Toshiba Aplio 500 User manual

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No. 2B771-004EN*M

OPERATION MANUAL

FOR

DIAGNOSTIC ULTRASOUND SYSTEM

MODEL TUS-A500

[FUNDAMENTALS]

(2B771-004EN*M)

CAUTION:

In the USA, federal law restricts this device to sale by or on the order of a physician.

IMPORTANT!

Read and understand this manual before operating the equipment. After reading, keep this manual in an easily accessible place.

TOSHIBA MEDICAL SYSTEMS CORPORATION 2010-2014



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.

No. 2B771-004EN*M

Organization of the Operation Manuals

1. Notation Conventions

In this operation manual, the following word is used in addition to the signal words related to the safety precautions (refer to section 2 "General Safety Information"). Please read this operation manual before using the system.

NOTE: Indicates reference information that enables more efficient use of the equipment.

2. Operation Manuals

A TOSHIBA service person or instructor will explain the basic operating procedures for this system at the time of delivery. However, read this operation manual carefully before using the system in order to understand the detailed operating procedures, functions, performance, and maintenance procedures.

Operation manual for the main unit of the ultrasound system

Fundamentals volume (this manual)

Applications volume

Measurements volume

Acoustic power and surface temperature data

Operation manual for each transducer

..................... Describes the operating and

......... Describes the basic information

concerning the system, such as preparation for examination, operation, inspection, and functional descriptions of the system.

......... Describes the exam data manipulation

procedures and optional unit operation procedures.

......... Describes the registration and

measurement procedures.

......... Describes the acoustic power

transmitted from the ultrasound transducer.

disinfection/sterilization procedures for the transducer.

NOTE: For certain applications, the following manuals are available in English:  2B771-005EN Applications volume  2B771-006EN Measurements volume  2B771-007EN Acoustic power and surface temperature data (For regions other

than the USA)  2B771-008EN Acoustic power and surface temperature data (For the USA only)  2B771-010EN Operation card

NOTE: The operation manuals Applications volume and Measurements volume may be

supplied on electronic media.

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3. Switch Configuration

 The descriptions in this operation manual are based on the standard switch configuration. If

the switch configuration has been changed, the differences between the current configuration and the standard configuration must be understood before use.

 The layout, shapes, labels, and icons of the switches on the touch panel can be changed. All

the figures of touch panel and switches in this manual are examples and may differ from the actual display.

4. Operation Switches

 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

Organization of the Operation Manuals ...................................................... U-1

1. Intended Use ..................................................................................... 1-1

1.1 Intended Medical Use .......................................................................... 1-1

1.2 Intended Patient Information .......................................................... 1-1

1.3 User Profile

1.4

Operating Principles ............................................................................. 1-1

.................................................................................................. 1-1

2. General Safety Information ........................................... 2-1

2.1 Meaning of Signal Words .................................................................. 2-1

2.2 Meaning of Safety Symbols ............................................................ 2-1

2.3 Ensuring the Safety of Patients and Operators ................ 2-2

2.4 Preventing Electric Shocks, Fires, and

Power Supply Interruptions

2.5 Chemical Hazard ..................................................................................... 2-5

2.6

Electromagnetic Compatibility (EMC) ...................................... 2-5

2.7 Acoustic Power ........................................................................................ 2-6

............................................................ 2-3

2.8 Preventing System Malfunctions ................................................ 2-7

2.9 Handling Patient and Image Data ................................................ 2-9

2.10 Warning Labels ........................................................................................ 2-9

2.11 Regulatory Labels ................................................................................ 2-12

2.12 Precautions Concerning Clinical

Examination Techniques

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................................................................. 2-13

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3. General Information on Usage and

Maintenance ....................................................................................... 3-1

4. Use Conditions .............................................................................. 4-1

4.1 Power and Environmental Requirements ............................. 4-1

4.2 Environmentally Friendly Usage and

Maintenance Management

............................................................... 4-2

5. System Configuration ........................................................... 5-1

5.1 Standard Configuration ...................................................................... 5-1

5.2 List of Optional Units ........................................................................... 5-1

5.3 Compatible Peripheral Devices .................................................... 5-2

5.4 External Storage Devices ................................................................. 5-2

5.5 List of Optional Software .................................................................. 5-3

5.6 List of Available Transducers ........................................................ 5-4

6. Names and Functions of Each Section ........ 6-1

6.1 Name of Each Section ......................................................................... 6-1

6.2 Main Panel ................................................................................................... 6-3

6.3 Rear Panel .................................................................................................... 6-7

6.4 Symbols ......................................................................................................... 6-8

7. Preparation for Examination ....................................... 7-1

7.1 Moving and Installing the System .............................................. 7-1

7.2 Handling and Connecting/Disconnecting the

Transducer

7.2.1 Handling the transducer ............................................................................ 7-4

.................................................................................................. 7-4

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7.2.2 Connecting/Disconnecting the transducer ........................................ 7-4

7.3 Adjusting the Main Panel .................................................................. 7-6

7.4 Adjusting the Monitor .......................................................................... 7-8

7.4.1 Locking and releasing the monitor ....................................................... 7-8

7.4.2 Adjusting the angle of the monitor ........................................................ 7-9

7.4.3 Adjusting the monitor display ............................................................... 7-10

8. Checks Before and After Use ..................................... 8-1

8.1 Checks Before Turning ON the Power .................................... 8-1

8.2 Checks After Turning ON the Power ........................................ 8-2

9. Turning the Power ON/OFF ........................................... 9-1

9.1 Connecting the Power Cable and the

Protective Grounding

9.2 Turning ON the Power ......................................................................... 9-4

9.3 Turning the Power OFF ...................................................................... 9-6

9.4 Standby Mode ........................................................................................... 9-9

9.4.1 Setting Standby mode ................................................................................ 9-9

9.4.2 Recovery from the Standby status ...................................................... 9-11

9.5 Preparation for Use During Surgery or for

Emergency Cases

.......................................................................... 9-2

................................................................................ 9-12

9.5.1 Preparation of a backup system ........................................................... 9-12

9.5.2 Power OFF/ON in the case of system failure ................................... 9-12

10. Basic Screen and Menu ................................................... 10-1

10.1 Display of Various Data Items ..................................................... 10-1

10.2 Displaying the Acoustic Power Data ...................................... 10-2

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10.3 Thumbnail Display ............................................................................... 10-4

11. Starting an Examination .................................................. 11-1

11.1 Entering and Saving Data on the

[Patient Registration] Screen

....................................................... 11-2

12. Reference Signal Display ............................................... 12-1

12.1 Reference Signal Panel .................................................................... 12-4

12.2 Installing the Reference Signal Sensor ................................ 12-5

12.3 Adjusting Reference Signals ........................................................ 12-5

13. Common Operation for Each Mode ................. 13-1

13.1 Touch Panel Operation ..................................................................... 13-1

13.2 Trackball Functions ............................................................................ 13-8

13.2.1 Trackball function area ............................................................................. 13-8

13.2.2 Trackball operations .................................................................................. 13-9

13.3 Selecting an Imaging Preset During Examination ...... 13-10

13.3.1 [DEFAULT PRESET] tab ......................................................................... 13-12

13.3.2 [USER PRESET] tab ................................................................................. 13-15

13.3.3 [Sub Preset] menu .................................................................................... 13-15

13.4 Selecting an Application Preset

During Examination

.......................................................................... 13-16

13.5 Changing the Transducer During

Examination

............................................................................................ 13-18

14. Display and Operation in Each Mode ............ 14-1

14.1 2D Mode ....................................................................................................... 14-1

14.1.1 2D display layout ........................................................................................ 14-1

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14.1.2 Adjustment using the main panel ........................................................ 14-2

14.1.3 Adjustments using the touch panel .................................................... 14-5

14.1.4 Selection of image zooming method .................................................. 14-8

14.1.5 2D mode quick scan ................................................................................ 14-10

14.1.6 Trapezoid scan .......................................................................................... 14-12

14.2 M Mode ....................................................................................................... 14-13

14.2.1 M display layout ........................................................................................ 14-13

14.2.2 Adjustment using the main panel ...................................................... 14-14

14.2.3 Adjustment using the touch panel .................................................... 14-16

14.2.4 FLEX-M mode ............................................................................................. 14-18

14.3 CDI Mode ................................................................................................... 14-20

14.3.1 CDI display layout .................................................................................... 14-20

14.3.2 Adjustment using the main panel ...................................................... 14-21

14.3.3 Adjustment using the touch panel .................................................... 14-23

14.4 Power Angio Mode (Power Mode) .......................................... 14-25

14.4.1 Power Angio display layout .................................................................. 14-25

14.4.2 Adjustment using the main panel ...................................................... 14-25

14.4.3 Adjustment using the touch panel .................................................... 14-26

14.5 Dynamic Flow Mode (ADF Mode) ............................................ 14-28

14.5.1 Dynamic Flow display layout ............................................................... 14-28

14.5.2 Adjustment using the main panel ...................................................... 14-28

14.5.3 Adjustment using the touch panel .................................................... 14-29

14.6 TDI Mode (Tissue Doppler Imaging Mode) ....................... 14-31

14.6.1 TDI display layout ..................................................................................... 14-31

14.6.2 Adjustment using the main panel ...................................................... 14-31

14.6.3 Adjustment using the touch panel .................................................... 14-32

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14.7 Doppler Mode ........................................................................................ 14-34

14.7.1 Doppler display layout ............................................................................ 14-34

14.7.2 Adjustment using the main panel ...................................................... 14-35

14.7.3 Adjustments using the touch panel .................................................. 14-38

15. Cine Function ................................................................................. 15-1

15.1 Overview ..................................................................................................... 15-1

15.2 Cine Operations ..................................................................................... 15-1

16. Body Mark ........................................................................................... 16-1

16.1 Body Mark Entry Mode ..................................................................... 16-1

16.2 Setting and Editing Body Marks ................................................ 16-2

17. Entering Comments .............................................................. 17-1

17.1 Entering Comment Entry Mode .................................................. 17-1

17.2 Entering/Editing Characters and Arrow Marks ............... 17-1

18. Needle Mark ...................................................................................... 18-1

18.1 Applicable Transducers and Biopsy Adapters ............... 18-3

18.2 Needle Mark Display and Angle Change

Procedures

................................................................................................ 18-5

18.2.1 Needle mark display .................................................................................. 18-6

18.2.2 Needle mark angle change procedures ............................................. 18-8

19. Storing Image Data ................................................................. 19-1

19.1 Storing Still Images ............................................................................. 19-1

19.1.1 Operations using the touch panel ....................................................... 19-1

19.2 Storing a Dynamic Image ................................................................ 19-2

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19.2.1 Operations using the touch panel ....................................................... 19-3

19.2.2 Snapshot Clips ............................................................................................ 19-4

19.2.3 Cine Clips (storage of cine image data) ............................................ 19-6

19.2.4 Setting of the storage format (for retrospective storage) .......... 19-8

19.3 File Handling for Image Data ........................................................ 19-8

19.4 Displaying Saved Images ............................................................... 19-8

20. Maintenance ..................................................................................... 20-1

20.1 Technical Descriptions ..................................................................... 20-1

20.2 Outline of Preventive Maintenance .......................................... 20-1

20.3 Preventive Maintenance Performed by the User ........... 20-2

20.3.1 Cleaning the system .................................................................................. 20-2

20.3.2 Disinfecting the system ........................................................................... 20-8

20.3.3 Creating a backup copy of the system hard disk ........................ 20-10

20.3.4 [Maintenance] menu ................................................................................ 20-10

20.3.5 Backing up the customer-specific data (Backup) ....................... 20-11

20.4 Preventive Maintenance Performed by

Service Personnel

.............................................................................. 20-14

20.5 Periodically Replaced Parts and

Consumable Parts

.............................................................................. 20-14

20.6 Checks During Storage .................................................................. 20-14

21. Disposal ................................................................................................. 21-1

22. Checks Before the System

Is Judged Defective ............................................................... 22-1

23. Specifications ................................................................................ 23-1

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23.1 External Dimensions and Mass .................................................. 23-1

23.2 Essential Performance of This System................................. 23-1

23.3 Conformance Standards ................................................................. 23-2

23.4 Safety Classification ........................................................................... 23-3

23.5 Accuracy of Measurement ............................................................. 23-4

24. Using MI/TI ......................................................................................... 24-1

24.1 Using MI/TI (Outside the USA and Canada) ....................... 24-1

24.1.1 Basic knowledge of MI/TI ......................................................................... 24-1

24.1.2 MI/TI display description.......................................................................... 24-3

24.1.3 Parameters affecting the MI/TI values ................................................ 24-4

24.1.4 Operating procedures for MI/TI ............................................................. 24-5

24.1.5 Output display .............................................................................................. 24-6

24.1.6 Reminder ........................................................................................................ 24-6

24.1.7 Ultrasonic output power and acoustic output ................................ 24-7

24.1.8 References for MI/TI ................................................................................... 24-8

24.2 Using MI/TI (in the USA and Canada) ..................................... 24-9

24.2.1 Basic knowledge of MI/TI ......................................................................... 24-9

24.2.2 MI/TI display description........................................................................ 24-11

24.2.3 Parameters affecting the MI/TI values .............................................. 24-12

24.2.4 Operating procedures for MI/TI ........................................................... 24-13

24.2.5 Output display ............................................................................................ 24-14

24.2.6 Information contained in the system documentation ................ 24-15

24.2.7 Measurement uncertainty and precision ........................................ 24-15

24.2.8 Reminder ...................................................................................................... 24-15

24.2.9 Ultrasonic output power and acoustic output .............................. 24-16

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24.2.10 References for MI/TI ................................................................................. 24-18

25. Guidance and Manufacturer's

Declaration ......................................................................................... 25-1

26. Intellectual Property .............................................................. 26-1

26.1 Availability of This Software and

1. Intended Use

1.1 Intended 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".

1.2 Intended 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.

1.3 User 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.

1.4 Operating 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.

2.1 Meaning 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.

Signal word Meaning

DANGER

WARNING

CAUTION

CAUTION Indicates a potentially hazardous situation which, if not

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

avoided, may result in property damage.

2.2 Meaning of Safety Symbols

Symbol Description

Type-B applied part

* Type B when Type-B applied parts are connected.

The heart sound sensor and pulse wave sensor that can be connected to this system are Type-B applied parts.

Type-BF applied part

* Type BF when Type-BF applied part is connected.

The reference signal cables that can be connected to this system are Type-BF applied parts.

"Attention" (Refer to the operation manual.)

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2.3 Ensuring 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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2.4 Preventing 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.

2.5 Chemical 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.

2.6 Electromagnetic 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.

2.7 Acoustic 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.

No. 2B771-004EN*M

2-6

2.8 Preventing 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:

<1> The security of the system is not controlled by

the user.

<2> The system can be accessed by persons not

authorized by the user.

<3> The system is capable of wireless

communication.

(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.

No. 2B771-004EN*M

2-7

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.

If the power is not turned ON after holding down for 5 seconds

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.

No. 2B771-004EN*M

2-8

2.9 Handling 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.

2.10 Warning Labels

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

* The symbol

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.

on the warning labels indicates safety precautions. Warning labels

No. 2B771-004EN*M

2-9

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

No. Label Meaning <1>

<2>

<3>

<4>

<5>

Urges caution related to handling of the transducers. For handling of the transducers, refer to the transducers' operation manual.

Cautions that the MI/TI must be controlled as low as reasonably achievable.

(a) Cautions that the system must be placed on a

horizontal surface.

(b) Cautions that the cover must not be removed in

order to prevent electric shock.

nor pushed from the side.

Cautions regarding handling of the monitor arm.

(a) Cautions against sitting on the system.

<6>

<7>

(b) Urges caution related to the switches on the

main panel.

Cautions that the system must not be used around flammable gases.

Cautions that hands may be caught when the height of the main panel is adjusted.

No. 2B771-004EN*M

2-10

Warning labels on other systems

No. Label Meaning

<1> Cautions that restrict this device to sale by or on the

order of a physician. (USA/Canada only)

<2> Urges caution related to handling of the transducers.

<3>

<4>-1 Cautions that the system must be placed on a

<4>-2 Cautions that the cover must not be removed in

(a) Cautions that the MI/TI must be controlled as

low as reasonably achievable.

(b) As in the USA and Canada, cautions that

displayed MI/TI are mean values. Refer to subsection 24.2.2 "MI/TI display description".

horizontal surface.

order to prevent electric shock.

<5> Cautions regarding handling of the monitor arm.

<6> (a) Cautions against sitting or leaning on the

system.

(b) Urges caution related to the switches on the

main panel.

No. 2B771-004EN*M

2-11

No. Label Meaning

<7> Cautions that the system must not be used around

flammable gases.

<8> Cautions that hands may be caught when the height

of the main panel is adjusted.

<<Warning labels for options>>

Item Label Meaning

Cautions that the Fusion function (option) must not be used for patients who use electronic life-

Fusion unit

(UIFR-A500A)

Fusion Pole Cart

(UZWT-A500A)

support devices (for example, a cardiac pacemaker or defibrillator). The magnetic field generated in Fusion mode may affect such devices.

Cautions that the operation manual must be referred to.

Cautions that the Fusion pole cart must not be leaned on or pushed forcefully from the side.

M-TEE hanger kit

(UAEH-770A)

Motor drive

M-TEE hanger kit

(UAEH-002A)

2.11 Regulatory Labels

Label Meaning

Precautions related to handling

1. Place the transducer in the box for transportation.

This label indicates this device complies with European Directive 93/42/EEC and subsequent amendments.

2. Do not allow the transducer to bump against the main unit.

No. 2B771-004EN*M

2-12

2.12 Precautions 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.

No. 2B771-004EN*M

2-13

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.

No. 2B771-004EN*M

3-1

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.

No. 2B771-004EN*M

3-2

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.

No. 2B771-004EN*M

3-3

4. Use Conditions

4.1 Power and Environmental Requirements

Item Specifications

Power Line voltage

Line frequency 50 Hz to 60 Hz

Power consumption USA 1440 VA

Operating environmental conditions

Storage and transportation conditions

Patient environment This system is designed to be used in the

Ambient temperature 10°C to 35°C

Relative humidity 35% to 80% (no condensation)

Atmospheric pressure

Ambient temperature -10°C to 50°C

Relative humidity 30% to 80% (no condensation)

Atmospheric pressure

USA 120 VAC 10%

Europe 220 to 240 VAC 10%

Other 1 110 to 120 VAC 10%

Other 2 220 to 240 VAC 10%

Europe 1500 VA

Other 1 1440 VA

Other 2 1500 VA

700 hPa to 1060 hPa

50% or less if the ambient temperature exceeds 40°C

700 hPa to 1060 hPa

environment specified in the figure below.

No. 2B771-004EN*M

4-1

4.2 Environmentally 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

performed.

whenever examination is not being

No. 2B771-004EN*M

4-2

5. System Configuration

5.1 Standard Configuration

(1) Main unit of the system

(2) Accessories

 Operation manuals  Cables  Transducer holder  Gel holder

5.2 List of Optional Units

The following optional units are available with this system.

No. Item Model

1 CW unit UICW-A500A 2 Reference signal unit UJUR-A500A (Except for USA) 3 Reference signal unit UJUR-A501A (Only for USA) 4 Reference signal sensor unit UJUR-772A 5 Mounting kit for peripheral unit UZRI-A500A 6 Mounting kit for peripheral unit UZRI-A501A 7 Footswitch UZFS-A500A 8 Gel warmer UZGW-007A

9 M-TEE hanger kit UAEH-770A 10 Motor drive M-TEE hanger kit UAEH-002A 11 4D unit UIMV-A500A 12 Battery kit UEBT-A500A 13 HV power kit UIHV-A500A 14 Fusion unit UIFR-A500A 15 Fusion Pole Cart UZWT-A500A 16 Mounting kit for fusion sensor* UAFS-001A 17 Mounting kit for fusion sensor* UAFS-002A 18 Mounting kit for fusion sensor* UAFS-003A 19 Transducer cable hanger kit UZMK-A500A 20 CV kit UACV-A500A

*: The mounting kit for fusion sensor is used in combination with the fusion unit

UIFR-A500A.

No. 2B771-004EN*M

5-1

5.3 Compatible Peripheral Devices

The following devices are available with this system.

No. Item Model

1 Black-and-white digital printer UP-D897 (SONY)

P95DW (MITSUBISHI)

2 Color digital printer CP30DW (MITSUBISHI)

UP-D25MD (SONY)

3 DVD video recorder DVO-1000MD (NTSC/PAL: SONY)

BD-X201M (NTSC/PAL: JVC, for regions other than Europe)

BD-X201ME (PAL: JVC, for Europe)

* 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.

5.4 External Storage Devices

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

No. 2B771-004EN*M

5-2

5.5 List of Optional Software

The following optional software is available with this system.

No. Item Model

1 Realtime ASQ kit* USAS-A500A, USAS-A500A/EL

2 Smart Fusion kit USFN-A500A, USFN-A500A/EL

3 Fly Thru. kit USFT-A500A, USFT-A500A/EL

4 Elastography kit USEL-A500A, USEL-A500A/EL

5 2D Wall Motion Tracking kit USWT-A500A, USWT-A500A/EL

6 MicroPureTM kit USMP-A500A, USMP-A500A/EL

7 CHI-Q kit USCQ-A500A, USCQ-A500A/EL

8 CHI kit USHI-A500A, USHI-A500A/EL

9 Panoramic View kit USPV-A500A, USPV-A500A/EL

10 4D STIC Imaging kit USST-A500A, USST-A500A/EL

11 Stress Echo kit USSE-A500A, USSE-A500A/EL

12 DICOM kit USDI-A500A, USDI-A500A/EL

13 1.5D Transducer kit USMS-A500A, USMS-A500A/EL

14 Protocol Assistant kit USPA-A500A, USPA-A500A/EL

15 Parametric MFI kit* USPM-A500A, USPM-A500A/EL

16 Vascularity Index kit USVI-A500A, USVI-A500A/EL

17 FLR kit* USFL-A500A, USFL-A500A/EL

18 Elastography-FLR kit* USEL-A501A, USEL-A501A/EL

19 FLEX-M kit USXM-A500A, USXM-A500A/EL

20 Luminance kit USLM-A500A, USLM-A500A/EL

21 Superb Micro vascular Imaging kit USMI-A500A, USMI-A500A/EL

*: This option is not available in the USA.

NOTE: "/EL" is a supplemental model name indicating options supplied by electronic

license.

No. 2B771-004EN*M

5-3

5.6 List of Available Transducers

The following transducers are available with this system.

Transducer name Principal use PST-25BT Cardiac, pediatric, abdominal, adult cephalic, neonatal cephalic PST-30BT Cardiac, abdominal, adult cephalic, neonatal cephalic PST-50BT Cardiac, pediatric, and neonatal cephalic PST-65AT Cardiac, neonatal cephalic, pediatric PVT-350BTP*2 Abdominal PVT-375BT Abdominal, fetal, pediatric PVT-375MV Abdominal, fetal, pediatric PVT-382BT Abdominal, fetal, pediatric PVT-382MV Abdominal, fetal, pediatric PVT-661VT Transrectal, transvaginal PVT-674BT Abdominal, fetal PVT-675MV Fetal PVT-681MV Transvaginal, transrectal PVT-712BT Neonatal cephalic, abdominal PVT-745BTF Abdominal, small organs, intraoperative PVT-745BTH Abdominal, small organs, intraoperative PVT-745BTV Abdominal, small organs, intraoperative PVT-770RT Transrectal PVT-781VT Transrectal, transvaginal PLT-308P*2 Abdominal PLT-604AT Peripheral vascular, small organ, musculoskeletal PLT-704AT Peripheral vascular, small organ, musculoskeletal PLT-704SBT Small organs, peripheral vascular, musculoskeletal PLT-705BTF Abdominal PLT-705BTH Abdominal PLT-805AT Peripheral vascular, small organs, musculoskeletal PLT-1005BT Peripheral vascular, small organs, musculoskeletal PLT-1202S Peripheral vascular, small organs, musculoskeletal, intraoperative PLT-1204BT Peripheral vascular, small organs, musculoskeletal PLT-1204BX*1 Peripheral vascular, small organs, musculoskeletal PLT-1204MV Small organs, peripheral vascular, musculoskeletal PET-508MA Cardiac (transesophageal) PET-510MA*3 Cardiac (transesophageal) PET-510MB*4 Cardiac (transesophageal) PET-511BTM*2 Cardiac (transesophageal) PET-512MA*2 Cardiac (transesophageal) PET-512MC Cardiac (transesophageal) PC-20M Cardiac, pediatric PC-50M Cardiac, peripheral vascular, pediatric

*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.

No. 2B771-004EN*M

5-4

Transducer

name

PST-25BT PST-30BT PST-50BT PST-65AT PVT-350BTP PVT-375BT

PVT-375MV PVT-382BT

No. 2B771-004EN*M

PVT-382MV PVT-661VT PVT-674BT

5-5

PVT-675MV PVT-681MV PVT-712BT PVT-745BTF PVT-745BTH PVT-745BTV

PVT-770RT PVT-781VT PLT-308P PLT-604AT PLT-704AT PLT-704SBT PLT-705BTF PLT-705BTH

PLT-805AT

PLT-1005BT

PLT-1202S PLT-1204BT

2D mode

Fund.

Pulse

Subtract

Pulse

Subtract

OFF

mode

                                 

             

 *2  *2

 *2  *2  *2  *2  *2  *2  *2  *2  *2  *2  *2

 *2

                               

                           

CDI

mode

Power

mode

/ /

Dynamic

          

       

 



 *2  *2  *2  *2  *2

 *2

       

                

   

Flow

mode

/ /

SMI*4 mode



   

                

                        

  



Elasto-

TDI

graphy

mode

   

mode

 

  

 

  

          

   



 *2

   

  



       

mode

          

 











 







     



    











    



     



    





















 

CHI mode*4

        

          



Precision

imaging

/TE



           

          

    

ASQ*4

Apli-

Dynamic

Flow

 

MFI VRI

 

Pure

     

 



 *3  *3



  



    

 *3  *3





 













 

 

 









 



 



 

    



 *3  *3

 *3 



 *3  *3

 

















   

MicroPure

       

 

 

 





   





 : Available  : Not available

 

 



       





Transducer

name

PLT-1204BX

PLT-1204MV

PET-508MA

PET-510MA/ MB

PET511BTM

PET-512MA

No. 2B771-004EN*M

PET-512MC

PC-20M

5-6

PC-50M

Transducer name

PVT-375MV

PVT-382MV

PVT-675MV

PVT-681MV

PLT-1204MV

2D mode

CDI

Fund.

Pulse

Subtract

 

    

          

Pulse

Subtract

OFF



mode

   

Power

mode

Dynamic

mode

Flow

mode

  

SMI*4 mode



  

Elasto-

TDI

graphy

mode

  



mode



mode



 

mode

    





     



       



       

CHI mode*4

Dynamic

Flow



MFI VRI





ApliPure



MicroPure



Precision

imaging

/TE

 



ASQ*4



 : Available  : Not available

4D Live mode*4 Single Sweep mode*4

Fund.



Pulse

Subtract



 

Pulse

Subtract

Fund.

OFF

  

 

Pulse

Subtract

Pulse

4D CHI

Subtract

OFF

 *2  *3

 *2

 *2  *3

STIC*4

/

STIC

color*4

/ *1

 

 / *1 / *1

 

Volume

color*4

Biopsy*4

  





  

FlyThru*4



 : Available  : Not available

*1) Depends on the preset. *2) Differential THI *3) Not available in the USA. *4) Optional software is required. *5) TE

6. Names and Functions of Each Section

6.1 Name of Each Section

 Systems with the main power switch on the rear

No. 2B771-004EN*M

6-1

 Systems with the main power switch on the side

No. 2B771-004EN*M

6-2

6.2 Main Panel

The default switch layout is shown in the figure below:

 The functions assigned to the switches can be changed. Therefore, the actual switch

settings of the system may differ from the default settings described in this manual. Confirm the Output, Store, Freeze, and other important settings before using the system.

 It is also possible to change the positions of switches related to measurements,

modes, or printer output (user function switches). To change the settings, contact your TOSHIBA service representative.

CAUTION: Do not press several switches at the same time. Doing so may cause a

malfunction.

No. 2B771-004EN*M

6-3

No. Switch name Function

<1>

<2>

<3>

<4>

<5>

<6> Touch panel

<7>

Turns the power ON/OFF.

Lights when the main power switch on the power panel is ON.

Goes out when the system is started up.

Lights again when the system is shut down.

Indicates the battery charge level. (Lights when the main power switch on the power panel is ON.)

Lights green if the batteries are adequately charged.

Lights orange if the batteries need to be charged.

Displays the [Patient Registration] screen. The ID and measurement data for the previous patient are deleted and the initial conditions are restored.

Used to select the transducer.

Displays switches specific to the type of examination (switches for image control, measurements, etc.). The desired switch can be touched with a finger to operate it.

The functions of these knobs vary depending on the mode or other conditions. The functions currently assigned to the knobs are displayed on the touch panel.

<8>

<9>

<10>

<11>

<12>

<13>

<14>

<15>

Used to specify the echo reception sensitivity for various depths calculated from the body surface.

Used to set the acoustic power.

Returns the settings of scan range, Color ROI, and sampling gate to their initial values.

Displays monochrome and color images simultaneously in real time.

Starts trapezoid scanning.

Enables text annotations to be added to images.

Starts the [Worksheet] screen.

Starts the [Exam Review] screen.

No. 2B771-004EN*M

6-4

No. Switch Function

<16>

<17>

<18>

<19>

<20>

<21>

<22>

<23>

Starts up the [Patient Browser] screen. Displays the previously acquired images or other data.

Starts basic measurement mode.

Starts application measurement mode.

The function of this knob varies according to the mode.

Measurement modes : Used to edit measurement results (for

example, modification of an ellipse or a trace).

Body mark entry mode : Rotates the transducer mark on the

body mark.

Annotation mode : Rotates the arrow mark.

Switches to M mode.

The dial around the knob is used to adjust the gain in M mode.

Switches to CW mode.

Switches to PW mode.

The dial around the knob is used to adjust the gain in Doppler mode.

<24>

<25>

<26>

<27>

<28>

Switches to POWER mode.

Switches to CDI mode.

The dial around the knob is used to adjust the gain in Color mode.

Switches to Dynamic Flow

mode.

Switches to 2D display mode.

The dial around the knob is used to adjust the gain in 2D mode.

Trackball : Used to move the cursor and measurement

markers.

Palm Dial :

During real-time display : Used to specify the gain in 2D mode.

In Freeze mode : Used to play back a loop in Cine

review mode and to adjust the playback speed. Used to edit measurement results in measurement modes. Rotates the transducer mark on the body mark in Body mark entry mode. Rotates the arrow mark in Annotation mode.

No. 2B771-004EN*M

6-5

No. Switch Function

<29>

<30>

<31>

<32>

<33>

<34>

(Wheel)

Used to insert a body mark.

Turns display of the cursor ON/OFF.

Used to manipulate thumbnails.

Used to switch trackball functions or specify the cursor position.

Pressing (in Freeze mode) : Returns to Cine mode (when Cine

mode has been stopped due to a measurement operation, insertion of a body mark, insertion of an annotation, or a similar operation).

Rotation : Feeds frames in Cine mode.

Switches the displayed image in Exam Review mode.

Used to switch trackball functions or specify the cursor movement.

Displays 2D mode and M or Doppler mode images at the same time.

Freezes/unfreezes the 2D mode image.

<35>

<36>

<37>

<38>

<39>

<40>

<41>

<42>

<43>

Used for automatic adjustment of the image quality. (Refer to panel")

Used to specify the depth and the zoom level.

Press to switch between depth and zoom modes.

Used to change the layout format.

Switches to the dual screen. Each time this switch is pressed, the real-time display is switched between the right and left images.

Switches to the single screen.

Freezes the screen.

Saves short dynamic image clips.

Saves still images.

Outputs data to the specified recording device. Monochrome printer is set as the default.

of subsection 14.1.2. "Adjustment using the main

No. 2B771-004EN*M

6-6

6.3 Rear Panel

CAUTION: 1. Do not connect any devices other than those specified by

2. Do not connect any device that is not compliant with the

CAUTION: 1. Connect or disconnect the Ethernet cable only when the power is OFF.

If the cable is connected or disconnected while the power is ON, the system may malfunction.

2. If a hub is being used, turn ON the power of the hub before turning ON

the power of the system. Otherwise, it may not be possible to establish connection with the network.

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

required safety standards to the Ethernet port. Doing so might cause smoke generation or electric shock.

No. Name Function

<1> S output terminal Output terminal for external imaging device

<2> Color composite terminal Output terminal for external imaging device

<3> External monitor DVI-I output Output terminal for external digital imaging

device

<4> Ethernet port Port for connection to a network for the transfer

of digital images via the network

<5> USB connector Connector for connection of a USB device

<6> USB connector Connector for connection of a USB device

NOTE: The video recording unit and the printer must be connected connectors inside

the system. Before connecting cables, contact your TOSHIBA service representative.

No. 2B771-004EN*M

6-7

6.4 Symbols

The following symbols are used on this system. Note that the safety symbols are not shown here; they are shown in section 2 "General Safety Information".

Symbol Description

Functional ground

Equipotential

Main power switch OFF (AC power not supplied to system)

Main power switch ON (AC power supplied to system)

Power OFF (power not supplied to electronic circuits)

Power ON (power supplied to electronic circuits)

Transducer connector A

Transducer connector B

Transducer connector C

Transducer connector D

Pencil transducer connector

ECG (Electrocardiogram)

PCG (Phonocardiogram)

PULSE

External input terminal

Footswitch

Alternating current (AC) Manufacturer

Date of manufacture

Serial number

Authorized representative in the EC (on systems complying with European Directive 93/42/EEC)

No. 2B771-004EN*M

6-8

7. Preparation for Examination

7.1 Moving and Installing the System

WARNING: 1. Use the system only on a level floor. Do not place the

system at a location where the slope is 5° or more. Doing so may result in the system falling over and causing an injury.

2. Do not push the system from the side. If the system is

pushed from the side, it may fall down and cause injury.

3. When the system is moved over a sloped surface, it must

be moved slowly by two persons. Otherwise, the system may slide unexpectedly and cause a serious injury.

4. When the system is moved over a step, be careful not to

allow the system to fall. When holding the system at the bottom to help move it over a step, take special care to prevent hand injuries.

CAUTION: 1. Lock the casters once the system is moved to its installation

location. Otherwise, the system may move unexpectedly, injuring the patient or the operator.

2. Before moving the system, lock all movable sections, such

as the LCD monitor main panel. Otherwise, parts may move unexpectedly, causing injury.

3. Before moving the system, confirm that all peripheral

devices are secured. If a peripheral device is not secured, it may fall, causing injury or damage.

4. When a reference signal cable is used, disconnect it before

moving the system. Otherwise, the cable might catch the feet or the casters, causing injury or damage.

CAUTION: 1. To prevent system malfunction, be sure to perform the following

operations before moving the system.

(a) Turn OFF the power and also turn OFF the main power switch on

the power panel.

(b) Stow the transducer in the transducer holder and hang the cables

on the transducer cable hanger.

system by pushing the panel or any part other than the handle.

2. Except in emergencies, do not attempt to stop system movement by

engaging the caster locks. Doing so may damage the casters.

No. 2B771-004EN*M

7-1

(1) Before moving the system, be sure to release the caster locks.

(a) Releasing all of the locks

(b) Locking the caster for forward motion

No. 2B771-004EN*M

7-2

(2) Move the system to its installation position using the handle.

(3) Lock the casters.

No. 2B771-004EN*M

7-3

7.2 Handling and Connecting/Disconnecting the Transducer

7.2.1 Handling the transducer

CAUTION: 1. Do not subject the acoustic lens surface of the transducer to shock by

hitting it against a hard object or dropping it on the floor. A failure affecting the safety or functionality of the transducer may result.

2. Do not apply stress to the transducer cable (tension, twisting, bending,

pinching, etc.). The shield wire or signal wire inside the cable may break or short-circuit, which could result in electric shock to the patient or operator, or abnormal ultrasound images.

3. Do not scratch or rub the acoustic lens surface of the transducer. This

may cause the transducer to fail.

For other precautions concerning handling of the transducer, read all instructions provided in this operation manual and the operation manual supplied with the transducer.

7.2.2 Connecting/Disconnecting the transducer

CAUTION: 1. Be sure to turn OFF the power or select another transducer connector

before connecting a transducer to or disconnecting the transducer from the currently selected transducer connector. Connecting a transducer to or disconnecting the transducer from the currently selected transducer connector can cause damage to the system or the transducer.

2. Do not connect or disconnect a transducer during system startup or

shutdown. Doing so may cause a malfunction.

(1) Connect the transducer.

No. 2B771-004EN*M

7-4

(2) Hang the transducer cable on the cable hanger or cable hook and place the

transducer in the transducer holder.

(3) Disconnect the transducer.

No. 2B771-004EN*M

7-5

7.3 Adjusting the Main Panel

CAUTION: When lowering the main panel, do not subject the cable hanger, cable

hook, or transducer holder to any loads. Doing so may damage them.

Adjusting the height of the main panel

Hold the handle and press the vertical adjustment lever upward to raise or lower the height.

When the lever is released, the position is locked.

No. 2B771-004EN*M

7-6

Adjusting the horizontal position of the main panel

(1) Pull the slide lever toward

you to release its lock.

(2) While pulling the slide lever,

hold the handle, move the main panel to adjust the position, and then release the slide lever. The nearest position is locked when the lever is released.

No. 2B771-004EN*M

7-7

7.4 Adjusting the Monitor

CAUTION: Before moving the system, be sure to lock the movable section

of the arm. Otherwise, the arm may move unexpectedly, resulting in an injury

7.4.1 Locking and releasing the monitor

Locking and releasing the arm

<<Locking the arm>>

Lower the arm and turn the locking knob in the

direction.

<<Releasing the arm>>

While pressing the locking knob, turn it in the

direction.

Locking the monitor

No. 2B771-004EN*M

7-8

7.4.2 Adjusting the angle of the monitor

CAUTION: Do not touch the arm or the bottom of the monitor when

adjusting the angle. Doing so may result in a hand injury.

Moving the monitor vertically

Moving the monitor horizontally

No. 2B771-004EN*M

7-9

7.4.3 Adjusting the monitor display

The brightness ( ) and the contrast ( ) can be adjusted as required using the buttons of the monitor.

Displaying the adjustment menu

Adjusting setting for the selected function

NOTE: 1. To restore the factory default settings, press the [+] switch while holding

down the [-] switch.

2. Pressing the [-] switch while holding down [] of the Menu switches turns

the monitor display ON/OFF.

No. 2B771-004EN*M

7-10

8. Checks Before and After Use

In the interests of safety, it is the user's responsibility to carry out the following checks before and after using the system.

8.1 Checks Before Turning ON the Power

Perform the following checks before the system power is turned ON and after the system power is turned OFF.

No. Check item Check column

1 The temperature, humidity, and atmospheric pressure should meet the

conditions of use.

2 There should be no condensation.

3 There should be no deformation, damage, or stains to the system and

peripheral units.

* If any stains are present, perform cleaning referring to subsection 20.3.1

"Cleaning the system".

4 There should not backlash or loose screws in the casters, monitor, panel,

etc.

5 Caster locks should function correctly.

6 There should be no damage to the reference signal cable and no

looseness of the connector.

7 There should be no abnormalities such as damage, wear, or bent pins on

the power cable or plug.

8 There should be no abnormalities or stains of the transducer surface, cable

sheath, or connector, such as peeling, cracks, protruding parts, or loss of firmness of the acoustic lens.

* If any stains are present, perform cleaning, disinfection, or sterilization

referring to the operation manual provided with the transducer.

9 No clips etc. are placed on the main panel or keyboard.



10 There should be no obstacles near the movable sections and air filter of

the system.

No. 2B771-004EN*M

8-1



8.2 Checks After Turning ON the Power

Perform the following checks after the system power is turned ON and before the system power is turned OFF.

No. Check item Check column

1 There should be no abnormal sound, unusual smells, or overheating.

2 No error message is displayed.

3 There should be no obviously abnormal noise, discontinuous display, or

dark areas for 2D-mode images.

4 There should be no abnormality in the date and time.

* Refer to the operation manual Applications volume for the procedures

for changing the system time.

5 The acoustic lens surface of the transducer should not be unusually hot.

(Perform check by hand.)

6 Switches and knobs on the panel should function normally.

7 There should be no abnormality in the color or display position of images

output on a printer or recorded on a video recording unit.



No. 2B771-004EN*M

8-2

NOTE: IQ Report Feature

If an error message appears or an image with unsatisfactory quality is displayed, use the IQ Report feature to save the image and the system information.

<<Quick Procedure>>

* If it is not possible to perform the operation above (the menu pane is not

displayed, etc), perform the following operation.

+ +

After the operation above is completed, contact your TOSHIBA service

representative.

No. 2B771-004EN*M

8-3

9. Turning the Power ON/OFF

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. 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.

3. A functional ground terminal ( ) is used to connect a

4. Use a separate socket with an appropriate rated capacity

for the supply of power to this system.

5. Do not connect this system to an outlet that shares a

No. 2B771-004EN*M

9-1

WARNING: 6. 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.

9.1 Connecting the Power Cable and the Protective Grounding

(1) Connect the power plug to an outlet for medical equipment. By doing this, the

protective ground line is connected.

(2) Turn ON the main power switch on the power panel.

The [STANDBY] LED lights.

 Systems with the main power switch on the rear

No. 2B771-004EN*M

9-2

 Systems with the main power switch on the side

No. 2B771-004EN*M

9-3

9.2 Turning ON the Power

CAUTION: 1. Do not disconnect the power plug while the system is starting up.

Doing so may cause the system to malfunction.

2. 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.

If the power is not turned ON after holding down for 5 seconds 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.

NOTE: 1. If the power is turned ON while a USB device, such as a flash drive, is

connected to one of the five external USB connectors, the system may not start normally. Disconnect any USB device(s) before turning the power ON.

2. When turning ON the power, confirm that the [STANDBY] LED is lit and

then press .

3. Do not operate the operating panel switches or keyboard while the system

is starting up. The system may not start up normally.

4. After the main power has been turned OFF on the power panel, wait for at

least for 15 seconds before turning the power ON again. If the main power switch is turned ON immediately after the power has been turned OFF, the system may malfunction.

No. 2B771-004EN*M

9-4

NOTE: 1. For a cold boot, the time required to display the ultrasound image is usually

approximately 3 minutes, but varies according to the system conditions.

2. If the registration screen is closed without registering any patient data, the

2D mode screen appears and the system enters Freeze mode.

3. Directly after the system power is turned ON, the fan noise is initially loud

but reduces after a short while.

No. 2B771-004EN*M

9-5

9.3 Turning the Power OFF

CAUTION: 1. If the power cannot be turned OFF by the normal procedure, press and

hold down for at least 5 seconds. If the power is still not turned

OFF, turn OFF the main power switch on the power panel. These methods should not be used under normal conditions. They may damage the system.

2. Do not turn OFF the power while printing or data saving or retrieval is in

progress. Doing so may result in printing being terminated prematurely or in data being lost. Also, if the power is turned OFF during access to media, the media may be damaged.

3. Do not turn the system power OFF during video recording. Doing so

may damage the hard disk of the video recording device or the inserted media.

NOTE: If the power is turned OFF while a USB device, such as a flash drive, is

connected to one of the five external USB connectors, the system may not shut down normally. Disconnect any USB device(s) before turning the power OFF.

No. 2B771-004EN*M

9-6

NOTE: 1. If the system is unlikely to be used for a long period after the power is

turned OFF, turn OFF the main power switch on the power panel and then unplug the power cable.

2. If the power cannot be turned OFF by following the normal procedures, 2D

mode images may not be displayed when the system power is turned ON again. In this case, perform the following procedures:

 Shut down the system and turn OFF the main power switch on the

power panel on the rear of the system.

 Wait for at least 15 seconds, turn ON the main power switch on the

power panel, and then turn ON the power again.

3. After the main power has been turned OFF on the power panel, wait for at

least 15 seconds before turning the power ON again. If the main power switch is turned ON immediately after the power has been turned OFF, the system may malfunction.

4. The following message may be displayed during operation.

This message indicates that a problem has occurred with the patient data

handling functions (image storage, playback, or deletion) and that the system has entered restricted operation mode to protect the data. In restricted operation mode, do not use the Store, Exam Review, or Patient Browser functions. If these functions are used, the patient data handling functions cannot be performed. Reboot the system as soon as the current examination is completed.

Note that the message can be cleared by clicking [Close] and scanning can be performed normally.

No. 2B771-004EN*M

9-7

NOTE: 5. When [Shutdown] is selected in the [Power Control] dialog during

copying of patient data, transfer of patient data, or burning of patient data onto a CD/DVD, the following dialog is displayed.

No. Item Function

[Continue]

<1>

[After procs end]

<2>

[Save procs]

<3>

[Cancel]

<4>

The current process is terminated and the shutdown process is started. If this is selected during CD/DVD burning, the burn process is canceled (the CD/DVD will be damaged) and the shutdown process is started.

The shutdown process is started after the current process is completed.

The current process is paused (resumed) and the shutdown process is started. If this is selected during CD/DVD burning, the burn process is canceled (the CD/DVD will be damaged) and the shutdown process is started.

The dialog is closed and the current process is continued.

No. 2B771-004EN*M

9-8

9.4 Standby Mode

Standby mode is a function for suspending system operation without shutting down the system completely.

CAUTION: 1. Do not set the system to Standby mode while printing or data saving or

retrieval is in progress. Doing so may result in printing being terminated prematurely or in data being lost. Also, if the power is turned OFF during access to media, the media may be damaged.

2. Do not set the system to Standby mode during video recording. Doing

so may damage the hard disk of the video recording device or the inserted media.

9.4.1 Setting Standby mode

No. 2B771-004EN*M

9-9

NOTE: 1. A message recommending standard power OFF (shutdown) is displayed in

the following cases.

 The continuous power ON time*1 has exceeded 48 hours or the

cumulative power ON time*2 has exceeded 3.5 days (84 hours). Displayed message: [Due to the length of elapsed time since Startup, Shutdown is recommended.]

 The system has been started up from Standby mode 7 times or more

continuously. Displayed message: [Overuse of resume. Shutdown is

recommended.]

2. In the following cases, a message is displayed and the Standby function

cannot be used. Turn the system power OFF in standard mode (shutdown).

 The continuous power ON time*1 has exceeded 96 hours or the

cumulative power ON time*2 has exceeded 5 days (120 hours). Displayed message: [Due to the length of elapsed time since Startup, select Shutdown or Cancel.]

 The system has been started up from Standby mode 10 times or more

continuously. Displayed message: [Overuse of resume. Select Shutdown or Cancel.]

*1: This is the cumulative time for which the system has been used

continuously.

*2: When Standby mode is used, this is the cumulative time for which the

system power has been ON after the system power was last turned ON in standard mode (the standby periods are not included).

3. The standby function cannot be used in the following cases. In such

cases, the message shown below is displayed. When the use of these functions is completed or terminated, the Standby function becomes effective again. Note that if any settings of the functions have been changed, the system power should be turned OFF in standard mode (shutdown).

 When using a maintenance function or a preset function

Displayed message: [You can only select shutdown from

maintenance menu.]

 When a USB flash drive is connected

Displayed message: [Standby is disabled while the USB flash drive is connected.]

4. If the main power switch on the power panel is turned OFF or the system

power cable is disconnected while the system is in Standby mode, Standby mode is canceled and the system is started up in standard power ON mode. If the battery kit (option) is installed, Standby mode is maintained even when the main power switch on the power panel is turned OFF during Standby mode. If the battery level is low, however, the system is started up in standard power ON mode when it recovers from the Standby status.

 If the battery kit is installed, the battery is charged automatically while the

main power switch on the power panel is ON.

 The battery is intended to maintain the memory that stores system

information required for the Standby function. The system cannot be started up using the battery only.

 Contact your TOSHIBA service representative for the battery kit.

No. 2B771-004EN*M

9-10

NOTE: 5. Do not connect a USB device such as a flash drive to any of the external

USB connectors (the system is provided with five USB connectors) when the system is in the Standby status. Doing so may result in the system not starting up normally from the Standby status.

9.4.2 Recovery from the Standby status

CAUTION: 1. Do not disconnect the power plug from the outlet while the system is

resuming after being paused. The system may malfunction.

2. 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.

If the power is not turned ON after holding down for 5 seconds 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.

NOTE: 1. When resuming the system from pause status, confirm that the

[STANDBY] LED is blinking and then press .

2. Do not operate the operation panel switches or keyboard while the system

is recovering from Standby status. The system may not start up normally.

3. Normally, the ultrasound image is displayed approximately 1 or 2 minutes

after the power switch is pressed in the standby status; however, the actual time required varies depending on the system status.

No. 2B771-004EN*M

9-11

NOTE: 4. Directly after the system power is turned ON, the fan noise is initially loud

but reduces after a short while.

5. Rarely, the message shown below may be displayed when an attempt is

made to start the system from the Standby status. In such cases, select [OK] to close the message dialog. Then shut down the system and start it up again. Displayed message: [The system failed to start. Please restart the

system. Error code: XXX]

6. After the main power has been turned OFF on the power panel, wait for at

least 15 seconds before turning the power ON again. If the main power switch is turned ON immediately after the power has been turned OFF, the system may malfunction.

9.5 Preparation for Use During Surgery or for Emergency Cases

WARNING: Prepare a backup system when an urgent examination is to

be performed, for example during an operation or for an emergency case. If a severe problem should occur with the system, the normal operation of the system may not be recovered by turning the power OFF/ON and the examination may not be able to continue.

9.5.1 Preparation of a backup system

Prepare a backup system when an urgent examination is to be performed (for example, examination during emergency surgery).

9.5.2 Power OFF/ON in the case of system failure

When any of the following abnormalities occurs in the system, recovery may be possible by turning the system power OFF/ON.

 An error message is displayed and does not disappear.

 The screen display is abnormal.

 System operations are disabled.

If the system is still abnormal even after power OFF/ON, use the backup system.

NOTE: When turning ON the power, confirm that the [STANDBY] LED is lit and then

press .

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10. Basic Screen and Menu

10.1 Display of Various Data Items

In addition to ultrasound images, various data items are displayed on the monitor.

This section describes the screen display common to all modes. Refer to section 14 "Display and Operation in Each Mode" for the display specific to each mode.

CAUTION: The free space on the hard disk is displayed at the top of the

screen as " ". If there is less than 35 GB of free space, the icon is highlighted in yellow. The color of the free space

indicator changes to red when the free space falls below 20 GB. When the free space falls below 1 GB, the message [HDD is full. Please delete some images in Patient Browser and try again.] is displayed in the information message display area on the screen and no more data can be stored. Delete unnecessary data before saving new data.

* For the data deletion procedure, refer to section 2 of the

operation manual, Applications volume.

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CAUTION: When

system is ready to output images to the printer. Confirm that printing is completed by checking the printed images output from the printer. Note that if the next print operation is performed while this icon is lit, the next image is not printed. Wait until the icon goes out before performing the next print operation.

at the bottom left of the screen lights, it indicates that the

10.2 Displaying the Acoustic Power Data

The acoustic power data transferred from the transducer is displayed in the image display area and in the acoustic power display area.

NOTE: Whether or not the acoustic power data is displayed depends on the mode. If

the value is low, display is not performed.

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No. Label Description Display location

<1> [AP] Acoustic power

The current transmission value (%) is displayed.

<2> [TIS] Thermal index soft tissue

Displayed as the calculated/estimated value for temperature increase in the soft tissues.

<3> [TIB] Thermal index bone

Displayed as the calculated/estimated value for temperature increase in the cranial bones of a fetus or newborn child.

<4> [MI] Mechanical index

Displayed as the value related to the mechanical effectiveness such as cavitation.

No. Label Description Display location

<1> [AP] Acoustic power

The current transmission value (%) is displayed.

<2> [TISm] Thermal index soft tissue

Displayed as the calculated/estimated mean value for temperature increase in the soft tissues.

Acoustic power display area

Image display area

Acoustic power display area

<3> [TIBm] Thermal index bone

Displayed as the calculated/estimated mean value for temperature increase in the cranial bones of a fetus or newborn child.

<4> [MIm] Mechanical index

Displayed as the mean value related to the mechanical effectiveness such as cavitation.

Image display area

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10.3 Thumbnail Display

The thumbnails representing the data acquired in the current study are displayed in the thumbnail area.

If previous study datasets for the same patient are present in the HDD, the study dates and exam types of these datasets are displayed in the study area. When a study date is clicked, the thumbnails representing the data for that date are displayed.

The system recognizes different studies as belonging to the same patient when all of the following items in the studies match.

Patient ID

Patient name

Sex

If any of these items do not match and the studies are therefore not recognized as belonging to the same patient, the patient information edit function (refer to subsection

2.2.6 of the operation manual Applications volume) of the [Patient Browser] can be used to make the system recognize these studies as belonging to the same patient.

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11. Starting an Examination

CAUTION: 1. 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. Enter the height and the weight correctly. Otherwise, the

BSA may be calculated incorrectly.

3. Check the date format before entering the date of birth.

Otherwise, the age may be calculated incorrectly.

NOTE: 1. Be sure to register and save the patient ID before starting an examination

for a new patient. If measurement is performed for a new patient for whom the patient ID has not been registered or saved, the measurement results and other data cannot be saved in the system.

2. Periodically back up the saved data (image data and exam history) to

external storage media. Data stored in the system may be deleted as a result of an operational error or an accident (problems that occur in personal computers can also occur in this system).

3. Delete unnecessary data regularly. If the available storage space is low,

new data may not be saved.

4. Before deleting data, confirm the date and the patient ID, patient name,

etc. to ensure that incorrect data is not deleted.

5. If patient data or exam data is to be modified, confirm that the modifications

are correct before saving them. Once the data is saved, the previous data cannot be restored.

6. If the rows of the History data in the patient data entry screen are switched,

turn ON the system again.

7. When the patient information is registered and is then

selected, the live image is normally displayed within 10 seconds. However, if relatively high-load processing (such as saving, loading, copying, or conversion of a large amount of data) is performed immediately before this, it may take approximately 30 seconds to display the live image. If the live image is not displayed after 30 seconds, an error message is displayed. Reboot the system.

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11.1 Entering and Saving Data on the [Patient Registration] Screen

Start the exam by entering the patient details on the [Patient Registration] screen.

<<Exam types>>

Dropdown list item Exam type Dropdown list item Exam type

[Abdomen] Abdomen general [Neo-Head] Neonatal head

[Carotid] Carotid arteries [Neo-General] Neonatal abdomen

general

[Thyroid] Thyroid glands [Neo-Hip] Neonatal hip joints

[Breast] Breast, including

mammary glands

[OB] Obstetrics [PV-Arterial] Peripheral blood vessels

[GYN] Gynecology [Digits] Peripheral blood vessels

[Endo-Vaginal] Endovaginal [MSK] Musculoskeletal

[Fetal Heart] Fetus cardiovascular [Prostate] Prostate gland

[Adult Heart] Cardiovascular [Kidney] Kidneys

[Pediatric Heart] Pediatric cardiovascular [Testes] Testes

[Coronary] Coronary arteries [OTHER] Others

[TCD] Transcranial Doppler [M-TEE] Transesophageal

[PV-Venous] Peripheral blood vessels

(veins)

(arteries)

(fingers and toes)

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NOTE: 1. The ID and name are displayed as "date + unique character string".

If more than one system is used at the site, be sure to set a unique character string so that the system can be identified.

2. Do not enter a patient ID consisting of spaces only. The examination will

not start.

3. Equations for calculating BSA (body surface area)

BSA (m2) is calculated when patient height (cm) and weight (kg) are

entered on the [Patient Registration] screen.

The following expressions are available for calculating BSA. The desired expression can be selected from a pull-down menu.

(a) Occidental

BSA = 0.007184  Height

0.725

 Weight

0.425

(b) Oriental (Adult)

BSA = 0.007358  Height

0.725

 Weight

0.425

BSA = 0.010265  Height

0.651

 Weight

0.423

(d) Oriental (6-11)

BSA = 0.008883  Height

0.663

 Weight

0.444

(e) Oriental (1-5)

BSA = 0.038189  Height

0.362

 Weight

0.423

(f) Oriental (0)

BSA = 0.009568  Height

0.655

 Weight

0.473

4. It is also possible to enter the year of a date of birth using the Japanese

calendar (combination of the era name "M (Meiji)", "T (Taisho)", "S (Showa)", or "H (Heisei)" and the year in the era). The entered year is converted into the corresponding Western calendar year and displayed.

<<Example>>

If "S42" is entered ············ The year is displayed as 1967.

5. When settings are added or deleted for any of the following items, the

changes are applied only after the system is rebooted.

 [Operator]

 [Physician]

 [Ref. Physician]

 [Department]

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NOTE: 6. If the patient's date of birth has not been entered on the [Patient

Registration] screen, the date of birth is not displayed in the [Comment]

field in the [Patient Info] display of [Patient Browser], [History Browser], or the patient/exam information editing form.

7. The start function, which is normally assigned to , can be assigned to

any other function key ( ) on the keyboard. To change key

assignments, contact your TOSHIBA service representative.

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12. Reference Signal Display

In the 2D, M, or M+2D (including Doppler) display modes, it is possible to display up to two types of reference signals of the electrocardiogram (ECG), the phonocardiogram (PCG), etc. This feature is optional.

WARNING: 1. For protection against electric shock, confirm the

following items before use:

 There are no abnormalities in the reference signal

cables.

 The cable combination used is correct.

* The reference signal cable supplied with the

UJUR-A500A is used.

2. Connect the reference signal cables to the system before

setting the ECG electrodes on the patient. Do not touch any conductive areas, including the grounding, while ECG electrodes are attached to the patient. If an electrode or a reference signal cable connector touches any conductive area, including the grounding, the patient might be electrocuted.

3. Do not allow the ECG electrode to touch the patient's

heart directly. Doing so may lead to cardiac arrest.

* The ECG unit is a type BF unit. It is not designed for

direct contact with the heart.

4. Use commercially available ECG electrodes. The user is

responsible for selection of appropriate ECG electrodes.

5. Remove the ECG electrodes from the patient before using

CAUTION: Information derived from reference signals should be used

purely for reference. Do not use the waveforms or other reference signal information for diagnosis or monitoring. Note also that in patients with cardiac pacemakers or implantable electrostimulators and in patients with arrhythmia, the heart rate may not be calculated correctly.

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NOTE: Changing the lead type by changing the reference signal cable connections without

using the ECG Lead function

1. The relationships between the lead wire colors of the reference signal cable and the

electrode positions are described below.

For regions other than the USA

Electrode positions (lead I)

Three electrode leads Electrode positions

Symbol

R Red Right infraclavicular fossa

L Yellow Left infraclavicular fossa

F Green Lowest rib on the left

Lead color (clip color)

Application position

anterior axillary line

To use lead II or lead III, connect the lead wires of the reference signal cable to the

electrodes as shown below.

2. This system is designed to use ECG lead I. To use lead II or lead III, the lead colors

and the connection destinations differ from the standard arrangement.

To display both the ECG waveform and the respiratory waveform (using the reference signal cable), use lead I.

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NOTE: Changing the lead type by changing the reference signal cable connections without

using the ECG Lead function

1. The relationships between the lead wire colors of the reference signal cable and the

electrode positions are described below.

For the USA

Electrode positions (lead I)

Three electrode leads Electrode positions

Symbol

RA White Right infraclavicular fossa

LA Black Left infraclavicular fossa

LL Red Lowest rib on the left

Lead color (clip color)

Application position

anterior axillary line

To use lead II or lead III, connect the lead wires of the reference signal cable to the

electrodes as shown below.

2. This system is designed to use ECG lead I. To use lead II or lead III, the lead colors

and the connection destinations differ from the standard arrangement.

To display both the ECG waveform and the respiratory waveform (using the reference signal cable), use lead I.

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12.1 Reference Signal Panel

CAUTION: 1. Do not connect any medical device that is not fully

compliant with IEC 60601-1 to [ECG DC IN] or [AUX]. Doing so may result in an electric shock.

2. If external signals are to be input to [ECG DC IN] or [AUX],

contact your TOSHIBA service representative. The signal input level is restricted.

No. Name Function

<1> [ECG] (patient) Connector for ECG cord (this cord can also be used as

an impedance respiratory sensor)

<2> [ECG DC IN] Connector for ECG signal input from an external monitor

<3> [AUX] Connector for signal input from an external device

<4> [PULSE] Connector for pulse wave sensor signal input

<5> [PCG] (input) Connector for heartbeat sensor signal input

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12.2 Installing the Reference Signal Sensor

(1) Connect the reference signal sensor cable to the reference signal panel while the

system power is OFF.

(2) Turn ON the power.

(3) Set the sensor on the patient.

12.3 Adjusting Reference Signals

(1) [PHYSIO] menu and reference signal display

* Up to two reference signals can be displayed simultaneously.

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(2) Adjusting the reference signal display

The position of the waveform and the gain can be adjusted using the switches in the [PHYSIO] menu on the touch panel and the relevant knobs.

[PHYSIO] page 1/2

[PHYSIO] page 2/2

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NOTE: [PACE MAKER] switch

1. When a patient with a cardiac pacemaker is examined, the pacing pulses

generated by the pacemaker may be incorrectly recognized as the R-wave signals, and as a result, ECG gating or heart rate counting may not be performed correctly.

When the [PACE MAKER] switch is set to ON, the pacing pulses and

R-wave signals can be distinguished, allowing ECG gating and heart rate counting to be performed based on the R-wave signals. However, even when the [PACE MAKER] switch is set to ON, ECG gating or heart rate counting may be performed based on the pacing pulses depending on the particular pacemaker or patient.

Diagnosis should be performed based on a comprehensive assessment of

all available information, including the displayed waveforms.

2. When examining a patient with strong R waves, the system may

mistakenly recognize these R waves as pacing pulses. If this is the case, set the [PACE MAKER] switch to OFF.

No. Menu Function

<1>

<2>

<3>

<4>

<5>

<6>

<7>

<8>

Used to turn the ECG waveform display ON/OFF.

Used to turn the PCG waveform display ON/OFF.

Used to turn the display of signals from external devices ON/OFF.

Used to avoid incorrect R-wave trigger detection due to the pacing pulses generated by a cardiac pacemaker (when examining patients with cardiac pacemakers).

Used to invert the ECG waveform. This switch is effective only in Real-time display mode.

Used to turn the respiratory signal display ON/OFF.

Used to turn the pulse signal display ON/OFF.

[MANUAL]: The gain of ECG, AUX, PULSE, RESP, or

[AUTO]: The gains of these signals are all adjusted

PCG (<16> to <20>) is adjusted individually.

at the same time. The [ECG GAIN] switch changes to

[AUTO GAIN], and the [PCG Gain], [RESP Gain], [Pulse Gain], and [AUX Gain] switches are disabled.

<9>

<10>

Used to reset the ECG waveform to the reference position when the ECG waveform is disturbed.

Used to adjust the baseline position of the ECG waveform.

No. 2B771-004EN*M

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No. Menu Function

<11>

<12>

<13>

<14>

<15>

<16>

<20>

<21>

[AUX/Pulse/RESP/ PCG/ECG GAIN]

Used to adjust the display position of the signal from the external device.

Used to adjust the display position of the peripheral pulse signals.

Used to adjust the display position of the respiratory signals.

Used to adjust the display position of the PCG waveform.

Used to adjust the display position of the ECG waveform.

Used to adjust the sensitivity of the displayed signal. This switch is effective only when [MANUAL] is selected for [GAIN MODE].

Used to change the ECG lead type. Note that for the lead type to be changed correctly by this function, the electrodes must be applied as follows.

For regions other than the USA

Red : Right infraclavicular fossa Yellow : Left infraclavicular fossa Green : Lowest rib on the left anterior axillary line

For the USA

White : Right infraclavicular fossa Black : Left infraclavicular fossa Red : Lowest rib on the left anterior axillary line

<22>

<23>

Used to adjust the harmonic components of the phonocardiogram (0, 1, 2).

Used to close the menu.

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13. Common Operation for Each

Mode

13.1 Touch Panel Operation

CAUTION: Do not press two or more switches simultaneously. Doing so may cause

a system malfunction.

In this system, it is possible to change the switch layout on the touch panel and the knob operating directions. It is also possible to add customized menus (touch panel customization). Customization is performed by service personnel. Contact your TOSHIBA service representative.

NOTE: 1. To enter another mode, press the corresponding mode switch on the main

panel.

2. When several modes such as 2D, CDI, and PW are active at the same

time, switch the tab to change the parameter as needed.

3. In Freeze mode, the switches that are disabled are grayed out.

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Using the knobs

The knobs corresponding to the icons displayed in the function menus can be used for setting as explained below.

Icon Knob operation direction

Tab functions

Tab Function

Left/right

Up/down

Rotate

Includes presets which can be selected in order to change their settings.

Includes menus related to image saving and printing.

Includes optional functions and menus such those related to screen brightness and sound volume.

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PIMS menu

[PIMS] page 1/2

No. Switch Function

<1>

<2>

<3>

<4>

<5>

<6>

<7>

<8>

Turns the display of the [Patient Registration] screen ON/OFF.

Ejects the media from the CD/DVD unit.

Ejects the media from the peripheral unit.

Turns the display of patient information ON/OFF. It is possible to set the system not to display the patient information (patient ID, name, sex, age, name of the system used to acquire the data, date and time, hospital name). Refer to subsection 22.2.1 of the operation manual <<Applications volume>>.)

Turns the display of the [Exam Review] screen ON/OFF.

Disconnects USB flash drive.

Displays the video playback menu.

Used for full-screen printing.

<9>

Used to transfer data to the DICOM printer.

Refer to section 19 "Storing Image Data" for other functions provided in the PIMS menu.

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[PIMS] page 2/2

Refer to section 19 "Storing Image Data".

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Operations from the touch panel ([OTHER] tab menu)

[OTHER] page 1/3

No. Switch Function

<1>

<2>

<3>

<4>

<5>

<6>

Resets the settings of Scan Range, Color ROI, and Doppler range gate position in 2D mode or volume display in 4D mode to the initial values during measurement or imaging.

Displays the cursor on the monitor.

Used to select the image zooming method (Center or Spot). * Refer to subsection 14.1.4 for details.

Displays the [PHYSIO] menu.

Used to adjust the brightness and contrast of the touch panel.

* Press the corresponding knob to toggle the label of this

switch between [TCS Brightness] and [TCS Contrast].

Used to adjust the volume and tone of the beep that is output when a switch on the main panel is pressed.

* Press the corresponding knob to toggle the label of this

switch between [Panel Beep Volume] and [Panel Beep Tone].

<7>

<8>

Used to adjust the volume and tone of the beep that is output when a printing, storage, or video recording operation is performed.

* Press the corresponding knob to toggle the label of this

switch between [Output Beep Volume] and [Output Beep Tone].

Switches the exam image display area on the monitor (normal/expand).

No. 2B771-004EN*M

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[OTHER] page 2/3

No. Switch Function

<1>

<2>

<3>

<4>

<5>

<6>

Updates the gain offset values set with the STC sliders during Quick Scan.

Resets the gain offset values updated using [Q. Scan Comp Update] to the values immediately after Quick Scan was started.

Displays the angle icon for the M-TEE transducer.

* This switch is displayed when an M-TEE transducer is

connected to the system.

Displays the [Maintenance] menu.

Displays the menu for setting the presets.

Saves the error messages and abnormal images. (This switch should be pressed when an error message or an abnormal image is displayed.)

No. 2B771-004EN*M

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[OTHER] page 3/3

No. Switch Function

<1>

<2>

Starts up the [Report] screen.

Starts up the [Worksheet] screen.

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13.2 Trackball Functions

Functions corresponding to the system status are assigned to the trackball.

13.2.1 Trackball function area

The icon indicating the function currently assigned to the trackball (function icon) is displayed on the monitor.

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13.2.2 Trackball operations

When multiple functions are available

Press

To assign a function to the trackball that is not shown in the trackball function

area

Directly press the switch for the desired function.

To set the trackball back to the cine control function

Press the wheel.

To perform measurement

Directly press the switch for the desired function.

or to select the function to be used.

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13.3 Selecting an Imaging Preset During Examination

Imaging preset: Preset of the parameters related to image quality

To select an imaging preset

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To change the image quality conditions for the currently active mode (sub-

preset) only

Switch displays

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13.3.1 [DEFAULT PRESET] tab

Imaging presets with default settings (factory defaults) can be selected.

[DEFAULT PRESET] page 1/3

No. Exam type Description

<1> [Abdomen] Abdomen general

<2> [OB] Obstetrics

<3> [Prostate] Prostate gland

<4> [PV Arterial] Peripheral vessel (artery)

<5> [Neo-Head] Infant head

<6> [Neo-Hip] Infant hip joint

<7> [Endo-Vaginal] Endovaginal

<8> [Digits] Peripheral vessel (of finger)

<9> [Neo-General] Infant abdomen general

<10> [Fetal Heart] Fetal circulation

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Toshiba Aplio 500 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Organization of the Operation Manuals

1. Intended Use

1.1 Intended Medical Use

1.2 Intended Patient Information

1.3 User Profile

1.4 Operating Principles

2. General Safety Information

2.1 Meaning of Signal Words

2.2 Meaning of Safety Symbols

2.3 Ensuring the Safety of Patients and Operators

2.4 Preventing Electric Shocks, Fires, and Power Supply Interruptions

2.5 Chemical Hazard

2.6 Electromagnetic Compatibility (EMC)

2.7 Acoustic Power

2.8 Preventing System Malfunctions

2.9 Handling Patient and Image Data

2.10 Warning Labels

2.11 Regulatory Labels

2.12 Precautions Concerning Clinical Examination Techniques

3. General Information on Usage and Maintenance

4. Use Conditions

4.1 Power and Environmental Requirements

4.2 Environmentally Friendly Usage and Maintenance Management

5. System Configuration

5.1 Standard Configuration

5.2 List of Optional Units

5.3 Compatible Peripheral Devices

5.4 External Storage Devices

5.5 List of Optional Software

5.6 List of Available Transducers

6. Names and Functions of Each Section

6.1 Name of Each Section

6.2 Main Panel

6.3 Rear Panel

6.4 Symbols

7. Preparation for Examination

7.1 Moving and Installing the System

7.2 Handling and Connecting/Disconnecting the Transducer

7.2.1 Handling the transducer

7.2.2 Connecting/Disconnecting the transducer

7.3 Adjusting the Main Panel

7.4 Adjusting the Monitor

7.4.1 Locking and releasing the monitor

7.4.2 Adjusting the angle of the monitor

7.4.3 Adjusting the monitor display

8. Checks Before and After Use

8.1 Checks Before Turning ON the Power

8.2 Checks After Turning ON the Power

9. Turning the Power ON/OFF

9.1 Connecting the Power Cable and the Protective Grounding

9.2 Turning ON the Power

9.3 Turning the Power OFF

9.4 Standby Mode

9.4.1 Setting Standby mode

9.4.2 Recovery from the Standby status

9.5 Preparation for Use During Surgery or for Emergency Cases

9.5.1 Preparation of a backup system

9.5.2 Power OFF/ON in the case of system failure

10. Basic Screen and Menu

10.1 Display of Various Data Items

10.2 Displaying the Acoustic Power Data

10.3 Thumbnail Display

11. Starting an Examination

11.1 Entering and Saving Data on the [Patient Registration] Screen

12. Reference Signal Display

12.1 Reference Signal Panel

12.2 Installing the Reference Signal Sensor

12.3 Adjusting Reference Signals

13.1 Touch Panel Operation

13.2 Trackball Functions

13.2.1 Trackball function area

13.2.2 Trackball operations

13.3 Selecting an Imaging Preset During Examination

13.3.1 [DEFAULT PRESET] tab