Samsung-Sonoace-R7-Ultrasound-User-Manual

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[Page 5] Diagnostic Ultrasound System Version 3.01.00 English MI68-02773A

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

[Page 8] Safety Requirements „ „ Classifications: X „ Type of protection against electrical shock: Class I X „ Degree of protection against electrical shock (Patient connection): Type BF or CF Applied Part X „ Degree of protection against harmful ingress of water: Ordinary equipment X „ Degree of safety of application in the presence of a flammable anesthetic material with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. X „ Mode of operation: Continuous operation „ „ Electromechanical safety standards met: X „ Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance [IEC 60601-1:2005] X „ Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Compatibility - Requirements and Tests [IEC 60601-1-2:2007] X „ Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability [IEC 60601-1-6:2010] X „ Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2007] X „ Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with A1:1991 and A2:1995] X „ Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standard: safety Requirement for Medical Electrical Systems [IEC 60601-1-1:2000] X „ Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001, A1:2004] X „ Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999]

[Page 9] X „ Medical Electrical Equipment, Part 2-37: Particular Requirements for Safety - Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2001 with A1:2004, A2:2005] X „ Medical Devices - Application of Risk Management to Medical Devices [ISO 14971:2007] X „ Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-1:2003] X „ Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA C22.2 No.601.1-M90:1990, with R2003, with R2005] X „ Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management process [ISO 10993-1:2009] X „ Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment [IEC 61157:2007] „ „ Declarations: This is CSA symbol for Canada and United States of America. This is manufacturer’s declaration of product compliance with applicable EEC directive(s) and the European notified body. This is manufacturer’s declaration of product compliance with applicable EEC directive(s).

[Page 10] Read This First  How to Use Your Manual This manual addresses the reader who is familiar with ultrasound techniques. Only medical doctors or persons supervised by medical doctors should use this system. Sonography training and clinical procedures are not included here. This manual is not intended to be used as training material for the principles of ultrasound, anatomy, scanning techniques, or applications. You should be familiar with all of these areas before attempting to use this manual or your ultrasound system. This manual does not include diagnosis results or opinions. Also, check the measurement reference for each application’s result measurement before the final diagnosis. It is useless to make constant or complex adjustments to the equipment controls. The system has been preset at the factory to produce an optimum image in the majority of patients. User adjustments are not usually required. If the user wishes to change image settings, the variables may be set as desired. Optimal images are obtained with little difficulty. We are not responsible for errors that occur when the system is run on a user’s PC. Non-Samsung Medison product names may be trademarks of their respective owners. Please keep this user guide close to the product as a reference when using the system. For safe use of this product, you should read ‘Chapter1. Safety’ and ‘Chapter8. Maintenance’ in this manual, prior to starting to use this system. NOTE: Some features are not available in some countries. The features with options, and specifications that this manual present can be changed without notice. Government approval is still pending in some nations.

[Page 11] Conventions Used in This Manual DANGER: Describes precautions necessary to prevent user hazards of great urgency. Ignoring a DANGER warning will risk life-threatening injury. WARNING: Used to indicate the presence of a hazard that can cause serious personal injury, or substantial property damage. CAUTION: Indicates the presence of a hazard that can cause equipment damage. NOTE: A piece of information useful for installing, operating and maintaining a system. Not related to any hazard. If You Need Assistance If you need any assistance with the equipment, like the service manual, please contact the Samsung Medison Customer Service Department or one of their worldwide customer service representatives, immediately.

[Page 12] Revision History VERSION DATE NOTE v3.01.00-00 2013-09-26 Initial Release v3.01.00-01 2013-11-28 Add State of California Proposition 65 Warning (US Only) System Upgrades and Manual Set Updates Samsung Medison Ultrasound is committed to innovation and continued improvement. Upgrades may be announced that consist of hardware or software improvements. Updated manuals will accompany those system upgrades. Verify that Check if this version of the manual is correct for the system version. If not, please contact the Customer Service Department.

[Page 13] Table of C ontents Table of Contents – Volume 1 Indication for Use 1-3 Safety Signs 1-4 Safety Symbols 1-4 Symbols 1-5 Labels 1-6 Electrical Safety 1-8 Prevention of Electric Shock 1-8 ECG-Related Information 1-10 ESD 1-10 EMI 1-11 EMC 1-11 Mechanical Safety 1-18 Moving the Equipment 1-18 Safety Note 1-19 Biological Safety 1-20 ALARA Principle 1-20 Environmental Protection 1-33 Correct Disposal of This Product (Waste Electrical & Electronic Equipment) 1-33 Specifications 2-3 Product Configuration and Installation 2-6 Monitor 2-9 Control Panel 2-11 Console 2-16 Peripheral Devices 2-18 Probe 2-21 Accessories 2-22 Optional Functions 2-23

[Page 14] Operation M anual Power Supply 3-3 Powering On 3-3 Powering Off 3-3 Probes & Applications 3-4 Probe Selection and Application 3-5 Changing Application 3-5 Editing Probe Preset Values 3-5 Patient Information 3-7 Patient Information for Application 3-9 Finding Patient Information 3-15 Managing Patient Exams 3-17 Changing Measurements 3-23 Information 4-3 Diagnosis Mode Type 4-3 Basic Use 4-4 Basic Mode 4-6 2D Mode 4-6 Panoramic 4-13 M Mode 4-15 Color Doppler Mode 4-17 Power Doppler Mode 4-20 PW Spectral Doppler Mode 4-22 CW Spectral Doppler Mode 4-27 TDI Mode 4-28 TDW Mode 4-29 ElastoScan Mode 4-30 Combined Mode 4-37 2D/C/PW Mode 4-37 2D/PD/PW Mode 4-37 2D/C/CW Mode 4-37 2D/PD/CW Mode 4-37 2D/C/M Mode 4-38 2D/C Live Mode 4-38

[Page 15] Table of C ontents Multi-Image Mode 4-39 Dual Mode 4-39 Quad Mode 4-40 3D/4D Mode 4-41 3D/4D Mode 4-41 3D StandBy Mode 4-43 3D View-MPR 4-47 3D XI Mode (Optional) 4-63 Measurement Accuracy 5-3 Causes of Measurement Errors 5-3 Optimization of Measurement Accuracy 5-5 Measurement Accuracy Table 5-7 Basic Measurements 5-9 Distance Measurement 5-11 Circumference and Area Measurement 5-16 Volume Measurement 5-18 Calculations by Application 5-21 Things to note 5-21 Common Measurement Methods 5-25 OB Calculation 5-31 Gynecology Calculation 5-44 Cardiac Calculation 5-51 Carotid Calculation 5-63 Urology Calculation 5-75 Fetal Echo Calculation 5-80 LE Artery Calculation 5-85 UE Artery Calculation 5-95 LE Vein Calculation 5-100 UE Vein Calculation 5-104 Radiology Calculation 5-109 TCD Calculation 5-117 Thyroid Calculation 5-123 Breast Calculation 5-125 Testicle Calculation 5-127 Superficial Calculation 5-129 Pediatric Hips Calculation 5-131 Musculoskeletal Calculation 5-133

[Page 16] Operation M anual Report 5-134 Viewing Report 5-135 Video Out 5-136 Editing Report 5-136 Adding Comment 5-138 Printing Report 5-139 Saving Report 5-139 Transferring Report 5-140 Stress Echo Report 5-140 Graph Function 5-141 Closing Report 5-145 ** Reference Manual Samsung Medison is providing an additional SONOACE R7 Reference Manual. GA tables and references for each application are included in the Reference Manual.

[Page 17] Chapter1 Safety ‹ ‹ Indication for Use 1-3 ‹ ‹ Safety Signs 1-4 Safety Symbols 1-4 Symbols 1-5 Labels 1-6 ‹ ‹ Electrical Safety 1-8 Prevention of Electric Shock 1-8 ECG-Related Information 1-10 ESD 1-10 EMI 1-11 EMC 1-11 ‹ ‹ Mechanical Safety 1-18 Moving the Equipment 1-18 Safety Note 1-19 ‹ ‹ Biological Safety 1-20 ALARA Principle 1-20 ‹ ‹ Environmental Protection 1-33 Correct Disposal of This Product (Waste Electrical & Electronic Equipment) 1-33

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[Page 19] Indication for Use The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.  Contraindications The SONOACE R7 system is not intended for ophthalmic use or any use causing the acoustic beam to pass 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 'Chapter 3. Starting Diagnosis' and 'Chapter 4. Diagnosis Modes'. 1-3

[Page 20] Safety Signs Please read this chapter before using the Samsung Medison ultrasound system. It is relevant to the ultrasound system, the probes, the recording devices, and any of the optional equipment. SONOACE R7 is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of the medical device. Safety Symbols The International Electro Technical Commission (IEC) has established a set of symbols for medical electronic equipment, which classify a connection or warn of potential hazards. The classifications and symbols are shown below. Symbols Description Symbols Description Alternating current voltage source Input port CAUTION: Risk of electric shock Output port Type BF applied part (Classification based on degree of protection against Print remote output electric hazard) Defibrillation-proof type CF applied part (Classification based on degree of Foot Switch Port protection against electric hazard) Power on/off ECG port Power on USB port Power off Network port 1-4

[Page 21] Symbols Description Symbols Description WARNING: The accompanying information must be followed to prevent Microphone Port serious accidents and/or damage to property. CAUTION: The accompanying IPX 7: Protected against the effects of information helps to prevent minor temporary immersion in water accidents and/or damage to property. IPX 1: Protected against vertically falling Refer to the operation manual. water drops IPX 8: Protected against the effects of Power ON for part of the product continuous immersion in water Equipotentiality Probe port Dangerous voltage (Indicates dangerous CAUTION: Electrostatic sensitive devices voltages over 1000V AC or 1500V DC) (ESD) Protective earth (ground) Do not sit on the product. Data output port Do not push the product. Data input port Do not lean against the product. Data Input/Output port Follow the operation manual. Symbols Symbols Description Symbols Description Authorised Representative In The Manufacturer European Community 1-5

[Page 22] Labels To protect the system, you may see ‘Warning’ or ‘Caution’ marked on the surface of the product. [Label 1. ID label] 275-K-A4288 [Label 2. Marked below OUTLET] 1-6

[Page 23] [Label 3. Safety note for “TIP-OVER” Precaution] [Label 4. Prohibition of seating on Control panel] 1-7

[Page 24] 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 Shock In a hospital, dangerous currents are due to the potential differences between connected equipment and touchable conducting parts found in medical rooms. The solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up of angled sockets to the equipotential bonding network in medical rooms. [Figure 1.1 Equipotential bonding] 1-8

[Page 25] Additional equipment connected to medical electrical equipment must comply with the respective IEC standards (e.g., IEC 60950/EN 60950 for data processing equipment, IEC 60601-1/EN 60601-1) for medical devices). Furthermore, all components of the product shall comply with the requirements for medical electrical systems IEC 60601-1-1/EN 60601-1-1. A person connecting additional equipment to signal input and output ports of medical electrical equipment must verify that the equipment complies with IEC 60601-1-1/EN 60601-1-1. WARNING: X ‹ Electric shock may exist result if this system, including and all of its externally mounted recording and monitoring devices, is not properly grounded. X ‹ Do not remove the covers on the system; hazardous voltages are present inside. Cabinet panels must be in place while the system is in use. All internal adjustments and replacements must be made by a qualified Samsung Medison Customer Service Department. X ‹ Check the face, housing, and cable before use. Do not use and disconnect the power source, if the face is cracked, chipped, or torn, the housing is damaged, or if the cable is abraded. X ‹ Always disconnect the system from the wall outlet prior to cleaning the system. X ‹ All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to application of a high voltage defibrillation pulse. X ‹ The use of flammable anesthetic gas or oxidizing gases (N 2 O) should be avoided. X ‹ Avoid places where the system is likely to be difficult to operate the disconnection device. X ‹ Do not use HF surgical equipment with the system. Any malfunctions in the HF surgical equipment may result in burns to the patient. X ‹ The System must only be connected to a supply mains with protective earth to avoid risk of electric shock. X ‹ The system has been designed for 100-120VAC and 200-240VAC; you should select the input voltage of printer and VCR. Prior to connecting a peripheral power cord, verify that the voltage indicated on the power cord matches the voltage rating of the peripheral device. 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 ‹ The auxiliary socket outlets installed on this system are rated 100-120V and 200-240V with maximum total load of 150W. 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 ‹ Do not connect peripheral devices, not listed in this manual, to the auxiliary socket outlets of the system. X ‹ Do not touch SIP/SOP and the patient simultaneously. There is a risk of electric shock from leakage current. 1-9

[Page 26] ECG-Related Information WARNING: 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 of HF surgical equipment. Any malfunctions in the HF surgical equipment may result in burns to the patient. X ‹ Do not use ECG electrodes during cardiac pacemaker procedures or other electrical stimulators. X ‹ Do not use ECG leads and electrodes in an operating room. ESD Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. During low humidity conditions, electrical charges naturally build up on individuals, creating static electricity. An ESD occurs when an individual with an electrical energy build-up comes in contact with conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals. The static shock or ESD is a discharge of the electrical energy build-up from a charged individual to a lesser or non-charged individual or object. 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 on 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. 1-10

[Page 27] EMI Although this system has been manufactured in compliance with existing EMI (Electromagnetic Interference) requirements, use of this system in the presence of an electromagnetic field can cause momentary degradation of the ultrasound image. If this occurs often, Samsung Medison suggests a review of the environment in which the system is being used, to identify possible sources of radiated emissions. These emissions could be from other electrical devices used within the same room or an adjacent room. Communication devices such as cellular phones and pagers can cause these emissions. The existence of radios, TVs, or microwave transmission equipment nearby can also cause interference. CAUTION: In cases where EMI is causing disturbances, it may be necessary to relocate this system. EMC The testing for EMC (Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC 60601-1-2). This IEC standard was adopted in Europe as the European norm (EN 60601-1-2).  Guidance and manufacturer’s declaration - electromagnetic emission This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment. Emission test Compliance ElectroMagnetic environment -guidance The Ultrasound System uses RF energy only for its internal RF Emission Group 1 function. Therefore, its RF emissions are very low and are not CISPR 11 likely to cause any interference in nearby electronic equipment. RF Emission Class B CISPR 11 The Ultrasound System is suitable for use in all establishments, Harmonic Emission including domestic establishments and those directly connected Class A IEC 61000-3-2 to the public low-voltage power supply network that supplies building used for domestic purpose. Flicker Emission Complies IEC 61000-3-3 1-11

[Page 28]  Approved Cables, Transducers and Accessories for EMC „ ‹ Approved Cable for ElectroMagnetic Compliance Cables connected to this product may affect its emissions; Use only the cable types and lengths listed below table. Cable Type Length VGA Shielded Normal Parallel Shielded Normal RS232C Shielded Normal USB Shielded Normal LAN (RJ45) Twisted pair Any S-Video Shielded Normal Foot Switch Shielded 2.73yd B/W Printer Unshielded Coaxial Normal MIC Unshielded Any Printer Remote Unshielded Any Audio R.L Shielded Normal VHS Shielded Normal ECG AUX input Shielded < 3m e-Motion Marker Shielded 3m „ ‹ Approved Transducer for ElectroMagnetic Compliance The probe listed in ‘Chapter 9. Probes’ when used with this product, have been tested to comply with the group1 class B emission as required by International Standard CISPR 11. „ ‹ Approved Accessories for ElectroMagnetic Compliance Accessories used with this product may effect its emissions. CAUTION: When connecting other customer-supplied accessories to the system, such as a remote printer or VCR, it is the user’s responsibility to ensure the electromagnetic compatibility of the system. Use only CISPR 11 or CISPR 22, CLASS B compliant devices. 1-12

[Page 29] WARNING: The use of cables, transducers, and accessories other than those specified may result in increased emission or decreased Immunity of the Ultrasound System. ElectroMagnetic environment Immunity test IEC 60601 Test level Compliance level - guidance Floors should be wood, Electrotatic concrete or ceramic tile. ±6KV Contact ±6KV Contact discharge (ESD) If floors are covered with synthetic material, the relative ±8KV air ±8KV air IEC 61000-4-2 humidity should be at least 30%. Electrical fast ±2KV ±2KV Mains power quality should be transient/burst for power supply lines for power supply lines that of a typical commercial or ±1KV ±1KV hospital environment. IEC 61000-4-4 for input/output lines for input/output lines ±1KV differential Surge ±1KV differential mode Mains power quality should be mode that of a typical commercial or IEC 61000-4-5 ±2KV common mode hospital environment. ±2KV common mode <5% U т for 0.5cycle <5% U т for 0.5cycle Mains power quality should be (>95% dip in U т) (>95% dip in U т) Voltage that of a typical commercial dips, short or hospital environment. If the 40% U т for 5 cycle 40% U т for 5 cycle interruptions and user of this product requires (60% dip in U т) (60% dip in U т) voltage variations continued operation during on power supply power mains interruptions, 70% U т for 25 cycle 70% U т for 25 cycle input lines it is recommended that this (30% dip in U т) (30% dip in U т) product be powered from an IEC 61000-4-11 uninterruptible power supply <5% U т for 5 s <5% U т for 5 s or a battery. (<95% dip in U т ) (<95% dip in U т ) Power frequency magnetic Power frequency fields should be at levels (50/60Hz) characteristic of a typical magnetic field 3 A/m 3 A/m location in a typical commercial or hospital IEC 61000-4-8 environment. NOTE: U т is the a.c. mains voltage prior to application of the test level. 1-13

[Page 30] IEC 60601 Compliance ElectroMagnetic Immunity test Test level level environment - guidance Conducted RF 3 Vrms 0.01V Portable and mobile RF communications IEC 61000-4-6 150 kHz equipment should be used no closer to any part to 80MHz of the Ultrasound System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80MHz to 800MHz 800MHz to 2.5GHz Radiated RF 3 V/m 3V/m Where P is the maximum output power rating IEC 61000-4-3 80 MHz of the transmitter in watts (W) according to the to 2.5GHz transmitter manufacturer and d is the recomm- ended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol : NOTE 1) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Ultrasound System is used exceeds the applicable RF compliance level above, the Ultrasound System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Ultrasound System or using a shielded location with a higher RF shielding effectiveness and filter attenuation. b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V ] V/m. 1-14

[Page 31]  Recommended separation distances between portable and mobile RF communications equipment and the SONOACE R7 This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help Prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter [m] Rated maximum output 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz power of transmitter [W] V1=0.01Vrms E1=3 V/m E1=3V/m 0.01 35.00 0.11 0.23 0.1 110.68 0.36 0.73 1 350.00 1.16 2.33 10 1106.80 3.68 7.37 100 3500.00 11.66 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.  Electromagnetic environment – guidance The Ultrasound System must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location. Field strengths outside the shielded location from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m. It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification. CAUTION: If the system is connected to other customer-supplied equipment, such as a local area network (LAN) or a remote printer, Samsung Medison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic phenomena. 1-15

[Page 32]  Avoiding ElectroMagnetic Interference Typical interference on Ultrasound Imaging Systems varies depending on Electromagnetic phenomena. Please refer to following table: 1 2 3 Imaging Mode ESD RF Power Line For sector imaging probes, white radial bands or flashes in the centerlines of the image. White dots, dashes, diagonal 2D or 3D For linear imaging probes, white lines, or diagonal lines near vertical bands, sometimes more the center of the image. pronounced on the sides of the Change of operating mode, system settings, or system Increase in the image White dots, dashes, diagonal M reset. background noise or white M lines, or increase in image Brief flashes in mode lines. background noise the displayed or recorded image. Color flashes, radial or vertical Color flashes, dots, dashes, Color bands, increase in background or changes in the color noise noise, or changes in color image. level. Horizontal lines in the spectral Vertical lines in the spectral Doppler display or tones, abnormal noise display, popping type noise in the audio, or both. in the audio, or 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 power lines or connected cables caused by other equipment, such as switching power supplies, electrical controls, and natural phenomena such as lightning. A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference. Samsung Medison Ultrasound Systems do not generate interference in excess of the referenced standards. An Ultrasound System is designed to receive signals at radio frequency and is therefore susceptible to interference generated by RF energy sources. Examples of other sources of interference are medical devices, information technology products, and radio and television transmission towers. Due to the difficulties in finding sources of interference, refer to the following when searching for them. 1-16

[Page 33] X ‹ Is the interference intermittent or constant? X ‹ Does the interference show up only with one transducers operating at the same frequency or with several transducer? X ‹ Do two different transducers operating at the same frequency have the same problem? X ‹ Is the interference present if the system is moved to a different location in the facility? The answers to these questions will help determine if the problem reside with the system or the scanning environment. After you answer the question, contact your local Samsung Medison customer service department. 1-17

[Page 34] Mechanical Safety Moving the Equipment WARNING: Be extra careful when transporting it. Careless transportation of the product may result in product damage or personal injury. „ ‹ Before transporting the product, check that the brakes on the front, back wheels or wheels are unlocked. Also, make sure to retract the monitor arm completely so that it is secured in a stationary position. „ ‹ Always use the handles at the console and move the product slowly. This product is designed to resist shocks. However, excessive shock, for example if the product falls over, may cause serious damage. If the system operates abnormally after repositioning, please contact the Samsung Medison Customer Service Department.  The Brakes Brakes are mounted on the front and back wheels of the console only. To lock the brakes, press the area under the locks with your foot. To unlock the brakes, press the Off area on the locks with your foot. You can use the brakes to control the movement of the product. We recommend that you lock the brakes when using the product.  Precautions on Ramps Always make sure that the control panel is facing the direction of movement. WARNING: Be aware of the castors, especially when moving the system. Samsung Medison recommends that you exercise caution when moving the product up or down ramps. When moving the product down a ramp or resting it temporarily on a ramp, the product may tilt over even with the brakes on depending on the direction of the product. Do not rest the product on ramps. 1-18

[Page 35] Safety Note X ‹ Do not press the control panel excessively. X ‹ Never attempt to modify the product in any way. X ‹ Check the operational safety when using the product after a prolonged break in service. X ‹ Make sure that other objects, such as metal pieces, do not enter the system. X ‹ Do not block the ventilation slots. X ‹ To prevent damage to the power cord, be sure to grip the plug head – not the cord – when unplugging. 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 ‹ Repair or replacement of parts of this equipment must be performed by a qualified Samsung Medison service technician. Assuming that the equipment is maintained by a qualified service technician and meets the guideline of this provided manual, the expected service life of the equipment is approximately 7 years. Please refer to “Chapter 8. Maintenance” for detailed information on protecting, cleaning and disinfecting the equipment.  Safety Note for Monitor When adjusting the height or position of the monitor, be careful of the space in the middle of the monitor arm. Having your fingers or other body parts caught in it may result in injury. [Figure 1.2 Safety note for monitor] 1-19

[Page 36] Biological Safety For more safety information on probes and biopsy, please refer to Chapter 9 'Probes.' WARNING: 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 low. Please refer to the ALARA principle. X ‹ Do not use the system if an error message appears on the video display indicating that a hazardous condition exists. Note the error code, turn off the power to the system, and call your local Samsung Medison Customer Service Department. X ‹ Do not use a system that exhibits erratic or inconsistent updating. Discontinuities in the scanning sequence are indicative of a hardware failure that should be corrected before use. X ‹ The system limits the maximum contact temperature to 43 degree Celsius, and the ultrasonic waves output observes American FDA regulations. ALARA Principle Guidance for the use of diagnostic ultrasound is defined by the “as low as reasonably achievable” (ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight of qualified personnel. No set of rules can be formulated that would be sufficiently complete to dictate the correct response for every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bioeffects. Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, the ultrasound system provides controls that can be manipulated during the exam to optimize the results of the exam. The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound not only in the technology but also in the applications of the technology, have resulted in the need for more and better information to guide the user. The output indices are designed to provide that important information There are a number of variables, which affect the way in which the output display indices can be used to implement the ALARA principle. These variables include mass, body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because the user controls it. The ability to limit the index values over time support the ALARA principle. 1-20

[Page 37]  Applying ALARA The system-imaging mode used depends upon the information needed. 2D-mode and M-mode imaging provide anatomical information, while Doppler, Power, and Color imaging provide information about blood flow. Scanned modes, like 2D-mode, Power, or Color, disperse or scatter the ultrasonic energy over an area, while an unscanned mode, like M-mode or Doppler, concentrates ultrasonic energy. Understanding the nature of the imaging mode being used allows the sonographer to apply the ALARA principle with informed judgment. The probe frequency, system set-up values, scanning techniques, and operator experience aid the sonographer in meeting the definition of the ALARA principle. The decision as to the amount of acoustic output is, in the final analysis, up to the system operator. This decision must be based on the following factors: type of patient, type of exam, patient history, ease or difficulty of obtaining diagnostically useful information, and the potential localized heating of the patient due to probe surface temperatures. Prudent use of the system occurs when patient exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve acceptable diagnostic results. Although a high index reading does not mean that a bioeffect is actually occurring, a high index reading should be taken seriously. Every effort should be made to reduce the possible effects of a high index reading. Limiting exposure time is an effective way to accomplish this goal. There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA. These controls can be divided into three categories: direct, indirect, and receiver control.  Direct Controls Application selection and the output intensity control directly affect acoustic intensity. There are different ranges of allowable intensity or output based on your selection. Selecting the correct range of acoustic intensity for the application is one of the first things required during any exam. For example, peripheral vascular intensity levels are not recommended for fetal exams. Some systems automatically select the proper range for a particular procedure, while others require manual selection. Ultimately, the user bears the responsibility for proper clinical use. The Samsung Medison system provides both automatic and user- definable settings. Output has direct impact on acoustic intensity. Once the application has been established, the output control can be used to increase or decrease the intensity output. The output control allows you to select intensity levels less than the defined maximum. Prudent use dictates that you select the lowest output intensity consistent with good image quality. 1-21

[Page 38]  Indirect Controls The indirect controls are those that have an indirect effect on acoustic intensity. These controls affect imaging mode, pulse repetition frequency, focus depth, pulse length, and probe selection. The choice of imaging mode determines the nature of the ultrasound beam. 2D-mode is a scanning mode, Doppler is a stationary or unscanned mode. A stationary ultrasound beam concentrates energy on a single location. A moving or scanned ultrasound beam disperses the energy over a wide area and the beam is only concentrated on a given area for a fraction of the time necessary in unscanned mode. Pulse repetition frequency or rate refers to the number of ultrasound bursts of energy over a specific period of time. The higher the pulse repetition frequency, the more pulses of energy in a given period of time. Several controls affect pulse repetition frequency: focal depth, display depth, sample volume depth, color sensitivity, number of focal zones, and sector width controls. Focus of the ultrasound beam affects the image resolution. To maintain or increase resolution at a different focus requires a variation in output over the focal zone. This variation of output is a function of system optimization. Different exams require different focal depths. Setting the focus to the proper depth improves the resolution of the structure of interest. Pulse length is the time during which the ultrasonic burst is turned on. The longer the pulse, the greater the time-average intensity value. The greater the time-average intensity, the greater the likelihood of temperature increase and cavitations. Pulse length or burst length or pulse duration is the output pulse duration in pulsed Doppler. Increasing the Doppler sample volume increases the pulse length. Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The higher the probe operating frequency, the greater the attenuation of the ultrasonic energy. Higher probe operating frequencies require higher output intensity to scan at a deeper depth. To scan deeper at the same output intensity, a lower probe frequency is required. Using more gain and output beyond a point, without corresponding increases in image quality, can mean that a lower frequency probe is needed. „ ‹ Receiver Controls Receiver controls are used by the operator to improve image quality. These controls have no effect on output. Receiver controls only affect how the ultrasound echo is received. These controls include gain, TGC, dynamic range, and image processing. The important thing to remember, relative to output, is that receiver controls should be optimized before increasing output. For example; before increasing output, optimize gain to improve image quality. 1-22

[Page 39]  Additional Considerations Ensure that scanning time is kept to a minimum, and ensure that only medically required scanning is performed. Never compromise quality by rushing through an exam. A poor exam will require a follow-up, which ultimately increases the time. Diagnostic ultrasound is an important tool in medicine, and, like any tool, should be used efficiently and effectively.  Output Display Features The system output display comprises two basic indices: a mechanical index and a thermal index. The thermal index consists of the following indices: soft tissue (TIs), bone (TIb) and cranial bone (TIc). One of these three thermal indices will be displayed at all times. Which one depends upon the system preset or user choice, depending upon the application at hand. The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1. The thermal index consists of the three indices, and only one of these is displayed at any one time. Each probe application has a default selection that is appropriate for that combination. The TIb or TIs is continuously displayed over the range of 0.0 to maximum output, based on the probe and application, in increments of 0.1. The application-specific nature of the default setting is also an important factor of index behavior. A default setting is a system control state which is preset by the manufacturer or the operator. The system has default index settings for the probe application. The default settings are invoked automatically by the ultrasound system when power is turned on, new patient data is entered into the system database, or a change in application takes place. The decision as to which of the three thermal indices to display should be based on the following criteria: Appropriate index for the application: TIs is used for imaging soft tissue; and TIb for a focus at or near bone. Some factors might create artificially high or low thermal index readings e.g. presence of fluid or bone, or the flow of blood. A highly attenuating tissue path, for example, will cause the potential for local zone heating to be less than the thermal index displays. Scanned modes versus unscanned modes of operation affect the thermal index. For scanned modes, heating tends to be near the surface; for unscanned modes, the potential for heating tends to be deeper in the focal zone. Always limit ultrasound exposure time. Do not rush the exam. Ensure that the indices are kept to a minimum and that exposure time is limited without compromising diagnostic sensitivity. 1-23

[Page 40] „ ‹ Mechanical Index (MI) Display Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The potential for mechanical bioeffects varies with peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring but there is no specific MI value that means that a mechanical effect will actually occur. The MI should be used as a guide for implementing the ALARA principle. „ ‹ Thermal Index (TI) Display The TI informs the user about the potential for temperature increase occuring at the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, and mode of operation etc. The TI should be used as a guide for implementing the ALARA principle. The bone thermal index (TIb) informs the user about potential heating at or near the focus after the ultrasound beam has passed through soft tissue or fluid, for example, at or near second or third trimester fetal bone. The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near the surface, for example, cranial bone. The soft tissue thermal index (TIs) informs the user about the potential for heating within soft homogeneous tissue. You can select either TIs or TIb using the TIs/TIb selection on the Miscellaneous system setups. TIc is displayed when you select a trans-cranial application. „ ‹ Mechanical and Thermal indices Display Precision and Accuracy The Mechanical and Thermal Indices on the system are precise to 0.1 units. The MI and TI display accuracy estimates for the system are given in the Acoustic Output Tables manual. These accuracy estimates are based on the variability range of probes and systems, inherent acoustic output modeling errors and measurement variability, as described below. The displayed values should be interpreted as relative information to help the system operator achieve the ALARA principle through prudent use of the system. The values should not be interpreted as actual physical values investigated tissue or organs. The initial data that is used to support the output display is derived from laboratory measurements based on the AIUM measurement standard. The measurements are then put into algorithms for calculating the displayed output values. Many of the assumptions used in the process of measurement and calculation are conservative in nature. Over-estimation of actual in situ exposure, for the vast majority of tissue paths, is built into the measurement and calculation process. For example: 1-24

[Page 41] The measured water tank values are de-rated using a conservative, industry standard, attenuation coefficient of 0.3dB/cm-MHz. Conservative values for tissue characteristics were selected for use in the TI models. Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat capacity, and tissue thermal conductivity were selected. Steady state temperature rise is assumed in the industry standard TI models, and the assumption is made that the ultrasound probe is held steady in one position long enough for steady state to be reached. A number of factors are considered when estimating the accuracy of display values: hardware variations, algorithm accuracy estimation and measurement variability. Variability among probes and systems is a significant factor. Probe variability results from piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens focusing parameter variations. Differences in the system pulse voltage control and efficiencies are also a contributor to variability. There are inherent uncertainties in the algorithms used for estimating acoustic output values over the range of possible system operating conditions and pulse voltages. Inaccuracies in laboratory measurements are related to differences in hydrophone calibration and performance, positioning, alignment and digitization tolerances, and variability among test operators. The conservative assumptions of the output estimation algorithms of linear propagation, at all depths, through a 0.3dB/cm-MHz attenuated medium are not taken into account in calculation of the accuracy estimate displayed. Neither linear propagation, nor uniform attenuation at the 0.3dB/cm-MHz rate, occur in water tank measurements or in most tissue paths in the body. In the body, different tissues and organs have dissimilar attenuation characteristics. In water, there is almost no attenuation. In the body, and particularly in water tank measurements, non-linear propagation and saturation losses occur as pulse voltages increase. The display accuracy estimates take into account the variability ranges of probes and systems, inherent acoustic output modeling errors, and measurement variability. Display accuracy estimates are not based on errors in, or caused by measuring according to, the AIUM measurement standards. They are also independent of the effects of non-linear loss on the measured values.  Control Effects - Control affecting the indices As various system controls are adjusted, the TI and MI values may change. This will be most apparent as the POWER control is adjusted; however, other system controls will affect the on-screen output values. „ ‹ Power Power controls the system acoustic output. Two real-time output values are on the screen: a TI and a MI. They change as the system responds to POWER adjustments. In combined modes, such as simultaneous Color, 2D-mode and pulsed Doppler, the individual modes each add to the total TI. One mode will be the dominant contributor to this total. The displayed MI will be from the mode with the largest peak pressure. 1-25

[Page 42]  2D-mode Controls „ ‹ 2D-mode size Narrowing the sector angle may increase the frame rate. This action will increase the TI. Pulse voltage may be automatically adjusted down with software controls to keep the TI below the system maximums. A decrease in pulse voltage will decrease MI. „ ‹ Zoom Increasing the zoom magnification may increase frame rate. This action will increase the TI. The number of focal zones may also increase automatically to improve resolution. This action may change MI since the peak intensity can occur at a different depth. „ ‹ Persistence A lower persistence will decrease the TI. Pulse voltage may be automatically increased. An increase in pulse voltage will increase MI. „ ‹ Focal no. More focal zones may change both the TI and MI by changing frame rate or focal depth automatically. Lower frame rates decrease the TI. MI displayed will correspond to the zone with the largest peak intensity. „ ‹ Focus Changing the focal depth will change the MI. Generally, higher MI values will occur when the focal depth is near the natural focus of the transducer.  Color and Power Controls „ ‹ Color Sensitivity Increasing the color sensitivity may increase the TI. More time is spent scanning for color images. Color pulses are the dominant pulse type in this mode. „ ‹ Color Sector Width Narrower color sector width will increase color frame rate and the TI will increase. The system may automatically decrease pulse voltage to stay below the system maximum. A decrease in pulse voltage will decrease the MI. If pulsed Doppler is also enabled then pulsed Doppler will remain the dominant mode and the TI change will be small. 1-26

[Page 43] „ ‹ Color Sector Depth Deeper color sector depth may automatically decrease color frame rate or select a new color focal zone or color pulse length. The TI will change due to the combination of these effects. Generally, the TI will decrease with increased color sector depth. MI will correspond to the peak intensity of the dominant pulse type, which is a color pulse. However, if pulsed Doppler is also enabled then pulsed Doppler will remain the dominant mode and the TI change will be small. „ ‹ Scale Using the SCALE control to increase the color velocity range may increase the TI. The system will automatically adjust pulse voltage to stay below the system maximums. A decrease in pulse voltage will also decrease MI. „ ‹ Sec Width A narrower 2D-mode sector width in Color imaging will increase color frame rate. The TI will increase. MI will not change. If pulsed Doppler is also enabled, then pulsed Doppler will remain as the primary mode and the TI change will be small.  M mode and Doppler Controls „ ‹ Speed M-mode and Doppler sweep speed adjustments will not affect the MI. When M-mode sweep speed changes, TI changes. „ ‹ Simultaneous and Update Methods Use of combination modes affects both the TI and MI through the combination of pulse types. During simultaneous mode, the TI is additive. During auto-update and duplex, the TI will display the dominant pulse type. The displayed MI will be from the mode with the largest peak pressure. „ ‹ Sample Volume Depth When Doppler sample volume depth is increased the Doppler PRF may automatically decrease. A decrease in PRF will decrease the TI. The system may also automatically decrease the pulse voltage to remain below the system maximum. A decrease in pulse voltage will decrease MI. 1-27

[Page 44]  Doppler, CW, M-mode, and Color Imaging Controls When a new imaging mode is selected, both the TI and the MI will change to default settings. Each mode has a corresponding pulse repetition frequency and maximum intensity point. In combined or simultaneous modes, the TI is the sum of the contribution from the modes enabled and MI is the MI for the focal zone and mode with the largest derated intensity. If a mode is turned off and then reselected, the system will return to the previously selected settings. „ ‹ Probe Each probe model available has unique specifications for contact area, beam shape, and center frequency. Defaults are initialized when you select a probe. Samsung Medison factory defaults vary with probe, application, and selected mode. Defaults have been chosen below the FDA limits for intended use. „ ‹ Depth A decrease in 2D-mode depth will automatically decrease the 2D-mode frame rate. This would decrease the TI. The system may also automatically choose a deeper 2D-mode focal depth. A change of focal depth may change the MI. The MI displayed is that of the zone with the largest peak intensity. „ ‹ Application Acoustic output defaults are set when you select an application. Samsung Medison factory defaults vary with probe, application, and mode. Defaults have been chosen below the FDA limits for intended use.  Related Guidance Documents For more information about ultrasonic bioeffects and related topics refer to the following; X ‹ AIUM Report, January 28, 1993, “Bioeffects and Safety of Diagnostic Ultrasound” X ‹ Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1998: Vol. 7, No. 9 Supplement X ‹ Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM, NEMA. 1998) X ‹ Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998) X ‹ Second Edition of the AIUM Output Display Standard Brochure, Dated March 10, 1994. (A copy of this document is shipped with each system.) X ‹ Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. FDA. September 1997. FDA. X ‹ Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA. 1998) 1-28

[Page 45] X ‹ WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non-Thermal Mechanisms for Biological Effects of Ultrasound, Ultrasound in Medicine and Biology , 1998: Vol. 24, Supplement1.  Acoustic Output and Measurement Since the first usage of diagnostic ultrasound, the possible human biological effects (bioeffects) of ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement), sometimes referred to as the Stowe Report, which reviewed available data on possible effects of ultrasound exposure. Another report “Bioeffects and Safety of Diagnostic Ultrasound,” dated January 28, 1993 provides more up to date information. The acoustic output for this system has been measured and calculated in accordance with the December 1985 “510 (K) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices,” except that the hydrophone meets the requirements of “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD 2-1992)  In Situ, Derated, and Water Value Intensities All intensity parameters are measured in water. Since water does not absorb acoustic energy, these water measurements represent a worst case value. Biological tissue does absorb acoustic energy. The true value of the intensity at any point depends on the amount and type of tissue and the frequency of the ultrasound that passes through the tissue. The intensity value in the tissue, In Situ , has been estimated using the following formula: 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 .53 Heart .66 Kidney .79 Liver .43 Muscle .55 1-29

[Page 46] l = skin line to measurement depth (cm) f = Center frequency of the transducer/system/mode combination (MHz) Since the ultrasonic path during an examination is likely to pass through varying lengths and types of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used for general reporting purpose; therefore, the In Situ value which is commonly reported uses the formula: 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 the maximum water values do not always occur at the same operating condition; therefore, the reported maximum water and derated values may not be related to the In Situ (derated) formula. Take for example a multi-zone array transducer that has maximum water value intensities in its deepest zone: the same transducer may have its largest derated intensity in one if its shallowest focal zones.  Acoustic Output and Measurement The terms and symbols used in the acoustic output tables are defined in the following paragraphs. ISPTA.3 The derated spatial-peak temporal-average intensity (milliwatts per square centimeter). ISPPA.3 The derated spatial-peak pulse-average intensity (watts per square centimeter). The value of IPA.3 at the position of global maximum MI (IPA.3@MI) may be reported instead of ISPPA.3 if the global maximum MI is reported. MI The Mechanical Index. The value of MI at the position of ISPPA.3, ([email protected]) may be reported instead of MI (global maximum value) if ISPPA.3 is 190W/cm2 Pr.3 The derated peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the reported MI value. WO The ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, WO is the total time-average power;. For operating conditions subject to reporting under ISPPA.3, WO is the ultrasonic power associated with the transmit pattern giving rise to the value reported under ISPPA.3 fc The center frequency (MHz). For MI and ISPPA.3, fc is the center frequency associated with the transmit pattern giving rise to the global maximum value of the respective parameter. For ISPTA.3, for combined modes involving beam types of unequal center frequency, fc is defined as the overall ranges of center frequencies of the respective transmit patterns. ZSP The axial distance at which the reported parameter is measured (centimeters). 1-30

[Page 47] x-6,y-6 are respectively the in-plane (azimuth) and out-of-plane (elevation) -6 dimensions in the x-y plane where ZSP is found (centimeters). PD The pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of the respective parameter. PRF The pulse repetition frequency (Hz) associated with the transmit pattern giving rise to the reported value of the respective parameter. EBD The entrance beam dimensions for the azimuth and elevation planes (centimeters). EDS The entrance dimensions of the scan for the azimuth and elevation planes (centimeters).  Acoustic Measurement Precision and Uncertainty The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below. Quantity Precision Total Uncertainty PII.3 (derated pulse intensity integral) 3.2 % +21 % to - 24 % Wo (acoustic power) 6.2 % +/- 19 % Pr.3 (derated rarefaction pressure) 5.4 % +/- 15 % Fc (center frequency) < 1 % +/- 4.5 % „ ‹ Systematic Uncertainties. For the pulse intensity integral, derated rarefaction pressure Pr.3, center frequency and pulse duration, the analysis includes considerations of the effects on accuracy of: Hydrophone calibration drift or errors. Hydrophone / Amp frequency response. Spatial averaging. Alignment errors. Voltage measurement accuracy, including. X ‹ Oscilloscope vertical accuracy. X ‹ Oscilloscope offset accuracy. X ‹ Oscilloscope clock accuracy. X ‹ Oscilloscope Digitization rates. 1-31

[Page 48] X ‹ Noise. The systematic uncertainties Acoustic power measurements using a Radiation Force are measured through the use of calibrated NIST acoustic power sources. We also refer to a September 1993 analysis done by a working group of the IEC technical committee 87 and prepared by K. Beissner, as a first supplement to IEC publication 1161. The document includes analysis and discussion of the sources of error / measurement effects due to: 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. The overall findings of the analysis give a rough Acoustic Power accuracy figure of +/- 10% for the frequency range of 1 - 10 MHz.  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. 1-32

[Page 49] Environmental Protection X ‹ The console and peripherals could be sent back to manufacturers for recycling or proper disposal after their useful lives. X ‹ Disposal of waste shall be disposed in accordance with national laws. X ‹ The waste sheaths are to be disposed of safely and national regulations must be observed. Correct Disposal of This Product (Waste Electrical & Electronic Equipment) Applicable in countries with separate collection systems This marking on the product, accessories or literature indicates that the product and its electronic accessories (e.g. charger, headset, USB cable) should not be disposed of with other household waste at the end of their working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources. Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can take these items for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchase contract. This product and its electronic accessories should not be mixed with other commercial wastes for disposal. State of California Proposition 65 Warning (US only) WARNING: This product contains chemicals known to the State of California to cause cancer and reproductive toxicity. 1-33

[Page 50]

[Page 51] Chapter 2 Introduction ‹ ‹ Specifications 2-3 ‹ ‹ Product Configuration and Installation 2-6 Monitor 2-9 Control Panel 2-11 Console 2-16 Peripheral Devices 2-18 Probe 2-21 Accessories 2-22 Optional Functions 2-23

[Page 52]

[Page 53] Specifications Height: 1,380mm (with monitor) Width: 450mm Physical Dimensions Depth: 700mm Weight: more than 64kg (with monitor) 2D imaging mode M imaging mode Color Doppler Imaging (CDI) mode Power Doppler Imaging (PDI) mode Directional Power Doppler Imaging (DPDI) mode Pulse Wave (PW) Spectral Doppler imaging mode Continuous Wave (CW) Spectral Doppler imaging mode Imaging modes Tissue Doppler Imaging (TDI) mode 3D imaging mode Dual modes Quad modes Combined modes Simultaneous mode ElastoScan mode (E Mode) Zoom Gray Scale 256 (8 bits) Transmit focusing, maximum of eight points (four points simultaneously selectable) Focusing Digital dynamic receive focusing (continuous) Mini DLP Type Curved Linear Array C2-5, C2-8, C4-9, CF4-9 Linear Array L3-8, L5-12/50, LN5-12 Phased Array P2-4, PN2-4, SP3-8 Endocavity Curved Linear Array ER4-9, EVN4-9 Volume Probe 3D4-8, 3D4-9, 3DC2-6, VN4-8 CW Probes CW2.0 (Type BF / IPX7) 156 Pin Type Curved Linear Array C2-5, C2-8, C4-9/10ED Linear Array HL5-12ED, L3-8, L5-12/50EP, LN5-12 Phased Array P2-4AH, P3-7AC Endocavity Curved Linear Array ER4-9/10ED, EV4-9/10ED Volume Probe (260 Pin) 3D4-8ET, 3D4-9ES, 3DC2-6 2-3

[Page 54] Probe connections 4 probe connectors (including one CW probe connector) 19 inch LCD monitor (LED Backlight unit) called "LCD monitor" henceforth ECG Type CF VHS and SVHS VCR left and right audio B/W printer video and remote control Rear Panel VGA monitor Input / Output Parallel port Connections USB LAN Maximum 7084 frames for Cine memory Image Storage Maximum 8192 Lines for Loop memory Image filing system Obstetrics, Gynecology, Abdomen, Cardiac, Urology, Vascular, Small Parts, Application Musculoskeletal, TCD, Pediatric Electrical Parameters 100-120V/200-240VAC, 680VA, 50/60Hz Obstetrics, Gynecology, Cardiac, Carotid, Fetal Echo, UE Artery, LE Artery, UE Vein, LE Measurement Packages Vein, Urology, Radiology, TCD, Thyroid, Breast, Testicle, Superficial, Pediatric Hips, MSK * Refer the Chapter 5 for additional information TGC control Mode-independent gain control Acoustic power control (adjustable) Signal processing Dynamic aperture (Pre-processing) Dynamic apodization Dynamic range control (adjustable) Image view area control M-mode sweep speed control Frame average Edge Enhancement / Blurring Signal processing Gamma-scale windowing (Post-processing) Image orientation (left/right and up/down, rotation) White on black/black on white Zoom Trackball operation of multiple cursors 2D mode: Linear measurements and area measurements using elliptical Measurement approximation or trace M mode: Continuous readout of distance, time, and slope rate Doppler mode: Velocity and trace 2-4

[Page 55] VCR Video Page Printer Color Video Page Printer USB Video Printer USB Color Video Printer USB HDD Auxiliary USB Wireless LAN USB Foot Switch (IPX1) USB Flash Memory Media Microphone e-motion marker (IPX7) User Interface English, German, French, Spanish, Italian, Russian, Chinese, Portuguese Operating: 700hPa to 1060hPa Pressure Limits Storage: 700hPa to 1060hPa Operating: 30% to 75% Humidity Limits Storage & Shipping: 20% to 90% Operating: 10°C ~ 35°C Temperature Limits Storage & Shipping: -25°C ~ 60°C 2-5

[Page 56] Product Configuration and Installation This product consists of the monitor, the control panel, the console, the peripheral devices, and the probes. 1 Monitor 2 Monitor Hinge 1 3 Speaker 4 Keyboard & Control Panel 5 Probe Holder 6 Handle 2 7 Cable Hook 8 Lift 4 9 DVD Drive 0 Probe Port ! Wheel [Figure 2.1 Front of the SONOACE R7] 2-6

[Page 57] 1 Handle (Optional) 2 Storage Space 3 Ventilation 4 Rear Panel 5 Cable Hook 6 Power Connection Part [Figure 2.2 Back of the SONOACE R7] 2-7

[Page 58] Principles of Operation Tips! Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a probe. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. For example, in the case of tissue, an echo is created where a signal passes from an adipose tissue region to a muscular tissue region. The echoes return to the probe where they are converted back into electrical signals. These echo signals are highly amplified and processed by analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. All signal transmission, reception and processing characteristics are controlled by computer. Type of probe port Tips! SonoAce R7 v3.01.00 features the Mini DLP type probe port. If you have the lower version than v2.00, the probe port is 156/260 Pin type. <Mini DLP Type PSA> <v1.xx.xx :156 Pin Type PSA> ※ 3D probes are 260 pin type. 2-8

[Page 59] The color LCD monitor displays ultrasound images and other information. NOTE: The monitor of this system does not provide an OSD (On Screen Display) feature.  Monitor Display The monitor displays ultrasound images, operation menus and a variety of other information. As shown in the figure below, the screen contains: ① Title Area, ② Menu, ③ Image Area, ④ Thumbnail Area, ⑤ User Information Area, ⑥ Soft Menu. [Figure 2.3 Monitor Display] „ ‹ Title Area The title area displays the patient name, hospital name, application, frame rate and depth, probe information, acoustic output information, and the date and time. 2-9

[Page 60] „ ‹ Menu This displays the utility menu or measurement menu. „ ‹ Image Area The ultrasound image, image information, annotation, and measurement are displayed in the image area. „ ‹ Thumbnails Area When clicking on the Save button, the saved images are displayed. If you place the pointer on an image and click, the image is magnified. Up to 7 images are displayed. „ ‹ User Information Area User information area provides a variety of information necessary for system use e.g. current system status, image information, available items, BodyMarkers, and so on. Displaying the current status of the system Tips! : Shows the status of LAN connection. : Shows whether a removable disk is connected to the system. Double-click the icon to display the Storage Manager window. : Shows the total disk space and available disk space for the system. : Shows Caps Lock ‘On’ When user press the Caps Lock on the alphanumeric keyboard. Under the ‘Caps Lock On’ status, user can input text as large character. „ ‹ Soft Menu Different items are displayed in the menu, depending on the current status of the system. To set or change the items in the Soft Menu, use the dial-button for the corresponding number on the control panel. 2-10

[Page 61] Control Panel The system can be controlled with the control panel. Quad APTD × T TD HC BPD AC FL CRL GS [Figure 2.4 Control Panel] The control panel consists of a keyboard, buttons, dial-buttons, a switch, a slide, and a Trackball. The dial-button can be used both as a dial and a button.  Control Panel Map The following are descriptions and instructions for the controls on the control panel. For more information on the buttons with multiple functions, see Chapter 3 and later of this manual. Button Turns the system on/off. On/Off Displays the Patient Information screen, which allows you to select a patient Patient Button ID or enter information on a new patient. 2-11

[Page 62] Displays the Probe Selection screen to select or change probes Probe Button and applications. End Exam Button Finishes the current patient’s exam and resets the related data. Displays the Report screen to show the measurement results of the Report Button corresponding application. Performs preset functions. See Chapter 7 ‘Setting Peripheral Devices’ in User 1 Button ‘Utilities’ for more detailed information. SonoView Button Runs SonoView, which is the image filing program. Freq. Switch Changes the frequency of the probe. Focus Switch Moves focus onto the area for observation. Depth Switch Adjusts the scanning depth of the image. Dual Button Used for Dual mode. M Button Press this dial-button to start/stop M mode. PD Button Press this dial-button to start/stop Power Doppler mode. C Button Press this dial-button to start/stop Color Doppler mode. 2D Button Press this dial-button to start 2D mode. PW Button Press this dial-button to start/stop PW Spectral Doppler mode. Press this dial-button to start/stop CW Spectral Doppler mode. CW Button This can only be used for the Phased Array probe. X ‹ Q Scan: When pressing this dial-button, the Quick Scan function turns on. The Q Scan indication displays at the top of an image. This can be used in specific applications with specific probes. Q Scan Dial- / Gain / R.S button X ‹ Gain: Rotate this dial-button to adjust the gain. X ‹ R.S: In 3D View mode, you can move the reference slice parallel by rotating this dial-button. R.S stands for Reference Slice. 3D / 4D Button Starts/Finishes 3D/4D mode. Button Pauses/Resumes scanning. Freeze Button Prints the image on the screen using the printer connected to the system. Print 2-12

[Page 63] Button Saves the images or reports on the screen in the database. Save X ‹ Menu: Press this dial-button to change a page on the Soft Menu. Select an item when the measurement menu or utility menu is displayed. X ‹ Angle: Adjust the angle by rotating this dial-button. In Spectral Doppler Menu Dial- / Angle button mode, the angle of a sample volume is adjusted by 1°. In 2D mode, if the sector width is not 100%, the image can be shifted horizontally. In BodyMarker mode and Indicator mode, the angle of the probe cursor and the indicator can be adjusted. Deletes the text, indicator, BodyMarker, and measurement result, etc. Clear Button displayed on an image. Changes the Soft Menu. Every time you press this button, the Soft Menu Active Mode Button changes to the Soft Menus for the other modes that are used in the current Active mode. Button Selects an item or value using the trackball. Set Button Exits the currently used function and returns to the previous function. Exit Button Starts to measure distance, circumference, area, and volume. Caliper Button Starts measurements by application. Calculator Changes the function of the trackball to other functions. For example, this Button button resets the location of the dot which was last placed during the Change measurement. Changes the image to panning status. Button In PW or CW Spectral Doppler mode, if this button is pressed, the mode Update changes to D only mode. Button Displays an arrow-shaped pointer on the screen. Pointer Trackball Trackball Moves the cursor on the screen and scrolls through Cine images. Adjusts the TGC values for each depth using 8 slides. TGC stands for Time TGC Slide Gain Compensation. CAUTION: If the gain values of neighboring TGC slides are adjusted with a large difference, bands may occur on the image. 2-13

[Page 64] „ ‹ Soft Menu Performs the functions of the corresponding number on the Soft Menu. Soft Menu Dial- Different items are displayed in the menu, depending on the current 1 ~ 6 button status of the system. Adjust the items by pressing or rotating the dial- button. How to use the Soft Menu Dial-Buttons Tips! The Soft Menu is divided into top and bottom rows. Depending on the situation, you can use two functions with one Soft Menu button. X ‹ Soft Menu Top ( 1 ): Turn the Soft Menu dial-button to select or adjust a function. X ‹ Soft Menu Bottom ( 2 ): Press the Soft Menu dial-button to select or adjust a function. [Figure 2.5 Soft Menu] Soft Menu Dial-buttons [4] to [6] Tips! In 3D View mode, the Soft Menu dial-buttons [4] to [6] have the following functions: X ‹ Soft Menu Dial-button [4] : Rotates the image to the X axis. X ‹ Soft Menu Dial-button [5] : Rotates the image to the Y axis. X ‹ Soft Menu Dial-button [6] : Rotates the image to the Z axis. „ ‹ Keyboard The keyboard allows you to enter text and execute a variety of functions quickly using the function keys. Quad APTD × T TD HC BPD AC FL CRL GS [Figure 2.6 keyboard] 2-14

[Page 65] Esc Quad Starts Quad mode. F1 Displays the Help Manual on the screen. Help F2 Starts Indicator mode. Indicator Starts Text mode. But, if you select the checkbox: Utility > Setup > Utility F3 > Text Setup > Quick Text, you can enter text immediately without Text pressing this key. F4 Starts BodyMarker mode. BodyMarker F5 Displays the Utility menu on the screen. Utility F6 APTD X TTD Starts APTD X TTD measurement F7 HC Starts HC measurement F8 BPD Starts BPD measurement. F9 AC Starts AC measurement. F10 FL Starts FL measurement. F11 CRL Starts CRL measurement. F12 GS Starts GS measurement. Every time you press the Space bar, the information on the screen disappears in this sequence, Image Information → Gray Scale Bar / Color Space Bar Bar → TGC. After all the information has disappeared, if you press the Space bar, all the information returns to the screen.  ,  Allows you to adjust the monitor brightness.  ,  Allows you to adjust volume in Spectral Doppler Mode.  Adjusting Control Panel Carefully move the control panel up and down while pressing the lever on the control panel handle. CAUTION: Do not apply excessive force to the control panel. 2-15

[Page 66] Console The console consists of two parts – the inner unit and the outer unit. The interior of the console mainly contains devices that produce ultrasound images. On the exterior of the console are various connectors, probe holders, storage compartments, handles, wheels, etc.  Rear Panel A monitor and other peripheral devices like printer, VCR, etc. are connected via the rear panel at the back of the system. 1 MIC Port (Input): Connects the mic. 2 Remote Print Port (Output): Prints out remotely by connecting the Echo printer. 3 B/W Printer Port (Output): Connects the Echo printer. 4 Parallel Port (Output): Connects the printer and foot switch. 5 DVI Port (Output): Outputs digital signals on the monitor. 6 USB Port: Connects USB peripheral devices. 7 Network Port: Connects to network. Patient information can be transferred to other servers through the DICOM network. 8 S-VHS Port (Output): Connects S-VHS VCR. 9 VHS Port (Output): Connects VHS VCR. 0 Audio Port (Output): Used for outputting audio signals. [Figure 2.7 Rear Panel] 2-16

[Page 67]  Power Connection Part The power connection part is located at the back of the system body. [Figure 2.8 Power Connection Part] Item Descriptions 1 Power Switch: Supplies or cuts power to the entire system. 2 Power Inlet: Connects the power cable to an external power source. 3 Fuse Holder: Holds the inlet fuse Equipotential Terminal: This should be connected to the equipotential connection part in the exam room. 5 Output rating change switch: Selects the output power. Auxiliary socket outlet: Supplies an external peripheral device with power from the product's internal power supply.  Probe Holder A probe holder is mounted at the left and right side of the control panel. 2-17

[Page 68] Peripheral Devices CAUTION: Do not place peripheral devices, not listed in this manual, inside the patient environment. If you place them in the patient environment, it may cause electrical hazard. N N N N [Figure 2.9 Patient Environment] NOTE: Refer to the operation manual of peripheral device about its operating.  Internal Peripheral Devices These are peripheral devices mounted in the system. „ ‹ DVD-Multi DVD+R, DVD+R DL, DVD+RW, DVD-R, DVD-R DL, DVD-RW, DVD -RAM, DVD-ROM, CD-ROM, CD-R, CD-RW „ ‹ Hard Disc Drive Min. 200Gbyte-SATA 2-18

[Page 69]  External Peripheral Devices These are peripheral devices that can be connected for use when needed and are connected via the USB port located at the rear panel. X ‹ When using a peripheral device from a USB port, always turn the power off before connecting/ disconnecting the device. Connection/discon-nection of USB devices during power-on may lead to malfunction of the system and USB devices. X ‹ Do not connect additional external peripheral devices to the auxiliary socket outlet. Doing so may decrease safety level. X ‹ When remove the removable disk, use Utility > Storage manager . X ‹ USB ports are located both on the front panel and the rear panel of the console. Connect a USB storage device (Flash memory media, etc) to the port on the front panel. Connect other USB peripheral devices to the port on the rear panel for your convenience. The following products are recommended: „ ‹ Video Cassette Recorder (VCR) Panasonic MD835, SONY DVO-1000MD, JVC BD-X201 „ ‹ Video Page printer X ‹ Color : Mitsubishi CP910U, Mitsubishi CP910E, SONY UP-20 X ‹ Black and White : Mitsubish P93W, SONY UP-897MD „ ‹ USB Video Printer X ‹ Color : Mitsubish 30DW, SONY UP-D23MD, SONY UP-D25MD X ‹ Black and White : Mitsubishi P93DW, Mitsubishi P95D, SONY UP-D897 X ‹ You must install a Microsoft Windows XP™ or above (English) compatible printer and driver. Contact Samsung Medison Customer Service Center 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 used in printer before connecting. Printers should be connected to the Printer port while the USB printer connected to the USB port. 2-19

[Page 70] „ ‹ USB to RS-232C Serial Cable USB to Serial (RS-232C) Converter with FTDI Chipset (FTDI FT232BM Compatible) NOTE: For more information about the Open Line Transfer, refer to `Chapter 5. Measurements and Calculations’. „ ‹ USB Foot Switch Set the function of the foot switch in Utility > Setup > Peripherals > Foot Switch ; Freeze, Update, Record, Print, Store, or Volume Start. WARNING: Foot Switch cannot be used in the operating room. „ ‹ Others Flash Memory media X ‹ If you use the USB 1.1 flash memory, the system cannot recognize it. In the case of this, delete the flash memory from the console and quip again. 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 a Flash Memory. 2-20

[Page 71] Probe Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation. NOTE: For more information, refer to `Chapter9 Probes’. Be sure to connect or disconnect probes when the power is off to ensure the safety of the system and the probes. 1. Push the probe’s lockdown switch to the left and disconnect the probe. 2. Connect the probe to the probe port. 3. Push the probe’s lockdown switch to the right to lock it in place. How to connect 156 Pin Type probe (include 3D probes) Tips! 1. Equip probes to the probe connectors on the front panel of the system. A maximum of three probes can be connected at one time. 2. Turn the connector-locking handle clockwise. 2-21

[Page 72] Accessories An accessory box containing the items below is supplied with the product. CAUTION: Main cord set, separately certified according to the relevant standards, is to be used when supplied to EU and USA/CAN. SONO GEL GROUND CABLE VTR CORD FUSE MANUAL CLAMP VELCRO POWER CORD WINDOWS XP LABEL DVI2RGB GENDER [Figure 2.10 Accessories] NOTE: Accessories can be different according to the country. 2-22

[Page 73] Optional Functions This product has the following optional functions: X ‹ 4D X ‹ DICOM X ‹ 3D XI X ‹ Auto IMT X ‹ Cardiac Measurement X ‹ Auto IMT+ X ‹ Spatial Compound X ‹ CW Function X ‹ ElastoScan X ‹ DynamicMR/DynamicMR+ X ‹ Stressecho X ‹ Panoramic X ‹ Strain X ‹ e-Motion Marker For further information about optional functions, please refer to the relevant chapters in this manual. 2-23

[Page 74]

[Page 75] Chapter 3 Starting Diagnosis ‹ ‹ Power Supply 3-3 Powering On 3-3 Powering Off 3-3 ‹ ‹ Probes & Applications 3-4 Probe Selection and Application 3-5 Changing Application 3-5 Editing Probe Preset Values 3-5 ‹ ‹ Patient Information 3-7 Patient Information for Application 3-9 Finding Patient Information 3-15 Managing Patient Exams 3-17 Changing Measurements 3-23

[Page 76]

[Page 77] Power Supply Boot the system for use. CAUTION: Make sure to connect the probe and peripheral devices that will be used before powering on the system. If you attempt to connect them during system use, it may lead to patient injury or fatal damage to the console. Powering On Press the On / Off button when the power is off. Booting begins, and the product logo appears on the screen. When booting is completed, the 2D mode screen appears in End Exam status. CAUTION: Before starting the diagnosis, you must register the patient information. X ‹ The product should be turned on about 10 seconds after the power switch at the back of the product is turned on. X ‹ During system booting, do not press any key on the keyboard. It may cause product malfunction. X ‹ If you turn on the power after turning it off forcibly, the system may turn on and off momentarily. This is one of the characteristics of the Intel® PC main board, not a system error. Powering Off Press the On / Off button while using the system. CAUTION: If you hold down the On / Off button for five seconds or longer, the product power is turned off forcibly. This may cause hard disk damage. NOTE: To ensure that the product is safely cut off from electrical power, always set the power switch at the rear of the product to the Off position when the product is not in use. 3-3

[Page 78] Probes & Applications Before scanning, select a probe and an application. CAUTION: Please refer to "Chapter 9. Probes” for more information about the probes supported by this system. Press the Probe button on the control panel and then the Probe Selection screen will appear. In this window, you can select or change probes and applications and edit probe presets. [Figure 3.1 Probe Selection] 3-4

[Page 79] Probe Selection and Application 1. Select a probe and an application on the screen by using the Trackball and the Set button. 2. Press the Soft Menu dial-button [5] OK to make a selection. Press the Soft Menu dial-button [6] Cancel to cancel a selection. Selecting a probe with a Soft Menu button Tips! Press a Soft Menu button for the probe that you want. Changing Application 1. After checking the currently selected probe, select an application using the Trackball and Set button. 2. Press the Soft Menu dial-button [5] OK on the screen. Press the Soft Menu dial-button [6] Cancel to cancel a selection. Editing Probe Preset Values The probe settings are preset with optimal values for each application. However, if needed, you can change the preset values as follows: 1. After checking the currently selected probe and application, change the probe settings using the Trackball and Set button under Preset. X ‹ A Userset such as User1 can be selected for each setting. Usersets are available under Preset. User Preset Tips! If user presets are specified, the specified name will appear in the title area. For example, if the Cardiac application along with the preset User1 is selected, ‘Cardiac/User1’ will be displayed in the title area. 2. Press the Soft Menu dial-button [5] OK on the screen. Press the Soft Menu dial-button [6] Cancel to cancel a selection. 3-5

[Page 80] Changing probe settings with a Soft Menu button Tips! Press the Utility button on the control panel. The current probe settings are shown in the Soft Menu [2] and [3] . Rotate the Soft Menu dial-button [2] and [3] to select desired settings. Press the Soft Menu dial-button [3] to apply the selected settings to the system. NOTE: To change the value for presets, press Utility . Please refer to ‘Chapter 7. Utility’ for details. 3-6

[Page 81] Patient Information Press the Patient button on the control panel and the Patient Information screen will appear on the screen. In this screen, you can enter, search, or change patient information. Patient information includes basic information such as the patient ID, name, DOB, and gender, together with additional information for applications. NOTE: The ID and name fields are required.  Entering Basic Patient Data You can enter or change basic patient data at the top of the Patient Information screen. Use the Trackball and the Set button to select the desired field. Or, use the Menu dial-button to move between fields. „ ‹ ID Enter a patient ID. X ‹ To enter it manually, enter an ID in the ID field. X ‹ To enter it automatically, select Auto ID Creation and press New . The icon is changed to . X ‹ If you enter an ID that exists already, the icon next to the ID field is changed to . „ ‹ Name Enter patient’s full name. X ‹ Last Name: Enter the patient’s last name. X ‹ First Name: Enter the patient’s first name. X ‹ Middle Name: Enter the patient’s middle name. X ‹ The name that you have entered will appear in the title area and reports. „ ‹ Birth Enter the patient’s birth date in the specified format. 3-7

[Page 82] „ ‹ Age Enter the patient’s age in “yy-mm” format. When a birth date is specified in the Birth field, this information is automatically calculated and displayed. „ ‹ Gender Select the patient’s gender. „ ‹ Accession When viewing the worklist for a patient via the DICOM server, this information is automatically filled. [Figure 3.2 The Patient Information] 3-8

[Page 83] Patient Information for Application In Study Information, enter additional patient information or change the existing patient information required for a diagnosis. 1. In the Patient Information screen, press the Study Information tab. 2. In Category , select an application. 3. Enter additional information required for a diagnosis. Pressing Clear Measure deletes all existing measurements entered.  General In Category , select General . Enter additional information. The items in General are also included in the patient information screen for other applications. „ ‹ Height Enter the patient’s height in Inches (in) or Centimetres (cm). Press the unit button to change the unit. When the unit is changed, the entered number is automatically recalculated and displayed in the changed unit. „ ‹ Weight Enter the patient’s weight in Ounces (oz), Pounds (lb) or Kilograms (Kg). Press the unit to change it. „ ‹ BSA (Body Surface Area) When height and weight are entered, BSA (Body Surface Area) is automatically calculated and displayed. „ ‹ HR (Heart Rate) Enter a heart rate. „ ‹ Diag. Physician (Diagnostic Physician) Enter the name of the physician who diagnosed the patient. When there is more than one physician available, you can use the combo button to make a selection. 3-9

[Page 84] „ ‹ Ref. Physician (Ref. Physician) Enter the name of the physician. When there is more than one physician available, you can use the combo button to make a selection. „ ‹ Sonographer Enter the name of the sonographer who scanned the patient. When there is more than one sonographer available, you can use the combo button to make a selection. „ ‹ Description Enter a description of the diagnosis. If a description is entered, it can be searched for and viewed under Description in SonoView . „ ‹ Indication Enter a brief description of the symptom or disease. [Figure 3.3 Study Information - General] 3-10

[Page 85]  OB In Category , select OB . Enter additional information for OB. [Figure 3.4 Study Information - OB] „ ‹ LMP (Last Menstrual Period) Enter the last menstrual period for a patient. You can enter it manually in the specified format, or have it automatically calculated and displayed with the GA entered. „ ‹ GA (LMP) It indicates the gestational age of a patient. You can enter it manually in the specified format, or have it automatically calculated and displayed with the LMP entered. „ ‹ EDD (LMP) With the LMP or GA entered, EDD (Expected Date of Delivery) is calculated and displayed. Calculating EDD (LMP) Tips! EDD can be calculated by entering LMP or GA. X ‹ When LMP is entered: GA and EDD are automatically calculated and displayed on the screen. X ‹ When GA is entered: LMP and EDD are automatically calculated and displayed on the screen. „ ‹ Estab. Due Date Enter EDD in the specified format. 3-11

[Page 86] „ ‹ Ovul. Date Enter an ovulation date in the specified format. LMP, GA, and EDD will be automatically calculated and displayed. Calculating LMP and EDD (LMP) with Ovul. Date Tips! The following formulae are used: X ‹ LMP = Ovul. Date - 14 X ‹ EDD = (280 -14) + Ovul. Date „ ‹ Gestations Enter the number of fetuses, up to maximum of 4. „ ‹ Day of Cycle Enter a menstrual period in number of days (dd). „ ‹ Ectopic Enter the number of ectopic pregnancies „ ‹ Gravida Enter the number of pregnancies. „ ‹ Para Enter the number of deliveries. „ ‹ Aborta Enter the number of miscarriages. „ ‹ New Pregnancy Delete previous OB data for this patient. 3-12

[Page 87]  Gynecology In Category , select Gynecology . Enter additional information for Gyn. This is the same information as for OB. NOTE: In the GYN information input screen, even if the Ovul. Date is entered, LMP and EDD will not be calculated automatically. [Figure 3.5 Study Information - Gynecology]  Cardiac In Category , select Cardiac . Enter additional information for Cardiac. [Figure 3.6 Study Information - Cardiac] „ ‹ RAP (Right Atrium Pressure) Enter blood pressure. „ ‹ BP (Body Pressure) Enter maximum/minimum blood pressures. 3-13

[Page 88]  Urology In Category , select Urology . Enter additional information for Urology. „ ‹ PSA (Prostate Specific Antigen) Enter the PSA value. [Figure 3.7 Study Information - Urology] 3-14

[Page 89] Finding Patient Information In the Patient Information screen, select the Search tab.  Local Search Search through the information stored in the system. 1. In Search Source , select Local . 2. In Search By , select a search condition. X ‹ Select Patient ID to search by ID, or select a patient’s name under Patient Name to search by name. 3. In the Search window, enter an ID or name and press Search . The list of patients who meet the conditions will appear. Pressing Search All will show a list of all the patients stored in the system. X ‹ In the list, press ID or Name to sort the information alphabetically or numerically by the selected item. 4. Select the desired patient and press Apply . The information on the selected patient will be applied to the system. Press Select All to select all the patients in the list. Press Delete to delete the ID and other information for the selected patient. [Figure 3.8 Search - Local] WARNING: If a patient ID is deleted, all related data and images stored in SonoView are erased. 3-15

[Page 90]  Worklist Search Perform a search by connecting to the DICOM Modality Worklist server in the hospital network. 1. In Search Source , select Worklist . 2. Enter more than one item from among Patient ID, Last Name, Accession # or Procedure ID, and then press Search . The list of patients who meet the condition will appear. X ‹ In the list, press Date/Time or Patient Name to sort the information alphabetically or numerically by the selected item. 3. Select the desired patient and press Apply . The information on the selected patient will be applied to the syste m. [Figure 3.9 Search - Worklist] NOTE: The worklist server is configured under the DICOM tab on the Setup screen. Please refer to “DICOM Setting” in ‘Chapter 7. Utility’. 3-16

[Page 91] Managing Patient Exams In the Patient Information screen, select the Exam View tab. The list of exams for the patient ID applied in the previous search will appear. NOTE: The exam list appears only when a patient searches is completed and the related patient information is applied to the system. In addition to the patient ID, Age and Gender, information such as the Exam Date, the number of images stored (Images), the measurement status (Measure), the report creation status (Structured Report, SR), the exam transfer status (Storage Commit, SC) and the lock status are displayed. You can press ID or Name to sort the information alphabetically or numerically by the selected item. To select more than one exam, press the Set button while holding down the Ctrl button on the keyboard. [Figure 3.10 Exam View]  Executing Exam Use the Trackball and the Set button to select an exam, and then press Review Exam or Continue Exam on the screen. For an exam currently being executed, the button is displayed as Current Exam and disabled. NOTE: If the selected exam has been executed in the past 24 hours, the button in the lower left corner is displayed as Continue Exam . If the exam was executed earlier than this, the button is displayed as Review Exam . 3-17

[Page 92] „ ‹ Continue Exam In addition to using the Resume Exam function, you can update the current scan with the exam executed previously. The selected exam appears on the screen and scanning is available. The initial execution date for the corresponding exam (Exam Resumed) is displayed in the feedback area. Double-clicking a stored image in the thumbnail area in the right side of the screen retrieves the image and displays the stored image information. In the retrieved exam screen, you can perform measurements or enter text, BodyMarkers or indicators. „ ‹ Review Exam The selected exam appears on the screen. Double-clicking a stored image in the thumbnail area in the right side of the screen retrieves the image and displays the initial execution date for the corresponding exam (Exam Reviewed) and the stored image information. In the retrieved exam screen, you can perform measurements or enter text, BodyMarkers or indicators.  Viewing Exam Select an exam by using the Trackball and the Set button, and press Review on the screen. Switch to the SonoView screen. NOTE: For information on using SonoView, please refer to "Chapter 6. Image Management.”  Deleting Exam Select an exam by using the Trackball and the Set button, and press Delete on the screen. All images for the exam will be deleted. However, an exam in progress or a locked exam cannot be deleted. NOTE: Once deleted, exams cannot be restored. 3-18

[Page 93]  Sending Exams via DICOM You can send the selected exams via the DICOM network. NOTE: Before using this feature, make sure that DICOM is properly configured. For information on configuring DICOM, please refer to the “DICOM Setting” section in ‘Chapter 7. Utility’. 1. Select an exam(s) and then press Send on the screen. The DICOM Storage window will appear. X ‹ To check the connection between the server and DICOM before sending, press Test . [Figure 3.11 DICOM Storage] 2. Select an image or report to send. You can select images under Storage Image, and reports under Storage SR. 3. Pressing Transfer starts a transfer and displays the transfer progress (%). To cancel the transfer, press Close . 3-19

[Page 94]  Printing Exams via DICOM You can print the selected exams via the DICOM network. You cannot print exams if DICOM has not been properly configured. 1. Select an exam(s) and then press Print on the screen. The DICOM Printer window will appear. X ‹ To check the connection between the server and DICOM before sending, press Test . 2. Select an Exam(s) to print. 3. Pressing Print starts printing and displays the transfer progress (%). To cancel printing, press Close . [Figure 3.12 DICOM Printer]  Exporting Exam You can save the selected exams in an external storage device. 1. Select exam(s) and then press Export on the screen. The Image Export window will be displayed. 2. Under Drive , select a media where the selected exams will be saved. You can select CD-ROM or Flash Memory. 3. Under File Name , specify the file name. The same file name is assigned to all images associated with an exam. When there is more than one image, a serial number is automatically appended to the end of the file name. 4. Under File Format , specify a file format in which files will be saved. You can select BMP, JPEG, TIFF or DICOM. 5. Under Export Option , select a file option(s). You can select more than one option. 3-20

[Page 95] X ‹ 3D Volume Data: Export the 3D volume data along with an image. X ‹ 2D Cine: Convert the stored Cine image to an. AVI file before exporting. X ‹ 3D and Live Cine: Convert the 3D Cine and Live Cine images to an .AVI file before exporting. X ‹ Use Patient ID for File Name: Use patient ID for file name automatically. X ‹ Hide Patient Information: Export an image without a patient ID and name. 6. Under Directories , select a location where the selected exams will be saved. To create a new directory, press and specify a directory name. To delete a directory, press . Under Files , files saved in the storage device are displayed. 7. Press Export to start saving. To cancel saving, press Close . [Figure 3.13 Image Export] 3-21

[Page 96]  Backing up Exam You can back up the selected exams in an external storage device. 1. Connect a storage media for backup. CD-ROM or Flash Memory can be used. 2. Select an exam(s) and then press Backup on the screen. 3. A confirmation window will appear asking whether to continue the backup. Press Yes to continue. Press No to cancel. 4. The Select Drive window will appear. Under Drive , select the media where the selected exams will be saved. 5. Press OK to start the backup. Press Cancel to cancel. [Figure 3.14 Exam Backup] 3-22

[Page 97] Changing Measurements In the Patient Information screen, press the Measure Data tab. Under the Measure Data tab, you can enter obstetrics measurements for a patient or check the existing measurements. Press the button, and the Insert screen will appear. X ‹ This option is available for obstetrics only and enabled only when a patient ID is selected. X ‹ If OB data has been changed under New Pregnancy at Patient Information > Study Information > OB , enter LMP before measurement data can be changed.  The Insert Screen You can enter the existing obstetrics measurements. „ ‹ Exam. Date Enter the measurement date. NOTE: If OB data has been changed under New Pregnancy , only dates between the new LMP and yesterday can be entered. „ ‹ Fetus If the fetus is a twin, identify each fetus. Up to 4 fetuses (A, B, C, D) can be specified. „ ‹ Exam No. Up to 8 exam numbers can be entered for each date. An exam number appears next to the Fetus field. „ ‹ New Data Cancel all measurement data entered for other exams and enter new measurement data. „ ‹ Clear Cancel entering the measurement data. 3-23

[Page 98] „ ‹ Insert Complete entering the measurement data. „ ‹ Page Browse Use the >> or << button. „ ‹ View Switch to the View screen. [Figure 3.15 Measure Data - Insert]  The View Screen You can view the measurements entered or save them in an Excel file. The * symbol next to Exam Date indicates that the data is the current measurement data. „ ‹ Package Select a measurement package to display on the screen. Enter the measurement date. „ ‹ Refresh Update the measurement data. New measurements, or the measurements entered, are added. 3-24

[Page 99] „ ‹ Save The Save To Excel window appears, allowing you to save information on the screen in an Excel file. By default, the Excel file name is set to the measurement ID. After specifying the target path and file name, press Save to save the information. To cancel saving, press Close . NOTE: Checking the HTML checkbox saves information in an HTML file instead of an Excel file. „ ‹ Insert Switch to the Insert screen. [Figure 3.16 Measure Data - View] 3-25

[Page 100]

[Page 101] Chapter 4 Diagnosis Modes ‹ ‹ Information 4-3 Diagnosis Mode Type 4-3 Basic Use 4-4 ‹ ‹ Basic Mode 4-6 2D Mode 4-6 Panoramic 4-13 M Mode 4-15 Color Doppler Mode 4-17 Power Doppler Mode 4-20 PW Spectral Doppler Mode 4-22 CW Spectral Doppler Mode 4-27 TDI Mode 4-28 TDW Mode 4-29 ElastoScan Mode 4-30 ‹ ‹ Combined Mode 4-37 2D/C/PW Mode 4-37 2D/PD/PW Mode 4-37 2D/C/CW Mode 4-37 2D/PD/CW Mode 4-37 2D/C/M Mode 4-38 2D/C Live Mode 4-38

[Page 102] Chapter 4 ‹ ‹ Multi-Image Mode 4-39 Dual Mode 4-39 Quad Mode 4-40 ‹ ‹ 3D/4D Mode 4-41 3D/4D Mode 4-41 3D StandBy Mode 4-43 3D View-MPR 4-47 3D XI Mode (Optional) 4-63

[Page 103] Information Diagnosis Mode Type This product supports a variety of diagnosis modes including Basic Mode, Combined Mode, Multi-Image Mode, and 3D Mode. „ ‹ Basic Mode: Consists of different modes, each of which has a specific usage and function. By default, 2D Mode is applied together with other mode. „ ‹ Combined Mode: For an image, two or three Basic Modes are applied at the same time. By default, 2D Mode is applied together with other mode. An image is viewed in a single screen. „ ‹ Multi-Image Mode: The screen is divided into two (dual) or four (quad) sub screens, each of which is used to view an image. Since each sub screen can display a different image, it can be a very useful feature, allowing multilateral views of an organ. „ ‹ 3D / 4D Mode: 3D images can be obtained. Consist of Freehand 3D, Static 3D Mode and 4D Modes. The types of diagnosis mode that are available with the product are shown below: Mode Type 2D Mode Color Doppler Mode Power Doppler Mode M Mode Basic Mode PW Spectral Doppler Mode CW Spectral Doppler Mode TDI Mode TDW Mode ElastoScan Mode (E Mode) 2D/C/PW Mode 2D/PD/PW Mode 2D/C/CW Mode Combined Mode 2D/PD/CW Mode 2D/C/M Mode 2D/C Live Mode Dual Mode Multi-Image Mode Quad Mode Freehand 3D Mode 3D / 4D Mode Static 3D Mode 4D Mode NOTE: The functionalities for each mode may be restricted by the selected probe. 4-3

[Page 104] Basic Use The items that can be used commonly in each diagnosis mode are shown below:  Using Control Panel The items that can be used in each diagnosis mode are provided as menu items. You can change the image format or optimize an image to facilitate your diagnosis. „ ‹ Q Scan / Gain / R.S X ‹ Q Scan: Press the dial-button to turn the Quick Scan function on. The Q Scan indication is displayed at the top of an image. In 2D Mode, the brightness and shading are optimized by automatically adjusting the gain and TGC. NOTE: The Quick Scan function can be used in specific diagnoses with specific probes. X ‹ Gain: Rotate the dial-button to adjust the gain. The Gain buttons differ depending on the diagnosis mode and the dial-button is usually used for selecting diagnosis modes. Also use the dial-button to adjust the brightness of the image. Rotating the dial-button clockwise increases the gain. X ‹ R.S: In 3D View mode, you can move the reference slice parallel by rotating the dial-button. R.S stands for Reference Slice. „ ‹ TGC (Time Gain Compensation) Use the TGC slide on the control panel. In general, ultrasound penetration gets weaker with depth. TGC can be used to compensate for this effect. The product provides eight TGC slides for varying depths, allowing you to adjust Gain by area. Among the eight slides, the top slide represents the shallowest area, while the lower slides represent the deeper ones. Move the slide to the right (+) to increase Gain, brightening the image. 4-4

[Page 105] „ ‹ Frequency Use the Freq. switch-button on the control panel. Use the switch-button to adjust the frequency of the currently used probe. Select from Res, Pen and Gen. X ‹ Res (Resolution): High frequency X ‹ Gen (General): General frequency X ‹ Pen (Penetration): Low frequency The selected frequency is displayed in the title area, allowing you to determine the state of the current frequency easily. „ ‹ Focus Use the Focus switch-button on the control panel. Use the switch-button to adjust the location of the focus. When the top of this button is pressed, the location of the focus becomes shallow. „ ‹ Depth Use the Depth switch-button on the control panel. Use the switch-button to adjust the scanning depth of an image. When the upper end of the button is pressed, the scanning depth of the image becomes shallow. When the lower end of the button is pressed, the scanning depth of the image becomes deep. The range of adjustment differs depending on the probe type you use.  Using Soft Menu The items that are commonly used in each diagnosis mode during scanning are provided as Soft Menu items. You can use the Soft Menu dial-button corresponding to a specific menu item on the control panel. If you rotate the dial-button, the setting for the selected item changes. If the Soft Menu is more than a page long, press the Menu dial-button on the control panel to change pages. 4-5

[Page 106] Basic Mode 2D Mode This basic mode, also referred to as B Mode (Brightness mode), provides scan planes of organs. This is used to display two-dimensional anatomy images in the direction of scanning in real time. [Figure 4.1 2D Mode]  Entering 2D Mode NOTE: Because 2D Mode is applied by default for all diagnosis modes, it cannot be terminated. Press the 2D button on the control panel. If you press the 2D button in other diagnosis modes, it will switch to the basic 2D Mode. 4-6

[Page 107]  2D Mode Soft Menu The items that are commonly used in 2D Mode during scanning are provided as Soft Menu items. You can use the Soft Menu dial-button corresponding to a specific menu item on the control panel. If you rotate the dial-button, the setting for the selected item changes. „ ‹ Dynamic Range / Harmonic Use the Soft Menu dial-button [1] . X ‹ Dynamic Range The contrast of an image is adjusted by adjusting the ratio of the minimum and maximum values of the input signals. Select a value between 50 and 200 by rotating the Soft Menu dial-button [1] . The larger the ratio, the smoother the image gets. X ‹ Harmonic When pressing the Soft Menu dial-button [1] , the HAR indication appears on the image information. The OHI (Optimal Harmonic Imaging) function, which allows you to optimize images by using high frequencies, is provided. NOTE: The Harmonic function can be used with specific probes. „ ‹ Reject Level / 2D/C Live Use Soft Menu dial-button [2] . X ‹ Reject Level Noise or echo is removed to make the image clearer. Select a value between 1 and 32 by rotating the Soft Menu dial-button [2] . X ‹ 2D/C Live Press the Soft Menu dial-button [2] . You can observe a scanned area in 2D and Color Doppler images simultaneously in real time. 4-7

[Page 108] „ ‹ FSI / M Line Use the Soft Menu dial-button [3] . X ‹ FSI Select a value between 1 and 3 by rotating the Soft Menu dial-button [3] . FSI stands for Full Spectrum Imaging. An image can be combined with the data obtained in 2D Mode using frequencies with various characteristics. Therefore the resolution is improved in a shallow area for observation and the penetration is improved in a deep area for observation. X ‹ M Line An M line is displayed on an image. Press the Soft Menu dial-button [3] to turn it on or off. The M line indicates where the observing image is located in the 2D image when M Mode or PW Mode is used with 2D mode. „ ‹ Read Zoom / Write Zoom Use the Soft Menu dial-button [4] . You can magnify an image. The zoom function is categorized as Read Zoom and Write Zoom according to magnification methods. X ‹ Read Zoom: Magnifies the images stored on the hard disk drive. 1. Rotate the dial-button to the left or right. 2. Adjust the location of the Zoom box using the Trackball. The location of the Zoom box on the image can be found through the Zoom Navigation box on the top left side of the screen. 3. Observe the magnified image. Rotate the dial-button clockwise to magnify the image. X ‹ Write Zoom: Magnifies and scans an image in real time. 1. Press the dail-button to select Write Zoom box. 2. The image is magnified and scanned. Use the Change button to adjust the location and size of the Zoom box. Every time the Change button is clicked, the current status of the Zoom box is displayed on the bottom left of the screen. − PreZoom position: The location of the Zoom box can be changed. Move the Zoom box using the Trackball. − PreZoom size: The size of the Zoom box can be changed. Use the Trackball to adjust the size of the Zoom box. If you change the depth of the image when using the Write Zoom function, the Zoom mode ends automatically. 4-8

[Page 109] „ ‹ Spatial Compound (Optional) & Trapezoidal Use the Soft Menu dial-button [5] . X ‹ Spatial Compound: Rotate the dial-button to select from Off, Low, Middle or High. NOTE: This item appears in the Soft Menu only when a Linear Probe is used. X ‹ Trapezoidal: Press the dial-button to turn it on or off. In general, the rectangular frame provided by a Linear Probe is changed to a trapezoidal shape. This allows a wider view of an image. The Trapezoid function may not be available for certain depths. In addition, the Write Zoom function cannot be accessed with the Zoom button when the Trapezoidal function is in use. (However, Read Zoom can be used.) NOTE: The Trapezoidal item appears in the menu only when a Linear Probe is used. „ ‹ SRF Press the Soft Menu dial-button [6] to turn it on or off. X ‹ SRF Index: SRF stands for Speckle Reduction Filter. The image is optimized by minimizing the noise and automatically adjusting the brightness of the boundaries. Select a value between 0 and 3 by rotating the dial-button. „ ‹ Chroma Press the Soft Menu dial-button [1] to turn it on or off. X ‹ Chroma Map: Changes the color of an image. Select Type 1 to Type 9 or User 1 to User 3 by rotating the dial-button. NOTE: The user type setting can be changed in Utility > Post Curve > 2D Post > Edit . See ‘Post Curve’ in ‘Chapter 7 Utility’. for detailed information. 4-9

[Page 110] „ ‹ Gray Map / L/R Flip X ‹ Gray Map Changes a 2D Post Curve. Select from Type 1 to Type 9 or User 1 to User 2 by rotating the Soft Menu dial-button [2] . X ‹ L/R Flip When the Soft Menu dial-button [2] is pressed, the left and right sides of an image are flipped. The M indication at the top of the image indicates the direction of the current image. „ ‹ Focus / U/D Flip X ‹ Focus Use the Soft Menu dial-button [3] to set the number of focusing points to between 1 and 4. X ‹ U/D Flip Press the Soft Menu dial-button [3] . Whenever the dial-button is pressed, an image is flipped upside down. „ ‹ Sector Width Change the sector width. Select a value of between 40 to 100 % by rotating the Soft Menu dial-button [4] . When the width is increased, the frame rate is reduced. NOTE: If the application is set as Fetal Heart, you can select up to 20%. „ ‹ Frame Avg When images are updated, the previous and current images are averaged. Select a value between 0 and 15 by rotating the Soft Menu dial-button [5] . If you scan the same area repeatedly, speckles may appear on the updated image. This item is used to minimize this phenomenon. „ ‹ Power Adjusts the intensity of the ultrasound output. Select a value between 10 and 100 by rotating the Soft Menu dial-button [6] . 4-10

[Page 111] „ ‹ 2D Image Size Press 2D Image Size in the menu. You can adjust the overall size of a 2D image. Select a value between 80~100(%). NOTE: You can set this function in Utility > Menu Edit . For details on Menu Edit, please refer to ‘Chapter 7. Utility’. „ ‹ Edge Enhance Press Edge Enhance in the menu. This function allows you to view more accurate images of organ or tissue boundaries. Use the Menu dial-button to select a value between -3 – 3. A higher value provides more accurate images of boundaries. NOTE: You can set this function in Utility > Menu Edit . For details on Menu Edit, please refer to ‘Chapter 7. Utility’. „ ‹ Pulse Inversion Press the dial-button to turn it on or off. If it is turned on, pulses are inverted for a clear view of images. X ‹ Pulse Inversion is available with specific probes only. X ‹ You can set this function in Utility > Menu Edit . For details on Menu Edit, please refer to ‘Chapter 7. Utility’. „ ‹ Tissue Press Tissue in the menu. Optimize an image by using an appropriate ultrasound speed for the characteristics of the object (tissue) to view. Use the Menu dial-button to select from Solid, Normal, Adipose or Cystic. NOTE: You can set this function in Utility > Menu Edit . For details on Menu Edit, please refer to ‘Chapter 7. Utility’. 4-11

[Page 112] „ ‹ Frame Rate Press Frame Rate in the menu. The frame rate is the number of images generated per second. Use the Menu dial-button to select from Fast, Normal or Slow. It is recommended to set a high frame rate for objects that are highly active or fast-moving. NOTE: You can set this function in Utility > Menu Edit . For details on Menu Edit, please refer to ‘Chapter 7. Utility’. „ ‹ DynamicMR (Optional) Press DynamicMR in the menu. You can obtain a clearer image by eliminating noise and enhancing boundaries. Five pre-configured indices are provided. If it is turned on, the DMR Index appears in the menu. Use the Menu dial-button to set the index between 1~3. DynamicMR+ is available with OB, Gynecology, Urology only and set the index between 1~5. X ‹ Connect a dongle to the console before using DynamicMR. (Dongles can be purchased separately from the product.) X ‹ For information on installing a dongle, please refer to the DynamicMR User Manual. X ‹ You can set this function in Utility > Menu Edit . For details on Menu Edit, please refer to ‘Chapter 7. Utility’. 4-12

[Page 113] Panoramic X ‹ Panoramic is an optional feature of this product. X ‹ The Panoramic function is only available in 2D mode with Linear and Convex probes. Panoramic Imaging is the function that acquires images over a wider range by using continuous ultrasonographic images. Up to 500 frames can be used. „ ‹ Acquiring a Pasnoramic Image 1. Press Panoramic . The monitor will switch to the Panoramic Ready screen. 2. Press the Start/Stop button. Acquisition of the Panoramic image will begin. 3. To finish acquiring the Panoramic image, press the Start/Stop button. The monitor will switch to the Panoramic Review screen. Cautions for Acquiring a Panoramic Image Tips! 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 fast or the angle of the contact surface of the probe changes, artifacts may occur. „ ‹ Reviewing a Panoramic Image X ‹ You can take measurements by using the Ruler button. X ‹ L/R Flip , U/D Flip , and Magnifying are available only when the Layout is set to Full Screen. X ‹ L/R Flip: Flip the panoramic image horizontally. X ‹ U/D Flip: Flip the panoramic image vertically. X ‹ Ruler: Press this button to turn this function on/off. When turned on, a ruler will be displayed in the Panoramic image. 4-13

[Page 114] X ‹ Cine Save: Save Cine images. X ‹ Layout: Specify how the panoramic image will be displayed on the screen. − Full Screen: Display the panoramic image in full screen mode. − Left/Right: Display the 2D and panoramic images at the left and right of the screen, respectively. − Top/Down: Display the 2D and panoramic images at the top and bottom of the screen, respectively. X ‹ Rotation: Rotate the panoramic image. X ‹ Magnifying: Magnify the panoramic image. X ‹ Return: Return to the Panoramic Ready screen. X ‹ Exit: Exit Panoramic Imaging. NOTE: For more information on other items, refer to the ‘2D Mode’ section. 4-14

[Page 115] 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 [Figure 4.2 M Mode]  Entering & Exiting M Mode Press the M button on the control panel. Press the M button again. M Mode will be terminated and the mode switched to 2D. 4-15

[Page 116]  M Mode Screen „ ‹ M Line Use the Trackball on the control panel to move to the right or left. 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.  M Mode Soft Menu „ ‹ Speed Rotate the dial-button to adjust the progression speed of M images. Available options are 60Hz, 120Hz, 180Hz, 240Hz, 300Hz and 360Hz. „ ‹ Negative Reverses the color of an M image. Press the Soft Menu dial-button [6] to turn it on or off. „ ‹ Display Format Select the M image and 2D image layout. Press the control panel dial-button Menu/Angle to select a layout; rotate the Soft Menu dial-button [4] to select Side By Side, 4:6, 5:5, or 6:4. X ‹ Side By Side: Places a 2D image on the left and an M image on the right side of the screen. „ ‹ FreeAngle M You can use the FreeAngle M function to freely define the M line and study the image. Use the Trackball and the pointer on the control panel to define the length, position, and angle of the M line. X ‹ Use the Menu Edit to add this function to the Soft Menu. X ‹ The FreeAngle M function appears in the Soft Menu only when a phased array probe is used. 4-16

[Page 117] Color Doppler Mode This mode displays the colored blood flow pattern of the ROI (Region of Interest) within the 2D image. It is appropriate for examining the presence of the blood flow, its average speed and direction. The 2D Mode image is also shown allowing the marking and adjustment of the ROI within the entire image. [Figure 4.3 Color Doppler Mode]  Entering & Exiting C Mode Press the C button on the control panel. Press the C button again. C Mode will be terminated and the mode switched to 2D. 4-17

[Page 118]  C Mode Screen „ ‹ ROI Box ROI stands for Region of Interest. The ROI Box outlines the area of the 2D image where color (blood flow) information is displayed in Color Doppler Mode. Use the Change button to move and resize the ROI box. Each time you press the Change button, the current state of the ROI box is displayed in the lower left of the screen. X ‹ ROI Position: You can move the ROI box. Use the Trackball to move the ROI box. X ‹ ROI Size: You can resize the ROI box. Use the Change button to resize the ROI box.  C Mode Soft Menu „ ‹ Steer / Invert Use the Soft Menu dial-button [1] . X ‹ Steer: Rotate the dial-button to adjust the angle of the ultrasound beam. This can minimize loss of color information based on the angle of the ultrasound beam. Select ROI from Left, None or Right. NOTE: The Steer function appears in the Flexible Soft menu only when a Linear Probe is used. X ‹ Invert: Press the dial-button to invert the color bar. Inverting the color bar also inverts the colors displayed on the image. „ ‹ Sensitivity Use the Soft Menu dial-button [2] to select a value between 8 and 31. Increasing Sensitivity enhances the sensitivity of a color image, but reduces the frame rate. „ ‹ Density Selects the density of a scan line. Select Low, Middle1, Middle2 or High using the Soft Menu dial-button [3] . If you select High, the number of scan lines are increased and the resolution of an image improves. The Frame Rate however reduces. 4-18

[Page 119] „ ‹ Scale (PRF) Use the Soft Menu dial-button [5] . Rotating the Scale dial clockwise makes the PRF (Pulse Repetition Frequency) increase so that the speed range of the blood flow is widened, and vice versa. „ ‹ Baseline / Filter X ‹ Baseline If you rotate the Soft Menu dial-button [6] clockwise, the baseline rises. In Color Doppler Mode, the color bar indicates the direction and speed of blood flow. Relative to the baseline in the centre, the red color indicates the direction and speed of the blood flow towards a probe. By contrast, the blue color indicates the direction and speed of the blood flow away from a probe. X ‹ Filter The filter is an electrical filter used to eliminate low-frequency Doppler signals caused by the motion of vessel walls. Adjust the Cutoff Frequency to remove the Doppler signals for which the frequencies are lower than the Cutoff Frequency from the screen. Select a value between F 0 and F 3 by pressing the Soft Menu dial-button [6] . The value will be displayed on the monitor. „ ‹ Color Map Sets the Post Curve of an image. Select a type between 1 and 14 by rotating Soft Menu dial-button [1] . „ ‹ Balance Adjust the range of color image display by comparing the Gray Level of the 2D image with the Doppler signal values of the color image. As the Balance value increases, the color image appears, even in regions with a high Gray Level in 2D image (bright regions), expanding the range of the color image. Use the Soft Menu dial-button [2] to choose a Balance value between 1~16. „ ‹ Color Format Sets C Mode to use. Select Color + B/W, B/W Only or Color Only by rotating the Soft Menu dial-button [3] . „ ‹ Color Mode Sets the color display. Select Velocity or Vel + Var by rotating the Soft Menu dial-button [4] . If Velocity or Vel+ Var is selected, a numeral representing the number of a color scale is indicated above and below the color bar. 4-19

[Page 120] Power Doppler Mode This mode displays the color intensity of blood flow within the ROI in the 2D image. It is appropriate for examining the presence and amount of blood flow. The 2D Mode image is also shown, allowing the marking and adjustment of the ROI within the entire image. [Figure 4.4 Power Doppler Mode]  Entering & Exiting PD Mode Press the PD button on the control panel. Press the button again. PD Mode will be terminated and the mode switched to 2D. 4-20

[Page 121]  PD Mode Screen „ ‹ Color Bar In Power Doppler Mode, the colour bar varies depending on the screen display for Power Doppler Mode that is selected in the PD Mode menu. X ‹ PD Mode: The color bar indicates the presence of blood flow and its amount. The top of the colour bar is the brightest section, where the amount of blood flow is at its highest. X ‹ DPDI Mode: The color bar indicates the direction and intensity of blood flow. With the baseline in the centre, the red colour represents the direction and intensity of blood flow moving toward the probe, and the blue colour represents the direction and intensity of blood flow away from the probe. „ ‹ 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.  PD Mode Soft Menu „ ‹ PD Mode Rotate the Soft Menu dial-button [4] to select between PD Mode and DPDI Mode. X ‹ PD Mode: Shows only the intensity of the blood flow. X ‹ DPDI Mode: Directional Power Doppler Imaging (DPDI) shows the intensity and direction of blood flow. NOTE: Use of the menu and Soft Menu items is the same as in Color Doppler Mode. 4-21

[Page 122] PW Spectral Doppler Mode PW stands for Pulse Wave. PW Spectral Doppler Mode gives information on the speed of blood flow at a specific site in the form of a spectral trace and audio signal. Distance (depth) information can also be obtained by transmitting pulses over time frames. This mode is useful for measuring low-speed blood flow such as in the abdomen and peripheral vessels. The 2D Mode image is also shown, allowing the marking and adjustment of an observation area within the entire [Figure 4.5 PW Spectral Doppler Mode]  Entering & Exiting PW Spectral Doppler Mode Press the PW dial-button on the control panel. Press it again to return to 2D Mode. Click the Update button to obtain a Spectral Doppler image. 4-22

[Page 123]  PW Spectral Doppler Mode Screen „ ‹ Sample Volume When Sample Volume is on the blood flow of the 2D image, it represents Doppler Spectrum. The size and depth of Sample volume is displayed in [mm] units. Its position is moved with the Trackball and displayed in the [email protected] mm format. The format means that a Sample Volume of ‘xx.xx’ mm size is located at a depth of ‘yy.yy’ mm. For example, [email protected] mm means that a Sample Volume of 2.00mm size is located at a depth of 16.07mm. X ‹ Moving Sample Volume Use the Trackball on the control panel. X ‹ Resizing Sample Volume Adjust the Sample Volume size by pressing the Change button and using the Trackball on the control panel. Press the Change button again to return to the Sample Volume Position Control screen. The icon showing the two Trackball functions (SV Position/SV Size) is shown for a second and then disappears. X ‹ Adjusting the angle of Sample Volume Use the Menu dial-button on the control panel. If you rotate the dial-button clockwise, the angle increases from between –70 ~ +70. „ ‹ HPRF (High PRF) Function This function measures blood flow for which the speed exceeds the specified limit at a specified depth. It expands the scale into double the size of the original scale. This function is available only in PW Spectral Doppler Mode (D Only). X ‹ Activating HPRF To activate HPRF, increase the Scale values at the required depth. A 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. The maximum PRF values in PW Spectral Doppler Mode are shown. 4-23

[Page 124] X ‹ Moving Sample Volume To move the Sample Volume position in the D Only state, the system calculates PRF values and the Phantom Gate position, and updates them on the PW Spectral Doppler image. HPRF is terminated when HPRF cannot be activated. When Sample Volume is moved in the 2D Only state, the PRF values don’t change. NOTE: HPRF is not activated in Simultaneous Mode. It is also not activated if [PRF*2] exceeds 23KHz. 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.  PW Spectral Doppler Mode Soft Menu „ ‹ SV Size / Angle X ‹ SV Size Set the size of the Sample Volume. Select a size between 0.5 and 15 by rotating the Soft Menu dial- button [2] . X ‹ Angle If you press the Soft Menu dial-button [2] , the angle changes – 60, 0 or 60 degrees. The speed can be measured accurately by adjusting the angle of the Sample Volume. „ ‹ Auto Calc Press the Soft Menu dial-button [3] to turn it on or off. If it is turned on, Doppler Trace is performed and the resulting values are displayed. When it is on, the Mean Trace button is activated. The displayed values are as below. For information on setting display values, please refer to "Chapter 7. Utility.” 4-24

[Page 125] X ‹ Peak Systolic Velocity (PSV) X ‹ Time Averaged Mean Velocity (TAM) X ‹ End Diastolic Velocity (EDV) X ‹ Diastole / Systole Ratio (D/S) X ‹ Time Averaged Peak Velocity (TAP) X ‹ Max Pressure Gradient (PGmax) X ‹ Resistive Index (RI) X ‹ Mean Pressure Gradient (PGmean) X ‹ Pulsatility Index (PI) X ‹ Velocity Time Integral (VTI) X ‹ Systole / Diastole Ratio (S/D) X ‹ PeakA CAUTION: The measurements done by Auto Trace under Measure and Real Time Automatic Doppler Trace (Automatic Calculator) may be different from each other. This is because the algorithms for these two methods are different. It is recommended to use Auto Trace under Measure for more accurate measurement. Things to Consider for Real Time Automatic Doppler Trace Tips! 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. The trace and/or results of Real Time Automatic Doppler Trace may not be accurate in the above situations. Furthermore, during auto calculation, results will not be displayed if the Freeze function is run against inaccurate values. „ ‹ AutoCalc Direction Use the Soft Menu dial-button [3] . You can select the part of spectrum to use AutoCalc from Up, Down, or All. „ ‹ Simultaneous Each time you press the Soft Menu dial-button [4] , the Simultaneous function turns on and off. NOTE: It appears in the PW menu only when “ Utility > Setup > General > Simultaneous Mode ” is set to Allow. If the Simultaneous function is enabled, you can view the 2D image and Spectral Doppler image simultaneously in real time. If it is disabled, you can view only one of the two images. The Simultaneous function decreases Doppler PRF, thus decreasing the measurable speed range. 4-25

[Page 126] „ ‹ Mean Trace NOTE: When AutoCalc is on, Mean Trace is displayed in the Soft Menu. Displays a mean value by performing Doppler Trace. Press the Soft Menu dial-button [5] to turn it on or off. „ ‹ Baseline Use the Soft Menu dial-button [6] . Adjust the X-axis of a Doppler image by rotating the dial-button. NOTE: For information on the menu and other items in the Soft Menu, please refer to ‘2D Mode’ and ‘Color Doppler Mode.’ . 4-26

[Page 127] CW Spectral Doppler Mode CW stands for Continuous Wave. PW Spectral Doppler Mode gives information on the speed/direction of blood flow at a specific site in the form of a spectral trace and audio signal. Unlike PW Spectral Doppler Mode, it does not provide Sample Volume. [Figure 4.6 CW Spectral Doppler Mode]  Steered CW Spectral Doppler Mode This mode is available with a Phase Array Probe only. The 2D Mode image is also shown, allowing the marking and adjustment of an observation area within the entire image.  Entering & Exiting CW Spectral Doppler Mode Press the CW button on the control panel. Press it again to return to 2D Mode. NOTE: The information on menu and Soft Menu items for PW Spectral Doppler Mode also applies to this mode. 4-27

[Page 128] TDI Mode NOTE: This function appears in the Soft Menu only when a Phased Array Probe is used for cardiac application. TDI stands for Tissue Doppler Imaging. It represents movements of tissues such as a heart. [Figure 4.7 Tissue Dopple Imaging Mode]  Entering TDI Mode Press the Soft Menu dial-button [6] in Color Doppler Mode. NOTE: For information on other items, please refer to ‘Color Doppler Mode’. 4-28

[Page 129] TDW Mode NOTE: TDW is available only when the cardiac application with a Phased Array probe is selected. TDW stands for Tissue Doppler Wave. It represents movements of tissues such as a heart. [Figure 4.8 TDW Mode]  Entering TDW Mode Press the Soft Menu dial-button [6] in Color Doppler Mode or PW Spectral Doppler Mode. NOTE: For information on other items, please refer to ‘PW Spectral Doppler Mode. 4-29

[Page 130] ElastoScan Mode The elasticity of ROI in a 2D image is shown in color. The 2D Mode image is also shown, so that you can mark and adjust the position of the ROI within the scanned image. X ‹ ElastoScan Mode is an option for this product. X ‹ The probes, applications, and presets that support ElastoScan are as follows: LN5-12 (Small parts – Breast), L5-12/50 (Small parts – Breast), EVN4-9 (Gynecology-Uterus, Urology-Prostate), ER4-9 (Gynecology-Uterus, Urology-Prostate) ElastoScan Tips! This process converts the elastic modulus (ultrasound image data) of a target object, obtained from continuous ultrasound images, into an elastogram. A lesion’s location can be estimated by using the differences in elastic modulus obtained from elastograms. The function of elastography is to determine the difference in hardness or stiffness between healthy organs and lesions. Palpation has been used to measure stiffness, but this method is only useful at depths close to the surface of tissue. ElastoScan allows the user to identify the existence of solid masses in tissue, and converts the hardness data into an image by sonically enhancing the palpation. Elastography shows the spatial distribution of tissue elasticity properties in a region of interest by estimating the strain before and after tissue distortion caused by external or internal forces. Quantitative elastography is not provided.  E Entering and Exiting E Mode In 2D mode, press ElastoScan in the menu.  E Mode Screen „ ‹ E Dual Mode In this mode, the elastogram and the 2D image are displayed together on the screen. Press Single/Dual to select either Single or Dual mode. To facilitate comparative observation, the 2D image is shown on the left and an E image is shown on the right. 4-30

[Page 131] [Figure 4.9 E Dual Mode] „ ‹ E Single Mode In this mode, the E image is displayed alone on the screen. Press Single/Dual to select either Single or Dual mode. 4-31

[Page 132] [Figure 4.10 E Single Mode] „ ‹ ROI Mode ROI stands for Region of Interest. In E Mode, the ROI Box represents the area where elasticity information is shown. Press ROI Mode to enter or exit ROI Mode. You can adjust the position and size of the ROI box by using the Change button on the control panel. Each time the Change button is pressed, the current status of the ROI Box is shown in the bottom left corner of the screen. − E ROI Pos.: In this state, the position of the ROI Box can be changed. Use the trackball to reposition the ROI Box. − E ROI Size: In this state, the size of the ROI Box can be changed. Use the trackball to resize the ROI Box, and press the Change button to apply the new size. NOTE: ROI Mode is available in E Single Mode as well as in E Dual Mode. 4-32

[Page 133] [Figure 4.11 ROI Mode]  Performing a Scan When using E mode, place a probe onto the surface of the area you wish to observe and apply periodic compression to it. The compression should be adjusted so that the strain stays within 3 - 5 %. „ ‹ Breast A breast is a complex organ that consists of latecomer, laticifer, glandular mammaria, fatty tissues, fibrous tissues and chest muscles. Moving a probe along vertically causes unintended movements of the tissues. To observe a lesion in ElastoScanMode (E Mode), it is recommended that you minimize lateral or other directional movements, including vertical movement of tissues along the axis. The following are the images of a breast tumor scanned in 2D mode and E mode. 4-33

[Page 134] a: b: [Figure 4.12 Image of a Breast Tumor (a: 2D Mode, b: E Mode)] „ ‹ Prostate The prostate consists of tissues that are simpler than those of a breast, and there are relatively fewer unintended movements. The following are the images of a prostate tumor scanned in 2D mode and E mode . a: b: [Figure 4.13 Image of a Prostate Tumor (a: 2D Mode, b: E Mode)]  Screen Layout „ ‹ Color Bar In E Mode, the color bar indicates the stiffness of the 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. 4-34

[Page 135]  E Mode Menu „ ‹ Invert Color Map Inverts the color bar. Inverting the color bar also inverts the color displayed on the image. „ ‹ Alpha Blending Press Alpha Blending to turn this function On or Off. Alpha Blending blends 2D and E images so that they appear to overlap with each other. Use Blending Level to adjust the blending ratio. „ ‹ E Gain Adjust the brightness of E image between 1 – 100%. „ ‹ Contrast Select the contrast for an E image between 1 – 100%. „ ‹ Enhancement Adjusts the enhancement of the image. Use the Soft Menu dial-button to select a value between 0 and 100%. A higher value provides more clearly defined boundaries, at the expense of increased noise. „ ‹ Color Map Index Select the color of the elastogram. Use the Soft Menu dial-button to select from types 1 to 5. If you change the Color Map, the color bar will also change accordingly. „ ‹ Blending Level Select the ratio of Alpha Blending. You can adjust the level in 1% increments between 0 and 100% by using the Soft Menu dial-button. Setting the value to 0% shows an E image only and setting it to 100% shows a 2D image only. „ ‹ Persistence Level Specify the speed of change between frames. You can adjust the level in 1% increments between 0 and 100% by using the Soft Menu dial-button. Selecting a lower value increases the rate of frame change. 4-35

[Page 136] X ‹ The Following are not available or have limited functionality in E mode; − Unavailable functions: Scan Area, ECG − Only one Focus option is available. − Biopsy can only be turned On or Off. − Only distance, circumference, area, volume, and other measurements that can be taken in 2D mode are supported. „ ‹ Cine/Measurement X ‹ Elastograms processed with ElastoScan are saved in the Cine Memory; 728 images from Freeze are stored. X ‹ After performing a scan, press the Freeze button to enter Freeze mode. In Cine mode, you can use the trackball and menu buttons to review the elastogram. X ‹ 2D-image measuring tools that are relevant to elastogram, including Line, Line Trace, Hip joint, Ellipse, and Trace, Vol., are provided. „ ‹ Cine Edit Define the area in the Cine Memory which you can explore and save. „ ‹ Cine Review Explore the area you have defined with Cine Edit. „ ‹ Cine Save You can save the elastogram. 4-36

[Page 137] Combined Mode 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. In Color Doppler Mode, press the PW button on the control panel. Or, in PW Spectral Doppler Mode, press the C button on the control panel. 2D/PD/PW Mode Power Doppler Mode and PW Spectral Doppler Mode are displayed simultaneously. In Power Doppler Mode, press the PW button on the control panel. Or, in PW Spectral Doppler Mode, press the PD button on the control panel. 2D/C/CW Mode Color Doppler Mode and CW Spectral Doppler Mode are displayed simultaneously. This mode is available only with certain probes. In Color Doppler Mode, press the CW button on the control panel. Or, in CW Spectral Doppler Mode, press the C button on the control panel. 2D/PD/CW Mode Power Doppler Mode and CW Spectral Doppler Mode are displayed simultaneously. This mode is available only with certain probes. In Power Doppler Mode, press the CW button on the control panel. Or, in CW Spectral Doppler Mode, press the PD button on the control panel. 4-37

[Page 138] 2D/C/M Mode Color Doppler Mode and M Mode are displayed simultaneously. In Color Doppler Mode, press the M dial-button on the control panel. Or, in M Mode, press the C dial-button on the control panel. (This button is enabled for specific diagnostic applications with specific probes only.) 2D/C Live Mode 2D Mode and Color Doppler Mode are displayed simultaneously. In 2D Mode, press the Soft Menu dial-button [2] 2D/C Live.  Changing Combined Mode Format „ ‹ Changing the active image mode Press the Update button on the control panel. The current active image mode - ‘D Only’ or ‘2D Only’ - is displayed above the menu on the screen. In Combined Mode, more than two image modes are used at the same time. The image mode currently in use is called ‘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 the Update button change the active image mode. Note that the active image mode cannot be changed with the Update button when the Freeze function is in effect. „ ‹ Changing menu Press the Active Mode button on the control panel. You can change the menu and Soft Menu items without changing the active image mode. Buttons for the active image mode appear on the control panel. For example, if the Soft Menu for 2D Mode is displayed on the screen in 2D/C/PW Mode, press the Active Mode button to switch to the Soft Menu for Color Doppler Mode. NOTE: For information on optimizing an image in Combined Mode, please refer to “Basic Mode.” 4-38

[Page 139] Multi-Image Mode The product supports Dual Mode and Quad Mode. In Multi-Image Mode, an image can be displayed in different combined modes. Button operations in an active area are the same as in Combined Mode. Dual Mode Press the Dual button on the control panel. You can compare two different images at the same time. Each time you press the Dual button, one of the two images is selected. The current active image mode is displayed as a yellow line at the top. Button and menu items for the current image mode are displayed. Press the 2D button on the control panel to exit Dual Mode. [Figure 4.14 Dual mode] 4-39

[Page 140] Quad Mode Press the ESC key button on the keyboards. You can compare four different images at the same time. Each time you press the ESC key, one of the four images is selected. The current active image mode is displayed as a yellow line at the top. The button controls and menus of the active image mode are used. To exit from Quad Mode, press the 2D button. [Figure 4.15 Quad mode] 4-40

[Page 141] 3D/4D Mode An observation area is displayed in a 3D image. SONOACE R7 provides 3D and 4D Modes. 3D/4D Mode  3D Mode In this mode, 3D or standard probes are used to obtain 3D images. NOTE: Standard probes may not be used in 4D Modes and their use may be limited in 2D and 3D Modes. Depending on the probe used and how images are obtained, 3D Mode can be divided into the following: „ ‹ 2D/3D In this mode, 3D or standard probes are used to obtain 3D images. Tips! In Static 3D Mode, a 3D probe is used. In Freehand 3D Mode, a standard probe is used.  4D Mode In this mode, a 3D probe is used to obtain 3D images in real time. It is also called Live 3D Mode.  Entering & Exiting 3D/4D Mode Press the 3D/4D button on the control panel. Press it again to exit 3D/4D Mode and return to 2D Mode. 4-41

[Page 142]  3D/4D Mode Screen „ ‹ ROI Box In 3D/4D Mode, the ROI box is also called the Volume Box, which indicates an area in a 2D image to be converted into a 3D/4D image. The location and size of the ROI box can be adjusted with the Change button on the control panel. Each time the Change button is pressed, the state of the ROI box is shown in the lower left corner of the screen as below: X ‹ ROI Position: The ROI Box can be relocated. Use the Trackball to move the ROI box to another location. X ‹ ROI Size: The ROI Box can be resized. Use the Trackball to change the size of the ROI box, and then press the Change button to set the new size. 4-42

[Page 143] 3D StandBy Mode In this mode, various parameters can be set before 3D or 4D images are obtained. [Figure 4.16 3D StandBy Mode]  3D StandBy Mode Soft Menu NOTE: In Freehand 3D Mode, where only standard probes are allowed, Soft Menus [1] , [2] and [3] are available. „ ‹ Scan Mode Use the Soft Menu dial-button [1] . Rotate the dial-button to select the desired 3D Mode between 3D and 4D. When a standard probe is used, 3D is displayed, and this may not be changed. 4-43

[Page 144] „ ‹ View Mode Use the Soft Menu dial-button [2] . Rotate the dial-button to select the desired View Mode from MPR, MSV and Oblique View. X ‹ MPR (Multi Planar Rendering): A standard 3D mode. Once 3D images are obtained, the 3D View screen appears. X ‹ MSV (Multi Slice View): A type of 3D XI. Once 3D images are obtained, the 3D XI screen appears. X ‹ Oblique View: A type of 3D XI. Once 3D images are obtained, the Oblique View screen of 3D XI appears. When a standard probe is used, MPR is displayed, and this may not be changed. NOTE: For more information on MSV and Oblique View, please refer to ‘3D XI.’ „ ‹ Load Preset Use the Soft Menu dial-button [3] . Rotate the dial-button to select the desired preset. When a standard probe is used, available options are Default or User1 - User5. NOTE: You can select Default, Surface, Skeleton or User3~User5 for OB application. „ ‹ Scan Quality / Auto ROI X ‹ Scan Quality Use the Soft Menu dial-button [5] . Rotate the dial-button to select the scan speed from Low, Middle, High, Extreme. − Extreme: The image quality is excellent. Use this option to observe detailed images. − High: The image quality is lower than Extreme but the speed is faster than Extreme. − Middle: The image quality is lower than High but the speed is faster than High. − Low: The image quality is low but the 3D image speed (or rendering speed) is fast. X ‹ Auto ROI NOTE: This option appears only when the application for a 3D probe is set to OB. 4-44

[Page 145] Select Auto ROI in the menu. Press the button to turn it on or off. If it is turned on, the Volume Box is automatically placed over an area that will be converted to a 3D image. When Auto ROI is used, the following should be considered: − Images can be obtained over the fetal body only. − The resulting 3D image is affected by the brightness or contrast of a 2D image. − Once Auto ROI is turned on, the location or size of the Volume Box cannot be changed. „ ‹ Scan Angle Use the Soft Menu dial-button [6] . Rotate the dial-button to adjust the scan angle. The desired scan angle varies depending on the probe used.  Acquiring 3D Images 1. Select the desired 3D Mode in the Soft Menu [1] . 2. Specify the location and size of the ROI box as desired. 3. Use the Menu button and the Soft Menu dial-buttons [2] - [6] to set various parameters. 4. Once done, press the Freeze or Set button. The system will start acquiring 3D images. 5. Once 3D images are acquired, the 3D View or 3D XI screen appears. X ‹ In the Soft Menu [2] , if MPR is selected, 3D View is enabled, and if MSV or Oblique View is selected, 3D XI is enabled. Depending on the mode selected, 3D View or 3D XI is displayed in the upper left corner of the screen. X ‹ If a 3D image is acquired with its left and right sides flipped, it appears in 3D View or 3D XI with its sides flipped. 6. After optimizing the acquired 3D images, proceed with diagnosis 4-45

[Page 146] How to Improve 3D Image Quality Tips! X ‹ Consider the direction, division and size of the viewpoint, as well as the visibility of an object. X ‹ Before acquiring 3D images, adjust the contrast in 2D Mode. X ‹ If the ROI box is bigger, it takes more time to acquire 3D images. Therefore, set the ROI box to an appropriate size. X ‹ To see the 3D scan of a fetus in a frontal view, position the fetal head in the direction of “Direction Mark”, putting it in the coronal plane. Then scan the fetus from back to abdomen. X ‹ The 3D image of the fetal face can be more easily found in the coronal plane than in the sagital plane. X ‹ In case echo is not generated (ex. amniotic fluid), to determine surface contour, the surfaces of objects should be insulated with hypo-echoic textures. X ‹ To obtain a high quality 3D surface, adjust Low-Threshold. As a general rule, do not adjust High- Threshold; set it to the maximum value of 255. 4-46

[Page 147] 3D View-MPR This screen appears after 3D images are acquired when View Mode is set to MPR in 3D StandBy Mode. 3D View is displayed in the upper left corner of the screen. After optimizing the acquired 3D images, proceed with diagnosis and measurement. NOTE: When 3D images are acquired with a standard probe, 3D View is automatically enabled. [Figure 4.17 3D View - MPR]  3D View Screen „ ‹ Screen Layout The main 3D View screen consists of Axial Section, Sagital Section and Coronal Section surface images — which are volume data cut by anatomical locations — and 3D images. For the purpose of convenience, Axial Section is displayed as “A plane,” Sagital Section as “B plane,” and Coronal Section as “C plane.” 4-47

[Page 148] „ ‹ Trackball Mode The current Trackball mode is displayed in the user information area. You can choose Trackball mode from Cursor, Move and ROI. To change the Trackball mode, press the Change button on the control panel. Each time the button is pressed, the Trackball mode is toggled. X ‹ Cursor: The Trackball can be used to position the cursor. Use the Trackball and Set button to select the icon menu on the screen. Press the Pointer button on the control panel to switch to the cursor mode. X ‹ Move: The Trackball can be used to move 3D images. The acquired 3D image is moved around according to the movement of the Trackball. X ‹ ROI: The Trackball can be used to resize the ROI box. The size of the ROI box over a 3D image is changed according to the Trackball movement. The ROI mode is available only when Basic in the icon menu is set to ROI. „ ‹ Moving Images Place the Trackball pointer over an image to move, and then move it while pressing the Set button. Alternatively, use the Trackball to move an image when Trackball mode is set to Move. X ‹ Set Button: An image can be rotated around the center. X ‹ Exit Button: An image can be moved up/down/left/right. 4-48

[Page 149] „ ‹ Resizing ROI When the Trackball mode is set to ROI, move the Trackball to resize the ROI box. When the Trackball mode is set to Cursor, place the cursor over the ROI box and then use the Trackball and Set button to resize it. „ ‹ Rotating Images by X-axis Use the Soft Menu dial-buttons [4/X] on the control panel. Alternatively, when the Trackball mode is set to Cursor, place the cursor on the A Plane image and then move the Trackball while pressing the Set button. „ ‹ Rotating Images by Y-axis Use the Soft Menu dial-buttons [5/Y] on the control panel. Alternatively, when the Trackball mode is set to Cursor, place the cursor on the B Plane image and then move the Trackball while pressing the Set button. „ ‹ Rotating Images by Z-axis Use the Soft Menu dial-buttons [6/Z] on the control panel. Alternatively, when the Trackball mode is set to Cursor, place the cursor on the C Plane image and then move the Trackball while pressing the Set button. „ ‹ Showing/Hiding Menu Press the Menu dial-button to show the menu on the screen. Press the Exit button to hide the menu. „ ‹ Moving Menu Tabs Use the Trackball and the Set button to move a tab in the menu. The Active mode can also be used. „ ‹ Selecting Items Press the Menu dial-button. „ ‹ Returning to Upper Menu Press the Exit button. 4-49

[Page 150]  Entering Text and Indicator „ ‹ Entering Text Press the [F3] button on the alphanumeric keyboard. „ ‹ Entering Indicator Press the [F2] button on the alphanumeric keyboard.  Saving and Printing „ ‹ Saving Images Press the Save button on the control panel. The 3D Data Save window will appear. Select Image under Save Type and then press the Save button to save images [Figure 4.18 3D Data Save] „ ‹ Saving Images with Volume Data Press the Save button on the control panel and then the 3D Data Save window will appear. Select Volume under Select Item and then press the Save button again to save images along with volume data. If volume data contains Cine images, they are also saved together. 4-50

[Page 151] NOTE: If volume data contains both 4D and 3D Cine images, choose one or other under Select Item and save it. X ‹ If images are saved with volume data, they can be converted to 3D rendering images with SonoView. „ ‹ Printing Image Press the Print button on the control panel.  MPR Mode Menu Display Select Display in the menu to specify the desired display format. „ ‹ 2D Axial, Sagital or Coronal plane images and Orientation Help (OH) are displayed on the screen. OH shows the relative position of the selected plane in reference to volume data. How to Improve 3D Image Quality Tips! Since diagnosis is performed with multi-planar images only in 2D Mode, Soft Menu Full can be used for more detailed observation. „ ‹ 2D / 3D Axial, Sagital or Coronal plane images and 3D images are displayed on the screen. „ ‹ Volume CT Axial, Sagital or Coronal plane images and the actual combination of them are displayed on the screen. The boundary of each plane is shown in a different color. „ ‹ ROI 3D Axial, Sagital or Coronal plane images and 3D images are displayed on the screen. The ROI Box can be changed for better observation. 4-51

[Page 152] „ ‹ Fixed 3D Axial, Sagital or Coronal plane images and the 3D image that is set within the ROI box in ROI 3D Mode are displayed on the screen. The ROI Box does not appear. Ref. Image Use the Menu dial-button to select a reference image from A, B and C. Depending on the reference image selected, the direction of the arrow changes. 3D Orientation Select 0, 90, 180 or 270 degrees using the Menu dial-button. The coordinate system rotates to the Z-axis in the 3D Reference Coordinate System. VCE Press the Menu dial-button to turn it on or off. If it is on, the contrast ratio of a 3D image is enhanced. VCE stands for Volume Contrast Enhancement. X ‹ Select VCE in the Quick menu in MPR Mode. X ‹ VCR is available only in the 2D/3D , ROI 3D and Fixed 3D modes. Auto Contour Press the Menu dial-button to turn it on or off. This function automatically locates the fetal face area in a fetus image scanned for Sagital. If it is turned on, a contour line appears and a 3D image is contoured in the ROI box on A Plane. NOTE: This function is only available in ROI 3D Mode where Render Direction under Render Setup is C+ . 3D Cine Use the Menu dial-button to select 3D Cine in the 3D View menu. Then 3D Cine Mode will be enabled. § 3D Cine Define Specify settings required for Cine execution. 4-52

[Page 153] „ ‹ Rotation Angle Use the Soft Menu dial-button [1] to set all of the rotation angles for an image. Valid values are 30, 45, 60, 90, 180 and 360˚. „ ‹ Step Angle Use the Soft Menu dial-button [2] to set the rotation angle by step for an image. Valid values are 1, 3, 5 and 15˚. The Difference between Rotation Angle and Step Angle Tips! A Cine image rotates to the angle set in Rotation Angle in increments as set in Step Angle . For example, if Rotation Angle is set to 360˚ and Step Angle is set to 15°, 3D Cine rotates to 360° using 15˚ steps. „ ‹ Rotate Axis Use the Soft Menu dial-button [3] to set the rotation direction to X or Y. „ ‹ Start Angle Use the Soft Menu dial-button [4] to set the start point of a Cine image. Valid values are -180 to -1. If Start Angle is set, Rotation Angle is disabled. „ ‹ End Angle Use the Soft Menu dial-button [5] to set the end point of a Cine image. Valid values are 1 - 180. If End Angle is set, Rotation Angle is disabled. „ ‹ Mix Use the Soft Menu dial-button [6] to set the rendering mix. Valid values are 0 - 100. „ ‹ Calculate Press the Soft Menu dial-button [6] . Start configuring a Cine image with the specified settings. „ ‹ 3D Cine Specify settings required for Cine execution. 4-53

[Page 154] „ ‹ Play Mode Use the Soft Menu dial-button [1] to select how 3D Cine is played. X ‹ Loop: Continues to play 3D Cine in one direction repeatedly. X ‹ Yoyo: Plays 3D Cine in one direction until the end is reached and then continues to play it in the reverse direction. „ ‹ Speed (%) Use the Soft Menu dial-button [2] to set the playback speed of a Cine image. Valid options are 25, 50,100, 200, 300 and 400%. „ ‹ Cine Frame Use the Soft Menu dial-button [3] to select and observe a specific Cine image. Cine Frame is displayed in the menu only when the Cine playback is stopped. The number of the frame for the current image, out of all the frames, is indicated in the menu. „ ‹ Mix Use the Soft Menu dial-button [4] to set the rendering mix. Valid values are 0 - 100. „ ‹ Cine Playback / Pause Press the Soft Menu dial-button [4] to pause or play. „ ‹ New Cine Use the Soft Menu dial-button [5] to enable New Cine Mode. Return to the 3D Cine Define screen. „ ‹ Clear Cine Use the Soft Menu dial-button [6] to delete the current Cine image. Return to the 3D Cine Define screen. 4-54

[Page 155] [Figure 4.19 3D Cine] 4-55

[Page 156] 4D Cine Use the Menu dial-button to select 4D Cine in the 3D View menu. Then 4D Cine Mode will be enabled. [Figure 4.20 4D Cine] NOTE: 4D Cine can also be enabled by pressing the Freeze button in 4D Mode. After specifying the playback mode and Cine type, press the Play button to start playing a Cine image. „ ‹ Cine Type In the menu on the screen, use the Menu dial-button to select Cine type. X ‹ Image: The standard Cine playback mode. [Start Angle], [End Angle], [Speed(%)], [Image Position] appear in the Soft Menu. X ‹ Volume: While a Cine image is being played, the MPR screen appears on the screen. The display format can be changed to optimize Cine image playback. Vol. Indexs appears in the Soft Menu. 4-56

[Page 157] „ ‹ Play Mode Use the Soft Menu dial-button [1] to select the playback mode of a Cine image. X ‹ Loop: Continues to play a Cine image in one direction repeatedly. X ‹ Yoyo: Plays a Cine image in one direction until the end is reached and then continues to play it in the reverse direction. „ ‹ Cine Type Use the Soft Menu dial-button [2] to select a Cine type. „ ‹ Start Angle Use the Soft Menu dial-button [3] to set the start point of a Cine image. This option appears only when Cine Type is Image. „ ‹ End Angle Use the Soft Menu dial-button [4] to set the end point of a Cine image. This option appears only when Cine Type is Image. „ ‹ Speed (%) Use the Soft Menu dial-button [5] to set the playback speed of a Cine image. Valid values are 25 - 400%. This option appears only when Cine Type is Image. „ ‹ Image Position Use the Soft Menu dial-button [6] to select a Cine image that will be shown on the current screen. This option appears only when Cine Type is Image. „ ‹ Vol. Index Use the Soft Menu dial-button [6] to select volume data that will be shown on the current screen. This option appears only when Cine Type is Volume. 4-57

[Page 158] Preset Use the Menu dial-button to select. Set or rename a preset as desired. „ ‹ Preset Select a preset between Default or User1 and User 5. If you click Default, it is set to the default value of the system. „ ‹ Load Preset Loads the selected preset onto the system. „ ‹ Save Preset Saves the changes of the preset. „ ‹ Rename Changes the name of a User Preset in a Name pop-up window. Render Setup Use the Menu dial-button to select Render Setup . § Gray Render Mode This mode shows volume data acquired by the gray method as a 3D rendering image. „ ‹ Render Mode 1 Sets Render Mode 1. X ‹ Surface: Represents a 3D image in the Ray-casting method where the surface of an image is expressed with curves. X ‹ Smooth: Provides a 3D image that is smoother than Surface . X ‹ Max: Represents a 3D image in maximum intensity. This option can be useful for observation of bone structure. X ‹ Min: Represents a 3D image in minimum intensity. This option can be useful for observation of vessels or cavities in the human body. X ‹ X-Ray: Represents a 3D image in average intensity. An image is shown like an X-ray image. 4-58

[Page 159] „ ‹ Render Mode 2 Sets Render Mode 2. It can be set in the same way as for Render Mode 1. „ ‹ TH. High Sets the minimum range of a threshold. Select between 0 and 255. MagiCut Use the Menu dial-button to select MagiCut in the 3D View menu. MagiCut can be used to eliminate parts in a 3D image that are irrelevant for diagnosis. NOTE: This function is not available in 4D Mode. [Figure 4.21 MagiCut] 4-59

[Page 160] „ ‹ CutMode Use the Menu dial-button to set Cut 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 with a small eraser. X ‹ Big Eraser: Cuts with a big eraser. „ ‹ Depth Use the Menu dial-button to set Cut Depth. X ‹ Full: Cuts the entire area. X ‹ Defined: Cuts the defined area. Define an area to cut as below: 1. Use the Trackball and the Set button to define an area to cut. 2. Use the Menu dial-button to set the cutting depth. Valid values are 1 - 100. − Use the Undo function or Undo All function to restore the image and to cut the same area. − Undo : Cancels cutting the selected area. − Redo : Redoes the cancelled area. − Undo All: Cancels all cutting operations. 3. Press the Soft Menu dial-button [6] Apply to complete the setting. Palette Use the Menu dial-button to select Palette in the 3D View menu. Then set the colors for 2D and 3D images. „ ‹ 2D Palette Use the Soft Menu dial-button [1] to set the color of a 2D image. Valid options are Palettes 0 - 9. „ ‹ 3D Palette Use the Soft Menu dial-button [2] to set the color of a 3D image. Valid options are Palettes 0 - 9. 4-60

[Page 161]  MPR Mode Soft Menu „ ‹ Mix Use the Soft Menu dial-button [1] to set the rendering mix between 0 and 100. NOTE: This option is available in 2D/3D, ROI 3D and Fixed 3D only. „ ‹ Init Press the Soft Menu dial-button [1] . The initial 3D image and settings will be restored. „ ‹ Th.Low Use the Soft Menu dial-button [2] to set the value between 0 and 254. Threshold Tips! A threshold is used to eliminate unnecessary data from an image. If it is increased, more cyst components are shown. If it is decreased, more bone components are shown. NOTE: This option is available in 2D/3D , ROI 3D and Fixed 3D only. „ ‹ Full Press the Soft Menu dial-button [2] . A 3D image will be displayed in the full screen mode. Press the button again to return to the previous screen. „ ‹ Transparency Use the Soft Menu dial-button [3] to set the transparency to between 20 and 250 for a 3D image. The lowest value of 20 is the most transparent level, and the highest value of 250 is a completely opaque level. NOTE: This option is available in 2D/3D , ROI 3D and Fixed 3D only. 4-61

[Page 162] „ ‹ U/D Flip Press the Soft Menu dial-button [3] . An image is flipped upside down. „ ‹ Rotate X / Y / Z Rotates a 3D image in the selected axis direction. Use the Soft Menu dial-buttons [4] , [5] or [6] to rotate the image to the X, Y or Z axis, respectively. „ ‹ Next Page Press the Soft Menu dial-button [6] to move to the next page. „ ‹ Select Use the Soft Menu dial-button [1] to select a Post Curve to change the settings for. NOTE: This option is available in 2D/3D , ROI 3D and Fixed 3D only. „ ‹ Position Use the Soft Menu button [2] to change the location of a Post Curve that is selected under Select . Valid values are 0 – 100. „ ‹ Bias Use the Soft Menu button [3] to change the bias of a Post Curve that is selected under Select . Valid values are -100 to 100. „ ‹ Zoom Use the Soft Menu dial-button [4] to adjust a value between 25 and 400. „ ‹ Prev Page Press the Soft Menu dial-button [6] to move to the previous page. 4-62

[Page 163] 3D XI Mode (Optional) If View Mode is set to MSV or Oblique View in 3D StandBy Mode, this screen appears when a 3D image is acquired. 3D XI is displayed in the upper left corner of the screen. 3D XI Mode also appears if MSV , Oblique View or Volume CT is selected in the 3D View screen. 3D XI is displayed in the upper left corner of the screen. In 3D XI Mode, the plane of an image is divided into several sections and displayed to enhance the effectiveness of diagnosis. It has three sub-modes as below. NOTE: 3D XI is available only when a 3D probe is used.  MSV Mode Press the MSV tab in the menu. MSV stands for Multi-Slice View, which allows you to divide an image into several slices for better observation. [Figure 4.22 Multi-Slice View] 4-63

[Page 164] NOTE: This mode provides a number of functions including Calculator , Caliper , Text and Indicator .  MSV Mode Menu „ ‹ Layout Set the screen layout by selecting one out of the 1x1 , 2x1 , 3x2 , 3x3 , 4x3 and 6x4 buttons on the screen. X ‹ If 1×1 is selected, one image can be viewed at a time. - If 6×4 is selected, 24 slice images can be Tips! viewed at a time. X ‹ Each time a new layout is selected, the currently selected image moves to the first position on the screen. „ ‹ Ref. Image Choose a plane in which to view multi-slice images by selecting from A, B and C planes. „ ‹ Ref. OH Select a plane to be used as Reference OH. X ‹ If Ref. OH is 3D : Indicates the location of the selected slice in relation to volume data. X ‹ If Ref. OH is A , B or C : Indicates the location of the selected slice. „ ‹ Preset Sets a preset or renames. X ‹ Preset: Use the dial-button to select Default or User1 ~ User5 . If you select Default , it is set to the default value of the system. X ‹ Rename: Renames a preset. If you press the dial-button, a Name window will appear. X ‹ Save Preset: Press the dial-button to save changes of a preset. X ‹ Load Preset: Press the dial-button to load the selected preset onto the system. 4-64

[Page 165] „ ‹ Palette Set the color of a 2D image. The Soft Menu changes. X ‹ 2D Palette: Use the dial-button to set the color to between 0 and 9 for a 2D image. Post Processing Use the Menu dial-button to select Post Processing in the 3D XI menu. The Post Processing menu will appear. Post Processing performs post processing for a multi-slice image. „ ‹ Invert Press the Menu dial-button to turn it on or off. If it is turned on, the brightness of multi-slice images is inverted. „ ‹ Auto Contrast Press the Menu dial-button to turn it on or off. If it is turned on, the brightness of multi-slice images is automatically adjusted. „ ‹ Thres. Press the Menu dial-button to turn it on or off. This function moderates excessive brightness in an image. If it is turned on, Th. Low and Th. High appear in the Soft Menu. X ‹ Th. Low: Use the Soft Menu dial-button [3] . X ‹ Th. High: Use the Soft Menu dial-button [4] . „ ‹ Sharp Press the Menu dial-button to turn it on or off. This function allows you to adjust the boundary of Multi-Slice images. If it is turned on, Sharp appears in the Soft Menu. X ‹ Sharp: Use the Soft Menu dial-button [5] to set the value between 100 and 400. If it is set to a higher value, the boundary becomes clearer. 4-65

[Page 166] „ ‹ XI MR Press the Menu dial-button to turn it on or off. XI MR is used to improve the image quality by stressing the contrast and edges of images. When it is turned on, it only affects the index image in a yellow frame. „ ‹ Gradient Mask Rotate the Menu dial-button to select Top , Bottom , Left or Right . Gradient Mask adjusts the brightness of a certain area in a multi-slice image. An area corresponding to the selected button gets brighter. NOTE: For information on Preset and Palette , please refer to ‘3D View-MPR Mode.’ MSV Mode Soft Menu „ ‹ Slice Thickness Use the Soft Menu dial-button [1] to select a multi-slice cutting space between 0.5, 1.0, 2.0, 3.0, 4.0 and 5.0 mm. NOTE: Slice Thickness represents a slice space in the volume data, and thus it does not represent the actual anatomical location. „ ‹ Selected Slice Use the Soft Menu dial-button [2] to select a slice line. The selected line can be viewed in a 2D reference image. The volume slice image for the selected slice line is indicated with an orange color band. „ ‹ Page Change Use the Soft Menu dial-button [3] to change page. This option is used when there is more than one page due to multiple indices. „ ‹ Orientation Dot Press the Soft Menu dial-button [4] to turn it on or off. If it is on, a dot is indicated in the center of the 4-66

[Page 167] „ ‹ Init Press the Soft Menu dial-button [5] to return to the initial screen in MSV Mode. „ ‹ Ruler Press the Soft Menu dial-button [1] to set the location of the ruler. You can select None, Right, Left, Top, Bottom or All. „ ‹ Bias Use the Soft Menu dial-button [3] to adjust the bias of a Post Curve. Valid values are -100 to 100. „ ‹ Position Use the Soft Menu dial-button [2] to adjust the location of a Post Curve. Valid values are 0 to 100. „ ‹ Zoom Use the Soft Menu dial-button [4] to adjust a value between 25 and 400. „ ‹ L/R Flip Use the Soft Menu dial-button [4] . When the button is pressed, the left and right sides of an image are flipped. „ ‹ U/D Flip Use the Soft Menu dial-button [5] . When the button is pressed, an image is flipped upside down.  Oblique View Press the Oblique View tab in the menu. Perpendicular plane images can be viewed by applying a line or contour on Coronal, Sagital and Axial images. 4-67

[Page 168] The View Direction of Perpendicular Plane Image Tips! The direction of view is perpendicular to a cross-sectional plane in volume data. Please refer to the following illustration: NOTE: While measurement functions such as Calculator and Caliper are not available, Text and Indicator functions are available. [Figure 4.23 Oblique View] 4-68

[Page 169] Oblique View Mode Menu „ ‹ Single Static Line This allows you to view a plane that is perpendicular to the default line in an image. Use the Soft Menu dial-button [2] Rotation Line dial-button on the control panel to rotate the default line. „ ‹ Dynamic Line This allows you to draw a straight line and view a plane that is perpendicular to the line. X ‹ Use the Trackball and the Set button to draw a straight line. For the line drawn, the start point is marked with S and the end point is marked with E. X ‹ Use the Change button on the control panel to move the line. Use the Trackball to place the line at the desired location and then press the Set button to set the new location. X ‹ Use the Angle dial-button on the control panel or the Soft Menu dial-button [2] Rotation Line to change the angle of the line. „ ‹ Contour This allows you to contour a straight line or curve and view a plane that is perpendicular to it. The contouring, moving and modifying of a line are the same as in Dynamic Line . „ ‹ Multi-Line This allows you to draw a straight line and view a plane that is perpendicular to the line. The drawing, moving and modifying of a line are the same as in Dynamic Line . NOTE: With Multi-Line and Multi-Contour , more than one line can be drawn only when Auto Increase is turned on. „ ‹ Multi Contour This allows you to contour a straight line or curve and view a plane that is perpendicular to it. The contouring, moving and modifying of a line are the same as in Dynamic Line . „ ‹ Multi Parallel If you draw a straight line, four lines parallel to it are applied to a reference image to display an oblique 4-69

[Page 170] X ‹ After pressing Multi-Parallel , use the Trackball and the Set button to draw a reference line. Parallel lines are then automatically drawn. X ‹ Use the Soft Menu dial-button [3] Slice Thickness to adjust the spaces between parallel lines. „ ‹ Multi Plumb If you draw a straight line, four lines perpendicular to it are applied to a reference image to display an oblique image. X ‹ After pressing Multi-Plumb , use the Trackball and the Set button to draw a reference line. Perpendicular lines are then automatically drawn. X ‹ Use the Soft Menu dial-button [3] Slice Thickness to adjust the spaces between perpendicular lines. X ‹ For information on Orientation Dot , please refer to ‘MSV Mode.’ X ‹ For information on Preset and Palette , please refer to ‘3D View-MPR Mode.’ Oblique View Mode Soft Menu „ ‹ Rotate Line Use the Soft Menu dial-button [2] to adjust the location of a line. This option is not available when Contour or Multi-Contour is selected in the Oblique View Mode menu. „ ‹ Rotate X / Y / Z Rotates a 3D image in the selected axis direction. Use the Soft Menu dial-buttons [4] , [5] or 6 to rotate the image to the X, Y or Z axis, respectively. „ ‹ Orientation Dot Press the Soft Menu dial-button [5] to turn it on or off. If it is on, a dot is indicated in the center of the „ ‹ Next Page Press the Soft Menu dial-button [6] to move to the next page. 4-70

[Page 171] „ ‹ Position Use the Soft Menu dial-button [2] to adjust the location of a Post Curve. Valid values are 0 – 100. „ ‹ Bias Use the Soft Menu dial-button [3] to adjust the bias of a Post Curve. Valid values are -100 to 100. „ ‹ Prev Page Press the Soft Menu dial-button [6] to move to the previous page.  Volume CT Mode Press the Volume CT tab in the menu. In this mode, an image is divided into Axial, Sagital and Coronal images, which are then recombined in 3D for display. This mode provides information on surface images. Volume CT Mode has two sub-modes: Cube Volume CT and Cross Volume CT. NOTE: While measurement functions such as Calculator and Caliper are not available, Text and Indicator functions are available. 4-71

[Page 172] § Cube Volume CT Press the Cube in the Volume CT menu. This mode provides information on neighboring external surface images in a cube. [Figure 4.24 Cube VolumeCT] „ ‹ Select Surface Use the Menu dial-button to select a reference surface to view. Available options are Front, Back, Left, Right, Up and Down. The selected surface appears in frontal view. The orientation of the current cube is shown in the lower right corner of the screen. Use the Soft Menu dial-buttons [1]~[6] to change the location of the selected reference surface. „ ‹ Init Press the Soft Menu dial-button [1] to return to the initial screen in Volume CT Mode. 4-72

[Page 173] „ ‹ Boundary Press the Soft Menu dial-button [3] to turn it on or off. This option allows you to show or hide additional boundary lines in Cube Volume CT. Additional boundary lines indicate the external area of the entire volume. „ ‹ Zoom Use the Soft Menu dial-button [1] on the control panel to zoom an image by 25 – 400 times. „ ‹ Rotation Use the 4/X, 5/Y and 6/Z dial-button on the control panel to rotate a Cube Volume CT image by the X-, Y- or Z-axis. § Cross Volume CT Press the Cross in the Volume CT menu. This mode provides information on images within the planes intersecting each other. [Figure 4.25 Cross Volume CT] 4-73

[Page 174] „ ‹ A Plane Use the Soft Menu dial-button [1] to set the location of the Front Surface from between -127 and 127. It will be displayed in blue frames on the screen. „ ‹ B Plane Use the Soft Menu dial-button [2] to set the location of the Upper Surface from between -127 and 127. It will be displayed in red frames on the screen. „ ‹ C Plane Use the Soft Menu dial-button [3] to set the location of the Left Surface from between -127 and 127. It will be displayed in frames on the screen. NOTE: Other usages are the same as for Cube Volume CT. 4-74

[Page 175] Measurements and Chapter 5 Calculations ‹ ‹ Measurement Accuracy 5-3 Causes of Measurement Errors 5-3 Optimization of Measurement Accuracy 5-5 Measurement Accuracy Table 5-7 ‹ ‹ Basic Measurements 5-9 Distance Measurement 5-11 Circumference and Area Measurement 5-16 Volume Measurement 5-18 ‹ ‹ Calculations by Application 5-21 Things to note 5-21 Common Measurement Methods 5-25 OB Calculation 5-31 Gynecology Calculation 5-44 Cardiac Calculation 5-51 Carotid Calculation 5-63 Urology Calculation 5-75 Fetal Echo Calculation 5-80 LE Artery Calculation 5-85 UE Artery Calculation 5-95 LE Vein Calculation 5-100 UE Vein Calculation 5-104 Radiology Calculation 5-109 TCD Calculation 5-117

[Page 176] Chapter 5 Thyroid Calculation 5-123 Breast Calculation 5-125 Testicle Calculation 5-127 Superficial Calculation 5-129 Pediatric Hips Calculation 5-131 Musculoskeletal Calculation 5-133 ‹ ‹ Report 5-134 Viewing Report 5-135 Video Out 5-136 Editing Report 5-136 Adding Comment 5-138 Printing Report 5-139 Saving Report 5-139 Transferring Report 5-140 Stress Echo Report 5-140 Graph Function 5-141 Closing Report 5-145

[Page 177] Measurement Accuracy Measurement values can vary, depending on the nature of the ultrasound, the body’s response to ultrasound, the measurement tools, algorithms, product settings, probe type and user operation. Before using this product, make sure to read and understand the following information regarding the causes of measurement errors, and measurement optimization. Causes of Measurement Errors  Image Resolution The resolution of ultrasound images may be limited by the available space. X ‹ Errors due to a signal range may be minimized by adjusting 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, increasing the frequency of ultrasound enhances resolution.  Pixel Size X ‹ An ultrasound images in the product 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 velocity of ultrasound used during measurement is usually 1,540 m/s on average. X ‹ The velocity of ultrasound may vary depending on the cell type. X ‹ The possible range of error is between approximately 2-5% depending on the structure of cells (about 2% for typical cells and about 5% for fatty cells). 5-3

[Page 178]  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 by 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. X ‹ Aliasing is dramatically reduced in CW Spectral Doppler Mode.  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. X ‹ This can be minimized through compliance with and thorough understanding of the manuals. 5-4

[Page 179] Optimization of Measurement Accuracy  2D Mode X ‹ Resolution is in proportion to the frequency of the probe. X ‹ Penetration is in inverse proportion 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. The accuracy decreases as the distance from the focus increases, widening the beam width. 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 speed 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 higher values.  Doppler Mode X ‹ It is recommended to use lower frequency ultrasound 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 speed 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. 5-5

[Page 180]  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 when measurements are taken in B/W images apply to the accuracy of the measurements taken in these modes. X ‹ It is not recommended to use images in Color/Power Doppler Mode for measurement of accurate blood flow velocity. 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/CW Spectral Doppler Mode.  Cursor Position X ‹ All measurements are affected by input data. X ‹ To ensure accurate positioning of the cursor: 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 direction is always aligned during measurement. 5-6

[Page 181] Measurement Accuracy Table The following tables show the accuracy of the measurements available using the product. Ensure that the results of measurement accuracy checks are kept within the ranges specified in the table. Except for certain applications or probes, the following accuracy ranges should be maintained for measurement of a straight distance. NOTE: To ensure accurate measurements, an accuracy check should be performed at least once per year. If the measurement accuracy falls outside the ranges specified in the following table, contact Samsung Medison Customer Service.  2D Mode (1) System Tolerance Accuracy (2) Measurements Test Methodology Range (Whichever is greater) Based on Axial Distance < +/- 4% or 1mm Phantom Acquisition Full Screen Lateral Distance < +/- 4% or 2mm Phantom Acquisition Full Screen (1) The accuracy of the measurements differs from the table above, depending on the user’s skills. (2) The distance is indicated as ‘cm’ up to two decimal points.  M Mode (1) System Tolerance Test Accuracy (2) Measurements Range (whichever is greater) Methodology Based on Depth <+/- 5% or 3 mm Phantom Phantom 1 - 25 cm Time < +/- 5%. Signal generator Phantom .01 - 11.3 sec (1) The accuracy of the measurements differs from the table above, depending on the user’s skills. (2) The distance is indicated as ‘cm’ up to two decimal points. The speed is indicated as ‘cm/s’ up to two decimal points. 5-7

[Page 182]  PW/CW Spectral Doppler Mode Doppler System Tolerance (2) Methodology Range Measurement (whichever is greater) PW:0.1cm/s - 8.8 m/s Velocity < ± 15% Phantom CW:.1cm/s - 19.3 m/s Time: < +/- 5%. Signal generator .01 - 11.3 sec (1) The accuracy of the measurements differs from the table above, depending on the user’s skills. (2) The distance is indicated as ‘cm’ up to two decimal points. The speed is indicated as ‘cm/s’ up to two decimal points. 5-8

[Page 183] Basic Measurements Press the Caliper button on the control panel. NOTE: Take basic measurements of distance and area regardless of the application. For information on measurements for each application, please refer to “Measurements by Application” in this chapter. The available measurement methods vary depending on the current diagnosis mode. Please refer to the following table: Measurement Diagnosis Mode Measurement Method Distance Line Trace 2D, M, D Angle %StD Distance Measurement M M Distance D Velocity D A/B D Trace D time Ellipse Circumference and Area 2D, M, D Trace Measurement %StA 3 Distance 1 Distance Volume Measurement 2D, M, D Distance + Ellipse Ellipse MOD [Table 5.1 Basic Measurements by Diagnosis Mode]  Basic Measurement Operations The following is the information on common button operations for basic measurements: „ ‹ Select/Change Measurement Method Use the Soft Menu dial-button on the control panel. The Soft Menu items displayed vary depending on the diagnosis mode. The selected measurement method is displayed in the user information area. 5-9

[Page 184] „ ‹ Set Display Location of Measurement Results Use the Soft Menu dial-button [4] Result Action. X ‹ Move : Change the display location of measurement results. Use the Trackball to change the location and then press the Set button. X ‹ Reset : Press the Soft Menu dial-button to initialize the display location of measurement results. NOTE: When measurement results are displayed in more than one screen because there are too many of them, use Move to find the desired measurement results. „ ‹ Cancel Measurement Results Press the Soft Menu dial-button [5] Undo to cancel the current measurement and take it again. NOTE: Among volume measurement items, only 3 Distance and Distance+Ellipse can be undone. „ ‹ Delete Measurement Result Press the Clear button on the control panel. „ ‹ Print Measurement Result Press the Print button on the control panel. „ ‹ Finish Basic Measurements Press the Exit button on the control panel. NOTE: To change various settings such as measurement units, press [F5] Utility and select Measure Setup > General . For more information, please refer to "Chapter 7. Utility.” 5-10

[Page 185] Distance Measurement  Distance This is a basic measurement that is available in all diagnosis modes. You can specify two points in a 2D image and measure the straight distance between them. 1. Select Distance in the Soft Menu [1] . Distance will appear in the user information area. 2. Use the Trackball and the Set button on the control panel to specify both end points of the measurement area. X ‹ Use the Trackball to place the cursor at the desired position and press the Set button. Repositioning Point Tips! Pressing the Change button before pressing the Set button to complete positioning resets the position of a point just set. 3. Specify both end points and then the distance between them will be measured. 4. Once measurement is done, the result is displayed on the screen.  Line Trace It is a basic measurement that is available in all diagnosis modes. You can specify a point in a 2D image and trace a curve from that point to measure the distance between them. 1. Select Line Trace in the Soft Menu [1] . Line Trace will appear in the user information area. 2. Use the Trackball and the Set button on the control panel to specify the start point of the measurement area. X ‹ Use the Trackball to place the cursor at the desired position and press the Set button. 3. Use the Trackball to draw the desired curve and then press the Set button to set the end point. Editing Curve Tips! Before pressing the Set button to specify the end point, you can rotate the Soft Menu dial-button [5] Delete to delete a part of the curve being traced. 4. Specify both end points and then the length of the curve will be automatically measured. 5-11

[Page 186]  Angle A basic measurement that is available in all diagnosis modes. Specify two straight lines in a 2D image and measure the angle between them. 1. Select Angle in the Soft Menu [1] . Angle will appear in the user information area. 2. Draw two straight lines. For information on drawing a straight line, please refer to ‘Distance.’ 3. The angle between two lines will be calculated and displayed on the screen. X ‹ When two angles are calculated, the smaller angle is displayed.  %StD StD stands for Stenosis Distance, which is a basic measurement available in all diagnosis modes. In a 2D image, the diameter of a vessel is measured and the stenosis ratio calculated. 1. Select %StD in the Soft Menu [1] . %StD will appear in the user information area. 2. Measure the total diameter of a vessel using the Distance measurement method. 3. When a new cursor appears, measure the inner wall diameter of the vessel under stenosis. 4. Calculate %StD with the following equation: X ‹ %StD = (Outer Distance – Inner Distance) / Outer Distance × 100  M Distance This is a basic measurement that is available in M Mode only. You can specify two points in an M image and measure the distance, elapsed time and velocity between them. 1. Select M Distance in the Soft Menu [1] . M Distance will appear in the user information area. 2. Specify two points and then measure the shortest distance between them. The way that it is measured is the same as in ‘Distance.’ 5-12

[Page 187]  D Velocity This is a basic measurement that is available in Spectral Doppler Mode only. You can specify two points in a Spectral Doppler image and measure the distance between them, and the velocity at each point to calculate the velocity change, time change and acceleration. NOTE: In a Spectral Doppler image, the X- and Y-axes represent time and velocity, respectively. 1. Select D Velocity in the Soft Menu [1] . D Velocity will appear in the user information area. 2. Specify two points and then measure the shortest distance between them. The way that it is measured is the same as in ‘Distance.’ X ‹ V1 : Velocity at Point 1 X ‹ Time : Change in Time X ‹ V2 : Velocity at Point 2 X ‹ Acc : Acceleration X ‹ PGmax : Max Pressure Gradient X ‹ RI : Resistivity Index X ‹ V2-V1 : Change in Velocity X ‹ S/D : Systolic to Diastolic Ratio The equations used for D Velocity measurement are as follows: X ‹ X ‹ X ‹ including Vmax, PGmax, V2-V1, Time, and Acc will be shown on the screen. 5-13

[Page 188]  D A/B This is a basic measurement that is available in Spectral Doppler Mode only. You can specify two points in a Spectral Doppler image and measure the velocity at each point to calculate the ratio of the velocity between them. 1. Select D A/B in the Soft Menu [1] . D A/B will appear in the user information area. 2. Specify two points for which to measure velocity. X ‹ Use the Trackball to place the cursor at the desired position and press the Set button. X ‹ V1 : Velocity at Point 1 X ‹ PGmax : Max Pressure Gradient X ‹ V2 : Velocity at Point 2 X ‹ V1/V2 : The Ratio of Velocity including Vmax, PGmax, V2-V1 will be shown on the screen. 5-14

[Page 189]  D Trace This is a basic measurement that is available in Spectral Doppler Mode only. You can specify a point in a Spectral Doppler image and trace a curve from that point to calculate the velocity, integral value and average velocity of blood flow. 1. Select the Soft Menu dial-button [1] D Trace. “D Trace” is displayed in the user information area. 2. Trace a curve. The method for measuring a curve is the same as in “2D Line Trace.” 3. When the measurement is finished, its result is shown on the screen. X ‹ PSV: Peak Systolic Velocity X ‹ PGmean: Mean Pressure Gradient X ‹ EDV: End Diastolic Velocity X ‹ VTI: Velocity Time Integral X ‹ PI: Pulsatility Index X ‹ PHT: Pressure Half Time X ‹ RI: Resistivity Index X ‹ Acc: Acceleration X ‹ S/D: Ratio of PSV to EDV X ‹ AccT: Acceleration Time X ‹ Vmax: Max Velocity X ‹ Dec: Deceleration X ‹ Vmean: Mean Velocity X ‹ DecT: Deceleration Time X ‹ PGmax: Max Pressure Gradient The equations used for D Trace measurement are as follows: X ‹ X ‹ X ‹ X ‹ including Vmax, PGmax, PGmean, VTI, PHT, Acc, AccT, Dec and DecT will be shown on the screen. 5-15

[Page 190] Circumference and Area Measurement  Ellipse This is a basic measurement that is available in all diagnosis modes. You can measure the circumference and area of a circular (elliptical) object in a 2D image. 1. Select the Soft Menu [2] Ellipse. “Ellipse” is displayed in the user information area. 2. Use the Trackball and the Set button on the control panel to specify the diameter (axis) of the measurement area. X ‹ Place the cursor at a desired position with the Trackball, and press the Set button. Repositioning Point Tips! Pressing the Change button before pressing the Set button to complete positioning resets the position of a point just set. 3. Specify the size of the circle (ellipse). X ‹ Adjust the size using the Trackball, and press the Set button. The equations used for ellipse measurement are as follows: (A: Long axis, B: Short axis) Area (a, b: Axis) 5-16

[Page 191]  Trace This is a basic measurement that is available in all diagnosis modes. You can measure the circumference and area of an irregular object in a 2D image. 1. Select the Soft Menu [2] Trace. “Trace” is displayed in the user information area. 2. Use the Trackball and the Set button on the control panel to specify the start point for tracing over the contour of the measurement area. X ‹ Place the cursor at a desired position with the Trackball, and press the Set button. 3. Trace the curve so that the measurement cursor returns to the start point, and then press the Set button. NOTE: Trace lines must be closed. If you press the Set button before tracing is complete, tracing may be done over a straight line between the current point and the start point, resulting in a significant error. The equations used for Trace measurement are as follows: sum (N = 1,2… last point) Area sum (N = 1,2… last point)  %StA StA stands for Stenosis Area, which is a basic measurement available in all diagnosis modes. In a 2D image, the area of a vessel is measured and the stenosis ratio (%) calculated. 1. Select %StA in the Soft Menu [2] . %StA will appear in the user information area. 2. Measure the area of the vessel outer wall using the Area measurement method. 3. When a new cursor appears, measure the inner wall area of the vessel under stenosis. 4. Calculate %StA with the following equation: %StA = (Outer Area – Inner Area) / Outer Area × 100 5-17

[Page 192] Volume Measurement NOTE: Since Dual Mode simultaneously displays two images on the screen, you don’t have to return to the diagnosis mode to measure volume in Dual Mode.  3 Distance This is a basic measurement that is available in all diagnosis modes. You can measure the volume of an object in a 2D image by using 3 straight lines. 1. Select the Soft Menu [3] 3 Distance. “3 Distance” is displayed in the user information area. 2. Specify two points and measure the straight distance between them. The method for measuring a line is the same as in “Distance.” 3. Measure the length of the remaining two straight lines as in the above. Measure other two distance using the same method with 2. 4. When the measurement is finished, its result is shown on the screen. The volume of the object along with the length of each straight line are calculated. The equations used for 3 Distance measurement are as follows: (D: distance)  1 Distance This is a basic measurement that is available in all diagnosis modes. You can measure the volume of an object in a 2D image by using only one straight line. 1. Select the Soft Menu [3] 1 Distance. “1 Distance” is displayed in the user information area. 2. Specify two points and measure the straight distance between them. The method for measuring a line is the same as in “Distance.” 3. When the measurement is finished, its result is shown on the screen. The volume of the object along with the length of the straight line are calculated. The equations used for 1 Distance measurement are as follows: (D: distance) 5-18

[Page 193]  Distance + Ellipse This is a basic measurement that is available in all diagnosis modes. You can measure the volume of an object in a 2D image by using one straight line and one circle (ellipse). 1. Select the Soft Menu [3] Distance + Ellipse. “Distance + Ellipse” is displayed in the user information area. 2. Specify two points and measure the straight distance between them. The method for measuring a line is the same as in “Distance.” 3. Specify the size of the circle (ellipse). The method for measuring a circle (ellipse) is the same as in “Ellipse.” X ‹ D: The length of a straight line X ‹ Area: The area of a circle X ‹ Long: The length of the long axis in an ellipse X ‹ Vol.: Volume X ‹ Short: The length of the short axis in an ellipse The equations used for Distance + Ellipse measurement are as follows: ( a : Short axis, b : Long axis , d : Distance)  Ellipse A basic measurement that is available in all diagnosis modes. In a 2D image, the volume of a conical object is measured using an ellipse. 1. Select Ellipse in the Soft Menu [3] . Ellipse will appear in the user information area. 2. Set the size of the ellipse. The way it is measured is the same as in ‘Ellipse.’ The following equation is used for ‘Ellipse’ measurement: Long Short Short 5-19

[Page 194]  MOD A basic measurement that is available in all diagnosis modes. In a 2D image, the area of an irregular object and the length of its long axis are obtained to calculate its volume. MOD is an abbreviation for ‘Method of Disk.’ 1. Select MOD in the Soft Menu [3] . MOD will appear in the user information area. 2. Draw a contour to measure. The way it is measured is the same as in ‘Trace.’ 3. Measure the length of the long axis. The way it is measured is the same as in ‘Distance.’ 4. Once measurement is done, the result is displayed on the screen. 5-20

[Page 195] Calculations by Application Press the Calc button on the control panel. Things to note  Before Taking Measurements „ ‹ Register Patient Make sure t hat the currently registered patient information is correct. If the patient is not registered, press the Patient button on the control panel. „ ‹ Check Probe, Application & Preset X ‹ Check the probe name and application that are displayed in the title bar. Press the Probe button on the control panel to use another probe or application. X ‹ Check the preset settings in the Probe Selection screen.  Measurement Operations The following gives information on the common button operations for measurements: „ ‹ Change/Select Application Use the Calculator button on the control panel. Each time the Calculator button is pressed, the application toggles in the order determined under Measure Setup. The order in which applications appear can be specified at Utility > Measure Setup > General > Packages . „ ‹ Select Measurement Item After moving the cursor by using the Trackball or the Menu dial-button on the control panel, press the Set button or the Menu dial-button. 5-21

[Page 196] „ ‹ Change Measurement Method Press the Change button on the control panel. If the current measurement item can be measured in more than one way, the measurement method is changed. The current measurement method is displayed in the user information area. Once measurement is started, it cannot be changed. „ ‹ Measurement Result Display Settings Use the Soft Menu dial-button on the control panel to set the location and to adjust the font size. „ ‹ Delete Measurement Result Press the Clear button on the control panel. NOTE: The measurement results are deleted from the screen but still shown on the report for the corresponding application. „ ‹ Print Measurement Result Press the Print button on the control panel. „ ‹ Exit Measurement Press the Exit button on the control panel. „ ‹ End Diagnosis Press the End Exam button on the control panel. The diagnosis for the current patient ends and all measurement results are saved.  Measurement [Figure 5.1 The Soft Menu for Measurement Results Display] 5-22

[Page 197] „ ‹ Package Rotate the Soft Menu dial-button [1] to set the package. „ ‹ HR Cycle Enabled when a heart rate is measured in M/D Mode. Rotate the Soft Menu dial-button [4] to set the Heart Rate Cycle and select a value between 1 and 20. „ ‹ EFW Enabled when obstetrics measurement menu is taken. you may use the dial-button [2] to change the EFW Reference. „ ‹ Trace Direction Enabled after Auto or Limited Trace is performed in Spectral Doppler Mode. Rotate the Soft Menu dial- button [3] and select a direction to trace from Up , Down and All . X ‹ Up : Traces only the positive part on the Doppler spectrum. X ‹ Down : Traces only the negative part on the Doppler spectrum. X ‹ All : Traces the whole Doppler spectrum. „ ‹ Threshold Rotate the Soft Menu dial-button [4] to set the threshold. Enabled after Auto or Limited Trace is performed in Spectral Doppler Mode. Adjusting the threshold value helps the contouring of a Doppler spectrum. „ ‹ Result Action Rotate the Soft Menu dial-button [5] to set the position for the measurement results. X ‹ Move : Change the position where the measurement results are displayed. After changing the position, press the Set button. NOTE: When there are too many measurement data and they cannot all be displayed on the screen at one time, the Move button can be used to navigate through the measurement data. X ‹ Reset : Press the Soft Menu dial-button to initialise the position where the measurement results are displayed. 5-23

[Page 198] „ ‹ Delete Enabled when a trace is measured. Rotate the Soft Menu dial-button [3] to delete the part of the curve which is being traced. „ ‹ Font Size Use the Soft Menu dial-button [6] to set the font size for the measurement results between 10 and 30. „ ‹ Undo Press the Soft Menu dial-button [6] to cancel the last measurement. 5-24

[Page 199] Common Measurement Methods This section provides information on the common measurement methods used for applications.  Measurements in Spectral Doppler Mode In general, if you trace a Doppler spectrum, you can obtain results for various measurement items automatically. There are 3 ways to trace a Doppler spectrum. SONOACE R7 also allows you to select a specific item under the Measurement menu and take measurements individually without tracing a Doppler spectrum. „ ‹ Auto Trace A spectrum is traced automatically. It is enabled in the Measurement menu in Spectral Doppler Mode. 1. Press Auto Trace in the Measurement menu. 2. The system traces a spectrum automatically. 3. When Trace is complete, the measurement results are displayed on the screen. 5-25

[Page 200] Things to consider for Doppler Spectrum Auto Trace Tips! The state of a Doppler spectrum may affect measurement results. Please see the following: X ‹ Causes for Trace Failure − If Gain is changed for a Doppler image in the Freeze state, Contour Trace and Peak Trace will not work. − If there is little or no noise in an image without a spectrum, Contour Trace will not work. − If there is severe noise in an image, Contour Trace will not work. − If the Clutter filter is set too high, Auto Trace or Limited Trace may not work. X ‹ Causes for Inaccurate Peak Trace − If PRF (Pulse Repetition Frequency) is lower than the velocity of the observation area, aliasing may occur. If the original signals are separated from aliasing, Trace can be done but the peak measurement may not be accurate. − If the peak of a spectral waveform is not clear or occurs intermittently, Trace can be done but the peak measurement may not be accurate. − If the Doppler Gain is set to high or low, it becomes difficult to distinguish spectrums. This may result in measurement error(s). − If the Wall Filter is set too high, only part of the spectrum is displayed. In this case, Trace can be done but Peak measurement may not be accurate. − If abnormal noise or artifact occurs, Trace can be done but Peak measurement may not be accurate. X ‹ Misc. Limited Trace is supported only for two-peak spectrums such as Mitral Valve Inflow and Tricuspid Valve Inflow in the cardiology application. 5-26

[Page 201] „ ‹ Limited Trace If you specify a measurement range, a spectrum is traced automatically. It is enabled in the menu in Spectral Doppler Mode. 1. Press Limited Trace in the Measurement menu. A bar appears allowing you to specify a measurement area. 2. Specify the measurement range. X ‹ Place the bar at a desired position with the Trackball, and press the Set button. 3. The system traces spectrums within the specified range automatically. 4. When Trace is complete, the measurement results are displayed on the screen. „ ‹ Manual Trace A spectrum is traced manually. It is enabled in the menu in Spectral Doppler Mode. 1. Press Manual Trace in the Measurement menu. A measurement cursor appears over a spectrum. 2. Trace the spectrum. The measuring method is the same as in “D Trace.” 3. When Trace is complete, the measurement results are displayed on the screen. „ ‹ Itemized Measurement In the Measurement menu, select an individual item and take a measurement. 1. Press the Calculator button on the control panel after obtaining a desired image. 2. Select a desired item in the Measurement menu. The “+” cursor appears over a spectral waveform. 3. Position the “+” cursor and press the Set button. 4. The measurement results for the selected item are displayed on the screen. 5-27

[Page 202] Measurement items for Doppler Spectrum are as follows: Item Type Unit Equation PSV (Peak Systolic Velocity) Velocity cm/s or m/s EDV (End Diastolic Velocity) Velocity cm/s or m/s TAMV (Time Average Mean Velocity) Velocity cm/s or m/s TAPV (Time Average Peak Velocity) Velocity cm/s or m/s PGmean (Mean Pressure Gradient) Calculation mmHg PGmax (Max Pressure Gradient) Calculation mmHg 4 × PSV 2 S/D (Ratio of PSV to EDV) Calculation Ratio (PSV / EDV) D/S (Ratio of EDV to PSV) Calculation Ratio EDV /PSV RI (Resistivity Index) Calculation Ratio (PSV – EDV) / PSV PI (Pulsatility Index) Calculation Ratio (PSV – EDV) / Vmean Taking measurements via Auto Calc Tips! You can use Auto Calc to take measurements on predetermined item(s). Items measured are as follows. For information on setting measurement item(s), please refer to “Auto Calc” in "Chapter 7. Utility.’ X ‹ Peak Systolic Velocity (PSV) X ‹ Time Averaged Mean Velocity (TAMV) X ‹ End Diastolic Velocity (EDV) X ‹ Diastole / Systole Ratio (D/S) X ‹ Time Averaged Peak Velocity (TAPV) X ‹ Max Pressure Gradient (PGmax) X ‹ Resistive Index (RI) X ‹ Mean Pressure Gradient (PGmean) X ‹ Pulsatility Index (PI) X ‹ Velocity Time Integral (VTI) X ‹ Systole / Diastole Ratio (S/D) X ‹ PeakA 5-28

[Page 203]  Volume Flow Measurement Select Volume Flow in the Measurement menu. Volume Flow allows you to measure and calculate an area or distance. For information on distance or area measurements, please refer to “Basic Measurements.” The TAMV (Time Avg. Mean Velocity) value is automatically measured. „ ‹ Vesl. Area (Vessel Area) Measure the area of a blood vessel and calculate TAMV and Volume Flow. „ ‹ Vesl. Dist. (Vessel Distance) Measure the width of a blood vessel and calculate TAMV and Volume Flow.  Stenosis Measurement You can measure the stenosis of each blood vessel system by measuring and calculating an area or distance. „ ‹ % StA Measure the area of the inner and outer walls of a blood vessel. StA stands for Stenosis Area. 1. Select the %StA menu and the first cursor will appear in 2D Mode. 2. Measure the area of the vessel’s outer wall using the Circ/Area measurement method. 3. When the second cursor appears, measure the area of the vessel’s inner wall under stenosis. %Stenosis Area. = (Outer Area – Inner Area) / Outer Area × 100 „ ‹ % StD Measure the diameter of a blood vessel. StD stands for Stenosis Distance. 1. Select the %StD menu and the first cursor will appear in 2D Mode. 2. Measure the total diameter of a blood vessel using the Distance measurement method. 3. When the second cursor appears, measure the diameter of the vessel’s inner wall under stenosis. %Stenosis Dist. = (Outer Distance – Inner Distance) / Outer Distance × 100 5-29

[Page 204]  Heart Rate Measurement „ ‹ HR (Heart Rate) You can calculate heart rates for a certain period of time. 1. Select HR in the Measurement menu. A bar appears allowing you to specify a measurement area. 2. Specify the measurement range. X ‹ Place the bar at a desired position with the Trackball, and press the Set button. 3. The system measures the heart rate within the specified range automatically. The measurement results are displayed on the screen. 5-30

[Page 205] OB Calculation  Before Taking OB Measurements „ ‹ OB Basic Information Enter the information required for OB diagnosis in the Patient Information window. The basic OB information includes LMP (Last Menstrual Period) and Gestations. Once LMP is entered, EDD (Estimated Delivery Date) and GA (Gestational Age) are calculated automatically. LMP is required for the calculation of values such as EDD and SD in obstetrics measurement. X ‹ EDD(LMP) = LMP + 280 days X ‹ GA(LMP) = Current System Date - LMP Regardless of LMP, enter the EDD with a physician’s opinion into Estab. Due Date. If LMP is not available, when Estab. Due Date is modified, LMP is automatically calculated and the “C” mark is displayed next to the LMP information. A maximum of four fetuses can be entered in the Gestations menu. The default value is ‘1’. In the case of twins, enter ‘2’. For further information about patient information menus and how to input patient information, refer to “Entering Patient Data” in "Chapter 7. Utility. „ ‹ OB Measurement Menu Settings Set up 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, refer to the Reference Manual. Refer to the "Setting Measurements" section in "Chapter 7. Utility" for additional information. X ‹ It will be convenient to set the function of the User Key 1 buttons on the control panel to the two obstetrics measurement items you want to use. Set their functions in Utility > Setup > Peripherals > User Key Setup . X ‹ For twins, distinguish fetuses by specifying them as Fetus A and Fetus B in the Measurement menu. Press the Change button on the control panel to change a fetus to measure. 5-31

[Page 206] When the measurements for the selected items are complete, the measurements and gestational age are displayed on the screen. The measurement method for each item is the same as for basic measurement. Measured items are automatically recorded in a report. [Figure 5.2 OB Measurement Menu] GS All Distance cm, mm MSD All Automatic calculation cm, mm D1 All Distance cm, mm D2 All Distance cm, mm Fetal Biometry D3 All Distance cm, mm CRL All Distance cm, mm YS All Distance cm, mm 5-32

[Page 207] BPD, HC All Distance cm, mm BPD All Distance cm, mm OFD All Distance cm, mm Circumference or automatic HC All cm, mm calculation APD All Distance cm, mm TAD All Distance cm, mm Circumference or automatic AC All cm, mm calculation Fetal Biometry FTA All Area or automatic calculation cm , mm FL All Distance cm, mm SL All Distance cm, mm APTD, TTD All Distance cm, mm APTD All Distance cm, mm TTD All Distance cm, mm Circumference or automatic ThC All cm, mm calculation HUM All Distance cm, mm ULNA All Distance cm, mm TIB All Distance cm, mm Fetal Long Bones RAD All Distance cm, mm FIB All Distance cm, mm CLAV All Distance cm, mm Vertebral All Distance cm, mm 5-33

[Page 208] CEREB All Distance cm, mm CM All Distance cm, mm NF All Distance cm, mm NT All Distance cm, mm OOD All Distance cm, mm IOD All Distance cm, mm Fetal Cranium NB All Distance cm, mm Rt.Va All Distance cm, mm Lt.Va All Distance cm, mm Rt.Vp All Distance cm, mm Lt.Vp All Distance cm, mm Rt.Hem All Distance cm, mm Lt.Hem All Distance cm, mm Foot All Distance cm, mm Ear All Distance cm, mm MP All Distance cm, mm Fetal Others Lt/Rt. Renal L All Distance cm, mm Lt/Rt.Renal AP All Distance cm, mm Pelvis All Distance cm, mm All All Distance cm, mm Q1 All Distance cm, mm Q2 All Distance cm, mm AFI Q3 All Distance cm, mm Q4 All Distance cm, mm MVP All Circumference cm, mm Cervix Cervix Length All Distance cm, mm 5-34

[Page 209] All (D) All % ThD ap All Distance cm, mm ThD trans All Distance cm, mm HrtD ap All Distance cm, mm CTAR HrtD trans All Distance cm, mm All (A) All % ThA All Area cm , mm HrtA All Area cm , mm Calculated after velocity All PW Sys Flow PW Velocity cm/s, m/s PLI A. Rev Flow PW Velocity cm/s, m/s Dias Flow PW Velocity cm/s, m/s Umbillical A EDV PW Velocity cm/s, m/s 5-35

[Page 210] Mid Cereb A EDV PW Velocity cm/s, m/s Rt. / Lt. Uterine Artery 5-36

[Page 211] Placenta A EDV PW Velocity cm/s, m/s Rt. / Lt. Fetal Carotids 5-37

[Page 212] Fetal Aorta EDV PW Velocity cm/s, m/s Duct V All PW Velocity cm/s, m/s Duct V S Vmax PW Velocity cm/s, m/s Duct V D Vmax PW Velocity cm/s, m/s Duct V A Vmax PW Velocity cm/s, m/s Ductus Venosus TAMV(M) PW Doppler spectrum Trace cm/s or m/s 5-38

[Page 213] Renal Artery PSV PW Velocity cm/s, m/s Calculated after Distance Volume PW Automatic calculation ml/m Flow(Auto) Volume Flow(D) PW Automatic calculation ml/m Volume Flow TAMV PW Doppler spectrum trace cm/s or m/s Vesl. Area. All Area cm , mm Fetal HR Fetal HR PW Heart Rate bpm Calculated after Distance Rt. / Lt. Ovary 5-39

[Page 214] Rt. / Lt. Ovarian A Vesl. Area. All Area cm , mm Fetal HR Fetal HR PW Heart Rate bpm X ‹ PLI, Renal Artery, and Fetal HR can only be measured in Doppler Mode. X ‹ For information on basic measurements, please refer to “Basic Measurements” in this chapter. X ‹ For references on measurement items, please refer to “Reference Manual – Part 1.”  Automatic Calculation Some items in the measurement menu are automatically calculated based on measurements of other items. „ ‹ HC This is automatically calculated using the following formula, provided there are measured BPD and OFD values. Exception: when you use Merz reference, „ ‹ AC This is automatically calculated using the following formula, provided there are measured APD and TAD values. Exception: when you use Merz reference, 5-40

[Page 215] „ ‹ FTA This is automatically calculated using the following formula, provided there are measured APD and TAD values. „ ‹ ThC This is automatically calculated using the following formula, provided there are measured APTD and TTD values.  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 plane, press the Freeze button to go to the diagnosis mode. After obtaining the image, press the Freeze button again to return to the measurement mode.  Calculating Fetal Weight (EFW) When measurements for the following items are complete, the system uses the results to calculate the estimated fetal weight automatically. For an equation for calculating fetal weight, please refer to “Estimated Fetal Weight Formula” in the Reference Manual Part 1. 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 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. 5-41

[Page 216]  Continuous Measurement / Review for EFW Calculation You can measure OB item(s) continuously for EFW calculation. Before Measurement Tips! 1. Check whether the User key has been set to measure the EFW consecutively. To measure the EFW consecutively using the User key, set it in Utility > Setup > Peripherals > User Key . 2. When the Confirm Current EFW Reference is not selected or when you want to change it, select or change it in Utility > Measure Setup > OB > Tables > Fetal weight > EFW Equation . NOTE: This function is not available in 3D Mode. „ ‹ How to measure 1. Press the User Key1 on the control panel. OB menu and measure items are displayed on the screen. 2. Measure the items for EFW calculation using trackball and the Set button. 3. Press the Freeze button to finish the first measurement. 4. Press the Freeze button to measure the next items. 5. When you finish the measurement for all items, the result will be displayed on the monitor. See following table; Reference Measure Item (by Order) Campbell AC Hadlock BPD → AC Hadlock1 AC → FL Hadlock2 BPD → AC → FL Hadlock3 AC → FL → HC Hadlock4 BPD, HC → AC → FL Hansmann BPD → TTD Merz BPD → AC Osaka BPD → FTA → FL 5-42

[Page 217] Reference Measure Item (by Order) Shepard BPD → AC Shinozuka1 BPD → AC → FL Shinozuka2 BPD → APTD, TTD → SL Shinozuka3 BPD → APTD, TTD → FL Ferrero AC → FL Higginbottom AC Thurnau BPD → AC Warsof BPD → AC Weiner1 HC → AC Weiner2 AC → FL → HC Woo BPD → AC → FL „ ‹ Review the Result of EFW Calculation X ‹ Press the User Key1 on the control panel. Measured items and its results are displayed on the screen. X ‹ To remove the results, press the Clear button on the control panel. 5-43

[Page 218] Gynecology Calculation  Before Taking GYN Measurements Enter the information required for GYN diagnosis in the Patient Information screen. Basic Information for gynecology includes Gravida, Para, Aborta, Ovul Date, Day of Cycle and Ectopic. [Figure 5.3 GYN Measurement Menu] 5-44

[Page 219] Uterus All All ml Uterus L All Distance cm, mm Uterus H All Distance cm, mm Uterus W All Distance cm, mm Uterus Endo. Thick All Distance cm, mm Cervix All All Volume ml Cervix L All Distance cm, mm Cervix H All Distance cm, mm Cervix W All Distance cm, mm Rt. / Lt. Cyst Rt. / Lt. Ovary Volume calculated after Rt. / Lt. Follicles 1 ~ 12 All cm, mm and ml distance measurement 5-45

[Page 220] Mass 1~3 Rt. / Lt. Ovarian A 5-46

[Page 221] Rt. / Lt. Uterine A Pericystic Endometrial 5-47

[Page 222] Endo. Polyp Vol. All ml Rt. / Lt. Ovarian Mass 5-48

[Page 223] Uterine Tumor 1~3 Cervical Tumor 5-49

[Page 224] Ectopic Fetal HR PW Heart Rate bpm 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 the Freeze button to switch to Scan Mode and obtain images from another perspective. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common X ‹ For references on measurement items, see the Reference Manual – Part 2. 5-50

[Page 225] Cardiac Calculation NOTE: Cardiac measurement is an optional item.  Before Taking Cardiac Measurements „ ‹ Cardiology Basic Information Enter the patient information required for cardiology diagnosis in the Patient Information window. The basic information for cardiology includes Height, Weight, HR (Heart Rate), RAP (Right Arterial Pressure) and BP (Blood Pressure). When the patient’s height and weight are entered, BSA (Body Surface Area) is automatically calculated and displayed. For more information about patient information menus and how to enter information, please refer to “Entering Patient Data” in "Chapter 7. Utility.” „ ‹ Cardiac Measurement Menu Settings Set the related menus for convenient measurement. You can specify how an area and volume can be calculated. Please refer to the “Setting Measurements” section in "Chapter 7. Utility” for more information on measurement menus and settings. „ ‹ Dist20 Traces the cardiac circumference and then draw the cardiac axis. The system automatically draws 20 straight lines perpendicular to the axis and calculates its volume. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common X ‹ For references on measurement items, see the Reference Manual – Part 2. 5-51

[Page 226] [Figure 5.4 Cardiac Measurement Menu] LVd All Continuous measurement IVSd All Distance cm, mm LVIDd All Distance cm, mm LVPWd All Distance cm, mm LVs All Continuous measurement IVSs All Distance cm, mm LV LVIDs All Distance cm, mm LVPWs All Distance cm, mm RVAWs All Distance cm, mm RVAWd All Distance cm, mm RVIDs All Distance cm, mm RVIDd All Distance cm, mm 5-52

[Page 227] LV M Continuous measurement IVSd M Distance cm, mm LVIDd M Distance cm, mm LVPWd M Distance cm, mm IVSs M Distance cm, mm LV(M) LVIDs M Distance cm, mm LVPWs M Distance cm, mm RVAWd M Distance cm, mm RVIDd M Distance cm, mm RVAWs M Distance cm, mm RVIDs M Distance cm, mm A2C Vol.d All Dist20 ml A2C Vol.s All Dist20 ml LV Vol. (Simpson) A4C Vol.d All Dist20 ml A4C Vol.s All Dist20 ml Vol. d All Volume ml LV Vol. (A/L) Vol. s All Volume ml LVAd sax All Area cm , mm LVAs sax All Area cm , mm LV Vol. (Bullet) LVLd apical All Distance cm, mm LVLs apical All Distance cm, mm Calculated after All All g area measurement LVAd sax epi All Area cm , mm LV Mass LVAd sax endo All Area cm , mm LVLd apical All Distance cm, mm 5-53

[Page 228] RVAWd All Distance cm, mm RVIDd All Distance cm, mm RVAd All Area cm , mm RVAWs All Distance cm, mm RVIDs All Distance cm, mm RV RVAs All Area cm , mm RV Major All Distance cm, mm RV Minor All Distance cm, mm LPA Diam All Distance cm, mm MPA Diam All Distance cm, mm RPA Diam All Distance cm, mm RVAWd M Distance cm, mm RVIDd M Distance cm, mm RVAWs M Distance cm, mm RV (M) RVIDs M Distance cm, mm RVPEP M Time ms RVET M Time ms Calculated after distance measurement LA Major All Distance cm, mm LA Vol. LA Minor All Distance cm, mm LA Diam All Distance cm, mm LA EDV A2C All Dist 20 ml LA ESV A2C All Dist 20 ml LA Vol. (Simpson) LA EDV A4C All Dist 20 ml LA ESV A4C All Dist 20 ml 5-54

[Page 229] All All Continuous measurement Ao Root All Distance cm, mm LA Diam All Distance cm, mm LVOT Diam All Distance cm, mm Ao Arch All Distance cm, mm Ao / LA Asc Ao All Distance cm, mm Desc Ao All Distance cm, mm Ao Isth Diam All Distance cm, mm Ao ST Junct Diam All Distance cm, mm Ao Sinus Diam All Distance cm, mm All M Continuous measurement Ao Root M Distance cm, mm AV Cusp Sep M Distance cm, mm Ao / LA (M) LA Diam M Distance cm, mm LVPEP M Time ms LVET M Time ms RA Major All Distance cm, mm RA Minor All Distance cm, mm RAAd All Area cm , mm RAAs All Area cm , mm RAEDV All Dist20 Ml RA RAESV All Dist20 Ml IVC Diam Exp. All Distance cm, mm IVC Diam Ins. All Distance cm, mm SVC Diam Exp. All Distance cm, mm SVC Diam Ins. All Distance cm, mm 5-55

[Page 230] LVOT LVOT Diam All Distance cm, mm LVOT Vmax PW Velocity cm/s, m/s LVOT LVOT VTI PW Distance cm, mm LVOT AccT PW Time ms LVOT ET PW Time ms RVOT RVOT Diam All Distance cm, mm RVOT Vmax PW Velocity cm/s, m/s RVOT VTI PW Distance cm, mm RVOT ET PW Time ms AV Auto Trace PW Doppler spectrum trace AV Limited Trace PW Doppler spectrum trace AV Manual Trace PW Doppler spectrum trace AV Cusp All Distance cm, mm AV Diam All Distance cm, mm AV AVA Planimetry All Area cm , mm AV Vmax PW Velocity cm/s, m/s AV PHT PW Time ms AV VTI PW Distance cm, mm AV AccT PW Time ms AV DecT PW Time ms 5-56

[Page 231] AV ET PW Time ms R-R Interval M, PW Heart Rate Bpm AR Auto Trace PW Doppler spectrum trace AR Limited Trace PW Doppler spectrum trace AR Manual Trace PW Doppler spectrum trace AR VC Diam All Distance cm, mm AR Vmax PW Velocity cm/s, m/s AR ed Vmax PW Velocity cm/s, m/s AR PHT PW Time ms AV AR VTI PW Distance cm, mm AR AccT PW Time ms AR DecT PW Time ms AR PISA Rad C PISA-Radius cm, mm AR Alias Vel. C Velocity cm/s, m/s AR IVRT PW Time ms AR IVCT PW Time ms AVO C,PW Time ms AVC C,PW Time ms All Points M Continuous measurement D-E M Distance cm, mm E-F Slope M Velocity cm/s, m/s MV (M) A-C Interval M Time ms EPSS M Distance cm, mm Propagation Vel. M Velocity cm/s, m/s 5-57

[Page 232] MV Ann Diam All Distance cm, mm MV Diam 1 All Distance cm, mm MV Diam 2 All Distance cm, mm MVA Planimetry All Area cm , mm MV Limited Trace PW Doppler spectrum trace MV Manual Trace PW Doppler spectrum trace E-DT-A PW Time-Velocity-Time ms and m/s MV Peak E PW Velocity cm/s, m/s MV Peak A PW Velocity cm/s, m/s MV Vmax PW Velocity cm/s, m/s MV PHT PW Time ms MV VTI PW Distance cm, mm MV AccT PW Time ms MV MV DecT PW Time ms MV A Dur. PW Time ms MV ET PW Time ms MV IVRT PW Time ms MV IVCT PW Time ms R-R Interval M, PW Heart Rate bpm MR VC Diam All Distance cm, mm MR Auto Trace PW Doppler spectrum trace MR Limited Trace PW Doppler spectrum trace MR Manual Trace PW Doppler spectrum trace MR Vmax PW Velocity cm/s, m/s MR VTI PW Distance cm, mm Calculated after time MR dp / dt PW mmHg/s 5-58

[Page 233] MR PISA-Rad. C Distance cm, mm MV MR Alias Vel. C Velocity m/s TV Limited Trace PW Doppler spectrum trace TV Manual Trace PW Doppler spectrum trace TV Ann Diam All Distance cm, mm TV Diam 1 All Distance cm, mm TV Diam 2 All Distance cm, mm TVA Planimetry All Area cm , mm TV Vmax PW Velocity cm/s, m/s TV Peak E PW Velocity cm/s, m/s TV Peak A PW Velocity cm/s, m/s TV PHT PW Time ms TV VTI PW Distance cm, mm TV AccT PW Time ms TV DecT PW Time ms TV TV A Dur. PW Time ms Q to TV Open PW Time ms R-R Interval M, PW Heart Rate bpm TR Auto Trace PW Doppler spectrum trace TR Limited Trace PW Doppler spectrum trace TR Manual Trace PW Doppler spectrum trace TR VC Diam All Distance cm, mm TR Vmax PW Velocity cm/s, m/s TR VTI PW Distance cm, mm Calculated after time TR dp / dt PW mmHg/s TR PISA-Rad. C PISA-Radius cm, mm TR Alias Vel. C Velocity cm/s, m/s 5-59

[Page 234] 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 cm, mm PVA Planimetry All Area cm , mm PV Vmax PW Velocity cm/s, m/s PV PHT PW Time ms PV AccT PW Time ms PV DecT PW Time ms PV ET PW Time ms PV R-R Interval M, PW Heart Rate Bpm Q to PV Close PW Time ms PR Auto Trace PW Doppler spectrum trace PR Limited Trace PW Doppler spectrum trace PR Manual Trace PW Doppler spectrum trace PR VC Diam All Distance cm, mm PR Vmax PW Velocity cm/s, m/s MPA Vmax PW Velocity cm/s, m/s PR PHT PW Time ms PR AccT PW Time ms PR DecT PW Time ms Calculated after continuous All MV TST PW Time ms Tei Index MV ET PW Time ms MV IVCT PW Time ms MV IVRT PW Time ms 5-60

[Page 235] All PW Continuous measurement Sys Vel. PW Velocity cm/s, m/s Pulm. Veins Dias Vel. PW Velocity cm/s, m/s A. Rev Vel. PW Velocity cm/s, m/s A. Rev Dur. PW Time ms All PW Continuous measurement Sys Vel. PW Velocity cm/s, m/s Hepatic Veins Dias Vel. PW Velocity cm/s, m/s A. Rev Vel. PW Velocity cm/s, m/s A. Rev Dur. PW Time ms All PW Continuous measurement Peak E’ PW Velocity cm/s, m/s Peak A’ PW Velocity cm/s, m/s Tissue Doppler Peak S’ PW Velocity cm/s, m/s AccT PW Time ms DecT PW Time ms LVOT Diam All Distance cm, mm Sys.HR PW Heart Rate bpm Sys.VTI PW Distance cm, mm Qp: Qs RVOT Diam All Distance cm, mm Pulm. HR PW Heart Rate bpm Pulm. VTI PW Distance cm, mm PEd All Distance cm, mm PE PEs All Distance cm, mm HR HR M, PW Heart Rate bpm 5-61

[Page 236] X ‹ In Dual 2D Mode, two images can be viewed simultaneously. X ‹ For RVAWd , RVIDd , RVAWs , and RVIDs , see 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 ‹ As PISA-Radius or PISA-Alias Vel. measurements require Velocity values, you have to select color display for Velocity or Vel + Var in C Mode. For more information, see the ‘Color Doppler Mode’ section in "Chapter 4. Diagnosis Mode”. 5-62

[Page 237] Carotid Calculation  Before Taking Carotid Measurements Set the related menus for convenient measurement. You can also specify how an area and volume are calculated. Please refer to the “Setting Measurements” section in "Chapter 7. Utility” for more information on the measurement menus and settings. [Figure 5.5 Carotid Measurement Menu] X ‹ For information on basic measurements, please refer to “Basic Measurements” in this chapter. X ‹ For references on measurement items, please refer to “Reference Manual – Part 2.” 5-63

[Page 238] Rt. / Lt. Subclavian A Rt. / Lt. Prox CCA 5-64

[Page 239] Rt. / Lt. Mid CCA Rt. / Lt. Distal CCA 5-65

[Page 240] Rt. / Lt. Bulb Rt. / Lt. Prox ICA 5-66

[Page 241] Rt. / Lt. Mid ICA Rt. / Lt. Distal ICA 5-67

[Page 242] Rt. / Lt. ECA Rt. / Lt. Vetebral A EDV PW Velocity cm/s, m/s 5-68

[Page 243] General EDV PW Velocity cm/s, m/s Volume Flow(Auto) PW Automatic calculation ml/m Volume Flow(D) PW Automatic calculation ml/m Volume Flow TAMV PW Doppler spectrum trace cm/s or m/s Vesl. Area. All Area cm , mm HR HR PW Heart Rate bpm 5-69

[Page 244]  Auto IMT (Optional) This function allows you to take IMT measurement easily and quickly. NOTE: Auto IMT is available only under the following conditions: X ‹ Probe: Linear Probe X ‹ Application: Vascular X ‹ Diagnosis Mode: 2D, C or PD Mode Auto IMT Screen „ ‹ Risk Color Bar It is shown in colors based on the IMT thickness. If the thickness is <= 0.5 mm, the entire bar is shown in green. If the thickness is >= 1.1 mm, the entire bar is shown in red. For a thickness between these values, it is shown in the corresponding color. „ ‹ Rular and Range Bar Use the Trackball and Set button to specify the location and range at which IMT will be measured. X ‹ Rular: The grid unit is 10 mm. This option is used when a vessel is lying laterally. At the measurement location, press the Set button to take IMT measurement at 10 mm interval. X ‹ Range Bar: This option is used when a vessel is not lying laterally, or the length of a specific segment is measured. Press and hold the Set button at the start point, and then drag the Trackball to specify the end point. „ ‹ Intima and Adventitia Pair X ‹ Between the Near and Far zones, the one with the higher QI is automatically selected as a measurement value and it is represented by the color of the Risk Color Bar. X ‹ A pair with lower QI is represented in dark sky blue. X ‹ Press Change to move the Near and Far zones that are automatically selected with QI. The measurement value and color presentation are also changed. However, if QI is 0, it will not be changed. 5-70

[Page 245] „ ‹ Measure Result Table 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. X ‹ Points: The total number of the measured Intima/Adventitia pairs. [Figure 5.6 Auto IMT] 5-71

[Page 246] Auto IMT Measurement 1. After checking the probe, application and preset, start carotid measurement. 2. If the desired images are obtained, press Freeze . Use the Trackball to select an image for IMT measurement. 3. Press the Soft Menu dial-button [1] Auto IMT. The Auto IMT screen will appear. X ‹ If scanning is performed when the center of the vessel is aligned with the center of the image area, IMT measurement starts automatically. 4. Use the Trackball and the Set button to set a location for IMT measurement. Operation #1, #2 Tips! If Operation #1, #2 in the user information area is followed, IMT measurement can be taken more easily. X ‹ Select a point between Near and Far. X ‹ If the vessel image quality is poor, select an area that is close to the Intima to be measured. X ‹ If a detailed area has to be selected, use Range Bar. X ‹ Press Space Bar in the keyboard to turn on/off the Intima and Adventitia Marker. 5. Once the measurement location is set, measurement values are listed in a table. Auto IMT Measurements Analysis 1. Press the Soft Menu dial-button [6] Analysis. The Analysis screen will appear. 2. Use the Trackball and the Set button to select the desired analysis from Framingham , Risk Factor , Normal IMT and User Graph . X ‹ Bars corresponding to the measurement results will be shown on each graph. However, bars are not shown when the measurement results are smaller than the Framingham Risk Factor. User Graph Tips! User Graph can be used to customize a graph for better analysis of measurement results. 3. Press the Soft Menu dial-button [6] Analysis again to complete analysis. 5-72

[Page 247] The following materials were referred to when analyzing the measurements of Auto IMT. „ ‹ Framingham 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 Saving Auto IMT Measurement Values 1. Use the Soft Menu dial-button [1] Direction to select the direction of the measurement area. 2. Use the Soft Menu dial-button [2] Position to select the location of the measurement area. 3. Use one of the Soft Menu dial-buttons 3 CCA, [4] ICA, and 5 Bulb to select the appropriate name for the study area. Press the button to save the measurement and exit Auto IMT measurement mode. The saved content will be displayed on the left side of the screen. 5-73

[Page 248] Annotation Displays information for the current measurement item on the screen. 1. Press the Annotation button at the bottom left corner of the image. 2. Select the information for the measured area, and press the OK button to record the position of the measured area at the location of the Annotation button. Press the Cancel button to cancel. X ‹ Direction (Left/Right): Shows the direction of the measured area. X ‹ Position #1(Distal/Mid/Proximal): Shows the position of the measured area. X ‹ Position #2(CCA/ICA/Bulb): Shows the name of the measured area. Auto IMT+ This system supports optional Auto IMT+. Auto IMT+ uses a more powerful engine than Auto IMT to provide more accurate measurements. X ‹ If both Auto IMT and Auto IMT+ options are installed, using this function will perform Auto IMT+; If you disable the Auto IMT+ option, the function will automatically switch to Auto IMT. X ‹ The button for using this function, as well as the on-screen description, will read ‘Auto IMT’, regardless of whether Auto IMT or Auto IMT+ is being used. 5-74

[Page 249] Urology Calculation  Before Taking Urology Measurements Set the related menus for convenient measurement. You can select the volume method for measurement. There are four types of volume method. The factor value can be set manually for the formulae that need it. For more information on the measurement menus and settings, please refer to “Setting Measurements” in "Chapter 7. Utility.” [Figure 5.7 Urology Measurement Menu] X ‹ The measurement methods of each menu vary with the Volume Method set at Utility > Measure Setup > Urology . X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common X ‹ For references on measurement items, see the Reference Manual – Part 2. 5-75

[Page 250] „ ‹ 3Distance Calculate a volume by measuring three distances. Auto Trace PW Doppler spectrum trace cm, mm Limited Trace PW Doppler spectrum trace cm, mm Manual Trace PW Doppler spectrum trace cm, mm General EDV PW Velocity cm/s, m/s Vesl.Area All Area cm2, mm2 Vesl.Dist. All Distance cm, mm Bladder Vol. WG Prostate Vol. T-Zone Vol. 5-76

[Page 251] Pre All All ml Pre L All Distance cm, mm Pre H All Distance cm, mm Pre W All Distance cm, mm Post All All ml Post L All Distance cm, mm Post H All Distance cm, mm Post W All Distance cm, mm Pelvis All Distance cm, mm Transitional Zone Prostate Volume, Bladder Volume, Left Renal Volume, Right Renal Volume are the same measurements as for Prostate Volume. 5-77

[Page 252] „ ‹ 3 Distance * Factor The same as for “3 Distance.” „ ‹ Ellipsoid Calculate a volume by using the Main Diameter and Beside Diameter values. Vol. All ml Bladder Vol. Main Dia. All Distance cm, mm Beside Dia. All Distance cm, mm Vol. All ml WG Prostate Vol. Main Dia. All Distance cm, mm Beside Dia. All Distance cm, mm Vol. All ml T-Zone Vol. Main Dia. All Distance cm, mm Beside Dia. All Distance cm, mm Pre All All ml Pre Main Dia. All Distance cm, mm Pre Beside Dia. All Distance cm, mm Post All All ml Post Main Dia. All Distance cm, mm Residual Vol. Post Beside Dia. All Distance cm, mm Main Dia. All Distance cm, mm Beside Dia. All Distance cm, mm Renal Pelvis All Distance cm, mm 5-78

[Page 253] „ ‹ Sum of 20 Disks After measuring the circumference of a prostate, use the Trackball and the Set button to calculate the volume by measuring the axis of the prostate. Bladder Vol. Vol. All Dist20 ml WG Prostate Vol. Vol. All Dist20 ml T-Zone Vol. Vol. All Dist20 ml Pre Vol. All Dist20 ml Post Vol. All Dist20 ml Vol. All Dist20 ml Renal Pelvis All Distance cm, mm 5-79

[Page 254] Fetal Echo Calculation  Before Taking Fetal Echo Measurements Set the related menus for convenient measurement. You can also specify how volume can be calculated. Please refer to the “Setting Measurements” section in "Chapter 7. Utility” for more information on the measurement menus and settings. The measurement method for each item is the same as for basic measurement. In addition, measurement items are similar to those for cardiac calculation. Measured items are automatically recorded in a report. [Figure 5.8 Fetal Echo Measurement Menu] X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common X ‹ For references on measurement items, see the Reference Manual – Part 2. 5-80

[Page 255] A2C Vol.d All Dist20 ml A2C Vol.s All Dist20 ml LV Vol. (Simpson) A4C Vol.d All Dist20 ml A4C Vol.s All Dist20 ml Asc Ao All Distance cm, mm MPA Diam All Distance cm, mm Duct Art All Distance cm, mm LA Diam All Distance cm, mm RA Diam All Distance cm, mm RV Diam All Distance cm, mm 2D Echo IVS All Distance cm, mm LVIDd All Distance cm, mm LVIDs All Distance cm, mm LVPW All Distance cm, mm HrtC All Circumference cm, mm ThC All Circumference cm, mm All (D) All % ThD ap All Distance cm, mm ThD trans All Distance cm, mm HrtD ap All Distance cm, mm CTAR HrtD trans All Distance cm, mm All (A) All % ThA All Area cm , mm HrtA All Area cm , mm 5-81

[Page 256] All M Continuous measurement cm, mm IVSd M Distance cm, mm LVIDd M Distance cm, mm LVPWd M Distance cm, mm Fetal M-mode IVSs M Distance cm, mm LVIDs M Distance cm, mm LVPWs M Distance cm, mm RVDd M Distance cm, mm MPA Manual Trace PW Doppler spectrum trace Duct Artriosus Manual Trace PW Doppler spectrum trace IVC Manual Trace PW Doppler spectrum trace 5-82

[Page 257] Duct Venosus Manual Trace PW Doppler spectrum trace Asc Aorta Manual Trace PW Doppler spectrum trace Dsc Aorta Manual Trace PW Doppler spectrum trace Peak E PW Velocity cm/s, m/s MV Inflow Peak A PW Velocity cm/s, m/s MV Regurg Vel. PW Velocity cm/s, m/s Peak E PW Velocity cm/s, m/s TV Inflow Peak A PW Velocity cm/s, m/s TV Regurg Vel. PW Velocity cm/s, m/s Calculated after velocity All PW PLI Sys Flow PW Velocity cm/s, m/s Dias Flow PW Velocity cm/s, m/s PLI A. Rev Flow PW Velocity cm/s, m/s 5-83

[Page 258] Calculated after continuous All PW Tei Index TST PW Time ms ET PW Time ms Fetal HR Fetal Heart Rate M, PW Heart Rate bpm „ ‹ CTAR (Cardio-Thorax Area Ratio) This measurement is for comparing the sizes of the fetus’ chest and heart. The comparison is made by obtaining the ThD ap, ThD trans, HrtD ap, and HrtD trans values. 5-84

[Page 259] LE Artery Calculation [Figure 5.9 LE Artery Measurement Menu] X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common X ‹ For references on measurement items, see the Reference Manual – Part 2. 5-85

[Page 260] Rt. / Lt. CIA EDV PW Velocity cm/s, m/s Rt. / Lt. IIA EDV PW Velocity cm/s, m/s 5-86

[Page 261] Rt. / Lt. EIA EDV PW Velocity cm/s, m/s Rt. / Lt. CFA EDV PW Velocity cm/s, m/s 5-87

[Page 262] Rt. / Lt. SFA EDV PW Velocity cm/s, m/s Rt. / Lt. DFA EDV PW Velocity cm/s, m/s 5-88

[Page 263] Rt. / Lt. Pop A EDV PW Velocity cm/s, m/s Rt. / Lt. ATA EDV PW Velocity cm/s, m/s 5-89

[Page 264] Rt. / Lt. PTA EDV PW Velocity cm/s, m/s Rt. / Lt. Peroneal A EDV PW Velocity cm/s, m/s 5-90

[Page 265] Rt. / Lt. DPA EDV PW Velocity cm/s, m/s Rt. / Lt. MPA EDV PW Velocity cm/s, m/s 5-91

[Page 266] Rt. / Lt. LPA EDV PW Velocity cm/s, m/s Rt. / Lt. Metatarsal A EDV PW Velocity cm/s, m/s 5-92

[Page 267] Rt. / Lt. Digital A EDV PW Velocity cm/s, m/s Vesl. Area All Area cm2, mm2 General EDV PW Velocity cm/s, m/s 5-93

[Page 268] Volume Flow(Auto) PW Automatic calculation ml/m Volume Flow(D) PW Automatic calculation ml/m Volume Flow TAMV PW Doppler spectrum trace cm/s or m/s Vesl. Area. All Area cm , mm HR HR M, PW Heart Rate bpm 5-94

[Page 269] UE Artery Calculation [Figure 5.10 UE Artery Measurement Menu] X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common X ‹ For references on measurement items, see the Reference Manual – Part 2. 5-95

[Page 270] Rt. / Lt. Subclabian A Rt. / Lt. Axillary A EDV PW Velocity cm/s, m/s 5-96

[Page 271] Rt. / Lt. Brachial A EDV PW Velocity cm/s, m/s Rt. / Lt. Radial A EDV PW Velocity cm/s, m/s 5-97

[Page 272] Rt. / Lt. Ulnar A EDV PW Velocity cm/s, m/s Rt. / Lt. SPA EDV PW Velocity cm/s, m/s 5-98

[Page 273] General EDV PW Velocity cm/s, m/s Volume Flow(Auto) PW Automatic calculation ml/m Volume Flow(D) PW Automatic calculation ml/m Volume Flow TAMV PW Doppler spectrum trace cm/s or m/s Vesl. Area. All Area cm , mm HR HR M, PW Heart Rate bpm 5-99

[Page 274] LE Vein Calculation X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common X ‹ For references on measurement items, see the Reference Manual – Part 2. [Figure 5.11 LE Vein Measurement Menu] 5-100

[Page 275] Rt. / Lt. FV Rt. / Lt. GSV Rt. / Lt. POP V 5-101

[Page 276] Rt. / Lt. SSV Rt. / Lt. MPV Rt. / Lt. LPV Vesl. Area All Area cm2, mm2 5-102

[Page 277] Rt. / Lt. Metatarsal V Rt. / Lt. Digital V General TAMV(M) PW Doppler spectrum trace cm/s or m/s 5-103

[Page 278] UE Vein Calculation [Figure 5.12 UE Vein Measurement Menu] X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common X ‹ For references on measurement items, see the Reference Manual – Part 2. 5-104

[Page 279] Rt. / Lt. Internal Jugular Rt. / Lt. Innominate V Rt. / Lt. Subclavian V 5-105

[Page 280] Rt. / Lt. Axillary V Rt. / Lt. Brachial V Rt. / Lt. Cephalic V 5-106

[Page 281] Rt. / Lt. Basilic V Rt. / Lt. Radial V Rt. / Lt. Ulnar V 5-107

[Page 282] General 5-108

[Page 283] Radiology Calculation [Figure 5.13 Radiology Measurement Menu] X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common 5-109

[Page 284] Aorta EDV PW Velocity cm/s, m/s Celiac A EDV PW Velocity cm/s, m/s 5-110

[Page 285] Splenic A EDV PW Velocity cm/s, m/s Splenic Vol. 5-111

[Page 286] Hepatic A EDV PW Velocity cm/s, m/s SMA EDV PW Velocity cm/s, m/s 5-112

[Page 287] IMA EDV PW Velocity cm/s, m/s IVC EDV PW Velocity cm/s, m/s 5-113

[Page 288] Rt. / Lt. Renal Vol. Length All Distance cm, mm Rt. / Lt. Renal A EDV PW Velocity cm/s, m/s 5-114

[Page 289] Rt. / Lt. Arcuate A EDV PW Velocity cm/s, m/s Bladder Vol. 5-115

[Page 290] General EDV PW Velocity cm/s, m/s HR Fetal Heart Rate M, PW Heart Rate bpm Renal A. PSV PW Velocity measurement cm/s, m/s Renal Aortic Ratio Aorta PSV PW Velocity measurement cm/s, m/s 5-116

[Page 291] TCD Calculation [Figure 5.14 TCD Measurement Menu] X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common 5-117

[Page 292] Rt. / Lt. ACA EDV PW Velocity cm/s, m/s Rt. / Lt. MCA EDV PW Velocity cm/s, m/s 5-118

[Page 293] Rt. / Lt. PCA(P1) EDV PW Velocity cm/s, m/s Rt. / Lt. PCA(P2) EDV PW Velocity cm/s, m/s 5-119

[Page 294] Rt. / Lt. Distal Basilar A EDV PW Velocity cm/s, m/s Rt. / Lt. Mid Basilar A EDV PW Velocity cm/s, m/s 5-120

[Page 295] Rt. / Lt. Prox Basilar A EDV PW Velocity cm/s, m/s General EDV PW Velocity cm/s, m/s 5-121

[Page 296] Volume Flow(Auto) PW Automatic calculation ml/m Volume Flow(D) PW Automatic calculation ml/m Volume Flow TAMV PW Doppler spectrum trace cm/s or m/s Vesl. Area. All Area cm , mm 5-122

[Page 297] Thyroid Calculation [Figure 5.15 Thyroid Measurement Menu] X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common Rt. / Lt. Vol. 5-123

[Page 298] Rt. / Lt. Flow 5-124

[Page 299] Breast Calculation [Figure 5.16 Breast Measurement Menu] NOTE: For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common Rt. / Lt. Mass 1-10 5-125

[Page 300] Rt. / Lt. Flow 5-126

[Page 301] Testicle Calculation [Figure 5.17 Testicle Measurement Menu] X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common Vol. All ml Rt. / Lt. Vol. 5-127

[Page 302] Rt. / Lt. Flow Calculated after Area 5-128

[Page 303] Superficial Calculation [Figure 5.18 Superficial Measurement Menu] X ‹ It is convenient to calculate each measurement value on the Spectral Doppler image. X ‹ For information on basic measurement methods, see ‘Basic Measurements’ and ‘Common Vol. All ml Vol. 5-129

[Page 304] Flow Calculated after area 5-130

[Page 305] Pediatric Hips Calculation Measured items are automatically recorded in a report. [Figure 5.19 Pediatric Hips Measurement Menu] Measurement Menu Item Method Unit Hip Angle Type Three Distance Measurement °  Measurement Method 1. Use the Trackball and the Set button on the control panel to specify the first straight line. X ‹ Place the cursor at a desired position with the Trackball, and press the Set button. Repositioning Point Tips! Pressing the Change button before pressing the Set button to complete positioning resets the position of a point just set. 2. Repeat the above process to specify two other straight lines. 3. The angle between them will be calculated automatically. X ‹ α: The angle between the first and second straight lines. X ‹ β: The angle between the first and third straight lines. 5-131

[Page 306] Please refer to the table below for Hip Joint Type information: Type α β 1a 60 ≤ α ＜ 90 0 ＜ β ＜ 55 1b 60 ≤ α ＜ 90 55 ≤ β ＜ 90 2a/b 50 ≤ α ＜ 60 0 ＜ β ＜ 90 2c 43 ≤ α ＜ 50 77 ≤ β ＜ 90 d 43 ≤ α ＜ 50 0 ＜ β ＜ 77 3/4 0 ≤ α ＜ 43 [Table 5.2 Hip Joint Type Table] 5-132

[Page 307] Musculoskeletal Calculation [Figure 5.20 MSK Measurement Menu] Measurement Menu Item Method Unit Rt. / Lt. Shoulder 1~10 Distance Measurement cm, mm Rt. / Lt. Wrist 1~10 Distance Measurement cm, mm Rt. / Lt. Knee 1~10 Distance Measurement cm, mm Rt. / Lt. Ankle 1~10 Distance Measurement cm, mm 5-133

[Page 308] Report Measurement results are arranged by application and displayed on the screen in the form of a report. [Figure 5.21 The Report Screen - Example] 5-134

[Page 309] Viewing Report Press the Report button on the control panel. The system switches to the Ultrasound Report screen. When measurement results cannot be displayed in a screen, they can be moved into the upper and lower portions of the screen in three ways as below: X ‹ Use the scroll bar on the right side of the screen. X ‹ Rotate the Menu dial-button on the control panel. X ‹ The measurement menus saved in the current application report are displayed in the left side of the screen. Select a menu to review from them. To view a report for another application, press Next App . on the screen. Each time Next App . is pressed, reports for other applications are shown. NOTE: Reports for applications in which no measurements have been made will not be shown. 5-135

[Page 310] Video Out Press Video Out on the Ultrasound Report screen. Choose whether to fit the size of the Report screen to 1024 x 768. Editing Report Press Edit on the Ultrasound Report screen to switch to a screen where the report can be edited. You can edit measurement results or change the way that measurements are displayed. Press OK on the screen or the Exit button on the control panel to save the changes and close the edit screen. Press Cancel to close the edit screen without saving the changes. [Figure 5.22 Editing Report] 5-136

[Page 311]  Modify Measurements Use the Trackball, the Set button and the alphanumeric keyboard on the control panel to modify measurements. The values are displayed in grey, indicating that they are modified.  Measurement Display Method The product allows you to measure one measurement item several times. However, only the first three measurement results are saved in a report. When taking the same item more than once, measurements can be displayed in four ways as below: On the edit report screen, you can specify or change the measurement display method. „ ‹ Avg. Obtain the average of measurements and display it on the screen. „ ‹ Last Display the last measurements 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.  Fetal Description Move the trackball to select Description at the bottom left corner of the screen. This item only becomes active when OB measurement is available. You may select Normal, Abnormal, Not seen, or Seen. If you select one of the group selection items in the combo box, it will be applied to all items. 5-137

[Page 312] Adding Comment Press Comment on the Ultrasound Report screen to switch to a screen where text can be entered. You can enter a comment or opinion. You can also modify existing comments. You can enter comments without acquiring a measurement. Press OK on the screen or the Exit button on the control panel to save the changes and close the edit screen. Press Cancel to close the edit screen without saving the changes. „ ‹ Comment Editor Use this function to save comments you use frequently, so that you can automatically paste the comments later. Enter your comment and press Apply to apply the comment immediately. Pressing Save will save up to 10 comments. [Figure 5.23 Comment] 5-138

[Page 313] Printing Report Press Print in the report screen. If there is no connection with a printer, this button will not be displayed. NOTE: You can change the settings for printing measurement reports in Utility > Setup > Peripherals > Print Setup > Measure Report Print . For more information, refer to “Peripherals Setup” in "Chapter 7. Utility”. Saving Report Press Export on the report screen. You can save reports into a file. NOTE: If Utility > Measure Setup > General > Data Transfer > Save to File > Write to file is checked, this button will be displayed. When the Write to file window opens, specify the directory, drive, filename and file type. When using an external storage media, make sure to connect to or disconnect from the storage media by using Storage Manager . Press OK to save the report. Press Cancel to cancel. [Figure 5.24 Saving Report] 5-139

[Page 314] Transferring Report Press Transfer on the report screen. Transfer the report data using an RS232C cable. A button is created when a measurement is completed. To use this button, 1. Connect the RS232C cable with the console. 2. Set Utility > Setup > Peripherals > COM as ‘Open Line Transfer’. Stress Echo Report Pressing the Report button on the control panel while measuring the Stress Echo opens the Stress Echo Report. X ‹ The Stress Echo Report cannot be edited. X ‹ Otherwise, it may be used in the same way as general reports. X ‹ For information on the Stress Echo, please refer to 'Chapter 7. Utility'. [Figure 5.25 Stress Echo Report] 5-140

[Page 315] Graph Function On the Ultrasound Report screen, pressing Graph switches to the graph screen, where you can review graphs and history. NOTE: The graph function is available with OB reports only. NOTE: If you select ‘Graph’ for the function of User Key, Graph screen will be displayed when you press the User Key button. Set the function for User Key at Utility > Setup > Utility > User Key Setup > User Key > User Key1 . Press Report on the screen to return to the report screen.  Graph The list of measured items appears in the left side of the screen. If you select an item, a graph for the selected item will appear on the screen. [Figure 5.26 Graph] 5-141

[Page 316] X ‹ To display a graph, the LMP or Estab. Due Date should be saved under Patient Information, and the GA table and Fetal Growth table should be enabled. X ‹ A graph is created based on the patient ID, LMP and measurement date. „ ‹ Select Graph Use the Trackball and the Set button to select an item from the list. „ ‹ Display Graph If the 2 x 2 checkbox is checked, 4 graphs will be displayed in a screen. Specify a desired graph by checking the checkbox for a measurement item. „ ‹ Percentile Criteria Select from LMP, EstabDD and Avg.US GA. X ‹ GA by LMP: GA is calculated based on the maternal LMP. X ‹ Estab. Due Date: GA is calculated based on the Estab. Due Date that is entered in the Patient Information. X ‹ Average US GA: GA is calculated using the average value of several ultrasound measurements. X ‹ GA View: If the checkbox is checked, the current GA instead of the current date is shown under History. „ ‹ Patient X ‹ Patient Information: View patient information. X ‹ Fetus Information: View fetus information. X ‹ Comment: Enter a comment or opinion. Modify existing comments. „ ‹ Measure View measurement data. „ ‹ Trend Select a graph you want, or select all. 5-142

[Page 317] „ ‹ History The current and past measurements for a fetus are displayed in a concise format. „ ‹ Print Checked Graph Set the graph layout when you wish to print the reports. NOTE: Only the graphs selected from the list will be printed. X ‹ Print Current Graph: Only the currently selected graph is printed. X ‹ Print Checked Graph (1 x 1): The selected graph is printed in a 1 x 1 format. X ‹ Print Checked Graph (3 x 2): The selected graph is printed in a 3 x 2 format. X ‹ Print Screenshot: Capture the screen to print the graph.  History Press History in the left menu on the graph screen. The current and past measurements for a fetus are displayed in a tabular format. You can change the percentile criteria as desired. [Figure 5.27 History] 5-143

[Page 318] Standard Deviation & Percentile Tips! Among 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 reference number of weeks for the Growth Table can be set to LMP, Estab. DD or Average US GA under [Pctl.Criteria] . The typical setting is LMP. When LMP is not known or uncertain, or when the difference between LMP and Average US GA is substantial, care must be taken, as selecting different [Pctl.Criteria] can result in a significant difference. The distribution of the number of weeks in the Growth Table for the selected reference is a normal distribution that is laterally symmetrical around 50% (the average), and it shows the distance from the average as a deviation. The deviation can be represented by Standard Deviation (SD) or Percentile. [Figure 5.28 The distribution of the Growth Table for the selected number of weeks (m: Average, σ : Standard Deviation)] 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, and ±1 SD represents 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 between 0 and 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, 50 Percentile). If a point is in the range between -1 SD and +1 SD, it falls within 68.3% of the entire range. This means that the point falls within the range between 16 and 84. Further, if a point is in the range between -2 SD and +2 SD, it falls within 95.5% of the entire range. Thus, the point falls in the range between 3 and 97. 5-144

[Page 319] SD and Percentile are interchangeable. Percentile can be used when a fetal measurement ranking is Tips! 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 user, the typical range accepted by most users is as below: 1) When references are created based on SD: X ‹ 2.0 SD - +2.0 SD (when converted to Percentile: 2.28 Percentile - 97.72 Percentile) X ‹ 1.5 SD - +1.5 SD (when converted to Percentile: 6.68 Percentile - 93.32 Percentile) X ‹ 1.0 SD - +1.0 SD (when converted to Percentile: 15.87 Percentile - 84.13 Percentile) 2) When references are created based on Percentile: X ‹ 2.5 Percentile - 97.5 Percentile (when converted to SD: -1.96 SD - 1.96 SD) X ‹ 5.0 Percentile - 95.0 Percentile (when converted to SD: -1.645 SD - 1.645 SD) X ‹ 10.0 Percentile - 90.0 Percentile (when converted to SD: -1.288 SD - 1.288 SD) Closing Report Press Exit on the Ultrasound Report screen or the Exit or Report button on the control panel. The system will return to the previous diagnosis mode screen. 5-145

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