Aplio 500 инструкция по применению

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Introduction

This operation manual describes the operating procedures for the diagnostic ultrasound system TUS-A500. To ensure safe and correct operation of the system, carefully read and understand the manual before operating the system.

Trademarks

Windows® is a registered trademark of Microsoft Corporation in the United States and other countries.

Clorox Healthcare is a trademark of The Clorox Company. Dispatch® is a registered trademark of The Clorox Company. Cleanisept® is a registered trademark of Dr. Schumacher GmbH. Java is a registered trademark of Oracle and/or its affiliates.

APLIO, Dynamic Flow, ApliPure, MicroPure, and TwinView are trademarks of Toshiba Medical Systems Corporation.

This manual may include trademarks or registered trademarks of other companies.

Note that the trademark symbol » » and the registered trademark symbol » » may or may not be used in this manual.

IMPORTANT!

1.No part of this manual may be copied or reprinted, in whole or in part, without prior written permission.

2.The contents of this manual are subject to change without prior notice and without legal obligation.

3.The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or erroneous descriptions, missing information, etc.

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Some operations can be performed using either the switches on the main panel or the corresponding switches on the touch panel.

The switches displayed on the touch panel differ depending on the selected exam type, transducer, and mode.

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Table of Contents

2.4Preventing Electric Shocks, Fires, and

2.12Precautions Concerning Clinical

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3.General Information on Usage and

4.2Environmentally Friendly Usage and

7.2Handling and Connecting/Disconnecting the

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9.1Connecting the Power Cable and the

9.5Preparation for Use During Surgery or for

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11.1Entering and Saving Data on the

13.4Selecting an Application Preset

13.5Changing the Transducer During

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18.2Needle Mark Display and Angle Change

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20.4Preventive Maintenance Performed by

20.5Periodically Replaced Parts and

22.Checks Before the System

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25.Guidance and Manufacturer’s

26.1Availability of This Software and

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1. Intended Use

1.1Intended Medical Use

(1)The intended use of this system is to visualize structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis.

(2)This system provides high-quality ultrasound images in all its modes: 4D mode, 2D mode, M mode, CDI (Color Doppler Imaging) mode (blood-flow imaging), and Doppler mode (blood-flow spectrum).

(3)This system is a general-purpose diagnostic ultrasound imaging system that conforms to the standard for Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (American Institute of Ultrasound in Medicine (AIUM), 1992). Note that transducers have their own characteristic applications. For the transducers that can be used with this system and their applications, refer to subsection 5.6 «List of Available Transducers».

1.2Intended Patient Information

Age, health condition: Not specified

However, do not use this system if it is judged that the patient will be exposed to hazard due to the patient’s own condition.

1.3User Profile

Only physicians or legally qualified persons who have received appropriate training

Before using this system, it must be ensured that the user has received sufficient training.

1.4Operating Principles

This system transmits ultrasound signals into the human body from a transducer and receives the reflected echoes from the human body using the same transducer. It then processes the received signals and displays them as images on a display screen (LCD monitor).

Gating signals are sent from the scan control circuit through the transmission delay circuit and are input to the reception circuit. The reception circuit then generates the transmission signals (electrical pulses) according to the gating signals.

These electrical pulses are applied to piezoelectric elements that convert the electrical signals into mechanical vibrations in the transducer. These mechanical vibrations, which are ultrasound signals, are then transmitted into the human body.

This system supports convex, sector, linear, and some other scanning techniques.

When the ultrasound signals transmitted into the human body encounter a substance with different acoustic characteristics, they are reflected and return to the transducer as echoes. Based on the time required for the ultrasound signals to return to the transducer, the distance between the transducer surface and the reflecting substance can be determined.

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In 2D (B) mode imaging, the echo amplitudes are represented as brightness changes on the image display screen. Since the ultrasound beam attenuates in tissue, the degree of amplification required generally increases as depth increases. Regions of high reflection are displayed as brighter, while regions of low reflection appear darker.

An M-mode image (cross-sectional image) can be displayed together with a 2D-mode image on the same screen through time-sharing control, allowing the user to perform M-mode diagnosis while observing a 2D-mode image.

In color Doppler imaging, phase detection is performed in a receive signal processing circuit to obtain I and Q signals. These signals undergo frequency analysis with the correlational method in a color Doppler imaging circuit to produce the mean velocity, variance, and power information of the blood flow. These information items are assigned color signals and represented as real-time two-dimensional color Doppler images.

In Doppler imaging, the signals output from the receive signal processing board are frequency-analyzed by fast Fourier transform (FFT) in a Doppler circuit to produce velocity and power information. A Doppler image is then displayed, plotting velocity on the vertical axis, time on the horizontal axis, and representing power as brightness.

This system supports basic measurements including distance, time, angle, and trace, as well as combinations of some basic measurements. In addition, calculations based on the measurement values can be performed for each region (circulatory organ, OB, etc.) using widely accepted expressions. The calculation results can be displayed in values, tables, or graphs.

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2. General Safety Information

This section describes the general precautions and details that must be observed when using this system. Precautions related to specific operations are described in the corresponding sections.

When using the system, be sure to also read the precautions in the operation manual Measurements volume and the operation manual Applications volume, respectively.

2.1Meaning of Signal Words

In this operation manual, the signal words DANGER, WARNING, and CAUTION are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.

2.2Meaning of Safety Symbols

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2.3Ensuring the Safety of Patients and Operators

Observe the following safety precautions to ensure the safety of patients and operators.

DANGER: This system must be used only when the potential benefits to

the patient are judged outweigh the possible risk to the patient.

WARNING: 1. Do not use damaged or defective transducers. Doing so may result in injury to the patient.

2.Take special precautions when examining a patient with high temperature. A high patient temperature may slow down cooling of the transducer surface, which may result in a burn injury to the patient.

If the surface temperature of the transducer becomes abnormally high, stop using the transducer and contact your TOSHIBA service representative.

3.This device is contraindicated for ophthalmic use or any application that causes the acoustic beam to pass through the eye.

4.Do not look inside the DVD/CD unit. The emitted laser beam is hazardous to the eyes and other parts of the body.

5.Prolonged and repeated use of keyboards can result in hand or arm nerve disorders in some individuals. Observe the local institutional work safety/health regulations on keyboard use.

6.Do not use the Fusion function (option) for patients who use electronic life-support devices (for example, a cardiac pacemaker or defibrillator). The magnetic field generated in Fusion mode may affect such devices.

CAUTION: 1. Do not use the transducer on the same region of the patient for a prolonged period. Low temperature burns may occur. Use the transducer for the minimum period of time that is required for diagnosis. Though the transducer surface temperature may exceed the patient’s body temperature under some ambient conditions and usage modes, the use of the transducer for normal ultrasound diagnosis is unlikely to cause low temperature burns.

2.Do not sit on the system. Doing so may result in the system moving unexpectedly, causing you to lose your balance and fall.

3.When this system is used to examine an elderly patient or an infant, an attendant should be present if required.

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2.4Preventing Electric Shocks, Fires, and Power Supply Interruptions

Observe the following safety precautions to prevent electric shocks, fires, and power supply interruptions.

DANGER: Never use flammable or explosive gases near this system.

Also do not use the system with oxygen or in an oxygenenriched atmosphere. Doing so may result in an explosion (the system is not explosion-proof).

WARNING: 1. Follow the instructions below regarding the power cable and plug.

Insert the power plug only into a 3-pin (with protective grounding) medical electrical outlet.

Do not connect the power cable to a 2-pin outlet using an adapter.

Do not forcibly bend the cable.

Do not modify the power cable or plug.

Do not damage the power cable or plug.

Do not twist the power cable or plug.

Do not bundle the power cable or plug.

Do not place heavy objects on the power cable or plug.

Do not pinch the power cable or plug.

Do not subject the power cable or plug to impact.

Do not pull the power cable to disconnect the plug from the outlet.

2.If any abnormalities (such as damage or wear) are found on the power cable or plug, the power cable and plug must be replaced. Stop using it immediately and contact your Toshiba service representative. Continuing to use the system may result in electric shock, fire, or interruption of power supply.

3.Do not use the system if the connection to the outlet is loose.

4.If an abnormal smell or noise, or smoke occurs, immediately turn the main power switch on the power panel OFF and disconnect the plug from the power outlet. Continuing to use the system with such an abnormality may result in a fire etc. When using the system, ensure that there is enough space for access to the main power switch.

5.Do not allow this system or other equipment to come into contact with the patient. If this system or other equipment is defective, the patient may receive an electric shock.

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WARNING: 6. Do not connect any devices other than those specified by

TOSHIBA to the USB connector or other connectors on the system.

7.Do not connect to the system transducers other than those specified by TOSHIBA, to prevent accidents such as fire.

8.Do not use a defective transducer.

9.Do not remove the covers or panels of the system. Doing so exposes high-voltage parts.

10.When in the patient environment, the operator must not touch any exposed connectors. In addition, if the system covers have been removed for some reason, the operator must be extremely careful not to touch any part where the voltage exceeds 25 VAC or 60 VDC and the patient at the same time. Doing so may result in an electric shock.

11.Connect the equipotential terminal () of this system to the equipotential bus of the facility using an equipotential conductor. When this system is used close to a device that is applied directly to the patient heart (such as in a cardiac catheterization room, CCU, or ICU), voltage equalization with the device is required to prevent an electric shock to the patient.

12.A functional ground terminal ( ) is used to connect a functional grounding wire between systems or between the system and the ground for functional purposes of the system (for example, to eliminate potential differences in the signal level between systems or to eliminate potential differences between the system and the ground). Do not use the functional ground terminal for protective grounding. Also, do not connect the functional ground terminal to a gas pipe or water pipe. Doing so may result in the failure of functional grounding or in a gas explosion.

13.Use a separate socket with an appropriate rated capacity for the supply of power to this system.

14.Do not connect this system to an outlet that shares a circuit breaker (or fuse) with an outlet to which a device such as a life-support system is connected. If this system malfunctions and generates an overcurrent, or if there is a current surge when the power is turned ON, the circuit breaker may trip (or the fuse may blow).

15.Do not connect the diagnostic ultrasound system to the same power outlet as another device. Doing so may cause the circuit breaker of the facility to trip, fuses to blow, or a fire or electric shock to occur.

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WARNING: 16. Remove the ECG electrodes from the patient before using

devices such as electric scalpels, high-frequency therapy equipment, electrostimulators, or electric defibrillators. In addition, when using such devices, do not let ultrasound transducers, PCG microphones, or pulse wave sensors to come into contact with the patient. Doing so may result in the patient receiving a burn injury or an electric shock.

CAUTION: 1. To prevent electric shock, do not connect peripheral units (such as a video printer or video recording unit) to an external outlet. Peripheral units should be connected inside the system. For the connection procedures, contact your TOSHIBA service representative.

2.If any abnormality of the system is found as a result of inspection, stop using the system and contact your TOSHIBA service representative for repair.

3.Do not spill or spray liquids such as water onto the system or peripheral units.

2.5Chemical Hazard

Observe the following instruction in order to protect patients and operators from inflammation or poisoning by chemical substances.

WARNING: Handling the cord on this product will expose you to lead, a

chemical known to the State of California to cause birth defects or other reproductive harm.

Wash hands after handling.

2.6Electromagnetic Compatibility (EMC)

Definition: Electromagnetic compatibility (EMC) refers to the ability to function without causing electromagnetic interference (EMI) in other devices or systems, as well as to a certain level of immunity to EMI from other devices or systems.

Observe the following precautions to ensure EMC.

WARNING: The use of transducers and cables other than those

specified, with the exception of transducers and cables sold by Toshiba Medical Systems Corporation as replacement parts, may result in increased emissions or reduced system performance.

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CAUTION: Malfunctions due to radio waves

(1)This system may malfunction due to electromagnetic influence from electric scalpels, high-frequency therapy equipment, or other devices that generate high frequencies.

(2)The use of radio-wave-emitting devices near this unit may interfere with its operation. Devices that generate radio waves, such as cellular phones, transceivers, and radiocontrolled toys, must not be brought into the room where this unit is installed and must never be used near the unit.

(3)If a device that generates radio waves is brought into the room where this unit is installed, instruct the user to turn OFF the power of the device immediately. This is necessary to ensure proper operation of the system.

CAUTION: 1. Do not use this system in locations exposed to strong electric or magnetic fields (near transformers, for example). Such fields may adversely affect the monitor.

2.Do not use this system near devices that generate high frequencies (such as medical telemeters and cordless telephones). Doing so may cause the system to malfunction or to adversely affect such devices.

3.Do not use devices that generate high frequencies near other devices or stack such devices on each other. If doing so is unavoidable, confirm that the system operates normally at its usual operating location.

2.7Acoustic Power

Observe the following safety precautions.

CAUTION: 1. When a fetus is to be exposed to ultrasound, set the acoustic power to as low a level as possible.

2.The FDA allows ultrasound equipment to output acoustic power level TRACK3, which is higher than TRACK1, provided that MI/TI values are displayed on the system. This means that users now have a higher degree of responsibility for safety. Users are thus required to understand the bioeffects of ultrasound and their causes, and to only then increase diagnostic capabilities by increasing MI/TI.

Refer to section 24 «Using MI/TI» for details.

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2.8Preventing System Malfunctions

Observe the following precautions to prevent system malfunctions.

CAUTION: 1. Only software authorized by TOSHIBA should be installed in this system. Otherwise, a system failure or malfunction may result.

2.If the system is infected with malware (malicious software, such as a computer virus or worm), data stored in the system may be deleted, altered, or disclosed or the system may malfunction or infect other systems. The user must establish security measures to prevent the system from being infected.

(a)Do not connect this system to a network for which any of the conditions below is true:

Security control is not established for the network.

There is a risk of malware invasion in the network.

A system for which any of the following conditions is true is connected to or can be connected to the network:

(b)The following instructions must be observed in order to prevent this system from being infected with malware:

Do not connect this system to the Internet.

When external storage media (such as a CD or USB flash drive) is to be used, confirm in advance that the media is not infected with malware.

Do not perform any other actions that may result in infection.

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CAUTION: 1. To prevent damage to the system, do not install it in a location where it may be exposed to the following:

Direct sunlight

Sudden temperature fluctuations

Excessive dust

Excessive shock or vibration

High temperatures

High humidity

Poor air circulation because the system air filter is blocked by a wall etc. (A space at least 10 cm wide and 20 cm deep is required.)

2.Do not disconnect the power plug while the system is starting up. Doing so may cause the system to malfunction.

3.If either of the following phenomena occurs, press and hold down

for 5 seconds or more to turn OFF the power of the system.

The startup screen is not displayed after waiting for 30 seconds.

The patient registration screen is not displayed after waiting for 10 minutes.

or more, turn OFF the main power on the power panel.

Do not turn OFF the power in this manner during normal operation. Doing so may cause the system to malfunction.

4.Do not press or use force on the main panel. Doing so may damage the system.

5.The service outlets on the main unit provide power for recommended external options only. Do not connect other devices to these outlets. Doing so may result in the outlet power capacity being exceeded and cause a system malfunction.

6.The cooling fan must be cleaned at least once a year. If the cooling fan is clogged, the internal temperature will rise, shortening the service life of the system. For inspection and cleaning by service personnel, contact your TOSHIBA service representative.

7.If the main power switch on the power panel or circuit protector trips, be sure to consult your TOSHIBA service representative. If the main power switch is turned ON again before the problem is corrected, the system or a connected device may sustain further damage.

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2.9Handling Patient and Image Data

To prevent incorrect diagnosis and reexaminations, observe the following precautions when handling data.

CAUTION: 1. Entering patient data

Before starting an examination for a new patient, confirm that the patient ID matches the patient to be examined. If images are recorded with an incorrect patient ID, the data may be mixed up with that for another patient, resulting in incorrect diagnosis.

2.This system is provided with a lossy data compression function for images. Although this function helps to reduce the size of stored images, it can cause image deterioration. The amount of compression must therefore be limited so that the image quality is maintained at a level that does not adversely affect image reading.

2.10Warning Labels

Various warning labels are attached to this system in order to call the user’s attention to potential hazards.

*The symbol on the warning labels indicates safety precautions. Warning labels use the same signal words as used in the descriptions in the operation manuals. Read the operation manuals carefully before using the system.

The appearance and location of each warning label are as follows.

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Warning labels on systems complying with the European Directive 93/42/EEC

Warning labels on other systems

<<Warning labels for options>>

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2.12Precautions Concerning Clinical Examination Techniques

(1)This operation manual is intended for users who are well-versed in the principles and basic techniques of ultrasound.

(2)This system must be used only by medical personnel fully trained in clinical examination techniques.

(3)This operation manual does not describe clinical examination techniques. Selection of the proper clinical examination technique must be based on specialized training and clinical experience.

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3.General Information on Usage and Maintenance

1.The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product.

2.The warranty does not cover the following items, even during the warranty period:

(1)Damage or loss due to misuse or abuse.

(2)Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc.

(3)Damage or loss caused by failure to meet the specified conditions for this system, such as inadequate power supply, improper installation, or unacceptable environmental conditions.

(4)Damage or loss due to mobile use in a vehicle which is not authorized by TOSHIBA.

(5)Damage or loss due to use outside the territory in which the system was originally sold.

(6)Damage or loss involving system purchased from a source other than TOSHIBA or its authorized distributors or agents.

3.This system shall not be used by persons other than fully qualified and certified medical personnel.

4.Do not make changes or modifications to the software or hardware of this product.

5.In no event shall TOSHIBA be liable for problems, damage, or loss caused by relocation, modification, or repair performed by personnel other than those designated by TOSHIBA.

6.The purpose of this system is to provide physicians with data for clinical diagnosis.

The responsibility for diagnostic procedures lies with the physicians involved. TOSHIBA shall not be liable for the results of diagnostic procedures.

7.Important data must be backed up on external recording media such as clinical records, notebooks, floppy disks, or magnetic tapes.

8.TOSHIBA shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents.

9.This manual contains warnings regarding foreseeable potential dangers. Be alert at all times to dangers other than those indicated.

10.TOSHIBA shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions contained in this operation manual.

11.Ultrasound transducers are precision equipment and should be handled with proper care. If they are not handled according to the instructions in the operation manual, problems such as scratches, holes, defects in the acoustic lens surface, twisting of the transducer cable, or degradation of the ultrasound images may result.

Note that the warranty does not cover problems caused by improper handling of the transducers.

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12.TOSHIBA shall not be liable for any error or malfunction that results from use of a transducer other than that specified by TOSHIBA.

13.On the occasion of change of the administrator or manager for this system, be sure to hand over this operation manual.

14.When this system is to be transported, be sure to contact your TOSHIBA service representative first. Special packaging must be performed by a TOSHIBA service engineer or a service engineer authorized by TOSHIBA. TOSHIBA does not assume any responsibility for damage resulting from transportation of this system without consulting TOSHIBA.

15.When disposing of this system, contact your TOSHIBA service representative. Do not dispose of this system without consulting TOSHIBA service representative first. TOSHIBA does not assume any responsibility for damage resulting from disposal of this system without consulting TOSHIBA.

NOTE: Concerning the WEEE label

The following information is only for EU member states: The use of this symbol indicates that this product should not be treated as household waste.

By ensuring that this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste-handling of this product.

For more detailed information concerning the return and recycling of this product, please consult the supplier from whom you purchased the product.

* For system products, this label may be attached to the main unit only.

NOTE: Concerning BATTERIES

The following information is only for EEA countries: The directive 2006/66/EC requires separate collection and appropriate disposal of spent batteries.

This product also contains batteries that are not intended to be replaced by the user.

Replacement of those batteries will usually be done during regular maintenance or service by service staff who can also arrange proper disposal.

NOTE: Regulatory information

The high-efficiency LCD backlights used in this product contain 5 mg or less of mercury, the disposal of which may be regulated due to environmental considerations.

For disposal or recycling information, please contact your local authorities or the Electronic Industries Alliance (www.eiae.org).

This information is only for the USA.

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NOTE: Perchlorate Material — special handling may apply.

See http://www.dtsc.ca.gov/hazardouswaste/perchlorate/

This is applicable to California, USA, only.

16.This system shall be connected to a network only if security measures against malware infection have been established for the network.

17.Expected service life

The expected service life is 7 years if the specified maintenance and inspection procedures are performed.

However, the service life depends on usage conditions, and individually specified periods, if any, take precedence.

18.This manual provides information on minimizing the environmental impact (carbon dioxide emission, power consumption, etc.) of this system. Use the information appropriately according to the intended use of the system.

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4. Use Conditions

4.1Power and Environmental Requirements

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4.2Environmentally Friendly Usage and Maintenance Management

Observe the following to keep environmental impact to a minimum.

(1)Turn the system power OFF when the system is not in use.

(2)When the system is not to be used for an extended period of time, turn OFF the main power switch on the power panel and disconnect the power plug from the outlet.

(3)Freeze the image by pressing whenever examination is not being performed.

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5. System Configuration

5.1Standard Configuration

(1)Main unit of the system

(2)Accessories

Operation manuals

Cables

Transducer holder

Gel holder

5.2List of Optional Units

The following optional units are available with this system.

*: The mounting kit for fusion sensor is used in combination with the fusion unit UIFR-A500A.

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5.3Compatible Peripheral Devices

The following devices are available with this system.

*It may not be possible to use some of the peripheral devices listed above depending on the power conditions of the country. For details, contact your TOSHIBA service representative.

5.4External Storage Devices

USB flash drives and barcode readers can be connected to this system. Contact your TOSHIBA service representative for the recommended models.

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5.5List of Optional Software

The following optional software is available with this system.

*: This option is not available in the USA.

NOTE: «/EL» is a supplemental model name indicating options supplied by electronic license.

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5.6List of Available Transducers

The following transducers are available with this system.

*1: When this transducer is used, optional unit UIHV-A500A and optional software USMS-A500A are required.

*2: This transducer is not available in the USA and Canada. *3: This transducer is not available in the USA.

*4: This transducer is available in the USA only.

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