SAMSUNG MEDISON ACCUVIX A30 (01) PDF MANUAL

The ACCUVIX A30 Diagnostic Ultrasound System is classified as follows:

• Type of protection against electrical shock: Class I

• Degree of protection against electrical shock (Patient connection): Type BF equipment

• Degree of protection against harmful ingress of water: Ordinary equipment

• Degree of safety of application in the presence of a flammable anesthetic material with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

• Mode of operation: Continuous operation

It meets the following Electromechanical safety standards:

• Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance [IEC 60601-1:2005]

• Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Compatibility – Requirements and Tests [IEC 60601-1-2:2007]

• Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability [IEC 60601-1-6:2006]

• Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC60601-2-37:2007]

• Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with A1:1991 and A2:1995]

• Medical Electrical Equipment, Part 1: General Requirements for Safety – 1 Collateral Standard: Safety Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]

• Medical Electrical Equipment, Part 1: General Requirements for Safety – 2 Collateral Standard: Electromagnetic Compatibility – Requirements and Test [IEC 60601-1-2:2001, A1:2004]

• Medical Electrical Equipment, Part 1: General Requirements for Safety – 4 Collateral Standard: Programmable Electrical Medical Systems [IEC 60601-1-4: 1996, A1:1999]

• Medical Electrical Equipment, Part 2: Particular Requirements for Safety – 37 Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC60601-2-37: 2001 with A1:2004, A2:2005]

• Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]

• Medical Electrical Equipment, Part 1: General Requirements for Safety [UL60601-1:2003]

• Medical Electrical Equipment, Part 1: General Requirements for Safety [CAN/CSA 22.2 No.601.1-M90:1990, with R2003, with R2005]

• Biological Evaluation of Medical Devices [ISO10993 : 2009]

• Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment [IEC61157:2007]

The International Electrotechnical Commission (IEC) has established a set of symbols for medical electronic equipment, which classify connections or warn of potential hazards. Their meanings are as follows:

Symbols	Description	Symbols	Description
	AC (Alternating Current) voltage source		Left and right Audio / Video input
	Electric shock hazard warning		Left and right Audio / Video output
	Classification based on degree of protection against electric hazard (Type BF)		Remote print output
	Classification based on degree of protection against electric hazard (Type CF)		Foot switch connector
	Power switch (Supplies/cuts the power to the product)		ECG connector
	OFF (Cuts the power to a part of the product)		USB connector
	WARNING: The accompanying information must be followed to prevent serious accidents and/or damage to property.		Microphone connector
	CAUTION: The accompanying information helps to avoid accidents and/or damage to property.		Protection against the effects of immersion
	Refer to the operation manual		Protection against dripping water
	ON (Supplies power to a part of the product)		Probe connector
	Identifies an equipotential ground		Do not sit on the control panel
	Indicates dangerous voltages over 1000V AC or 1500V DC		Do not push the product
	Protective earth connected to conductive parts of Class I equipment for safety purposes		Follow the operation manual
	Data Output port
	Data Input port
	Data Input/Output port

Additional symbols and their meanings:

Symbols	Description	Symbols	Description
	Authorized Representative In The European Community		Manufacturer

You should be familiar with all these areas before attempting to use the manual or the ultrasound system.

• 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 ‘Chapter 1. Safety’ and ‘Chapter 8. Maintenance’ in this manual, prior to starting to use this system.

• This manual does not include diagnosis results or opinions. Also, check the measurement reference for each application’s result measurement before making the final diagnosis.

• This product is an ultrasound scanner and cannot be used from a user’s PC. The manufacturer is not responsible for errors that occur when the system software is run on a user’s PC.

• Only medical doctors or persons supervised by medical doctors should use this system. Persons who are not qualified must not operate this product.

• The manufacturer is not responsible for any damage to this product caused by carelessness and/or neglect by the user.

• Information contained in this operating manual is subject to change without prior notice.

• Products that are not manufactured by Samsung Medison are marked with the trademark of their respective copyright holders.

The following headings describe vitally important precautions necessary to prevent hazards:

• DANGER: 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: The accompanying information covers an installation, operation, or maintenance procedure that requires careful attention of the user, but has little chance of leading directly to a dangerous situation.

The Accuvix A30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.

Contraindications:

The Accuvix A30 system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

CAUTION:

• Federal law restricts this device to sale by or on the order of a physician.

• The method of application or use of the device is described in the manual ‘Chapter 3. Starting Diagnosis’ and ‘Chapter 4. Diagnosis Modes’.

This equipment has been verified as a Class I device with Type BF applied parts.

CAUTION:

• As for US requirement, the LEAKAGE CURRENT might be measured from a center-tapped circuit when the equipment connects in the United States to 240V supply system.

• To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded power outlet.

In a hospital environment, hazardous current can form due to potential differences between exposed conductive parts and connected devices. The solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up of sockets which are angled to the equipotential bonding network in medical rooms.

WARNING:

• Electric shock may result if this system, including all of its externally mounted recording and monitoring devices, is not properly grounded.

• Never remove the cover from the product. Hazardously high voltage flows through the product. All internal adjustments and replacements must be made by a qualified Samsung Medison Customer Service Department.

• Always check the product’s casing, cables, cords, and plugs for damage before using the product. Disconnect and do not use the power source if the face is cracked, chipped, torn, the housing is damaged, or if the cable is abraded.

• Always disconnect the system from the wall outlet prior to cleaning it.

• All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to the application of a high voltage defibrillation pulse.

• The use of flammable anesthetic gas or oxidizing gases (N2O) should be avoided. Doing so may cause an explosion.

• Avoid placing the system where it is likely to be difficult to operate, or disconnect.

• Do not use HF surgical equipment with the system. Any malfunctions in the HF surgical equipment may result in burns to the patient.

• The System must only be connected to a supply mains with protective earth to avoid risk of electric shock.

CAUTION:

• The system has been designed for 100-120VAC and 200-240VAC; you should select the input voltage of the printer and VCR. Prior to connecting a peripheral power cord, verify that the voltage indicated on the power cord matches the voltage rating of the peripheral device.

• An isolation transformer protects the system from power surges. This continues to operate when the system is on standby.

• Do not immerse the cable in liquids. Cables are not waterproof.

• The auxiliary socket outlets installed on this system are rated 100-120V and 200-240V, with a maximum total load of 150VA. Only use these outlets for supplying power to equipment that is intended to be part of the ultrasound system. Do not connect additional multiple-socket outlets or extension cords to the system.

• Do not connect any peripheral devices not listed in this manual to the auxiliary socket outlets of the system.

• Do not touch SIP/SOP and the patient simultaneously. There is a risk of electric shock from current leakage.

ECG-Related Information WARNING:

• This product does not support ECG monitoring. Therefore, it will not recognize incompatible ECG signals.

• Do not use the ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical equipment may result in burns to the patient.

• Do not use ECG electrodes during cardiac pacemaker procedures or other electrical stimulators.

• Do not use ECG leads and electrodes in an operating room.

ESD (Electrostatic discharge), 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. The static shock, or ESD, is a discharge of the electrical energy build-up from a charged individual to a lesser or uncharged individual or object. An ESD occurs when an individual with an electrical energy build-up comes in to contact with conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals.

ESD CAUTION:

• The level of electrical energy discharged from a system user or a patient to an ultrasound system can be significant enough to cause damage to the system or probes.

• Always perform the pre-ESD preventive procedures before using connectors marked with the ESD warning label.

  • Apply anti-static spray to carpets or linoleum.

  • Use anti-static mats.

  • Ground the product to the patient table or bed.

• It is highly recommended that the user be given training on ESD-related warning symbols and preventive procedures.

This product complies with EMI (Electromagnetic Interference) standards. However, using the system inside an electromagnetic field can lower the quality of ultrasound images and even damage the product.

If this occurs often, Samsung Medison suggests a review of the environment 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 the system.

The testing for the EMC (Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC60601-1-2). This IEC standard was adopted in Europe as the European norm (EN60601-1-2).

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions:

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.

WARNING: The use of cables, transducers, and accessories, other than those specified, may result in increased emissions or decreased immunity of the Ultrasound System.

Immunity test compliance:

NOTE: Uт is the AC mains voltage, prior to application of the test level.

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.

Typical interference on ultrasound imaging systems varies depending on electromagnetic phenomena. Refer to the following table for guidance:

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.

An ultrasound system is designed to receive signals at radio frequency and is therefore susceptible to interference generated by RF energy sources. Examples of other sources of interference are medical devices, information technology products, and radio and television transmission towers. Tracing the source of radiated interference can be a difficult task. Consider the following to locate the source:

• Is the interference intermittent or constant?

• Does the interference show up only with one transducer operating at the same frequency or with several transducers?

• Do two different transducers operating at the same frequency have the same problem?

• Is the interference present if the system is moved to a different location in the facility?

The answers to these questions will help determine if the problem resides with the system or the scanning environment.

The product is intended for use in an electromagnetic environment where radiated RF disturbances are controlled. To prevent electromagnetic interference, maintain a minimum distance between portable and mobile RF communications equipment (transmitters) and this product. The recommended distances are listed below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W), according to the transmitter’s manufacturer.

NOTE 1) At 80MHz and 800MHz, the 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 only be used in a shielded location with a minimum RF shielding effectiveness, and each cable should also be connected and used within 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.

Approved Cable for Electromagnetic Compliance:

Cables connected to this product may affect its emissions. Refer to the table below for recommended cable types and lengths:

Probe:

The probes listed in ‘Chapter 9. Probes’ of this manual comply with Group1 Class B emission requirements of International Standard CISPR 11.

Approved Accessories for Electromagnetic Compliance:

Accessories used with this product may affect its emissions.

CAUTION: When connecting other customer-supplied accessories to the system, such as a remote printer, 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.

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.

The Ultrasound System is designed to receive signals at radio frequency and is therefore susceptible to interference generated by RF energy sources. Examples of other sources of interference are medical devices, information technology products, and radio and television transmission towers. Tracing the source of radiated interference can be a difficult task. Consider the following to locate the source:

• Is the interference intermittent or constant?

• Does the interference show up only with one transducer operating at the same frequency or with several transducers?

• Do two different transducers operating at the same frequency have the same problem?

• Is the interference present if the system is moved to a different location in the facility?

The answers to these questions will help determine if the problem resides with the system or the scanning environment.

WARNING: The product weighs more than 100kg. Be extra careful when transporting it. Careless transportation of the product may result in product damage or personal injury.

• Before transporting the product, check that the wheel brakes 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 back of the console and move the product slowly.

This product is designed to resist shocks. However, excessive shock, for example – if the product falls over, may cause serious damage.

If the system operates abnormally after being repositioned, please contact Samsung Medison customer service department.

The Brakes:

You can use the brakes to control the movement of the product. The front wheel brakes are on the center of the consol pedal and the back wheel brakes are on the top of each wheel. The brakes at the front can help you to control the two front wheels simultaneously, using the pedal.

• The front wheel brakes: To lock the brakes, press the front part of the brake with your foot. To unlock the brakes, press the back of the pedal.

• To lock the brakes, press the bottom part of the brake with your foot. To unlock them, press the part labeled OFF at the top of the brake with your foot.

It is recommended 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 the product is facing. Do not leave the product on ramps.

Safety Notes CAUTION:

• Do not press the control panel excessively.

• Never attempt to modify the product in any way.

• Check the operational safety when using the product after a prolonged break in service.

• Make sure that other objects, such as metal pieces, do not enter the system.

• Do not block the ventilation slots.

• Do not pull on the power cord to unplug it. Doing so can damage the cord and cause short circuiting and cord snapping. Always unplug by pulling on the plug itself.

• Excessive bending or twisting of cables, on parts that are applied to the patient, may cause failure or intermittent operation of the system.

• Improper cleaning or sterilization, of parts that are applied to the patient, may cause permanent damage.

• Servicing the product, including repairs and replacement of parts, must be done by qualified Samsung Medison service personnel. Assuming that the product is used in accordance with the guidelines contained in this manual and maintained by qualified service personnel, the expected lifespan of the product is approximately 7 years.

For detailed information on cleaning and disinfecting the product, refer to “Chapter 8. Maintenance”.

Monitor Safety Note:

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.

Control Panel Caution:

CAUTION:

• Do not press on the control panel with excessive force or lean against it.

• Do not sit on the control panel or apply too much pressure to it.

When adjusting the control panel’s height or position, be mindful of the space between the panel and the lift. Having your fingers, or other body parts, caught in it may result in injury.

WARNING:

• Ultrasound waves may have damaging effects on cells and, therefore, may be harmful to the patient. If there is no medical benefit, minimize the exposure time and maintain the ultrasound wave output level at low. Please refer to the ALARA principle.

• Do not use the system if an error message appears on the video display indicating that a hazardous condition exists. Note the error code, turn off the power to the system, and call Samsung Medison customer service department.

• Do not use a system that exhibits erratic or inconsistent functioning. Discontinuities in the scanning sequence are indicative of a hardware failure that should be corrected before use.

• The system limits the maximum contact temperature to 43 degrees Celsius, and the ultrasonic wave 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 to every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bioeffects.

Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, the Ultrasound System provides controls that can be manipulated during the exam to optimize the results.

The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound, not only in the technology but also in its applications, have resulted in the need for increased and improved information to guide the user. The output indices are designed to provide that important information.

There are a number of variables, which affect the way in which the output display indices can be used to implement the ALARA principle. These variables include mass, body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because the user controls it. The ability to limit the index values over time supports the ALARA principle.

The system imaging mode used depends upon the information needed. 2D-mode and M-mode imaging provide anatomical information, while Doppler, Power, and Color imaging provide information about blood flow. Scanned modes, like 2D-mode, Power, or Color, disperse or scatter the ultrasonic energy over an area, while an unscanned mode, like M-mode or Doppler, concentrate the ultrasonic energy. Understanding the nature of the imaging mode being used allows the sonographer to apply the ALARA principle with informed judgment. The probe frequency, system set-up values, scanning techniques, and operator experience aid the sonographer in meeting the ALARA principle. The decision as to the amount of acoustic output is, in the final analysis, up to the system operator. This decision must be based on the following factors: type of patient, type of exam, patient history, ease or difficulty of obtaining diagnostically useful information, and the potential localized heating of the patient due to probe surface temperatures. Prudent use of the system occurs when patient exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve acceptable diagnostic results.

Although a high index reading does not mean that a biological effect is actually occurring, it should be taken seriously. Every effort should be made to reduce the possible effects of a high index reading. Limiting exposure time is an effective way to accomplish this goal.

There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA and can be divided into three categories: direct, indirect, and receiver control.

Direct Controls:

Application selection and the output intensity control directly affect acoustic intensity. There are different ranges of allowable intensity or output depending on your selection. Selecting the correct range of acoustic intensity for the application is one of the first things required during any exam. For example, peripheral vascular intensity levels are not recommended for fetal exams. Some systems automatically select the proper range for a particular procedure, while others require manual selection. Ultimately, the user bears the responsibility for proper clinical use. Samsung Medison systems provide both automatic and user-definable settings.

Output has direct impact on acoustic intensity. Once the application has been established, the output control can be used to increase or decrease the output intensity. The output control allows you to select intensity levels less than the defined maximum. Prudent use dictates that you select the lowest output intensity consistent with good image quality.

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 that is 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.

The focus of the ultrasound beam affects the image resolution. To maintain or increase resolution at a different focus requires a variation of output over the focal zone. This variation of output is a function of system optimization. Different exams require different focal depths. Setting the focus to the proper depth improves the resolution of the structure of interest.

Pulse length is the time during which the ultrasonic burst is turned on. The longer the pulse, the greater the time-average intensity value. The greater the time-average intensity, the greater the likelihood of temperature increase and cavitations. Pulse length, burst length or pulse duration is the output pulse duration in pulsed Doppler. Increasing the Doppler sample volume, increases the pulse length.

Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The higher the probe operating frequency, the greater the attenuation of the ultrasonic energy. Higher probe operating frequencies require higher output intensity to scan at an increased depth. To scan deeper at the same output intensity, a lower probe frequency is required. Using more gain and output beyond a point, without corresponding increases in image quality, can mean that a lower frequency probe is needed.

Receiver Controls:

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

Additional Considerations:

Ensure that scanning time is kept to a minimum, and ensure that only medically required scanning is performed. Never compromise quality by rushing through an exam. A poor exam will require a follow-up, which ultimately increases the scanning time. Diagnostic ultrasound is an important tool in medicine, and, like any tool, should be used efficiently and effectively.

Output Display Features:

The system output display comprises two basic indices: a mechanical index and a thermal index. The thermal index consists of the following indices: soft tissue (TIs), bone (TIb) and cranial bone (TIc). One of these three thermal indices will be displayed at all times. Which one depends upon the system’s default setting 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 the 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. The 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. the presence of fluid or bone, or the flow of blood. A highly attenuated 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 but do not rush the exam. Ensure that the indices are kept to a minimum and that exposure time is limited without compromising diagnostic sensitivity.

Mechanical Index (MI) Display:

Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The potential for mechanical biological effects varies with peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. However, there is no specific MI value that means that a mechanical bioeffect will actually occur. The MI should be used as a guide for implementing the ALARA principle.

Thermal Index (TI) Display:

The TI informs the user about the potential for temperature increase occurring at the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, 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 of, for example, cranial bone. TIc is displayed when you select a trans-cranial application.

The soft tissue thermal index (TIs) informs the user about the potential for heating within soft homogeneous tissue.

You can select TI Display in Utility > Setup > Display > Display.

Precision and Accuracy of Mechanical and Thermal Indices Displays:

The mechanical and thermal indices on the system are precise to 0.1 units.

The MI and TI display accuracy estimates for the system are given in the Acoustic Output Tables Manual. These accuracy estimates are based on the various range of probes and systems, inherent acoustic output modeling errors, and measurement variation, 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 from investigated tissue or organs. The initial data that is used to support the output display is derived from laboratory measurements based on the AIUM measurement standard. The measurements are then put into algorithms for calculating the displayed output values.

Many of the assumptions used in the process of measurement and calculation are conservative in nature. Over-estimation of actual in situ exposure, for the vast majority of tissue paths, is built into the measurement and calculation process. For example, the measured water tank values are derated using a conservative, industry standard, attenuation coefficient of 0.3dB/cm-MHz.

Conservative values for tissue characteristics were selected for use in the TI models. Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat capacity, and tissue thermal conductivity were selected.

A steady state temperature rise is assumed in the industry standard TI models, and the assumption is made that the ultrasound probe is held steady in one position long enough for a steady state to be reached.

A number of factors are considered when estimating the accuracy of display values: hardware variations, algorithm accuracy estimation and measurement variation. Variation among probes and systems is a significant factor. Probe variation 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, as well as variation 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 varying ranges of probes and systems, inherent acoustic output modeling errors, and measurement variations. 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.

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 an 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.

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 via software controls to keep the TI below the system maximums. A decrease in pulse voltage will decrease the MI.

• Zoom: Increasing the zoom magnification may increase the frame rate. This action will increase the TI. The number of focal zones may also increase automatically to improve resolution. This action may change the 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 the MI.

• Focal No.: More focal zones may change both the TI and MI by changing the frame rate or focal depth automatically. Lower frame rates decrease the TI. The 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 as the primary mode and the TI change will be small.

• Color Sector Depth: Deeper color sector depth may automatically decrease color frame rate or change 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 the color frame rate. The TI will increase and the 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, the TI changes.

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 the MI is 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.

• 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 the MI.

• Probe: Each probe model available has unique specifications for contact area, beam shape, and center frequency. Defaults are initialized when you select a probe. Factory defaults vary with probe, application, and selected mode. Defaults have been chosen below the FDA limits for intended use.

• Depth: An increase in 2D-mode depth will automatically decrease the 2D-mode frame rate. This would decrease the TI. The system may also automatically choose a deeper 2D-mode focal depth. A change of focal depth may change the MI. The MI displayed is that of the zone with the largest peak intensity.

• Application: Acoustic output defaults are set when you select an application. Factory defaults vary with probe, application, and mode. Defaults have been chosen below the FDA limits for intended use.

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, (MI@ISPPA.3) 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).

• x-6,y-6: These 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).

The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below:

Systematic Uncertainties – for the pulse intensity integral, derated rarefaction pressure, Pr.3:

Center frequency and pulse duration, the analysis includes considerations of the effects on accuracy of:

• Hydrophone calibration drift or errors.

• Hydrophone / Amp frequency response.

• Spatial averaging.

• Alignment errors.

• Voltage measurement accuracy, including:

  • Oscilloscope vertical accuracy.

  • Oscilloscope offset accuracy.

  • Oscilloscope clock accuracy.

  • Oscilloscope digitization rates.

  • Noise.

The systematic uncertainties of acoustic power measurements using a radiation force are measured through the use of calibrated NIST acoustic power sources.

The document includes analysis and discussion of the sources of error/measurement effects due to:

• Balance system calibration.

• Absorbing (or reflecting) target suspension mechanisms.

• Linearity of the balance system.

• Extrapolation to the moment of switching the ultrasonic transducer (compensation for ringing and thermal drift).

• Target imperfections.

• Absorbing (or reflecting) target geometry and finite target size.

• Target misalignment.

• Ultrasonic transducer misalignment.

• Water temperature.

• Ultrasonic attenuation and acoustic streaming.

• Coupling or shielding foil properties.

• Plane-wave assumption.

• Environmental influences.

• Excitation voltage measurement.

• Ultrasonic transducer temperature.

• Effects due to non-linear 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.

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.

Operating Environment:

When installing the console, please consider the following:

CAUTION: Placing the system near generators, X-ray machines or broadcast cables may result in screen noise and abnormal visual images. Sharing the power source with other electrical devices may also cause noise.

• Optimal conditions for the system are temperatures of 10 ~ 35°C and humidity of 30 ~ 75%.

• Avoid excess humidity.

• Avoid direct sunlight.

• Avoid places with extreme temperature variations.

• Avoid heat sources.

• Avoid dusty and unventilated areas.

• Avoid places where the system is likely to be exposed to vibration or impacts.

• Avoid places where the system is likely to be exposed to chemical substances or gases.

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.

CAUTION:

• For disposing of the system or accessories that have come to the end of their lifespan, contact the vendor or follow appropriate disposal procedures.

• You are responsible for complying with the relevant regulations for disposing of wastes.

• The lithium ion battery used in the product must be replaced by a Samsung Medison service engineer or an authorized dealer.

Specifications:

Specifications continued:

This Product consists of the monitor, the control panel, the console, the peripheral devices, and the probes.

Rear Panel:

A monitor and other peripheral devices are connected via the rear panel at the back of the system.

NOTE: Connecting the Full HD wide monitor is recommended if you use the DVI port and connector. If you connect an RGB monitor, it might not display properly.

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.

Be sure to connect or disconnect probes when the power is off to ensure the safety of the system and the probes.

1. Connect probes to the probe connectors on the front panel of the system. A maximum of five probes including the CW probe can be connected at one time. The CW probe should only be connected to its own connector.

2. To install, turn the connector turning handle clockwise.

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.

Internal Peripheral Devices:

• DVD-Multi: DVD-RW, DVD+RW, DVD-R, DVD+R, CD-R, CD-RW, CD-ROM

• Hard Disc Drive: At least 500 GB

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.

CAUTION: When using a peripheral device via a USB port, always turn the power off before connecting/disconnecting the device. Connection/disconnection of USB devices during power-on may lead to malfunction of the system and the USB devices.

NOTE:

• When removing the removable disk, use Utility > Storage manager.

• USB ports are located both on the front panel and the rear panel of the console.

• It is recommended that you connect USB storage devices (flash memory media, etc.) to the ports on the front panel and other USB peripheral devices to the rear panel for convenience.

The following products are recommended:

• USB video printer:

  • Black and White: Mitsubishi P-95DE, Sony UP-D897

  • Color: Mitsubishi CP-30DW, Sony UP-D25MD

CAUTION:

• You must install a Microsoft Windows XP™ or above compatible printer and driver. Contact Samsung Medison customer service department for inquiries about printer driver installation.

• When connecting the printer, ensure that the printer is configured under Microsoft Windows™ or system setup and has been chosen as the default printer.

• Please check the port that the printer uses before connecting. Printers should be connected to the printer port while the USB printer should be connected to the USB port.

• 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’.

Foot Switch:

To configure the foot switch function, go to Utility > Setup > Peripherals > Foot Switch. Select from Freeze, Update, Record, Print1, Save, Store Clip, and Volume Start, or EZ Exam.

WARNING: Foot Switch cannot be used in the operating room.

Misc. Flash Memory Media:

NOTE:

• The system cannot recognize USB 1.1 flash memory. Remove the flash memory from the console and equip again with an appropriate device.

• Regarding file formats that are not ordinarily saved: Please check first to see if it is possible to save the file format on a desktop PC before trying to save the file on flash memory.

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.

NOTE: Accessories can be different according to the country.

The accessories include:

• FUSE

• SONO GEL

• MANUAL

• GROUND CABLE

• POWER CORD

• WINDOWS XP LABEL

• DVI2RGB GENDER

This product has the following optional functions:

• 4D

• 3D XI

• CW Function

• Cardiac Measurement

• DICOM

• Spatial Compound

• XI STIC

• Auto IMT

• ElastoScan

• Panoramic

• 3DMXI Upgrade

• HDVI

• VolumeNT

• ADVR

• ECI

• FRV

For further information about optional functions, please refer to the relevant chapters in this manual.

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.

NOTE:

• The product should turn on about 10 seconds after the power switch at the back of the product is turned on.

• During system booting, do not press any key on the keyboard. It may cause product malfunction.

• If you turn on the power after turning it off suddenly, the system may turn on and off momentarily. This is one of the characteristics of the Intel® PC main board, not a system error.

Powering Off:

Press the On/Off button while using the system to initiate shutdown.

CAUTION: Pressing the On/Off button for longer than five seconds will immediately turn the power off and result in damage to the hard disk. Please refrain from such use unless there is a serious emergency.

Before scanning, select a probe, an application and a Preset/Userset.

Press the Probe button on the control panel and the Probe screen will be displayed on the touch screen. From this screen, you can select or change the probe, application, Preset or Userset.

Press the Probe button again or the Exit button to exit from the Probe screen without applying the changes.

CAUTION: Refer to ‘Chapter 9. Probes’ for more information on probes and applications and the Preset/Userset supported by the system.

Probe Screen:

The Probe screen consists of the following items:

• Probe tab: Displays a list of probes currently connected to the system.

• Application group: Displays a list of applications and their presets that the selected probe supports.

• Userset group: Displays a list of settings you can configure according to your preferences.

Probe and Application Selection:

Select Probe then Application then Probe Preset/Userset. Tapping the Preset/Userset loads the settings and initiates the diagnosis mode. The selected probe and settings are shown in the title area of the monitor. The selected probe and Preset/Userset are displayed in yellow on the Probe screen.

Changing Pages:

Use the Page Index dial-button to change the touch screen page.

Probe Userset Management:

Adding a Probe Userset:

The application and settings currently in use are added to the Userset.

1. Tap ‘+’ in the Userset group on the touch screen. The Name window is then shown on the touch screen.

2. Enter the name you want to use and tap Ok. Click Cancel to cancel.

3. Userset and the application name are added to Userset group.

Tips! Userset Group Name:

The application name of the Userset which is added to the Userset list first time is entered as the name of Userset group. Go to Edit > Rename > Application to edit the name of Userset group.

Changing the Position of the Group:

You can change the position of the application group or Userset group currently in use.

1. Tap Edit on the touch screen.

2. Rotate the App Name dial-button to change the position.

3. Tap Edit again to confirm the new position.

Overwriting a Userset:

You can save the current probe settings to the selected Userset.

1. Tap Edit on the touch screen.

2. Tap Overwrite on the touch screen. The confirmation message ‘Save Success’ will be displayed on the monitor.

3. Tap Edit again to confirm the overwritten value.

Renaming a Userset:

NOTE: You cannot edit or delete the Userset name currently in use.

1. Tap Edit on the touch screen.

2. Use the Rename dial-button to select the Userset to rename. Select Application or Preset.

3. Tap the dial-button to display the Rename window on the touch screen.

   • Application: The Application Rename window will be displayed. Change a Userset group name using this screen.

   • Preset: The Rename window will be displayed. Change a Userset name using this screen. You cannot change an application shown with the Userset name.

4. Change the name and tap Ok. Click Cancel to cancel.

5. Tap Edit again to confirm the change.

Deleting a Userset:

NOTE: You cannot edit or delete the Userset currently in use.

1. Tap Edit on the touch screen.

2. Select a userset and tap Delete on the touch screen.

3. Tap Edit again to confirm the change.

Exporting/Importing a Userset:

NOTE: The Userset Manager button is only active when a USB flash memory device is being used.

You can export and import Usersets to and from external storage media.

1. Tap Edit on the touch screen.

2. Select a Userset and tap Userset Manager on the touch screen. The Userset Export/Import window is then shown on the monitor.

3. To save the Userset on USB flash memory, tap the Export button. To copy a userset from USB flash memory to the system, tap the Import button. Tap Close on the screen.

4. Tap Edit again to confirm the change.

Press the Patient button on the control panel and the Patient Information screen will appear. In this screen, you can enter, search, or change patient information.

NOTE: The ID and name fields are required.

Once you have entered the patient information, tap on the OK button on the monitor or the touch screen to exit. Press Cancel to cancel. Alternatively, you can press the control panel’s Patient button once more or the Exit button.

Patient Information Screen:

The Patient Information screen consists of two sections.

• Page Tab: Pages related to patient information entry are shown as tabs.

• Study Information Tab: Depending on the selected menu option, the patient information entry or management screen is shown.

Patient Information Entry:

From the Patient Information screen, tap on the Patient tab. Alternatively, use the touch screen’s Page dial-button to select Patient.

The Patient Information Entry screen has the following layout:

• Basic Patient Information: Enter or edit ID, name, age, gender, and other types of basic patient information.

• Application Information: Add or edit required information for individual applications. To select an application, select the corresponding tab or use the touch screen’s Category dial-button.

Clear Measurements:

Clears all measured values previously entered.

Basic Patient Information Entry:

• ID: Enter a patient ID.

  • To enter it manually, enter an ID in the ID field.

  • To enter it automatically, select Auto ID Creation and click New. The icon, next to the ID field, is changed.

  • If you enter an ID that already exists, the icon, next to the ID field, is changed.

• Name: Enter the patient’s full name. The name that you have entered will appear in the title area and reports.

  • Last Name: Enter the patient’s last name.

  • First Name: Enter the patient’s first name.

  • Middle: Enter the patient’s middle names if they have any.

• Ez Exam Setup: Ez Exam Setup allows you to specify exam items and their order.

NOTE: For more information on Ez Exam Setup, refer to ‘Chapter 7. Utilities’.

• Accession: When viewing the work list for a patient via the DICOM server, this information is automatically displayed in the appropriate fields.

• Representation: Specify how the names of Asian patients, including Korean, Chinese and Japanese are displayed.

  • Roman: Type in Roman letters.

  • Ideographic: Type in ideographic letters.

  • Phonetic: Type in phonetic letters.

NOTE:

• This button appears on the screen only in a product that supports Asian patient names.

• For information on specifying the order or way in which names are displayed, refer to ‘Screen Display Settings’ in ‘Chapter 7. Utilities’.

• Birth: Enter the patient’s birth date in the specified format.

• 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.

General (Patient Information):

Enter additional information. Information entered in General is applied to all application information entry screens.

• Height: Enter the patient’s height. Height can be specified in inches (in.) or centimeters (cm). Tap on the Unit button to change units. When the unit is changed, the entered number is automatically recalculated and displayed in the new unit of measurement.

• Weight: Enter the patient’s weight. Supported units are ounces (oz), pounds (lb), and kilograms (Kg). Press the corresponding unit button to change the unit of measurement.

• BSA: When the height and weight are entered, the BSA (Body Surface Area) is automatically calculated and displayed.

• HR: Enter a heart rate.

• Diag. Physician: Enter the name of the physician who diagnosed the patient. When there is more than one physician involved, you can use the Combo button to make a selection.

Tips! Typing in Korean, Japanese or Chinese:

Diag. Physician, Ref. – The Physician, Sonographer, Description and Indication can be entered in Korean, Japanese or Chinese. Choose the desired language by using the Language button on the touch screen.

• Korean: Entry in Korean.

• Alpha: Entry in English.

• Ref. Physician: Enter the name of the referring physician. When there is more than one sonographer involved, 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 involved, 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.

From the Patient Information Entry screen, tap on the Measure Data button.

NOTE: Appears only when a patient ID has been selected.

Insert Measurement Data Screen:

Tap on the Insert Measurement Data tab. You can enter the existing obstetrical measurements.

• Exam Date: Enter the measurement date.

• Fetus: If there are multiple fetuses, identify each one. Up to four fetuses (A, B, C, D) can be specified.

• Exam No.: Up to eight exam numbers can be entered for each date. The Exam number is displayed at the bottom of the screen.

• New Data: Cancel all measurement data entered for all exams and enter new measurement data.

• Clear: Cancel entering the measurement data.

• Insert: Complete entering the measurement data.

• Page Browse: Use the [>>] or [<<] button.

• Study Information: Loads application-specific Patient Information screen.

View Measurement Data Screen:

Tap on the View Measurement Data tab. Measured values can be viewed on the screen or saved in an Excel file. The * symbol next to the Date indicates that the data is the current measurement data.

• Package: Select a measurement package to display on the screen.

• Refresh: Update the measurement data. Newly calculated measurements, or the measurements entered, are added.

• Save: The Save To Excel window appears, allowing you to save information on the screen in an Excel file.

  1. Designate the path.

     • To create a folder, select Create.

     • To delete a folder, select Delete.

  2. Enter the file name. By default, the Excel file name is set to the measurement ID.

  3. Select Save to finish. Press Close to cancel.

NOTE: Checking the HTML checkbox saves information as an HTML file instead of an Excel file.

On the Patient Information screen, select the Work list tab. Alternatively, use the touch screen’s Page dial-button to select Work list. Perform a search by connecting to the DICOM Modality Work list server in the hospital network.

NOTE: A work list search is available only when DICOM is enabled. The Work list Server can be specified at Utility > Setup > DICOM. Refer to the ‘Setting DICOM’ section of ‘Chapter 7. Utilities’

1. After entering at least one item out of Patient ID, Last Name, Accession # (work list number) and Procedure ID, click Search. The list of patients who match the criteria will be displayed.

Tips! Clicking items such as Date/Time or Patient Name sorts entries into alphabetical or numerical order for the selected criteria.

2. Select a patient list and tap on the Apply button. This applies the selected patient information to the system. Tapping on the Start Exam button applies the patient information to the system and switches the system to scan mode.

Exam List:

Displays a list of exams returned from Search. In addition to patient ID, name, age, and gender, the exam list contains the following information:

• Exam Date: Exam date.

• Images: Number of images on record.

• Measurements: Measurement status.

• SR: Structured report status.

• SE: Stress echo exam status.

• SC: The transfer status of the exam (Storage Commit).

• Lock Status: Lock status.

Tips! When you tap one of the fields, such as Patient ID and Name, the data is sorted by the alphabetic or numeric order of the selected field.

Tips! Multi Select:

It’s possible to select multiple exams using one of the following two options:

• Tap on the Multi Select button and then select the desired exams.

• Hold down the keyboard’s Ctrl key, press the Set button, and then select the desired exams.

Viewing Exam:

Select an exam by using the trackball and the Set button, and click Review on the screen. Switch to the SONOVIEW screen.

NOTE: For instructions on using SONOVIEW, refer to ‘Chapter 6. Image Management’.

Deleting Exam:

Select an exam by using the trackball and the Set button, and click Delete on the screen. All images from the exam will be deleted. However, an exam in progress or a locked exam cannot be deleted.

Select either to delete only the image or to delete only the exam. An exam without Measurement Data will not be displayed on the screen if only the image is deleted.

NOTE: Once deleted, exams cannot be recovered.

Tips! To select more than one image, press the Set button while holding down the Ctrl key on the keyboard.

Sending Exams via DICOM:

You can send selected exams via the DICOM network.

NOTE: Before using this feature, make sure that DICOM is properly configured. For instructions on configuring DICOM, refer to ‘Chapter 7. Utilities’.

Perform the following steps to send the selected exam via DICOM:

1. Select exam(s) and then click Send on the screen. The DICOM Storage window will appear.

Tips! To select more than one image, press the Set button while holding down the Ctrl key on the keyboard.

2. Select the alias you wish to transmit. You can select images under Stored Images and reports under Storage SR.

3. Click Transfer. The transfer will be started and its progress (%) will be displayed. Press Close to cancel.

• Click Test, before sending the exam, to check the DICOM’s connection with the server.

Printing Exams via DICOM:

NOTE: Before using this feature, make sure that DICOM is properly configured. For instructions on configuring DICOM, refer to the Set DICOM section of ‘Chapter 7. Utilities’.

Perform the following steps to print the selected exam via DICOM:

1. After selecting an exam, click Print on the screen. The DICOM Printer window will be displayed.

Tips! To select more than one image, press the Set button while holding down the Ctrl key on the keyboard.

2. Click Transfer. The transfer will be started and its progress (%) will be displayed. Press Close to cancel.

• Click Test, before sending the exam, to check the DICOM’s connection with the server.

Exporting the Exam:

Perform the following steps to export the selected exam to an external storage device:

1. After selecting an exam, click Export on the screen. The Image Export window will be displayed.

Tips! To select more than one image, press the Set button while holding down the Ctrl key on the keyboard.

2. In Drive, select the device on which the exam will be saved. You can select CD-ROM, or flash memory.

3. In File Name, enter the file name. The same file name is given to all images of an exam. When an exam contains multiple images, a serial number is automatically added to the end of the file name.

4. In File Format, select the format in which the files will be saved. You can select BMP, JPEG, TIFF, or DICOM.

5. In Export Option, select the options to apply to the files. You can select multiple options.

   • 3D Volume Data: Export the 3D volume data together with the image.

   • 2D Cine: Export the stored Cine images after converting them to video files (AVI files).

   • 3D and Live Cine: Export 3D Cine and Live Cine images after converting them to video files (AVI files).

   • Hide Patient Information: Export images from which the patient ID and name have been deleted.

6. In Directories, select the location in which the exam will be saved. To create a new directory, click the new directory icon and enter the name. To delete a directory, select it and click the delete icon. In Files, the files currently saved in the selected directory are displayed.

7. Click Export to begin exporting. Press Close to cancel.

Backing Up the Exam:

You can back-up the selected exams on an external storage device.

NOTE: USB devices with anti-virus software installed are not supported.

1. Insert a storage medium for backups. CD-ROM or flash memory can be used.

2. Select exam(s) and then click Back-up on the screen.

Tips! To select more than one image, press the Set button while holding down the Ctrl key on the keyboard.

3. A Confirmation window will appear asking whether to continue the back-up. Click Yes to continue. Click No to cancel.

4. The Back-up window will appear. Under Drive, select the media where the selected exams will be saved.

5. Click OK to start the back-up. Press Cancel to cancel.