/n modulation 9 9 217 Hz NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a For Some services, only the uplink frequencies are included. b The carrier shall be modulated using a 50% duty cycle square wave signal. c As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. 1-19

[Page 36] X Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. X Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. X Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME EQUIPMENT or ME SYSTEM , including cables specified by the manufacturer. X Failure to use this equipment in the specified type of shielded location could result in degradation of the performance of this equipment, interference with other equipment or interference with radio services. X This equipment has been tested for radiated RF immunity only at selected frequencies, and use nearby of emitters at other frequencies could result in improper operation. NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If it is used in a residential environment (for which CISPR 11 Class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. 1-20

[Page 37]
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 ensure that they meet the minimum specification. CAUTION: If the system is connected to other customer-supplied equipment, such as a local area network (LAN), Samsung Medison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic emission phenomena. 1-21

[Page 38]
Avoiding Electromagnetic Interference Typical interference on Ultrasound Imaging Systems varies depending on Electromagnetic phenomena. Please refer to the following table: Imaging Mode ESD 1 RF 2 Power Line 3 For sector imaging probes, white radial bands or flashes in the centerlines of White dots, dashes, the image. diagonal lines, or diagonal 2D For linear imaging lines near the center of the probes, white vertical image. bands, sometimes more pronounced on the sides of Change of operating the image. mode, system settings, or system Increase in the image White dots, dashes, M reset. Brief flashes background noise or white diagonal lines, or increase in the displayed or M mode lines. in image background noise recorded image. Color flashes, radial or Color flashes, dots, dashes, vertical bands, increase Color or changes in the color in background noise, or noise level. changes in color image. Horizontal lines in the Vertical lines in the spectral display or tones, spectral display, popping Doppler 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. 1-22

[Page 39] A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference. Electromagnetic interference generated by Samsung Medison’s ultrasound system does not exceed the standard level. 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 sources of interference are medical devices, information technology products, and radio and television transmission towers. Tracing the source of radiated interference can be a difficult task. Customers should consider the following in an attempt to locate the source: 1. Is th e interference intermittent or constant? 2. Does the interference show up only with one transducer operating at the same frequency or with several transducers? 3. Do two different transducers operating at the same frequency have the same problem? 4. Is the interference present if the system is moved to a different location in the facility? The answers to these questions will help to determine if the problem resides with the ultrasound system or its operating environment. After you have answered all of the questions, contact your local service representative. 1-23

[Page 40] Electrical Safety Check The product’s maintenance status may affect the electrical safety of the product. The product should be maintained in an electrically safe state to ensure human safety. CAUTION: Users may request safety inspections as required, but only trained persons are allowed to perform the safety inspection. 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. The equations and tables related to measurement accuracy are included in the ‘Measurements’. CAUTION: In case of doubt in the measurements, please contact your local Service Department for an accuracy test. 1-24

[Page 41] Mechanical Safety Product Transfer and Brakes WARNING: Special caution should be taken during movement. Careless transportation of the product may result in product damage or personal injury. X Before transporting the product, make sure that the caster brakes are released. Also, make sure that any parts that may move, such as the monitor arm or keyboard, are secured into position before moving. X You can use the caster brakes on the product to control their movement. Make sure that the brakes are engaged before you use the product. X Always use the handles on the console and move the product slowly. X Excessive shocks, such as a fall, may seriously damage the product. X When you need to move the product up or down an inclined plane, make sure that the control panel is facing the direction in which you are moving and that it is moved by at least two people. X If the product is temporarily left on a slope, it can still fall over even with the caster brakes on. Do not leave the product on a slope. NOTE: If the product does not work properly after you move it, please contact the Customer Service Department. 1-25

[Page 42] Safety Precautions When Using the Product X Never attempt to modify the product in any way. X If using the product after a prolonged period of non-use, always check that it can be safely operated. X Make sure that other objects, such as metal pieces, do not enter the system. X Do not block the ventilation slots. X Do not pull on the power cord to unplug the product. Doing so might damage the cord and cause the product to short-circuit, or the cord itself to break. Unplug the cord by pulling on the plug itself. X Excessive bending or twisting of cables on patient-applied parts may cause failure or intermittent operation of the system. X Improper cleaning or sterilization of a patient-applied part may cause permanent damage. X All internal component repairs and part replacements must be done by qualified Samsung Medison service personnel. Assuming that the product is used in accordance with the guidelines contained in this manual and maintained by qualified service personnel, the expected service life of the product is approximately 7 years. 1-26

[Page 43]
Monitor When adjusting the height or position of the monitor, be careful of the space in the middle of the monitor arm. Catching your fingers or other body parts in it may result in injury. [Figure 1.1 Safety Note for Monitor] X When moving the product, be sure to keep the monitor arm locked. X When rotating the monitor, be sure to release the lock first. Rotating the monitor while it is locked may cause damage to the internal cables. 1-27

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Control Panel Pull the height adjustment lever to adjust the height of the control panel. When adjusting the height or position of the control panel, pay attention to the space between the bottom of the control panel and the lever. Catching your fingers or other body parts in it may result in injury. X Do not push the control panel with excessive force or lean on it. X Do not sit on the control panel or exert excessive force on it. X Do not lift the product using the handles on the control panel. Height Adjustment Lever [Figure 1.2 Safety Note for Control Panel] NOTE: When you adjust the height of the control panel of this product, a rail mark (or track mark) and oil film may be left on the lift. They are the result of the lift's movements, and not an indication the product is defective.
Touchscreen CAUTION: Do not push the touchscreen with excessive force. 1-28

[Page 45]
Air Filters The air filter minimizes the amount of dust that enters the product. When the air filter is clogged with dust, it may cause the product to overheat and generate noise. It may also reduce the reliability and system performance. Clean the filter once every month to maintain the system in optimal condition. CAUTION: Be sure to lock the brakes on the wheels before removing or installing the air filter. Otherwise, unexpected movement of the product may result in injury. [Figure 1.3 Removing the Air Filter] CAUTION: Installing a damp filter may cause product malfunction. Make sure that you install a completely dry filter. 1-29

[Page 46] Biological Safety For safety information on the probes and biopsies, please refer to ‘Probes’. X 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 a low setting. Please refer to the ALARA principle. X Do not use the product if an error message appears on the screen indicating that a hazardous condition exists. Note down the message displayed on the screen, turn off the power, and then contact Samsung Medison’s Customer Service Department. X Do not use a product that exhibits unexpected or abnormal operation. Discontinuities in the scanning sequence are indicative of a hardware failure that should be corrected before use. X This product limits the temperature that patients are allowed to come into contact with to 43°C or less. The ultrasound power output (AP&I) is in compliance with the US FDA’s standards. ALARA Principle Guidance for the use of diagnostic ultrasound is defined by the “ A s L ow A s R easonably A chievable” (ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight of qualified personnel. No set of rules can be formulated that would be sufficiently complete to dictate the correct response to 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. The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound, not only in the technology but also in its applications, have resulted in the need for increased and improved 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 1-30

[Page 47] time is an especially useful variable, because the user controls it. The ability to limit the index values over time supports the ALARA principle.
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, concentrate the 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 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 biological effect is actually occurring, it should be taken seriously. Every effort should be made to reduce the possible effects of a high index reading. Limiting 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 and 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 depending 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. Samsung Medison systems provide 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 output intensity. 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. 1-31

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Indirect Controls The indirect controls are those that have an indirect effect on the acoustic intensity. These controls affect the 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. The pulse repetition frequency or rate refers to the number of ultrasound bursts of energy over a specific period of time. The higher the pulse repetition frequency, the more pulses of energy in a given period of time. Several controls affect pulse repetition frequency: focal depth, display depth, sample volume depth, color sensitivity, number of focal zones, sector width controls, etc. The focus of the ultrasound beam affects the image resolution. To maintain or increase resolution at a different focus requires a variation of output over the focal zone. This variation of output is a function of system optimization. Different exams require different focal depths. Setting the focus to the proper depth improves the resolution of the structure of interest. Pulse length is the time during which 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, burst length or pulse duration is the output pulse duration in Pulsed Doppler. Increasing the Doppler sample volume, increases the pulse length. Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The higher the probe operating frequency, the greater the attenuation of the ultrasonic energy. Higher probe operating frequencies require higher output intensity to scan at an increased depth. To scan deeper at the same output intensity, 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. 1-32

[Page 49]
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 scanning 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), bone (TIb) and cranial bone (TIc). One of these three thermal indices will be displayed at all times. The thermal index to be displayed is determined by the system preset or user choice, depending upon the application. 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 all the time. Each diagnostic probe application has a default selection. The TIb or TIs is continuously displayed over its range of 0.0 to maximum output, based on the probe and application, in increments of 0.1. The default setting of the application-specific nature is also an important factor of index selection. A default setting is a system control state which is preset by the manufacturer or the operator. The system has default index settings for the probe application. The default settings are applied automatically by the ultrasound system when the power is turned on, new patient data is entered into the system database, or a change of 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 a 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, may cause the potential for local zone heating to be lower than the thermal index indicates. The selection of scanned modes or unscanned modes of operation also 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 scanning. Ensure that the indices are kept to a minimum, and that exposure time is limited without compromising diagnostic sensitivity. 1-33

[Page 50] „ 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. However, there is no specific MI value that means that a mechanical bioeffect 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 of potential temperature increase occurring on the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, and mode of operation. The TI should be used as a guide for implementing the ALARA principle. The bone thermal index (TIb) informs the user about potential heating at or near the focus after the ultrasound beam has passed through soft tissue or fluid, such as the skeletal structure of a 2-3 month old fetus. The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near the surface, for example, the cranial bone. The soft tissue thermal index (TIs) informs the user about the potential for heating within soft homogeneous tissue. TIc is displayed when you select a trans-cranial application. You can select a TI to display in Setup > Imaging > Application/Preset > Preset Settings > Thermal Index Type. „ 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 manual‘s Acoustic Output Tables. These accuracy estimates are based on the variability ranges of probes and systems, inherent acoustic output modeling errors, and the 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 of investigated tissue or organs. The initial data that is used to support the output display is derived from laboratory measurements based on the AIUM measurement standard. The measurements are then put into algorithms to calculate the displayed output values. 1-34

[Page 51] Many of the assumptions used in the process of measurement and calculation are conservative in nature. Over-estimation of actual In Situ exposure, for the vast majority of tissue paths, is built into the measurement and calculation process. For example, the acoustic output values measured underwater are derated using a conservative, industry standard, attenuation coefficient of 0.3dB/cm-MHz. Conservative values for tissue characteristics were selected for use in the TI models. Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat capacity, and tissue thermal conductivity were selected. A steady state temperature rise is assumed in the industry standard TI models, and the assumption is made that the ultrasound probe is held steady in one position long enough for a steady state to be reached. A number of factors are considered when estimating the accuracy of display values: Hardware deviation, algorithm accuracy, and measurement deviation. Deviation among probes and systems in particular is an important factor. Probe deviation results from piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens focusing parameter variations. Differences in the system pulser 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 pulser 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 the calculation of the accuracy estimate displayed. Neither linear propagation nor uniform attenuation at the 0.3dB/cm-MHz rate occurs in underwater measurements, or in most tissue paths in the body. In the body, different tissues and organs have dissimilar attenuation characteristics. In water, there is almost no attenuation. In the body, and particularly in underwater measurements, non-linear propagation and saturation losses occur as pulser voltages increase. The display accuracy estimates take into account the variability ranges of probes and systems, inherent acoustic output modeling errors, and the measurement variability. Display accuracy estimates are measured according to AIUM measurement standards but not based on errors caused during the measurement or inherent errors. They are also independent of the effects of non-linear loss on the measured values. 1-35

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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 also 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 total TI is the sum of TIs of the individual modes. Each mode is a vital contributor to this total; the displayed MI will be from the mode with the largest peak pressure.
2D Mode Controls „ 2D Mode Size Narrowing the sector angle may increase the frame rate. This will increase the TI. The pulser voltage may be automatically adjusted down with software controls to keep the TI below the system maximum. A decrease in pulser voltage will decrease MI. „ Zoom Increasing the zoom magnification may increase frame rate. This will increase the TI. The number of focal zones may also increase automatically to improve the resolution. This action may change the MI, since the peak intensity can occur at a different depth. „ Number of Focal Zones Increasing the number of focal zones may change both the TI and MI by automatically changing the frame rate or focal depth. Lower frame rates decrease the TI. The MI displayed will correspond to the focal zone with the largest peak intensity. „ Focus In general, higher MI values will occur when the focal depth is near the natural focus of the probe (transducer). 1-36

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Color and Power Controls „ Color Sensitivity Increasing the color sensitivity may increase the TI. More time is required for the scanning of color images. Color pulses are the dominant pulse type in this mode. „ Color Sector Width Narrower color sector width will increase the color frame rate, and so the TI will increase. The system may automatically decrease the pulser voltage to stay below the system maximum. A decrease in pulser 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. „ 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 the pulser voltage to stay below the system maximum. A decrease in pulser voltage will also decrease MI. „ 2D Mode Size 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 the dominant mode and the TI change will be small. 1-37

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M Mode and Doppler Controls „ 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 an ancillary element. During auto-update and duplex, the TI will display the dominant pulse type. The displayed MI will be from the mode with the largest peak pressure. „ Sample Volume Depth When Doppler sample volume depth is increased, the Doppler PRF may automatically decrease. A decrease in PRF will decrease the TI. The system may also decrease the pulser voltage to remain below the system maximum. A decrease in pulser voltage will decrease MI.
Other „ 2D, Color, M Mode, PW and CW When a new imaging mode is selected, both the TI and the MI will change to their 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 the MI is the value for the focal zone of the 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 the contact area, beam shape, and center frequency. Defaults are initialized when you select a probe. Samsung Medison’s manufacturer default settings vary, depending on the probe, application, and mode selected. Defaults have been chosen below the FDA limits for intended use. „ Depth An increase in the 2D mode depth will automatically decrease the 2D mode frame rate. This would decrease the TI. The system may also automatically choose a deeper 2D mode focal depth. A change of focal depth may change the MI. The MI displayed is that of the zone with the largest peak intensity. 1-38

[Page 55] „ Application Acoustic output defaults are set when you select an application. Samsung Medison’s manufacturer default settings vary, depending on the probe, application, and mode selected. Defaults have been chosen below the FDA limits for intended use.
Related Guidance Documents The terms and symbols used in the acoustic output tables are defined in the following paragraphs. X Medical Ultrasound Safety (AIUM, 2014). X AIUM Consensus Report on Potential Bioeffects of Diagnostic Ultrasound: Executive Summary, J. Ultrasound in Medicine, 2008, Vol. 27, Num. 4. X WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non-thermal Mechanisms for Biological Effects. Ultrasound in Med. & Biol; 1998, 24: Supplement 1. X Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993) X Guidelines for the safe use of diagnostic ultrasound equipment. (BMUS, 2009) X Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (U.S. FDA - 2008) X Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (IEC, 2007) X Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 2008) X Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment. (IEC, 2007) X Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (AIUM/NEMA, 2004) X Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC, 2005) X Measurement and Characterization of Medical Ultrasonic Fields up to 40 MHz. (IEC, 2007) X Ultrasonics-Power Measurements - Radiation Force Balances and Performance Requirements. (IEC, 2006) X Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM/NEMA, 2004). 1-39

[Page 56]
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 (Bioeffect Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement), sometimes referred to as the Stowe Report, which reviewed available data on possible effects of ultrasound exposure. Another report, “Bioeffects and Safety of Diagnostic Ultrasound”, dated January 28, 1993, provides more up to date information. In addition, periodically updated reports on biological effects, results, and guidelines on safe usage have been published by groups such as the WFUMB (World Federation of Ultrasound in Medicine and Biology), AIUM, and BMUS. The Acoustic output for this system has been measured and calculated in accordance with the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (AIUM/NEMA, 2004) and Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (AIUM/NEMA, 2004). 1-40

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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 the largest possible value. Biological tissue absorbs 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: In Situ = Water [ e - (0.23 alf) ] 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) 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 purposes; therefore, the In Situ value is commonly reported using this formula: In Situ (derated) = Water [ e - ( 0.069 lf) ] Since this value is not the true In Situ intensity, the term “derated” is used. The maximum derated and maximum water values do not always occur under the same operating conditions. Therefore, the reported maximum water and derated values may not be related to the In Situ (derated) formula. For example, a multi-zone array transducer has the greatest water value intensities at its deepest zone. The same transducer may have its largest derated intensity at one of its shallowest focal zones. 1-41

[Page 58]
Terms and Symbols Related to Acoustic Output and Measurement The terms and symbols used in the acoustic output tables are defined in the following paragraphs. fawf The ACOUSTIC WORKING FREQUENCY. Center frequency. (Unit: MHz) Ipa,α at zpii,α The ATTENUATED PULSE-AVERAGE INTENSITY at the depth of maximum ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY. (Unit: Watts per square centimeter) I ta (z) The TEMPORAL-AVERAGE INTENSITY at axial distance z. (Unit: Milliwatts per square centimeter) Ita, α (z) The ATTENUATED TEMPORAL-AVERAGE INTENSITY at axial distance z. (Unit: Milliwatts per square centimeter) MI The MECHANICAL INDEX is a displayed parameter representing potential cavitation bioeffects. (Unit: N/A) npps The number of acoustic pulses travelling along a particular ULTRASONIC SCAN LINE. P The time-average ultrasonic OUTPUT POWER radiated by the transducer for the transmit pattern(s) associated with the reported Index. (Unit: mW) P 1x1 Maximum value of the time average acoustic output power emitted from any one-centimeter square region of the active area of the transducer, the one- centimeter square region having 1 cm dimensions in the x- and y-directions. (Unit: mW) Pr at zpii The PEAK-RAREFACTIONAL ACOUSTIC PRESSURE at the depth of maximum SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY. (Unit: Megapascals) P r,α at zMI The ATTENUATED PEAK-RAREFACTIONAL ACOUSTIC PRESSURE associated with the transmit pattern giving rise to the reported value of MI. (Unit: Megapascals) prr The reciprocal of the continuous PULSE REPETITION PERIOD at which it represents the recorded MI value. (Unit: Pulses per second or Hz) 1-42

[Page 59] srr The SCAN REPETITION RATE is reciprocal of the SCAN REPETITION PERIOD when time interval between identical points on two successive frames, sectors, or scans, applying to automatic scanning systems with a periodic scan sequence only. (Unit: Pulses per second or Hz) TIB The BONE THERMAL INDEX is a thermal index for applications such as fetal (second and third trimester), in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. (Unit: N/A) TIC The CRANIAL BONE THERMAL INDEX is a thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body, such as pediatric and adult cranial or neonatal cephalic applications. (Unit: N/A) TIS The SOFT TISSUE THERMAL INDEX is a thermal index related to soft tissues including all body tissues and fluids except skeletal tissues. (Unit: N/A) zb The distance where TIB_non-scan is determined. For non-scanned modes, Distance along the beam axis to the plane where the product of the ATTENUATED OUTPUT POWER and ATTENUATED TEMPORAL-AVERAGE INTENSITY (Pα(z) x Ita,α(z)) maximizes, where z >= zbp. (Unit: cm) zMI Depth on the BEAM-AXIS from the EXTERNAL TRANSDUCER APERTURE to the plane of maximum ATTENUATED PULSE INTENSITY INTEGRAL (piiα). (Unit: cm) zs The distance where TIS_non-scan is determined. The axial distance corresponding to the location of max[min(Pα(z), Ita,α(z)x1 cm )], where z >= zbp . (Unit: cm) zpii,α Position of maximum ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY for NONSCANNING MODE components, determined beyond the BREAK-POINT DEPTH, zbp, on the BEAM-AXIS. (Unit: cm) 1-43

[Page 60]
Acoustic Measurement Precision and Uncertainty The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below. Quantity Precision Total Uncertainty pii α (attenuated pulse intensity integral) 3.2% +21% to -24% P (acoustic power) 6.2% ±19% P r,α (attenuated rarefaction pressure) 5.4% ±15% fawf (acoustic working frequency) < 1% ±4.5% „ Systematic Uncertainties For the pulse intensity integral, attenuated rarefaction pressure, 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. X Oscilloscope vertical accuracy. X Oscilloscope offset accuracy. X Oscilloscope clock accuracy. X Oscilloscope Digitization rates. X Noise. 1-44

[Page 61] The acoustic power is measured using a radiation force for systematic uncertainties through the use of calibrated NIST acoustic power sources. We also refer to a September 1993 analysis conducted by the working group of the IEC technical committee 87 and prepared by K. Beissner, as a first supplement to IEC publication 1161. The document includes analysis and discussion of the sources of error/measurement effects due to: X Balance system calibration. X Absorbing (or reflecting) target suspension mechanisms. X Linearity of the balance system. X Extrapolation to the moment of switching the ultrasonic transducer (compensation for ringing and thermal drift). X Target imperfections. X Absorbing (reflecting) target geometry and finite target size. X Target misalignment. X Ultrasonic transducer misalignment. X Water temperature. X Ultrasonic attenuation and acoustic streaming. X Coupling or shielding foil properties. X Plane-wave assumption. X Environmental influences. X Excitation voltage measurement. X Ultrasonic transducer temperature. X Effects due to nonlinear propagation and saturation loss.
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. 1-45

[Page 62] Maintenance Cleaning and Frequency Component Cycle Cleaning Method Console Please clean and disinfect according to ‘Cleaning and Every day or after Monitor Disinfection’ of this chapter. (Touchscreen: If applicable to each exam the product) Touchscreen Remove the trackball rim by turning it counterclockwise, Trackball wipe it using a soft cloth, and then assemble in reverse order of disassembly. Every month Identify the location of the filter in the product, separate it Air Filter from the product, and then remove dust using a brush or a vacuum cleaner. Slide the filter back into the product. Probe holders can be removed depending on the product. Every day or after Probe Holders Please clean and disinfect probe holders according to each exam ‘Cleaning and Disinfection’ of this chapter. Please clean, disinfect and sterilize probes according to Probe After each exam ‘Cleaning, Disinfecting, and Sterilizing the Probe’ in the ‘Probes’ chapter. Peripheral Devices Clean peripheral devices according to the manufacturer’s instructions. NOTE: Since a pH neutral soap solution does not contain strong chemical ingredients, it will not irritate the skin. The solution must not contain any fragrances, oil, or alcohol. X Make sure that the touchscreen is not contaminated by an electrically conductive substance. X Contamination of the LCD screen by ultrasound gel or other substances may degrade the sensitivity of the touchscreen and cause malfunctions. This phenomenon is caused by the contact between the capacitive touchscreen and the conductive substance. If you find foreign substances on the screen, clean it with a dry cloth, and then restart the system. 1-46

[Page 63] Cleaning and Disinfection The ultrasound system, probes, and other components that are used with the product may come in direct contact with the user and patient. Hence, to prevent infections, clean and disinfect the product in accordance with the procedures specified in this user manual or the manufacturer's user manual that comes with each product. X Always wear a protective face mask and gloves when cleaning and disinfecting the product. X Turn off the system and disconnect the power cord from the wall outlet before cleaning and disinfecting. Otherwise, there is a risk of electric shock or fire. X Do not clean the electrical contacts or connectors. X Clean and disinfect the product every day or after each exam. NOTE: To learn how to clean and disinfect probes, please refer to ‘Probes’.
Information on Detergents and Disinfectants The device care method determines the appropriate disinfectant for your device. An appropriate detergent or disinfectant should be used for all products. For the latest details about compatible detergents and disinfectants, please see the user guide, and information on the Samsung Medison website. X User Guide: This is provided as a booklet upon purchase of the product. X Website: http://www.samsunghealthcare.com X Using an inappropriate disinfection procedure may damage the system. Make sure that you check the disinfectant’s expiry date. X Mix the disinfectant solution to the strength specified on the instruction of the disinfectant manufacturer. X When using a disinfectant, wipe it carefully with a soft cloth. X If the disinfectant solution remains on the product, it may cause the product to malfunction. After using the disinfectant on the product, please be sure to wipe away any remaining disinfectant with a soft cloth before using the product. 1-47

[Page 64]
Cleaning The device must be cleaned according to this instruction. Cleaning is an important procedure that must be carried out before disinfection. 1. Turn off the system and disconnect the power cord from the wall outlet. 2. Wipe off any gel or biological material with a soft, lint-free cloth moistened with detergent solution (made using manufacturer’s instructions) or tap water, taking care to remove all visible contamination. Dispose of the used cloths appropriately according to the local medical waste regulations. 3. For a list of compatible cleaning or disinfectant agents, see the user guide, or ‘Disinfectants for System Surfaces, Disinfectants for Monitor Surface’ on the Samsung Medison website (http://www.samsunghealthcare.com). Follow the detergent manufacturer’s instructions for preparation, temperature, solution strength, and duration of contact. If a premixed solution is used, be sure to observe the solution expiration date. 4. Wipe off the device’s surface according to the disinfectant manufacturer’s instructions for temperature, wipe durations, and duration of disinfectant contact. For difficult parts to wipe such as cracks and edges of the device, use a cotton swab wrapped with a cloth soaked with the detergent. Make sure that liquids or other objects do not enter the inside of the product. 5. Visually inspect for any remaining soil and if necessary repeat the steps, starting at step 4. 6. According to the detergent manufacturer's instruction, air dry the device or remove water from all surface of the device using a soft and clean disposable, lint-free cloth. 7. Examine the device for damage such as cracks, splitting, sharp edges, or projections. If such damage is found, discontinue use of the device and contact your Samsung Medison representative. 1-48

[Page 65] X When you use a detergent, follow the recommendations of the detergent manufacturer. X Do not spray detergent directly onto the product’s exterior. Doing so may discolor or crack the surface. X Repeated use of disinfectants may cause discoloration. X When using a spray cleaner, do not spray it directly onto the product surface to prevent liquid from entering the product. X Do not use chemicals such as wax, benzene, alcohol, paint thinner, insecticide, air freshener, or lubricant. X Do not use glass cleaners or products containing bleach. X Make sure that liquids or other objects do not enter the inside of the product. X Do not use any liquid containing glycol components such as Propylene glycol, Butylene glycol, or Polyethylene glycol, including cosmetics, on the external surface of the product. Doing so may discolor or crack the external surface of the product. 1-49

[Page 66]
Disinfection In general, an ultrasound system has an irregular surface, and disinfection of the entire surface of the product is not recommended. Therefore, users should follow the instructions of reprocessing method suggested. X When you use a disinfectant, follow the recommendations of the disinfectant manufacturer. X Use only the disinfectants recommended in the product user manual to disinfect the system’s surfaces. 1. Clean the device according to the procedures in ‘Cleaning’ of this chapter. 2. After cleaning, choose the disinfectant that is compatible with your device. For a list of compatible disinfectant agents, see the user guide, or ‘Disinfectants for System Surfaces, Disinfectants for Monitor Surface’ on the Samsung Medison website (http://www.samsunghealthcare.com). Follow disinfectant manufacturer’s instructions for preparation, temperature, solution strength, and duration of contact. If a premixed solution is used, be sure to observe the solution expiration date. 3. Wipe off the device’s surface according to the disinfectant manufacturer’s instructions for temperature, wipe durations, and duration of disinfectant contact. For difficult parts to wipe such as cracks and edges of the device, use a cotton swab wrapped with a cloth soaked with the disinfectant. Make sure that liquids or other objects do not enter the inside of the product. 4. Wipe off the device surface using a sterile cloth soaked with PURW according to the disinfectant manufacturer’s rinsing instruction. 5. According to the disinfectant manufacturer's instruction, air dry the device or remove water from all surface of the device using a sterile, lint-free cloth. 6. Examine the device for damage such as cracks, splitting, sharp edges, or projections. If such damage is found, discontinue use of the device and contact your Samsung Medison representative. 1-50

[Page 67] Battery Pack Management The battery pack is a consumable, and will lose performance over time. If the battery life becomes less than half of what it was when first purchased, it is time for a replacement. X The warranty period for battery packs is six months. X Samsung Medison recommends that you replace the battery pack once a year. NOTE: To purchase a battery pack, please contact Samsung Medison Service Department. Replacing the Battery Pack To replace a battery pack, please contact Samsung Medison Service Department. WARNING: Disconnect the power cord if you are not planning to use the product. Leaving the product unused and not plugged in to a power outlet for an extended period of time may deplete the battery completely, making it impossible to recharge the batteries. In addition, allowing the battery pack to become completely depleted may cause communication problems for the product. Recharging the Battery Pack Connecting the AC adapter automatically begins to recharge the battery pack. The battery pack must be charged and discharged within the following temperature ranges: State Ambient Temperature Charging 5 – 35°C Discharging 10 – 35°C CAUTION: The ideal charging temperature is from 10 to 35°C. The battery pack can overheat if the ambient temperature is too high, or can take much longer than normal to recharge if the temperature is too low. 1-51

[Page 68] Disposing of the Battery Pack A service representative of Samsung Medison or an authorized dealer must replace and dispose of the battery. WARNING: Do not dispose of the battery pack carelessly. Do not incinerate the battery, as this may cause an explosion or a fire. 1-52

[Page 69] Information Management CAUTION: You may lose user settings or patient information files because of physical shocks to the product or internal errors. Therefore, you should back up this information on a regular basis. User Settings Backup Always keep a backup copy of all information related to the user settings in case of data loss. Users should not attempt to back up the product’s User Settings themselves. A Samsung Medison Customer Service representative should perform all backups upon customer request. Patient Information Backup The SonoView program can be used to back up patients’ basic information and scanned images. They can be saved by users, but only to external media such as a CD or DVD. For more information, please refer to ‘Starting Modes of Operation’. If the system needs to be reinstalled because of an issue with the product, then a Samsung Medison Customer Service representative should restore the basic information and scanned images of patients saved on the system. Software The software may be changed to improve the product’s performance. Users should not attempt to modify the software by themselves; they must consult staff at Customer Service Department and ask them to guide them through the modification process. CAUTION: Minor software updates may be carried out without prior notice from the manufacturer. If an error occurs in the operating system (Windows), or you need to upgrade it, please follow the operating system manufacturer’s instructions. NOTE: This product uses the Windows firewall to prevent any hackers or malicious software from accessing the system through the internet or network. 1-53

[Page 70] Network
Wireless LAN (WLAN) Specifications Wireless Standards IEEE 802.11ac, IEEE 802.11a, IEEE 802.11n, IEEE 802.11g, IEEE 802.11b Wireless Security 64/128 bit WEP, WPA-PSK/WPA2-PSK, WPA2-Enterprise Frequency 5 GHz, 2.4 GHz Certification KC, CE, FCC, RoHS Modulation Technology DBPSK, DQPSK, CCK, 16-QAM, 64-QAM, 256-QAM
Protocols for Interhost Communication X DNS – Only used as client. X DHCP – Only used as client.
Required Network Characteristics 53 DNS Client 68 DHCP Client 104 Open port for DICOM (configurable on the system) Image file transfer (Minimum 100 Mbit/sec, recommended 1 Gbit/sec) 135 System Log (Only used as log source) 1-54

[Page 71]
Potential Hazardous Situations resulting from network security vulnerabilities X The following situations may occur in connection of ultrasound system to a less secure network. – Delayed or impaired access to scan image – Delayed or impaired access to patient data or exam information – Temporary damage or permanent loss of all the data stored X Problems may occur in changes to network environment such as those listed below, which require consistent analysis and risk management (identification, analysis, evaluation and control). – Changes in network configuration (add or disconnect items) – Update or upgrade of items connected to network 1-55

[Page 72] Cybersecurity In recent years, cybersecurity threats have intensified. Threats manifest in a variety of forms, including system breakdowns caused by virus infections or leaking of patient data stored on the system, and unfortunately, no security measure can prevent such threats 100%. Therefore, please comply with the following to prepare for cyber threats. X Do not connect the product to an unsecured public wired or wireless network, and under no circumstances do you connect to the Internet via this product. X To start functions that require network connection (Export, Remote Control etc.), use firewall to restrict access to the network connected with product. X Place this product in an area where it cannot be operated or tampered with physically by non - designated persons, and shut off power when it is not in use. X Only external devices (e.g., USB drive) that have been scanned for viruses and malwares should be connected to the product. X If you suspect that the product is infected, stop using it immediately, shut off the power, and make sure that you contact the Security Manager (Technical Support). X If a new security patch has been released, adjust the schedule with the Service Team to apply the patch promptly. X Samsung Medison provides remediation support for known cybersecurity vulnerabilities of its products until the end of their lifecycle. 1-56

[Page 73] Environmental Protection X For disposal of the system or accessories that have come to the end of their service lives, contact the vendor or follow appropriate disposal procedures. X Waste must be disposed of in compliance with the local regulations. X The lithium ion battery used in the product must be replaced by a service representative or an authorized dealer.
EU WEEE Directive For Correct disposal of this product. Please visit: http://www.samsung.com/weee.pdf
EU REACH Regulation For information on Samsung’s environmental commitments and product specific regulatory obligations e.g. REACH visit: www.samsung.com/uk/aboutsamsung/sustainability/environment/our-commitment/data/
EU Battery Directive Correct disposal of batteries in this product (Applicable in countries with separate battery return systems.) The marking on the battery, manual or packaging indicates that the battery in this product should not be disposed of with other household waste. Where marked, the chemical symbols Hg, Cd or Pb indicate that the battery contains mercury, cadmium or lead above the reference levels in EC Directive 2006/66. The battery incorporated in this product is not user replaceable. For information on its replacement, please contact your service provider. Do not attempt to remove the battery or dispose it in a fire. Do not disassemble, crush, or puncture the battery. If you intend to discard the product, the waste collection site will take the appropriate measures for the recycling and treatment of the product, including the battery. 1-57

[Page 74]

[Page 75] Chapter 2 Introduction ‹ Indications for Use 2-3 Contraindications 2-3 ‹ Product Specifications 2-4 ‹ Product Configuration 2-8 Monitor 2-10 Control Panel 2-12 Console 2-20 Peripheral Devices 2-22 Probes 2-27 Accessories 2-28 Optional Accessories 2-29 Optional Functions 2-30

[Page 76]

[Page 77] Indications for Use The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. NOTE: For more information on applications and presets, please refer to ‘Introduction’ and ‘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 eye. X Federal law restricts this device to sale by or on the order of a physician. X The method of application or use of the device is described in the manual ‘Starting Modes of Operation’ and ‘Modes of Operation’. 2-3

[Page 78] Product Specifications Height: 1,620 mm (with Monitor) Width: 520 mm Physical Dimensions Depth: 730 mm (with Keyboard) Weight: 54 kg (without accessories) Weight: Approx. 57 kg (with Safe Working Load) 2D Mode M Mode Color Doppler Mode Pulsed Wave (PW) Spectral Doppler Mode Continuous Wave (CW) Doppler Mode Tissue Doppler Imaging (TDI) Mode Imaging Modes Tissue Doppler Wave (TDW) Mode Power Doppler (PD) Mode ElastoScan™ Mode 3D/4D Mode Dual Mode Quad Mode Combined Mode Gray Scale 256 (8 bits) Transmit focusing, maximum of eight points (four points simultaneously Focusing selectable) Digital dynamic receive focusing (continuous) 2-4

[Page 79] Linear Array LA3-16AD, LN5-12, L5-12/50, L4-7, LS6-15, LA2-9S Curved Array CA2-8AD, CF4-9, C2-5, C2-8, CA2-6BM, CA4-10M, CA1-7AD Phased Array PN2-4, SP3-8, PA3-9B Endo Cavity Probes EVN4-9, ER4-9 (Type BF/IPX7) 3D VN4-8, V5-9, EV2-10A Pencil DP2B, DP8B NOTE: CA2-6BM is not supported in XH40. 3 Probe Ports, 4 Probe Ports for option Probe Connections CW Probe Port Main Monitor Number of Pixel: 1920 x 1080 21.5 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD monitor”) Touchscreen Monitor Number of Pixel: 1280 x 800 10.1 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD monitor”) ECG USB Type (Defibrillation-proof type CF) Audio Output Port (Right/Left) VGA monitor S-Video Output Rear Panel LAN Input/Output USB Port Connections CW HDMI Output HDMI Input (HDMI Input is currently not supported.) 2-5

[Page 80] Maximum 45,000 frames for Cine memory Image Storage Maximum 14,000 Lines for Loop memory Image filing system Obstetrics, Gynecology, Urology, Abdomen, Cardiac, Vascular, Small Parts, Application MSK, Pediatric Electrical Parameters 100 - 240VAC, 620VA, 50/60Hz Obstetrics, Fetal Heart, Gynecology, Cardiac, Abdomen, Pediatric Hips, Measurement Packages Urology, Small Parts, MSK, Vascular Acoustic Power Control Analog TGC Control Signal Processing Dynamic Aperture Control (Pre-Processing) Dynamic Apodization Control Dynamic LPF Control Digital TGC Control Slider TGC Control Mode-Independent Gain Control Black Hole/Noise Spike Filtering 1D Lateral/Axial Filtering Signal Processing 2D Edge/Blurring Filtering (Post-Processing) Frame average M/D Mode Sweep Speed Control Zoom Image View Area Control Image Orientation (left/right and up/down) Trackball operation of multiple cursors X 2D Mode: Linear measurements and area measurements using elliptical approximation or trace X M Mode: Continuous readout of distance, time, and slope rate X Doppler Mode: Velocity and trace 2-6

[Page 81] DVD Multi-Drive Digital B/W Video Printer Digital Color Video Printer USB Printer DVD Recorder Auxiliary Foot switch (IPX8) USB Flash Memory Media USB HDD USB ECG User Interface English, German, French, Spanish, Italian, Russian, Chinese, Portuguese Operating: 700 – 1060 hPa Pressure Limits Storage: 700 – 1060 hPa Operating: 30 – 75% Humidity Limits Storage & Shipping: 20 – 90% Operating: 10 – 35°C Temperature Limits Storage & Shipping: -25 – 60°C 2-7

[Page 82] Product Configuration This product consists of monitor, control panel, console, peripheral devices and probes. 1 Monitor 2 Monitor arm 3 Touch Panel 1 2 4 Speaker 5 Control Panel & Handle 6 USB port 7 Probe holder 8 Lift & Lift Lever 5 9 ECG port 0 Outlet for internal peripheral devices ! Probe port 9 @ CW Port # Wheel ! $ Brake % Filter [Figure 2.1 Front of the Product] 2-8

[Page 83] 1 Storage compartments 2 Ventilation 3 Cable holder 4 Rear panel 5 ID label 6 Power connection [Figure 2.2 Back of the Product] 2-9

[Page 84]
Screen Layout [Figure 2.3 Monitor Display] 1 Title Area Displays patient information, hospital name, application, frame rate, depth, probe information, acoustic output information, and the current date and time. 2 Image Area Displays ultrasound images. Image information, annotation, and measurement information are also displayed. 3 Thumbnail Area Images saved by pressing the preset Store button are shown in the thumbnails. Click it with the pointer to enlarge the preview image. 4 User Information and Status Information Area Information that is useful to the user, such as current system status, image information, selectable items, etc., is displayed. 2-10

[Page 85] Sleep Mode It reduces boot-up time by using sleep mode without having to shut down or restart the system. By entering Sleep Mode, you can quickly and conveniently use the previous settings through fast boot-up. When you press On/Off while the product is turned on, the product goes into Sleep Mode , which only turns off the power without shutting the product down. Pressing On/Off after the product goes into Sleep mode boots up the product quickly (i.e., Wake up mode). BatteryAssist™ BatteryAssist™ provides the system with battery power. It enables users to perform scans and transport the ultrasound system to other locations in environments where AC power may not be available temporarily. Please check the battery capacity before use. A ‘Battery’ icon will be displayed on a product that has a battery in it. The user can check the battery level as shown in the table below: Icon Desciption Tool Tip Message Charged (at least 81% charged) Charging (61–80%) Battery/‘Valid Capacity %’ Charging (41–60%) Battery 55% Charging (21–40%) Remaining battery level (11–20%) Remaining battery level (10% or below) 5 User Key (User Defined Key) Area Settings for User Defined Keys, including the positions of Set and Exit buttons, are displayed. NOTE: You can make changes in Setup > Customize > Buttons. 2-11

[Page 86] Control Panel [Figure 2.4 Control Panel] 2-12

[Page 87]
Adjusting the Control Panel X Do not apply excessive force to the control panel. X Use the handles on the console when moving the product. „ Adjusting the height You can move the control panel up and down only while pulling the lever at the side of the control panel. 2-13

[Page 88]
Functions of the Control Panel Button Turns the system on/off. On/Off Finishes the exam of the currently selected patient and resets the related data. End Exam Button Displays the screen for viewing and managing stored images. SonoView Displays the Report screen that shows the measurement results of the current application and other information. Report When you press the dial-button, the menu items that are available in the current scan mode are shown on screen. Rotating the EzExam Dial-button dial - button to the right selects the menu one row above the current menu selected, and rotating it to the left selects the menu one row EzExam below. Button Allows the user to enter a BodyMarker over an image. Adjusts the angle of the sample volume in Spectral Doppler mode. It is also used to adjust the Arrow’s angle or the probe angle for a Dial-button BodyMarker. In 3D View, turning this dial-button will rotate the image around the x-axis. Enter or exit PW Spectral Doppler Mode. Rotate this dial-button to adjust the Gain value. Dial-button In 3D View, turning this dial-button will rotate the image around the y-axis. Enter or exit Color Doppler Mode. Rotate this dial-button to adjust the Gain value. Dial-button In 3D View, turning this dial-button will rotate the image around the z-axis. 2-14

[Page 89] Press this button to enter 2D Mode. Rotate this dial-button to adjust the Dial-button Gain value. Button Enter or exit M Mode. Rotate this dial-button to adjust the Gain value. Enter or exit CW Spectral Doppler Mode. Available only with the phased array probe. Button Enter or exit Power Doppler Mode. Button Use this button to enter or exit 3D or 4D Mode. Press this button to turn the QuickScan™ function on. The ‘Q scan’ mark Button will appear at the top of the image. This can be used in applications for all probes. Compares two independent images. The active image mode is shown on the left. Compares two independent images. The activated image mode is shown on the right. Switch Adjusts the scanning depth of the image. Switch Moves the focus to the target area for observation. Makes the Zoom Box appear. In order to exit Zoom Mode, press the Exit Dial-button button. Button Pauses an image being scanned or reactivates a paused image. 2-15

[Page 90] Stands for User Key; the user can assign functions they need to each Button button. The function for each button can be assigned in Setup > Customize > Buttons. The user can select, set up, and use Set/Set , Set/Exit , or Exit/Set . The function for each button can be assigned in Setup > Customize > Buttons. Button X Set: Selects an item or value using the trackball. Alternatively, this can be used to change the function of the trackball. Set/Exit X Exit: Exits the function currently being used and returns to the previous screen. Deletes text, Arrows, BodyMarkers, measurement results, etc., displayed on an image. Clear Button In Scan Mode, an arrow-shaped pointer appears on the screen. Pointer Changes to a different function that can be supported by the current trackball setting. Change Button Allows the user to place text over an image. Button Starts measurements by application. Calculator Trackball Moves the cursor on the screen. Also, scrolls through Cine images. Trackball 2-16

[Page 91] „ Keyboard (Option) A keyboard, an optional item that you can connect via a USB port, is available. You can use the keyboard to enter text, etc. [Figure 2.5 Keyboard] 2-17

[Page 92]
Touchscreen Items that are available for use in each Operation mode will be enabled on the touchscreen. You can change the image format or optimize an image to facilitate your diagnosis. 3 5 [Figure 2.6 Touchscreen Display] 1 These buttons are always displayed on the touchscreen. The Patient Information screen will appear, where you can select a Patient ID Patient in the list or enter new patient information. It displays the Probe Selection screen where you can select and modify the Probe probe and application. With one touch, the user can select the most common transducer and preset combinations. QuickPreset increases efficiency to make a full day of QuickPreset 1–4 scanning simple and easy. It shows up to 4 Preset buttons configured at Setup. The general system settings that do not have a direct bearing on imaging Setup are explained below. NOTE: For more information about QuickPreset, please refer to ‘Setup > System > QuickPreset’. 2 Displays the mode that is currently used. 3 This is the Keyboard button. Clicking this button will activate the On-screen Keyboard. 4 This is the TGC (Time Gain Compensation) area. It displays sliders where you can control Gain. 2-18

[Page 93] CAUTION: Too great a difference in the gain value settings of adjacent TGC sliders may cause stripes in an image. X Penetration of ultrasound becomes weaker as the depth of the site to study increases. Use of TGC can compensate for this phenomenon. X TGC can adjust the Gain based on the depth. The depth increases gradually from the top to the bottom sliders and moving the slider to the right increases the Gain, which makes the image brighter. ※ TGC Preset: User can set and save the TGC form. [Figure 2.7 TGC – Touchscreen] 1. Use the TGC sliders to adjust the Gain, and select the User TGC button to save. 2. With the User TGC button, you can save the pattern you want. 3. Press Save to complete the User TGC settings. 5 The Operation mode that is currently in use and relevant function buttons are displayed. 6 Soft Menu Area: The Soft Menu items that are available in the current input mode are shown. The menu in use is shown in the border color. Press or rotate the dial-buttons right below each menu. When there are Two Soft Menus When there are two menus available – upper and lower, both menus can be adjusted with the corresponding dial-button. Or tap the button for the menu you want to use on the touchscreen and then use the dial-button. 2-19

[Page 94] Console The product consists mainly of ultrasound imaging components on the inside, and various connectors, probe holders, a storage compartment, handles, and wheels on the outside.
Rear Panel A monitor and other peripheral devices, like a printer, are connected via the rear panel at the back of the system. 1 Audio port (Output): Used for audio signal output. (Input: Not supported.) 2 S-VHS Port (Output): Provides an S-VHS connection for a VCR. 3 RGB Port (Output): Provides analog signal output to 2 be displayed on the monitor. 4 USB port: Used to connect to peripheral USB devices. 5 Network port: Connect to a network. You can transfer 3 patient information to another server via DICOM network. 6 HDMI port (Output): Outputs digital signals to the monitor. (Input: Not supported.) 7 Trig port (In/Output): Not used. [Figure 2.8 Rear Panel] 2-20

[Page 95]
Power Connection Part The power connection part is located at the bottom on the rear panel. [Figure 2.9 Power Connection Part] 1 Power switch: Turns on the power of the product, and cuts off power if overcurrent or overvoltage occurs. 2 Power inlet: Accepts the power cord, which connects to an external power supply. 3 Power fuse: Cuts off power if overcurrent or overvoltage occurs. 4 Equipotential Terminal: This should be connected to the equipotential connection part in the exam room.
Probe Holder Holders, which can hold and store probes, are attached to the left and right-hand sides of the control panel. These can be detached for cleaning. Hockey Stick Probe Holder Insert the Hockey stick probe holder into the probe holder to mount. It is provided as an option. 2-21

[Page 96] Peripheral Devices Peripheral devices can be connected to their corresponding ports on the left/right or rear sides of the console, as needed. X Do not install peripheral devices that are 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. X Do not connect additional external peripheral devices to the auxiliary socket outlet. Doing so may decrease safety level. [Figure 2.10 Patient Environment] NOTE: Refer to the user manual of the peripheral device for its operating information. 2-22

[Page 97] The following products are recommended: CAUTION: When using a peripheral device via a USB port, always turn the power off before connecting/disconnecting the device. Connection/disconnection of USB devices while the power is on may lead to malfunction of the system and the USB devices. NOTE: USB ports are located on both the control panel and the rear panel of the console. We recommend that you connect USB storage devices (flash memory media, etc.) to the USB ports on the control panel, and other USB peripheral devices to the rear panel for convenience. „ Digital Video Printer X Black and White: Sony UP-D897, UP - X898MD, UP - D898MD X Color: Sony UP-D25MD NOTE: Sony UP-D897 and Sony UP-D897MD are not available in the US and Canada. „ USB Printer Samsung CLP-620NDK, Samsung ML-2950 X Be sure to check the English OS version first to install a compatible printer and driver. Contact Samsung Medison customer support division for inquiries about printer driver installation. X When connecting the printer, ensure that the printer is configured under Microsoft Windows or system setup and has been chosen as the default printer. X Please check the port that the printer uses before connecting. Printers should be connected to the printer port while the USB printer should be connected to the USB port. 2-23

[Page 98] „ Foot Switch 3 Pedals HID Type NOTE: Set the functions in Setup > Customize > General > Foot Switch. CAUTION: Connecting or removing the Foot Switch while the product is turned on may cause the system to malfunction. 2-24

[Page 99] „ Wi-Fi Adaptor Wi-Fi adaptor (USB Type): TP-LINK (Archer AC1300), Netis WF2120 NOTE: For more information about how to connect to wireless networks, please refer to ‘Setup > Connectivity > Network> Wireless’ in ‘Utilities’. The device’s transmitter/receiver protocol specifications may vary depending on the Wi - Fi Adaptor in use. Model TP-LINK (Archer AC1300) Netis WF2120 IEEE 802.11ac IEEE 802.11a IEEE 802.11b Protocol IEEE 802.11n IEEE 802.11g IEEE 802.11g IEEE 802.11n IEEE 802.11b 5 GHz 11ac: Up to 867 Mbps (dynamic) 11n: Up to 300 Mbps (dynamic) 11a: Up to 54 Mbps (dynamic) Signal Rate Up to 150 Mbps 2.4 GHz 11n: Up to 400 Mbps (dynamic) 11g: Up to 54 Mbps (dynamic) 11b: Up to 11 Mbps (dynamic) Frequency 2.4 GHz, 5 GHz 2.4-2.4835 GHz Transmit Power <20 dBm (EIRP) <20 dBm (EIRP) Support 64/128 bit WEP, Support 64/128 bit WEP, Wireless Security WPA-PSK/WPA2-PSK, 802.1x WPA-PSK/WPA2-PSK 2-25

[Page 100] The transmitter/receiver specifications, such as frequency or bandwidth, may vary depending on the Wi-Fi Adaptor in use and the protocol of the connected device. IEEE 802.11 Network PHY Standards Frequency Bandwidth Protocol Stream Data Rate (Mbit/s) Modulation (GHz) (MHz) 802.11a 5 20 6, 9, 12, 18, 24, 36, 48, 54 OFDM 802.11b 2.4 22 1, 2, 5.5, 11 DSSS 802.11g 2.4 20 6, 9, 12, 18, 24, 36, 48, 54 OFDM 20 Up to 288.8 802.11n (Wi - Fi 4) 2.4/5 40 Up to 600 20 Up to 346.8 MIMO-OFDM 40 Up to 800 802.11ac (Wi - Fi 5) 5 80 Up to 1733.2 160 Up to 3466.8 „ Misc. Flash Memory Media X The system cannot recognize USB 1.1 flash memory. Remove the flash memory from the console and equip again with an appropriate device. X Regarding file formats that are not ordinarily saved: Please check first to see if it is possible to save the file format on a desktop PC before trying to save the file on flash memory. X Do not use flash memory media which contain anti-virus programs or are defective. Otherwise, the product may fail to work properly. X Please use a flash drive compatible with Windows 10. Otherwise, some features may not work correctly. 2-26

[Page 101] Probes Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation. NOTE: For information on probes, refer to ‘Probes’ and the Reference Manual.
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. The CW probe should be connected to CW-only port. 2. Push down the probe’s lockdown switch to lock it in place. X When connecting a probe, make sure that the connector is not exposed to any liquid or foreign substance. Otherwise, fire, electric shock, injury, or damage to the product may occur. X The probe may experience connection problems caused by foreign objects. If such a problem occurs, remove any foreign objects and try again. 2-27

[Page 102] Accessories An accessory box containing the items below is supplied with the product. SONO GEL GROUND CABLE MANUAL USER GUIDE [Figure 2.11 Accessories] NOTE: Supplied accessories vary by region. 2-28

[Page 103] Optional Accessories The following optional accessories are provided with the product. HOLDER CHART COVER PRINTER COVER TRAY REAR KEYBOARD [Figure 2.12 Optional Accessories] 2-29

[Page 104] Optional Functions For more information about optional features, please refer to the relevant sections in this User Manual. X 4D X SEE Stream (RU region only) X 3D XI X NeedleMate+™ X DICOM X RealisticVue™ X EzExam+™ X 5D Follicle™ X MultiVision X Mobile Export X 5D NT™ X AutoIMT+ X CW Function X ElastoScan™ X Cardiac Measurement X Panoramic+ X Strain+ X StresEcho X 2D NT X HQ-Vision™ X E-Strain™ X Expanded Storage (1TB) X LaborAssist™ X 2D Follicle™ X ACE X S-Detect™ for Breast X System Activation X CrystalVue™ X XI STIC X Windows 10 X NerveTrack™ X UterineAssist™ X EzAssist™ X Optional features vary by country. Please check the product to confirm which features are available. X NerveTrack™ is not supported in XH40. 2-30

[Page 105] Chapter 3 Utilities ‹ Setup 3-3 System 3-3 Imaging 3-17 Application 3-24 Measurement 3-26 Report 3-43 Annotation 3-47 BodyMarker 3-51 Customize 3-55 Peripherals 3-60 Connectivity 3-67 Service 3-83 Help 3-83 ‹ Strain+ Image (Option) 3-84 Strain+ 3-85 Auto EF 3-92 TMAD 3-98 ‹ EzCompare™ 3-103 ‹ ECG (Option) 3-104

[Page 106] Chapter 3 ‹ StressEcho (Option) 3-106 Setting up a Protocol 3-106 Starting a Protocol and Acquiring Images 3-111 Reviewing an Image 3-117 ‹ EzAssist™ (Option) 3-123

[Page 107] Setup The general system settings that do not directly affect imaging are explained below. Select , and then press Setup . System Press System on the Setup screen. General [Figure 3.1 Setup – System – General] 3-3

[Page 108]
Location You can set the information that is displayed in the title area on the screen. „ Institute Enter the name of the hospital/institution where the product is installed. Special characters can be entered. „ Language Select the system language.
Date and Time „ Date Format Used to set a date display format. Select your desired display format. The selected date format will be applied to various date fields in Patient Information. „ Time Format Used to set a time display format. Select your desired display format. X You cannot change the date and time when a patient ID has been registered. You should finish the current diagnosis first by pressing End Exam , and then change the settings. X When the system time and date are changed, the change is not reflected in the time and date shown on previous diagnosis results. „ Date and Time Use the trackball and Set to configure the date and time. When properly set, press Save to apply the changes. Press Cancel to cancel the settings. „ Time Zone You can select your desired time zone. 3-4

[Page 109]
Temperature „ Temperature Unit Set the temperature unit.
Trackball Speed You can set the trackball speed separately for Scan Mode and Measurement. Slower trackball speeds allow more precise measurements.
Video Specify the format in which videos should be saved.
Beep Sound „ Touchscreen When turned ‘On’, it beeps every time you use the touchscreen. „ Control Panel When turned ‘On’, it beeps every time you use a button on the control panel.
Account Registers a user ID and password. „ User Account Manager This is the exclusive administrator function that is used to approve and manage accounts. X User Login: Sets the user account (log-in) function. When turned ‘On’, this applies to the following cases: – Screen Saver – System startup X Password Expiry Period (Days): Set the password expiry period. X Login Attempts for Account Lockout (times): Set the maximum number of login attempts. 3-5

[Page 110] X User Account List: You can manage user accounts. X Create: Fill out the ID, Password, Username, and Authority fields. Then, press OK to add a new ID. You can specify the Grade (i.e., Admin or User) of the created account. When you create a User Grade account, the following functions may be restricted: – Export (SonoView, Report, External Storage) – Backup & Restore (SonoView) – Delete (Patient, SonoView) – Connectivity (Setup) X Modify: Save the changes. X Delete: Delete the selected ID. X Close: Close the settings. Emergency This is an Emergency Login function provided in case of an emergency. You can use this function on the User Login screen. When you log in using Emergency Login, the function for using existing patient information is disabled. „ Log in You can set a User account ID after logging in with an Admin account. Please contact a service engineer regarding the Admin and User account reset function. X The Admin account can be configured when you run “User Account Manager” in Setup for the first time. X The Admin account cannot be deleted. X Once the User Accounts function is activated, you cannot load exams without logging in. X The password must be 8 to 16 characters and composed of at least three of the following: – Uppercase letters – Lower case English alphabet letters – Numbers – Special characters X If you exceed the maximum number of invalid password attempts, you will not be able to log in for a certain period of time. 3-6

[Page 111] „ Log out Logs the user out of the account.
Storage Management Manages the storage space. „ Auto Delete Audo Delete is a feature to automatically delete the saved images according to the period, size, etc. set by the user in the Setup menu. When ‘On’, you can set the Auto Delete by pressing Settings . When you turn on the system at the specified Auto Delete time, all exams will be deleted. When a pop-up message appears, select a deletion option. X Delete by Period: Deletes exams based on the period set by the user. – Delete per: Sets a cycle to delete exams. – Delete Range X Delete All: Deletes all exams. X Delete Except for: Deletes all exams except for the exams within the chosen period. X Delete only Image and SR Data: Deletes only the images and the SR data. X Delete by Capacity: Automatically deletes exams based on the capacity set by the user. – Delete All When Capacity is: Deletes exams when the capacity exceeds the entered capacity threshold. – Delete only Image and SR Data: Deletes only the images and the SR data. „ Date Scheduled to be Deleted Displays a date when exams will be automatically deleted. „ Delete Range Displays a range of exams that will be automatically deleted. 3-7

[Page 112] Display [Figure 3.2 Setup – System – Display]
Display „ System Logo Select a system logo. „ Direction Marker Sets the direction marker. „ Screen Saver Selects whether or not to display the screen saver. You can select ‘Off’, or specify when the screen saver should be activated. „ System Power Button X Ask me what to do: Displays a message that asks the user to confirm whether they really want to turn the system off when they choose Shut Down. X Shut Down: The system shuts down completely upon selecting Shut Down. 3-8

[Page 113] „ Option X Auto Freeze: Automatically switches to freeze state at the set time. X Prompt for Save on Exit: A message prompting you to save before ‘Exit’. X Boot up Caps Lock On: Caps Lock is turned On after the system boots up. „ Touchscreen Brightness Adjusts the brightness level of the touchscreen. 3-9

[Page 114] Patient [Figure 3.3 Setup – System – Patient]
Patient Data „ Name Display X Last, First Middle: Display the name of the patient in the order of last name, first name, and middle name. X First Last Middle: Display the name of the patient in the order first name, last name, then middle name. „ Title Display Show or hide patient information in the Title area of the screen. X None: Patient information is not displayed. X Date of Birth: Displays the patient’s date of birth. X Age: Displays the patient’s age. X Gender: Select this checkbox to display the patient’s gender. Note that the patient’s gender can only be displayed if their date of birth or age is also displayed. 3-10

[Page 115] „ Title LMP/GA/EDD Display X LMP/GA: The last menstruation period and estimated gestational age are shown on the screen. X EDD/GA: The expected delivery date and estimated gestational age are shown on the screen. „ Middle Name Input Box If set to ‘On’, a text input field where you can enter a middle name while creating patient records is displayed. „ Save Patent Page as First Image If it is ‘On’, the patient information is saved as the first image. „ Other ID When you create a patient record, you can fill out the Other ID field. X Other ID Format: Any, Numbers, Letters and Numbers, and NHS Number are available. Except for Any, you can enter text in the chosen format only. „ Temp ID Choose whether to use a Temp ID. When ‘On’, a Temp ID will be created automatically when an exam begins. X Send DICOM during Exam: When you perform an exam using a Temp ID, choose whether to send it to DICOM by pressing the U Key to which the Send DICOM function has been mapped. 3-11

[Page 116]
User Defined List You may enter information related to studies beforehand, so that you can assign the information easily when entering patient information. X Keep Last Physician/Operator Name: Choose whether you will keep using the last entered Physician/Operator’s name for the next patient. X Operator: You can save the name of the operator who scans the patient. X Diag. Physician: You can save the name of the physician who diagnosed the patient. X Ref. Physician: You can save the name of the referring physician. X Indication: You can save information on the patient’s medical history. X Description: You can save up to 20 diagnostic memos per application. 3-12

[Page 117] QuickPreset On the Setup screen, select the QuickPreset tab in the System category. [Figure 3.4 Setup – System – QuickPreset]
QuickPreset Select the probe connected to the Port, an Application, and a Preset, and then save them to a QuickPreset. You can save up to 4 QuickPresets. You can use Preview to check the saved Preset in advance. X In Operation mode, the saved probes and presets are shown as buttons on the touchscreen. 3-13

[Page 118] EzExam+™ EzExam+™ enables users to build or to use predefined protocols. It transforms the ultrasound investigation into a streamlined process. EzExam+™ ensures the full investigation is performed, eliminating the risk of forgetting an image or loop capture, as well as measurement and transducer preset changes. For fetus diagnosis in particular, you can arrange the examination order according to the fetus position using the touchscreen, and automatically apply the BodyMarker, Annotation, Measurement, etc. 1 0 [Figure 3.5 Setup – System – EzExam+™]
Protocol List Provides a protocol list for the application. The default list cannot be modified. 1 Category: A list of available applications is shown. If there are previously configured Exams, then they will appear in the list of presets when you select an application. 2 New Protocol: The EzExam+™ Creator window appears. 3 Edit: Edits the selected protocol. 4 Rename: Edits the name of the protocol. 5 Delete: Deletes the protocol. 6 Import: Imports the protocol data. 7 Export: Exports the protocol. 3-14

[Page 119] 8 Move Up Button: Moves the protocol up one row. 9 Move Down Button: Moves the protocol down one row.
Preview 0 Task List: Provides a list of tasks that belong to the protocol. „ EzExam+™ Creator [Figure 3.6 Setup – System – EzExam+™ Creator] 1 Options in Function Window X New: Creates a new protocol. X Open: Loads an existing protocol. X Save: Saves the current protocol. It is activated at any time even when there is no change of data. X Save As: Saves the current protocol with a different name. X Undo/Redo: Provides an undo function to reverse the last action and a redo function to redo an action that has been undone. X Format Painter: Applies the settings configured for a specific field to the same field in another protocol. 2 View Preview: Automatically runs a report when a task is performed. 3-15

[Page 120] 9 0 [Figure 3.7 Setup – System – EzExam+™ Creator] 1 Add Task(↑): Creates a new task above the selected task on the task list. 2 Add Task(↓): Creates a new task below the selected task on the task list. 3 Copy: Copies the task selected from the task list. 4 Cut: Cuts the task selected from the task list. 5 Paste: Pastes the cut/copied task below the task selected on the task list. 6 Delete: Deletes the task selected from the task list. 7 Move Up: Moves the selected task up the task list one row at a time. 8 Move Down: Moves the selected task down the task list one row at a time. 9 Task List: Provides a list of tasks that belong to the protocol. 0 Task Parameter: Provides a parameter which belongs to the task selected from the task list. 3-16

[Page 121] Imaging Common [Figure 3.8 Setup – Imaging – Common]
General Settings „ HPRF In PW Spectral Doppler mode, this detects blood flow that exceeds the velocity limit at the depth at which you want to obtain a sample volume. „ Color Map Auto Invert (on linear) Automatically inverts the Color Map when the Steer is changed. „ Write Zoom Rearrangement Enable this to align the Write Zoom image to the center. When disabled, the Write Zoom image is displayed in the same shape as the observed position. 3-17

[Page 122] „ Update 2D in Cursor Moving Stops the tracing and converts to 2D Live mode if the SV moves in PW Only mode, and then restarts the tracing once the SV stops moving. „ Relative Focal Position Enable this so that when the 2D Depth value is adjusted, a similar pre-modification ratio of depth to focus position is maintained. „ Enable MultiVision in Dual Live Mode Enable this so that in Dual Live, MultiVision is applied to the left image, regardless of the setting of the right image. Note that in B/BC Dual Live Mode, MultiVision will be applied to both images at all times regardless of this setting. „ Enable ClearVision in Dual Live Mode Enable this so that in Dual Live, ClearVision is applied to the left image regardless of the configuration of the right image. Note that in B/BC Dual Live Mode, ClearVision will be applied to both images at all times regardless of this setting. „ Auto Calc./Trace Type Type 1 is a general mode while Type 2 is the bradycardia mode. The Auto Calc. and Auto Trace detection ranges change in PW Mode depending on the setting. „ Trackball Operation while Zoomed Select a reference position for the Zoom Box. „ Preferred Probe Port Specify the probe port that should be selected first when the system starts or when you select a probe. „ Color Velocity Unit Select the units of velocity in Color mode. „ Doppler Scale Unit Select the units of measurement for the axis scale in Spectral Doppler mode. 3-18

[Page 123]
Strain+ „ Apical View Order Set the Apical View order to be used in Strain+.
Display Settings „ Show Image Info Show or hide the image information. „ Show Horizontal Scale Bar Show or hide the horizontal scale bar in Scan UI. „ Display Tx Frequency Specify how to display the Tx frequency for each probe. When this is checked, the current state appears as a value in MHz units; when it is unchecked, PEN, GEN, or RES appears. „ Display Linear Full Image in Single Mode Displays the full image of the Linear (including virtual convex) probe in Single mode. „ Display Linear Full Image in Dual Mode Displays the full image of the Linear (including virtual convex) probe in Dual mode (including Dual Live). „ Live Scan Display at EzCompare™ Specify where the Live image should be positioned when EzCompare™ is launched. „ TGC window Auto Close (sec) Specify how much time must elapse before the TGC Control Window on the touchscreen automatically closes when there is no user input. „ TGC Curve Display Specify how long the TGC curve should be displayed for in Scan UI. 3-19

[Page 124] „ Biopsy Guideline Type Select the type of Biopsy Guide Line displayed. „ Wide Dual View The checked item is displayed in wide screen. „ Wide Single View Single mode screen is provided in wide mode. „ Quad: Active Window Sequence Specify the order in which images should be displayed on the screen in Quad mode. X Zigzag: Set in the order of 1 > 2 > 3 > 4 . X Clockwise: Set in the order of 1 > 2 > 4 > 3 . 3-20

[Page 125] Application/Preset [Figure 3.9 Setup – Imaging – Application/Preset]
Application Settings „ Select Application Select the measurement application. „ Seamless Dual Mode When checked, the left and right images are shown without a space between them in Dual mode; when unchecked, a space is inserted between the two images. „ Enable Doppler Cursor Mode Before entering Doppler Mode, select whether or not to enter Cursor Mode. „ Enable M Cursor Mode Select whether or not to enter Cursor Mode before M Mode. 3-21

[Page 126] „ Activated Mode When Image Is Frozen Select a function to be executed when pressing Freeze . X D or M Mode Only: This is enabled when you select Measurement. When checked, after you press Freeze, a measurement starts only in D or M mode.
Preset Settings „ Select Preset Select a probe, application, and preset. „ ECG Enable or disable ECG for each preset. „ Thermal Index Type Select TIs (Soft tissue Thermal Index), TIb (Bone Thermal Index), or TIc (Cranial bone Thermal Index) as the TI displayed on the screen. You can select one for each preset. „ Limit MI Set the limit value for the Mechanical Index (MI). You can select one for each preset. „ Limit TI Set the limit value for the Thermal Index (TI). You can select a limit value for the Thermal Index Type chosen for each preset. 3-22

[Page 127] S-Detect™ Enable or disable the settings for Breast. [Figure 3.10 Setup – Imaging – S-Detect™]
S-Detect™ for Breast „ Description Choose whether to display the desired BI-RADS . When ‘Off’, the Category Description will not appear on the screen. „ Sensitivity Setting Select High Sensitivity, High Accuracy, or High Specificity. „ Classification Choose the desired BI-RADS classification. 3-23

[Page 128] Application General [Figure 3.11 Setup – Application – General]
Probe Select a probe.
Application Selects an application.
Preset Select a preset that is supported by the selected application. 3-24

[Page 129]
Select Library „ Annotation Setup a text library. „ BodyMarker Setup a BodyMarker library. „ Measurement X Application: Select the measurement application. X Package: Setup a package for the measurement application. 3-25

[Page 130] Specify various setup options for measurements. General [Figure 3.12 Setup – Measurement – General]
Menu „ Direction Select Left or Right as the Direction type that should apply to the measurement target in the initial system state. „ Location Select a location type that should be applied to the measurement target in the initial system state. „ Hide the menu on Unfreeze Show or hide the Measurement menu on the screen after taking measurements. 3-26

[Page 131]
Display „ 2D Line Type Select a line type to use as default for measurements in 2D mode. „ Ellipse Cross Line Select a line type to use as default for measurements in 2D mode. „ Clear Measurement(s) on Unfreeze Show or hide measurement results on the screen when switching to Scan mode after taking measurements. When checked, measurement results are hidden in 2D or M/D mode. „ Measurement Zoom Window Display an image by enlarging the area surrounding the marker.
Result Select a measurement result display method. „ Position on 2D Mode Reposition the measurement results when 2D mode is selected. X Left-Top: Measurement results are displayed in the top left corner of the screen. X Left-Bottom: Measurement results are displayed in the bottom left corner of the screen. X Right-Bottom: Measurement results are displayed in the bottom right corner of the screen. X Right-Top: Measurement results are displayed in the top right-hand corner of the screen. X Custom: Measurement results are displayed in a location selected by the user. 3-27

[Page 132] „ Position on M/D Mode Moves the measurement results. X Left-Top: Measurement results are moved towards the top left corner of the screen. X Left-Bottom: Measurement results are moved towards the bottom left corner of the screen. X Right-Bottom: Measurement results are moved towards the bottom right corner of the screen. X Right-Top: Measurement results are moved towards the top right corner of the screen. X Custom: Measurement results are moved to a location selected by the user. „ Font Size Select a font size that should be applied to displayed measurement results. „ Show Background Set the background of the measurement results area to transparent (Off) or opaque (On).
Key „ Trackball Operation Set the trackball’s operation setting. X Marker: Displays the default marker on the measurement screen and allows you to measure an object. X Cine: You can select a Cine Frame by using the trackball. „ Set Measurement on Store When turned on, you can end a measurement in progress by pressing the Store key on the control panel. „ Set Measurement on Unfreeze When turned 'On', a measurement in progress ends when the image unfreezes by pressing Freeze . 3-28

[Page 133]
Cursor „ Type Select the shape of the default caliper cursor displayed on the screen. „ Arrow Head Marker Show or hide the Head Marker when measuring a small area. „ Size Select the size of the default caliper cursor displayed on the screen. 3-29

[Page 134] Library [Figure 3.13 Setup – Measurement – Library]
Measure Displays the library in the Measure category. „ Application Selects an application. „ Create Group Creates a User Group that is separate from the default group. „ Create Label You can create a User Label. NOTE: The ‘User Label’ can be modified. „ Delete Deletes the newly created ‘Group’ and ‘Label’. 3-30

[Page 135]
Caliper Specify whether additional information should be shown along with the basic measurement values when basic measurements are taken by pressing the Caliper button. It will be also displayed when you save or print your measurement results. Selecting ‘General’ as the Application changes the ‘D Trace’ field. Selecting ‘Cardiac’ as the Application changes the ‘D Trace’ and ‘D Velocity’ fields. NOTE: ‘Cardiac’ can be selected only when the probe is set to Cardiac. You can specify the default tools that become active while the measurement cursor is in use for each Image mode. Distance, Trace, Trace Length, Ellipse, Open Spline, Closed Spline, Distance Stenosis, Trace Length Stenosis, Open Spline Stenosis, 2D Mode Ellipse Stenosis, Trace Stenosis, Closed Spline Stenosis, Ellipse Trace Stenosis, 2 Lines Angle, 3 Point Angle,1 Dist Volume, 2 Dist Volume, 3 Dist Volume, Ellipse Volume, Ellipse + Dist Vol, Disk Volume Velocity, Velocity (Cardiac), Accel, Time(D), HR(D), RI, Auto Trace, Limited Trace, Manual Trace, Auto Trace(Cardiac), Limited Trace(Cardiac), Manual Trace(Cardiac), Dist Volume Flow, Trace Length Volume Flow, Open Spline Volume Flow, Ellipse Volume Flow, Trace Volume Flow, Closed Spline Volume Flow, S/D Ratio, D/S Ratio, V1/V2 Ratio, D Mode Velocity(F), Velocity(F) (Cardiac), Auto Trace(F), Limited Trace(F), Manual Trace(F), Auto Trace(F) (Cardiac), Limited Trace(F) (Cardiac), Manual Trace(F) (Cardiac), Dist Volume Flow(F), Trace Length Volume Flow(F), Open Spline Volume Flow(F), Ellipse Volume Flow(F), Trace Volume Flow(F), Closed Spline Volume Flow(F), S/D Ratio(F), D/S Ratio(F), V1/V2 Ratio(F) M Mode Distance, Slope, Time(M), HR(M) 3-31

[Page 136] Menu [Figure 3.14 Setup – Measurement – Menu]
Library Measurement items provided for each application are shown in a list.
Menu „ Package Select packages supported by each application. „ Image Mode Check the Menu and Touch Menu provided for each Image mode. „ Group Group View lists the groups shown in the Menu. When it is ‘On’, you can delete or move a displayed group. 3-32

[Page 137] „ Label Label View lists the items shown in the Menu. When turned ‘On’, you can delete or move items. „ Auto Sequence This executes selected items in a group in sequential order. „ Up, Down Rearrange the order of groups or items in Group View or Label View. „ Remove Removes the selected group and item from Group View or Item View. „ Touch Place groups and items shown in Group View or Item View onto the touchscreen. Clicking a Touch button displays groups and items that can be assigned to that button. X Clear All: Clear all groups and items. X Add Page: Add a page. X Remove Page: Delete a page. „ Reset Defaults Reverts to default settings. 3-33

[Page 138] Applications [Figure 3.15 Setup – Measurement – Applications]
Caliper „ Default Tool For each Image mode, specify the default tools that become active while the measurement cursor is in use. „ Default Tool Category Assign default tools to each measurement category. „ Live Caliper (2D Only) Launches Caliper in Live mode. NOTE: The use of Live Caliper may not be supported with particular features. 3-34

[Page 139]
Caliper then Assign „ Mode After performing a basic measurement in each Image mode, assign the measurement result to a specific label.
Menu X Caliper then Calc.: Clicking the Calculator button switches the mode back and forth from Caliper to Calc. X Calc. then Caliper: Clicking the Calculator button switches the mode back and forth from Calc. to Caliper. X Caliper Only: Clicking the Calculator button switches the mode to Caliper. X Calc. Only: Clicking the Calculator button switches the mode to Calc. When the Menu type is set to Caliper Only or Calc. Only, pressing the Measurement key on the control panel during measurements will close the window.
Doppler „ Display Absolute Value The doppler measurement is displayed as an absolute value. „ Heart Rate X Cycle: Select the number of heart rate (HR) cycles. X Manual: Enter a heart rate manually. X Automatic: A heart rate is entered automatically through an ECG. 3-35

[Page 140] Additional Options [Figure 3.16 Setup – Measurement – Additional Options]
Application „ Cardiac X RAP default value: Configure the default value of RAP. X LV Volume Method: Specify how the volume of the left ventricle is measured. NOTE: For more information on calculation formulas, please refer to the reference manual. X LV Study On Straight Line: You can specify the measurement direction for LV measurements. When it is ‘On’, the direction is fixed to the first measurement direction. 3-36

[Page 141] „ OB X SD/Percentile Type: Select a type. X NT Marker: Select a marker that should be displayed for NT measurements. X 2D NT Line Type: Select the type of the line for measuring 2D NT. X Clear Measurement(s) on Unfreeze: Show or hide measurement results on the screen when switching to Scan mode after taking measurements. When checked, measurement results are hidden in 2D or M/D mode. X LaborAssist™: Set the default measurement method for LaborAssist™ to Auto or Manual. X BiometryAssist™: Choose whether to use BiometryAssist™ for the desired measurement item. You can set measurement criteria for the BPD Method. „ Vascular ICA/CCA Ratio: Select measurement items that should be applied to the ICA/CCA ratio. „ GYN X Follicle – Sort by: Select the sorting criteria for the Report data. Display the data in an Ascending or a Descending order. X 2D Follicle™ – Stage: Set the Early, Middle, or Post stage. – Display Average on Result: Obtain the average of the measurements and display it on the screen. X UterineAssist™: Set normal ranges of Endometrium Normal Range, Uterus Normal Range, Uterus in the Post menopause, and Flexion Position. – Reset Settings: Resets to default settings. NOTE: You may select this when the application is OB, GYN, Vascular, or Cardiac. 3-37

[Page 142] AutoCalc This is a feature supported in Power Doppler mode. It automatically calculates specific items using measured values. NOTE: The specified items only appear on the screen when you press AutoCalc in Power Doppler mode. [Figure 3.17 Setup – Measurement – AutoCalc]
AutoCalc Setting Set which items should be calculated automatically. X When the Peak Systolic Velocity and End Diastolic Velocity values are 0, no results for any items will be displayed on the screen. X Time Averaged Mean Velocity results are displayed only when Mean Trace is On. 3-38

[Page 143] Tables [Figure 3.18 Setup – Measurement – Tables] „ Select Category View or edit the tables in the relevant category. „ Select Label The label’s author list is populated in the combo box, and the first author’s data is displayed on the screen. „ Select Author The selected data is displayed on the screen. „ New Creates data. „ Copy Copies the data and then creates new author data. „ Edit Edits data. 3-39

[Page 144] „ Delete Deletes data. NOTE: Only the author data created by the user may be deleted. „ Author Name Indicates the selected author’s name. NOTE: You cannot save new author data without entering a name for the author. „ Author Data Label Indicates the selected author data label. „ Author Data Type Indicates the selected author’s data type. NOTE: Author data type may be changed when creating new Author data by using the New button. Note that Table type data cannot be created for EFW. „ Age Unit Indicates the Fetal Age unit that applies to the selected author data. „ Valid GA Range Indicates the valid gestational age (GA) range for the selected author data. „ Label Unit Indicates the label unit for the selected author data. 3-40

[Page 145] „ Valid Label Value Range Indicates the valid label value range for the selected author data. „ Table Type Indicates the table’s deviation type for the selected fetal age author data. „ SD Type Indicates the table’s deviation type for the selected fetal growth author data. „ EFW Unit Indicates the EFW unit of the selected EFW author data. „ Equation Indicates the selected author equation data. X If the equation contains a formulaic error, the data cannot be saved. X If you enter a label that is not found in the Input Parameter list box, the data cannot be saved. „ Table Indicates the selected author table data. NOTE: At least one row of data must be entered into the Table before data can be saved. 3-41

[Page 146] Author [Figure 3.19 Setup – Measurement – Author]
Fetal Age Specify the Fetal Age Author for each Label.
Fetal Growth Specify the Fetal Growth Author for each Label.
Estimated Fetal Weight Specify the EFW or EFW Percentile author. To refer to other EFW values calculated using different formulas, specify EFW2 Author.
Composite GA Author Specify the author to use for calculating composite GA.
Set Authors To This changes the Author of all applicable measurement values at a time as ‘Author’ is selected in the applicable list box. 3-42

[Page 147] Report Report Order [Figure 3.20 Setup – Report – Report Order]
Library Application ComboBox: A list of labels is provided for each application.
Report Order Add the items that you have chosen in the Library to the Report Order list. X Reset Defaults: Resets the Report Order to its default state. X Up/Down: Changes the order (up/down) of the selected items in Report Order. X Delete: Removes the items moved from the Library by the user. The application’s original items cannot be deleted. 3-43

[Page 148] Comment [Figure 3.21 Setup – Report – Comment]
Select Application You can display all information for the measured application and select the application to show in Report.
Comments The user can enter comments manually. „ Clear Deletes saved comments. 3-44

[Page 149] Description [Figure 3.22 Setup – Report – Description]
Application Select an available application. There are preset items in Application, and you can only add users to the other applications. „ Create Creates custom items.
Available Items This is a category or item list that can be added to the Anatomy page.
Selected Items This is a category or item list that has been added to the Anatomy page. 3-45

[Page 150]
Selection Menu This is a list of the child items that belong to an item you have already selected and added to the Anatomy page. X Edit: Items added by the user can be edited. X Delete: Items added by the user can be deleted. X Using the 1 buttons in Setup – Report – Description, you can add or remove the selected item. X Using the 2 buttons in Setup – Report – Description, you can rearrange the order of the selected items. 3-46

[Page 151] Annotation Library [Figure 3.23 Setup – Annotation – Library]
Library Select an application type.
User Defined Library The user can enter or delete text. „ Create Creates text. X List (L) Type: It is displayed as ‘- - -’ and the number of ‘- - -’ will be determined by the number of words. When there is only one word, it will not be displayed. X Group (G) Type: The Group color will be displayed on the bottom right side of the button. Nothing will be displayed for buttons that do not belong to the Group. „ Delete Deletes text. 3-47

[Page 152] „ Reset Default Reverts to default settings.
Touchscreen Page 1 Specify the items that will be displayed on the first page of the touchscreen.
Touchscreen Page 2 Specify the items that will be displayed on the second page of the touchscreen.
Replacement Words Select and edit the text you wish to modify, and then save it by tapping the Save button.
Group By providing group combo box, up to one page can be assigned per group. „ Multi-Assign Assigns a group to more than one items. „ Clear Group Cancels the assignment to a specific group on Touchscreen Page. „ Clear All Group Cancels all the group assignments on Touchscreen Page.
Copy From Existing Select the items provided by the system that you wish to setup. 3-48

[Page 153] Annotation On the Setup screen, select the Annotation tab in the Annotation category. Select whether or not to discard annotations from the screen when in Scan Mode or when the probe or application is changed. [Figure 3.24 Setup – Annotation – Annotation]
Common „ Erase when the image is unfrozen When UnFreeze is executed, the annotation is deleted. „ Erase when the probe or application is changed Select whether or not to erase annotations when the probe or application is changed. „ Erase when the mode is changed Select whether or not to erase annotations when the Operation mode is changed. „ Display Annotation on Thumbnail Images Selects whether or not to display annotations on thumbnail images. 3-49

[Page 154]
Annotation „ Home Position Set the text start point. „ Font Size Set the font size to use. „ Text Color Set the font color to use.
Arrow „ Arrow Size Select the size of the arrow. „ Arrow Type Select the shape of the arrow. „ Arrow Angle Select the angle of the arrow. 3-50

[Page 155] BodyMarker Library [Figure 3.25 Setup – BodyMarker – Library] You can create, edit, or delete a BodyMarker library. 1. Check the desired regions shown on Touchscreen Page 1 or Touchscreen Page 2 using the trackball. Then, the relevant touch button will be selected. 2. Select the desired BodyMarker in the Copy from Existing area, then the BodyMarker will appear in the area marked in blue. 3. Select a BodyMarker on Touchscreen Page 1 or Touchscreen Page 2 using the trackball. Then, the BodyMarker will be marked in blue. The BodyMarker can be deleted by pressing Erase . 3-51

[Page 156]
Library Selects an application.
User Defined Library The user can create or delete a Library. „ Create Create a new Library. „ Delete Delete a BodyMarker. „ Reset Default Reverts to default settings.
Touchscreen Page 1 Specify the items that will be displayed on the first page of the touchscreen.
Touchscreen Page 2 Specify the items that will be displayed on the second page of the touchscreen.
Copy From Existing Choose the BodyMarkers provided by the system that you wish to setup. 3-52

[Page 157] BodyMarker [Figure 3.26 Setup – BodyMarker – BodyMarker]
Common „ Activate when dual/quad mode on Choose whether to show or hide BodyMarkers when Dual or Quad mode is enabled. „ Erase when the image Is unfrozen Choose whether BodyMarkers should be deleted when you switch to Scan mode by pressing Freeze . „ Erase when the preset is changed Choose whether BodyMarkers should be deleted when the preset is changed. „ Copy to active area when dual/quad mode on Choose whether BodyMarkers should be copied to the active area while in Dual or Quad mode. 3-53

[Page 158]
BodyMarker „ Home Position Set the BodyMarker’s position. 3-54

[Page 159] Customize General [Figure 3.27 Setup – Customize – General]
Common „ Set/Exit Key X Set/Set: Both the left and the right buttons are set to the Set function. X Set/Exit: Assign Set to the left button and Exit to the right button. X Exit/Set: The left button is set to Exit and the right button is set to Set . „ Pointer Set to either Pointer or Arrow. 3-55

[Page 160] „ End Exam X End Exam + Patient: Pressing End Exam brings up the Patient Information screen. X End Exam Only: Pressing End Exam terminates Exam and brings up the B mode Scan screen. X Reset Preset: Pressing End Exam resets the preset. „ Foot Switch Assigns functions to each of the pedals of the foot switch.
Clip Store „ Clip Store Type X Retrospective: When saving images, images that were acquired before the button was pressed are saved. X Prospective: When saving images, images that are acquired after the button is pressed are saved. „ Clip Store Method X Clip Length (sec): Specifies the length of the image to save. Press the button to select the desired number of seconds. X Number of Heart Cycles: Specify the number of Heart Cycles to be included in images. X Time before Heart Cycle (ms): Specifies the time to be included before one heart cycle begins. X Time after Heart Cycle (ms): Specifies the time to be included before one heart cycle completes. 3-56

[Page 161] Buttons [Figure 3.28 Setup – Customize – Buttons] 3-57

[Page 162]
User Key Assign functions to the User Key buttons on the control panel. The available functions are shown below: U1, U2, U3, U4 None Quad Pointer Patient Biopsy Probe Change Exit Simultaneous TDI TGC Caliper TDW Q Scan Calculation Store/Send/Print Harmonic EFW Measure Steer Invert Single EFW Result Text Keyboard Dual AutoIMT+ StressEcho Protocol Start/Pause Dual Live Arrow StressEcho CC Start/Pause Cine Selection EzAssist™ X When you select Store/Send/Print, you can additionally configure the Store (e.g., Single, Clip, 3D Image Save, or Volume Save), Send, and Print-related settings. You can select External Storage, and specify an external storage device that you use to export images (e.g., a USB or network drive), directory, file format, image quality, display of patient information, etc. 3-58

[Page 163] Touch Menu [Figure 3.29 Setup – Customize – Touch Menu]
Mode Type You can setup the following functions: 2D Live, 2D Freeze, C Live, C Freeze, PD Live, PD Freeze, TDI Live, TDI Freeze, S-Flow™ Live, S-Flow™ Freeze, PW Live, PW Freeze, TDW Live, TDW Freeze, CW Live, CW Freeze, M Live, M Freeze, ECG Live, ECG Freeze, SEE Stream Live, SEE Stream Freeze, Panoramic Ready, Panoramic Review, ElastoScan™ Live, ElastoScan™ Freeze, Lithotripsy, NeedleMate+™, StressEcho, StressEcho Review. „ Touch Panel Specify items to be included on the touchscreen and their positions. „ Toggle Control Specify the dial-button activated items to be included in the bottom menu on the touchscreen and their positions. „ Reset Defaults Reverts to default settings. 3-59

[Page 164] Peripherals [Figure 3.30 Setup – Peripherals – Peripherals]
Printer „ Printer Settings Select the printer you wish to use. To remove a printer that is no longer used, select the printer and press Remove . „ Printing Image Adjustment Select the printer you wish to use. Enter values for 2D mode and 3D mode separately. Pressing Reset reverts to default settings. „ Printer Queue Choose whether or not to cancel a printer job while an image is being printed. Select the printer that is currently printing. Press Clear Print Queue to cancel a print job. X Select All Printers Select this checkbox to cancel the print jobs of all the connected printers. NOTE: A print job can be canceled only if the image data to print has not been completely sent to the printer. 3-60

[Page 165] „ Local Printing Area X Full Screen: Prints everything shown on the monitor screen. X Video Out: Prints a certain area of the screen, including the image area. X Image Only: Print the image area only. „ Hide Patient Data Select whether or not to display the patient information.
On Screen Keyboard Set the Auto Display function for the Screen Keyboard. X When the keyboard is not connected: A message prompts you to connect the keyboard. X When the keyboard is connected: You can setup the Auto Display function.
Export Image Compensation Any images you transfer externally can be calibrated by adjusting their Gamma, Brightness, and Contrast values. Pressing Reset reverts to default settings.
Barcode/Card Choose whether to use a barcode/card. To set the initial values that are required to use a barcode/card reader, press Set . X Only one type of barcode/card reader may be detected; two or more types cannot be used at the same time. X If no barcode/card reader is connected, the screen is disabled. CAUTION: A barcode/card reader must be connected before you open the Barcode/Card window; a barcode/card reader will not be detected if the Barcode/Card window is already open. 3-61

[Page 166] „ Readers Supported by the Product X 1D: Zebra LS2208 X 2D: Honeywell 1900, Zebra DS2208, WELCOM DESIGN SSHC65V X Card: System Gear PDC-30UR „ Barcode/Card Reader Setup Connect the reader that you want to use to the product’s USB port, and then turn it on. Then, scan barcodes in the order specified below: Model Order 1. Set Factory Defaults Zebra LS2208, DS2208 2. Set Interface as USB CDC Host 1. Set Factory Defaults Honeywell 1900 2. Set Interface as USB Serial 3-62

[Page 167] Model Order 1. Start Setting 2. Set Interface as USB Serial WELCOM DESIGN SSHC65V 3. Finish Setting System Gear PDC-30UR Install PeTool NOTE: For related information about how to install the PeTool to setup a card reader, please refer to the card reader’s user manual. „ Received Data Display the input data. „ Separator Enter a separator (special character) that separates the displayed data. „ Patient Fill out the Patient ID, Name (Last, First, Middle), Gender, Birth Year, Birth Month, and Birth Date fields. X Checkbox: Specify whether you wish to use the data or not. X Offset: Specify from which digit the number should be counted. X Length: Enter the maximum length of input data. X Order: Specify the order of the data among the separated. 3-63

[Page 168] „ Gender Type X MF: Display the gender type as M (male) or F (female). X ZeroOne: Display the gender type as 0 (male) or 1 (female). X OneTwo: Display the gender type as 1 (male) or 2 (female). X TwoOne: Display the gender type as 2 (male) or 1 (female). X OneZero: Display the gender type as 1 (male) or 0 (female). „ Study Fill out the Accession #, Ref Physician, and Description fields. „ Communication Setup a communication system. The recommended specifications for each reader are as follows: Model Baud Rate Parity Data Bits Stop Bits Barcode Type Zebra LS2208 9600, 19200, Code 39, Zebra DS2208 38400, 57600, None 8 1 Code 128, QR 115200 Honeywell 1900 2400, 4800, 9600, WELCOM DESIGN None, Code 39, 19200, 38400, 7, 8 1, 2 SSHC65V Even, Odd Code 128 57600, 115200 System Gear 2400, 4800, 9600, None, 7, 8 1, 2 - PDC - 30UR 19200, 38400 Even, Odd „ Character to Remove from Patient ID X Hyphen: Removes all hyphens from the Patient ID. X Space: Removes all spaces from the Patient ID. 3-64

[Page 169] „ Conversion Method of Patient ID X Standard setting: Displays the Patient ID as-is. X Replace top space with 0: If the Patient ID begins with a space, then the space is replaced with ‘0’. X Add 0 to the top: Adds a leading zero in front of the Patient ID. X Digit number: If you enter fewer than the specified number of digits for the Patient ID, then ‘0’ is added. „ Auto Reflection When the checkbox is selected, patient details entered by scanning the patient’s barcode/ card are automatically registered in the Patient window. „ Adjustment Result You can preview the data with the settings applied. „ Initialize Resets the entered settings. „ Save Saves the settings. NOTE: Once Barcode is enabled, you can check the patient details entered by scanning the patient’s barcode/card in the Patient window. 3-65

[Page 170] Device Press Eject to eject the disc from the device. Press Format Media to format the CD/DVD. [Figure 3.31 Setup – Peripherals – Device] „ Map Network Drive To connect to a network, 1. Select a Drive Name. 2. Enter a Network Folder path. 3. Enter User ID and password and then press the Connect button. 4. Select a Drive Name and press the Disconnect button to close it. 3-66

[Page 171] Connectivity DICOM Used to configure DICOM (Digital Imaging and Communication in Medicine) operation and server. NOTE: For more information, please refer to the server’s user manual, or the DICOM Conformance Statement. [Figure 3.32 Setup – Connectivity – DICOM]
System Configuration Information about the DICOM server in use is displayed. The server information is used to identify the DICOM for the system within a network. It is also used to transfer data to other DICOM servers. Select the DICOM server you want to use by using the Service Name checkbox. NOTE: For the ‘IP Address’, ‘AE Title’, and ‘Port No.’ settings, contact your organization’s network administrator. 3-67

[Page 172] „ Station Name Enter the name of the system. Along with the ‘AE Title’, it is often used to identify the system on the DICOM network. „ Port No. Enter the port number for the server being used. „ AE Title Enter the name of the DICOM AE (Application Entity). It is used to identify equipment that uses DICOM on the network. „ Use TLS Choose whether or not to use DICOM TLS when receiving data. X Verify Client Certificate: Check whether the certificate of the counterpart attempting to send data is valid using the Trusted Authority Certificate saved on the product. „ DICOM TLS Select a certificate required for DICOM communication encryption. For encrypted DICOM communication, the product must have a certificate; if not, you must register a new certificate. X Import: Register a certificate for the product. Select the certificate and private key file that you have. Fields marked in red are required fields. X Create: A certificate is self-generated for the product. Fields marked in red are required fields. X Delete: Delete a certificate from the product. X Export: Copy the product’s certificate to a USB drive. If a certificate has been self- generated by the product, other servers that you will access later may need to verify the product’s certificate. X Trusted Authority Certificates: When using the DICOM function, register the certificate for the certification authority which will verify the certificate of the counterpart you will access. Press Import under Trusted Authority Certificates and then select a certificate file. „ Qview Choose whether to use Qview. 3-68

[Page 173]
General Configuration „ SR Format Select a format to save SR. „ Store SR at End of Exam Select whether to store SR at the end of the exam. „ Create New Series by Pressing Continue Exam Even if patients are not examined continuously, the exam results are provided together, and not separated. „ Character Set Select Character Set to be used when perform Worklist and Storage Service using DICOM. X Except Escape Sequence when using Storage: Select the checkbox to send data except Escape Sequence when using Storage. This can be enabled for specific Character Set only.
Adding DICOM Services Press Add . A screen is displayed where you can enter a DICOM service to add. After adding a service, press Apply to save your entries. Press Cancel to cancel. „ DICOM Services Select the type of service to use via DICOM. „ Alias Enter the name of the DICOM server. „ AE Title Enter the AE Title of the DICOM server. Consult your network administrator before specifying this option. 3-69

[Page 174] „ Host Enter the IP address of the server being used. Consult your network administrator before specifying this option. „ Port No. Enter the port number for the server being used. Consult your network administrator before specifying this option. „ Connect Timeout The connection will time out if there is no response within the configured time period. You can specify this time period in seconds. „ Read Timeout Specify the Read Timeout time limit for the server you are adding. „ Retry Interval Specify how many seconds the system will wait before it retries a failed transmission. You can specify this time period in seconds. „ Maximum Retries Specify how many times a failed transmission will be retried. „ Packet Size Specify the size of the transfer packet. „ Use TLS Choose whether or not to use DICOM TLS when sending data. X Verify Server Certificate: Check whether the certificate of the server attempting to receive data is valid by using the Trusted Authority Certificates saved on the product. 3-70

[Page 175] Storage Server Information Configure the image storage service using DICOM. X Send After Acquisition: Send images whenever you save images using Store . X Send on End Exam: Send all saved images at once by pressing End Exam . „ Transfer Types X Include Multi Frame: When this is ‘On’, Cine Loops can be transferred. X Include 3D Volume: Enable this if you wish to transfer 3D volume data together with images. NOTE: Select this option only if you use a storage service that supports our 3D volume data format. „ Convert to Grayscale X No Conversion: Sends the original image without converting it. X All Images: Converts all images to grayscale before sending them. X B/W Image Only: Converts only the black and white images to grayscale before sending them. „ Support Include Pixel Spacing: In addition to the area information used in ultrasonography, the area information used in CT or radiography is also included. You can take measurements in a PACS system that does not support ultrasound area information. NOTE: However, only 2D and 2D Color mode images are supported. In Dual and Quad mode, the depths of the included images must be identical. 3-71

[Page 176] „ DICOM Compression Select whether or not to compress the images for the DICOM service. When you select Uncompressed, the images are saved without compression. NOTE: DICOM Compression settings are applied at the time an image is saved. For example, if it is set to JPEG Baseline or JPEG Lossless, the image is compressed when it is being saved. X Single Frame: Specifies the compression type for still images. X Multi Frame: Specifies the compression type for Cine images. X JPEG Baseline: You can prioritize either the quality or the compression ratio. You can specify the compression type, compression ratio, frame rate, and image size. „ VOI LUT Setup Configure VOI LUT (Value Of Interest, Look Up Table). Adjust the brightness and contrast of a DICOM image when saving it. The saved image can be viewed with any PACS devices that use the standard VOI LUT of DICOM. X Window Center: Enter a value for DICOM Tag (0028, 1050) settings. The set value indicates the brightness of an image that is displayed by the storage service. The image will get darker if the value is set to 128 or higher. Note that this function can be used only when it is supported by the storage service. X Window Width: Enter a value for the DICOM Tag (0028, 1051) setting. The setting value indicates the contrast of the image displayed by the storage service. Values set to higher than 256 will result in lower contrast. Note that this function is available only when it is supported by the storage service. SC Server Information Configure the Storage Commitment Service using DICOM. The Storage Commitment Service is used after a diagnosis is completed and all the saved images and reports are sent. „ Associated Storage Server Select an image storage server to connect to. „ Associated SR Server Select a Structured Report server to connect. 3-72

[Page 177] Worklist Server Information Set the Modality Worklist Service using DICOM. „ Query Setting Select the type of Modality to retrieve when updating the worklist. X Modality: Select either ultrasound images (US) or all images (All). Tips! After setting up the Worklist service, press Patient to go to the Worklist page. „ Update Method Specify the method of updating worklist. X Only on User Request: Update worklists only when the user wishes to. To update worklists, set Search Source to Worklist in the Search tab on the Patient Information screen, and then press Search . X When Worklist Page Opens: Perform updates every time the Worklist page opens. X On Startup and Every: Update worklists when the system boots up, and then automatically update them at specified intervals. „ Exam Description Specify from which section of the DICOM file you want to import information for the Exam Description. Print Server Information Configure the Print Service using DICOM. X You can configure a printer connected to the DICOM network only. X Depending on the printer, some of the following functions may not be available. Before configuring a printer, please refer to the printer user’s manual, or the DICOM Conformance Statement. 3-73

[Page 178] X Print After Acquisition: Pressing Store prints images whenever you save images. X Print on End Exam: Prints all saved images at once when you press End Exam . „ Layout Setting Specify the paper layout. „ Printer Setup X Color: Specify whether or not to use colors. X Orientation: Specify the paper orientation. X Magnification: Specify the interpolation method that will be used when resizing an image to output. X Border Density: Specify the border color of the image to be printed. X Priority: Specify a priority for the print command. X Destination: Specify the paper output pathway. X Medium Type: Specify the material type for the printout. X Copies (1–99): Set the number of copies to print. X Film Size: Select a paper size. X Smoothing Type: This option is available only when Magnification is set to CUBIC. Enter a value for the printer which is specified in the DICOM Conformance Statement. X Empty Density: Specify the background color of an image to print. X Min Density: Specify the minimum brightness of an image to print. If not specified, the printer’s default setting is applied. X Max Density: Specify the maximum brightness of an image to print. If not specified, the printer’s default setting is applied. X Configuration Info: Specify the unique value for a printer. Please refer to the DICOM Conformance Statement for the printer. 3-74

[Page 179] PPS (Performed Procedure Step) Server Information Configure the Modality Performed Procedure Step Service using DICOM. „ Always complete exams When you select this checkbox, exams are always reported in complete condition. If you press End Exam without selecting a checkbox, the cancellation message that was selected after you selected the cancellation message for End Exam will be sent to the RIS server. STORAGE SR (Storage Structured Report) Server Information Configure the Report Storage Service using DICOM. X Send After Acquisition: Whenever you press Store , the measurement data in the report is transferred. X Send on End Exam: Whenever you press End Exam , the measurement data in the report is transferred. QR Server Information Select ‘QR’ in the DICOM Service Options field. The configuration options are the same as those for the storage server. 3-75

[Page 180]
Editing DICOM Information Select a service and press Modify on the screen. The information for the selected service appears. After changing the information, click Apply to save the changes. Click Cancel to cancel.
Deleting DICOM Services Select a service and click Delete on the screen.
Testing DICOM Servers Select a service and click Verify on the screen. The connection with the selected service is tested and the results are shown under Verify. If the result is Success, the connection is normal.
Qview (Cloud Server) Qpath is a cloud server. It’s sold separately. This product allows you to check images sent by the product on the cloud server. „ Qpath Settings 1. Press Add , and select ‘Storage’ in the DICOM Service Options field and ‘Qpath’ in the Alias field. Then, enter a Host and Port No., and press Save to save the settings. 2. When ‘Success’ is displayed as the Verify value in the DICOM server information, it means a connection has been established. 3. Enter ‘Qpath’ in the Send field of the User Key. „ Viewing Qpath Images Pressing Qview on the Patient Information screen moves you to the cloud server. 3-76

[Page 181] HL7 HL7 (Health Level 7) is a set of standards accredited by the American National Standards Institute (ANSI) for transfer of information between health information systems; it is the most widely used set of standards for health information not only in the United States, but across the world. „ HL7 Manager The HL7 Manager window appears. You can configure settings required for transferring information about reports created by this system to the HL7 server (repository). „ Repository Displays information about the repository server. X Add: Add a server. The Repository Info window appears. For the ‘IP Address’ and ‘Port No.’ settings, please contact your organization’s network administrator. – Alias: Enter the name of the server. – IP Address: Enter the IP address of the server. – Port No.: Enter the port number of the server. – Connect Timeout: Enter the TCP/IP connection timeout (in seconds) for transferring data. – Read Timeout: Enter the TCP/IP connection timeout (in seconds) for receiving server response. X Edit: Edit the information for the selected server. X Delete: Delete the selected server. X Active: Select whether or not to use the repository server by selecting or deselecting the Active checkbox for the registered repository. 3-77

[Page 182] „ Job Status Review and manage the status of data transfer (jobs). Only jobs that are currently being transferred or have failed to transfer are displayed. To display all jobs, including the ones that have been successfully transferred, select the Show All checkbox. X Columns: The user can select columns to check. X Retry: The user can select to retry a job as long as its status is ‘FAIL’. X Delete: The user can delete a job as long as its status is ‘SUCCESS’ or ‘FAIL’. X Show All: Shows all jobs. X Delete Archived Job Status after(days): Deletes the jobs archived for the selected number of days. „ HL7 Export If there are one or more active repository servers registered to the HL7 Manager and you’ve performed one or more measurements on the Report screen, then you can export them using ‘HL7’ on the Report screen (However, patient information must exist; if not, a warning message of ‘Please enter a valid patient ID.’ will appear). 3-78

[Page 183] Network In the Setup screen, select the Network tab in the Connectivity category. Or tap Connectivity on the touchscreen. You can manage the network information for the current equipment. [Figure 3.33 Setup – Connectivity – Network]
Network Configuration Setup the network information for the current equipment. „ Automatic Configuration (DHCP) If the checkbox is selected, the IP information is configured automatically. „ Static Configuration If the checkbox is unselected (Automatic Configuration), you can enter a static IP address. Specify the IP Address, Subnet Mask, Gateway, and DNS information. „ Revert Clear the currently entered information and revert to the existing settings. „ Apply Use the currently entered information to setup the IP. 3-79

[Page 184]
Wireless „ Wireless LAN Connect the product to a wireless network through a USB adapter. NOTE: The Wireless Network Settings window is enabled only when the product is connected to a wireless USB adapter. X SSID(Service Set Identifier): Displays the name of the connected wireless network. X Authentication: Displays the access authentication method for the wireless network. X Data Encryption: Displays the data encryption method for communicating with the wireless network. X Password: Enter the password for the network. Connecting to a Wireless Network 1. Use the trackball and Set to press Scan . 2. Select an available wireless network, and then press Select . 3. Press Connect to connect the product to the wireless network. 4. Press Disconnect to disable the connection. 5. Press Close to finish the setup. „ Static IP Set a static IP address for wireless network. „ Set up a Connection or Network Open Wi-Fi Settings to connect with WPA2-Enterprise. „ Certificate Import Load a certificate from external storage to register. „ Delete Profile Delete the profile information of the previously connected AP. 3-80

[Page 185] Profile Manager This function allows the user to back up and restore the Connectivity Setup data. [Figure 3.34 Setup – Connectivity – Profile Manager] X Add: Save the current DICOM Service list, HL7 Repository list, and Local Network Setting information. X Modify: Edit the Institute and Department information of the saved Profile (other fields cannot be edited). X Refresh: Update the saved Profile List and display it on the screen. X Import: Imports the Profile settings from an external storage device (USB drive). (You can only import one profile at a time; the target profile names are displayed in the Import UI.) X Export: Exports the Profile settings to an external storage device (USB drive). X Delete/Delete All: Deletes the selected Profile or all Profiles. X Apply: Restores the Profile settings to the selected values and then shuts down the system. 3-81

[Page 186] X A maximum of 30 profiles can be registered. X When adding a profile, you can enter up to 30 English letters in the Profile Name, Institute, and Department fields. (Profile Name is a mandatory field; Institute and Department are optional fields.) X If there is no User Data setting for DICOM Service and HL7 Repository, an ‘X’ will be marked on the Profile List to indicate that the data does not exist. X If there are no additional User Data settings in the Local Network Settings, the Profile List will be disabled. X Other settings for DICOM and HL7 (e.g., System and General Configuration) are excluded from the Import, Export, and Apply actions. 3-82

[Page 187] Service X Users should not attempt to perform anything on their own. They must contact the customer service department of Samsung Medison who can perform this service for them. X Performs restoration of saved basic patient information and images, or changes the software. X This enables or disables optional software or hardware. – Option: Shows the types of optional software that can be installed on the product. – Status: Shows the current status of optional software. Registered means that the software can be used until the date specified by the Expiration Date is reached. Unregistered means that the software cannot be used now. X It displays the software version of the product. X It provides the built in Self Test function. X Demo videos related to optional features are saved in the Demo Play tab. Help Press Help . If the keyboard has been connected, you can open Help by pressing the Help key on the keyboard. The help text stored in the system will be displayed on the monitor screen. NOTE: There is no Return key on the Help screen. 3-83

[Page 188] Strain+ Image (Option) Strain+ Image provides the ability to support cardiovascular system applications. It uses a motion vector to see the heart movement. X Strain+ is an optional feature for this product. X The Strain+ Image function can only be used when the following conditions are met: – Application: Cardiac – Operation mode: 2D (Freeze state) – ECG: On, two or more ECG trigger points; ECG HR: 30–240 Range „ Quantification You may select Strain+, Auto EF, or TMAD. NOTE: If the image was not properly selected, it will not switch to the Quantification screen. 3-84

[Page 189] Strain+ Strain+ is a quantitative tool for measuring global and segmental wall motion of the left ventricle (LV). In Strain+, three standard LV views and a Bull’s Eye are displayed in a quad screen for easy and quick assessment of the LV function. Tap the Strain+ button on the touchscreen. You will be moved to the Strain+ screen. Strain+ is executed in the following order: Image selection → Contour line setup → Strain+ data calculation → Result analysis CAUTION: Use the Strain+ function only for adult cardiac images.
Select an image Select an image and chamber information. The Strain+ screen is composed as follows: 1 Thumbnail list: Saved images will be displayed as thumbnails. 2 Image Area: The images selected from the Thumbnail list are displayed. 3 Operation Guide: Display the methods of selecting images and retrieving them from the thumbnail list. 3-85

[Page 190] „ Selecting Images Select from one to three desired images from the thumbnail list. Use the trackball and the Set button on the control panel to select an image. The following two options are available: 1. When you double-click a desired image, the image will be displayed in the image area. 2. When you select a desired image and click the pointer on the image area, then the image will appear. X If one or more conditions for using the Strain+ Image function (e.g., Cardiac, 2D Mode, and ECG On (HR: 30–240)) are not met, the relevant items will be displayed in red in the top- left corner of the image. X You cannot use the same image twice. „ Selecting Cine Position Setup the Cine for each image displayed in the image area. Select an image by referring to the following: X Select an image that shows the entire wall of the heart. X We recommend that there is an R-Peak before/after the selected image and there are more than 70 Cine frames between the previous R-Peak image and the last one. „ Selecting Chamber Information Select Apical View or Short Axis View using the radio button on the left or the View button on the touchscreen. NOTE: If the stored Strain+ data differs from the current Chamber information, a warning window will appear. 3-86

[Page 191]
Contour Line Setup and Calculations Tap the Next button on the Strain+ screen. The screen will switch to the Contour Setup screen. In the Contour Setup screen, a contour line is drawn on the image and the calculations based on it are carried out. The Next button is enabled only when the three displayed images are different from one another. [Figure 3.35 Strain+ Screen] „ Step 1: Setting an Image View Method Set an image view method, and select three images. X Apical View: Displays each view in order of LAX, A2C, and A4C. X Short Axis View: Displays views in order of Basal, Mid, and Apical. 3-87

[Page 192] „ Steps 2, 3, and 4: Draw and Generate an Endocardial Contour Line Provides the same endocardial contour line for each view selected in Step 1. 1. Using the trackball and the Set button on the control panel, specify three points. Select three points that match the guide. If you want to edit point ‘a’ chosen while specifying 3 points, press the Undo button. Select Calculate when completed. X Clear: Resets all images that have been set. X Frame: You can explore the Cine Frame using the button. X Thickness: Once a contour is drawn automatically based on the 3 points, the thickness between Epicardial Line and Contour Line is adjusted. 3-88

[Page 193] 2. When you bring the cursor near the point on the Endocardial or Epicardial line that you want to edit, the point will be marked with yellow borders. Press the Set button on the control panel and then use the trackball to reposition the point. Press the Set button again to update the contour line according to the changed point. 3. A checkbox is provided to the left of the value displayed for each segment. Inaccurate segment results can be disabled by unticking the relevant checkboxes, and the AVO and AVC values can be adjusted using the provided buttons. 4. To repeat, select the Reset or Edit button; once completed, select Calculate . X Direction: Subcategories are determined by View. 5. In Apical View, EF values are provided for A4C and A2C, but not for LAX. The Short Axis method does not provide EF values. Please review the result. 3-89

[Page 194] „ Step 5: Calculating Strain+ Data The final results for the three images are provided based on the image view method. 1. Move on to Step 5. 2. You can check the Bull’s-eye and comprehensive results. X Frame, Cine Play, Cine Speed: Enabled when the Display field is set to Bull’s-eye + Images. X Display: Bull’s-eye (Default), Bull’s-eye + Images, and Bull’s-eye + Graph are provided as sub-categories. X Save as AVI: When selected, images are saved as AVI files. To use the Screen Capture function, press the Save button on the control panel. 3-90

[Page 195]
Strain+ Result The Strain+ Result screen is composed as follows: [Figure 3.36 Strain+ – Touch Panel] X Direction: In Apical View, you can change the Direction setting to Longitudinal or Radial, while in Short Axis View, you can change it to Circumferential or Radial. X Segment: It’s set to 18 Segment by default. You may change it to 17 Segment. X Save Strain Data: You can save Strain data. If you are retrieving a saved image, the used exam will be automatically loaded, and Step 5 will begin. X Assign to Report: Save the result analyzed by Strain+ to the report. X Export to Excel: Save the result and the representative image as an Excel file. This is available only if a USB flash memory drive is connected. X Export to AVI: Save the result as an AVI file. This is available only if a USB flash memory drive is connected. X Strain: The Strain value and relevant Parametric image are displayed on the screen. X Strain Rate: The Strain Rate value and relevant Parametric image are displayed on the screen. X Time to Peak Strain: The Strain’s Time to Peak value and relevant Parametric image are displayed on the screen in Step 5 only. After finishing reporting in the Strain+ Analysis screen, press the Report button on the control panel to open the Strain Report. X The Strain report cannot be edited. 3-91

[Page 196] Auto EF Press the Auto EF button on the touchscreen. CAUTION: Use the Auto EF function only for adult cardiac images. X The Auto EF function can only be used when the following conditions are met. – Operation mode: 2D (Freeze state) – Screen mode: Single mode X The Auto EF function is not an auto-complete option; the user needs to specify points and draw a contour line. [Figure 3.37 Auto EF Screen] 3-92

[Page 197]
Select an Image Select a View. A4C is selected by default. „ Automatically Calculate X When enabled: After 3 points are selected, it automatically switches to the Result screen. X When disabled: Modifications can be made after selecting 3 points. It switches to the Result screen once the Calculate button is selected manually. „ Calculate Go to the Result screen. This is enabled after 3 points are selected. „ Clear You can reset and start over. 3-93

[Page 198]
Contour Line Setup and Calculations „ Drawing Contour Lines Use the trackball and the Set button on the control panel to specify three points. Select three points that match the guide. While specifying three points, if you wish to edit any of the selected points, press the Undo button. Select the Calculate button when completed. „ Calculating Auto EF Data Press Calculate . The screen will switch to the Result screen. Pressing the Reset button will reset the data and switch to the screen where a three-point contour line can be drawn. 3-94

[Page 199]
Auto EF Result The Auto EF Result screen consists of the following items: 1 End Diastolic: The related information will be displayed in yellow. 2 End Systolic: The related information will be displayed in orange. 3 Calculation Result: The Stroke Volume (SV) and Ejection Fraction (EF) will be displayed. If the position of the Cine frame is changed, the calculation results will be changed accordingly. To change the frame’s position, use Diastolic or Systolic . To reset the frame’s changed position, use Reset Systolic or Reset Diastolic on the touchscreen. [Figure 3.38 Auto EF – Touch Panel] 3-95

[Page 200] „ Display Subcategories include Dual View + Graph and Quad View Layout. X Frame , Cine Play , Cine Speed : These are enabled when the Display field is set to Quad View. „ Assign to Report Relevant information is saved to the report. „ Frame Move the current Frame. „ Cine Speed Select the playback speed for Cine images. „ Cine Play Stop or resume playback of the image. 3-96

[Page 201] X Based on the Endocardial contour set by the user, it traces the endocardium in other images within the set Beat and finds its border. X Using the endocardial border calculated from all images of cardiac cycle and Simpson's Rule, it measures the volume. X Among all volumes of the heart intervals, use the smallest value (ES: End Systolic) and the biggest value (ED: End Diastolic) to calculate the Stroke Volume (SV) and the Ejection Fraction (EF). X The user checks ED and ES. Simpson’s Rule Find the position of the Apex, followed by the length component of the longest axis. Based on this information, measure the volume assuming that there are multiple disks. Stroke Volume SV = EDV – ESV EF (Ejection Fraction) EF(%) = SV / EDV * 100 (Terminology) EDV: End-Diastolic Volume ESV: End-Systolic Volume 3-97

[Page 202] TMAD Freeze in the Cardiac Preset, and then press the TMAD button. TMAD stands for Tissue Motion Annulus Displacement, which studies the function of the heart by analyzing the displacement of the motion of the annulus. CAUTION: Use the TMAD function only for adult cardiac images. NOTE: TMAD function can only be used when the following conditions are met: X Application: Cardiac X Operation mode: 2D (Freeze state) X Screen mode: Single mode X ECG: On [Figure 3.39 TMAD Screen] 3-98

[Page 203]
Select an image Select a View. A4C is selected by default. „ Automatically Calculate X When enabled: After 3 points are selected, it automatically switches to the Result screen. X When disabled: Modifications can be made after selecting 3 points. It switches to the Result screen once the Calculate button is selected manually. „ Calculate Go to the Result screen. This is enabled after 3 points are selected. „ Clear You can reset and start over. 3-99

[Page 204]
Contour Line Setup and Calculations „ Drawing Contour Lines 1. A4C is selected as the default screen. Use the trackball and the Set button on the control panel to specify three points. First, select a point in the direction of Septal, then a point in the Lateral, and finally one in the Apex. After specifying the points, a line connecting each point will be displayed. 2. Press Calculate . The screen will switch to the Result screen. Pressing the Reset button will reset the data and switch to the screen where a three-point contour line can be drawn. 3-100

[Page 205]
TMAD Result The TMAD result screen is composed as follows: 1 Measurement result and menu: The measurement result as well as the menus used to adjust and save Cine images are displayed. 2 Image area: The image with the specified points is displayed. 3 Graphs: The ECG and the graph of displacement by time are displayed. [Figure 3.40 TMAD – Touch Panel] 3-101

[Page 206] „ Measurement Result The displacement and gradient of TMAD points and median are displayed. The colors used to display the measurement result are identical to those used to display each point on the image. „ Position X Mid Point: Adjust the Apex point. X TMAD Point: Adjust the two Annuli. „ Export to Excel Save the result and the representative image as an Excel file. This is available only if a USB flash memory drive is connected. „ Export to AVI Save the result as an AVI file. This is available only if a USB flash memory drive is connected. „ Displacement Line Display the displacement line on the image. „ Displacement Graph Displays the displacement by time. The graph line to be studied can be selected from the check box on the right-hand side. The color used for the graph line corresponds to the color of each point in the image. The vertical dotted line indicates the current position. „ Frame Move the current Frame. „ Cine Speed Select the playback speed for Cine images. „ Cine Play Pause or resume the playback of the image. 3-102

[Page 207] EzCompare™ Displays the previous exam image and the current exam image side by side on the split screen, allowing you to compare and assess them. EzCompare™ also automatically displays the image settings, annotations, BodyMarkers, etc. used in the previous study. However, Live Scan is available only when you use the same probe preset as the saved image or scan. X Press Patient . Select the exam list that you need to analyze using the trackball and Set . (multiple selection of lists allowed) X Press EzCompare™ . X The saved screen is shown in the Thumbnail area with an exam list shown in the Date tab. X Select the desired image on the screen by double-clicking it. Then, the chosen exam image and date will be shown on the right or left side of the screen, while the Live Scan image is shown on the other side, with the same settings as the exam image applied to it. X Data saved on the EzCompare™ screen is saved to the Current Exam tab under the Thumbnail area. NOTE: Go to Setup > Imaging > Display Settings, and specify the position of the Live image to the left or right. 3-103

[Page 208] ECG (Option) If an ECG is installed, the ECG tab will be displayed on the touchscreen. In a multi-image mode such as Dual or Quad, ECG Cine can be used for each image. NOTE: You may set it to show or hide ECG on the screen for each Preset item in Setup > Application/Preset > Preset Setting.
ECG Settings „ Sweep Speed Press Sweep Speed to set an ECG display speed. „ Invert Press Invert to set. „ Gain Adjust the amplitude of the ECG. Adjust the Gain value by rotating the dial-button [1]. „ Position Rotating the dial-button [2] changes the display position of the ECG signal. The ECG moves toward the top as the value increases. „ Clip Rotate the dial-button [3] to select a clip saving interval. „ Trigger Configure the Trigger settings. Rotate the dial-button [4] and set the number of ECG triggers. 3-104

[Page 209] „ Trig Delay Select the time delay between the R-wave and the frame containing the trigger, which will be applied to the Trigger function. Rotate the dial-button [4] to configure the settings. „ Dual Trigger Turn Dual Trigger On or Off. „ Dual Trig Delay Select the time delay between the frame containing the first trigger and the frame containing the second trigger, which will be applied to the Dual Trigger function. Rotate the dial-button [4] to configure the settings. X If the ECG is less than 30 bpm, the Heart Rate (HR) may not be displayed. X The range of measurement error between the Heart Rate (HR) measured on the product and the Heart Rate (HR) measured on ECG is within 2%. 3-105

[Page 210] StressEcho (Option) The StressEcho package includes wall motion scoring and reporting. It includes exercise StressEcho, pharmacologic StressEcho, diastolic StressEcho and free programmable StressEcho. X StressEcho is an optional feature of this product. X You can use it only when the application is cardiac. The procedure for using StressEcho is as follows: X When setting up and using a new protocol: Register a patient ID → Setup a protocol → Select and start the protocol → Acquire and specify images → Reviewing an Image → Create a StressEcho report. X When selecting and using an existing protocol: Register the patient ID → Select and start the protocol → Acquire and specify images → Reviewing an Image → Create a StressEcho report. This manual provides instructions for using StressEcho by setting up a new protocol. To learn how to register a patient ID, please refer to ‘Starting Modes of Operation’. For information on StressEcho reports, please refer to ‘Measurements’. Setting up a Protocol After registering a patient ID, tap the StressEcho button on the touchscreen followed by the Template Editor button. The Protocol Template Editor screen will be displayed. You may edit an existing protocol or setup a new protocol. „ Creating a New Protocol Template Press the New button. „ Editing an Existing Protocol Template Press the combo button in the upper left corner of the screen, and select a protocol to use from the protocol list. 3-106

[Page 211]
The Protocol Template Editor Screen The Protocol Template Editor screen consists of the following items. Use these items to edit a protocol. [Figure 3.41 Protocol Template Editor] „ Protocol When you click the combo button, the default protocols and other existing protocols are listed. 3-107

[Page 212] Default Protocols This product offers the following five protocols by default: The default protocols cannot be deleted or transferred to external storage media. Also, you cannot modify one of the default protocols and save it with the same name. Protocol View Stage Two Stage PLAX, PSAX, A4C, A2C Rest, Peak Exercise Stress Three Stage PLAX, PSAX, A4C, A2C Rest, Peak, Post Bicycle Stress Four Stage Pharmacological PLAX, PSAX, A4C, A2C Stage 1–4 Stress MV-PW, TDI, LVOT-PW, TR, Baseline, Legs UP, 25W, 50W, Diastolic Stress PSAX - BASE, PSAX-Mid, PSAX-APEX, 75W, 100W, 125W, REC2, 4CH, 2CH, MR REC5, REC10 PLAX, PSAX, 4CH, APLAX, 2CH, Baseline, 5, 10, 20, 30, 40, Dobutamine Stress MV - PW, TDI, LVOT-PW, TR-CW atropine, recovery „ Stage Set the stage. Use button to add or delete a stage. To select one of the default Stages, use the Combo button. To enter it manually, use the keyboard. NOTE: You must create at least two stages, and you can add up to 10 stages. „ View Set the view. Use button to add or delete a view. To select one of the default Views, use the Combo button. To enter it manually, use the keyboard. NOTE: You must create at least two views, and you can add up to 10 views. 3-108

[Page 213] „ Additional Options X Go to ‘Select Cine’ after continuous capture per stage: After acquiring images using Continuous Capture in each stage, the Cine Selection screen appears. X Go to Review Screen after end of protocol: Once all images are assigned to the protocol, the Review screen appears. „ Capture Unit Select a method for image acquisition by pressing the Save button on the control panel. X Beats: Acquires images by the number of heartbeats. X Time: Acquires images by the unit of seconds. „ Cycle/Time Select the image acquisition interval by pressing the Save button on the control panel. For the Capture Unit, you can select a Beats value from 1 to 4 or a Time value from 2 to 4. „ Auto Assign Once images are acquired, they are automatically assigned to each stage and view. „ Show Reference Displays the reference image in Dual Mode when a stage image is acquired. This can only be used if the ‘Auto Assign’ checkbox is ticked. When this is enabled, the previous stage automatically becomes the reference image. Tick each stage’s checkbox to acquire images for each stage using the same settings as the reference image. „ Auto Next Stage When an image is assigned to the last view of the current stage, the system automatically proceeds to the next stage. „ Continuous Capture Acquires and saves images continuously, and then later assigns the images to each stage and view on the Cine Selection screen. „ Cine Preview Shows previews of acquired images before saving them. 3-109

[Page 214] „ Capture Method Select the video acquisition range for images by pressing the Save button on the control panel. X Prospective: Stores images that are acquired after the button is pressed. X Retrospective: Stores images that were acquired before the button was pressed. „ Timer Set the onscreen timer display settings. X Show Protocol Timer(T1): Displays the protocol’s time record (T1) on the screen. X Show Stage Timer(T2): Displays the current stage’s time record (T2) on the screen. „ New Template Press the New Template button on the touchscreen to create a new protocol. „ Save Press the Save button on the touchscreen to save the newly created protocol. This cannot be used when a default protocol has been changed. „ Save As Press the Save As button on the touchscreen to save a set protocol under a different name. „ Delete Template Press the Delete Template button on the touchscreen to delete the currently selected protocol and open a new protocol template. This cannot be used when a default protocol is selected. „ Apply & Exit Press the Apply & Exit button on the touchscreen to apply any changes made in the Protocol Template Editor and exit the screen. „ Exit Press the Exit button on the touchscreen to exit the Protocol Template Editor screen. 3-110

[Page 215] Starting a Protocol and Acquiring Images After registering a patient ID, tap the StressEcho button on the touchscreen. The Protocol Screen will be displayed. Select a protocol to start an examination, and review the acquired StressEcho images. „ Selecting a Protocol Press the combo button at the top of the screen, and select the protocol to use from the protocol list. „ Starting a Protocol Press Begin/Continue or the user key to which StressEcho Protocol Start/Pause has been assigned. The screen will switch to Operation mode. „ Capturing StressEcho Images Press the Save button on the control panel to acquire images for each view and stage. A matrix of captured StressEcho images is displayed on the left-hand side of the screen. [Figure 3.42 Matrix] X To return to the Protocol screen while acquiring an image, tap the StressEcho button on the touchscreen. X To change a stage and acquire images, use one of the following methods: 3-111

[Page 216] 1. Press the Pointer button on the control panel. Use the pointer to select the next stage. 2. Press Next Stage in StressEcho. To acquire images using Continuous Capture, press Start or Pause on the screen, or the user key to which StressEcho CC Start/Pause has been assigned. Pressing Stop ends Continuous Capture. (Note that there must be a heartbeat; if there is no heartbeat, a warning message will appear.) Auto Assign and Auto Next Stage If either Auto Assign or Auto Next Stage is enabled, images will be automatically assigned when you acquire StressEcho images. The matrix will be displayed as shown below: [Figure 3.43 Matrix – Auto Assign, Auto Next Stage] 3-112

[Page 217] Show Reference If Show Reference has been selected in the Protocol Template Editor screen, then the Protocol Screen scan is performed alongside the reference image. Show Reference is a feature that sets the first stage as the reference image and compares subsequent scans under identical conditions. This feature can only be used if the Auto Assign checkbox has been selected. Enabling this feature activates Dual mode. The reference image is shown on the left. The current image is shown on the right-hand side of the screen and can be acquired under the same conditions as the reference image. Applied reference image conditions are as follows: X Image Depth X Width X Dynamic Range X 2D Mode (Harmonic, etc.), Color Mode X ClearVision Index X Post-Processing (Gray map) X Gain (2D, C) X Read Zoom Continuous Capture and Cine Selection When Continuous Capture is enabled, images are acquired continuously, saved, and then later assigned on the Cine Selection screen. The matrix will be displayed as shown below: [Figure 3.44 Matrix – Continuous Capture] Cine Selection displays images acquired using Continuous Capture per beat, allowing you to assign the displayed images to each stage and view. 3-113

[Page 218]
Protocol Screen The Protocol Screen consists of the following items: 1 2 [Figure 3.45 Protocol Screen] 1 Protocol: Click the combo button, and the protocol list will be displayed. Select the protocol that you want to use. NOTE: Once a protocol has started, you cannot change it. 2 Stage: Click the combo button to display the stage list. Select a stage to use. The thumbnail list shows the images saved for the selected stage. Tips! The stage area of the stage currently being acquired is highlighted. 3 StressEcho Image Area: Displays StressEcho images by aligning them with the View of the horizontal axis and the Stage of the vertical axis. The currently selected StressEcho image is highlighted with a blue border. 4 Thumbnail list: Displays the acquired StressEcho images by stage. Images that have already been assigned to the StressEcho image area are not displayed in the thumbnail list. 5 StressEcho Information Area: Displays the StressEcho settings information. 3-114

[Page 219] „ Pause Protocol Pauses a protocol. The Pause Protocol button disappears, and the Begin/Continue Protocol button appears. „ Begin/Continue Starts a protocol. Closes the Protocol Screen. „ Review Switch to the StressEcho Review screen. „ Assign The stage selected in Stage is highlighted with a blue border. The StressEcho images in the thumbnail list are assigned as appropriate to each view and stage. This cannot be used after the protocol has ended. „ Change View If Auto Assign has been enabled, this changes the Acquisition Focus View. When you move the Change View knob on the Protocol window, the blue border also moves to the left or right in the direction of View. This will not be displayed if Auto Assign or Auto Next Stage has not been enabled. „ Next Stage The stage will change to the next one. The stage that is currently being acquired is displayed with a green outline in the Stage area on the left-hand side of the screen. „ Thumbnail Scroll This will only be displayed if there are four or more acquired images. It changes the page of the thumbnail list. „ Close Closes the Protocol Screen. 3-115

[Page 220] „ End Protocol Ends the protocol. „ Release Returns the images selected in the StressEcho Image area to the Thumbnail list. This cannot be used after the protocol has ended. „ Release All Returns all images in the StressEcho Image area to the Thumbnail list. This cannot be used after the protocol has ended. „ New Protocol Starts a new protocol. „ Cine Selection This only appears when you have acquired images using Continuous Capture. Press Cine Selection . Images acquired using Continuous Capture are displayed per beat. You can assign the displayed images to each stage and view. X All: Displays all images separated by beat. X Selected: Only displays the selected images out of the images separated by beat. X Previous Page: Moves to the previous page. X Next Page: Moves to the next page. X Reacquisition: Deletes the acquired images and acquires new images. X Select Later: Saves the acquired images and resumes Cine Selection later. X Complete: Finishes assigning the images for the current stage and moves on to the next stage. X Stage: If there is a stage where images have been acquired using Continuous Capture, then you can switch to that stage and proceed with Cine Selection. X Page Scroll: Navigates to a different page. 3-116

[Page 221] Reviewing an Image Select a StressEcho image on the Protocol Screen and press Review . The StressEcho Review screen will appear. Here you can review the selected image, and perform measurements and other tasks.
StressEcho Review Screen [Figure 3.46 StressEcho Review] 1 StressEcho Image Area: The images you selected on the Protocol Screen will be displayed. You can review up to four StressEcho images on one screen. At the top of each image, the stage and view names, as well as the Protocol Timer (T1) and Stage Timer (T2), are displayed. You can review up to four StressEcho images on one screen. 2 Image Information Area: The probe type, application, frame rate, depth, frequency, TI, image saving time, and matrix are displayed. 3 WMS Diagram Area: Four of the seven WMS diagrams are displayed. WMS stands for Wall Motion Scoring. At the top of each diagram, there is a combo button that can be used to select a stage. At the bottom of each diagram, the WMSI value and the current value selected from the score menu are displayed. NOTE: You can perform measurements using the Caliper and Calculator buttons. Pressing the Calculator button displays the heart measurement menu, and the current stage is displayed in the menu subject line. 3-117

[Page 222] „ Review Select a Review Set by turning the knob from Rest-IMPOST, to All Rest, to the Stage that comes after the relevant protocol’s Rest. Alternatively, you can select the images that you wish to review manually by using the trackball or Set . Rest-IMPOST All Rest Stage 1 after Rest Stage 2 after Rest „ IMPOST This is activated once you set the Review Set to Rest-IMPOST and there are two or more stages apart from Rest. It switches to the next Impost Stage each time. Review Set IMPOST Rest-IMPOST „ View Scroll Switches the view for the selected Review Set. This is not available if you have selected a Review Set manually. Review Set View Scroll View Scroll Rest-IMPOST All Rest Stage 1 after Rest Stage 2 after Rest 3-118

[Page 223]
WMS Four of the seven WMS diagrams are displayed. Enter WMS information after selecting a stage. 1. PLAX: Parasternal Long Axis 2. PSAX-Mid 3. A4C: Apical Four Chamber 4. A2C: Apical Two Chamber 5. APLAX 6. PASX-Base 7. PASX-Apex [Figure 3.47 WMS Diagram] 3-119

[Page 224] Left Ventricular Segment Area Number Basal Anterior 1 Basal Anteroseptal 2 Basal Inferoseptal 3 Basal Inferior 4 Basal Inferolateral 5 Basal Anterolateral 6 Mid Anterior 7 Mid Anteroseptal 8 Mid Inferoseptal 9 Mid Inferior 10 Mid Inferolateral 11 Mid Anterolateral 12 Apical Anterior 13 Apical Septal 14 Apical Inferior 15 Apical Lateral 16 Apex 17 [Table 3.1 Segments and Area Numbers] 3-120

[Page 225] „ Entering WMS 1. Select a segment that you want to enter a WMS into by using the trackball and the Set button. The Score menu will appear. 2. Select a value from the menu. It will be displayed in the segment’s number and color. Alternatively, 3. Select a desired value on the Score menu at the bottom of the screen. 4. Place the pointer in the segment that you want to enter a value into, and press the Set button. The segment color will change and the WMS will be displayed. When a WMS is entered into a segment, the same score is applied to all segments that have the same area number. „ Deleting a WMS To delete an input value, select the relevant segment and then ‘N-Not Scored’. The color of the selected segment will be reset. Tips! Press Delete WMS to delete all WMS data entered for the current stage. „ Delete WMS Deletes all WMS data entered for the current stage. „ Cine Play You can play or stop playing all Cine images shown in the StressEcho Image Area simultaneously. „ Strain+ You can use the Strain+ Image function. This is displayed only when the conditions for using the Strain+ Image function are met. 3-121

[Page 226] „ Change Sync Select Normal, Short, Long, or End to End as the synchronization method for Cine images. X Normal: Indicate the general Cine Play state. X Short: The shortest image of the four Cine images is played. X Long: The longest image of the four Cine images is played. X End to End: The four Cine images are played by synchronizing the beginning and the end. „ Protocol Screen Exit the StressEcho Review screen, and then switch to the Protocol Screen. NOTE: For information about StressEcho reports, please refer to ‘Measurements’. Pressing the Report button after finishing the WMSI Drawing on the StressEcho Review screen opens the StressEcho report. X The StressEcho Report cannot be edited. 3-122

[Page 227] EzAssist™ (Option) As a reference tool for plane scanning, EzAssist™ has multiple clinical applications during live scanning. This allows clinicians to practice procedures using valuable reference materials such as clinical reference images and animation. X EzAssist™ is not supported in the USA. X For the below cases, EzAssist™ is not accessible. – There is no patient created – If not in the Scan mode screen Setup, Patient, SonoView, Report, Help, etc. – When the mode is in CW, PW, TDW, TDI, 3D/4D, Dual Live – In Wide Single View, Dual, Quad – If Measure, Caliper, Annotation, or BodyMarker is enabled – When the below functions are enabled EzExam+, AutoIMT+, StressEcho, TMAD, Panoramic+, ElastoScan™, NeedleMate+, NerveTrack™, UterineAssist™, LoborAssist™, Auto EF WARNING: Do not use EzAssist™ in a clinical situation. EzAssist™ is not intended as workflow guides during a medical procedure. EzAssist™ represents only reference material that can be used at the discretion of the professional caregiver outside the clinical setting. 3-123

[Page 228] [Figure 3.48 EzAssist™]
Starting the EzAssist™ Press the user key to which EzAssist™ has been assigned. „ Application To update the Procedure list, you must select the application for which you need a guide image. „ Procedure A list of procedures that you can use are displayed. Upon entering for the first time, you can view the Procedure list for the first Application, and then from the second time onward, the last selected value will be maintained. It is enabled for all probes except for the Pencil probe. 3-124

[Page 229] X You can only launch EzAssist™ after you select an application and procedure, and then press Start. X If the EzAssist™ feature that you have selected is not supported by the currently selected probe and preset, the preset and probe that are suitable for the chosen procedure appear at the bottom of the screen in a red message. „ Procedure List Application Group Procedure Name Vascular Access 1.a Central Veins Evaluation 1.b Central Veins 2.a PVA Arm Evaluation 2.b PVA Arm 3.a PVA Femoral Evaluation 3.b PVA Femoral Vein V. Axillaris V. Femoralis V. Jugularis Interna Regional Anesthesia Axillary PL. BR. Distal N. Ischiadicus Infraclavicular PL. BR. Interscalene PL. BR. MED. FEM. - N. Ischiadicus N. CUT. FEM. LAT. N. Femoralis N. Intercostalis N. Obturatorius Proximal N. Ischiadicus Supraclavicular PL. BR. Tap 3-125

[Page 230] Application Group Procedure Name Pain treatment Greater Occipital Nerve Block Ilioinguinal Block Intercostal Block Saphenous Nerve Block Stellate Ganglion Block Suprascapular Block Tap Block Thoracic Paravertebral Block Musculoskeletar (MSK) Carpal Tunnel Diagnostic: Elbow Hip Intercarpal Scapholunate Knee Injection Lumbar Facet Joint Piriformis Muscle Sacroiliac Joint Shoulder 1: Shoulder Scanning Shoulder 2: Bursitis Shoulder 3: Tendinosis Shoulder 4: Impingement Shoulder 5: Injection Epidural and spinal Epidural and Spinal Rescue Blocks Axillary Block Medianus Nerve Radialis Nerve Ulnaris Nerve EMERGENCY Abdominal Aortic Aneurysm FAST FEEL Pleural Examination PREP 3-126

[Page 231]
EzAssist™ Mode Select an application and procedure and press Start. Then, EzAssist™ Mode will start. [Figure 3.49 EzAssist™ Mode] „ Left Menu X The steps that you need to take to use EzAssist™ are shown in list view. You can move/ select a step using the Knob menu or pointer. X Exit: EzAssist™ Mode ends. X Selecting a step displays the image and description of the selected step. X : You are moved to the EzAssist™ Select screen. X The below features are available In the EzAssist™ mode. – Menu Knob – Q-Scan, Depth, Focus, Freeze – Set/Exit, Pointer, Update – 2D, C, M, PD, S-Flow™ – End Exam, Probe X If you select End Exam , EzAssist™ will end. 3-127

[Page 232] „ EzAssist™ Player You can check the media and description for the selected step. „ Hide Reference When selected, EzAssist™ mode becomes hidden and the system switches to the default scan mode. 3-128

[Page 233] Chapter 4 Probes ‹ Probes 4-3 Ultrasound Transmission Gel 4-24 Using Sheaths 4-26 Probe Safety Precautions 4-27 Cleaning, Disinfecting, and Sterilizing the Probes 4-30 ‹ Biopsy 4-45 Biopsy Kit Components 4-46 Using Biopsy Kit 4-47 Assembling the Biopsy Kit 4-50 Cleaning and Disinfecting the Biopsy Kit 4-55

[Page 234]

[Page 235] Probes The probe is a device that sends and receives ultrasound for acquiring image data. The system limits patient contact temperature to 43 degrees Celsius, and acoustic output values to their respective U.S. FDA limits. A power protection fuse circuit protects against over-current conditions. If the power monitor protection circuit senses an over-current condition, then the drive current to the probe is shut off immediately, preventing overheating of the probe surfaces and limiting acoustic output.
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 use a preset that is best suited to the particular organ being scanned. „ Thermal Index (TI) Table The Thermal Index (TI) is displayed in the Title area of the screen, and represents the probability of temperature rise in a particular area of the body. The thermal index consists of the following indices: Soft tissue (TIs), bone (TIb), and cranial bone (TIc). This product automatically displays an appropriate thermal index for the current probe and application. Probe types, applications, presets and thermal index available for this product are as follows: 4-3

[Page 236] Abdomen, Renal, Bowel, Aorta TIs Abdomen Upper TIb LA3-16AD OB LN5-12 1st Trimester TIs OB 4-4

[Page 237] L5-12/50 1st Trimester TIs OB L4-7 1st Trimester TIs OB 4-5

[Page 238] MSK General, Superficial, Deep TIs LS6-15 OB Abdomen, Renal, Bowel, Aorta TIs Abdomen Upper TIb OB CA2-8AD MSK 4-6

[Page 239] OB CF4-9 Spine TIb OB C2-5 GYN Uterus, Adnexa TIs 4-7

[Page 240] OB C2-8 GYN Uterus, Adnexa TIs CA2-6BM Abdomen Abdomen, Renal TIs Cardiac Adult Echo, Ped Echo, Aortic Arch TIs PN2-4 Carotid, Arterial, Venous TIs Vascular Cardiac Adult Echo, Ped Echo, Aortic Arch TIs Carotid, Arterial, Venous TIs SP3-8 Vascular Pediatric OB EVN4-9 4-8

[Page 241] OB ER4-9 OB VN4-8 Spine TIb OB V5-9 Cardiac Adult Echo, Ped Echo TIs DP2B Carotid, Arterial, Venous TIs Vascular Cardiac Adult Echo, Ped Echo TIs DP8B Carotid, Arterial, Venous TIs Vascular OB EV2-10A 4-9

[Page 242] OB CA4-10M Spine TIb LA2-9S 1st Trimester TIs OB 4-10

[Page 243] OB CA1-7AD Spine TIb Cardiac Adult Echo, Ped Echo, Aortic Arch TIs Carotid, Arterial, Venous TIs PA3-9B Vascular Pediatric X In addition to the system-optimized settings, the user can configure the desired settings in UserPreset. X For more information on probe selection and settings, please refer to ‘Starting Modes of Operation’. X The default thermal index may vary, corresponding to the presets. X You can change the thermal index in Setup > Imaging > Application/Preset > Preset Settings > Thermal Index Type. X Intraoperative is not supported in Canada. 4-11

[Page 244] „ Function List The functions available in this product for various probes and applications are as follows: X (Super MSK O (General O X O O (General O) ficial O) O) LA3-16AD Small Parts O X (Breast, O X X O O Thyroid O) MSK O X O X X O O (General O) Small Parts O X (Breast, O X X O O LN5-12 Thyroid O) 4-12

[Page 245] MSK O X O X X O O (General O) Small Parts O X (Breast, O X X O O L5-12/50 Thyroid O) Small Parts O X X O X X O O L4-7 Vascular O X X O X X O O MSK O (General X O X X O O O) Small Parts O X X O X X O O LS6-15 4-13

[Page 246] O) CA2-8AD GYN O X X O X X O O CF4-9 MSK O X X O X X O O Urology X X X O X X O O O) C2-5 GYN O X X O X X O O 4-14

[Page 247] C2-8 O) CA2-6BM Abdomen O X X O X X O O Abdomen X X X O X X O O Cardiac X X X O O X X X PN2-4 Vascular X X X O X X O O Pediatric X X X O X X O O Abdomen X X X O X X O O Cardiac X X X O O X X X SP3-8 Vascular X X X O X X O O Pediatric X X X O X X O O OB X X X O X X O O GYN X X O O X X O O EVN4-9 Prostate Urology X X (O), Bladder O X X O O (X) OB X X X O X X O O GYN X X O O X X O O ER4-9 Prostate Urology X X (O), Bladder O X X O O (X) 4-15

[Page 248] O) VN4-8 GYN O X X O X X O O OB X X X O X X O O GYN X X O O X X O O V5-9 Prostate Urology X X (O), Bladder O X X O O (X) Cardiac X X X X X X X X DP2B Vascular X X X X X X X X Cardiac X X X X X X X X DP8B Vascular X X X X X X X X OB X X X O X X O O GYN X X O O X X O O EV2-10A Prostate Urology X X (O), Bladder O X X O O (X) 4-16

[Page 249] O) CA4-10M GYN O X X O X X O O Urology O X X O O X O O Small Parts O X X O X X O O LA2-9S Vascular O X X O X X O O O) CA1-7AD GYN O X X O X X O O 4-17

[Page 250] Abdomen X X X O X X O O Cardiac X X X O O X X X PA3-9B Vascular X X X O X X O O Pediatric X X X O X X O O 4-18

[Page 251] Small Parts O X X O O O O LA3-16AD Vascular O X X O O O O Small Parts O X X O O O O LN5-12 Vascular O X X O O O O Small Parts O X X O O O O L5-12/50 Vascular O X X O O O O Small Parts O X X O O O O L4-7 Vascular O X X O O O O 4-19

[Page 252] Abdomen X X X O O O X MSK X X X O O O X Small Parts X X X O O O X LS6-15 Vascular X X X O O O X OB X X X O O O X GYN X X X O O O X Pediatric X X X O O O X CA2-8AD MSK O X X O O O O Abdomen X X X O O X X OB X X X O O X X GYN X X X O O O O CF4-9 MSK X X X O O X X Pediatric X X X O O X X Vascular X X X O O X X Urology X X X O O O O C2-5 MSK O X X O O O O 4-20

[Page 253] C2-8 GYN O X X O O O O CA2-6BM Abdomen X X X O O O O Abdomen X X O X O O O Cardiac X O O X O O O PN2-4 Vascular X X O X O O O Pediatric X X O X O O O Abdomen X X O X O O O Cardiac X O O X O O O SP3-8 Vascular X X O X O O O Pediatric X X O X O O O EVN4-9 GYN O X X O O O O ER4-9 GYN O X X O O O O VN4-8 MSK O X X O O O O 4-21

[Page 254] V5-9 GYN O X X O O O O Cardiac X X O X X X X DP2B Vascular X X O X X X X Cardiac X X O X X X X DP8B Vascular X X O X X X X EV2-10A GYN O X X O O O O Abdomen X X X O O O O OB X X X O O O O GYN X X X O O O O CA4-10M MSK X X X O O O O Pediatric X X X O O O O Vascular X X X O O O O Urology X X X O O O O Small Parts O X X O O O O LA2-9S Vascular O X X O O O O 4-22

[Page 255] CA1-7AD MSK O X X O O O O Abdomen X X O X O O O Cardiac X O O X O O O PA3-9B Vascular X X O X O O O Pediatric X X O X O O O X The meaning of each symbol in the table is described below: – Q Scan: QuickScan™ – Har: Harmonic Imaging – S-Har™: S-Harmonic™ Imaging – CM: Color M – PD: Power Doppler – S-Flow™: Directional Power Doppler Imaging – TDW: Tissue Doppler Wave – CW: Continuous Wave X MultiVision is only available in 2D/C Mode. 4-23

[Page 256] Ultrasound Transmission Gel For successful acoustic signal transmission, ultrasound gels or couplant must be applied. X 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. X Only use the ultrasound gels approved by Samsung Medison. Using unapproved gels may result in damage to the probe and void the warranty. X Completely remove the remaining ultrasound gel on the probe surface after using the probe. Residues from the ultrasound gel may result in contamination and discoloration. X Do not use ultrasound gels or couplant that contain the following ingredients: – Oil based lotion type couplant – Mineral oil – Olive oil – Lubricant oil – Paraffin based grease – Dimethylsilicone – Alcohol such as methanol, ethanol, or isopropanol – Acetone – Dioctylphtalate – Aromatic substances – Iodine compounds – Aloe Vera. X The tip of injection nozzle may cause damage to the probe lens. X When applying the ultrasound gel to the probe, make sure that the tip of the ultrasound gel injection nozzle does not touch the surface of the probe lens. 4-24

[Page 257]
Gel Warmer (Option) The Gel Warmer keeps the ultrasound gel warm. Warming up ultrasound gel takes approximately 5 minutes. X Always turn the Gel Warmer off when it is not in use. X Do not put your hands inside the Gel Warmer, as it may burn your skin. X Do not use the Gel Warmer for purposes other than to control the temperature of ultrasound gel. X Do not place the probe or any other equipment inside the Gel Warmer. X Do not touch the power terminal of the Gel Warmer while you are examining a patient. There is a risk of electric shock from leakage current. X Do not apply excessive force to the Gel Warmer, or you may damage its support parts. 4-25

[Page 258] Using Sheaths Sheaths are recommended for clinical applications of an invasive nature, including intraoperative, transrectal, transvaginal, and biopsy procedures. Using a sheath also prevents contamination from blood or other bodily fluids during operations or biopsy. Samsung Medison does not supply sheaths, so appropriate sheaths should be purchased independently. X For more information about sheaths, please contact the manufacturer. X Always use sheaths certified and approved by relevant national/local authorities. X Use a sterile sheath for intraoperative or biopsy procedures. X Use a sterile, single-use, latex sheath for transesophageal procedures. X Use a sterile sheath (preferred) or single-use sheath for transrectal or transvaginal procedures. X Sheaths are disposable. Do not reuse them. X Make sure that you clean and disinfect the probes after every use. X Check the exterior of the Sheath before use. If a sheath is split or contaminated, do not use it. X In neurosurgical applications, a disinfected probe must be used with sterile gel and a sterile pyrogen-free sheath. X 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. X Some sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Please confirm whether the specific patient is allergic to those materials before using such sheaths. Please refer to the FDA Medical Alert released on March 29, 1991.
Installing the Sheath 1. Remove the sheath from the packaging, and fill it with ultrasound gel. Be sure to put on sterilized surgical gloves. 2. Insert the probe into the sheath and pull the latex tip to cover the probe completely. If possible, cover the probe cable as well. 3. Ensure that there are no air bubbles trapped within the ultrasound gel. If necessary, secure the sheath to the probe and the probe cable. 4. Dispose of the sheath after use. 4-26

[Page 259] Probe Safety Precautions The probe can be damaged by improper use or by coming into contact with certain chemical substances. Always follow the instructions in the user manual to inspect the probe cable, case and lens before and after each use. Check the probe for cracks, broken parts, leaks and sharp edges. If there is any damage, stop using the probe immediately and contact the Samsung Medison Customer Support Department. Using damaged probes may result in electric shocks and other hazards to the patients and/or users. X The user is responsible for cleaning, disinfecting, and sterilizing probes. Probes are not sterilized at the time of shipment. X Do not apply mechanical shock to the probe. X If a probe hits the ground or a hard surface, disconnect the probe immediately from the console of the ultrasound system. Damaged electrical insulation may cause an electrical shock. X 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. X Do not immerse the probe into any inappropriate chemical substances that are not compatible. X Do not expose it to temperatures of 50°C or higher. X 3D and 4D probes may make a slight noise if they are used for a long time or if a certain mode is in use. X Probes should be cleaned and disinfected prior to replacement or disposal. X Always inspect the lenses, cables, and connectors after using probes. If damaged, stop using them immediately. 4-27

[Page 260]
Using and Infection Control of the Probe The ultrasonographic image scanner uses ultrasound, and makes direct contact with the patient when in use. Depending on the types of examinations, such contact can be made to a wide variety of locations, including the ordinary skin or the location of blood transfusion during a surgical procedure. The most effective method of preventing infection among patients is to use each probe only once. However, probes may need to be reused, as they are complex in design and expensive. Consequently, the safety instructions must be followed carefully in order to minimize the risk of infection among patients. X No neurosurgical treatments or examinations should be carried out on a patient with Creutzfeldt-Jakob disease. If the probe has been used on such a patient, it cannot be sterilized by any method whatsoever. X If the probe or product is contaminated, dispose of it according to the local biohazardous waste disposal procedures. CAUTION: Sufficient washing and disinfecting must be carried out to prevent infection. This is the responsibility of the user who manages and maintains the disinfection procedures for the equipment. Always use legally approved cleansing solutions and sheaths. 4-28

[Page 261]
Electric Shocks The probe uses electrical energy. If it touches conductive materials, there are risks of electric shocks to the patient or the user. X The product should regularly be checked for electrical leakage by the Samsung Medison Customer Support Department. X Do not immerse the probe into liquid. X Do not touch the probe connectors or the connection pins on the product. X Do not drop the probe or apply mechanical shocks. X Inspect the housing, strain relief, lens, and seal for damage, and check for any functional problem before and after each use. X Do not apply excessive force to twist, pull or bend the probe cable. X 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. X 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. 4-29

[Page 262] Cleaning, Disinfecting, and Sterilizing the Probes All probes must be cleaned and disinfected after each use. Cleaning is an important procedure that must be carried out before disinfecting the probe. For information on cleaning and disinfecting the probe, please refer to the appropriate chapter. Using an inappropriate disinfectant may damage the probe. X Always use protective equipment such as face mask, eyewear, and gloves when cleaning, disinfecting, and sterilizing probes. X Inspect the housing, strain relief, lens and seal for damage, and check for any functional degradation before and after cleaning and disinfecting the probe. X Using an inappropriate cleaning or disinfecting agent may damage the probe.
Information on Cleaner, Disinfectant, and Ultrasound Gel „ Reprocessing Method by Probe Type To maintain the performance of ultrasound probes, proper maintenance is required. As ultrasound probes are classified into critical, semi-critical or non-critical devices based on the standards of FDA guidance* and the Hygiene Requirements for the Reprocessing of Medical Devices from Germany guideline of Robert Koch Institute (RKI), proper cleaning and disinfection or sterilization methods for that classification should be used. Table for Choosing the Correct Probe-Care Method Classification Contact Area Application Probe Level Selection Criteria Non-critical Curved, Linear, and Intact skin Low level disinfection device Phased array probes Semi-critical Mucous membrane and High level disinfection Endocavity, MPTEE device damaged skin or sterilization Critical device Blood, sterile tissue, etc. Intraoperative Sterilization * Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Appendix E * The FDA reprocessing guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff” March 17, 2015 (https://www.fda.gov/media/80265/download) 4-30

[Page 263] The care method for your probes determines the appropriate disinfectant for your probe. An appropriate cleaner, disinfectant or ultrasound gel should be used for all probes. For the latest details about compatible cleaner, disinfectants, and ultrasound gel, please see Samsung Medison website and the User Guide. X User Guides: This is provided as a booklet upon purchase of the product. X Website: http://www.samsunghealthcare.com
Warnings and Cautions During Cleaning, Disinfecting, Sterilizing Probes These general cleaning instructions must be followed for all probes. All probes must be cleaned after each use. Cleaning the probe is an essential step before effective disinfection or sterilization. Before cleaning a probe, read “Warnings and Cautions” below. After cleaning, you must disinfect or sterilize probes by following the appropriate procedures. X Always use protective equipment such as face mask, eyewear, and gloves when cleaning, disinfecting, and sterilizing probes. X If a premixed solution is used, be sure to observe the solution expiration date. X Probes must be cleaned after each use. Cleaning the probe is an essential step before effective disinfection or sterilization. Be sure to follow the manufacturer’s instructions when using cleaner, disinfectant, disinfection system and sterilization system. 4-31

[Page 264] X Attempting to disinfect a cable or connector by using a method other than the one included here can damage the device and voids the warranty. X Do not allow sharp objects, such as scalpels or cauterizing knives, to touch probes or cables. X When handling a probe, do not dump the probe on hard surfaces. X Do not use a brush on the connector label. X During cleaning, disinfection, and sterilization, orient the parts of the probe that must remain dry higher than the wet parts until all parts are dry. This will help keep liquid from entering unsealed areas of the probe. X Do not allow any type of fluid to enter the connector. Ensure that fluid does not enter through the strain relief, connector, electrical contacts, or areas surrounding the locking- lever shaft and the strain relief. Fluid in the connector may void the device warranty. X Ensure the solution contains only 70% or less alcohol when using an alcohol for disinfection. Solutions of more than 70% alcohol can cause product damage. X Do not use any alcohol or alcohol-based products on the cable or strain relief. X Avoid disinfectant contact with the connector label. X Be sure to use the proper concentration of enzymatic cleaner and rinse thoroughly. X Do not use paper products or products that are abrasive when cleaning the probe. They damage the lens of the probe. X Aggressive wiping or scrubbing can damage the probe. Use a gentle wiping motion for the probe lens, the strain relief, the areas surrounding the strain relief, and the cables. X When wiping the probe, hold the housing. Do not suspend the probe by the cable. This can damage probes. X Do not apply excessive force to twist, pull or bend the probe cable. This can damage probes. X Before storing probes, ensure that they are thoroughly dry. If it is necessary to dry the probe lens after cleaning, use a soft cloth and a blotting motion, instead of a wiping motion. 4-32

[Page 265]
Structure and Name of Probes 4 Strain Relief 6 Connector 3 Transducer 5 Cable 1 Lens 2 Housing 4 Strain Relief 3 Transducer 6 Connector 5 Cable 1 Lens 2 Housing [Figure 4.1 Structure and Name of a Probe] 4-33

[Page 266]
Cleaning Probes All probes must be cleaned according to this instruction after each use. Cleaning is an important procedure that must be carried out before disinfecting and sterilizing the probe. The cleaning method is applicable for all probes provided by Samsung Medison. X Only use a surgeon’s brushes on the housing. Do not use brushes on the other parts, including the probe lens, the strain relief, the areas surrounding the strain relief, and the cables, than the housing when cleaning probes. Using any types of brushes can damage the probe lens, the strain relief, the areas surrounding the strain relief, and the cables. X 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. X Do not bend or crimp the gastroscope or cable. X Do not use isopropyl alcohol on the strain relief/housing joint, the strain relief, or the cable. „ Wiping Method 1. Disconnect the probe from the system. 2. Remove the biopsy bracket or needle guide from the probe. Collect the reusable parts, reusable biopsy bracket, or needle guide that need to be disinfected or sterilized, and discard the disposable parts in the clinical waste bin (For more information on cleaning and disinfection/sterilization of the reusable parts, please refer to the ‘Cleaning and Disinfecting Biopsy Kits’ in this chapter.). 3. For a list of compatible cleaners, see the User Guide or Samsung Medison website: Follow the cleaner manufacturer's instructions for preparation, temperature, solution 4. Remove any visible gel or biological material on the surface with wipes or soft cloth soaked with the cleaner (made using manufacturer's instructions). For difficult to reach areas such as seams, cracks and crevices of the device, use a surgeon’s brush wrapped with a wipe or cloth soaked with the cleaner. Use a gentle wiping motion for the probe lens, the strain relief, the areas surrounding the strain relief, and the cables. When wiping the probe, hold the housing. Do not suspend the probe by the cable. Do not apply excessive force to twist, pull or bend the probe cable. These can damage probes. 4-34

[Page 267] Dispose of the used wipes or cloth appropriately according to the local medical waste regulations. 5. Wipe off the probe surface with fresh wipes or cloth soaked with the cleaner, following the cleaner manufacturer’s instruction on the temperature, wiping time, and cleaner contact time. 6. Visually inspect for any remaining soil and if necessary repeat the steps, starting at step 4. 7. Make sure to follow the rinse (and neutralization) instructions from the cleaner manufacturer for rinsing the probe. If insufficient instructions are supplied, then, as a minimum, thoroughly rinse the probe with a clean lint-free cloth dampened with pure water until all signs of residual debris and cleaning solution are removed. (at minimum of two minutes) For difficult to reach areas such as seams, cracks and crevices of the device, use a surgeon’s brush wrapped with a clean lint-free cloth dampened with pure water. 8. Repeat the step 7 (rinsing) at least three times with a fresh clean lint-free cloth dampened with pure water each time. 9. Following the dry instructions from the cleaner manufacturer, air-dry the probe or remove water from all surfaces of the probe with a clean, dry, disposable soft, lint-free cloth or wipe. If it is necessary to dry the probe lens after cleaning, use a soft cloth and a blotting motion, instead of a wiping motion. 10. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or 4-35

[Page 268] „ Immersion Method 1. Disconnect the probe from the system. 2. Remove the biopsy bracket or needle guide from the probe. Collect the reusable parts, reusable biopsy bracket, or needle guide that need to be disinfected or sterilized, and discard the disposable parts in the clinical waste bin (For more information on cleaning and disinfection/sterilization of the reusable parts, please refer to the ‘Cleaning and Disinfecting Biopsy Kits’ in this chapter.). Rinse off any visible gel or biological material with running tap water. If it is hard to remove materials with running tap water, wipe off any gel or biological material with a moist cloth or sponge moistened with cleaner (made using manufacturer's instructions) or tap water, taking care to remove all visible contamination. Dispose of the used cloth or sponge appropriately according to the local medical waste regulations. 3. For a list of compatible cleaners, see the User Guide or Samsung Medison website: Follow the cleaner manufacturer’s instructions for preparation, temperature, solution 4. Fill a sink or bowl with freshly-made cleaner solution. 5. Immerse the probe up to the immersion point shown in the figure below. X Some probes can be cleaned up to the cable. Do not clean the cable that is within 50 cm of the end of the cable from the connector. For a list of probes that can be cleaned up to the cable, see the User Guide or Samsung Medison website: [Figure 4.2 Immersion Point] 4-36

[Page 269] 6. Continue soaking the probe until the total cleaner contact time specified by the cleaner manufacturer is reached. 7. After the cleaner contact time, brush the probe housing with a surgeon’s brush at minimum of one minute to remove any visible soil. Pay close attention to seams, cracks and crevices during brushing time. Do not use brushes on the other parts than the housing; Using any types of brushes can damage the other parts, including the probe lens, the strain relief, the areas surrounding the strain relief, and the cables, than the housing. 8. Visually inspect for any remaining soil and if necessary repeat the steps, starting at step 4. 9. Make sure to follow the rinse (and neutralization) instructions from the cleaner manufacturer for rinsing the probe. If insufficient instructions are supplied, then, as a minimum, thoroughly rinse the probe with tap water at 22°C to 43°C (72°F to 110°F) to prevent the coagulation of blood and proteins until all signs of residual debris and cleaning solution are removed (at minimum of one minute) 10. Repeat the step 9 (rinsing) at least three times. 11. Following the dry instructions from the cleaner manufacturer, air-dry the probe or remove water from all surfaces of the probe with a clean, dry, disposable soft, lint- free cloth. If it is necessary to dry the probe lens after cleaning, use a soft cloth and a blotting motion, instead of a wiping motion. 12. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or 4-37

[Page 270]
Disinfecting Probes The probe must be cleaned and disinfected after each use. Disinfection of the probe is an important step that must be carried out. User must follow the reprocessing method appropriate for probe type as described in “Reprocessing Method by Probe Type” in this chapter. X Always use protective equipment such as face mask, eyewear, and gloves when cleaning, disinfecting, and sterilizing probes. X Inspect the housing, strain relief, lens and seal for damage, and check for any functional problem before and after disinfecting the probe. X Never use disinfectants after the expiration date. X The area the probe will contact during use dictates the level of disinfection required for a probe. Ensure that the solution strength and duration of contact are appropriate for disinfection. „ Low-Level Disinfection Low-level disinfection of probes uses the wipe method with a low-level disinfectant. Before performing this procedure, read the warnings and cautions in the “Warnings and Cautions During Cleaning, Disinfecting, Sterilizing Probes” section and “Table for Choosing the Correct Probe-Care Method” in this chapter. 1. Clean the probe according to the procedures in “Cleaning Probes” in this chapter. 2. After cleaning, choose low-level disinfectants that are compatible with your probe. For a list of compatible disinfectants, see the User Guide or Samsung Medison website: Follow disinfectant manufacturer’s instructions for preparation, temperature, solution 3. Wipe the probe surfaces, following disinfectant manufacturer’s instructions for temperature, wipe durations, and duration of disinfectant contact. Pay close attention to seams, cracks and crevices during wiping time. Ensure that the disinfectant solution does not enter the device or the connector. X Some probes can be disinfected up to the cable. Do not disinfect the cable that is within 50 cm of the end of the cable from the connector. For a list of probes that can be disinfected up to the cable, see the User Guide or Samsung Medison website: 4-38

[Page 271] X When disinfecting the connector, wipe only the outer surfaces of the connector; do not allow any type of fluid to enter through other parts than the connector surfaces, including the strain relief, electrical contacts, or areas surrounding the locking-lever shaft. 4. Make sure to follow the rinse (and neutralization) instructions from the disinfectant manufacturer for rinsing the probe. If insufficient instructions are supplied, then, fill a sink or a bowl with pure water and rinse the probe. Immerse the probe up to the immersion point shown in the figure below. (at minimum of one minute) X Some probes can be immersed up to the cable. Do not immerse the cable that is within 50 cm of the end of the cable from the connector. For a list of probes that can be immersed up to the cable, see the User Guide or Samsung Medison website: [Figure 4.3 Immersion Point] 5. Repeat the step 4 (rinsing) at least three times with a fresh batch of pure water each time. 6. Following the dry instructions from the disinfectant manufacturer, air-dry the probe or remove water from all surfaces of the probe with a sterile, lint-free cloth and store it properly (e.g. in a sterile bag) to prevent any further contamination. If it is necessary to dry the probe lens after cleaning, use a soft cloth and a blotting motion, instead of a wiping motion. 4-39

[Page 272] „ High-Level Disinfection High-level disinfection of probes typically uses the immersion method with a high level disinfectant or the disinfection system method. Before performing this procedure, read the warnings and cautions in the “Warnings and Cautions During Cleaning, Disinfecting, Sterilizing Probes” section and “Table for Choosing the Correct Probe-Care Method” in this chapter. X Inspect the housing, strain relief, lens and seal for damage, and check for any functional problem before and after disinfecting the probe. X Ensure that the cycle is appropriate for the desired disinfection level. X Using a probe that is not compatible with a disinfection system or not following the instructions of the disinfection system manufacturer can damage the probe. This could also void the probe warranty. X Disinfection wipes are not FDA-cleared for use on semi-critical devices, which require high-level disinfection. <Immersion Method> 1. Clean the probe according to the procedures in “Cleaning Probes” in this chapter. 2. After cleaning, choose high-level disinfectants that are compatible with your probe. For a list of compatible disinfectants, see the User Guide or Samsung Medison website: Follow disinfectant manufacturer’s instructions for preparation, temperature, solution strength, and duration of contact. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. If a premixed solution is used, be sure to observe the solution expiration date. 3. Immerse the probe into the appropriate disinfectant solution for your probe as shown in the figure below. Make sure that there are no air bubbles on the probe surfaces. Follow the instructions on the disinfectant label for the duration of probe immersion. Do not immerse probes longer than the minimum time needed for your level of disinfection. X Some probes can be disinfected up to the cable. Do not disinfect the cable that is within 50 cm of the end of the cable from the connector. For a list of probes that can be cleaned up to the cable, see the User Guide or Samsung Medison website: 4-40

[Page 273] [Figure 4.4 Immersion Point] 4. Make sure to follow the rinse (and neutralization) instructions from the disinfectant manufacturer for rinsing the probe. If insufficient instructions are supplied, then, fill a disinfected sink or a disinfected bowl with pure water and rinse the probe at minimum of one minute. 5. Repeat the step 4 (rinsing) at least three times with a fresh batch of pure water each time. 6. Following the dry instructions from the disinfectant manufacturer, air-dry the probe or remove water from all surfaces of the probe with a sterile, lint-free cloth and store it properly (e.g. in a sterile bag) to prevent any further contamination. If it is necessary to dry the probe lens after cleaning, use a soft cloth and a blotting motion, instead of a wiping motion. 7. Register the disinfection data for traceability according to local regulations. 8. Examine the probe and cable for damage such as cracks, splitting, sharp edges, or 4-41

[Page 274] <Disinfection System Method> 1. Clean the probe and cable according to the procedures in “Cleaning Probes” in this chapter. Observe all warnings and cautions. 2. Refer to the user instructions of the disinfection system for details of proper use, storage and disposal of waste. 3. Place the transducer of the probe in the disinfection system, following the user instructions of the disinfection system. 4. Start the desired disinfection process and wait until the end of the cycle. 5. Remove the probe at the end of the cycle from the disinfection system and store it properly (e.g. in a sterile bag) to prevent any further contamination. 6. Register the disinfection data for traceability according to local regulations. 4-42

[Page 275]
Sterilizing Probes Sterilization is required for probes when contact bloodstream, sterile tissue or body-space regardless the use of a sterile cover. X Always use protective equipment such as face mask, eyewear, and gloves when cleaning, disinfecting, and sterilizing probes. X In intraoperative applications, sterilized probes should be used with sterile gel and a sterile probe cover certified and approved by relevant national/local authorities. X Sterile probe covers are disposable and must not be reused. X Probes must be cleaned after each use. Cleaning the probe is an essential step before effective disinfection or sterilization. Be sure to follow the manufacturer’s instructions when using disinfectant, disinfection system, and sterilization system. X Use low temperature plasma sterilization system to sterilize probes. Using sterilization solution, autoclave, gas (EtO), or other methods not approved by Samsung Medison will damage your probe and void your warranty. X Do not allow sharp objects, such as scalpels and cauterizing knives, to touch probes or cables. 4-43

[Page 276] „ Sterilization System Method Using a probe that is not compatible with a sterilization system may damage the probe. X Inspect the housing, strain relief, lens and seal for damage, and check for any functional problem before and after sterilizing the probe. X Ensure that the cycle is appropriate for the desired disinfection or sterilization level. CAUTION: Using a probe that is not compatible with a sterilization system or not following the instructions of the sterilization system manufacturer can damage the probe. This could also void the probe warranty. 1. Clean the probe and cable according to the procedures in “Cleaning Probes” in this chapter. Observe all warnings and cautions. 2. Refer to the user instructions of the sterilization system for details of proper use, storage and disposal of waste. 3. Place the probe in the sterilization system, following the user instructions of the sterilization system. 4. Start the desired sterilization process and wait until the end of the cycle. 5. Remove the probe at the end of the cycle from the sterilization system and store it properly (e.g. in a sterile bag) to prevent any further contamination. 6. Register the sterilization data for traceability according to local regulations. 4-44

[Page 277] 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 imaging system shows the needle, which penetrates through the skin surface and veins, along with the examined body part, minimizing the potential risks to the patient. X Ultrasonographic studies using a biopsy kit must be conducted by a physician or qualified, experienced healthcare professional. Make sure that you comply with the preventive safety measures and sterilization procedure in all environments. X Do not use the biopsy kit for purposes other than ultrasonographic studies such as human anatomical dissection. X If the biopsy kit is not used according to the user manual or is used inappropriately, the user has a responsibility. X Please make sure to read the User Manual thoroughly. 4-45

[Page 278] Biopsy Kit Components The biopsy kit consists of the adapter, needle guide and needle. The components vary depending on the probe type. Needle Guide Needle Biopsy Adapter [Figure 4.5 Biopsy Kit Components] X Adapter: Prevents the needle guide from shaking by securing it to the probe tightly. X Needle Guide: Guides the angle (direction) of the needle so that it may reach the biopsy target accurately. It also secures the needle so that the needle does not waver. X 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. X Sheath: Prevents the probe and adapter from being contaminated by any unwanted substances (blood or other bodily fluids) discharged during examinations. X Ultrasound gel: Ensures the best quality images by filling the air space between the probe and the sheath with the ultrasound gel. 4-46

[Page 279] Using Biopsy Kit X Only use needles approved for use in your country. X Verify the condition of the biopsy needle before use. Do not use a bent biopsy needle. X The needle and guide must be sterilized before use. X The needle may bend while penetrating a tissue. Therefore, the precise location of the needle must be checked by monitoring the echo generated from the needle. CAUTION: For more information about conducting ultrasonographic studies using the biopsy kit, please contact the biopsy kit manufacturer.
Before Using Biopsy Kit Check all the components of the biopsy kit. Ensure that the biopsy kit you are using is compatible with the probe, system, and system software. X Biopsy kits not supplied by Samsung Medison may not be compatible with the probes. Always use biopsy kits supplied by Samsung Medison, since improper setup may adversely affect the patient. X Be sure to read the instructions for installing a sheath and aligning the needle guide thoroughly before performing a biopsy. X Always ensure that the probe and the needle guide are secured on both the left and the right sides. 4-47

[Page 280]
Biopsy Procedure The system generates a needle guideline through the displayed real-time ultrasound images to indicate the anticipated path of the needle. Use this guideline to ensure that the needle or other instrument follows the correct path. 1. Ready the patient according to the procedure appropriate for the examination objectives. 2. Install the sheath and the biopsy kit. 3. Set the system controls for the biopsy procedure. If necessary, apply acoustic gel to the patient. 4. Scan the patient. Adjust the patient so that the location for examination fits into the needle guideline on the screen. 5. Insert the needle into the needle guide. Perform the puncture by sliding the needle through the groove in the guide until the needle intercepts the target. To keep the needle securely in the needle guide, press down on the top of the biopsy adapter with your index finger. 6. To prevent the needle from shaking, press down on the top of the needle guide with your index finger during examinations. 7. When the examination site is reached, take the needle out of the needle guide. 8. Detach the needle guide, adapter, and sheath from the probe. 9. Dispose of the components that are not designed for reuse. X Dispose of non-reusable components according to infectious waste regulations. X Sterilize reusable components before disposing of them. 4-48

[Page 281]
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 biopsy. If the needle fails to follow an accurate path while verifying the alignment of needle guide, stop using the product and contact Samsung Medison Customer Support Department. Reverberation or other tissue artifacts may produce false needle images on the screen. Ensure the needle path is along the guideline and that you are not using a false needle image to locate the needle. X The needle used for alignment verification must not be used for the actual procedure. Always use a sterile needle for each biopsy procedure. X To assist in accurate projection of the needle, use a straight, new needle for each alignment procedure. X The needle guideline only displays the projected path of the needle. Since the default line may be different from the actual line, the actual location of the needle must be checked by monitoring the echo from the needle. 1. Attach the biopsy kit. 2. Set the system depth for the procedure to be performed and select the Biopsy menu. 3. Immerse the probe into the water bath, and insert the needle into the needle guide. 4. Confirm that the needle image is on the needle guidelines. If it is, then the needle guide is properly aligned. 5. If the needle image displayed on the screen is out of the needle guideline, check the needle guide or the probe adapter, etc. 4-49

[Page 282] Assembling the Biopsy Kit
Stainless Steel Biopsy Kit 1. Place a sheath up to the top of the probe’s handle. 2. Mount the adapter onto the probe. If the surface of probe is fluted, mount the adapter in accordance with it. 3. Insert the needle into the needle guide and start the exam. 4-50

[Page 283]
Plastic Biopsy Kit 1. Mount the adapter on the probe. 2. Cover the adapter and probe completely with the sheath. 3. Install the needle guide onto the adapter. 4-51

[Page 284] 4. Install the Needle Guide Clip if it is included in the components. 5. Insert the needle into the needle guide and start the exam. Using Multi Angle Use the angle adjuster. 4-52

[Page 285]
Biopsy Specifications Biopsy Probes Adapter Reusable/ Needle Multi Model Name Components Material Disposable Gauge Depth Biopsy Adapter Reusable 0.591, BP-KIT-068 Acetal 16, 18, 20, 0.984, 1.575 [BP-KIT-068-NG] copolymer 22 Needle Guide (in) Disposable & Probe Cover LA3-16AD Biopsy Adapter Reusable 0.591, BP-KIT-055 Acetal 16, 18, 20, 0.984, 1.575 [BP-KIT-055-NG] Needle Guide Copolymer 22 Disposable (in) & Probe Cover Biopsy Adapter Reusable BP-KIT-040 Acetal LN5-12 16, 18, 22 0.984 (in) [BP-KIT-040-NG] Needle Guide Copolymer Disposable & Probe Cover Biopsy Adapter Reusable 0.787, 1.181, BP-KIT-047 [BP- Acetal 16, 18, 20, L5-12/50 1.575, 1.969 KIT-047-NG] Needle Guide Copolymer 22 Disposable (in) & Probe Cover Biopsy Adapter Reusable 2.362, BP-KIT-054 Acetal 16, 18, 22, CA2-8AD 3.150, 3.937 [BP-KIT-054-NG] Needle Guide copolymer 25 Disposable (in) & Probe Cover Biopsy Adapter Reusable BP-KIT-045 Acetal 16, 18, 20, C2-5 2.362 (in) [BP-KIT-045-NG] Copolymer 22 Needle Guide Disposable Biopsy Adapter Reusable BP-KIT-035 Acetal C2-8 16, 18, 22 2.755 (in) [BP-KIT-035-NG] Needle Guide Copolymer Disposable & Probe Cover Biopsy Adapter Reusable 1.181, 1.969, BP-KIT-049 Acetal 20, 21, 22, 3.150, VN4-8 [BP-KIT-049-NG] Needle Guide copolymer 25 3.937, 4.724 Disposable & Probe Cover (in) 4-53

[Page 286] Biopsy Probes Adapter Reusable/ Needle Multi Model Name Components Material Disposable Gauge Depth Single BP-KIT-061 Needle Guide ABS Disposable 16, 18 EVN4-9 Angle 1° ER4-9 Single BP-KIT-024 Needle Guide Stainless Reusable 16 Angle 1° BP-KIT-029 Needle Guide Stainless Reusable 18 – V5-9 Single BP-KIT-060 Needle Guide ABS Disposable 16, 18 Angle 1.8° 14, 15, 16, Biopsy Adapter Reusable Acetal 17, 18, 20, 4, 5.5, 7 L4-7 BP-KIT-043 Copolymer 21, 22, 23, (cm) Needle Guide Disposable 8.5FR BP-KIT-086 Needle Guide Stainless Reusable 16 0° EV2-10A BP-KIT-085 Needle Guide PC Disposable 16–18 1.8° 14, 15, 16, Biopsy Adapter Reusable 17, 18, 20, 2, 3.22, Acetal LA2-9S BP-KIT-103 21, 22, 25G 4.76, 7.09, copolymer Needle Guide 7, 8, 9, 10, 9.82 (cm) Disposable & Probe Cover 12FR Biopsy Adapter Reusable 1.969, 3.937, BP-KIT-058 Acetal 14, 16, 18, CA1-7AD 5.906, 7.874 Needle Guide [BP-KIT-058-NG] copolymer Disposable 20, 22, 25 (in) & Probe Cover NOTE: None of the model numbers of biopsy kit is available in Canada. 4-54

[Page 287] Cleaning and Disinfecting the Biopsy Kit Reusable Biopsy adapters must be cleaned and disinfected after each use. Read the biopsy kit user manual carefully before cleaning and disinfecting. X Always use protective equipment such as face mask, eyewear and gloves when cleaning and disinfecting biopsy kit. X Disposable biopsy adapters and disposable biopsy kit parts must be disposed of as medical waste after each use.
Cleaning Biopsy Kit Cleaning is an important procedure that must be carried out before disinfecting or sterilizing reusable biopsy adapters. 1. After use, remove the biopsy kit from the probe. 2. Disassemble the biopsy kit into its component parts and discard the disposable parts in the clinical waste bin. 3. Rinse with water to remove excess dust from the device. 4. Prepare an enzymatic solution (e.g. Enzol), following the manufacturer’s instructions for proper dilution and immersion duration. Immerse the parts in the detergent and allow soaking for the prescribed time. 5. Clean the parts thoroughly using a soft brush. Clean the lumen using an appropriately- sized brush. If any visible parts remain, continue brushing until clean. 6. Rinse the device thoroughly with water and dry the components carefully. Dispose of the used drying cloths appropriately according to the local medical waste regulations. 4-55

[Page 288]
Disinfecting Biopsy Kit It must be disinfected after each use. Refer to the user instructions of the disinfectant for details of proper storage, use, and disposal of the disinfectant. X Always refer to the biopsy kit user manual for the latest information on the supported methods and disinfectants. X A stainless steel biopsy adapter is reusable; a plastic biopsy adapter may be reusable. A plastic biopsy needle guide is in general disposable. X Plastic biopsy kits can only be disinfected by using a chemically compatible cold- disinfectant, either manually or with a medical washer-disinfector. Do not use an autoclave, gas or radiation. 1. Clean the reusable parts of the biopsy adapter, according to the “Cleaning Biopsy Kits” in this chapter. 2. After cleaning, choose high-level disinfectants that are compatible with your reusable biopsy adapter. For the compatible disinfectants, see biopsy kit manufacturer’s instructions. Follow disinfectant manufacturer’s instructions for preparation, temperature, solution strength, and duration of contact. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. 3. Immerse the parts in high-level disinfectants and allow soaking for the prescribed time following the manufacturer’s instructions. 4. Rinse the device thoroughly with sterile water and dry the components. Dispose of the used drying cloths appropriately according to the local medical waste regulations. 5. Inspect the components for damage such as cracks, rust, or breakage; and if damage is found, stop using the device and contact the Samsung Medison Customer Support Department. 6. Properly pack the disinfected adapter and label it according to the local regulations. 4-56

[Page 289]
Sterilizing Stainless Steel Biopsy Kit The main difference between sterilization and high-level disinfection is the length of time that the device is immersed and the type of disinfectant or sterilant that is used. 1. Clean the reusable parts of the biopsy adapter, according to the “Cleaning Biopsy Kits” in this chapter. 2. After cleaning, choose high-level disinfectants/sterilants that are compatible with your reusable biopsy adapter. For the compatible disinfectants/sterilants, see biopsy kit manufacturer’s instructions. Follow sterilant/HLD disinfectant manufacturer’s instructions for preparation, temperature, solution strength, and duration of contact. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. 3. Immerse the parts in high-level disinfectants/sterilants and allow soaking for the prescribed time, or steam (autoclave) following the manufacturer’s instructions. Follow the instructions on the sterilization label for the duration of immersion or autoclave for sterilization. Do not immerse or steam the biopsy adapter longer than the minimum time needed for your level of sterilization. 4. Remove the biopsy adapter from the sterilization solution or steam (autoclave) after the recommended sterilization time has elapsed. 5. Only for immersion method, rinse the device thoroughly with sterile water and dry the components. Dispose of the used drying cloths appropriately according to the local medical waste regulations. 6. Inspect the components for damage such as cracks, rust, or breakage; and if damage is found, stop using the device and contact the Samsung Medison Customer Support Department. 7. Properly pack the sterilized adapter and label it according to the local regulations. 4-57

[Page 290]

[Page 291] Starting Modes of Chapter 5 Operation ‹ System Power 5-3 Powering On 5-4 Powering Off 5-5 Force Quit 5-6 ‹ Probes and Applications 5-7 Selecting Probes and Applications 5-8 Creating UserPreset 5-8 Modifying UserPreset 5-8 Deleting UserPreset 5-9 ‹ Patient Information 5-10 Searching Patient Information 5-18

[Page 292]

[Page 293] System Power Please check Safety Precautions before connecting power to the product. X Product Installation and initial operation should be done by trained experts. X Use the correct wattage to prevent short circuit and fire hazard. X Do not modify, change or remodel AC power plug in any case. X Do not use extension cords or multi-outlet converters for the product. X Use the electrical cord offered. NOTE: Power cord configuration may differ from country to countries. 5-3

[Page 294] Powering On 1. Check a wall outlet in the shape and location. 2. Check whether power switch is turned off on the back of the product. 3. Connect the offered electrical cord with the power input in product. [Figure 5.1 Power Connection] 1 Power Switch 2 Power Inlet 3 Power Fuse 4 Equipotential Terminal 4. Plug the cord into wall outlet. CAUTION: Do not use multi-socket converter, extension cord or plug adapter. 5. Turn on power switch on the back of the product. 6. Press Power On/Off on Control Panel to check the boot-up status on the monitor. X Plug the probe and peripherals in advance before power-on. X Do not press panel buttons or get it pressed while turning on. It may cause malfunction. X If the product gets unplugged while turning on or in use, it may damage data or circuit component, resulting in malfunction. 5-4

[Page 295] Powering Off Press Power On/Off on Control Panel with switch on. [Figure 5.2 System termination message] 1. Choose Shutdown to turn the power off. If sleep mode is selected, the system can switch to the sleep mode when it is not in use, and pressing the power button on the Control Panel will power on the system. 2. When the product is safely shut down, turn off the power switch. X Do not press panel button or get it pressed while turning off. It may cause malfunction. X If the product gets unplugged or forcefully shut down, it may damage data or circuit component, resulting in malfunction. NOTE: Wait over 15 seconds before turning the power on again. 5-5

[Page 296] Force Quit If you can’t quit the system normally, press Power On/Off on Control Panel for over 5 seconds to force the system to quit. CAUTION: Do not force quit in normal operation. It may cause malfunction. NOTE: If you turn on the power after turning it off suddenly, the system may turn on and off momentarily. This is one of the characteristics of the Intel ® PC main board, not a system error. 5-6

[Page 297] Probes and Applications Press Probe to select/change the current probe or application, or edit the probe settings. CAUTION: Refer to ‘Probes’ for more information on probes and applications supported by the system.
Probe Selection Screen 1 2 [Figure 5.3 Probe Selection] 1 Probe list: Displays a list of probes currently connected to the system. 2 Application list: Displays a list of applications the selected probe supports. 3 Preset list: Display a list of presets the selected application supports. 4 UserPreset list: Displays a list of presets you can configure according to your preferences. 5-7

[Page 298] Selecting Probes and Applications 1. Select the items in the following order: Probe → Application → Preset/Userpreset. 2. When you select Preset/UserPreset, the system automatically applies your selections and switches to Operation modes. 3. To cancel, press Probe . Creating UserPreset 1. Select Probe and then the + button to open the Create New User Preset window. 2. Enter the name you want to use and tap Save . Tap Close to cancel. Modifying UserPreset 1. Enter the Preset Setup by tapping Preset Setup on the touchscreen. 2. Select a Preset to rename and press Rename . 3. The Preset Setup window will open. 4. In the Preset Setup window, enter a new Preset Name and press Save . To cancel it, tap Close . The Reset function in the Preset Setup window After modifying and saving the default Preset values, you can use the Reset function to restore the settings to this default. 1. Adjust the default Preset values you wish to change. 2. Press Probe to open the Preset, and then press Save . 3. A dialog box will appear asking you to confirm whether or not you wish to overwrite the existing values. 4. Tap Save to set the modified values as the new, default Preset values. 5. To restore the Preset values to the default settings, tap Reset again. 5-8

[Page 299] Deleting UserPreset 1. Enter the Preset Setup by tapping Preset Setup on the touchscreen. 2. Select a Preset to delete and press Delete . 3. The Preset Setup window will open. 4. Tap Delete to delete the UserPreset. Tap Cancel to cancel it. 5-9

[Page 300] Patient Information In this screen, you can enter, search, or change patient information. NOTE: ID is required information.
Basic Patient Information Entry „ Patient ID Enter a patient ID. „ Last Name Enter the patient’s last name. „ First Name Enter the patient’s first name. „ Middle Name Enter the patient’s middle name. NOTE: The name that you have entered will appear in the title area and reports. „ Date of Birth (Age) Enter the patient’s date of birth in the specified format. „ Gender Select the patient’s gender. 5-10

[Page 301] „ Accession Number When viewing the worklist for a patient via the DICOM server, this information is automatically displayed in the appropriate fields. „ Diag. Physician Enter the name of the physician who diagnosed the patient. „ Ref. Physician Enter the name of the referring physician. „ Operator Enter the name of the operator who scanned the patient. Up to 20 persons may be entered. „ Description Enter a description of the diagnosis. „ Search Search through the information stored in the system. „ Worklist Perform a search by connecting to the DICOM Modality Worklist server in the hospital network. „ New Patient Enter new patient information. „ Auto ID Creation Create temporary patient information using a temporary ID. „ Keyboard Use the keyboard displayed on the touchscreen to enter text. 5-11

[Page 302] „ Start EzExam+™ This function helps you to link an exam with EzExam+™ when the exam starts. „ Start StressEcho Upon starting an exam, you can use this function to link it to StressEcho. This is available only if the conditions for using StressEcho have been met. „ DICOM Destination When an exam ends, the saved images are sent to the DICOM server. Select a DICOM destination, and then press the Set button. You can choose a location between Group 1 and Group 10, and change the group name as well. „ RIS Browser Moves you to a web browser. „ Qview Moves you to the cloud server. X For more information about the RIS Browser and Qview URL settings, please contact a service engineer. X Samsung Medison shall not be responsible for any damage to the product if you have used RIS Browser for anything other than its intended purposes (e.g., accessing inappropriate websites). 5-12

[Page 303]
OB Enter the additional obstetrical information. „ LMP (Last Menstrual Period) Indicates the patient’s last menstrual period. Once the details have been entered in the correct format, the EDD (LMP) and GA (LMP) are automatically calculated and displayed. „ DOC (Date of Conception) Indicates the patient’s date of conception. Once the details have been entered in the correct format, the EDD (DOC) and GA (DOC) are automatically calculated and displayed. „ EDD (Expected Date of Delivery) Indicates the patient’s expected date of delivery. Once the expected delivery date is entered, the GA (EDD) is automatically calculated and displayed. Once the user activates the LMP Link button ( ) in the EDD field, the LMP (EDD) is calculated automatically and then displayed on the screen. „ GA (Gestational Age) Indicates the gestational age of a patient. Once the details have been entered in the correct format, the EDD (GA) is automatically calculated and displayed. X “Clin” is short for Clinical. „ Transfer Date Indicates the transfer date of an embryo. Once the details have been entered in the correct format, a transfer type can be chosen and the EDD (Transfer) and GA (Transfer) are automatically calculated and displayed. „ Ovulation Date Enter expected ovulation date in accordance with defined format. Calculating the LMP and EDD (LMP) using the Ovulation Date: The following formulae are used: X LMP = Ovul. Date – 14 X EDD = (280 – 14) + Ovul. Date 5-13

[Page 304] NOTE: Values that have been calculated and entered cannot be changed. „ Day of Cycle Enter length of menstrual cycle in days (Date). „ Fetuses No. Enter the number of fetuses. Up to four may be entered. Calculation of EDD (LMP)/EDD (GA) The EDD can be calculated by entering the LMP or GA. X When the LMP is entered: The GA (LMP) and EDD (LMP) are automatically calculated and displayed on the screen. X When the GA is entered: The LMP (GA) and EDD (GA) are automatically calculated and displayed on the screen. „ Gravida Enter the number of pregnancies. „ Para Enter the number of deliveries. „ Aborta Enter the number of miscarriages. „ Ectopic Enter the number of ectopic pregnancies.. NOTE: Refer to ‘Utilities’ Setup > System > Patient > User Defined List. 5-14

[Page 305]
GYN Enter additional information for GYN. X On the GYN information input screen, the LMP and EDD values will not be calculated automatically even if you enter an Ovul. Date. X For other gynecological information, please refer to the ‘OB’ section.
Urology Enter urological information. „ PSA Enter the Prostate Specific Antigen (PSA) value. „ PPSA Coefficient 1 Enter predicted PSA coefficient 1. „ PPSA Coefficient 2 Enter predicted PSA coefficient 2. 5-15

[Page 306]
Vascular Enter vascular-related information. „ Left Systole Enter left systole blood pressure. „ Left Diastole Enter left diastole blood pressure. „ Right Systole Enter right systole blood pressure. „ Right Diastole Enter right diastole blood pressure.
Abdomen Enter abdomen-related information. „ Height Enter the patient’s height and the unit of measure. „ Weight Enter the patient’s weight and unit. 5-16

[Page 307]
MSK Enter MSK-related information.
Pediatric Enter pediatric-related information.
Small Parts Enter small parts-related information.
Cardiac Enter cardiac-related information. „ Height Enter the patient’s height and the unit of measure. „ Weight Enter the patient’s weight and unit. „ BSA When the height and weight are entered, the BSA (Body Surface Area) is automatically calculated and displayed.
TCD Enter transcranial doppler (TCD)-related information. 5-17

[Page 308] Searching Patient Information
Search Search through the information stored in the system. 1. When a search term is entered in the search field, the list of patients who match the criteria will be displayed. Press Search By and select a search condition for the patient you want to find. 2. Select the desired patient from the list and click OK . The selected patient information will be applied to the system. „ Show/Hide Show/Hide buttons or lists in the search area. „ Search by User can enter a search criteria. „ Exam List Show the exam list for a patient selected from the patient list. „ Back to Search Return to the search area. „ Review Images Show the image of a selected exam on Review Images screen. 1. Continue Exam: This is activated when an exam that is less than 24 hours old is selected. The page moves to 2D image screen of the selected exam. 2. Hide Annotation: Hide any annotations made to an image. 3. View Scale: Set the image size for review. Select either the Small , Mid , or Large buttons. 4. Favorite: Add/remove a selected image from Favorites. 5. Select/Deselect All: Select/deselect all images regardless of the exam date. 5-18

[Page 309] „ SonoView You can review a selected exam from SonoView. „ Review Exam The exams that were performed more than 24 hours before present, and their images, are displayed. When an exam is selected, the button is activated. When enabled, you can continue to view the exam images. „ Continue Exam Exams that were performed within 24 hours can be edited. When an exam is selected, the button is activated. You can use this button to edit the selected exam. „ EzCompare™ Press this button to view dual image of a selected exam image and a live scan image currently filming. 5-19

[Page 310] „ Edit Patient You can edit the selected Patient Information. This is activated when a Patient entered within 24 hours ago is selected from the Patient List. 1 2 4 5 6 [Figure 5.4 Edit Patient] 1 Original Patient Information: Displays the selected Patient Information and an Exam List of the patient. 2 Alternative Patient Information: Displays the new Patient information. Patient ID, Last Name, First Name, Middle Name, Date of Birth, Age, Gender can be edited. X Load Original: Loads the Original Patient Information to Alternative Patient Information field. X Clear All: Deletes all the information in Alternative Patient Information field. X Replace from Existing: Loads the selected Patient Information to Alternative Patient Information field by double-clicking on the Patient Information saved in the Local Storage or Worklist. X Search by: Sets search criteria. 3 Hide Patient Information: Selects whether or not to display the patient information. 4 Send DICOM after changing patient information: Group1: After you edit the Patient Information, choose whether to send it to DICOM by pressing the U Key to which the Send DICOM function has been mapped. 5 Change: Changes the Patient Information. 6 Cancel: Cancels the editing. 5-20

[Page 311] „ Send Send images to the DICOM server. „ Delete Delete the exam. 5-21

[Page 312]
Worklist Search Perform a search by connecting to the DICOM Modality Worklist server in the hospital network. NOTE: A worklist search is available only when DICOM is enabled. You can select the worklist server in Setup > Connectivity > DICOM. Refer to the ‘DICOM Settings’ section of ‘Utilities’ 1. Select Worklist in Patient . 2. After entering at least one item out of Patient ID, Last Name, Worklist Number (Accession Number), Procedure ID, Exam Date, and/or name of the equipment being used for exam (AE Title), click Search . The list of patients who match the criteria will be displayed. X Clicking items such as Date/Time or Patient Name sorts entries into alphabetical or numerical order for the selected criteria. X Select Today, Last Week, Last Month, or Manual as Exam Date. X After running a search, the date of the last update is displayed in the bottom right corner. 3. Double click on the desired patient list. This applies the selected patient information to the system. „ Start Exam with Temp ID Creates Temp ID automatically and starts Exam. 5-22

[Page 313] Chapter 6 Modes of Operation ‹ Information 6-3 Types of Mode and Basic Usage 6-3 ‹ Basic Modes 6-6 2D Mode 6-6 S-Detect™ for Breast 6-29 M Mode 6-39 Color Doppler Mode 6-41 Power Doppler Mode 6-45 PW (Pulse Wave) Spectral Doppler Mode 6-47 CW (Continuous Wave) Spectral Doppler Mode 6-53 TDI (Tissue Doppler Imaging) Mode 6-55 TDW (Tissue Doppler Wave) Mode 6-56 ElastoScan™ Mode 6-57 ‹ Combined Modes 6-65 2D/C/PW Mode 6-65 2D/PD/PW Mode 6-65 2D/C/CW Mode 6-65 2D/PD/CW Mode 6-65 2D/C/M Mode 6-65 2D/TDI/TDW Mode 6-66 Dual Live Mode 6-66

[Page 314] Chapter 6 ‹ Multi-Image Modes 6-67 Dual Mode 6-67 Quad Mode 6-68 ‹ 3D/4D Mode 6-69 3D Mode 6-70 4D Mode 6-74 3D Stand By 6-76 3D View – MPR 6-78 5D Follicle™ 6-86 VOCAL (Virtual Organ Computer Aided Analysis) 6-89 3D XI 6-97 XI VOCAL 6-107 XI STIC (Spatio-Temporal Image Correlation) 6-114 3D Utility Menu 6-118

[Page 315] Information This chapter provides the items that can be used in each Operation mode. You can change the image format or optimize an image to facilitate your diagnosis. Types of Mode and Basic Usage Mode Type Description 2D Mode Color Doppler Mode Power Doppler Mode M Mode Each mode has a specific usage and features. Basic Modes PW Spectral Doppler Mode By default, 2D mode is applied in addition to CW Spectral Doppler Mode any other mode. TDI Mode TDW Mode ElastoScan™ Mode 2D/C/PW Mode 2D/PD/PW Mode Two or three basic modes are applied to one 2D/C/CW Mode image at the same time. By default, 2D mode Combined Modes 2D/PD/CW Mode is applied as well and you can observe them 2D/C/M Mode all on a single screen. 2D/TDI/TDW Mode Dual Live Mode The screen is divided into two (Dual) or four (Quad) identical sections; each of which is Dual Mode used to view images. Since the split screen Multi-Image Modes Quad Mode can show different images, it can be very useful when observing an organ from different angles. Freehand 3D Mode 3D/4D Modes 3D Mode 3D and 4D images can be obtained. 4D Mode 6-3

[Page 316] NOTE: The functionalities for each mode may be restricted by the selected probe. „ Gain Adjusts the brightness of the applicable Operation mode. X M mode doesn’t provide a dial-button for this function. You can adjust the Gain value using the ‘Angle’ dial-button. X In Anatomical M Mode, you can adjust the Gain value using the touchscreen. „ Focus Adjusts the focus of an image. „ Depth Adjusts the scanning depth of an image. The range varies depending on the probe in use. „ Zoom Different zoom methods apply as follows: Read Zoom This function is used to enlarge the image displayed on the screen. 1. Rotate the Zoom dial-button left or right. 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. Observe the magnified image. Turning the button clockwise enlarges the image. Write Zoom This function allows you to magnify and scan an image in real time. 1. Press Zoom . The Write Zoom Box will appear on the screen. 2. Move and resize the Zoom Box using Change . 3. When you press Set , it changes to Write Zoom. To exit Zoom mode, press Zoom again. Changing Depth while Write Zoom is in use automatically ends Zoom mode. 6-4

[Page 317] „ Q Scan (QuickScan™) QuickScan™ technology provides intuitive optimization of gray scale and Doppler parameters. QuickScan™ enables users to adjust ROI box location with one touch of a button. In the image information, is displayed. X 2D mode: Adjusts Gain and TGC automatically. X PW Spectral Doppler mode: Adjusts the scale and baseline automatically. X Color mode: Automatically adjusts the position of the box (Only available with certain probes). 6-5

[Page 318] Basic Modes 2D Mode This basic mode, also referred to as B mode (Brightness mode), provides scan planes of organs. It displays two-dimensional anatomy images in the direction of scanning in real time.
Entering 2D Mode Pressing 2D in another mode starts the default mode, 2D mode. NOTE: 2D mode is applied by default for all Operation modes and it cannot be terminated.
2D Mode Menu [Figure 6.1 2D Mode – Touchscreen] 6-6

[Page 319] „ Harmonic This provides an OHI (Optimal Harmonic Imaging) function, which optimizes images using Harmonic Signal. In the image information, is displayed. NOTE: Only available with certain probes. „ Frequency This enables you to set the probe’s frequency. The selected frequency is displayed in the title area. X Res (Resolution): High frequency X Gen (General): Normal frequency X Pen (Penetration): Low frequency „ Line Density You can set the scan line density. Selecting High increases the number of scan lines and improves the image resolution. However, the frame rate is reduced. „ L/R Flip (Left/Right Flip) Flips the image horizontally. The direction marker at the top of the image shows the current image orientation. „ S-Harmonic™ S-Harmonic™ mitigates the signal noise, enhances contrast, and provides uniform image performance of overall image area from near-to-far. In the image information, is displayed. X Only available with certain probes. X S-Harmonic™ may show lines in the near field of certain probes while in a non-scan mode. This is due to the technical characteristics that improve the sensitivity and resolution of the ultrasound images, and does not cause any problems in Scan mode. 6-7

[Page 320] „ ClearVision The noise reduction filter improves edge enhancement and creates sharp 2D images for optimal diagnostic performance. In addition, ClearVision provides application- specific optimization and advanced temporal resolution in live scan mode. In the image information, is displayed. „ HQ-Vision™ HQ-Vision™ provides clear images by mitigating the characteristics of ultrasound images that are slightly blurred than the actual vision. Press HQ-Vision™ on the touchscreen to turn it On or Off. In the Image information, the HQ-Vision™ mark is displayed. Select an Index using the button on the touchscreen. X HQ-Vision™ is an optional feature of this product. X Only available with certain probes. For more information, please refer to the ‘Probe List’ section in the ‘Probes’ chapter. X HQ-Vision™ cannot be used with NeedleMate+™ while in 2D mode. X HQ-Vision™ can be used in 2D mode, 2D/C mode, and Write Zoom. 6-8

[Page 321] „ Biopsy Guide Make sure to adjust the biopsy guideline before using the biopsy feature. [Figure 6.2 Biopsy] Setting the Biopsy Guideline X To support for multiple guidelines If the probe supports multiple biopsy angles, the user may select the biopsy guide angle as desired. X To start and finish a biopsy 1. Press Biopsy Guide . 2. Insert a needle along the guideline. And then perform the biopsy as appropriate. 3. When all procedures are complete, tap Biopsy Guide again to turn this Off. Biopsy will end. 6-9

[Page 322] Biopsy Guide Edit Mode X Only available in 2D mode and Single mode. X Not available in Dual Live or Freeze state. X Not available in Write Zoom or Read Zoom state. X To start and end biopsy guide edit mode 1. Press Biopsy Guide . 2. Press the Angle dial-button to enter Biopsy Guide Edit mode. 3. When you enter Biopsy Guide Edit mode, Angle Offset appears. 4. Press the Angle dial-button and then select Angle Offset or Lateral Offset. – Angle Offset: This is the angle set for the currently selected biopsy guide. The maximum adjustable offset is the relevant guideline’s outer line angle. You can adjust this value in 0.1 degree increments by turning the Angle dial-button. – Lateral Offset: This is the lateral direction for the currently selected biopsy guide. You can adjust this value in 0.1 mm increments by turning the Angle dial-button. 5. Press Angle to exit Biopsy Guide Edit mode. „ U/D Flip (Up/Down Flip) This flips the image vertically. „ Dual Live The 2D and Color Doppler images for the scanned area are displayed on the screen simultaneously in real time. „ MultiVision MultiVision controls ultrasound beam electronically by steering, and compounds many scan lines for better image. MultiVision provides remarkable spatial and contrast resolution with even greater artifact suppression than ever before. In the image information, is displayed. NOTE: Only available with certain probes. 6-10

[Page 323] „ Free Angle Plane You can adjust the ScanHead of the 3D probe to a desired angle by using the dial-button. „ Trapezoid The rectangular frame provided by a Linear probe is changed to a trapezoidal shape. This allows a wider view of an image. X This is only available with Linear probes. X It is not available in certain depth. „ 2D NT You can use the ROI box to measure the NT more easily. X 2D NT is enabled under the following conditions: – 2D Freeze mode – Measurement item: OB X Changing the image, such as Zoom, is not available. X The 2D NT measurements will be saved and output in the report. CAUTION: The measurement value may have a margin of error of ±1mm. 1. Move the ROI box using the trackball, and press Set at the desirable location. Then, the measured value will appear on the screen. 2. If you want to measure a different location, press Set on the control panel to finish the current measurement and then press Set again. 3. You can press Reset for remeasurement. „ Rotation Rotates the 2D image. „ ElastoScan™ For more information, please refer to the ‘ElastoScan™ Mode’ section in this chapter. 6-11

[Page 324] „ Panoramic+ For more information, please refer to the ‘Panoramic+’ section in this chapter. „ NeedleMate+™ With pinpoint precision, NeedleMate+™ delineates needle location when performing interventions such as nerve blocks. Improved accuracy and efficiency in procedure are possible with beam steering added to NeedleMate+™. X Needle Direction: Sets the entry direction of the biopsy needle in images. X Needle Angle: Sets the entry angle of the biopsy needle in images. X Needle Enhance: Sets the enhancement and thickness of the biopsy needle. Enhance Level Feature 1 Needle thickness is thin and needle enhancement is low. 2 Needle thickness is thin and needle enhancement is high. 3 Needle thickness is thick and needle enhancement is low. 4 Needle thickness is thick and needle enhancement is high. X NeedleMate+™ is an optional feature of this product. X Only available with certain probes. „ DR (Dynamic Range) This function adjusts the contrast value by changing the ratio of the minimum and maximum values of input signals. The higher the value, the smoother the displayed image. „ Frame Average When an image is updated, the present image and the previous image are averaged. When you scan the same diagnosis site repeatedly, speckles may appear on the updated image. It is used to minimize these speckles. „ Focus Number Change the number of focusing points at the target area you wish to observe. 6-12

[Page 325] „ Reject This function reduces noise or echoes from an image in order to make the image clearer. „ Image Size Specify 2D image size. „ Gray Map Change the 2D Post Curve. „ Chroma Map You can select an image color. NOTE: For more details, please refer to ‘Post Curve’ in ‘Utilities’. „ Edge Enhance Allows you to view more accurate images of organ or tissue boundaries. A higher value provides more accurate images of boundaries. „ Power Set the ultrasound output intensity. „ Scan Area Select an image width (%). Increasing the image width reduces the frame rate. Press Change to change the trackball state to ROI Size, and then adjust the value using the trackball. „ Steer Angle You can change the angle of the ultrasound beam without moving the probe. NOTE: The Steer function only appears on the soft menu when a Linear probe is used. 6-13

[Page 326] „ NerveTrack™ NerveTrack™ is a function that detects and provides information of the location of nerve area in real-time during ultrasound scanning. Press NerveTrack™ to turn it On or Off. The BOXes appear on the nerve area in the image. X NerveTrack™ is an optional feature of this product. X NerveTrack™ is intended to be used only as an aid for qualified, experienced medical professionals in order to visualize the nerve in the ultrasound image. X Only available with certain probes. For more information, please refer to the ‘Probe List’ section in the ‘Probes’ chapter. X If you select End Exam , EzAssist™ will end. 6-14

[Page 327]
Panoramic+ Panoramic+ imaging displays as an extended field-of-view so users can examine wide areas that do not fit into one image as a single image. Panoramic+ images provide data obtained the linear and convex transducers. NOTE: Only available with certain probes. For more information, please refer to the ‘Probe List’ section in the ‘Probes’ chapter. „ Acquiring a Panoramic+ Image 1. Press Panoramic+ . 2. Press Start/Stop or Set to start acquisition of Panoramic+ images. 3. Press Start/Stop or Set to finish. Things to remember when acquiring a Panoramic+ image X When scanning a curved surface, ensure that the scan surface and the contact surface of the probe are always at right angles. X Moving in the opposite direction while acquiring an image erases the previously saved frames and saves new frames. X The image quality may deteriorate if the contact surface of the probe loses contact with the scan surface. X If the scan speed is too fast or the angle of the contact surface of the probe changes, artifacts may occur. [Figure 6.3 Panoramic Ready – Touchscreen] 6-15

[Page 328] „ Review a Panoramic+ Image NOTE: Only Caliper and each mode’s buttons can be used. L/R Flip , U/D Flip , and Zoom are available only when the Layout option is set to ‘Full Screen’. [Figure 6.4 Panoramic Review – Touchscreen] X L/R Flip: Flips the Panoramic+ image horizontally. X U/D Flip: Flips the Panoramic+ image vertically. X Return: Returns to the Panoramic Ready screen. X Cine Save: Saves Cine images. X Ruler: When turned On, a ruler is displayed on the Panoramic+ image. X Layout: Specifies how the Panoramic+ image is displayed on the screen. – Full Screen: Displays the Panoramic+ image in full screen. – Side by side: Displays the 2D and Panoramic+ images on the left and right of the screen, respectively. Move the ROI by turning the trackball. Then, the image is displayed in the 2D image area. – Up/Down: Displays the 2D and Panoramic+ images at the top and bottom of the screen, respectively. Move the ROI by turning the trackball. Then, the image is displayed in the 2D image area. X Press Panoramic+ one more time to end Panoramic+ Imaging. 6-16

[Page 329]
BiometryAssist™ A semi-automatic technology for biometric measurement, BiometryAssist™, enables users to measure the fetal growth parameters such as BPD, HC, AC and FL with one click while maintaining exam consistency. NOTE: It can be run only in 2D mode. „ Executing BiometryAssist™ 1. Select BPD, HC, AC, or FL in 2D mode, and place the caliper on the section of the screen that you believe to be the measurement area. Then, the measurement value will appear on the screen. 2. Press Set to confirm the measurement value displayed on the screen. Follow the BiometryAssist™ Operation Guideline to determine measurement positions more accurately. BiometryAssist™ Operation Guide X Position the target in the center of the screen using Image Panning, etc., not Rotation or Left/Right Flip. X To determine measurement positions more easily, resize the target using Image Size or Zoom so that it takes up 40 to 80% of the screen, and then take a measurement. NOTE: You can configure the relevant settings in Setup > Measurement > Additional Options. X Choose a measurement item from BPD , HC , AC , or FL . Then, the chosen item will be displayed on the screen. X The measurement standard for the BPD Method can be set to either Outer‑Inner or Outer‑Outer . 6-17

[Page 330]
LaborAssist™ LaborAssist™ is a function that provides information of the progress of delivery by the automatic measurement of AoP (Angle of Progress) and the direction of the fetal head. This not only helps in effective communication between the healthcare professionals and mothers, but also assists in deciding a delivery method for the healthcare professionals. * AoP complies with the metrics specified in the ISUOG Guidline. X LaborAssist™ is an optional feature of this product. X LaborAssist™ is enabled under the following conditions: – 2D Freeze mode – Curved Array probes (CA2-8AD, C2-5, and C2-8) – Measurement item: OB, GYN X The LaborAssist™ button is enabled when Rotation, L/R Flip, and U/D Flip are not in use. „ Running LaborAssist™ Run LaborAssist™ . Then, the touchscreen switches to LaborAssist ™. 1. Select a measurement method. The last measured value is displayed on the screen. X Auto: Automatically finds the position and measures it. X Manual: Measures the position entered by the user. Select three points using Set . Then, the angle formed by the three points will be calculated and displayed on the screen. NOTE: You can set the default measurement method in Setup > Measurement > Additional Options > OB. 2. When the measurement is finished, the result is shown on the screen. X Results table: Shows the Number (No.), AoP, Time, Interval (INT.), Station (STA.), and Cervix Dilatation (CX) information. X Screen: Shows the AoP, Station, Time, and Direction of Fetal Head (Direction) information. 3. If you need multiple images, then switch to Scan mode, acquire another image, and perform a measurement. 4. The measurement results are color-coded and numbered. 6-18

[Page 331] X Up to 20 measurement results can be displayed. X The Station information is provided only if the Station Table has been selected and there is available Station information. X The Direction information is provided only if the measurement has been performed using Auto . [Figure 6.5 LaborAssist™] „ Show All Lines Displays all measurement lines on the screen. „ Station Table Select an Author. Then, the Station information is provided based on the chosen Author’s data. If you select None, no Station information will be provided. „ Demo Video Plays a demo video. You may pause the video or skip the video forward or backward by three seconds. 6-19

[Page 332] „ Demo Image Turn the Demo Image dial-button in the soft menu and select an index. The demo image corresponding to the results of the selected number will then be shown. Displays the current page (the chosen number), the total number of pages (the total number of measurements), and the time when the result value of the chosen number is measured. „ Labor History LaborAssist™ checks the history of measurements. It can only check saved images. X Edit: Select the images that you wish to remove from the screen. Press Done . Then, the selected images will be removed from the screen. X Adjust: Arranges the displayed images by Pubis Line and only displays the ultrasound images and measurement lines. To view the original images again, press Origin . X Page: Navigates to a different page. „ Delete All Deletes all displayed results from the image and the results table. „ Delete Last Deletes the last displayed result from the image and the results table. „ Assign Cervix Enter the cervical length which has been set using Cervix Dilatation into the results table. „ Fetus If it is a multiple pregnancy, choose a fetus. 6-20

[Page 333] „ Font Size Specify the font size for the measurement results shown in the images. [Figure 6.6 LaborAssist™ – Touchscreen] 6-21

[Page 334]
UterineAssist™ UterineAssist™, based on Deep Learning technology, automatically measures the size and shape of the uterus, assisting in detecting signs of uterine-related abnormalities, as well as reducing scan time. X UterineAssist™ is an optional feature of this product. X UterineAssist™ is enabled under the following conditions: – Operation Mode: 2D – Image Mode: Single Mode – Endo cavity, 3D Endo cavity (V5-9, EV2-10A) probes – Measurement application: GYN (Only Uterus) X Automatic measurement function is not available in Rotation or Zoom state. „ Running UterineAssist™ 1. Run UterineAssist™ . Then, the touchscreen switches to UterineAssist™ . 2. Select a measurement method. The last measured value is displayed on the screen. X Auto Meas. Sagittal: Automatically finds the uterine measurement items and measures them in a Sagittal View image. X Auto Meas. Transverse: Automatically finds the uterine measurement items and measures them in a Transverse View image. X Automatic measurement items of each view are as follows: Measure View Measurement items Endo. Thick Uterus Total L Uterus L Uterus H Sagittal Roundness (H/L) Asymmetry (A/P) Fluid in the Endometrium Flexion Transverse Uterus W Both of Sagittal and Transverse measurements are completed Uterus Vol. 6-22

[Page 335] NOTE: You can set the normal range of each measurement item in ‘Utility > Setup > Measurement > Additional Options > GYN’. 3. When the measurement is finished, the result is shown on the screen. The user can select items and manually measure them again. Edited values are marked with an asterisk (*). X Image Area: Shows the measurement items with markers on the image and the measurement values at the bottom of the screen. X Variables: Displays the measurement results. The normal range is displayed, which is set by the user. If the results are out of the normal range, the measured value is displayed in red. [Figure 6.7 UterineAssist™] „ Menstrual Phase Selects menstrual phase. If LMP and Date of Cycle are registered in Patient information, menstrual phase is automatically selected. The user can modify. „ Fluid in the Endometrium Selects if there is fluid in the endometrium. If there is fluid (Yes), the user can assign Fluid Cursor on the line of Endometrium. 6-23

[Page 336] „ Version Selects the position of the uterus. „ Echogenicity Selects echogenicity of the tissue. „ Reset Initializes the measured results. „ Assign to Report Saves the measurement results to the report. „ Asymmetry Marker Mark the Asymmetry measurement position on the images in Sagittal View. [Figure 6.8 UterineAssist™ – Touchscreen] 6-24

[Page 337]
2D Follicle™ 2D Follicle™ is a function to measure the size of follicles based on 2D image and to provide information about the status during controlled ovarian simulation. X 2D Follicle™ is an optional feature of this product. X 2D Follicle™ is enabled under the following conditions: – 2D Freeze mode – Measurement item: OB, GYN – Endo Cavity, 3D Endo Cavity (EV2-10A, V5-9) probes X Changes to the image, such as Zooming, are not possible. „ Running 2D Follicle™ Run 2D Follicle™ . Then, the touchscreen switches to 2D Follicle™. 1. Specify the scanned position. Select Lt Ovary or Rt Ovary using the Ovary dial-button on the touchscreen. 2. Select a measurement method. The default measurement method upon launching 2D Follicle™ is Auto . X Auto: Automatically locates and measures a follicle. X Add Seed: Finds a follicle based on the seed position entered by the user and then measures it. Click the discovered target by using Set and then use Growth to specify the size. X Add Caliper: Finds a follicle based on the caliper position entered by the user and then measures it. Click the discovered target by using Set , and then use Growth to specify the size. 6-25

[Page 338] 3. When the measurement is finished, the result is shown on the screen. The measured follicles are numbered. [Figure 6.9 2D Follicle™] „ Delete All Deletes all detected targets from the image and the results table. „ Delete Deletes the selected target from the image and the results table. „ Min – Max Reset Resets the Min and Max values set by the user. „ Result Display Displays the results on the image. „ Growth Undo Cancel the last task performed using Growth. 6-26

[Page 339] „ Stage Specify the stages that you would like to show in the image and the results table. NOTE: You can set the Early, Middle, or Post stage in Setup > Measurement > Additional Options > GYN. „ Assign to Report Saves the measurement results to the report. „ Growth Rotate the dial-button to specify the size of the measurement target. „ Min Enter the minimum value that you would like to show in the image and the results table. „ Max Enter the maximum value that you would like to show in the image and the results table. „ Selected Follicle Select a detected target by turning the dial-button. Then, the index of the selected target is displayed. 6-27

[Page 340] „ Follicle Counts Specify the number of targets that you would like to show in the image and the results table. The set number of targets are then displayed, starting with the one that has the biggest value in the Long column. [Figure 6.10 2D Follicle™ – Touchscreen] 6-28

[Page 341] S-Detect™ for Breast The feature, which analyzes selected lesions in the breast ultrasound study and shows the analysis data, applies BI-RADS ATLAS* (Breast Imaging-Reporting and Data System, Atlas) to provide standardized reporting; and helps diagnosis with the streamlined workflow. * It is a registered trademark of ACR and all rights reserved by ACR. X S-Detect™ for Breast is an optional feature of this product. X S-Detect™ for Breast is not supported in Canada.
Running S-Detect™ for Breast S-Detect™ for Breast running conditions X Preset: Breast X Operation Mode: 2D (Freeze state) X Image Mode: Single mode X Patient information has been entered Cases when S-Detect™ for Breast cannot be run X Zoom is currently on X You have panned the image (2D Image Panning) 6-29

[Page 342]
S-Detect™ for Breast Screen 1 3 [Figure 6.11 S-Detect™ for Breast] 1 Ultrasound image area Shows the study image that has been acquired in 2D Mode. 2 Position information area X Items to be manually entered by the user after measurement – Position: Drag the point at the center of the coordinates with the mouse to specify the location on the breast from which the study image has been acquired. – Left/Right: Specify either the left or right breast. X Items automatically calculated at extraction of lesion contour – Distance: The distance from the center of the breast. – Angle: Clockwise angle from the center of the breast. – Depth: Depth from the skin surface to the location of the lesion. – Width: The horizontal length of the lesion. – Height: The vertical length of the lesion. – Area: The area of the lesion. 6-30

[Page 343] 3 BI-RADS Lexicon Classification area Provide the BI-RADS Lexicon Classification for the lesion that has been finally selected by the user. The Auto determination result is displayed in blue, and text will appear in yellow with an asterisk (*) if you modify the classification result. 4 BI-RADS Assessment Category Score It recommends whether the lesion selected by the user should be considered benign or malignant; the user makes a final decision on the BI-RADS Assessment Category Score. Using the final BI-RADS Assessment Category Score, S-Detect™ for Breast shows the category description. Category Description You can choose not to display the Category Description on the screen to protect the patient. For more information, please refer to ‘Setup > Imaging > S-Detect™’ in ‘Utilities’.
S-Detect™ for Breast Measurement Select a suspicious lesion. Use the trackball and Set . NOTE: Target Point and Target Area are not supported in China. „ Target Point Analyzes the area of the suspected lesion, based on the point specified by the user. „ Target Area Analyzes the area of the suspected lesion based on the ellipse specified by the user. The ellipse size can be adjusted by using the convert button on the control panel. „ Manual Contour Analyzes the area of the suspected lesion by arbitrarily selecting a point. „ Hide Contour When it is turned ‘On’, the user-defined area is not displayed on the screen. 6-31

[Page 344] „ Distance Shows the length of a specific area that is included in the image. „ Annotation Allows you to enter text in the image. „ Initialize Resets all results, allowing the user to re-specify the Target Point or Target Area. „ Point Edit Contour Modifies the area of the suspected lesion, based on the point specified by the user. „ Line Edit Contour Modifies the area of the suspected lesion, based on the line specified by the user. NOTE: Length and annotation may be used before and after extracting the contour of the lesion. 6-32

[Page 345]
S-Detect™ for Breast Analysis „ Extracting the Area of the Lesion The contour of the area of the suspected lesion is extracted and up to 6 candidates are shown on the touchscreen. Each image shows the Shape, Orientation, and Risk of the lesion. The user may select one of the candidates as the final area of the lesion. NOTE: The area of the lesion is extracted differently, depending on the Target Point or Target Area entered by the user; in some cases, no area of the lesion may be extracted. [Figure 6.12 S-Detect™ – Extracting the Area of a Suspected Lesion] 6-33

[Page 346] „ Classification (BI-RADS Lexicon Classification) The area of the lesion selected by the user is analyzed, and then the analyzed items are ® ® displayed. BI-RADS 2003, BI-RADS 2013 are available, and each is categorized as follows: Lexicon Classification Description Note Shape Oval, Round, Irregular Orientation Parallel, Not Parallel Circumscribed, Indistinct, Angular, Margin Microlobulated, Spiculated Lesion Boundary Abrupt Interface, Echogenic Halo No Posterior Findings, Posterior Feature Enhancement, Shadowing, Combined Pattern Anechoic, Hyperechoic, Complex Echo Pattern Echogenicity, Hypoechoic, Isoechoic Recommendation BI-RADS ® 2003 Macrocalcifications, Micro. Out of Features Excluded Calcifications Mass, Micro. In Mass Duct Changes, Cooper Ligament Surrounding Chg., Edema, Architectural Tissue Distortion, Skin Thickening, Skin Retraction None, In Lesion, Adjacent To Lesion, Vascularity Diffuse Vascularity Clustered Microcysts, Complicated Cysts, Mass In Or On Skin, Foreign Special Case Body, Intrama. Lymph Node, Axillary Lymph Node 6-34

[Page 347] Lexicon Classification Description Note Shape Oval, Round, Irregular Orientation Parallel, Not Parallel Circumscribed, Not Circumscribed Margin (Indistinct, Angular, Microlobulated, Spiculated) No Posterior Features, Posterior Features Enhancement, Shadowing, Combined Pattern Anechoic, Hyperechoic, Complex Echo Pattern Cystic And Solid, Hypoechoic, Isoechoic, Heterogeneous In a mass, Outside of a mass, Calcifications Recommendation BI-RADS ® 2013 Intraductal Features Excluded Architectural Distortion, Duct Changes, Skin Thickening, Skin Retraction, Edema, Vascularity Associated (Absent, Internal Vascularity, Features Vessels In Rim), Elasticity Assessment (Soft, Intermediate, Hard) Clustered Microcysts, Complicated Cyst, Mass In Or On Skin, Foreign Body + Implants, Intrama. Lymph Special Cases Node, Axillary Lymph Node, Simple Cyst, Vascular Abnormalities (AVMs, Mondor Disease), Post-surg. Fluid Coll., Fat Necrosis 6-35

[Page 348] „ BI-RADS Assessment Category Score Recommends whether the area of the lesion selected by the user should be considered benign or malignant. X BI-RADS 2003 BI-RADS ® Assessment Description Category Score 0 Incomplete 1 Negative Possibility of 2 Benign Benignancy 3 Probably benign 4a Low suspicion of Malignancy 4b Intermediate suspicion of malignancy Possibility of 4c Moderate concern, but not classic for malignancy Malignancy 5 Highly suggestive of malignancy 6 Known biopsy-proven malignancy X BI-RADS 2013 BI-RADS ® Assessment Description Category Score 0 Incomplete 1 Negative Possibility of 2 Benign Benignancy 3 Probably benign 4a Low suspicion for malignancy 4b Moderate suspicion for malignancy Possibility of 4c High suspicion for malignancy Malignancy 5 Highly suggestive of malignancy 6 Known biopsy-proven malignancy 6-36

[Page 349] X The Classification items and BI-RADS ® Score function may be applied differently in certain regions. X In the USA, Lexicon Classification is supported by an automatic determination feature for the Shape and Orientation items, which can also be directly entered by the user. The other items under Lexicon Classification and the Assessment Category Score must be entered manually by the user. X In the United States and China, the recommendation feature for the benignity or malignancy of a lesion is not supported. Editing the BI-RADS ® Lexicon Classification and BI-RADS ® Assessment Category Score The user can manually edit the BI-RADS ® Lexicon Classification items and the BI-RADS ® Assessment Category Score. X Editing the BI-RADS ® Lexicon Classification X Select the title of each item on the monitor screen. Alternatively, press Classification on the touchscreen and select a Classification item. X Editing the BI-RADS ® Assessment Category Score X Change the BI-RADS ® Assessment Category Score at the bottom of the screen. When the Category Score is changed, the verdict also changes accordingly.
S-Detect™ for Breast Sensitivity Setting This allows users to adjust the sensitivity and specificity levels for lesion analysis. X High Sensitivity: Increases the chance of detecting malignancy as its sensitivity is higher than that of the default mode (High Accuracy). X High Accuracy: This is the default mode. It can distinguish between benignity and malignancy more accurately than the High Sensitivity and High Specificity modes. X High Specificity: Increases the chance of detecting benignity, as its specificity is higher than that of the default mode (High Accuracy). X The Sensitivity Setting is not supported in the United States and China. X You can select it in Setup > Imaging > S-Detect™ > S-Detect™ for Breast > Sensitivity Setting. 6-37

[Page 350]
Displaying S-Detect™ for Breast Reports At completion of analysis on the lesion selected by the user, press Assign . The analysis result is then displayed as a patient report. The analysis results are presented as an S-Detect™ for Breast Report, which is a separate category within the patient report; the information included in this report is as follows: X Patient information: The patient’s information entered by the user upon starting the exam X Position information: Position, Distance, Angle, Depth, Height, Width, Area X BI-RADS Lexicon Version Information X BI-RADS Lexicon Classification X BI-RADS Score X S-Detect™ for Breast Screen Image X When printing a report, up to 10 images (5 left and 5 right) can be printed out in the report. X To attach saved images during the study, use Image on the Report screen. In each image, you can enter the location information (Left/Right) and description.
Closing S-Detect™ for Breast Press Close or the unfreeze or Operation mode buttons to exit. 6-38

[Page 351] M Mode The M mode is used to specify an observation area in a 2D image with the M Line, and display changes over time. This mode is appropriate for the observation of organs with a lot of movement, such as cardiac valves. The 2D mode image is also shown, allowing the marking and adjustment of an observation area within the entire image. [Figure 6.13 M Mode – Touchscreen]
M Mode Screen „ M Line The M Line indicates the relative position of the M Mode image in the 2D image. Therefore, you can move the M Line to change the observation area. Use the trackball to move the M Line to the right or left. 6-39

[Page 352]
M Mode Menu „ Anatomical M You can adjust the AMM Line position and angle. X AMM Angle: Rotates the Anatomical M cursor line. X Gain: You can adjust it using the dial-button. NOTE: This is available only for the Phased Array probe, Curved Array probe’s Fetal Heart preset, or the Cardiac application. „ Sweep Speed You can view various spectra on one screen by adjusting the Sweep Speed. „ Display Format Select either Up/Down, Side by Side, or M only for Display Format . „ Display Size This function is used to select the size of the M image. This option is not enabled if Display Format is set to M Only. „ M Mode Map You can set the Post Curve value for an M image. „ Steer Angle Adjust the angle of the ultrasound beam. NOTE: The Steer function only appears on the soft menu when a Linear probe is used. 6-40

[Page 353] Color Doppler Mode This mode displays the blood flow pattern in the ROI (Region of Interest) of a 2D image in color. It is appropriate for examining the presence of blood flow, its average speed, and its direction. The 2D mode image is also shown, allowing the marking and adjustment of the ROI within the entire image. [Figure 6.14 Color Doppler Mode – Touchscreen]
C Mode Screen „ ROI (Region Of Interest) Box Indicates the region of interest. The ROI Box outlines the area of the 2D image where color (blood flow) information is displayed in Color Doppler mode. You can move or resize the ROI Box using Change . Each time you press Change , the current state of the ROI Box is displayed in the lower center of the screen as shown below. X ROI Position: In this state, the position of the ROI Box can be changed. Use the trackball to move and position the ROI Box. X ROI Size: In this state, the size of the ROI box can be changed. Use the trackball to move the ROI Box and specify its size. 6-41

[Page 354] „ Color Bar In Color Doppler mode, the color bar indicates the direction and speed of blood flow. Based on the baseline at the middle, the red color indicates the direction and speed of blood flow moving toward the probe. By contrast, the blue color indicates the direction and speed of blood flow moving away from the probe. When you turn Baseline clockwise, the Baseline on the color bar will increase.
C Mode Menu „ Hide Color Select C mode to use. Pressing Hide Color only displays B mode images in the Color ROI area, without showing any Color mode images. Press this button again to cancel the selection and return to Color + B/W mode. „ Frequency This enables you to set the probe’s frequency. The selected frequency is displayed in the title area, allowing you to determine the state of the current frequency easily. „ Line Density Select the density of the scan line. Selecting High increases the number of scan lines and improves the image resolution. However, the frame rate is reduced. „ Invert The color bar is inverted each time this button is pressed. Inverting the color bar also inverts the color displayed on the image. „ Vel + Var This shows the blood flow velocity in green on the Color Bar. Vel and Var stand for Velocity and Variance, respectively. NOTE: This is available when the following conditions are met: X Cardiac: Adult Echo, Ped Echo, Arotic Arch X OB: Fetal Heart X Vascular: Carotid, Arterial, Venous 6-42

[Page 355] „ TDI (Tissue Doppler Imaging) For more information, please refer to the ‘TDI Mode’ section in this chapter. „ Auto Gain If turned On, the brightness of an image will be adjusted automatically. NOTE: The Auto Gain button is enabled for the Linear probe’s Carotid and Arterial presets in Live state. „ Steer Invert Pressing the button inverts the angle of the sample volume. NOTE: The Steer Invert button is only enabled when using a Linear probe. „ Scale Rotating the Scale dial-button clockwise increases the scale, extending the displayed blood flow speed range; rotating the dial-button counterclockwise decreases the scale, narrowing the displayed blood flow speed range. „ Sensitivity It enhances the sensitivity and accuracy or frame rate of color images. „ Filter This is an electric filter to remove the low-frequency doppler signals generated by the movement of blood vessel walls. Adjust the Cutoff Frequency to remove doppler signals whose frequency is lower than the cutoff frequency. „ BaseLine Rotating the dial-button clockwise decreases the Baseline. In Color Doppler mode, the color bar indicates the direction and speed of blood flow. Based on the baseline at the middle, the red color indicates the direction and speed of blood flow moving toward the probe. By contrast, the blue color indicates the direction and speed of blood flow moving away from the probe. 6-43

[Page 356] „ Color Map Used to configure the post curve in a color image. Use Color Map to make a selection. This can help to display blood flow with greater clarity. „ Steer Angle Adjust the angle of the ultrasound beam. Loss of color information resulting from the angle of the ultrasound beam is minimized. NOTE: The Steer function only appears on the soft menu when a Linear probe is used. „ Balance Select a Balance value using the dial-button. The range of a color image is adjusted by comparing the gray levels of 2D images with the doppler signal values of color images. When the Balance value increases, the color image also appears in the part where the gray level of a 2D image is high (the bright part), increasing the range of the color image. „ Smoothing (Spatial Filter) Set the Smoothing value. This allows for a smoother display of color images. „ Alpha Blending Superimposes a color image over a 2D image in the color image area. When turned ‘On’, Blending Level is enabled in the Soft Menu. „ Blending Level Specify the blending ratio between the 2D image and the color image. With the lower number, the higher the ratio of the 2D image gets. „ Color Optimizes colors in the image according to blood flow rate. 6-44

[Page 357] Power Doppler Mode This mode displays the intensity of blood flow in color within the ROI in the 2D image. It is appropriate for observing the presence and volume of blood flow. The 2D mode image is also shown, allowing the marking and adjustment of the ROI within the entire image. [Figure 6.15 Power Doppler Mode – Touchscreen]
Entering & Exiting PD Mode Press PD . Press the PD button again to exit PD Mode and enter 2D Mode.
PD Mode Screen „ Color Bar In PD mode, the color bar displayed varies depending on the Power Doppler mode display method that is in use. The color bar indicates the presence of blood flow and its amount. The top of the color bar is the brightest section, where the amount of blood flow is at its highest. „ ROI Box The ROI (Region of Interest) outlines the area of the 2D image where color (blood flow) information is displayed in Power Doppler mode. 6-45

[Page 358]
PD Mode Menu „ S-Flow™ The function uses directional power doppler technology, enabling you to examine even the peripheral vessels. It displays information on the intensity and direction of blood flow. X Only available with certain probes. X For more information, please refer to the ‘Probe List’ section in the ‘Probes’ chapter. „ Auto Gain When turned ‘On’, the brightness level of an image is automatically adjusted. X The Auto Gain button is enabled for the Linear probe’s Carotid and Arterial presets in Live state. X For more information on other touchscreen items, please refer to ‘Color Doppler Mode’. 6-46

[Page 359] PW (Pulse Wave) Spectral Doppler Mode This mode displays the blood flow speed at a specific blood vessel location within a specific time frame. Distance (depth) information can also be obtained by transmitting pulses over time frames. This mode is appropriate when observing relatively low-velocity blood flows, such as blood flows in the abdominal and peripheral vessels. The 2D mode image is also shown, allowing the marking and adjustment of an observation area within the entire image. [Figure 6.16 PW Spectral Doppler Mode – Touchscreen] 6-47

[Page 360]
Entering & Exiting PW Spectral Doppler Mode „ Entering PW Spectral Doppler Mode 1. Press PW . 2. Pressing PW again starts PW Spectral Doppler mode and displays a doppler image on the screen. „ Exiting PW Spectral Doppler Mode 1. Press PW while a doppler image is being displayed. Alternatively, press 2D to exit PW Spectral Doppler mode. 2. To obtain a Spectral Doppler image, press Set . NOTE: The Doppler image can only be obtained in the D Only or Simultaneous states. „ Sample Volume for PW Spectral Doppler Mode Screen The doppler spectrum is displayed when the Sample Volume is located above the blood flow on the 2D image. The size of the Sample Volume is displayed in mm units. Use the trackball to adjust the position of the Sample Volume. X Adjusting Sample Volume position: Use the trackball. X Resizing Sample Volume: When the touchscreen is in use, select the SV Size dial - button. X Adjusting Sample Volume angle: Turn the Angle dial - button to make a selection. „ Adjusting Doppler Baseline Rotate the dial-button to adjust the Baseline value. 6-48

[Page 361] „ HPRF (High PRF) Function Adjust the blood flow above the speed limit at a specific depth. The scale is increased; this can only be used in PW Spectral Doppler mode (D Only). NOTE: Configure the settings in Setup > Imaging > Common > HPRF. X Activating HPRF Increasing the scale at a specific depth to a certain point automatically activates HPRF. The Phantom Gate will appear on the D Line at a position higher than the sample volume. Once HPRF starts, PRF does not increase even if you increase the scale value. X Finishing HPRF While HPRF is in use, decrease the scale value by one step to finish HPRF. Here, the PRF value becomes the maximum value in the current PW Spectral Doppler mode. X Adjusting Sample Volume position If you move the Sample Volume in D Only state, then the system will calculate the PRF value and Phantom Gate position to update the Spectral Doppler image. HPRF is terminated when HPRF cannot be activated. If you move the Sample Volume in 2D Only state, the PRF value doesn’t change. X The Phantom Gate position can be located outside the 2D image area in Zoom Mode. X Make sure that sample volume and Phantom Gate are not placed together in the measuring area. If more than two Sample Volumes are located in the vessels, all doppler components will appear in the spectrum, causing noise. 6-49

[Page 362]
PW Spectral Doppler Mode Menu „ Simultaneous If it is turned ‘On’, you can view real-time 2D and Spectral Doppler images at the same time. When turned ‘Off’, images in only one mode can be observed. Using the Simultaneous feature will decrease Doppler PRF, and subsequently the speed measurement range. „ Invert Each time you press the button, the spectrum speed indicator inverts the position of + and –. „ AutoCalc X Live setting: The PS, ED, MD, PI, RI, PS/ED, ED/PS, HR, TAmax, and TAmean are calculated after acquiring the Doppler Trace. X Frozen setting: The PS, ED, MD, PI, RI, PS/ED, ED/PS, HR, TAmax, and TAmean values are calculated when the image is frozen. NOTE: Please refer to Setup > Measurement > AutoCalc. CAUTION: The measured values presented by Auto Trace used in Measure, and those presented by Real Time Automatic Doppler Trace (Automatic Calculator) may differ. This is because the algorithms for these two methods are different. It is recommended to use Auto Trace under Measure for more accurate measurement. 6-50

[Page 363] Things to Consider for Real Time Automatic Doppler Trace 1. Aliasing occurs because PRF is too low in comparison to the image speed, or the spectrum is clustered around the baseline because PRF is too high. 2. Peak is indistinctive or intermittent such as in Spectral waveforms for veins. 3. Meaningful spectrum distinction becomes difficult because Doppler Gain is set too high or too low. 4. An index is displayed during the transition time after Sample Volume is moved with the Trackball. 5. The major spectral signals are cut off because Doppler Wall Filter is set too high. 6. Peak Trace is interrupted due to abnormal Doppler noise or artifact, and the heart rate is above approximately 140 bpm. If any of the above apply, Real Time Automatic Doppler Trace may not produce an accurate trace or results. In addition, during Auto Calculation, results will not be displayed if the Freeze function is run against inaccurate values. „ Sensitivity Specify the minimum Sensitivity range. Sensitivity Sensitivity is a function that is used to adjust the Trace Line in Auto Trace or Limited Trace. Increase the value to capture a wider area, use a smaller value to make the waveform clearer. „ Trace Method Max or Mean Trace for the selected spectrum is performed. „ Trace Direction Select the part of the spectrum to calculate with AutoCalc from Both, Above, or Below. „ Sound Adjusts the doppler volume. „ Display Format Select a display format for doppler images. 6-51

[Page 364] „ Doppler Map Used to configure the Post Curve value for a Doppler image. „ TDW (Tissue Doppler Wave) For more information on TDW, please refer to ‘TDW Mode’. NOTE: This can only be used when the cardiac application is selected in Phased Array probe. 6-52

[Page 365] CW (Continuous Wave) Spectral Doppler Mode This mode displays the blood flow speed and direction at a specific blood vessel location within a specific time frame. Unlike PW Spectral Doppler Mode, it does not provide Sample Volume. Press CW . When you press the button again, it returns to 2D Mode. „ Steered CW Spectral Doppler Mode This mode can only be used if the Phased Array probe is used. The 2D mode image is also shown, allowing the marking and adjustment of an observation area within the entire image. „ Static CW Spectral Doppler Mode This is available only when the Static CW probe is in use. The 2D mode is not displayed with this mode. X CW Spectral Doppler mode is an optional feature of this product. X For more information on other touchscreen items, please refer to the ‘PW Spectral Doppler Mode’. 6-53

[Page 366]
CW Spectral Doppler Mode Menu [Figure 6.17 CW Spectral Doppler Mode – Touchscreen] NOTE: The menus in CW Spectral Doppler mode are identical to those in ‘PW Spectral Doppler mode’. 6-54

[Page 367] TDI (Tissue Doppler Imaging) Mode TDI stands for Tissue Doppler Imaging. This is used to view images of fast-moving tissue such as the heart. It’s available in Color Doppler mode. In Color Doppler mode, TDI shows cardiac tissues in color. NOTE: This only appears in the Soft Menu when the cardiac application for the Phased Array probe is being used.
Starting and Ending TDI Mode Press TDI in Color Doppler mode. Pressing the button once more switches the mode from TDI to C mode. NOTE: For information on the touchscreen menu, please refer to ‘Color Doppler Mode’. 6-55

[Page 368] TDW (Tissue Doppler Wave) Mode TDW mode represents the movements of tissues such as the heart. TDW mode is available in the PW Spectral Doppler mode. If it is used in Spectral Doppler Mode along with Color Doppler mode, changes in cardiac tissues over time can be observed. NOTE: This can only be used when the cardiac application is selected in Phased Array probe.
Starting and Ending TDW Mode Press TDW in PW Spectral Doppler mode to launch it. Pressing the button once more switches the mode from TDW to PW Spectral Doppler. NOTE: For information on the touchscreen menu, please refer to ‘PW Spectral Mode’. 6-56

[Page 369] ElastoScan™ Mode A diagnostic ultrasound technique for imaging elasticity, ElastoScan™ observes the transformation of the tissue strain by the internal or external forces, and converts relative stiffness into a color image. A 2D mode image is also provided to help you check the location of the ROI. X ElastoScan™ mode is an optional feature of this product. X Only available with certain probes. For more information, please refer to the ‘Probe List’ section in the ‘Probes’ chapter. X This function is not available in E mode. Angle, View Area, ECG ElastoScan™ An elastogram shows elasticity imaging of an object, based on continuous ultrasound images. The technique that obtains the elasticity of an object and converts it to images is called ElastoScan™. ElastoScan™ visualizes the presence of a solid mass or stiffness in tissue as an image. It is already well known that lesions such as tumors are different from healthy tissue in terms of their stiffness. Up until now, palpation has been used for examination, but this method has certain depth limitations. 6-57

[Page 370] „ E Dual Mode In this mode, the elastogram and the 2D image are displayed together on the screen. This option can be selected by pressing Dual Live . To facilitate comparative observation, the 2D image is shown on the left and an E image is shown on the right. X Wide Dual View is set for ElastoScan™ by default. X For more information about the Wide Dual View settings, please refer to ‘Setup > Imaging > Display Settings’ in ‘Utilities’. [Figure 6.18 E Dual Mode] 6-58

[Page 371] „ E Single Mode In E Single mode, only an E image is displayed in the screen. This option can be selected by pressing Dual Live . [Figure 6.19 E Single Mode] 6-59

[Page 372] „ ROI (Region of Interest) Mode In E mode, the ROI Box represents the area where elasticity information is processed and shown. To acquire a good elastogram, it is important that the valid tissue ratio is high and does not include bones, air, etc. To obtain high-quality elastograms for the breasts, It is recommended that you set the area as wide as possible in the lateral direction and include the area between the subcutaneous layer and muscle in the axial direction. Please choose appropriately according to your actual scanning environment. X ROI Position: You can reposition the ROI Box. Move the ROI Box with the trackball to confirm the new position. X ROI Size: You can resize the ROI Box. Resize the ROI Box using the trackball and then press Change to confirm the new size. NOTE: ROI mode is available in E Single mode as well as in E Dual mode. [Figure 6.20 ROI Mode] 6-60

[Page 373]
Entering and Exiting E Mode Press ElastoScan™ . Press the button again to return to 2D Mode.
E Mode Screen „ Color Bar In E Mode, the color bar indicates the stiffness of a tissue. Regardless of the color, the lower section of the bar indicates that the target area is stiffer than the surrounding tissues and the upper section indicates that the target area is less stiff than the surrounding tissues. „ Compression Guide Bar Step 0 The probe is almost stationary. (Block: Appears empty) When there are not enough valid areas in the ROI or when images rarely match up. Steps 1-2 (Gray) There is not enough pressure. Steps 3-7 (Blue or green) There is appropriate pressure. Each step is expressed as the number of corresponding blocks. This is enabled only when the application is Breast, Gynecology, or Prostate. Precautions for Scanning Place your probe close to the surface of the area that you wish to observe, specify the ROI accordingly, and apply pressure using the probe regularly. When the compression guide is supported, please refer to this guide to adjust the compression level. If the region being examined is quite deep, it is better to increase the compression. To observe the lesion closely, minimize the tissue movement. A breast is a complex organ which consists of lactiferous ducts, lactiferous glands, fatty tissue, fibrous tissue, and chest muscles. An axial movement of the probe may cause an unintended movement of the tissues. The prostate and the thyroid consist of tissues that are simpler than those of a breast and there are relatively fewer unintended movements. 6-61

[Page 374]
E Mode Menu „ ROI Mode Starts or ends ROI mode. [Figure 6.21 ElastoScan™ Mode – Touchscreen] „ Invert Tapping the button reverses the color bar. Inverting the color bar also inverts the color displayed on the image. „ Dual Live The elastogram and the 2D image are displayed together on the screen. Pressing Dual Live one more time displays only an E image on the screen. „ E Gain Adjust the brightness of the elastogram image. „ Persistence Level Specify the speed of change between frames. Selecting a higher value increases the rate of frame change. 6-62

[Page 375] „ Contrast Select the contrast of the elastogram. „ Color Map Select the color of the elastogram. If you change the Color Map, the color bar will also change accordingly. „ Blending Level Select the ratio of Alpha Blending. Setting the value to 0% shows only an E image, while setting it to 100% shows only a 2D image. „ Enhancement Adjusts the enhancement of the image. A higher setting provides more clearly defined boundaries, at the expense of increased noise.
E-Strain™ E-Strain™ is designed to enable quick and easy calculation of the strain ratio between two regions of interest for day-to-day practice. Simply by setting the two targets, you can receive accurate, consistent results and make informed decisions in many types of diagnostic procedures. X E-Strain™ is an optional feature of this product. X E ‑ Strain™ is enabled on the touchscreen only when the following conditions are met: – ElastoScan™ mode in Freeze sate 6-63

[Page 376] „ E-Strain™ 1. Press Freeze and then E-Strain™ . 2. Specify the position and size of ROI in the area of suspected lesion. X Make sure that breast fat is visible at the same level as the ROI or above it. X Adjust the size of the ROI by using the trackball and Change . 3. Press Set . The calculation is automatically performed, and the results will be displayed on the screen. X Strain A: Mean strain value inside the ROI A (Supported in all countries except the US and Canada) X Strain B: Mean strain value inside the ROI B (Supported in all countries except the US and Canada) X Ratio (B/A): Ratio of strain values (Strain B/Strain A) (Supported in all countries excluding Europe, China, and Japan) 4. If you need to adjust the Strain A and Strain B areas again, then use the following functions: X Delete A: You can clear the Strain A area and specify the ROI area again. (However, when Strain B is chosen, this button is disabled.) X Delete B: You can delete the Strain B area and set ROI again. E-Strain™ is unavailable when: X Zoom is currently on; or X You have panned the image (2D Image Panning). CAUTION: The image quality of strain elastography and the proper placement of ROI are important to reduce the measurement error of strain ratio. 6-64

[Page 377] Combined Modes In Combined Mode, three different modes are combined, including the default 2D Mode. Note that, in 2D/C Live Mode, only two modes are combined:2D and Color Doppler Modes. 2D/C/PW Mode Color Doppler mode and PW Spectral Doppler mode are displayed simultaneously. Press PW/y in Color Doppler mode. Alternatively, press C/z in PW Spectral Doppler mode. 2D/PD/PW Mode Power Doppler mode and PW Spectral Doppler mode are displayed simultaneously. Press PW/y in Power Doppler mode. Alternatively, press PD in PW Spectral Doppler mode. 2D/C/CW Mode Color Doppler mode and CW Spectral Doppler mode are displayed simultaneously. This mode is available only with certain probes. Press CW in Color Doppler mode. Alternatively, press C/z in CW Spectral Doppler mode. 2D/PD/CW Mode Power Doppler mode and CW Spectral Doppler mode are displayed simultaneously. This mode is available only with certain probes. Press CW in Power Doppler mode. Alternatively, press PD in CW Spectral Doppler mode. 2D/C/M Mode Color Doppler mode and M mode are displayed simultaneously. Press M in Color Doppler mode. Alternatively, press C/z in M mode (only available for certain diagnostic applications of specific probes). 6-65

[Page 378] 2D/TDI/TDW Mode TDI mode and TDW mode are displayed simultaneously. Press TDI in PD mode or Color Doppler mode, and then PW . NOTE: This can only be used when the cardiac application is selected in Phased Array probe. Dual Live Mode 2D mode and Color Doppler mode are displayed simultaneously. Select Dual Live in 2D mode or C mode.
Changing Combined Mode Format „ Changing the Active Image Mode Press Set . The current active image mode, such as ‘D Only’ or ‘2D Only’, is displayed above the menu on the screen. In Combined mode, two or more image modes are used at the same time. The image mode currently used in the Combined mode is called the ‘Active Image Mode’. For example, if Sample Volume is moved with the trackball in 2D/C/PW Mode, PW Spectral Doppler Mode becomes the current active image mode. Because the menu and button options vary depending on the active image mode, use Set to change the active image mode. Note that the active image mode cannot be changed with Set in the Freeze state. „ Changing the Menu You can change the menus on the touchscreen without modifying Active Image Mode. The functions of the buttons on the control panel vary depending on the active image mode. For example, if the touchscreen menus for 2D Mode are displayed on the screen in 2D/C/ PW Mode, you can select another mode from the touchscreen menu and switch to the mode you selected. NOTE: To learn how to optimize an image in Combined mode, please refer to the ‘Basic Mode’. 6-66

[Page 379] Multi-Image Modes The product supports Dual mode and Quad mode. In Multi-Image mode, each image can be displayed in different combined modes. The method of using buttons in an active area is the same as in Combined mode. Dual Mode Press L or R . You can compare two independent images with each other. You can alternate between the two images each time you press L or R . The currently active image mode is indicated by a blue marker at the top of the image. The buttons and menu operate according to the image mode that is currently in use. To exit Dual mode, press 2D , or press the button on the activated image (i.e., L or R ). 1 2 [Figure 6.22 Dual Mode] 6-67

[Page 380] Quad Mode Press Quad . You can compare four different images at the same time. You can alternate amongst the four images each time you press Quad or Set . The currently active image mode is indicated by a blue marker at the top of the image. The buttons and menu operate according to the image mode that is currently in use. To exit Quad mode, press Single or 2D . 1 2 3 4 [Figure 6.23 Quad Mode] Multi-Image Mode Screen Layout It shows recent Cine images on the screen. X Dual Mode Pressing L or R displays the current Cine image and the most recent Cine image in the order of 1 → 2 . You can set images to be displayed horizontally (Side by Side) or vertically (Up/Down) in Dual Layout . X Quad Mode When you press Quad , current Cine image and the most recent three Cine images are shown on the screen. For more information about image display methods, please refer to ‘Setup > Imaging > Common’ in ‘Utilities’. – Zigzag: Set in the order of 1 → 2 → 3 → 4 . – Clockwise: Set in the order of 1 → 2 → 4 → 3 . NOTE: For more information about how to optimize images in Multi-Image mode, please refer to ‘Basic Mode’. 6-68

[Page 381] 3D/4D Mode In 3D mode, you can acquire 3D images using a 3D probe. In 4D mode, you can acquire real-time 3D images using a 3D probe. Pressing Freeze opens the 4D Cine screen. X For information on Operation modes other than 3D/4D modes, please refer to ‘Modes of Operation’. X It supports 3D mode and 4D mode (optional).
Acquiring 3D/4D Images 1. Specify the location and size of the ROI Box as desired. 2. Configure various parameters on the 3D Stand By window on the touchscreen. Select the menu tab for 3D/4D mode, and configure in the following order: View Mode → Rendering Preset → Other Items. 3. Press Freeze or Set . The system will begin acquiring 3D images. Once a 3D image is acquired, the 3D View screen will appear according to the settings. 4. You can perform diagnosis by optimizing images. Press the 3D/4D button to acquire 3D images again. How to acquire good 3D images X Consider the direction, size and section of the viewpoint as well as the visibility of an object. X Before acquiring 3D images, adjust the contrast in 2D Mode. X The bigger the ROI box, the slower the rendering speed. Therefore, set an appropriate ROI box size. X To see the 3D image of a fetus in frontal view, position the fetal head in the direction of the Direction Mark, putting it in the coronal plane. Then scan the fetus from back to abdomen. X To determine the surface contour, subjects such as amniotic fluid that do not generate echoes should be insulated with hypo-echoic textures. X After acquiring a 3D image, you can adjust the low-threshold level to clean up the image. In general, it is recommended that you leave the High Threshold value at the maximum value of 255 rather than adjusting it. 6-69

[Page 382] 3D Mode You can use 3D mode and XI STIC with 3D probes or general probes. [Figure 6.24 3D Mode]
3D This mode uses a 3D probe to acquire 3D images. Freehand 3D Mode A mode where general probes, not 3D probes, are used is called Freehand 3D mode. Please note the following: X Available in MPR Mode only. X Not available while 2D Steer, Trapezoid, or Write Zoom are in use.
XI STIC In this mode, fetal cardiac cycles and STIC volume data can be obtained using 3D probes. For more information, please refer to the ‘XI STIC’ section in this chapter. NOTE: XI STIC is an optional feature of this product. 6-70

[Page 383]
Entering and Exiting 3D/4D Mode Press 3D/4D on the control panel. If you press this button again, you can exit the 3D/4D Mode and enter 2D Mode.
3D/4D Mode Screen „ ROI Box In 3D/4D Mode, the ROI Box is also referred to as the volume box. The box is used to indicate 3D/4D conversion areas. The position and the size of the ROI box is set by pressing Change . Whenever Change is selected, the state of the ROI box is displayed at the bottom of the screen as shown below: X Position: In this state, the position of the ROI Box can be changed. You can move the ROI box by using the trackball. X Size: In this state, the size of the ROI box can be changed. Resize the ROI box using the trackball and then press Change to confirm the new size. 6-71

[Page 384] 3D Cine The 3D images saved temporarily in the system can be reviewed.
3D Cine Define Specify the settings needed for creation of a Cine image. „ Rotate Angle Used to specify the total image rotation angle. „ Step Angle Specify the rotation angle per step of the image. The Difference between Rotate Angle and Step Angle A Cine image rotates by the angle specified in ‘Rotate Angle’. During this process, each rotational step is equivalent to the angle specified under Step Angle. For example, if the Rotation Angle is set to 360° while the Step Angle is set to 15°, then a 3D Cine image rotates 360° in increments of 15°, taking a total of 25 steps. „ Rotate Axis Specify the rotation axis. „ Generate Cine images are generated by applying the current settings. Once the images are generated, the touchscreen switches to 3D Cine Review. „ Review Review previously generated Cine images. The touchscreen switches to 3D Cine Review. „ Start Angle Used to set the start angle of a Cine image. Once the Start Angle value is set, the configuration of Rotate Angle value will be canceled. 6-72

[Page 385] „ End Angle Used to set the end angle of a Cine image. Once the End Angle value is set, the configuration of Rotate Angle value will be canceled.
3D Cine Review Specify the settings needed for the review of a Cine image. „ Play Mode Select the play mode for Cine images. X Loop: Repeats playback in one direction. X Yoyo: Plays until the end in one direction, and then plays in reverse direction. „ Cine Play When it is turned ‘On’, Cine images are played. When it is ‘Off’, Cine Frame appears. „ New Cine Clears the current Cine image and creates a new one. „ Speed Set the speed at which Cine images are played. „ Trim Start Specify the position of the first frame, and press Trim Start to save. „ Trim End Specify the position of the last frame, and press Trim End to save. „ Cine Frame Select a Cine frame to review. NOTE: This option is available when Play is turned Off. The ‘Current Cine Frame Number/Total Number of Cine Frames’ is displayed. 6-73

[Page 386] 4D Mode In 4D Mode, 3D images can be obtained in real time with 3D probes. This mode is also called Live 3D Mode. Smart 4D Smart 4D collectively refers to the 4D, 3D XI, and 3D MXI functions. NOTE: 4D Mode is an optional feature of this product. [Figure 6.25 4D Mode]
4D Mode Screen When you press Freeze , it will change to the 4D Cine screen. NOTE: In 4D, only MPR, MSV, and Oblique View Modes are available. For more information, please refer to ‘3D View – MPR’ and ‘3D XI’. 6-74

[Page 387] 4D Cine The 4D images saved temporarily in the system can be reviewed. NOTE: You can also press Freeze in 4D mode to run 4D Cine. The cine bar is shown on the screen. The Cine Bar shows the ‘Current Cine Frame Number/Total Number of Cine Frames’. „ Play Mode X Loop: Repeats playback in one direction. X Yoyo: Plays until the end in one direction, and then plays in reverse direction. „ Cine Type Select the type of Cine image. X Volume: This button appears when Cine images are played. The MPR , MSV , or Oblique buttons are enabled, depending on the state before the 4D Cine was started. Cine images can be played by changing Display Format, etc. X Image: This is a general Cine playing method. „ Cine Play X Volume: Press Play to play. Press Freeze to stop. X Image: Press Play to play. Press Play again to stop. „ Cine Speed Set the speed at which Cine images are played. „ Vol.Index Set the index. The ‘Current volume data number/Total number of volume data’ is displayed. 6-75

[Page 388] 3D Stand By This window appears on the touchscreen when 3D/4D Mode starts. Select various parameters and configure the settings for acquiring 3D images. [Figure 6.26 3D Stand By – Touchscreen]
Menu Tab Select a tab for 3D/4D Modes. Different tabs are displayed on the touchscreen depending on the probe currently being used. Adjusting 2D Images in 3D/4D Modes X Tap the 2D Menu tab on the touchscreen to optimize a 2D image before acquiring the corresponding 3D image. X Once the 2D image is optimized, you can return to 3D Standby Mode by tapping 3D Menu on the touchscreen.
View Mode Select a view mode to use after 3D images are acquired. „ 3D View The standard view mode for 3D image review. Press MPR to select. 6-76

[Page 389]
Rendering Preset Select a preset for 3D images. For more information, please refer to ‘Preset’ in the ‘3D View – MPR Mode’.
Curved ROI When turned ‘On’, change the ROI Line shape to a curve, and then select a rendering area. X It cannot be used when OH (Orientation Help) is on. X It is supported when the Render Direction value is ‘C+’. X It is supported in Dual and Quad modes.
Breech Sweep You can also scan a breech baby from its head to abdomen without changing the probe direction.
Scan Quality Selects the quality of 3D images. X High: Image quality is high, but the speed of capturing (or rendering) 3D image is low. X Med2: Provides a faster image capturing speed and lower image quality than the value High. X Med1: Provides better image capturing speed and lower image quality than the Med2 setting. X Low: Provides the highest 3D image capturing speed and the lowest image quality. X Scan Quality is not available in the XI STIC menu tab. X Scan Quality is not available in Freehand 3D Mode.
Volume Angle Set the scan angle. The setting range varies depending on the selected probe. X In XI STIC , set a scan angle between 10 and 60˚. X Volume Angle is not available in Freehand 3D Mode. 6-77

[Page 390] 3D View – MPR This view mode is enabled upon acquisition of images when MPR is selected in 3D Stand By. You can optimize 3D images, perform diagnosis, and take measurements. Changing View Mode Select the 3D Menu tab on the touchscreen to change the view mode.
Basic Usage „ Zooming In to/Out of Images Rotate Zoom to zoom in/out on the images. The current zoom factor appears at the bottom of the screen. „ VCT Zoom Press VCT Zoom and then Zoom . The VCT Zoom function will be enabled. Turn the dial- button to zoom in to/out of VCT images. The current VCT Zoom factor appears at the bottom of the screen. NOTE: This option is available in VCT . „ Post Gain Make adjustments using the 2D Knob button. Works independently from 2D Gain, with a separate value. In 4D mode, Post Gain works during Freeze. „ Rotating Image around the X, Y, or Z Axis Use Angle/x , PW/y , or Color/z , respectively. „ Measurements by Application Press Calculator . The measurement method is the same as that described for each application in ‘Measurements’ as well as that of 5D NT™. X In the 4D mode, measurements of XI STIC and VOCAL are not available. X In MSV mode, you can’t perform measurements if the display format is 2x3 or higher. 6-78

[Page 391] „ Basic Measurement Press Calculator . For more information, please refer to ‘Measurement’. „ Entering Text Press Text . With the Quick Text function enabled, pressing any key on the keyboard immediately switches the mode to Text Mode. For more information, please refer to ‘Image Management’. „ Entering Arrows Press Text and then tap Arrow on the touchscreen. For more information, please refer to ‘Image Management’. „ Saving Images 1. Press the button mapped as Store/Send/Print . The 3D Data Save screen is displayed on the touchscreen. 2. Specify settings such as Data Type, Save Item, and Volume Format. 3. To save changes, press Save . Tap Exit to cancel. NOTE: If volume data contains both 4D and 3D Cine images, choose either 4D or 3D for saving. Volume Data 1. If volume data contains a Cine image, the Cine image will be saved with it. 2. If images are saved with volume data, they can be converted to new 3D rendering images with SonoView. „ Printing Images Save the desired printing method to either the U1 , U2 , U3 , or U4 button in U Key . For more information, please refer to ‘Setup > Customize > Buttons’. 6-79

[Page 392]
The Basics of 3D View Mode „ Screen Layout 1 2 3 4 [Figure 6.27 3D View] 1 A Plane: Image of the Longitudinal section. 2 B Plane: Image of the Transversal section. 3 C Plane: Image of the Horizontal section. 4 3D Image 5 Trackball status indication: The current state of the trackball is displayed at the bottom of the monitor screen. Press Change on the control panel to change the trackball state. The trackball state changes sequentially each time the button is pressed. X Pointer: Re-adjusts the position of ROI Box. When you press Pointer , it is switched to the Pointer state. You can rotate it around the image axis by pressing Set simultaneously. Press Change again to switch to another state. X Move: You can move a 3D image with the trackball. The acquired 3D image moves as you move the trackball. X ROI: You can resize the ROI box with the trackball. The ROI box on the 3D image is resized as you move the trackball. 6-80

[Page 393] „ Touchscreen Layout Only those buttons that are available in the current mode are enabled. [Figure 6.28 3D View Menu] 6-81

[Page 394]
Mode Select the display format in which 3D images are presented. „ Render Longitudinal, Transversal, Horizontal plane images are displayed with the 3D images. „ 2D Longitudinal, Transversal, Horizontal plane images, along with OH (Orientation Help), are displayed on the screen. OH indicates the relative position of the currently selected plane with regard to volume data. Tips! Use Single to view further details. „ VCT Longitudinal, Transversal, Horizontal plane images and combinations of them are displayed. Each plane is displayed with a different colored frame. NOTE: Accept ROI is available in Render. Turn it On or Off by tapping on the touchscreen. If this is turned On, no ROI will be displayed.
Display Format You can change the Display Format. The display format varies for each mode. X Single: Switches to Full screen. X Dual: Switches to 2D/3D screen. X Quad: Switches to ROI 3D screen. NOTE: In 2D or VCT mode, only Single or Quad Format can be used. 6-82

[Page 395]
Ref. Image Select A, B, or C as the reference image. The image that is selected will be highlighted with blue borders. X A: Longitudinal Section X B: Transversal Section X C: Horizontal Section „ OH (Orientation Help) Press this button on the touchscreen to turn it On or Off. If it is turned On, a 3D image will be displayed along with OH. NOTE: This option may be used in 2D and Render . „ Clear Vision ClearVision removes noise from the image and enhances outlines to help show the image more clearly.
3D Rotation Set the rotation value for the coordinate system based on the currently displayed 3D image. NOTE: Mix, Th. Low, and Transparency are available in Render .
Init Pressing Init resets the 3D image’s position. 6-83

[Page 396]
FAD (Fetal face Auto Detection) This automatically detects the face of the fetus and removes the images of any limbs that obscure the face.
VSI (Volume Shading Imaging) It displays a realistic image by using the Depth and Intensity values. When Surface or Surface Smooth is enabled in Render Mode 1, Shading is enabled in Render Mode 2.
Accept ROI Reviews the 3D image in a fixed ROI area. NOTE: This may be used in Render .
Mix Configure the mix of Render modes 1 and 2. NOTE: For more information about Render mode, please refer to ‘Render Setup’ in ‘3D Utility Menu’.
Th. Low Specify the minimum threshold range. Threshold This option allows you to adjust the threshold value in order to eliminate unnecessary data from images. As the number increases, cyst elements become more apparent. As the number decreases, bone elements become more apparent.
Select Select Post Curve. 6-84

[Page 397]
Position Set the position of the Post Curve selected under Select .
Bias Set the bias of the post curve selected under Select .
Transparency Set the transparency of a 3D image. The lowest value (20) is for complete transparency, and the highest value (250) is for complete opacity.
Reference Slice It moves the Reference Slice in a straight line horizontally. Use the dial-button on the touchscreen. 6-85

[Page 398] 5D Follicle™ This feature measures the sizes of multiple follicles and provides information on their statuses during gynecological exams. NOTE: 5D Follicle™ is an optional feature of this product. 1. Specify the scanning position. Use Position to select either Lt or Rt. 2. Select a measurement method. Measurement will start using the selected method. X Auto: Automatically locates and measures a follicle. X Manual: The user needs to find and measure a follicle manually. 3. When the measurement is finished, its result is shown on the screen. The scanned parts are color-coded and numbered. [Figure 6.29 5D Follicle™ – Touchscreen] 6-86

[Page 399] [Figure 6.30 5D Follicle™]
Edit Results Edit the results of measurement. Press Edit to turn it On or Off. Press Change to select a task to perform. In Edit Mode, the Single and Quad options of Display Format are disabled. „ Slice Review An image can be viewed in multiple slices. You can determine whether there are any follicles that have not been found yet. „ Delete Delete the detected target. 1. Select Change or Delete . 2. Use Set to click the target. 3. The selected target will be deleted from the image and the results table. 6-87

[Page 400] „ Add Seed A measurement target will be added based on the seed positions entered by the user. You can use this when you find a follicle that has not been detected before. 1. Select Change or Add Seed . 2. Click the discovered target by using Set and then use Growth to specify the size. 3. The specified size will be calculated again and displayed in the results table. „ Add Contour A measurement target will be added based on the contours entered by the user. You can use this when you find a follicle that has not previously been detected. 1. Select Change or Add Contour . 2. Specify the contour for the detected target using Set . 3. The specified size will be calculated again and displayed in the results table. „ Growth Specify the size of the target to measure. The button is enabled only when an additional follicle is detected manually using Add Seed in Edit mode. „ Assign Measurement results will be saved to the report. [Figure 6.31 5D Follicle™ Edit – Touchscreen] 6-88

[Page 401] VOCAL (Virtual Organ Computer Aided Analysis) Measure the volume of tissues within the human body. VOCAL is performed in the following order: VOCAL Define → VOCAL Edit → VOCAL [Figure 6.32 VOCAL] VOCAL Define Specify the settings required for VOCAL execution.
Contour Type Select the contour line type. A contour line is automatically created for all types except Manual . „ Solid Used for object data with many echoes. „ General Draw a contour line based on a typical object. This is faster than other automatic contour types, but less accurate. 6-89

[Page 402] „ Prostate Used for prostate data. „ Cystic Used for object data with fewer echoes. „ Sphere After creating a spherical object, edit its contour to make it into the desired shape. „ Manual Create the desired shape of an object manually.
Ref. Image Press the button on the touchscreen to select a reference image among A, B, and C.
Step Angle Set the rotation angle.
Pole Point Move Using Trackball Set the range to perform VOCAL in a reference image. In the reference image, Pole 1 indicates the position of the upper arrow and Pole 2 indicates the position of the lower arrow. Make adjustments using the trackball and Set , or the dial-button on the touchscreen.
Init Pressing Init resets the 3D image’s position. 6-90

[Page 403]
Next Pressing Next starts generating VOCAL data. When the Contour Type is set to Manual 1. Press Next . The Image Position screen will be displayed on the touchscreen. 2. Press Set on an image, and then move the trackball to draw the contour line. X Press Next to move to the next frame. X Press Previous to move to the previous frame. 3. Press Done . Start VOCAL. If you press Done without contouring, VOCAL is performed over a sphere. [Figure 6.33 VOCAL Define – Touchscreen] 6-91

[Page 404] Vocal Edit Once VOCAL data is created, volume information will be displayed on the screen. In VOCAL Edit Mode, you can modify or redraw the existing contour lines.
Shell Mode Set the external surface (shell) of an object based on its contour line. „ Off Do not use Shell Mode. The created contour and the shell overlap. „ Inside The shell is drawn inside the contour generated by the Shell Thick. specified. „ Outside The shell is drawn outside the contour generated by the Shell Thick. specified. „ Symmetric Half the shell is drawn inside the contour and the other half of the shell is drawn outside the contour, with each drawn at half of the Shell Thick. specified.
Image Position Review the contour lines for each frame. Use Previous and Next to move through frames.
Multi Edit Modify more than one contour line at once. If it is turned ‘On’, up to 6 contour lines can be displayed simultaneously on the screen. When there are six or more lines, use MEV (Multi Edit View) Page to navigate through the pages. Use Pole 1 and Pole 2 to edit contour lines. Alternatively, use the trackball and Set . Once the editing is complete, press Exit Multi Edit again to turn it Off. 6-92

[Page 405]
Clear Contour Pressing Clear Contour clears the VOCAL data while keeping the settings, and takes you back to the VOCAL Define step.
New Contour Pressing New Contour moves you from the VOCAL Manual page to the VOCAL Setup page. This button only appears if Contour Type is set to Manual.
Accept Contour Pressing Accept Contour applies changes. The screen will switch to the VOCAL data review screen. [Figure 6.34 VOCAL Edit – Touchscreen] 6-93

[Page 406] VOCAL Optimize VOCAL data for review.
VOCAL Mode Specify how VOCAL data are presented. „ ROI 3D Shows images in the Longitudinal, Transversal, Horizontal planes together with VOCAL data. „ Fixed 3D Shows images in the Longitudinal, Transversal, Horizontal planes, together with 3D images for VOCAL data. „ VCT Shows the actual combinations of images in the Longitudinal, Transversal, Horizontal planes and VOCAL data. Set the Type using VCT Type .
Display Format When you select Single or Quad , the VOCAL data are displayed in full screen. This can be used in every mode. When you press this button again, the display returns to the previous screen.
Ref. Image Select A, B, or C as the reference image. The selected image is highlighted with a blue border. 6-94

[Page 407]
Mode NOTE: This option is available with ROI 3D . Specify how the surface of VOCAL data is presented. X Surface: VOCAL data are represented using the method of expressing the exterior of images by curves. X Wireframe: Represent VOCAL data with dots and lines. 6-95

[Page 408]
Histogram A shell histogram is calculated and displayed on the screen. It represents the gray value distribution within the 2D and Power Doppler images of an object for which VOCAL is performed. It also indicates Mean Gray (MG), Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI). NOTE: Histogram is available only for 2D images and Power Doppler 3D images. Formula for Shell Histogram: X MG: The average value of gray voxel brightness (gray) MG = The sum of brightness (gray)/The total number of voxels X VI: The ratio of color voxels to all voxels within the shell VI = Number of color voxels/Total number of voxels X FI: The average value of brightness (color) for color voxels within the shell FI = Sum of brightness (color)/Total number of color voxels X VFI: The average value of brightness (color) for all voxels within the shell VFI = Sum of brightness (color)/Total number of voxels [Figure 6.35 VOCAL – Touchscreen] 6-96

[Page 409] 3D XI Comprised of a suite of outstanding imaging applications (Multi-Slice View, Oblique View, and XI VOCAL), 3D XI offers precise control over 3D/4D volume data manipulation to improve diagnostic accuracy. X 3D XI (MSV, Oblique View, and XI VOCAL) is an optional feature of this product. X 3D XI is only available when 3D probes are used. MSV (Multi Slice View) An image can be viewed in multiple slices. [Figure 6.36 Multi Slice View] NOTE: Available options are Calculator , Caliper , Text , and Arrow . 6-97

[Page 410]
MSV Screen The images sliced with the thickness value configured under Slice Thick . are displayed on the screen. The ‘Slice Number/Total Number of Slices’ is shown at the bottom of each slice image. The currently selected slice image is indicated by a blue contour. The image information displays the current mode, Ref. Image, and Slice Thick. „ Rotating Image Around X/Y/Z Rotating the Reference Plane affects all the other planes. When the trackball is in Pointer mode, move the trackball near to the X/Y/Z axis of the image. „ Moving X/Y Images Set the trackball in Move Mode, and then move it up/down/left/right. Move the image to the X- and Y-axes on the coordinate system. [Figure 6.37 Multi Slice View – Touchscreen] 6-98

[Page 411]
Display Format Set the layout of slice images. The number of slices that can be displayed simultaneously on the screen varies based on this setting. If the layout is changed, the selected slice image moves to the first position on the screen.
Ref. Image Select a reference image. „ MSV OH When it is turned ‘On’, the A, B, and C planes of the selected slice image will appear on the screen. „ Clear Vision ClearVision removes noise from the image and enhances outlines to help show the image more clearly.
Page Change the page on the screen. This option can be used when the total number of slice images exceeds the number specified in Display Format . Select a page by pressing Previous and Next .
Selected Slice Select a slice image to observe. The selected index is highlighted with a blue border.
Slice Thick Set the cut depth of images. Depending on your selection, the number of indices and pages will vary. NOTE: The Slice Thick value is the slice interval within the volume data, and does not represent actual anatomical locations. 6-99

[Page 412]
Position Set the position of the post curve.
Bias Set the bias of the post curve.
Ruler Set the position of the ruler.
Select Select Post Curve. X The following 3D Utility Menu items are enabled in MSV mode: Orientation Dot, Chroma, 4D Cine, Post Processing, Preset X For more information on 3D Utility, please refer to ‘3D Utility Menu’. 6-100

[Page 413] Oblique View After drawing a straight or curved line in the selected image in MSV Mode, you can study the related oblique image. Usage instructions are as follows: 1. Select Display Format and then specify the number of oblique images for observation. 2. Set the Cut Type . 3. Draw a straight or curved line on a reference image by using the trackball and Set . Start (S) and end (E) points, and an oblique image appear. If the Cut Type is set to Line and the trackball is moving, then you can reposition the line. 4. Optimize the image for observation by using other buttons. X Features such as Text and Indicator can be used. X When the Display Format is 2x1, measurement functions, such as Calculator and Caliper , can be used. [Figure 6.38 Oblique View] 6-101

[Page 414]
Oblique View Screen The reference image selected in MSV Mode is displayed on the screen. The reference image is highlighted with a blue border and is always placed at the top of left corner of the screen. When more than one line is used for observation, each line is indicated by different color and number. The image information displays the current mode, Ref. Image, Oblique Cut Type, and Plumb Size (or Slice Thick.). NOTE: When OVIX is in use, the image information also displays OVIX Line Offset, Mix, Threshold Low, Render Mode 1 or 2, etc. Direction of View of Oblique Image The observer is located perpendicular to the section of a reference image. Please refer to the ‘View Direction’ below: View Direction End Point Start Point Start Point End Point View Direction
Display Format Specify the layout. Depending on this setting, the number of oblique images and the Oblique Cut Type will vary. 6-102

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Cut Type Specify the method of cutting oblique images. „ Line The oblique image of a straight line can be observed. „ Contour The oblique image of a curved line or contour line can be observed. Multi Line & Multi Contour When the Display Format is set to 3x2 or 3x3, you need to turn Auto Increment on to draw two or more lines. „ Parallel The oblique image of a straight line and its parallel lines can be studied. If a straight line is drawn, its parallel lines are automatically shown on the screen. NOTE: This is not available when the Display Format is 2x1. „ Plumb The oblique image of a straight line and its perpendicular lines can be observed. If a straight line is drawn, its perpendicular lines are automatically shown on the screen. NOTE: This is not available when the Display Format is 2x1. „ ClearVision ClearVision removes noise from the image and enhances outlines to help show the image more clearly. 6-103

[Page 416]
Image Rotation Specify the direction of an oblique image. Select the oblique image that you want to change in Selected Slice .
Clear Line Delete the Oblique image.
Selected Slice Select a line on the image. The oblique image of the selected line is indicated by blue contour. NOTE: This is not available when the Display Format is 2x1.
Plumb Size Adjust the length of the vertical line on the image. You can adjust the length in 1 mm increments; the current length is displayed in Image Information. NOTE: This is only used when Cut Type is Plumb.
Slice Thick. Adjust the distance between the vertical lines on the image. You can adjust the length in 1 mm increments; the current length is displayed in Image Information. NOTE: This is used only when the Oblique Cut Type is set to Parallel. 6-104

[Page 417]
Rotate Line Rotate a straight line on the image. When the line is rotated, the oblique image is also changed accordingly. NOTE: This cannot be used when: X Cut Type is Contour; or X When the Selected Slice is Selected Slice Select All.
OVIX (Oblique View eXtended) OVIX sets the cross-sectional thickness of an oblique image to show the image in 3D. When turned ‘On’, an OVIX Line, which indicates the cross-sectional thickness of the oblique image, appears on the reference image. The thickness of the OVIX Line can be adjusted by OVIX Thick. To change the 3D image settings, select and adjust Setting or OVIX Post Curve from the 3D Utility Menu. NOTE: This cannot be used when Cut Type is Contour.
OVIX Thick. Adjust the thickness of OVIX. The 3D image for the set thickness appears.
Select Set the Post Curve value. 6-105

[Page 418]
Init Pressing Init deletes the oblique image and resets the position of Ref. Image at the same time. X The following 3D utility menu items are enabled in Oblique View mode: Orientation Dot, 4D Cine, Post Processing, Render Setup, Chroma, Preset X For more information on 3D Utility, please refer to ‘3D Utility Menu’. [Figure 6.39 Oblique View – Touchscreen] 6-106

[Page 419] XI VOCAL Measure the volume of tissues in 3D XI Mode. NOTE: XI VOCAL is one of the 3D XI features. It is available as an optional feature of this product. [Figure 6.40 XI VOCAL] VOCAL vs XI VOCAL X VOCAL: Measures the volume of an object in a general 3D image. Uses rotating slices. X XI VOCAL: Measures the volume of an object in the selected reference image in MSV Mode. Uses parallel slices. Calculates the volume of an object by cutting it into multiple slices. XI VOCAL is performed in the following order: XI VOCAL Define → XI VOCAL Edit → XI VOCAL. 6-107

[Page 420] XI VOCAL Define Specify how slice and contour lines are retrieved. In the left side of the screen, reference images and slice lines are displayed. Slice images with the start (S) and end (E) points of a slice line are displayed on the right side of the screen. [Figure 6.41 XI VOCAL Define]
Contour Type Select the contour line type. A contour line is automatically created for all types except Manual . „ Solid Used for object data with many echoes. „ Cystic Used for object data with fewer echoes. „ General Draw a contour line based on a typical object. This is faster than other automatic contour types, but less accurate. 6-108

[Page 421] „ Manual Create the desired shape of an object manually. A contour line can be specified in the XI VOCAL Edit screen.
Ref. Image Select A, B, or C as the reference image. The image that is selected will be highlighted with blue borders. „ Ref. Contour When turned ‘On’, you can manually draw a contour line on the reference image using Set and the trackball.
Slice Direction Set the direction of a slice line. Changing the direction of a slice line also changes the slice image displayed on the screen.
Init Resets the positional information of the 3D image.
Start The system will switch to the XI VOCAL Edit screen. NOTE: If the Contour Type is set to Manual, the system switches to the XI VOCAL screen when Next is pressed. 6-109

[Page 422]
# of Slices Specify the number of slice images. Depending on the selected number of images, the interval between slices will vary. [Figure 6.42 XI VOCAL Define – Touchscreen] 6-110

[Page 423] XI VOCAL Edit Specify the contour extraction range or run XI VOCAL. Based on slice lines, slice images and pole points will be displayed on the screen. A pole point is a reference point against which an object contour is extracted. Two pole points appear in each slice image. The selected slice image is marked with blue borders. The ‘Image Number/Total Number of Slice Images’ is shown at the bottom of each image. Reference Image and Slice Line These always appear in the lower right corner of the XI VOCAL Edit screen. They can be useful when the position of a slice image needs to be considered. [Figure 6.43 XI VOCAL Edit] 6-111

[Page 424]
Ref. Page Change the page on the screen.
New Contour Delete the current data and return to the XI VOCAL Define stage.
Accept Contour Apply the changes and perform XI VOCAL. When the Contour Type is set to Manual Before pressing Accept Contour , draw a contour line using Set and the trackball. If you press Accept Contour without drawing a contour line, a general type contour line will be extracted. [Figure 6.44 XI VOCAL Edit – Touchscreen] 6-112

[Page 425] XI VOCAL Optimize XI VOCAL data for review. Slice images with their contour line shown and 3D reference images are displayed. The 3D reference image is highlighted with blue borders, and the calculated volume is shown at the bottom of the image. The current mode is shown in the 3D image information area. 3D Reference Image Use XI VOCAL to display an object for which volume has been obtained in 3D. Use Zoom , Angle/X , PW/y , or Color/z to enlarge or rotate the object for observation.
View All Slice When it is turned ‘On’, all XI VOCAL data, including reference image, slice line, and plane image, appear on the screen simultaneously.
Edit Contour You are returned to the XI VOCAL Edit screen. You can edit the contour line by using the trackball and Set . [Figure 6.45 XI VOCAL – Touchscreen] 6-113

[Page 426] XI STIC (Spatio-Temporal Image Correlation) This option can be used to obtain the fetal cardiac cycle with volume data on the fetal cardiac area, and to recompile the volume data for display. X XI STIC is an optional feature of this product. X XI STIC is only available when 3D probes are used. X This only appears when the Application is set to OB . X When you enter 3D Standby in Fetal Heart Preset, the system will automatically switch to STIC. [Figure 6.46 XI STIC] 6-114

[Page 427]
Acquiring XI STIC Images NOTE: If the motion artifacting is severe, data does not contain the cardiac cycle, or the heart rate cannot be calculated for any other reason, you will be returned to the XI STIC image preparation screen. 1. Select the XI STIC tab in the 3D StandBy screen. 2. Set the various parameters as you would for acquisition of standard 3D images. 3. Press Freeze or Set to start acquisition of 3D images. 4. Check the fetal cardiac cycle calculated on the screen. 5. To continue, cancel Progress or to re-acquire the image, press Discard . 6. You can perform diagnosis by optimizing images. How to Obtain Good STIC Volume Data X Volume Angle: If the size of the fetal heart is small, use a smaller Volume Angle. X ROI Position: Adjust the scan position so that the center of the Volume Angle and the fetal heart are aligned properly. X ROI Box: Adjust the size of the volume box so that it nearly fits the size of the fetal heart.
Volume Angle Set the scan angle.
Scan Time Set the image acquisition time. 6-115

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Trimester Set the pregnancy trimester. Trimester If 1st–3rd are selected, the recommended scan time and STIC angle are automatically set for the specified trimester. Please see the following table: Trimester 1st 2nd 3rd Scan Time 10 seconds 12 seconds 15 seconds Volume Angle 20° 25° 30° If a scan time and Volume Angle other than those shown in the table above are set, the trimester is displayed as User Set. NOTE: For other usage methods, please refer to ‘3D Stand By’.
Reviewing XI STIC Image XI STIC image is played as a Volume Cine; on the left side of the screen, XI STIC information is indicated. Press Freeze to stop Volume Cine. NOTE: During Volume Cine, only MPR, MSV, and Oblique View Modes are available.
Speed Select the playback speed for XI STIC images. This rate is based on the fetal heart rate (100%). 6-116

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Vol. Index Select an index. X This option is only available when Freeze is enabled. X For other usage methods, please refer to ‘3D View ‒ MPR’ and ‘3D XI’. [Figure 6.47 XI STIC – Touchscreen] 6-117

[Page 430] 3D Utility Menu
MagiCut You can cut out the parts that are not relevant to diagnosis from 3D images. Set the area to cut by using the trackball and Set . X Available in MPR Mode only. X If MagiCut is enabled, Accept ROI is turned On automatically. X If you switch to a mode other than MPR Mode after MagiCut is enabled, MagiCut will be disabled. „ Mode X Inside Contour: Cuts the inside of the selected area. X Outside Contour: Cuts the outside of the selected area. X Inside Box: Cuts the inside of the box. X Outside Box: Cuts the outside of the box. X Small Eraser: Cuts the selected contour line. X Big Eraser: Cuts the selected contour line. This uses a thicker contour line than Small Eraser. „ Full Depth When turned ‘On’, the entire area is cut out; when turned ‘Off’, Depth appears on the touchscreen. „ Depth Set the cut depth. „ Undo X Undo: Cancels the last task. X Undo All: Cancels all tasks that have been done so far. 6-118

[Page 431] „ SmoothCut Mode X Erase Small: Enables to use the trackball to rub out the portion you wish to erase. X Erase Big: Removes a larger area. X Recovery Small: Restores the volume image for the desired portion. X Recovery Big: Restores the image in a larger area. „ Mix Configure the mix of Render modes 1 and 2. „ Th.Low Specify the minimum threshold range. [Figure 6.48 MagiCut – Touchscreen] 6-119

[Page 432]
Orientation Dot When this is turned ‘On’, a dot appears at the center of the reference image. NOTE: Only available in MSV and Oblique View Modes.
Render Setup You can specify the image rendering method. It specifies and displays the Render direction and Render mode on the image. X In Oblique View Mode, this option is available only when OVIX is On. X Color and SeeThru. tabs are only available in color 3D Mode. [Figure 6.49 Render Setup – Touchscreen] „ Gray Specify how volume data acquired with the Gray method should be rendered into 3D images. „ Render Direction Used to specify the rendering orientation. ‘+’ indicates the facing direction, and ‘-’ indicates the opposite of the facing direction. 6-120

[Page 433] „ Render Mode 1, 2 Set Render mode 1 and Render mode 2. X Surface: Represents 3D images in the Ray-Casting method, which shows the shell of an image with curved surfaces. X Smooth: Provides 3D images that are smoother than Surface . X Max: Represents 3D images at maximum intensity. It can be useful for observing bone structures in a human body. X Min: Represents 3D images at minimum intensity. It can be useful for observing vessels or hollow parts in a human body. X Light: Represents the depth of 3D images in terms of brightness. X X-Ray: Represents 3D images in terms of average intensity. Provides images that are similar to X-ray images. X AmbientLight: For improved 3D effect, depth, margin expression, and distinction of eyes, nose, and mouth, shading effect is applied on certain areas, such as face and hands/feet of the fetus that will provide better presentation of curves or bumps on the surface. You can change the direction of the light that is applied to the volume by pressing Light Direction . NOTE: You need to press Light Direction and then Move Light in order to enter Trackball mode. NOTE: For more information on other menu items, please refer to ‘Render Setup’. „ Mix Configure the mix of Render modes 1 and 2. „ Th (Threshold).High Specify the maximum range. „ Th (Threshold).Low Specify the minimum range. 6-121

[Page 434] Threshold This option allows you to adjust the threshold value in order to eliminate unnecessary data from images. As the number increases, cyst elements become more apparent. As the number decreases, bone elements become more apparent. „ Th (Threshold).Power Specify the color threshold. As this value increases, more color is removed from an image. Color Specify how the volume data acquired with the Angio/CFM method can be rendered into 3D images. SeeThru. Specify how the combined data of Gray+Angio or Gray+CFM can be rendered into 3D images. „ Transparent-Transparent Adjust the transparency of both gray and color data to view color data as gray data. The parts hidden by gray data may appear slightly darker. „ Transparent-Surface Adjust the transparency of gray data to view color data within the gray data. The parts hidden by gray data may appear slightly darker. „ Max-Transparent Set gray data to ‘Max’ and color data to ‘Transp’ to study color data. The parts hidden by gray data may appear slightly brighter. „ Max-Surface Set gray data to ‘Max’ and color data to ‘Surface’ to study color data. The parts hidden by gray data may appear slightly brighter. „ Inversion This option shows inverted images when the volume data acquired by the gray method is rendered into 3D images. 6-122

[Page 435]
RealisticVue™ RealisticVue™ displays high resolution 3D anatomy with detailed expression and realistic depth perception. User selectable light source direction creates intricately graduated shadows for better defined anatomical structures. NOTE: RealisticVue™ is an optional feature of this product. „ Light Direction You can move the light direction that is applied to the volume. NOTE: Press Move Light to see the trackball mode. „ Set Color Use the dial-button to select the Set Color to apply to RealisticVue™. NOTE: You can configure the color settings by using the Hue , Saturation , and Lightness dial - buttons. [Figure 6.50 RealisticVue™ Setup – Touchscreen] 6-123

[Page 436]
CrystalVue™ CrystalVue™ is an advanced volume rendering technology that enhances visualization of both internal and external structures in a single rendered image using a combination of intensity, gradient and position. X CrystalVue™ is an optional feature of this product. X Available in MPR Mode only. X This feature is enabled in Gray Mode under Render Setup (Render Mode1: Surface, Render Mode2: Smooth), (Render Mode1: Surface, Render Mode2: VSI). This feature is enabled in Inversion Mode under Render Setup (Render Mode1: Surface, Render Mode2: Smooth), (Render Mode1: Surface, Render Mode2: VSI). X You can open RealisticVue™ in CrystalVue™. „ CrystalVue™ Setup Press the button on the touchscreen to select this option. „ Save You can set or edit a Userset that can be used in CrystalVue™. „ Context The volume data area of the selected context is rendered. „ ROI Contour The context information is only displayed as rendered images for the user-defined areas; for other areas, only the surface information is displayed. „ ROI Circle The user selects a circular area for which to show the context information. The context information is only displayed as rendered images for the user-defined circular area; for other areas, only the surface information is displayed. „ Strength At higher Strength Values, the context information becomes clearly visible and turns opaque. At higher Strength values, the image has a wider range of complexity. 6-124

[Page 437] „ Complexity If the Complexity value is 0, only the surface information is displayed; at higher Complexity values, however, the context information is shown as rendered images. „ CrystalVue™ Transparency Set the transparency of the image for which the Context information has been rendered. The lowest value is for complete transparency and the highest value is for complete opacity. „ Circle Type In this mode, select ROI Circle and resize the circular area for which the context information should be displayed. „ Transparency Set the transparency of a 3D image. The lowest value is for complete transparency and the highest value is for complete opacity. [Figure 6.51 CrystalVue™ Setup – Touchscreen] 6-125

[Page 438]
Chroma Specify the color of 2D and 3D images in Chroma Map. [Figure 6.52 Chroma Map – Touchscreen] 6-126

[Page 439]
Post Processing [Figure 6.53 Post Processing – Touchscreen] „ Gradient Mask Adjust the brightness of a specific area in an image. „ Flip Image Inverts the position of an image. NOTE: This option is only available in MSV Mode. It may not be used when OH is set to On, however. „ Clear SFVI (Smart Filter Volume Imaging) It reduces noise. „ Detailed SFVI Set the value by turning the Strength dial-button. „ VC (Volume Compound) Sets the Volume Compound. 6-127

[Page 440] „ Negative Inverts the brightness of an image. „ Auto Contrast Automatically adjusts the contrast of an image. „ Threshold Adjusts the threshold values. „ Sharp If it is turned ‘On’, the boundary of an image will become more apparent. „ 3D CI (Compound Imaging) If it is turned ‘On’, images are composed to reduce noise and enhance image quality. „ Smooth Filter Set the Filter’s blur level. 6-128

[Page 441]
Preset Sets or edits Preset or Userset that can be used in 3D mode. [Figure 6.54 Preset – Touchscreen] „ Default Use the default setting (General Preset) for the probe. „ Load Apply the selected preset to the system and close the Preset screen. „ Save Save the current preset’s details. „ Rename Change the name of the selected Rendering Preset. „ Reset This button is enabled only when the userset is selected. After restoring the Preset to the system default value, exit the Preset screen. However, the location information is not restored. 6-129

[Page 442]
5D NT™ 5D NT™ provides the midsagittal plane view automatically by rotating and magnifying the images when measuring the nuchal translucency (NT) of the fetus in early weeks. X 5D NT™ is an optional feature of this product. X Available in MPR Mode only. Use the trackball to place NT Seed in the NT area and then press Set to display the NT measurement on Plane A. How to Obtain Good Results X You can get better results when the Sagittal View of the fetus is captured as accurately as possible. X The higher the contrast between the fetus’ palate and nasal bone is, the better. X It is preferable to have the lateral direction of the probe be parallel to the body orientation of the fetus. X It is preferable to have the probe’s angle to the fetus’s nasal bone as close to 30 degrees as possible. 6-130

[Page 443] „ Caliper Placement X On to On Cusor Place the cursor on the NT’s inner-inner for measurement. X On to Max Brightness Cusor Place one of the cursors on the outside of NT/IT and measure the inner-outer. This method is useful when harmonic is used and one side of the translucency is blurred. X In to In Cusor Similar to On to On, this method takes measurement with inner-inner, albeit with a narrower cursor interval. „ Items X NT: The acquired A, B, and C plane images and the automatically measured NT are displayed on the 3D View screen. X IT: Locates mid-sagittal view and tests the fetus for spina bifida. „ Assign Include the selected items in the results in the OB report. „ 5D NT™ This function helps the user easily see the NT measurement process. This assigns a certain thickness to the A, B, and C sections of the image and displays a 3D Rendering image. „ Init Resets the position information of the image. 6-131

[Page 444] „ Hide All Pressing this button will hide the marker and the measurements for NT and IT from the screen. „ Auto If it is turned ‘On’, it automatically searches the midsagittal View. To calculate NT, place the cursor on the NT area and press Set . „ Edit Edit markers for each item that is displayed as a result. If the trackball’s state is Cursor, moving the cursor near the a + marker will change the marker’s color from green to orange. When you move the trackball after pressing Set , you can modify the marker as desired. „ ROI Height Adjust the ROI Line’s Height to set the range of application. The ROI Height may be adjusted while measurements are being taken or in Edit mode. „ Marker Size Set the marker size. 6-132

[Page 445] Chapter 7 Measurements ‹ Measurement Accuracy 7-3 Causes of Measurement Errors 7-3 Optimization of Measurement Accuracy 7-5 Measurement Accuracy Table 7-7 ‹ Basic Measurements 7-9 Distance Measurement 7-12 Circumference and Area Measurement 7-21 Volume Measurement 7-24 ‹ Measurements by Application 7-27 Things to Note 7-27 Common Measurement Methods 7-30 OB Measurements 7-33 Fetal Heart Measurements 7-42 Gynecology Measurements 7-45 Cardiac Measurements 7-48 Abdomen Measurements 7-61 Pediatric Hips Measurements 7-63 Urology Measurements 7-65 Small Parts Measurements 7-66 MSK (Musculoskeletal) Measurements 7-70 Vascular Measurements 7-71

[Page 446] Chapter 7 ‹ Report 7-81 View Reports 7-81 Report Preview 7-82 Editing Report (Worksheet) 7-84 Adding Comments 7-86 Printing Reports 7-86 Saving Reports 7-86 Store SR 7-86 Image 7-87 OB Graph 7-88 Description 7-92 Fetus Compare 7-93 Closing Reports 7-93

[Page 447] Measurement Accuracy Measurement values can vary depending on the nature of the ultrasound wave, the body’s response to ultrasound waves, the measurement tools, algorithms, product settings, probe type, and the actions performed by the user. 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 an ultrasound image may be limited by spatial causes. X Errors caused by signal range may be minimized by adjusting the focus settings. Optimizing focus settings increases the resolution of the measurement area. X 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. X Gain has a direct impact on resolution. Gain can be adjusted by using the Gain button for each mode. X In general, the higher the frequency of the ultrasonic waves, the better the resolution.
Pixel Size X This product’s ultrasound images consist of pixels. X 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. X However, this error becomes significant only when a narrow area in an image is measured.
Ultrasound Velocity X The average velocity of ultrasound used for measurement is 1,540 m/s. X The velocity of ultrasound may vary depending on the cell type. X The possible range of error is approximately 2-5% depending on the structure of cells (about 2% for typical cells and about 5% for fatty cells). 7-3

[Page 448]
Doppler Signal Adjustment X During velocity measurement, an error may occur depending on the cosine angle between the blood flow and the ultrasound beam. X For doppler velocity measurements, the most accurate results can be ensured when the ultrasound beam is aligned in parallel with the blood flow. X If that is not possible, the angle between them should be adjusted using the Angle option.
Aliasing X PW Spectral Doppler Mode uses a signal sampling technique to calculate the frequency (or velocity) spectrum. X Adjust the baseline or the velocity scale to minimize aliasing. A lower frequency probe can also be used to reduce aliasing.
Calculation Equation X Some of the calculation equations used for clinical purposes originate from hypotheses and approximation. X All calculation equations are based on medical reports and articles.
Human Error X Human error may occur due to inappropriate use or lack of experience of the product. X This can be minimized through compliance with and thorough understanding of the manuals. 7-4

[Page 449] Optimization of Measurement Accuracy
2D Mode X Resolution is in proportion to the frequency of the probe. X Penetration is inversely proportional to the frequency of the probe. X The highest resolution can be obtained at the focus of the probe where the ultrasound beam is narrowest. X The most accurate measurements can be obtained at the focus depth. As the distance from the focus increases, the beam width increases, which results in lower accuracy. X Using the zoom function or minimizing the depth display makes distance or area measurements more accurate.
M Mode X The accuracy of time measurements can be increased when the sweep velocity and the display format are set to high values. X The accuracy of distance measurements can be increased when the display format is set to a higher value.
Doppler Mode X Using lower frequency ultrasound is recommended for measurement of faster blood flows. X The size of the sample volume is limited by the axial direction of the ultrasound. X Using lower frequency ultrasound increases penetration. X The accuracy of time measurements can be increased when the sweep velocity is increased. X The accuracy of velocity measurements can be increased when the vertical scale is set to smaller values. X It is most important to use an optimal Doppler angle to enhance the accuracy of velocity measurements. 7-5

[Page 450]
Color/Power Doppler Mode X A protocol is not specified for images in Color Doppler Mode or Power Doppler Mode. Therefore, the same limitations imposed on measurements taken in B/W images also apply to the accuracy of measurements taken in Color Doppler and Power Doppler Modes. X Using Color/Power Doppler Mode images to measure accurate blood flow velocity is not recommended. X The amount of blood flow is calculated based on the average velocity rather than the peak velocity. X In all applications, the amount of blood flow is measured in PW Spectral Doppler Mode.
Cursor Position X All measurements are affected by input data. X Adjust the images on the screen so that they are displayed at maximum granularity. X Use the front edge or boundary point of a probe to make the start and end points of a measurement object more distinct. X Make sure that the probe’s direction remains aligned during the measurement. 7-6

[Page 451] Measurement Accuracy Table The following tables show the accuracy of the measurements that can be taken using this 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 distance on a straight line. NOTE: In the event that you doubt the measurements, you can request an accuracy test from your local Samsung Medison Service Department.
2D Mode Accuracy Test Accuracy Measurements Range (Whichever is greater) Methodology Based on Axial Distance < ± 4% or 1 mm Phantom Acquisition Full Screen Lateral Distance < ± 4% or 2 mm Phantom Acquisition Full Screen Area < ± 8% or 4 mm 2 Measurement Equation Full Screen Volume < ± 12% or 8 mm 3 Measurement Equation Full Screen Angle < ± 4% or 1° Measurement Equation Full Screen
M Mode Accuracy Test Accuracy Measurements Range (Whichever is greater) Methodology Based on Time < ± 5% or 1 ms Signal Generator Acquisition 0.01 – 11.3 sec Slope < ± 8% or 4 mm/ms Measurement Equation Full Screen 7-7

[Page 452]
PW/CW Spectral Doppler Mode Doppler Accuracy Test Accuracy Test Range Measurement (Whichever is greater) Methodology Based on PW: 30, 50, 70, 90 cm/sec Velocity < ± 15% Phantom Acquisition CW: 110 cm/sec Signal Time < ± 5% Acquisition 10 ms – 9.44 s Generator Heart Rate < ± 5% or 1 bpm Measurement Equation 1 – 43,200 bpm The accuracy would be ±1 of the least significant digit that is displayed on the screen. (For example, when XX.X mm is displayed, the accuracy is ±0.1 mm; when XX% is displayed, it’s ±1%). 7-8

[Page 453] Basic Measurements Start your measurement using the Caliper button. NOTE: Perform basic measurements of distance and area regardless of the application. For information on measurements for each application, please refer to the ‘Measurements by Application’ section of this chapter. The available measurement methods vary depending on the current Operation mode. Please refer to the following table: Measurement Category Operation Mode Measurement Method Distance Trace Length Open Spline 2D, M, D 3 Points Angle 2 Lines Angle % Stenosis(D) Distance(M) Slope HR(M) Time(M) Velocity Distance Measurement Accel RI Manual Trace Limited Trace HR(D) D VolumeFlow(D) VolumeFlow(A) Time(D) Auto Trace S/D Ratio D/S Ratio V1/V2 Ratio 7-9

[Page 454] Measurement Category Operation Mode Measurement Method Ellipse Circumference and Area Trace 2D, M, D Measurement Closed Spline % Stenosis(A) 1 Dist Volume 2 Dist Volume 3 Dist Volume Volume Measurement 2D, M, D Ellipse Volume Ellipse+Dist.Vol Disk Volume [Table 7.1 Basic Measurements by Operation Mode]
Basic Measurement Operations The following is the information on common button operations for basic measurements: „ Selecting/Changing Measurement Method Select your desired measurement method. The menu items that you can select vary by Operation mode. „ Adjusting Font Size Use Font Size to specify the font size of the measurement results. „ Canceling Measurement Results You can press Delete Last to cancel the measurements currently being made in reverse order. The value displayed in the corresponding application report will also be deleted. „ Specifying Measurement Result Display Position To reposition a measurement result, place the pointer over the measurement result, press Set , move the pointer to the desired position using the trackball, and then press Set again. 7-10

[Page 455] „ Resetting Measurement Result Position Go to Setup > Measurement > General Page, and then change the Position on 2D mode value or Position On D/M mode value in the Result field to reset the position of the measurement results as desired. NOTE: You may select Left-Top , Left-Bottom , Right-Bottom , Right-Top , or Custom . „ Deleting Measurement Results Press Clear to delete measurement items. „ Printing Measurement Results Press the U Key that is set as Store/Print button. NOTE: Under Setup > Customize > Buttons, you can set which functions related to Store/Print to use. „ Exiting Basic Measurement After completing (or canceling) all measurements in progress, press Exit . NOTE: To change measurement units and other settings, select Setup > Measurement > General on the keyboard. 7-11

[Page 456] Distance Measurement There are basic measurements that you can perform in all modes whilst some measurements can only be performed in certain modes. Once the measurement is complete, the result is displayed on the screen.
Distance Specify two points on a 2D image and measure the length of the straight line between the points. 1. Select Distance . Use the trackball and Set to specify both end points of the measurement area. Place the cursor at the desired position and then press Set . Repositioning Point Before pressing Set to specify the point’s position, you can press Change to revert to the previous point’s position. 2. Specify both end points and then the distance between them will be measured.
Trace Length Specify a point on a 2D image and trace a curve from that point to measure its length. 1. Press Trace Length and use the trackball and Set to specify the start point of the measurement area. Place the cursor at the desired position using the trackball and then press Set . 2. Using the trackball, draw the desired curve, and then press Set again to specify the end point. Editing Curves Before specifying the end point by pressing Set , you can erase some parts of the curve being traced by turning the soft menu dial-button [5] counterclockwise. 3. Specify both end points, then the length of the curve will be measured automatically. 7-12

[Page 457]
Open Spline Specify multiple points on a 2D image to measure the length of the resulting Open Spline curve. 1. Press Open Spline and use the trackball and Set to choose as many points as desired. After selecting the last Open Spline point, you can press Set twice to complete the Open Spline measurement. You need to select at least three points in order to complete the Open Spline measurement. 2. The length of the Open Spline curve created with the points you have specified will be calculated and displayed on screen.
3 Point Angle Designate three points on a 2D image and measure the angle formed by the points. 1. Press 3 Point Angle . 2. Specify three points. 3. The angle formed by the three points will be calculated and displayed on the screen.
2 Lines Angle Specify two straight lines on a 2D image to measure the angle between the two lines. 1. Press 2 Lines Angle . 2. Draw two straight lines. To learn how to draw a straight line, please refer to the ‘Distance’ section. 3. The angle between two lines will be calculated and displayed on the screen. When two angles are calculated, the smaller angle is displayed.
% Stenosis(D) (Distance) The diameter of a blood vessel is measured on a 2D image to calculate its stenosis ratio (%). 1. Press % Stenosis(D) . 2. Measure the total diameter of a vessel using the distance measurement method. 3. When the second cursor appears, measure the diameter of the stenosed vessel’s inner wall. 4. It is calculated with the following equation: %Stenosis(D) = (Outer Distance - Inner Distance) / Outer Distance × 100 7-13

[Page 458]
Distance(M) This is a basic measurement that is available in M mode only. Specify two points on an image, and measure the distance between the two points. 1. Press Distance(M) . Specify two points and measure the length of the straight line between the points. Measurement is taken in the same way as ‘Distance’.
Slope This is a basic measurement that is available in M mode only. Specify two points on an image, and measure the velocity between the two points. 1. Press Slope . 2. Specify two points and measure the length of the straight line between the points. Measurement is taken in the same way as ‘Distance’.
HR(M) Place two bars on an image and measure the heart rate between the two bars. 1. Press HR(M) . 2. Use the trackball and Set to select two bars.
Time(M) This is a basic measurement that is available in M mode only. Specify two bars on an image, and measure the time between the two bars. 1. Press Time(M) . 2. Use the trackball and Set to select two bars. 7-14

[Page 459]
Velocity This is a basic measurement that is available in Spectral Doppler mode only. Specify one point on an image, and measure the velocity. 1. Press Velocity . 2. Specify a point. NOTE: In a Spectral Doppler image, the X- and Y-axes represent time and velocity, respectively.
Accel This is a basic measurement that is available in Spectral Doppler mode only. Specify two points on an image, and then measure the distance between the two points as well as the velocity of each point to calculate the time and acceleration. 1. Press Accel . 2. Specify two points and measure the length of the straight line between the points. Measurement is taken in the same way as ‘Distance’.
RI This is a basic measurement that is available in Spectral Doppler mode only. Specify two points on an image, and measure the velocity of each point to calculate the Resistivity Index (RI). 1. Press RI . 2. Specify two points and measure the length of the straight line between the points. Measurement is taken in the same way as ‘Distance’. 7-15

[Page 460]
Manual Trace This is a basic measurement that is available in Spectral Doppler mode only. This is mainly used in cases where Auto Trace or Limited Trace fail. Select the start and end points on the image and draw a line between them while including the EDV so that one cycle can be created. Then, the curve is traced, and the blood flow velocity, average velocity, RI, Pulsatility Index (PI), etc., are calculated. 1. Press Manual Trace . 2. Trace the curve. When the measurement is finished, its result will be shown on the screen. The measurement results displayed will vary, depending on the settings you have selected in Setup > Measurement > Library > Caliper > D > Manual Trace. X PS: Peak Systolic Velocity X MD: Min Diastolic Velocity X ED: End Diastolic Velocity X TAmax: Time Averaged Max Velocity X PI: Pulsatility Index X RI: Resistivity Index X PS/ED: PS ED Ratio X ED/PS: ED PS Ratio 7-16

[Page 461]
Limited Trace This is a basic measurement that is available in Spectral Doppler mode only. Select two bars at the start and end points on the image while including the EDV. Then, the average velocity between the bars, RI, Pulsatility Index (PI), etc., are calculated. 1. Press Limited Trace and select two bars using the trackball and Set . X PS: Peak Systolic Velocity X MD: Min Diastolic Velocity X ED: End Diastolic Velocity X TAmax: Time Averaged Max Velocity X TAMEAN: Time Average Mean Velocity X PI: Pulsatility Index X RI: Resistivity Index X PS/ED: PS ED Ratio X ED/PS: ED PS Ratio X HR 2. It is calculated with the following equation: 7-17

[Page 462]
VolumeFlow(D) This is a basic measurement that is available in Spectral Doppler mode and 2D Image mode. Specify two bars on an image and two points in 2D Image mode. Then, calculate the VolumeFlow. 1. Press VolumeFlow(D) , and then select two bars using the trackball and Set . Measurement is taken in the same way as ‘M Time’. This can only be done in the Loop area. 2. Select two points using the trackball and Set . 2D Image Mode will activate automatically so that you can measure the distance. Measurement is taken in the same way as ‘Distance’.
Time(D) This is a basic measurement that is available in Spectral Doppler mode only. Specify two bars on an image and then calculate the time between the two bars. 1. Press Time(D) . 2. Use the trackball and Set to specify the bar position.
HR(D) This is a basic measurement that is available in Spectral Doppler mode only. Place two bars on an image and measure the heart rate between the two bars. 1. Press HR(D) , and then select two bars using the trackball and Set . 7-18

[Page 463]
Auto Trace Spectrum is traced automatically. 1. Press Auto Trace . 2. The system traces the spectrum automatically. Things to Consider when using Doppler Spectrum Auto Trace The state of a Doppler spectrum may affect measurement results. Please pay attention to the following: X Causes for Trace Failure – If Gain is changed for a Doppler image in 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. X Causes for Inaccurate Peak Trace – If the PRF (Pulse Repetition Frequency) is lower than the velocity at the site being examined, aliasing may occur. If the original signals are separated from aliasing, a Trace can be carried out, but the peak measurement may not be accurate. – If the peak of a spectral waveform is not clear or occurs intermittently, a Trace can be carried out, but the peak measurement may not be accurate. – If the Doppler Gain is set too high or too low, it becomes difficult to distinguish spectra. This may result in measurement error. – If the Wall Filter is set too high, the spectrum will only be partially displayed. In this case, a Trace can be carried out, but Peak measurement may not be accurate. – If abnormal noise or artifacts occurs, a Trace can be carried out, but Peak measurement may not be accurate. 7-19

[Page 464]
S/D Ratio, D/S Ratio This is a basic measurement that is available in Spectral Doppler mode only. Specify two points on an image, measure the velocity at each point, and then calculate the velocity ratio. NOTE: In a Spectral Doppler image, the X- and Y-axes represent time and velocity, respectively. 1. Press S/D . Specify two points and measure the velocity at each point. Measurement is taken in the same way as ‘RI’.
V1/V2 Ratio This is a basic measurement that is available in Spectral Doppler mode only. Specify two points on Spectral Doppler images. Then, the velocity at each point is measured and the velocity ratio is calculated. Note that the velocity ratio is calculated by measuring the V1 and V2 from different Spectral Doppler images. 1. Tap V1/V2 Ratio on the touchscreen. 2. Select one point and then measure its velocity. 3. Press Freeze to switch to diagnosis mode and acquire images. Then, press Freeze again and return to measurement mode. 4. Measure the velocity at the second point. 5. When the measurement is finished, the result will be shown on the screen. 7-20

[Page 465] Circumference and Area Measurement There are basic measurements that you can perform in all modes whilst some measurements can only be performed in certain modes. Once the measurement is complete, the result is displayed on the screen.
Ellipse Measure the circumference and area of circle (ellipse) shaped objects on a 2D image. 1. Press Ellipse , and then specify the diameter (axis) of the measurement area using the trackball and Set . Place the cursor at the desired position using the trackball, and then press Set . Repositioning Point Before pressing Set to specify the point’s position, you can press Change to revert to the previous point’s position. 2. Specify the size of the circle (ellipse). Adjust the size using the trackball, and then press Set . , (a: Half Long axis, b: Half Short axis) Area = , (a, b: Axis) 7-21

[Page 466]
Trace Measure the circumference and area of an irregularly shaped object on a 2D image. 1. Press Trace , and then specify the trace start point on top of the contour of the measurement area using the trackball and Set . Place the cursor at the desired position using the trackball, and then press Set . 2. Trace the curve so that the measurement cursor returns to the start point and then press Set . NOTE: The trace line must be a closed curve. If you press Set before tracing is complete, it will be traced in a straight line from the current position to the starting point, resulting with a significant error. , (N = 1, 2… last point) , (N = 1, 2… last point) Editing Curves Before specifying the end point by pressing Set , you can erase some parts of the curve being traced by turning the soft menu dial-button [5] clockwise. To restore the erased parts of the curve, turn it counterclockwise.
Closed Spline Specify multiple points on a 2D image to measure the circumference and area of the resulting closed spline. 1. Press Closed Spline and use the trackball and Set to choose as many points as the user desires. After selecting the last Spline point, press Set twice to complete the Spline measurement. You need to select at least three points in order to complete the Spline measurement. 7-22

[Page 467]
% Stenosis(A)(Area) The area of a blood vessel is measured on a 2D image to calculate its stenosis ratio (%). 1. Press % Stenosis(A) . Measure the area of outer vessel walls using the ‘Ellipse’ measurement method. 2. When the second cursor appears, measure the area of the stenosed vessel’s inner wall. Follow the same measurement method as the ‘Trace Measurement Method.’ %Stenosis(A) = (Outer Area – Inner Area) / Outer Area × 100
VolumeFlow(A) This is a basic measurement that is available in Spectral Doppler mode and 2D Image mode. Specify two bars on an image and an ellipse in 2D Image mode. Then, calculate the VolumeFlow. 1. Press VolumeFlow(A) , and then select two bars using the trackball and Set . Measurement is taken in the same way as ‘M Time’. This can only be done in the Loop area. 2. Use the trackball and Set to select an ellipse. 2D Image mode will activate automatically so that you can measure the ellipse. Measurement is taken in the same way as ‘Ellipse’. 7-23

[Page 468] Volume Measurement There are basic measurements that you can perform in all modes whilst some measurements can only be performed in certain modes. Once the measurement is complete, the result is displayed on the screen. NOTE: Since Dual mode displays two images on the screen at the same time, you don’t have to return to the Operation mode to measure volume.
1 Distance Volume Measure the volume of an object by using only one straight line on a 2D image. 1. Press 1 Distance Volume to specify two points. Then, measure the straight length between the two points. Measurement is taken in the same way as ‘Distance’. 2. The volume (Vol.) will be calculated along with the length of the line. , (D: distance)
2 Distance Volume This is a basic measurement available in all Operation modes. Measure an object’s volume using two straight lines on an image. 1. Press 2 Distance Volume to specify two points. Then, measure the straight line between the two points. Measurement is taken in the same way as ‘Distance’. 2. Measure the length of the last remaining straight line using the same method as above. 3. The volume (Vol.) will be calculated along with the length of each line. 4. It is calculated with the following equation: D1 > D2 , , (D: distance) 7-24

[Page 469]
3 Distance Volume This is a basic measurement available in all Operation modes. Measure the volume of an object by using three straight lines on the image. 1. Press 3 Distance Volume to specify two points. Then, measure the straight line between the two points. Measurement is taken in the same way as ‘Distance’. 2. Measure the length of the remaining two straight lines using the same method as above. 3. The volume (Vol.) will be calculated along with the length of each line. 4. It is calculated with the following equation: , (D: distance)
Ellipse Volume Measure the volume of a cone-shaped object by using one circle (ellipse) on a 2D image. 1. Press Ellipse Volume to set the size of the circle (ellipse). Measurement is taken in the same way as ‘Ellipse’. 2. It is calculated with the following equation:
Ellipse+Dist Vol. This is a basic measurement available in all Operation modes. Measure the volume of an object by using one straight line and one circle (ellipse) on a 2D image. 1. Press Ellipse+Dist Vol. to set the size of the circle (ellipse). Measurement is taken in the same way as ‘Ellipse’. 2. Specify two points and measure the length of the straight line between the points. Measurement is taken in the same way as ‘Distance’. 7-25

[Page 470]
Disk Volume This is a basic measurement available in all Operation modes. Calculate the volume of an irregularly shaped object by measuring the area and the length of its long axis on a 2D image. 1. Press Disk Volume and draw a contour for the measurement area. Measurement is taken in the same way as ‘Trace’. 2. Measure the length (L) of the long axis. Measurement is taken in the same way as ‘Distance’. X D: Length of a straight line X Area: Area of a circle X Volume: Volume 3. It is calculated using the following formula: , (D: diameter of the circle; L: length of the major axis) D L Editing Curves Before specifying the end point by pressing Set , you can delete a part of the curve being traced by rotating the soft menu dial-button [5] counterclockwise. 7-26

[Page 471] Measurements by Application Use Calculator button to start the measurement. Things to Note
Before Starting Measurement „ Registering the Patient Make sure the current information about the registered patient is correct. If the patient is not registered yet, then press Patient and register the patient. Use the Study Information tab to enter or change a patient’s information according to the diagnosis item. For more information about the Patient Information menus and information input methods, please refer to ‘Patient Information’ in ‘Starting Modes of Operation’ in this user manual. „ Checking the Probe, Application, and Preset Check the name of the probe and the application displayed in Title area. To change to other probes or applications, check the preset settings on the Probe screen. „ Setting the Application Measurement Menus Set the related menus for convenient measurement. The measurement method for each item is the same as for basic measurement. Measured items are automatically entered into the report. For information on the measurement-related menus and setup methods, please refer to ‘Measurement Settings’ in ‘Utilities’ of this manual. 7-27

[Page 472]
Measurement Operations „ Change of Measurement Method Press Change . If the current measurement may be taken in more ways than one, the measurement method may be changed. The current measurement method will be displayed in the User Information area. Once measurement starts, the method cannot be changed. „ Deleting Trace Line Move the trackball in the opposite direction to delete the traced line. It can be deleted only when ‘Manual Trace’ is used to measure the Doppler spectrum. „ Deleting Measurement Results Press Clear . NOTE: The measurement results are deleted from the screen, but still shown on the report for the corresponding application. „ Printing Measurement Results Press the button that you have set as Store/Print . „ Exiting Measurement Press Calculator one more time, or press Exit . „ Finishing Diagnosis Press End Exam . The exam for the currently registered patient ends and all measurement results are saved. „ Fetus Press Fetus , turn the dial-button [1], and then select A , B , C , or D as the fetus that you need to measure. „ Direction Press Direction , turn the dial-button [2], and then select your measurement target’s position. This is available in specific packages only. 7-28

[Page 473] „ Location Press Location , turn the dial-button [3], and then select your measurement target’s position. „ Trace Direction Select the trace direction of the Doppler spectrum. This is activated only after Auto or Limited Trace has been performed in Spectral Doppler mode. X Up: Only the + part of the doppler waveform is traced. X Down: Only the – part of the doppler waveform is traced. X All: All parts of the doppler waveform are traced. „ Measured Frame Save the frame that has been measured. You can turn the knob button to move to the measured frame. „ Sensitivity Adjust how much weak signal should be eliminated during trace measurements in Spectral Doppler mode. „ HR Cycle Select the number of heart rate (HR) cycles. This is enabled only when ‘HR’ is selected as the measurement item. „ Specifying Measurement Result Position Place the pointer over a measurement result and press Set . To reposition a measurement result, use the trackball and press Set at the desired position. „ Deleting a Recent Measurement Item Press Delete Last to cancel the last measurement. „ Report Switches to the Report screen. 7-29

[Page 474] Common Measurement Methods
Measurements in Spectral Doppler Mode In general, if you trace a doppler spectrum, you obtain results for various measurement items automatically. Three methods are available. Once the tracing is complete, the measurement results appear on the screen. „ Auto Trace Spectrum is traced automatically. This is enabled in the measurement menu in Spectral Doppler mode. „ Limited Trace Specify a measurement range and trace a spectrum within the range automatically. This is enabled in the measurement menu in Spectral Doppler mode. 1. A bar appears that specifies the range. Use the trackball to place the bar at the desired location and press Set to specify the range. 2. The system traces spectrums within the specified range automatically. „ Manual Trace A spectrum is traced manually. This is enabled in the measurement menu in Spectral Doppler mode. The measurement cursor appears on top of the spectrum and begins tracing. Measurement method is the same as that for ‘D Trace’. „ Measurement by Item 1. After obtaining the desired image, press Calculator. 2. Select the item you want from the Measurement menu. The + cursor will appear over the spectral waveform. 3. Position the + cursor and then press Set . 7-30

[Page 475] 4. The measurement results for the selected item are displayed on the screen. Item Category Unit Formula PS (Peak Systolic Velocity) Velocity cm/s or m/s ED (End Diastolic Velocity) Velocity cm/s or m/s MD (Minimum Diastole Velocity) Velocity cm/s or m/s PI (Pulsatility Index) Calculation Ratio (PS-ED)/TAMAX RI (Resistivity Index) Calculation Ratio (PS-ED)/PS or (PS-MD)/PS PS/ED (Ratio of PS to ED) Calculation Ratio PS/ED ED/PS (Ratio of ED to PS) Calculation Ratio ED/PS TAMAX (Time Average Max Velocity) Velocity cm/s or m/s TAMEAN (Time Average Mean Velocity) Velocity cm/s or m/s Taking measurements via AutoCalc X You can use AutoCalc to take measurements on predetermined items. X For information on setting measurement item(s), please refer to ‘AutoCalc’ in ‘Utilities’.
Volume Flow Measurement This can be calculated by measuring an area or distance. To learn how to measure a distance or area, please refer to the ‘Basic Measurement’ section. The TAmean (Time Avg. Mean Velocity) value is measured automatically. „ Vesl. Area (Vessel Area) Measure the area of a blood vessel to calculate TAmean and Volume Flow. „ Vesl. Dist. (Vessel Distance) Measure the width of a blood vessel to calculate TAmean and volume flow. 7-31

[Page 476]
Stenosis Measurement You can assess the narrowing of a blood vessel (stenosis) by measuring and calculating its area or distance. „ % Stenosis(A) (Stenosis Area) Measures the area of the inner wall and the outer wall of the blood vessel. 1. Select the % Stenosis(A) 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 stenosed vessel’s inner wall. % Stenosis(A) = (Outer Area – Inner Area) / Outer Area × 100 „ % Stenosis(D) (Stenosis Distance) Measure the diameter of the blood vessel. 1. Select the % Stenosis(D) menu. Then, the first cursor appears in 2D mode. 2. Measure the total diameter of a vessel using the distance measurement method. 3. When the second cursor appears, measure the diameter of the stenosed vessel’s inner wall. 4. It is calculated with the following equation: % Stenosis(D) = (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 from the Measurement menu. A bar appears, with which you can specify the range. 2. Specify the measurement range. X Place the bar at the desired position using the trackball, and press Set . X Enter the number of cycles during the set period of time within the measurement range. 3. The system then automatically measures the heart rate per minute within the measurement range. 7-32

[Page 477] OB Measurements X Ductus Venosus and Fetal HR can be measured in Doppler mode only. X For references on measurement items, please refer to the ‘Reference Manual’.
Before Taking OB Measurements „ OB Basic Information OB information required includes LMP (Last Menstrual Period) and Gestations. Once you enter an LMP, the EDD (Estimated Delivery Date) and GA (Gestational Age) are filled out automatically. An LMP value is required for the calculation of values, such as the EDD and SD, in OB measurements. X EDD(LMP) = LMP + 280days X GA(LMP) = Current System Date – LMP X LMP = Ovul. Date – 14 Once you enter an EDD, a GA (EDD) is filled out automatically. Once you enter a DOC, the EDD and GA are filled out automatically. Once you enter a GA, the EDD (GA) is filled out automatically. You can enter a maximum of four fetuses in the Fetuses No. field. If it’s left blank, the number is deemed to be ‘1’. In the case of twins, enter ‘2’. For more information about other Patient Information menus and information input methods, please refer to ‘Patient Information Entry’ in ‘Starting Modes of Operation’ of this manual. 7-33

[Page 478] „ Setting OB Measurement Menu Set the GA Equation, GA Table, and OB measurement menus that are used in obstetrics measurements. The user can manually write, back up, or restore GA Tables. For more information on the GA Equation and Table, please refer to the ‘Reference Manual’. NOTE: For twins, distinguish fetuses by specifying them as Fetus A and Fetus B in the Measurement menu. Either click Fetus displayed at the top of the left menu or rotate the dial-button [1] to select the fetus to measure among A , B , C , or D . For more information on measurement-related menus and configuration method, please refer to ‘Measurement Settings’ in ‘Utilities’.
1 Trim. Measurement Menu 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 entered into the report. GS All Distance Measurement cm YS All Distance Measurement cm MSD All Distance Measurement cm Fetal Biometry CRL All Distance Measurement cm BPD All Distance Measurement cm FL All Distance Measurement cm AC All Circumference Measurement cm NT All Distance Measurement mm Fetal Cranium IT All Distance Measurement mm NB All Distance Measurement cm D Vmax PW Velocity Measurement cm/s Ductus Venosus A Vmax PW Velocity Measurement cm/s TAmax PW Velocity Measurement cm/s Fetal HR PW Heart Rate bpm Fetal HR Fetal HR PW, M Heart Rate bpm 7-34

[Page 479]
Automatic Calculation Some items in the measurement menu are automatically calculated based on measurements of other items. „ Measurement by Item Each chosen item’s measurement result is calculated automatically using the corresponding formula as follows: Item Category Unit Formula S/D (Ratio of PSV to EDV) Calculation Ratio |S/D| D/S (Ratio of EDV to PSV) Calculation Ratio |D/S| S/a (Ratio of PSV to Atrial Velocity) Calculation Ratio |S/a| RI (Resistivity Index) Calculation Ratio |(S-D)/S| PI (Pulsatility Index) Calculation Ratio |(S-a)/TAmax| PLI (Preload Index) Calculation Ratio |(S-a)/S| PVIV (Peak Velocity Index for Veins) Calculation Ratio (S-a)/D NOTE: For reference, the Osaka University/Tokyo University methods are mainly used in Asia, the Merz method in Europe, and the Shepard/Hadlock methods on the American continent. 7-35

[Page 480]
2-3 Trim. Measurement Menu 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 entered into the report. GS All Distance Measurement cm CRL All Distance Measurement cm YS All Distance Measurement cm MSD All Distance Measurement cm BPD, OFD All Continuous Measurement BPD All Distance Measurement cm OFD All Distance Measurement cm BPD, HC All Continuous Measurement HC All Circumference Measurement cm APAD, TAD All Continuous Measurement Fetal Biometry APAD All Distance Measurement cm TAD All Distance Measurement cm AC All Circumference Measurement cm FTA All Area Measurement cm 2 FL All Distance Measurement cm SL All Distance Measurement cm APTD, TTD All Continuous Measurement APTD All Distance Measurement cm TTD All Distance Measurement cm ThC All Circumference Measurement cm EFW All - - 7-36

[Page 481] HL All Distance Measurement cm ULNA All Distance Measurement cm TIB All Distance Measurement cm Fetal Long Bones RAD All Distance Measurement cm FIB All Distance Measurement cm CLAV All Distance Measurement cm LV All Distance Measurement cm NT All Distance Measurement mm IT All Distance Measurement mm NB All Distance Measurement cm NF All Distance Measurement cm CEREB All Distance Measurement cm Fetal Cranium CM All Distance Measurement cm Lat Vent All Distance Measurement cm OOD All Distance Measurement cm IOD All Distance Measurement cm HW All Distance Measurement cm FMF angle All Angle Calculation degree Foot All Distance Measurement cm Ear All Distance Measurement cm Lt. Fetal Others MP All Distance Measurement cm Rt. Fetal Others Renal L All Distance Measurement cm Renal AP All Distance Measurement cm Pelvis All Distance Measurement cm Q1 All Distance Measurement cm Q2 All Distance Measurement cm AFI Q3 All Distance Measurement cm Q4 All Distance Measurement cm MVP All Distance Measurement cm 7-37

[Page 482] ThD ap All Distance Measurement cm ThD trans All Distance Measurement cm HrtD ap All Distance Measurement cm CTAR HrtD trans All Distance Measurement cm ThA All Area Measurement cm 2 HrtA All Area Measurement cm 2 Cervix L All Distance Measurement cm Maternal Others Placenta Thick All Distance Measurement cm PLI D Vmax PW Velocity Measurement cm/s Umbilical A Auto Trace PW Doppler Spectrum Trace Lt. Mid Cereb A Rt. Mid Cereb A Lt. Uterine A Rt. Uterine A Placenta A ED PW Velocity Measurement cm/s Lt. Fetal Carotids Rt. Fetal Carotids Fetal Aorta Lt. Renal A Rt. Renal A S/D PW Continuous Measurement Calculation after TAmean, VF(D) PW ml/min Vesl., and Dist. Measurements VF(A) PW ml/min Fetal HR Fetal HR M, PW Heart Rate bpm 7-38

[Page 483] D Vmax PW Velocity Measurement cm/s Ductus Venosus TAmax PW Velocity Measurement cm/s
AFI (Amniotic Fluid Index) Measure the amniotic fluid index. 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. To obtain a specific image from each quadrant, press Freeze and then switch to an Operation mode. After obtaining the image, press Freeze again and return to the measurement mode.
Calculating Estimated Fetal Weight (EFW) When measurements for the following items are complete, the system uses the results to calculate the estimated fetal weight automatically. For the formula for calculating fetal weight, please refer to the ‘Estimated Fetal Weight Formula’ section in ‘Reference Manual’. X BPD and AC X AC and FL X BPD, FL and FTA X BPD, AC and FL X BPD, APTD, TTD, and FL X HC, AC and FL X BPD, APTD, TTD, and SL X BPD, HC, AC and FL X BPD and TTD X AC X BPD, FL, APAD, and TAD X AC and HC 7-39

[Page 484]
Continuous Measurements for EFW Calculation & Review of EFW Calculation Results You can measure a series of OB items to calculate the EFW. Before starting measurement: 1. Make sure that the User Key has been set for EFW continuous measurements. You can configure the User Key for EFW continuous measurements at Setup > Customize > Buttons > User Key > EFW Measure . For more information, please refer to ‘Peripheral Device Settings’ in ‘Utilities’ of this manual. 2. Check EFW reference. If not selected or wish to change EFW, select it in Setup > Measurement > Author > Estimated Fetal Weight . „ Measurement Method 1. Press the button assigned for EFW Measure function. The OB Measurement menu will be displayed on the screen. 2. Use the trackball and Set to perform a measurement. 3. Use the trackball and Set to start the next measurement. 4. Once all measurements have been taken, the EFW is displayed on the screen. 7-40

[Page 485] The EFW measurements taken and the order in which they are measured are as follows: Reference Measure Item (by Order) Campbell AC Hadlock AC→BPD Hadlock1 AC→FL Hadlock2 BPD→AC→FL Hadlock3 HC→AC→FL Hadlock4 BPD, HC→AC→FL Hansmann BPD→TTD INTERGROWTH-21st AC→HC Merz BPD→AC Osaka BPD→FL→FTA Persson BPD→FL→APAD→TAD Schild HC→AC→FL Shepard AC→BPD Shinozuka1 BPD→FL→AC Shinozuka2 BP→APTD, TTD→SL Shinozuka3 BPD→APTD, TTD→FL Tokyo BPD→APTD, TTD→FL „ Review the Result of EFW Calculation 1. Press the button assigned for EFW the Result function. The measured items taken for calculating EFW will be displayed on the screen together with the result. 2. To remove measurement results from the screen, press Clear . NOTE: For more information on adding measurement menus, please refer to ‘Utilities’. 7-41

[Page 486] Fetal Heart Measurements X For references on measurement items, please refer to the ‘Reference Manual’. LVEDV A2C All Dist 20 ml LVESV A2C All Dist 20 ml LV Vol. (Simpson) LVEDV A4C All Dist 20 ml LVESV A4C All Dist 20 ml Asc Ao All Distance Measurement cm MPA Diam All Distance Measurement cm Duct Art All Distance Measurement cm LA Diam All Distance Measurement cm RA Diam All Distance Measurement cm RVDd All Distance Measurement cm 2D Echo IVS All Distance Measurement cm LVIDd All Distance Measurement cm LVIDs All Distance Measurement cm LVPW All Distance Measurement cm HrtC All Circumference Measurement cm ThC All Circumference Measurement cm ThD ap All Distance Measurement cm ThD trans All Distance Measurement cm HrtD ap All Distance Measurement cm CTAR HrtD trans All Distance Measurement cm ThA All Area Measurement cm 2 HrtA All Area Measurement cm 2 Fetal HR Fetal HR PW, M Heart Rate bpm 7-42

[Page 487] IVSd M Distance Measurement cm LVIDd M Distance Measurement cm LVIDs M Distance Measurement cm M Echo LVPWd M Distance Measurement cm IVSs M Distance Measurement cm LVPWs M Distance Measurement cm RVDd M Distance Measurement cm MPA Duct Artriosus IVC ED PW Velocity Measurement cm/s Asc Aorta Dsc Aorta S/D PW Continuous Measurement Duct Venosus D Vmax PW Velocity Measurement cm/s E PW Velocity Measurement cm/s MV A PW Velocity Measurement cm/s TV Vmax PW Velocity Measurement cm/s PLI D Vmax PW Velocity Measurement cm/s TST PW Time Measurement ms TEI ET PW Time Measurement ms 7-43

[Page 488] „ CTAR (Cardo-Thorax Area Ratio) This measurement compares the size of the fetus’ heart in relation to the size of its thorax. ThD ap, ThD trans, HrtD ap, and HrtD trans values are acquired to obtain the comparative value. 7-44

[Page 489] Gynecology Measurements X For references on measurement items, please refer to the ‘Reference Manual’.
Before Taking GYN Measurements Enter the information required for GYN diagnosis in the Patient Information window. Basic information for gynecology includes Gravida, Para, Aborta, and Ectopic.
Measurement Menu Most of the gynecology measurements are distance measurements and volume measurements based on the distance measurement results. If multiple images, such as long axis images and transverse axis images, are needed, press Freeze to switch to Scan mode, and then obtain images from another perspective. Uterus Endo.Thick All Distance Measurement cm Cervix Lt. Cyst Rt. Cyst Width All Distance Measurement cm Lt. Ovary Rt. Ovary 7-45

[Page 490] Follicle #1 All Volume Measurement ml Follicle #2 All Volume Measurement ml Follicle #3 All Volume Measurement ml Follicle #4 All Volume Measurement ml Follicle #5 All Volume Measurement ml Follicle #6 All Volume Measurement ml Follicle #7 All Volume Measurement ml Follicle #8 All Volume Measurement ml Follicle #9 All Volume Measurement ml Lt. Follicle Follicle #10 All Volume Measurement ml Rt. Follicle Follicle #11 All Volume Measurement ml Follicle #12 All Volume Measurement ml Follicle #13 All Volume Measurement ml Follicle #14 All Volume Measurement ml Follicle #15 All Volume Measurement ml Follicle #16 All Volume Measurement ml Follicle #17 All Volume Measurement ml Follicle #18 All Volume Measurement ml Follicle #19 All Volume Measurement ml Follicle #20 All Volume Measurement ml 7-46

[Page 491] Lt. Ovarian A Manual Trace PW Doppler Spectrum Trace Rt. Ovarian A Lt. Uterine A Rt. Uterine A Pericystic Endometrial PI PW Velocity Measurement - Calculation After TAmean, Vesl., and Dist. Measurements Calculation After TAmean and Vesl. Area Measurements Mass1 Mass2 Auto Trace PW Doppler Spectrum Trace Mass3 Limited Trace PW Doppler Spectrum Trace Endo. Polyp Lt. Ovarian Mass Rt. Ovarian Mass Uterine Fibroid1–12 ED PW Velocity Measurement cm/s Cervical Fibroid MD PW Velocity Measurement cm/s Ectopic 7-47

[Page 492] Cardiac Measurements NOTE: Cardiac measurement is an optional item. The measurement method for each item is the same as for basic measurement. Measured items are automatically entered into the report. X For references on measurement items, please refer to the ‘Reference Manual’.
Measurement Menu All LVd (2D) All Continuous Measurement IVSd All Distance Measurement cm LVIDd All Distance Measurement cm LVPWd All Distance Measurement cm LV (2D) All LVs (2D) All Continuous Measurement IVSs All Distance Measurement cm LVIDs All Distance Measurement cm LVPWs All Distance Measurement cm LV(2D)HR All Heart Rate bpm 7-48

[Page 493] RVAWd All Distance Measurement cm RVIDd All Distance Measurement cm RVAd All Area Measurement cm 2 RVAWs All Distance Measurement cm RV (2D) RVIDs All Distance Measurement cm RVAs All Area Measurement cm 2 RV Major All Distance Measurement cm RV Minor All Distance Measurement cm All LV/RV (M) M Continuous Measurement All LV (M) M Continuous Measurement LV EF(M) M Continuous Measurement IVSd M Distance Measurement cm LVIDd M Distance Measurement cm LVPWd M Distance Measurement cm IVSs M Distance Measurement cm LV (M) LVIDs M Distance Measurement cm LVPWs M Distance Measurement cm LVET M Time Measurement ms LVPEP M Time Measurement ms LV(M) HR M Heart Rate bpm Time Sept to PW M Time Measurement ms MAPSE M Distance Measurement cm 7-49

[Page 494] All RV (M) M Continuous Measurement RVAWd (M) M Distance Measurement cm RVIDd (M) M Distance Measurement cm RVAWs (M) M Distance Measurement cm RV (M) RVIDs (M) M Distance Measurement cm RVPEP M Time Measurement ms RVET M Time Measurement ms TAPSE M Distance Measurement cm LVEDV A2C All Dist 20 ml LVESV A2C All Dist 20 ml LV Vol. (Simpson) LVEDV A4C All Dist 20 ml LVESV A4C All Dist 20 ml BP HR All Heart Rate bpm LVEDV A2C AL All Dist 20 ml LVESV A2C AL All Dist 20 ml HR A2C All Heart Rate bpm LV Vol. (A/L) LVEDV A4C AL All Dist 20 ml LVESV A4C AL All Dist 20 ml HR A4C All Heart Rate bpm LVAd SAX MV All Area Measurement cm 2 LVAs SAX MV All Area Measurement cm 2 LV Vol. (Bullet) LVLd Apical All Distance Measurement cm LVLs Apical All Distance Measurement cm HR Bullet All Heart Rate bpm 7-50

[Page 495] All LV Mass All Continuous Measurement - LVAd SAX PM Epi All Area Measurement cm 2 LVAd SAX PM All Area Measurement cm 2 LV Mass LVLd apical All Distance Measurement cm LV TE a All Distance Measurement cm LV TE d All Distance Measurement cm Ao Diam (2D) All Distance Measurement cm Ao Diam(M) M Distance Measurement cm Asc Ao Diam All Distance Measurement cm Desc Ao Diam All Distance Measurement cm Aorta Ao Arch Diam All Distance Measurement cm Ao Isth Diam All Distance Measurement cm Ao ST Junct Diam All Distance Measurement cm Ao Sinus Diam All Distance Measurement cm All LA Vol. All Continuous Measurement LA/Ao (2D) All Distance Measurement cm LA Diam (2D) All Distance Measurement cm LA/Ao(M) M Distance Measurement cm LA/Diam(M) M Distance Measurement cm LA LA Major All Distance Measurement cm LA Minor All Distance Measurement cm LAAd A2C All Area Measurement cm 2 LAAs A2C All Area Measurement cm 2 LAAd A4C All Area Measurement cm 2 LAAs A4C All Area Measurement cm 2 LAEDV A2C All Dist 20 ml LAESV A2C All Dist 20 ml LA Vol. (Simpson) LAEDV A4C All Dist 20 ml LAESV A4C All Dist 20 ml 7-51

[Page 496] RA Diam(2D) All Distance Measurement cm RA Major All Distance Measurement cm RA Minor All Distance Measurement cm RA RAAd All Area Measurement cm 2 RAAs All Area Measurement cm 2 RAEDV All Dist 20 ml RAESV All Dist 20 ml LVOT LVOT Diam All Distance Measurement cm LVOT Vmax PW Velocity Measurement cm/s LVOT VTI PW Doppler Spectrum Trace cm LOVT HR PW Heart Rate bpm RAEDV A2C All Dist 20 ml RAESV A2C All Dist 20 ml RA Vol. (Simpson) RAEDV A4C All Dist 20 ml RAESV A4C All Dist 20 ml RVOT RVOT Diam All Distance Measurement cm RVOT Vmax PW Velocity Measurement cm/s RVOT VTI PW Doppler Spectrum Trace cm RVOT HR PW Heart Rate bpm AV Auto Trace PW Doppler Spectrum Trace AV Limited Trace PW Doppler Spectrum Trace AV AV Manual Trace PW Doppler Spectrum Trace AV Cusp All Distance Measurement cm 7-52

[Page 497] AV Cusp(M) M Distance Measurement cm AV Diam All Distance Measurement cm AVA Planimetry All Area Measurement cm 2 Q to AV Open M Time Measurement ms AV Vmax PW Velocity Measurement cm/s AV PHT PW Time Measurement ms AV VTI PW Doppler Spectrum Trace cm AV AccT PW Time Measurement ms AV ET PW Time Measurement ms AV AccT/ET PW Continuous Measurement AV DecT PW Time Measurement ms Desc. Ao Vel. PW Velocity Measurement cm/s AV Acc PW Velocity Measurement cm/s 2 AR Auto Trace PW Doppler Spectrum Trace AV AR Limited Trace PW Doppler Spectrum Trace AR Manual Trace PW Doppler Spectrum Trace AR VCW All Distance Measurement cm AR Vmax PW Velocity Measurement cm/s AR ed Vmax PW Velocity Measurement cm/s AR PHT PW Time Measurement ms AR VTI PW Doppler Spectrum Trace cm AR AccT PW Time Measurement ms AR DecT PW Time Measurement ms AR PISA Rad C PISA-Radius cm AVO PW Time Measurement ms AVC PW Time Measurement ms AR Jet Diam All Distance Measurement cm AR Jet Area All Area Measurement cm 2 AR Acc PW Velocity Measurement cm/s 2 7-53

[Page 498] All MV(M) M Continuous Measurement - MV D-E M Distance Measurement cm MV E-F Slope M Velocity Measurement cm/s MV A-C Interval M Time Measurement ms MV EPSS M Distance Measurement cm MV Vp M Velocity Measurement cm/s MV Ann Diam All Distance Measurement cm MV Diam1 All Distance Measurement cm MV Diam2 All Distance Measurement cm MVA Planimetry All Area Measurement cm 2 MV Auto Trace PW Doppler Spectrum Trace MV Limited Trace PW Doppler Spectrum Trace MV Manual Trace PW Doppler Spectrum Trace MV E-DT-A PW Continuous Measurement MV MV E/A PW Continuous Measurement - MV Peak E PW Velocity Measurement cm/s MV Peak A PW Velocity Measurement cm/s MV VTI PW Distance Measurement cm MV Vmax PW Velocity Measurement cm/s MV PHT PW Time Measurement ms MV AccT PW Time Measurement ms MV DecT PW Time Measurement ms MV A Dur PW Time Measurement ms MV ET PW Time Measurement ms MV Acc PW Velocity Measurement cm/s 2 MR Auto Trace PW Doppler Spectrum Trace MR Limited Trace PW Doppler Spectrum Trace MR Manual Trace PW Doppler Spectrum Trace 7-54

[Page 499] MR VCW All Distance Measurement cm MR Vmax PW Velocity Measurement cm/s MR VTI PW Doppler Spectrum Trace cm MR dp/dt PW Continuous Measurement mmHg/s MV MV IVRT M, PW Time Measurement ms MR PISA Rad C PISA-Radius cm MV HR PW Heart Rate bpm E/E’ PW Continuous Measurement TV D-E M Distance Measurement cm TV E-F Slope M Velocity Measurement cm/s TV A-C Interval M Time Measurement ms TV Auto Trace PW Doppler Spectrum Trace TV Limited Trace PW Doppler Spectrum Trace TV Manual Trace PW Doppler Spectrum Trace TV Ann Diam All Distance Measurement cm, mm TV Diam1 All Distance Measurement cm TV Diam2 All Distance Measurement cm TV TVA Planimetry All Area Measurement cm Q to TV Open M Time Measurement ms TV Vmax PW Velocity Measurement cm/s TV VTI PW Doppler Spectrum Trace cm TV E/A PW Continuous Measurement - TV Peak E PW Velocity Measurement cm/s TV Peak A PW Velocity Measurement cm/s TV PHT PW Time Measurement ms TV AccT PW Time Measurement ms 7-55

[Page 500] TV DecT PW Time Measurement ms TV A Dur PW Time Measurement ms TV Acc PW Velocity Measurement cm/s 2 TR Auto Trace PW Doppler Spectrum Trace TR Limited Trace PW Doppler Spectrum Trace TR Manual Trace PW Doppler Spectrum Trace TV TR VCW All Distance Measurement cm TR Vmax PW Velocity Measurement cm/s TR VTI PW Doppler Spectrum Trace cm Calculation after time TR dp/dt PW mmHg/s measurement TR PISA Rad C PISA-Radius cm RAP M, PW RAP mmHg TV HR PW Heart Rate bpm PV Auto Trace PW Doppler Spectrum Trace PV Limited Trace PW Doppler Spectrum Trace PV Manual Trace PW Doppler Spectrum Trace PV Ann Diam All Distance Measurement cm PVA Planimetry All Area Measurement cm 2 PV Vmax PW Velocity Measurement cm/s, m/s PV PHT PW Velocity Measurement cm/s PV PV VTI PW Doppler Spectrum Trace cm PV AccT/ET PW Continuous Measurement PV AccT PW Time Measurement ms PV ET PW Time Measurement ms PV DecT PW Time Measurement ms PV Acc PW Velocity Measurement cm/s 2 Q to PV Open M Time Measurement ms 7-56

[Page 501] Q to PV Close M Time Measurement ms PR Auto Trace PW Doppler Spectrum Trace PR Limited Trace PW Doppler Spectrum Trace PR Manual Trace PW Doppler Spectrum Trace MPA Vmax PW Velocity Measurement cm/s PR VCW All Distance Measurement cm PR Vmax PW Velocity Measurement cm/s PV PR PHT PW Time Measurement ms PR VTI PW Doppler Spectrum Trace cm PR AccT PW Time Measurement ms PR DecT PW Time Measurement ms PR End Vel. PW Velocity Measurement cm/s PR PISA Rad C PISA-Radius cm PR Acc PW Velocity Measurement cm/s 2 All LV Tei Index PW Continuous Measurement LV TST PW Time Measurement ms MV ET PW Time Measurement ms LV IVCT PW Time Measurement ms LV IVRT PW Time Measurement ms Tei Index All RV Tei Index PW Continuous Measurement RV TST PW Time Measurement ms RV ET PW Time Measurement ms RV IVCT PW Time Measurement ms RV IVRT PW Time Measurement ms P Vein S/D PW Continuous Measurement P Vein S Vmax PW Velocity Measurement cm/s Pulm. Veins P Vein D Vmax PW Velocity Measurement cm/s P Vein A Vmax PW Velocity Measurement cm/s P Vein A Dur PW Time Measurement ms 7-57

[Page 502] H Vein S/D PW Continuous Measurement H Vein S Vmax PW Velocity Measurement cm/s Hepatic Veins H Vein D Vmax PW Velocity Measurement cm/s H Vein A Vmax PW Velocity Measurement cm/s H Vein A Dur PW Time Measurement ms LV E’-A’-S’ PW Continuous Measurement LV Peak E’ PW Velocity Measurement cm/s LV Peak A’ PW Velocity Measurement cm/s LV Peak S’ PW Velocity Measurement cm/s LV AccT PW Time Measurement ms LV DecT PW Time Measurement ms RV E’-A’-S’ PW Continuous Measurement RV Peak E’ PW Velocity Measurement cm/s RV Peak A’ PW Velocity Measurement cm/s Tissue Doppler RV Peak S’ PW Velocity Measurement cm/s RV AccT PW Time Measurement ms RV DecT PW Time Measurement ms LV Lat E’-A’-S’ PW Continuous Measurement LV Lat Peak E’ PW Velocity Measurement cm/s LV Lat Peak A’ PW Velocity Measurement cm/s LV Lat Peak S’ PW Velocity Measurement cm/s LV Lat AccT PW Time Measurement ms LV Lat DecT PW Time Measurement ms Systemic VTI PW Doppler Spectrum Trace cm Systemic HR PW Heart Rate bpm Qp/Qs Pulmonic VTI PW Doppler Spectrum Trace cm Pulmonic HR PW Heart Rate bpm 7-58

[Page 503] MPA Diam All Distance Measurement cm LPA Diam All Distance Measurement cm RPA Diam All Distance Measurement cm SVC Diam, Exp All Distance Measurement cm SVC Diam, Insp All Distance Measurement cm SVC S/D PW Continuous Measurement SVC S Vmax PW Velocity Measurement cm/s SVC D Vmax PW Velocity Measurement cm/s Shunts SVC A Vmax PW Velocity Measurement cm/s SVC A Dur PW Time Measurement ms IVC S/D PW Continuous Measurement IVC S Vmax PW Velocity Measurement cm/s IVC D Vmax PW Velocity Measurement cm/s IVC A Vmax PW Velocity Measurement cm/s IVC A Dur PW Time Measurement ms PEd All Distance Measurement cm PEs All Distance Measurement cm IVC Diam, Exp All Distance Measurement cm IVC Diam, Insp All Distance Measurement cm IVC IVC Diam, Exp(M) M Distance Measurement cm IVC Diam, Insp(M) M Distance Measurement cm 7-59

[Page 504] „ Dist 20 Trace the circumference of the heart and then draw the axis of the heart. The system automatically draws 20 lines perpendicular to the axis to calculate the volume. X MR dp/dt can be measured at 1–3 m/s only. X TR dp/dt can be measured at 1–2 m/s only. X In Dual 2D mode, two images can be viewed simultaneously. X For RVAWd , RVIDd , RVAWs , and RVIDs , please refer to the LV measurement method. X MPA Diam , RPA Diam , and LPA Diam are measured under Aortic Valve Level in Parasternal Short Axis. X C Mode is mainly used for measuring reverse cardiac blood flow. X Since velocity data is required for measuring PISA-Radius or PISA-Alias Vel. , set color display to Velocity or Vel + Var in C Mode. For information on relevant settings, please refer to the ‘Color Doppler Mode’ section in ‘Modes of Operation’ in this manual. X Tissue Doppler measurements can be performed in TDI mode. 7-60

[Page 505] Abdomen Measurements X It is convenient to calculate each measurement value on the Spectral Doppler image.
Abdomen Measurement Menu CBD All Distance Measurement cm GB Wall All Distance Measurement cm Gallbladder Length All Distance Measurement cm Head All Distance Measurement cm Body All Distance Measurement cm Pancreas Tail All Distance Measurement cm Duct All Distance Measurement cm Stomach Wall All Distance Measurement cm Bowel Small Bowel Wall All Distance Measurement cm Large Bowel Wall All Distance Measurement cm Lt. Kidney Vol. Length All Distance Measurement cm Rt. Kidney Vol. Liver Spleen Width All Distance Measurement cm 7-61

[Page 506] Aorta %StA All % Lt. RA Rt. RA Lt. Seg.A Rt. Seg A Manual Trace PW Doppler Spectrum Trace Lt. Arc.A Rt. Arc A Celiac A Splenic A C Hepatic A PI PW Velocity Measurement - R Hepatic A RI PW Velocity Measurement - L Hepatic A S/D PW Continuous Measurement SMA Calculation After TAmean, IMA Vol.Folw(D) PW ml/min Vesl., and Dist. measurements IVC VMax PW Velocity Measurement cm/s Renal V R Potal V M Potal V Dur T PW Time Measurement ms L Potal V R Hepatic V M Hepatic V Vesl.Dist. PW Distance Measurement cm L Hepatic V SMV IMV 2 Vesl.Area PW Area Measurement cm Splenic V RA PS PW Velocity Measurement cm/s Renal Aortic Ratio Aorta PS PW Velocity Measurement cm/s 7-62

[Page 507] Pediatric Hips Measurements
Measurement Menu NOTE: For information on basic measurement methods, please refer to the ‘Basic Measurements’ and ‘Common Measurement Methods’ sections in this chapter. Calculation of angle after Type All degree measurement of three straight lines Hip Angle Calculation of angle after specifying Angle All degree three points
Measurement Methods 1. Use the trackball and Set to set the first straight line. Place the cursor at the desired position using the trackball, and then press Set . Repositioning Point Before pressing Set to specify the point’s position, you can press Change to revert to the previous point’s position. 2. Repeat the above process to specify two other straight lines. 3. The angles between them will be calculated automatically. X α: The angle between the first and the second straight lines X β: The angle between the first and the third straight lines 7-63

[Page 508] See 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 0 < β < 77 d 43 ≤ α < 50 77 ≤ β < 90 3/4 0 < α < 43 [Table 7.2 Hip Joint Type] 7-64

[Page 509] Urology Measurements
Before Taking Urology Measurements Configure the measurement-related menus. You can select the Volume Method to use for measuring volume. There are four types of Volume Method; in equations that require a factor, you may define the factor as desired. For more information on measurement-related menus and configuration method, please refer to ‘Utilities’.
Measurement Menu X For references on measurement items, please refer to the ‘Reference Manual’. „ 3 Distance Calculate a volume by measuring three distances. WG Prostate T-Zone Bladder Height All Distance Measurement cm Pre Residual Post Residual Lt. Renal Height All Distance Measurement cm Rt. Renal Width All Distance Measurement cm Renal Pelvis All Distance Measurement cm 7-65

[Page 510] Small Parts Measurements X It is convenient to calculate each measurement value on the Spectral Doppler image.
Thyroid Measurement Menu Lt. Thyroid Vol. Rt. Thyroid Vol. Lt. Thyroid Flow Rt. Thyroid Flow 7-66

[Page 511]
Breast Measurement Menu Lt. Mass 1–10 Rt. Mass 1–10 Lt. Breast Flow Rt. Breast Flow 7-67

[Page 512]
Testis Measurement Menu Lt. Testis Vol. Rt. Testis Vol. D1 All Distance Measurement cm Epididymis D2 All Distance Measurement cm Lt. Testis Flow Rt. Testis Flow 7-68

[Page 513]
Superficial Measurement Menu Lt. Superficial Vol. Rt. Superficial Vol. Lt. Superficial Flow Rt. Superficial Flow 7-69

[Page 514] MSK (Musculoskeletal) Measurements
Measurement Menu NOTE: For information on basic measurement methods, please refer to the ‘Basic Measurements’ and ‘Common Measurement Methods’ sections in this chapter. Measurement Menu Item Method Unit Lt. Shoulder #1–#10 Distance Measurement cm Rt. Shoulder Lt. Wrist #1–#10 Distance Measurement cm Rt. Wrist Lt. Knee #1–#10 Distance Measurement cm Rt. Knee Lt. Ankle #1–#10 Distance Measurement cm Rt. Ankle 7-70

[Page 515] Vascular Measurements X For references on measurement items, please refer to the ‘Reference Manual’.
Carotid Measurement Menu IMT All Distance Measurement mm Average calculation after IMT Mean All mm distance measurement Lt. CCA Auto Trace PW Doppler Spectrum Trace Rt. CCA Lt. Bulb Rt. Bulb Lt. ICA PS PW Velocity Measurement cm/s Rt. ICA ED PW Velocity Measurement cm/s Lt. ECA Rt. ECA S/D PW Continuous Measurement 7-71

[Page 516] Lt. Subclavian A Rt. Subclavian A Lt. Vertebral A Rt. Vertebral A S/D PW Continuous Measurement 7-72

[Page 517]
AutoIMT+ (Option) AutoIMT+ is a screening tool to analyze a patient’s potential risk of cardiovascular disease. It allows easy intima-media thickness measurement of both the anterior and posterior wall of the common carotid by the click of a button. X AutoIMT+ is an optional feature of this product. X AutoIMT+ is available only under the following conditions: – Probe: Linear – Application: Vascular – Operation mode: 2D Freeze mode AutoIMT+ Screen [Figure 7.1 AutoIMT+] 7-73

[Page 518] „ AutoIMT+ Measurement 1. After checking the probe and the application, start a carotid scan. 2. Press Freeze to obtain the desired image. Use the trackball to select the image you want to measure the IMT on. 3. Tap AutoIMT+ on the touchscreen. The AutoIMT+ screen appears. 4. Use the trackball and Set to set the IMT measurement location. X Measure the length of a specific section. Press and hold Set at the start point and then use the trackball to specify the end point. X You can change the Near and Far positions of the measurement area using Change . 5. Once the measurement finishes, the measurement values will be listed in a table. 6. Using the touchscreen and dial-button, select a measurement item, location of blood vessel, and direction of blood flow. „ Setting Up Measurement Items Using the touchscreen menu, you can select a measurement item, location of blood vessel, and direction of blood flow. X Measurement item: Select measurement items from among CCA, Bulb, ICA, and ECA. Use the touchscreen button. X Direction: Select the blood flow direction (either left or right). Use the dial-button [2]. X Location: Select Prox (Proximal), Mid (Middle), or Dist (Distal) as the location of the blood vessel to measure. Use the dial-button [3]. NOTE: Exit AutoIMT+ using the following functions: X Change image mode and zoom X Annotation, BodyMarker, Patient, SonoView, Report, Setup, Help 7-74

[Page 519] „ Measurement Result X Max: The maximum thickness of the Intima/Adventitia pair X Mean: The average thickness of the Intima/Adventitia pair X SD: Standard Deviation X QI: The distance ratio of the measured point in a distance for Quality Index measurement NOTE: The measurement result window cannot be repositioned and it is displayed in the position set before the AutoIMT+ measurement. „ Applying to the Report AutoIMT+ measurement results are automatically applied to the report. Report/AutoIMT+ measurement results can be checked. „ AutoIMT+ Measurement Analysis 1. Pressing Analysis displays the Analysis screen. 2. Use the trackball and Set to select the desired analysis from Framingham/CHD , Risk Factor , Normal IMT , and User Graph . The bar that corresponds to the measurement will be displayed on each graph. However, if the measurement result is smaller than the Framingham/CHD or Risk Factor value, then no bar will be displayed. User Graph You can use User Graph to adjust the graph and analyze the measurement results as you want. 3. To complete the analysis, press Exit . 4. The following references were used for the AutoIMT+ measurement analysis: 7-75

[Page 520] „ Framingham/CHD Correlation between the Framingham Risk Score and Intima Media Thickness: the Paroi Arterielle et Risque Cardio-vasculair (PARC) Study. Pierre-Jean Touboul, EricVicaut, Julien Labreuche, Jean-Pierre Belliard, Serge Cohen, Serge Kownator, Jean-Jacques Portal, Isabelle Pithois-Merli, Pierre Amarenco. On behalf of PARC Study participating physicians. „ Risk Factor Mannheim Carotid Intima-Media Thickness Consensus (2004–2006) P.-J. Touboul, M.G. Hennerici, S.Meairs, H.Adams, P.Amarenco, N.Borstein, L.Csiba, M.Desvarieux, S.Ebrahim, M.Fatar, R.Hermandez Hernandez, M.Jaff, S.Kownator, P.Prati, T.Rundek, M.Sitzer, U.Schiminke, J.-C. Tardif, A.Taylor, E.Vicaut, K.S.Woo, F.Zannad, M.Zureik „ Normal IMT Simon A, Gariepy J, Chironi G, Megnien JL, Levenson J: Intima-media thickness: a new tool for diagnosis and treatment of cardiovascular risk. Journal of Hypertension 20:159-169, 2002 7-76

[Page 521]
UE Artery Measurement Menu Lt. Subclavian A Rt. Subclavian A Lt. Axillary A Rt. Axillary A Manual Trace PW Doppler Spectrum Trace Lt. Brachial A Rt. Brachial A Lt. Radial A Rt. Radial A Lt. Ulnar A PI PW Velocity Measurement - Rt. Ulnar A RI PW Velocity Measurement - Lt. SPA S/D PW Continuous Measurement Rt. SPA 7-77

[Page 522]
UE Vein Measurement Menu Lt. Internal Jugular V Rt. Internal Jugular V Vmax PW Velocity Measurement cm/s Lt. Innominate V Rt. Innominate V Lt. Subclavian V Rt. Subclavian V Lt. Axillary V Dur T PW Time Measurement ms Rt. Axillary V Lt. Brachial V Rt. Brachial V Lt. Cephalic V Vesl.Dist PW Distance Measurement cm Rt. Cephalic V Lt. Basilic V Rt. Basilic V Lt. Radial V Rt. Radial V Vesl.Area PW Volume Measurement cm 2 Lt. Ulnar V Rt. Ulnar V 7-78

[Page 523]
LE Artery Measurement Menu Lt. CIA, Rt. CIA Calculation After Distance Lt. IIA, Rt. IIA Lt. EIA, Rt. EIA Calculation After Distance Lt. CFA, Rt. CFA Measurement Lt. SFA, Rt. SFA Auto Trace PW Doppler Spectrum Trace Lt. DFA, Rt. DFA Lt. Popliteal A Rt. Popliteal A Lt. ATA, Rt. ATA Lt. PTA, Rt. PTA ED PW Velocity Measurement cm/s Lt. Peroneal A Rt. Peroneal A Lt. DPA, Rt. DPA Lt. MPA, Rt. MPA Lt. LPA, Rt. LPA S/D PW Continuous Measurement Lt. Metatarsal A Calculation After TAmean, Vesl., Rt. Metatarsal A and Dist. Measurements Lt. Digital A Rt. Digital A Vesl. Area Measurements 7-79

[Page 524]
LE Vein Measurement Menu Lt. CIV, Rt. CIV Lt. IIV, Rt. IIV Vmax PW Velocity Measurement cm/s Lt. EIV, Rt. EIV Lt. CFV, Rt. CFV Lt. PFV, Rt. PFV Lt. SFV, Rt. SFV Lt. GSV, Rt. GSV Lt. Popliteal V Dur T PW Time Measurement ms Rt. Popliteal V Lt. LSV, Rt. LSV Lt. ATV, Rt. ATV Lt. PTV, Rt. PTV Lt. Peroneal V Vesl.Dist PW Distance Measurement cm Rt. Peroneal V Lt. MPV, Rt. MPV LT. LPV, Rt. LPV Lt. Metatarsal V Rt. Metatarsal V 2 Vesl.Area. PW Volume Measurement cm Lt. Digital V Rt. Digital V 7-80

[Page 525] Report Measurement results will be organized by application, and will be displayed on the screen. NOTE: Reports for the applications with measurement results are only displayed. View Reports „ Page The pages are divided into Worksheet, Description, Comment, and Image for each application; opening a report displays the Preview screen by default. You can move to each section from the menu on the left side of the screen or touchscreen. If a section contains a large amount of data to display, it will be divided into multiple pages, and you can navigate between pages on the touchscreen. 7-81

[Page 526] Report Preview „ Property X Print: Set the Printer type, Application, Print color, and Page. X Settings: You can set the Header & Footer, Logo, Title, Patient Info, and Table Form for the report. [Figure 7.2 Report Preview] „ Printer Select the USB Printer that is connected to the equipment. „ Orientation Specify the paper orientation. Select either Portrait or Landscape. „ Range Set the page(s) that you need to print out or whose images you need to save. X Current Page: Select the currently set page. X All Pages: Select all pages. 7-82

[Page 527] „ Application Select the Preview screen and the application(s) whose images you need to save or print out. X Current Application: Select the application specified on the Worksheet screen. X All Applications: Select all applications. „ Color(Print) Print images in color. „ Color(Store) Set the color of the image before saving it. „ Paper Type Set the Preview screen and the page whose images you need to save or print out. When Echo Page is selected, reports are displayed in landscape orientation. „ Header & Footer Set the header and footer. Checking ‘Show Date in Footer’ displays a date in the bottom- right side. „ Logo Set the logo to be inserted at the top of the report. It can be changed once a USB connection is established. „ Title Set the title. The user-defined title or the one set under Patient appears. „ Patient Info. Set the patient information shown on the page. ‘Only 1st Page’ displays the patient information on the first page only. Checking Institution will display institution in the Patient information area. „ Table Form Set the report form. ‘Brief’ shows the results only while ‘2 Columns’ shows the measurement items in two separate columns. 7-83

[Page 528] Editing Report (Worksheet) When you move the focus to a value that can be edited in a Worksheet, the borders of the Edit window will be marked in blue, and Edit mode will start automatically.
Modify Measurements After editing a value, if the focus is moved away from the input window or you press Enter on the keyboard, the edited value is applied. Edited values have an asterisk (*) before them. Clicking the value you want to delete activates Delete . „ Default Author Reverts to the default Author settings in Setup. „ Delete Cell Select and delete a measurement value. „ Delete Line Delete all values with the same label as the selected value. NOTE: When you change the author of a report, the new author is only valid within that report. When performing measurements in Measurement mode, the author specified on the Setup screen is used for calculations. „ Av.US When Composite GA is set to Average, select or exclude items for your calculation. 7-84

[Page 529]
Measurement Display Method This product allows you to re-measure a single item multiple times; however, a report can save only three re-measurement results. When taking measurements for the same item more than once, measurements can be displayed in four ways. On the Edit Report screen, you can specify or change the measurement display method. „ Average Obtain the average of the measurements and display it on the screen. „ Last Display the last measurement on the screen. „ Max Display the largest value of the measurements on the screen. „ Min Display the smallest value of the measurements on the screen. NOTE: Select ‘On’ under Setup > Measurement > Application > Doppler > Display Absolute Value , then absolute values are displayed in reports. 7-85

[Page 530] Adding Comments Pressing Comment displays a screen where you can enter opinions or comments. Pressing the area at the bottom of the input window or Comment opens a window where you can select the comment that you have previously added in the Setup window. Select Comment in the window and the selected text will be entered at the location of the cursor in the comment entry window. NOTE: You can add a comment in Setup > Report > Comment . For more information, please refer to the ‘Report’ section in the ‘Utilities’ chapter. Printing Reports Press Print . The measurement report for the selected application will be printed on a connected printer. NOTE: You can change the printer settings for printing measurement reports at Setup > Peripherals > Peripherals > Printer . For more information, please refer to the ‘Peripheral Device Settings’ section in the ‘Utilities’ chapter. Saving Reports Press Export . The Export button is activated only when USB storage is connected. The Export window will appear, allowing you to save the report to external storage media. When the Export window opens, specify the directory, drive, file name, and file type. Store SR Pressing Store SR saves the Measure SR information. 7-86

[Page 531] Image Select this if you want to attach images to the report. Pressing Image opens a window where you can select images. 1. Select images from the thumbnails on the right. 2. Selecting images activates Add . Pressing Add attaches the selected images to the report. Alternatively, double-click selected images from among the thumbnails to attach the associated images. 3. When you select any of the images attached to the report, Delete becomes activated, allowing you to delete the attached images. Pressing Delete All clears all attached images. 4. You can select 1x1, 2x2, 3x3, or 4x4 as the layout. 7-87

[Page 532] OB Graph After taking an OB measurement, tap Report . Tapping OB Graph on the touchscreen displays the Graph screen. Press Single or Quad , and select a layout of the Graph screen. You can review the graph and trends. To return to the Report screen, press Preview . NOTE: The graph function can be used with OB reports only. The list of measured items appears on the right side of the screen. If you select an item, a graph for the selected item will appear on the screen. X To execute the graph function, at least one Label containing a Growth Table must be measured, and only a Label that has been measured may display graphs. X A graph is created based on the patient ID, LMP, and measurement date. „ Select a Graph Use the trackball and Set to select an item from the list. „ Single A graph representing one obstetrics measurement will be displayed. „ Quad A graph representing four obstetrics measurements will be displayed. „ Hide Grid Erase the grids on a graph. „ Show Grid Indicate grids to a graph. „ All Fetus Display graphs for all measured fetuses. 7-88

[Page 533] „ Current Fetus Display graphs for the fetus currently being measured. „ Trend The current and past measurements made of a fetus are displayed by study date. When the study date changes, the marker’s shape is changed and displayed on the graph. „ Current The current measurements made for a fetus are displayed. „ User History You can manually enter measurement values that will be shown on the OB Growth Curve by date and then view them in a trend. Input values have an asterisk (*) before them. „ Manual Trend The current and past studies conducted on a fetus are searched. The measurement values of the chosen study are shown in Trend. „ Prev Return to the previous page. „ Next Move on to the next page. 7-89

[Page 534] Standard Deviation & Percentile Among the OB information, the Growth table and the typical fetal distribution for the same number of weeks are used to determine the following information: X the normal distribution curve. X the measurements for an actual fetus or a position in EFW distribution. X whether a distribution point is within the normal range. The distribution of the relevant number of weeks in the Growth table for the selected reference is a symmetric normal distribution, as 50% of the data is displayed on either side of the mean; it shows the distance from the average as a deviation. The deviation can be represented by Standard Deviation (SD) or Percentile. 68.3% 68.3% 95.5% 99.7% [Figure 7.3 Distribution of the Growth Table for the selected number of weeks (m: mean, σ : standard deviation)] 7-90

[Page 535] When represented by SD, a point near the average indicates a value closer to ±0 SD and a point away from the average indicates a value closer to the maximum or minimum value. The greater part of the range falls within ±3 SD, with ±1 SD representing 68.3% of the entire range. Thus it can be seen that most fetal measurements are tightly clustered around the average value. The Percentile represents a point in distribution from 0 to 100 inclusive. Therefore, the average point is represented as 50 Percentile. As shown in the figure, the average point corresponds to 0 SD (that is, a Percentile of 50). If a point is in the range from -1 SD to +1 SD, it falls within the central 68.3% of the entire range. This means that the point falls within the range from 16th to 84th. Further, if a point is in the range from -2 SD to +2 SD, it falls within 95.5% of the entire range. Thus, the point falls in the range from 3 to 97. You can switch between SD and Percentile. Percentile can be used when a fetal measurement ranking is desired, and SD can be used when the distance between actual fetal measurements and the average measurement is sought. While the range of Growth Table references that are primarily used with OB measurement data varies depending on the author, the typical range accepted by most authors is as follows: X When references are created based on SD: – -2.0 SD to +2.0 SD (when converted to Percentile:2.28 Percentile to 97.72 Percentile) – -1.5 SD to +1.5 SD (when converted to Percentile:6.68 Percentile to 93.32 Percentile) – -1.0 SD to +1.0 SD (when converted to Percentile:15.87 Percentile to 84.13 Percentile) X When references are created based on Percentile: – 2.5 Percentile to 97.5 Percentile (when converted to SD: -1.96 SD to 1.96 SD) – 5.0 Percentile to 95.0 Percentile (when converted to SD: -1.645 SD to 1.645 SD) – 10.0 Percentile to 90.0 Percentile (when converted to SD: -1.288 SD to 1.288 SD) 7-91

[Page 536] Description Press Description . OB, Gyn, Vascular, and Urology applications have their own preset items; for other applications, only user-added items are available. „ General OB This item only becomes active when OB measurement is available. By pressing General OB , you can select a description for the selected item. „ Early OB This item only becomes active when OB measurement is available. By pressing Early OB , you can select a description for the selected item. „ Biophysical Profile The five fields, Movement, Breathing, Tone, AFV, and NST, can be left blank or set to 0, 1, or 2; the sum of the values entered in these fields is displayed in Total. NOTE: Biophysical Profile is activated only when OB measurement values exist. „ Default Set with a value preset by the user. „ Save as Default Saves the values currently specified on the screen as the default values. „ Clear Delete all items. 7-92

[Page 537] Fetus Compare Once you set the Number of Fetuses in the OB Study Information window, you can measure each fetus during OB measurements. Pressing Fetus Compare shows measurement values per fetus. Closing Reports Press Exit or Report . 7-93

[Page 538]

[Page 539] Image Chapter 8 Managements ‹ Cine 8-3 ‹ Annotating Images 8-5 Annotation 8-5 BodyMarker 8-8 ‹ Saving, Playing and Transferring Images 8-10 Saving Images 8-10 Playing Images 8-11 Transferring Images 8-12 ‹ Printing Images 8-13 Printing Images 8-13 ‹ SonoView Mode 8-14 Exam List 8-15 Review – Exam Mode 8-17 Review – Compare Mode 8-20 DICOM Q/R 8-24

[Page 540]

[Page 541] Cine Images are automatically saved in the memory during scanning. The saved images are useful for patient diagnosis and review. X 2D Cine: These are images temporarily saved in all Operation modes except M Mode and Spectral Mode. X Trace Cine: Images that are saved in M Mode and Spectral Mode.
Starting and Finishing Image Review Press Freeze while scanning. This stops the scan and switches the unit to the image review mode screen. Pressing Freeze again returns you to Scan mode.
How to Review Images Move the cursor to the Cine or Bar in the user information area to review an image. You can search through saved images by moving the cursor with the trackball. The total number of saved images and the number of the image currently being reviewed are shown next to the bar. „ Selecting 2D Cine/Trace Cine When both 2D Cine and Trace Cine are available, as in Spectral Doppler mode, press Change to switch between 2D Cine and Trace Cine . The touchscreen menu is changed when images are reviewed. „ Cine Save Images within the specified range will be saved. The saved images are displayed in the thumbnail list on the screen, and can be reloaded or replayed in Scan mode or SonoView. „ Cine Play You can stop or replay images. 8-3

[Page 542] „ Cine Speed Specify the automatic playback speed of 2D Cine or Trace Cine images. NOTE: For an explanation of the other items on the touchscreen, refer to ‘Basic Mode’ in ‘Modes of Operation’.
Reviewing Image in Multi-image Mode Only the images in an active area can be reviewed. To review the images in other areas, change the activated area using L , R , or Quad . 8-4

[Page 543] Annotating Images Annotation Enter or display text, Arrow, or BodyMarker on an image. This function is useful for differentiating or marking a diagnosis area.
Starting Annotation Mode Press Text or Arrow .
Typing Text Press Text and enter text directly using the keyboard, or select predefined text on the touchscreen to enter it. Use the trackball to move the cursor.
Text Mode Menu „ Change Lib. Tap the touchscreen or use the dial-button to change application. The text list will change depending on the selected application. „ Keyboard Tap on the touchscreen to activate the on-screen keyboard. You can configure the Word Recommend function to display words that match the entered characters at the top of the OSK. NOTE: Turn this function On or Off in Setup > Annotation > Word Recommend . Please refer to ‘Utilities’. 8-5

[Page 544] „ Arrow You can enter an arrow in a place you want over an image. „ Delete Last Word Erases the last text entered. Alternatively, use Delete Word on the keyboard. „ Delete All Words All of the entered text is erased. Alternatively, use Delete All on the keyboard. NOTE: Selecting Setup > Annotation > Select Library allows you to edit the entire page. For a more detailed description, refer to ‘Utilities’. „ Replace If it is ‘On’, the texts previously entered will be replaced with the new texts selected. Replace will be executed only when the texts included in the same group are entered. NOTE: For more details, please refer to ‘Utility > Setup > Annotation > Library’. „ Home Position Pressing Home Position moves the cursor to the position where it was set using Set as Home Position . „ Set as Home Position You can set the initial cursor position when Annotation mode starts. Place the cursor on any position of the screen and press Set as Home Position on the touchscreen. „ Layer Set Layers A and B. „ Font Size Set the font size to use. 8-6

[Page 545]
Deleting Text Press Clear . All the text entered on the screen will be deleted.
Exiting Text Mode Press Exit .
Arrow Mode You can enter an arrow over an image.
Entering Arrow 1. Pressing Arrow starts arrow input mode. 2. Select the desired arrow shape by using Arrow Type . 3. Move the arrow to the desired position by using the trackball. 4. To adjust the size of the arrow, use the dial-button’s Arrow Size . 5. To adjust the rotation angle of the arrow, use the dial-button’s Rotate Arrow . It rotates by the angle specified in Rotate Step . 6. Press Set to complete entry. Press Exit to cancel. NOTE: You can configure the Size, Type, and Angle values for the Arrow in Setup > Annotation > Annotation . Please refer to ‘Utilities’. Arrow and Pointer Button Pointer function is available in Annotation mode.
Deleting Arrows Pressing Clear or Delete All Arrows deletes all arrows entered on the screen. Press Delete Last Arrow to delete only the last entered arrow.
Exiting Arrow Mode Press Exit . 8-7

[Page 546] BodyMarker Enter a BodyMarker over an image. This function is useful for differentiating or marking a diagnosis area.
Entering BodyMarkers 1. Press BodyMarker . X The types of BodyMarker shown on the touchscreen vary depending on the selected application. X Up to 19 BodyMarkers can be listed on the screen at one time. If the number of BodyMarkers provided exceeds 19, use the > button on the touchscreen to navigate the pages. 2. Selecting the button corresponding to the desired BodyMarker on the touchscreen adds the BodyMarker to the image. 3. Press Change Lib. to switch to the desired application instantly. 4. Select the desired probe shape using Probe Type . Adjust the cursor angle using Rotate Probe or Angle . It rotates by the angle specified in Rotation Step . 5. Adjust the cursor size by using Size . 6. Set the initial cursor position when BodyMarker starts. Place the cursor on the screen, and then press Store Probe Position to complete the setup. 7. Press Set or Exit to complete entry. Press Clear or Delete to cancel.
Changing BodyMarker Position 1. Press Change . 2. Move the BodyMarker to a desired position by using the trackball. 3. Press Set again to confirm the new position. 8-8

[Page 547]
Deleting a BodyMarker Press Clear or Delete to cancel.
Exiting BodyMarker Mode Press Exit . NOTE: Go to Setup > BodyMarker > Library to set the library of BodyMarker. For a more detailed description, refer to ‘Utilities’. 8-9

[Page 548] Saving, Playing and Transferring Images Saving Images The saved images are displayed in the thumbnail area. WARNING: You must always enter the patient ID, because all images are saved according to patient ID. Failure to enter a patient ID may result in a loss of and/or critical errors in previously saved images.
Saving Image If no patient information has been entered, a Temp ID will be created and saved. The saved images can then be edited and managed in SonoView mode. Temp ID Setup For more information, please refer to ‘Utility > Setup > System > Patient’.
Saving (Still Image/Multi Frame Image) To save, use the Store Clip function of the U Key . For more information about the Store/Print settings, please refer to the ‘Utilities’ chapter. X In Freeze mode: Specify the range of images that you want to save by using the trackball, Trim Start , or Trim End , and then press the set U Key to save the Cine images. X In Live mode: It functions as described below, depending on the configured settings. For information on how to configure the settings, please refer to ‘Utilities.’ – When basic patient information is absent: When saving Cine images in Freeze mode, a Temp ID is first created, and then the images are saved. – In Live mode: Once all frames have been saved, the saving process will be automatically completed at the set time. 8-10

[Page 549] Playing Images You can play the saved images in SonoView and Operation modes.
Playing Images in SonoView NOTE: Refer to ‘SonoView’ in this chapter.
Playing Images in Operation modes Use Pointer . Note that this function is only available when there are images saved in the thumbnail list. 1. Pressing Pointer displays a cursor on the screen. 2. Select images from the thumbnail area to play on the screen. The image is displayed in the image area. 3. In Multi Mode, you can specify a location and play an image. 3D View is loaded for 3D images. 8-11

[Page 550] Transferring Images You can transfer images to a PACS system that supports DICOM. NOTE: For information on the DICOM server settings and DICOM operations, please refer to ‘DICOM’ section in ‘Utilities’.
Transferring Images in Operation modes You can transfer images automatically. Images are transferred by using the transmission method of the storage server. DICOM Settings To configure the DICOM server, go to ‘Utility > Setup > Connectivity > DICOM’. For more details, please refer to ‘Utilities’.
Transferring Images in SonoView You can transfer images manually. „ Sending Exam Send all images for an exam. 1. Select an Exam from the Exam List. 2. Press Send . All images for the selected exam will be sent. „ Sending Selected Images Select a desired image from among the images for an exam and send it out. 1. Select the image in the SonoView screen. 2. Press Send . The selected images will be sent. 8-12

[Page 551] Printing Images NOTE: Use this option after configuring the Printer function in Setup > Peripherals > Printer . Printing Images Press the U Key on the control panel. Images are printed via an echo printer. For information on how to set up a printer, please refer to ‘Utilities’. 8-13

[Page 552] SonoView Mode This is an integrated image management program. It provides image saving/filing, preview, deletion, and other PC-compatible export features. The image file types used in this product follow the international standard DICOM (Digital Imaging and Communication in Medicine). As a result, the PACS (Picture Archiving Communication System) can be implemented without any additional costs, and it’s easy to exchange image files with other hospitals or equipment. This product supports the Bitmap file format (.bmp), which is commonly used on standard PCs, ensuring easier exchange of image data.
Launching SonoView Mode Press SonoView . If there are saved images available for the current exam, the information and saved images for the exam will appear when SonoView Mode starts. X Before saving images or using SonoView Mode, you must register the patient information. X All diagnosis information in the product is saved and managed for each patient ID. 8-14

[Page 553] Exam List This appears when you press SonoView for the first time. Alternatively, in Review mode, pressing Exam list displays the Exam List. Setup search criteria, and then press Search . Search results are displayed in the list on the screen. You can select an exam from the list and examine, delete, or send it. Refer also to ‘Printing Images’ and ‘Transferring Images via DICOM’ later in the document. You can select the data storage location. HDD, Media, and Q/R are provided.
Hide Search Hides the Exam list.
Show Search Shows hidden Exam list.
Backup Exam Gets activated when selecting an exam in HDD. Continue to back up the selected exam. Select a backup drive and press Yes to start the backup process. „ Delete Patient Information Deletes patient information. 8-15

[Page 554]
Restore Exam Gets activated when selecting an exam from USB storage or CD/DVD. Load the selected exam to HDD.
Review When one or more exams are selected, the button is activated. The review screen for the selected exams will open. For a more detailed description, refer to ‘Review – Exam Mode’.
Continue Exam Is activated when an exam from the last 24 hours is selected. This allows you to modify the exam. 8-16

[Page 555] Review – Exam Mode Press the Exam tab. In the Exam Mode, you can review the current or saved exam. The image that is selected on the screen will be highlighted with a white border.
Exam Mode Screen Exams are categorized by Patient ID, sorted by date, and displayed in tree view. The number represents the number of saved images. To show or hide sub-exams, press ID by using the trackball and Set .
Exam Select Use the trackball and Set to select an exam from the list on the left side of the screen. The selected exam will be marked on the list in blue. The saved image will also be displayed on screen. „ Reviewing the Current Exam Click Current Exam . The current exam and its images are displayed on the screen. This button is only enabled when the patient ID is registered. „ Reviewing Exams Performed within the Last 24 Hours Double-click an image. The exams that were performed within the last 24 hours and their images, are displayed. The first performance date of the exam appears in the feedback area. You can place measurements, annotations, and BodyMarkers on the loaded exam screen. In addition, you can update the exam with new image scans. „ Reviewing Exams Performed Prior to the Last 24 Hours Double-click an image. The exams that were performed prior to the last 24 hours and their images, are displayed. The first performance date of the exam appears in the feedback area. You can place measurements, annotations, and BodyMarkers on the loaded exam screen. However, you cannot update the exam with new image scans. 8-17

[Page 556]
Exam Scroll The image of the previous or next page is displayed on the screen. Access by rotating the Page dial-button on the touchscreen. However, this button may not be used when the number of exams saved is less than the number of images that appear on a page under the current layout.
Closing Exam Review Tap Close on the touchscreen. To close all listed exams on the screen, press Close All .
Pan Using Set , you can move images or scans within the chosen image layout.
Reset Reset the selected image or scan to the initially saved screen.
Select All All images in the current exam will be selected.
Unselect All All images in the selected exam will be deselected.
Favorite After selecting an image in Exam SonoView mode, press Favorite . Then, appears in the top-right corner of the thumbnail image.
Delete Delete the selected image. 8-18

[Page 557]
Zoom Enlarges only one image.
Page Move images of the selected exam.
Layouts You can adjust the number of images displayed on the screen. The numbers shown in the layout section indicate the column and row of where an image will be displayed on the screen. You can change the numbers shown in the layout section to customize the layout.
Displaying in Full Screen Place the cursor on an image and press Set twice. The thumbnail will then be loaded onto the screen in Scan mode.
Reviewing 3D Images If the saved image is 3D, the 3D indicator will appear at the bottom of the image. Double clicking the screen will start 3D View for image review.
Cine Play If the saved image is Cine, the playback and search scroll bar appear on the bottom of the image. You can play, pause, stop or search forward/backward with the scroll bar. NOTE: Cine images can be played only in 2×2 layout or smaller. 8-19

[Page 558] Review – Compare Mode Press Compare in the upper left corner of the screen. In Compare Mode, you can select the images related to an exam to compare and review them. The image that is selected on the screen will be highlighted with a blue border.
Compare Mode Screen As in Exam Mode, exams for each ID appear on the screen. In addition, images for the selected exam are displayed in thumbnail format. * All functions except Page and the details below are the as same as those in Exam Mode.
Select an Image Using the trackball and Set , select an image from the thumbnail list. The selected image is highlighted in blue in the list. Select a location on the screen where the image will be displayed and then the selected image will appear. NOTE: Only scanned data can be loaded into the image area.
Thumbnail Scroll The image of the previous or next page is displayed on the thumbnail list. Use the trackball to scroll to the desired image and then select it, or use the Thumbnail Scroll dial-button. Rotating the dial-button to the left displays the previous page’s images in the thumbnail list. Rotating it to the right displays the next page’s images in the thumbnail list.
Image Scroll The image of the previous or next page is displayed on the screen. Use the trackball to scroll to the desired image and then select it, or use Image Scroll . 8-20

[Page 559]
Mobile Export (Option) Preparation To use Mobile Export, the system and your smartphone need to be connected via Wi-Fi. 8 9 [Figure 8.1 Exam Mode – Mobile Export] 1 Patient Name, Patient ID: Display Patient Name and ID. 2 Image List: Display images available to send through Mobile Export. 3 Select/Deselect All: Select/Deselect all images to send. 4 ID/Password: Automatically create and display the ID and Password used to download images from Web Page. The ID and Password can be modified. 5 Address: Display Web Page address to download images. 6 QR Code: Display Web Page Information with QR code to download images. 7 Status Indicator: Display the status of data conversion and transmission state. 8 Export: Send the selected images to the server. 9 Close: Close Mobile Export. NOTE: Images that can be transferred through the Mobile Export are available only for acquired still image or recorded video. WARNING: Smartphones have not been cleared by the FDA for diagnostic image review or other diagnostic use. Therefore, images viewed on a smartphone are for information or communication purposes only. 8-21

[Page 560]
Printing Images 1. Press Print . 2. Select the type, printing direction, and options for the printer. 3. Press Print to print. Press Close to cancel. Canceling a Print Job in Progress To cancel a print job in progress, use Setup > Peripherals > Peripherals > Printer > Printer Setting. Select the printer that has the queued job that you want to clear, and then press Clear Print Queue . For more information, refer to ‘Utilities’ in this manual. NOTE: If Thermal Printer is selected, Include Header and Include Page Numbers will be inactive, and headers and page numbers will not be printed on the pages.
Transferring Images via DICOM Transfer the selected image and measurement data via DICOM. The icon is enabled only when an image is selected. The icon is disabled in a system where DICOM is not enabled. 1. Select an image and press Send on the screen. 2. Press the Send button to transfer the selected image to the DICOM server. Click Close to cancel. 8-22

[Page 561]
Saving Images 1. Press Export . 2. Specify the various parameters, such as directory, drive, filename and file format. X Create Patient Folder(s): Automatically creates folders using patient information. X Hide Patient Information: Hides patient information. X You can specify the image quality. X If you select DICOM in the File Format field, you can further specify how the file should be saved. – Include 3D Volume Data: Saves the file including the 3D data. – Include DICOM SR: Saves the file including the Measure SR information. – With DICOMDIR: Saves the file as a DICOM DIR file. 3. Press Export to save. Press Close to cancel.
Exiting SonoView Click Exit on the screen. Alternatively, you can press SonoView and Exit to exit from SonoView. 8-23

[Page 562] DICOM Q/R At least one server should be registered in the DICOM Q/R settings. NOTE: Before using this feature, make sure that DICOM Q/R is properly configured. To configure DICOM Q/R, please refer to ‘Utilities’ and configure Setup > Connectivity > DICOM functions before use. There is no limit on the number of DICOM Q/R servers you can register.
Run DICOM Q/R Retrieve an image from the selected server by following this process: 1. After entering the ID in the Patient window, register or start an exam. In the SonoView mode, enter an Exam List and select the combobox to Q/R. 2. Enter the Patient ID, Accession Number, or Last Name as a search term. X Alternatively, search by selecting the modality you wish to find. You may select MR, CT, Mammo, US, DR, or PET for the modality. X You may search by designating a period. Select Period. Select either Today, Last Week, Last Month, or Manual in the combo box. If Manual is selected, you do not have to select date separately. 3. Press Search and perform a search. 4. Patient ID, Patient Name, Modality, Exam Date, Accession Number, Description, and Series Count will appear on the Study List search result. 5. Up to three studies can be selected from the Study List of the same Patient ID. 6. Select a study on the Study List to search within a series. Modality, Exam Date, Description, Series No., Image Count, and Status will appear on the Series List search result. 7. After searching for Series, select the Series you wish to retrieve. You may select or deselect up to 10 series by using the Select All checkbox. Click Retrieve . If 10 series are selected, no additional series can be selected. 8-24

[Page 563]
Retrieval Data Manager 1. Press Retrieval Manager . 2. In the Retrieval Data Manager window, select the series by using the checkbox. NOTE: If you have not started the diagnosis, select the series in the Data Manager window by using the checkbox and press Delete to delete. Locked exams cannot be deleted by using the checkbox. 3. Press SonoView to view the exam image selected in the SonoView window. 4. This function can be used to compare data by pressing Compare . 5. Checking Show Only Selected will show the selected exams only. 6. Tap Close on the screen. 8-25

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[Page 565] Chapter 9 Appendix ‹ Technology and Design 9-3 ACE 9-3 CrystalLive™ 9-3 EC Transducer Holder 9-3 Gel warmer 9-3 Height-adjustable operating panel 9-3 HelloMom™ 9-3 Low noise 9-4 Measure Navigation 9-4 Monitor Arm 9-4 Solid State Drive (SSD) 9-4 Side storage 9-4

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[Page 567] Chapter 9 Appendix Technology and Design ACE ACE is not a product name but is Samsung’s marketing terminology. This term may vary by country, time and model. CrystalLive™ CrystalLive™ is Samsung’s up-to-date ultrasound imaging engine with enhanced 2D image processing, 3D rendering and color signal processing, to offer outstanding image performance and efficient workflow during complex cases. EC Transducer Holder It provides EC transducer holder for stable mounting of the endocavity transducer when performing gynecological scanning. Gel warmer Two-level adjustable gel warmer maintains ultrasound gel at a comfortable temperature. Height-adjustable operating panel Adjust the operating panel to your preferred height without straining, thanks to the smooth upward and downward motion of the gas lift. HelloMom™ HelloMom™ supports simple and secure transfer of fetal ultrasound images and clips wirelessly from the ultrasound system directly to an external device. These images can be shared easily with others. 9-3

[Page 568] Low noise This exceptionally quiet device allows physical exams to be performed, including auscultation, while the ultrasound system is turned on. Measure Navigation When placing a caliper, Measure Navigation automatically magnifies the area of interest using a picture-in-picture window to allow more precise placement of the calipers. This is especially useful when measuring small structures or when accuracy is critical. Monitor Arm With a wide range of motion, the fully articulating monitor arm adapts to your changing needs. X Swivel: +/- 160° X Tilt: +10° / -75° X Lift: 180 mm Solid State Drive (SSD) The HS40/XH40 uses advanced solid state drives. These stable and dependable drives allow faster bootup, better frame rates, and fast processing speeds. * Option (1TB expanded storage) Side storage The side storage is ideal for storing a tablet, patient charts, or other items that you need to keep close at hand. 9-4