SSA-530A

No. 2B730-670E

OPERATION MANUAL FOR DIAGNOSTIC ULTRASOUND SYSTEM

MODEL SSA-530A [FUNDAMENTALS] (2B730-670E)

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

 TOSHIBA MEDICAL SYSTEMS CORPORATION 2004 ALL RIGHTS RESERVED

Introduction This operation manual describes the operating procedures for the diagnostic ultrasound system SSA-530A. To ensure safe and correct operation of the system, carefully read and understand the manual before operating the system.

IMPORTANT! 1. No part of this manual may be copied or reprinted, in whole or in part, without written permission. 2. The contents of this manual are subject to change without prior notice and without our legal obligation.

No. 2B730-670E C-1

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REVISION RECORD REV.

INI.

DATE (MM/YY)

04/'04

REASON /AUTHOR Mr. Matsumoto

PAGE CHANGED -------

SER. No.

DOC. PRODUCT.

TM-WI2

No. 2B730-670E R-1

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Intellectual Property Availability of This Software and Related Documents is Restricted. The software used for this system is licensed to Toshiba Medical Systems Corporation by a Licensor. (1) The software and related documents must be used only for this system. (2) The intellectual property of this software and related documents is not assigned to you. (3) You must not copy the software or documents, nor modify the software in whole or in part. (4) You must not recompile or reassemble the software. (5) You must not assign, disclose, transfer, or sublicense the software or documents to a third party. (6) The software is subject to the U.S. and Japanese Export Administration Laws and Regulations and you must not export or re-export the software in whole or in part unless properly authorized by the U.S. or Japanese government. (7) The information in the documents, or programs in the software are subject to change without notice.

No. 2B730-670E L-1

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Organization of the Operation Manuals 1.

Notation Conventions

In this operation manual, the following words are used in addition to the signal words related to the safety precautions (refer to "Safety Precautions"). Please read this operation manual before using the system. NOTE:

2.

Indicates information of interest to users of system as to exceptional conditions or operating procedures.

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. The organization of the documents supplied with this system is shown below:

Main unit operation manual

Describes detailed system information on preparation, operating procedures, maintenance checks, and functions.

Transducer operation manuals

Describe the operating and sterilization procedures for transducers.

NOTE:

For certain applications, the following manuals are available in English: • 2B730-672E (Application volume) • 2B730-674E (Acoustic power data)

No. 2B730-670E U-1

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Table of Contents Introduction ......................................................................................................................C-1 Intellectual Property ................................................................................................... L-1 Organization of the Operation Manuals ......................................................U-1 Safety Precautions ......................................................................................................S-1 Important Information ..............................................................................................W-1

Outline of the SSA-530A 1.

Intended Use and Specifications ........................... 1-1

1.1

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

1.2

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

2.

System Configuration ........................................................... 2-1

2.1

Standard Configuration....................................................................... 2-1

2.2

List of Optional Devices ..................................................................... 2-1

2.3

List of Available Transducers ........................................................ 2-2

3.

System Overview ......................................................................... 3-1

3.1

Name of Each Part .................................................................................. 3-1

3.2

Main Panel..................................................................................................... 3-2

3.3

Side Panel ..................................................................................................... 3-4

3.4

Rear Panel ..................................................................................................... 3-5

3.5

Power Panel ................................................................................................. 3-6

3.6

Symbols .......................................................................................................... 3-7

No. 2B730-670E -a-

Operation 4.

Preparation for Examination ........................................ 4-1

4.1

Moving the System ................................................................................. 4-1

4.2

Connecting the Transducer ............................................................. 4-2

5.

Connecting the Power Cable and Protective Earth ................................................................ 5-1

6.

Power ON/OFF ................................................................................. 6-1

6.1

Power ON ....................................................................................................... 6-1

6.2

Power OFF .................................................................................................... 6-1

6.3

Preparation for Use During an Operation or for Emergency Cases ........................................... 6-2

7.

Checks Before and After Use ..................................... 7-1

7.1

Check Before Turning ON the Power ....................................... 7-1

7.2

Check After Turning ON the Power ............................................ 7-2

8.

Basic Screen and Menu ...................................................... 8-1

8.1

Display of Various Data Items ........................................................ 8-1

8.2

Display and Operation of the Menu ........................................... 8-2

9.

Entering the Patient ID ......................................................... 9-1

9.1

Entering and Saving Data on the Patient ID Registration Screen ...................................................... 9-2

9.2

Sorting and Calling a Patient ID.................................................... 9-4

9.3

Deleting Saved Patient IDs ............................................................... 9-4

No. 2B730-670E -b-

10.

Selecting Presets ....................................................................... 10-1

10.1

Introduction................................................................................................ 10-1

10.2

Procedure for Selecting Presets ................................................ 10-1

11.

Display and Operation in Each Mode ............ 11-1

11.1

B Mode ........................................................................................................... 11-1

11.2

M Mode .......................................................................................................... 11-5

12.

Cine Function.................................................................................. 12-1

12.1

Introduction................................................................................................ 12-1

12.2

Cine Playback ........................................................................................... 12-1

13.

Display of Reference Signals.................................... 13-1

13.1

Display Procedures .............................................................................. 13-1

13.2

Adjustment of Reference Signals .............................................. 13-2

14.

Body Mark Entry and Deletion ................................ 14-1

14.1

Display of a Body Mark ..................................................................... 14-1

14.2

Selection of a Body Mark ................................................................. 14-1

14.3

Movement of the Transducer Mark........................................... 14-2

14.4

Movement of the Body Mark.......................................................... 14-2

14.5

Deletion of the Body Mark............................................................... 14-2

15.

Entry and Deletion of Comments ........................ 15-1

15.1

Entry from the Keyboard .................................................................. 15-1

15.2

Entry of Registered Comments ................................................... 15-1

No. 2B730-670E -c-

15.3

Entry of the Arrow Mark .................................................................... 15-2

15.4

Entry of Gender Symbols ( , ) ................................................... 15-2

15.5

Moving the Selected Comment ................................................... 15-3

15.6

Correcting the Comments ............................................................... 15-3

15.7

Deletion of the Selected Comment ........................................... 15-3

15.8

Deletion of All Comments ............................................................... 15-4

15.9

Initial Cursor Display Position Setting .................................. 15-4

16.

Needle Mark Display .............................................................. 16-1

16.1

Display Method ........................................................................................ 16-3

16.2

Adjustment of the Needle Mark Angle ................................... 16-4

16.3

Display/Hiding of Biopsy Range Marks ................................ 16-4

16.4

Selection of the Biopsy Guide Size .......................................... 16-4

16.5

Selection of the Biopsy Adaptor ................................................ 16-4

Measurements 17.

Measurement ................................................................................... 17-1

17.1

Basic Operation ...................................................................................... 17-1

17.2

B-mode Measurements ..................................................................... 17-2

17.3

M-mode Measurements ..................................................................... 17-3

General Information 18.

Output/Saving of Image Data .................................... 18-1

18.1

Data Archive to a CD-R...................................................................... 18-1

18.2

Data Archive to the DICOM Server ........................................... 18-2

18.3

Loading the Archived Data ............................................................. 18-3 No. 2B730-670E -d-

19.

Other Function .............................................................................. 19-1

19.1

Beep Tone Adjustment ...................................................................... 19-1

19.2

Adjustment of the Panel Backlight ........................................... 19-1

20.

Using MI/TI .......................................................................................... 20-1

20.1

Basic Knowledge of MI/TI ................................................................ 20-1

20.2

MI/TI Display Description ................................................................. 20-3

20.3

Parameters Affecting the MI/TI Values .................................. 20-3

20.4

Operating Procedures for MI/TI ................................................... 20-4

20.5

References for MI/TI ............................................................................. 20-5

21.

Maintenance Check ................................................................ 21-1

21.1

Maintenance Checks to Be Carried Out by Customers ................................................................................. 21-1

21.2

Maintenance Checks to Be Carried Out by Service Personnel ................................................................ 21-3

21.3

Consumable Parts and Parts Requiring Periodic Replacement ............................................... 21-3

22.

Checks Before the System Is Judged Defective ................................................................ 22-1

23.

Accuracy of Measurement ............................................ 23-1

24.

Conformance Standards ................................................. 24-1

25.

Safety Classification ............................................................. 25-1

No. 2B730-670E -e-

26.

Guidance and Manufacturer's Declaration.......................................................................................... 26-1

27.

Indication of Year of Manufacture ...................... 27-1

No. 2B730-670E -f-

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Safety Precautions 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

DANGER

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

WARNING

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

CAUTION

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

CAUTION

2.

Meaning

Meaning of Safety Symbols Symbol

Description Type-BF applied part ECG

:

Others :

Type-BF equipment Type-BF when Type-BF applied part is connected. All ultrasound transducers can be connected to this system are Type-BF applied part.

"Attention" (Refer to the operation manual.)

No. 2B730-670E S-1

3.

Safety Precautions

Please observe the following precautions to ensure patient and operator safety when using this system.

DANGER:

WARNING:

Do not use flammable gasses such as anesthetics, or flammable liquids such as ethanol, near this product, because there is danger of explosion.

1. Be sure to connect the power plug to a two-pin (with dual earth terminal) outlet meeting the ratings indicated on the rating nameplate. If this type of outlet is not available, contact your TOSHIBA representative. 2. Information concerning the terminal to which the potential equalization conductor is to be connected (

):

To use another medical device in combination with this system, an equipotential wire for connecting to an equipotential bus must be supplied. For more information, contact your TOSHIBA representative. *

Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle. Also, be sure to remove the equipment power plug from the receptacle before disconnecting the wire to avoid electrical shock.

3. Information concerning the functional earth terminal ( ): Use of the functional earth terminal is not allowed in Europe. The system should be connected according to local requirements. 4. Connect the earth conductor only before turning ON the system. Disconnect the grounding cable only after turning OFF the system. Otherwise, electric shock may result. 5. Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as lifesupport systems. If this system malfunctions and generates an overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped. 6. 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. 7. Do not connect to the system transducers other than those specified by TOSHIBA, to prevent accidents such as burns, electrical shock, or fire.

No. 2B730-670E S-2

WARNING:

8. Do not subject the transducers to knocks. Use of defective transducers may cause an electric shock. 9. Do not remove the covers or panels of the system, or electric shock may result. 10. Prolonged and repeated use of keyboards can result in hand or arm nerve disorders in some individuals. Observe the local institution work safety/health regulations on keyboard use. 11. When the optional ECG cable is used, the following measures are required. (1) To prevent electric shock, check the following items before operation. • There must be no abnormality of the ECG cable. • The ECG cable must be connected correctly. (2) Connect the ECG cable to the system before attaching the pick-up of the ECG to the patient. If the connector of the ECG cable comes into contact with live parts, the patient may receive an electric shock. (3) Do not place the ECG electrodes in direct contact with the patient's heart. Cardiac arrest may occur. *

The ECG electrodes are of the BF type and are not designed to be placed in direct contact with the heart.

(4) To reduce the risk of electric shock or burns, use only the cable and patient leads supplied with the reference signal unit . (5) The ECG electrodes used should be commercially available products provided by the customer. 12. Before using equipment such as an electric scalpel, highfrequency therapy equipment, a defibrillator, etc., remove the ECG electrodes from the patient. In addition, do not allow ultrasound transducers to come into contact with the patient. The patient may be burned or receive an electric shock. 13. 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 resetting the system and the examination may not be able to continue.

No. 2B730-670E S-3

CAUTION: 1. Precautions concerning clinical examination techniques (1) This system must be used only by medical personnel fully trained in clinical examination techniques. (2) 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. 2. Malfunctions due to radiowaves (1) Use of radiowave-emitting devices in the proximity of this kind of medical electronic system may interfere with its operation. Do not bring or use devices which generate radio waves, such as cellular telephones, transceivers, and radio controlled toys, in the room where the system is installed. (2) If a user brings a device which generates radio waves near the system, they must be instructed to immediately turn OFF the device. This is necessary to ensure the proper operation of the system. 3. Precautions concerning installation and movement of the system (1) Be sure to install the system on a level floor and lock the casters. If this is not done, the system may move, injuring the patient. (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) Do not sit on the system. The system may move, causing you to lose your balance and fall. (5) Do not place any objects on top of the monitor. They may fall, causing injury. (6) Confirm that the peripheral units are secured before moving the system. Otherwise, the peripheral units may fall and cause injury. (7) If the ECG cable is connected, disconnect it before moving the system. Otherwise, the cable may get caught in the casters or someone may trip over the cable and injury may result. (8) 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.

No. 2B730-670E S-4

CAUTION: 4. To prevent electric shock, do not connect the peripheral units (video printer, VCR, etc.) to an external outlet (except for Deskjet series printers). Peripheral units should be connected to the service outlet of the system. For the connection procedures, contact your TOSHIBA representative. In addition, be sure to use the cable supplied with the system to connect a Deskjet series printer. If a different cable is used, there is a risk of electric shock. 5. Before cleaning the system, be sure to disconnect the power cable from the outlet. If the system is defective, there is a risk of electric shock. 6. Do not allow fluids such as water to contact the system or peripheral devices. Electric shock may result. 7. Terminals and switches on the system rear panel (1) Only equipment that conforms to the safety standards must be connected to the ETHERNET terminal on the rear panel. Otherwise, smoke or an electric shock may result. (2) Turn OFF the system power before connecting or disconnecting the cable from the ETHERNET terminal. If the cable is connected or disconnected with the system power ON, the system may not operate properly. (3) When a HUB is used, turn ON the system power only after tuning ON the power to the HUB. (4) Do not press the RESET switch when the system is operating normally. Data loss or damage to the system may result. 8. In normal diagnostic ultrasound mode, there is no danger of a lowtemperature burn; however, keeping the transducer on the same region of the patient may cause such a burn. 9. If there is any possibility of secondary infection, cover the entire system with a sterile cover. To obtain a sterile cover, contact your TOSHIBA representative.

No. 2B730-670E S-5

CAUTION: 10. Precautions regarding patient information entry (1) Before examining a new patient, press

to delete the

patient information and data recorded in the image memory for the previous patient. Otherwise, the new data may be confused with the data of the previous patient. (2) If the patient information is modified by pressing

PATIENT ID

, the

patient information for the data already recorded in the image memory is not modified (the data recorded in the image memory is not deleted). Thus, if the data recorded in the image memory is that for the previous patient, images for the different patients will have the same patient information, and this may cause confusion. It a patient ID is to be changed, press

to delete the patient

information and data recorded in the image memory for the previous patient. Otherwise, the data belonging to the current patient may be confused with the data for the previous patient. (3) Confirm that the patient to be examined is the same as the patient ID. There is a possibility of recording images with incorrect patient IDs. (4) Enter the patient's height and weight correctly in the patient ID registration screen. If the entered height and weight are not correct, the BSA will be calculated incorrectly. (5) Enter the patient information including LMP and IVF correctly in the patient ID registration screen. Otherwise, the fetal growth data will be calculated incorrectly. 11. Do not turn OFF the power supply of the system during printing, data saving, or invoking. Doing so may cause these processes to not operate correctly. In addition, doing so during access to a CD-R or an HDD may damage these media. 12. When discarding any part of this system, follow all applicable local regulations.

No. 2B730-670E S-6

CAUTION: 1. Do not use this system in locations subject to intense electric or magnetic fields (near transformers, for example). In such locations, the monitor will be adversely affected. 2. Do not use this system near devices generating high frequencies (such as medical telemeters and cordless telephones). The system can malfunction or adversely affect such devices. 3. To prevent damage to the system, do not use it in: • • • • • • •

Locations where it may be exposed to direct sunlight Locations where it may be subject to sudden changes in temperature Locations that are dusty Locations where it may be subjected to vibrations Locations near heat generators Locations where the humidity may be high Locations where the air filter of the system is blocked (for example, near a wall or another unit)

4. Turn ON the system only after the power has been OFF for more than 5 seconds. If the system is turned ON immediately after being turned OFF, the system may malfunction. 5. Turn OFF the system subswitch or stop transmission by FREEZE switch before connecting or disconnecting a transducer. If a transducer is connected or disconnected with an image displayed, the system and/or the transducer may malfunction. 6. The user can record ID registration and user registrations (with a function to permit user-specific items such as the hospital name to be registered). Be sure to back up such information on external storage media. Data stored in the system may be lost due to improper operation or an accident. 7. Move the system by the handle. If the user pushes or pulls other sections, the system may be damaged. 8. Do not press or use force on the main panel. It may damage the system. 9. If this system is used in a small room, it may cause the room temperature to rise. Proper ventilation must be provided. 10. Do not connect or disconnect a printer from the Deskjet series when the system power is ON. The printer may become defective. 11. The air filter at the left of the system must be cleaned once every 6 months. If the air filter is clogged, the internal temperature will rise, shortening the service life of the system. For inspection and cleaning by service personnel, contact your TOSHIBA representative. 12. Deterioration of electrical and mechanical safety characteristics (such as generation of a leakage current or deformation/abrasion of mechanical parts) and of image sensitivity and resolution may occur over a period of time. A maintenance service contract is recommended to avoid accidents and erroneous diagnosis and to maintain system performance. 13. Manage the system properly to prevent it from being infected with computer viruses.

No. 2B730-670E S-7

4.

Warning Labels

Various warning labels are attached to this system in order to call the user's attention to potential hazards. on the warning labels attached to the system indicates safety precautions. * The symbol The warning labels use the same signal words as used in the descriptions in the operation manuals. * Detailed information about the warning labels is given in the main body of this operation manual. Read the operation manual carefully before using the system. The name, appearance, indication, and location of each warning label is as follows.





No.

Label

Meaning



(a) Cautions against sitting on the system. (b) Precautions regarding the registration of panel switches (a)

(b)



(a) Urges caution related to handling of the transducers. For handling of the transducers, refer to the transducers’ operation manual. (a)

(b)



(b) Cautions that the system must not be used around flammable gasses. (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.

(a)

(b)

No. 2B730-670E S-8







No.

Label

Meaning (a) Cautions against sitting on the system.

(b) Precautions regarding the registration of panel switches



(a) Cautions that the system must not be used around flammable gasses.

(b) Urges caution related to handling of the transducers. For handling of the transducers, refer to the transducers’ operation manual.

(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.

No. 2B730-670E S-9

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Important Information 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, or CD-R.

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.

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

12.

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

No. 2B730-670E W-1

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1. Intended Use and Specifications 1.1

Intended Use (1) This system provides high-quality ultrasound images in B mode and M mode. (2) Transducers have their own characteristic applications. However, this system allows transducers to be used for regions other than those specified as applicable, because this system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment. For the transducers that can be used with this system and their applications, refer to subsection 2.3 "List of Available Transducers".

1.2

Specifications (1) Power (a) Line voltage

:

100 VAC ±10% 120 VAC ±10% 100 VAC to 127 VAC ±10% 220 VAC to 240 VAC ±10%

(b) Line frequency

:

47 Hz to 63 Hz

(c) Power consumption

:

Maximum 600 VA (including external devices) (100 V, 120 V, and 100 V to 127 V system) Maximum 580 VA (including external devices) (220 V to 240 V system)

(2) Operating environmental conditions (a) Ambient temperature :

10°C to 35°C

(b) Relative humidity

35% to 85% (no condensation)

:

(c) Atmospheric pressure :

700 hPa to 1060 hPa

(3) Storage and transportation conditions (a) Ambient temperature :

-10°C to 55°C

(b) Relative humidity

30% to 85% (no condensation)

:

(c) Atmospheric pressure : NOTE:

700 hPa to 1060 hPa

The line voltage differs depending on the area.

(4) External dimensions and mass (not including optional units) (a) External dimensions :

420 mm wide × 630 mm deep × 1260 or 1300 mm high

(b) Mass

Approx. 73 kg

:

No. 2B730-670E 1-1

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2. System Configuration 2.1

Standard Configuration (1) Main unit (2) Monitor (3) Accessories • Transducer cable hanger • Transducer holder • Operation manual

2.2

List of Optional Devices The following list is accurate and complete at the time of printing. Due to constant developments, certain products may change or be no longer available at a later stage. For an up-to-date overview of available options, please consult your TOSHIBA representative. The following optional devices are available with this system. No.

Item

Model

1

Reference signal unit

UJUR-530A

2

VCR installation kit

UZRI-530A

3

DICOM kit

USDI-530A

4

Footswitch

UZFS002A

5

VCR

SVO-9500MD (SONY/NTSC) SVO-9500MDP (SONY/PAL)

6

Black-and-white printer

UP-895MD (SONY) P91W (MITSUBISHI) TP-8010 (MITSUBISHI)

7

Printer

Deskjet 5650/5652 (HP)

* 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 representative.

No. 2B730-670E 2-1

2.3

List of Available Transducers Transducer name

Indications for use

PLF-308P

Abdominal, intraoperative, pediatric

PLQ-805A

Peripheral vascular, small organ, musculoskeletal

PLQ-1203A

Peripheral vascular, small organ, musculoskeletal

PVQ-375A

Abdominal, fetal, pediatric

PVQ-381A

Abdominal, fetal, pediatric cardiac, neonatal cephalic

PVQ-641V

Endocavitary

PVQ-662A

Abdominal, pediatric, neonatal cephalic

PVF-738F

Abdominal, small organ, intraoperative

PVF-738H

Abdominal, small organ, intraoperative

PVF-745V

Abdominal, small organ, intraoperative

PVF-715R

Endorectal

No. 2B730-670E 2-2

*

3. System Overview 3.1

Name of Each Part

Monitor Transducer cable hanger Transducer holder

Main panel

CD-R drive Transducer connector

Side panel

Caster

Handle

Subswitch Rear panel

Power panel

* Before disconnecting the power cable of the system from the commercial power supply, turn OFF the sub switch, wait until the screen display disappears, and then turn OFF the main switch on the power panel.

No. 2B730-670E 3-1

3.2

Main Panel









PRESET PATIENT ID

A



TRANSDUCER

B

C

STANDBY

A/B

HDD



ACOUSTIC POWER

1

2

3

Q A

Ctrl

W S

Z

Shift

4

5

E D

X

6

R F

C

7

T

Y

G V

8

H B

9

U J

N

BS

0

I

O

K

P

L

M

Alt

Alt



Ins

Del







THI / FREQ

IP

F-POSI













B

No.





GAIN

Name

Function

ACOUSTIC POWER Adjusts the ultrasonic beam output. NEW PATIENT

Deletes the data for the previous patient, including the ID and measured values, and resets the system.

PATIENT ID

The patient ID registration screen appears.

PRESET

Invokes the registered initial settings (presets).

TRANSDUCER

Selects a transducer.

STANDBY/HDD

The STANDBY LED blinks when the main switch is ON and the subswitch is OFF (standby status). The HDD LED blinks when the HDD is being accessed.

STC

Adjusts the ultrasound echo reception sensitivity according to the depth from the body surface.

Keyboard

Used to enter characters and symbols Shift

+ alphabetic character keys;

Lowercase letters can be entered. Shift

+ keys other than alphabetic character keys );

(such as

The symbol in the upper row can be entered. MENU

Displays a menu according to the system status.

Body mark

Permits entry of body marks.

No. 2B730-670E 3-2

No.

Name

Function

Multifunctional dial

Used for editing measurements. Also used to adjust the angle of the needle mark, input auto annotation, and rotate the transducer mark on the body mark.

IP

Adjusts the image quality according to the registered image conditions.

M+B

Displays B-mode and M-mode simultaneously.

M

Displays M-mode images in full screen mode.

B single

Displays a standard (single) B-mode image.

B dual

Displays two B-mode images side by side.

THI/FREQ

Switches the transmission/reception frequencies. When a transducer that supports THI mode is used, this switch is also used to set the system in THI mode.

DEPTH/ZOOM

Adjusts the viewing depth for display of the ultrasound images. Every time this dial is pressed, the function is switched between DEPTH and ZOOM.

F-POSI

Adjusts the focus position.

OUTPUT B

Controls assigned output device (such as VCR or blackand-white printer).

OUTPUT A

Controls assigned output device (such as VCR or blackand-white printer).

CINE

Sets the trackball to image memory control mode.

SET

Determines the cursor position for measurement, and determines the selected items, etc.

Trackball

Moves the cursor or mark during image movement or measurement.

GAIN

Adjusts the sensitivity of black/white images. Also used to play back the cine loop.

NEXT

Moves the cursor to the next position during measurement, selected items, etc.

STILL REVIEW

No function is registered to this switch at the time of shipment.

FREEZE

Freezes and unfreezes the image.

NOTE:

User function switches User function switches are switches to which other functions can be registered. These include switches to which functions have already been assigned and switches to which no functions are registered, such as the switch. For details, contact your TOSHIBA representative. * To check the functions registered to the user function switches, select [Panel View] from the [Other] menu.

No. 2B730-670E 3-3

3.3

Side Panel NOTE:

The ECG input is optional.

ECG

GAIN

ECG gain

POSI.

ECG position

PATIENT

Input terminal for ECG lead

FOOT SW

A

For connection of the footswitches B

No. 2B730-670E 3-4

3.4

Rear Panel CAUTION: 1. Only equipment that conforms to the safety standards must be connected to the ETHERNET terminal on the rear panel. Otherwise, smoke or an electric shock may result. 2. Turn OFF the system power before connecting or disconnecting the cable from the ETHERNET terminal. If the cable is connected or disconnected with the system power ON, the system may not operate properly. 3. When a HUB is used, turn ON the system power only after tuning ON the power to the HUB.

VIDEO





PARALLEL

REMOTE

SERIAL

OUT

RESET

ETHERNET

IN

No.

Name

Functions



VIDEO

External video device input/output terminals



PARALLEL

Parallel ports



REMOTE

Printer connection terminals



RESET

System reset switch



SERIAL

Serial ports



ETHERNET

Terminal for digital data transfer

No. 2B730-670E 3-5

3.5

Power Panel NOTE:

The voltage and current indications of the AC line differ depending on the area.









FUSE 250V T4.0A

100V TOTAL MAX. 264VA (ISOLATED/SWITCHED)

100V 50/60Hz 600VA



No.



Name

Functions



FUSE

Fuse



Main switch

This is a circuit breaker.



Functional earth terminal

Terminal for the functional earth cable.



Equipotential terminal

Terminal for the potential equalization conductor.



Outlet

Connector for peripheral devices.



Inlet

Connector for the power cable.

No. 2B730-670E 3-6

3.6

Symbols This system uses the following symbols. For safety symbols, refer to page S-1. Symbol

Description Functional grounding Equipotentiality Main switch OFF (The AC power is turned OFF.) Main switch ON (The AC power is turned ON.) Subswitch OFF (The power to electronic circuits is turned OFF: Standby status) Subswitch ON (The power to electronic circuits is turned ON.)

TRANSDUCER A TRANSDUCER B

ECG FOOT SW

Transducer connector A Transducer connector B Electrocardiogram (option) Footswitch AC (Alternating current) The device fully complies with European Directive 93/42/EEC.

No. 2B730-670E 3-7

*

4. Preparation for Examination 4.1

Moving the System CAUTION: 1. Be sure to install the system on a level floor and lock the casters. If this is not done, the system may move, injuring the patient. 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. Do not sit on the system. The system may move, causing you to lose your balance and fall. 5. Do not place any objects on top of the monitor. They may fall, causing injury. 6. Confirm that the peripheral units are secured before moving the system. Otherwise, the peripheral units may fall and cause injury. 7. If the ECG cable is connected, disconnect it before moving the system. Otherwise, the cable may get caught in the casters or someone may trip over the cable and injury may result. 8. 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: Observe the following precautions before moving the system to prevent system malfunctions. 1. Turn OFF the subswitch and the main switch on the power panel on the rear of the system. 2. Store the transducer in the transducer holder and hang the cable on the transducer cable hanger. 3. When moving the system, use the handle. Do not push weak sections such as the panel. (1) Unlock the four casters. (2) Move the system using the handle. (3) When the system is in the desired position, lock the four casters.

No. 2B730-670E 4-1

4.2

Connecting the Transducer CAUTION:

Turn OFF the system subswitch or stop transmission by FREEZE switch before connecting or disconnecting a transducer. If a transducer is connected or disconnected with an image displayed, the system and/or the transducer may malfunction.

(1) Connect the transducer and turn the lock handle clockwise to lock the connector. (2) When disconnecting the transducer, turn the lock handle counterclockwise to unlock the connector and then hold the connector and pull it straight out.

Lock Lock handle

No. 2B730-670E 4-2

*

5. Connecting the Power Cable and Protective Earth WARNING:

1. Be sure to connect the power plug to a two-pin (with dual earth terminal) outlet meeting the ratings indicated on the rating nameplate. If this type of outlet is not available, contact your TOSHIBA representative. 2. Information concerning the terminal to which the potential equalization conductor is to be connected (

):

To use another medical device in combination with this system, an equipotential wire for connecting to an equipotential bus must be supplied. For more information, contact your TOSHIBA representative. *

Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle. Also, be sure to remove the equipment power plug from the receptacle before disconnecting the wire to avoid electrical shock.

3. Information concerning the functional earth terminal (

):

Use of the functional earth terminal is not allowed in Europe. The system should be connected according the local requirements. 4. Connect the earth conductor only before turning ON the system. Disconnect the grounding cable only after turning OFF the system. Otherwise, electric shock may result. 5. Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life-support systems. If this system malfunctions and generates an overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped. Connect the power plug to an outlet for medical equipment. By doing this, the protective earth line is connected.

Protective earth terminal

No. 2B730-670E 5-1

*

6. Power ON/OFF 6.1

Power ON (1) Check the items below before turning the power ON. • The power cable should be connected. • One or more transducer should be connected. (2) Turn ON the main switch on the power panel on the rear of the system. The STANDBY LED blinks. (3) Turn ON the subswitch. Some time after the setup screen is displayed, the B-mode screen appears. (4) If required, adjust the brightness ( corresponding knobs on the monitor. (a) Set the contrast (

) and contrast (

) using the

) to minimum. The image disappears.

) so that the brightness level of the screen is the (b) Adjust the brightness ( same as in the examination room. (c) Then adjust the contrast ( NOTE:

6.2

) to set the maximum luminance.

When this system is started up or another transducer is selected, you may hear a click. This does not indicate abnormality.

Power OFF CAUTION: Do not turn the system power OFF while a CD-R disk or HDD is being accessed. If the system power is turned OFF during access to the CD-R disk or HDD, the disk may be damaged and recorded data may be lost. (1) Before turning OFF the system, confirm that the CD-R or HDD is not being accessed. (2) Turn OFF the subswitch. The STANDBY LED blinks. (3) When the system is not going to be used for an extended period of time, turn OFF the main switch on the power panel and disconnect the power plug.

No. 2B730-670E 6-1

6.3

Preparation for Use During an Operation 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 resetting the system and the examination may not be able to continue.

6.3.1 Preparation of a backup system Prepare a backup system when an urgent examination is to be performed, for example during an operation or for an emergency case.

6.3.2 Power OFF/ON in the case of system failure When any of the following abnormalities occurs with the system, the system may be able to recover from the abnormality by pressing the RESET switch. • An error message is displayed and does not disappear. • The screen display is abnormal. • The system operations are disabled. Follow the steps below to reset the system. (1) Press the main switch on the power panel. (2) Wait at least 5 seconds, and then turn ON the main switch. The system is restarted. (3) If the system is still abnormal even after power OFF/ON, use the backup system.

No. 2B730-670E 6-2

*

7. 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.

7.1

Checks Before Turning ON the Power Before turning ON the power, perform the following checks.

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 21.1.1 "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 cables (power cable, ECG cable etc.) and no looseness in the connectors.

†

7

There should be no damage or stains to the transducer and transducer cables.

†

* If any stains are present, perform cleaning, disinfection, or sterilization referring to the operation manual provided with the transducer. 8

No clips etc. are placed on the main panel.

†

9

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

†

No. 2B730-670E 7-1

7.2

Checks After Turning ON the Power After turning ON the power, perform the following checks.

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 B-mode images.

†

4

There should be no abnormality in the date and 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 VCR.

†

No. 2B730-670E 7-2

*

8. Basic Screen and Menu 8.1

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 11 "Display and Operation in Each Mode" for the display specific to each mode. Patient ID

Scanning direction

Heart rate Preset name

Hospital name

TOSHIBA

123456789012 ABCDEF

999

Abdominal 9.9C9.9 100%

Date Time 2004/03/16 PM 07:05:43

0

Transducer frequency Acoustic power 5

Focus mark Image Process (1) MI (2) TIS (3) TIB (4) TIC

IP MI 10 9.9 TIS 9.9 TIB 9.9 TIC 9.9 9.9M

999 fps

BG99

DR99

B frequency Current B gain Dynamic frame rate range value

0:00:00

VCR

(1) MI (Mechanical Index) This is a measure of the mechanical effects such as cavitation. (2) TIS (Thermal Index Soft Tissue) This is a measure of the calculated/estimated rise in temperature of soft tissues. (3) TIB (Thermal Index Bone) This is a measure of the calculated/estimated rise in temperature of the cranial bone of fetuses/infants. (4) TIC (Thermal Index Cranial) This is a measure of the calculated/estimated rise in temperature of the cranial bone of children/adults.

No. 2B730-670E 8-1

8.2

Display and Operation of the Menu The functions not available on the panel are displayed in the menu. The menu should be displayed when required. (1) Press

MENU

. The menu appropriate for the current display mode is displayed.

Functions that cannot be selected or switched in the menu are displayed in gray. (a) Movement of the menu display position The menu can be moved to the left or right by operating the trackball to the left or right. (b) Display of other menus Move the cursor to the top of the menu and then move the trackball slightly to the left or right, depending on the position in which the menu is displayed. A pull-down menu, which can be used to select other menus, is displayed. Select the menu to be displayed and press

SET

.

Top of the menu B Focal Ptn Density DR Time Smth Axial Smth LateralSmth Mid Filter E.Enhance AGC PostProcess Reject L/R U/D Rotation Scan Rang High Frame

B M Other

Needle

(2) Operate the trackball up and down to move the cursor to the desired item.

No. 2B730-670E 8-2

(3) Press

on the main panel.

SET

• For an item with only ON and OFF options The item toggles between ON and OFF each time

SET

is pressed.

• For an item with several options When

SET

is pressed or the trackball is slightly moved laterally, a pull-down

menu appears next to the menu. Select the desired item by operating the trackball and then press

.

SET

 mark on the right of an item indicates that other pull-down menus or pages exist. (4) To close the menu, press

MENU

.

No. 2B730-670E 8-3

*

9. Entering the Patient ID CAUTION: Observe the following precautions to avoid erroneous diagnosis. 1. Before examining a new patient, press

to delete the

patient information and data recorded in the image memory for the previous patient. Otherwise, the new data may be confused with the data of the previous patient. 2. If the patient information is modified by pressing

PATIENT ID

, the

patient information for the data already recorded in the image memory is not modified (the data recorded in the image memory is not deleted). Thus, if the data recorded in the image memory is that for the previous patient, images for the different patients will have the same patient information, and this may cause confusion. It a patient ID is to be changed, press

to delete the

patient information and data recorded in the image memory for the previous patient. Otherwise, the data belonging to the current patient may be confused with the data for the previous patient. 3. Confirm that the patient to be examined is the same as the patient ID. There is a possibility of recording images with incorrect patient IDs. 4. Enter the patient's height and weight correctly in the patient ID registration screen. If the entered height and weight are not correct, the BSA will be calculated incorrectly. 5. Enter the patient information including LMP and IVF correctly in the patient ID registration screen. Otherwise, the fetal growth data will be calculated incorrectly.

No. 2B730-670E 9-1

9.1

Entering and Saving Data on the Patient ID Registration Screen (1) Press (2) Press

to initialize the system. PATIENT ID

. The patient ID registration screen appears. Patient Data Input 2004/03/16

ID Number

AM06:54:47

Name Date of Birth Sex

(YYYY/MM/DD) Male

Female

Height

cm

Weight

kg

BSA

m2

Blood Pressure High/Low LMP

PRV

EDD

IVF

Age

Unknown

ADULT /

mmHg

CLN

Comment ABC

ID List Used:

10

Free:

ID Save

1990 Total:

2000

Close

(3) Enter the appropriate patient information in the fields. • In the "Date of Birth" field, enter the date using the same format as the current date displayed at the top right of the screen. When the date of birth is entered, the age is calculated automatically and displayed in the "Age" field. It is also possible to type a value directly in the "Age" field. • When the height and weight are entered, the BSA (body surface area) field is automatically filled with a calculated value. • Depending on the preset menu setting, the BP fields and options for obstetric data may not be displayed. • When one of [LMP], [PRV], [EDD], [IVF], or [CLN] is selected and the Enter key is pressed, the screen for entering the date and the number of weeks appears. On this screen, enter the date. (4) After the data has been entered, press [ID Save]. A confirmation dialog is displayed. Select [OK] to save the data. (5) When [Close] is selected, the system returns to normal ultrasound image display.

No. 2B730-670E 9-2

NOTE:

(1) Units of height and weight The units of height and weight differ depending on the setting of "Entry System" in the preset menu. (a) Metric ............ "cm" and "kg" (b) English .......... "feet", "inch", "lb", or "cm", "kg" (2) Formula for body surface area The formula differs depending on the setting of "Calculation" in the preset menu. (a) Oriental • ADULT

:

BSA = WT0.425 * HT0.725 * 73.58 / 10000

• PEDI 12-14 :

BSA = WT0.423 * HT0.651 * 102.65 / 10000

• PEDI 6-11

:

BSA = WT0.444 * HT0.663 * 88.83 / 10000

• PEDI 1-5

:

BSA = WT0.423 * HT0.362 * 381.89 / 10000

• PEDI 0

:

BSA = WT0.473 * HT0.655 * 95.68 / 10000

:

BSA = WT0.425 * HT0.725 * 71.84 / 10000

(b) Occidental • ADULT HT : WT :

Height (cm) Weight (kg)

No. 2B730-670E 9-3

9.2

Sorting and Calling a Patient ID (1) Press [ID List] on the patient ID registration screen. The list of patient IDs saved in the system is displayed in ascending order of ID number. ID List No. 1 2 3

ID 111 123 222

Select

Name AAA BBB CCC

Delete

Delete All

Sort key ID:

Name:

EDD (YYYY/MM/DD)

EDD

Used:

3

Free:

1997

Total:

2000 Close

(2) When the button for "ID", "Name", or "EDD" is selected in the [Sort Key] field, the patient ID numbers are sorted according to the selected condition. (3) Select the desired patient data item and select [Select] or move the cursor to the desired patient data and press

SET

twice. The patient data is displayed on the

Patient ID Registration screen.

9.3

Deleting Saved Patient IDs (1) To delete a patient ID (a) Using the trackball, select the patient ID to be deleted. (b) Press [Delete]. (c) Select [OK] on the deletion confirmation screen. The patient ID data is deleted. (2) To delete all the saved patient IDs (a) Press [Delete All]. (b) Select [OK] on the deletion confirmation screen. All the saved patient ID data is deleted.

No. 2B730-670E 9-4

*

10. Selecting Presets 10.1 Introduction In this system, 12 types of initial settings can be saved for examinations. These initial settings are called presets. The examination presets can be selected by pressing the PRESET switch on the main panel.

10.2 Procedure for Selecting Presets When * When

or

A

C

B

is pressed, the corresponding preset is selected.

is pressed, the Exam Select menu is displayed. The desired preset can

be selected from the displayed list by using the trackball and

SET

.

Exam Select ABDOMINAL1 ABDOMINAL2 OB/GY1 OB/GY2 S-PARTS1 S-PARTS2 PV Cardiac PROSTATE 10 11 12

PRESET

Display example

No. 2B730-670E 10-1

*

11. Display and Operation in Each Mode 11.1 B Mode (1) Entering B single mode Press

B

.

(2) Entering B dual display mode Press

DUAL

.

No. 2B730-670E 11-1

(3) Adjustment on the panel

PRESET PATIENT ID

A

TRANSDUCER

B

C

A/B

STANDBY HDD

ACOUSTIC POWER

1

2

3

Q A Shift

Ctrl

4

W S

Z

5

E D

X

6

R F

C

7

T G

V

8

Y H

B

Alt

9

U J

N

BS

0

I

O

K

P



L

M Alt

Ins

Del



, THI /FREQ

IP

F-POSI



B

GAIN

Adjustment items

Procedures Use the GAIN dial of the palm controller.

Sensitivity of the entire image Gain 2D



GAIN

Field depth

Use the DEPTH/ZOOM dial. * When the ZOOM LED is lit, hold down the dial to light the DEPTH LED. DEPTH ZOOM



Sensitivity according to the depth

Use the STC slide controls.



Calls up registered image-quality conditions.

Use IP to select the desired image-quality conditions.

IP



Switches the focus position.

Use F-POSI to switch the focus position.

F.POSI

No. 2B730-670E 11-2

Adjustment items

Procedures Use the DEPTH/ZOOM dial and the trackball.

Magnification, reduction, and movement of the image (PAN/ZOOM)

(1) When the DEPTH LED is lit, hold down the dial to light the ZOOM LED. (2) When the dial is turned, the image is magnified/reduced. When the trackball is operated, the image moves.

DEPTH ZOOM



(3) When the dial is held down again, the system quits PAN/ZOOM and the DEPTH function is selected.

Switches the transmission/reception frequencies or switches to THI mode

Switches the transmission/reception frequencies. When a transducer that supports THI mode is used, this switch is also used to set the system in THI mode.

THI/FREQ



Freeze the image (to a still image). FRZ

Press

FRZ

. When it is pressed again, the

frozen image is restored to a real-time image.

No. 2B730-670E 11-3

(4) Adjustment using the menu When

MENU

is pressed, the B menu is displayed.

Automatically sets the focus of the ultrasound beam. Increases image sharpness. Adjust the dynamic range. B Focal Ptn Density DR Time Smth Axial Smth LateralSmth Mid Filter E.Enhance AGC PostProcess Reject L/R U/D Rotation Scan Rang High Frame

Adjusts the image smoothness. Adjusts the image smoothness in the axial direction. Adjusts the image smoothness in the lateral direction. Selects the filter type. Enhances the edge of the image. Suppresses comet-tail and reduces noise. Adjusts the image display intensity. Reduces noise at the low brightness level. Displays the image right-left reversed. Displays the image top-bottom inverted. Rotates the image in 90° steps. Sets the field angle (field width).

Needle

Sets the High Frame function ON/OFF. Displays the needle mark for biopsy procedures.

No. 2B730-670E 11-4

11.2 M Mode (1) Entering M mode Press

M

.

(2) Entering M + B mode Press

B M+B

.

(3) Setting the M mark (a) Enter M + B mode. The M mark is displayed on the B-mode image. (b) Move the M mark display position using the trackball. (4) Adjustment on the panel Refer to page 11-2.

No. 2B730-670E 11-5

(5) Adjustment using the menu When

MENU

is pressed, the M menu is displayed.

Adjusts the sweep speed of the M-mode image. Adjusts the dynamic range. M M Speed M DR M Gain Cmp M E.Enhance M AxialSmth M Time Mark M Time Smth M Post Proc M AGC M Max Smple

Adjusts the sensitivity of the M-mode image. Enhances the edge of the image. Adjusts the image smoothness in the axial direction. Turns ON/OFF the Time mark display for the M image area. Adjusts the image smoothness. Adjusts the image display intensity. Suppresses comet-tail and reduces noise. Selects the Max Sampling pattern.

No. 2B730-670E 11-6

*

12. Cine Function 12.1 Introduction CAUTION: When performing examination of a new patient, press

to

delete the recorded data in the image memory. Otherwise, the new data may be confused with the data of the previous patient. When an image is frozen, the images immediately before the frozen image can be played back and edited. This function is called Cine. Cine images are cleared by turning OFF the power or unfreezing the frozen image.

12.2 Cine Playback (1) Press

to freeze the image.

FRZ

(2) When the trackball is operated, the system enters frame-advance playback mode. • Operate the trackball to the right for forward playback. • Operate the trackball to the left for reverse playback. * For M-mode images, the trackball operation is opposite to the above. (3) When the trackball dial (the dial around the trackball) is turned during frameadvance playback, the system enters continuous playback mode. The playback speed can be changed using the dial. • Operate the dial clockwise to increase the playback speed. • Operate the dial counterclockwise to decrease the playback speed. When the trackball is operated, the system returns to frame-advance playback mode. (4) Continuous playback edit function (setting of the playback range) It is possible to set the start frame and end frame for continuous playback in frameadvance playback mode. (a) Operate the trackball to display the start frame of the playback range and press

SET

.

(b) Operate the trackball to display the end frame and press

NEXT

.

(c) Turn the trackball dial. The images between the specified start and end frames are played back continuously.

No. 2B730-670E 12-1

*

13. Display of Reference Signals Electrocardiographic (ECG) reference signals can be displayed during B-mode display, B Dual mode display, M-mode display, and M+B mode display. This function is optional.

WARNING:

1. To prevent electric shock, check the following items before operation. • There must be no abnormality of the ECG cable. • The ECG cable must be connected correctly. 2. Connect the ECG cable to the system before attaching the pick-up of the ECG to the patient. If the connector of the ECG cable is in contact with live parts, the patient may suffer an electric shock. 3. Do not place the ECG electrodes in direct contact with the patient's heart. Cardiac arrest may occur. *

The ECG electrodes are of the BF type and are not designed to be placed in direct contact with the heart.

4. To reduce the risk of electric shock or burns, use only the cable and patient leads supplied with the reference signal unit . 5. The ECG electrodes used should be commercially available products provided by the customer. 6. Before using equipment such as an electric scalpel, highfrequency therapy equipment, a defibrillator, etc., remove the ECG electrodes from the patient. In addition, do not allow ultrasound transducers to come into contact with the patient. The patient may be burned or receive an electric shock.

13.1 Display Procedures (1) Turn OFF the power of the system and connect the pick-up cable etc. to the side panel. (2) Turn ON the power of the system. (3) Attach the ECG electrodes to the patient. (4) Set the mode to M mode in which reference signals can be displayed. * If the signals need to be displayed in B-mode and B dual mode, it is necessary to preset the display setting to ON.

No. 2B730-670E 13-1

13.2 Adjustment of Reference Signals (1) Adjustment of the ECG waveform Use the ECG dial on the side panel to adjust the ECG waveform. • GAIN: Adjusts the sensitivity. • POSI: Adjusts the display position. (2) Adjustment using the menu When [ECG] is selected from the [Other] menu, the following menu is displayed. The settings can be changed using the trackball and

SET

.

Sets ECG synchronization mode. ECG Sync Mod Sync+Real CH1 Delay Interval

Displays ECG-gating images and live images simultaneously (for dual-display mode). Performs ECG-gating at the delay time set. Sets the delay time from detection of the R wave to refereshing of the B screen. Sets the interval before the B screen is updated in internal gating mode.

No. 2B730-670E 13-2

*

14. Body Mark Entry and Deletion A body mark, which indicates the anatomical region for the current examination, can be displayed on the screen.

14.1 Display of a Body Mark (1) Press the body mark switch on the main panel. The preset body mark for the current examination region is displayed.

14.2 Selection of a Body Mark (1) To display another body mark for the same examination region Press

SET

and then

NEXT

. The body mark is switched.

(2) To display a body mark for another examination region (a) Press

MENU

. The body mark menu is displayed.

(b) Move the cursor to the upper part of the menu and move the trackball slightly to the left or right, depending on the position in which the menu is displayed. A pull-down menu is displayed. (c) Select the desired examination region and press

(d) Select the body mark to be displayed and press mark is displayed on the screen.

No. 2B730-670E 14-1

SET

SET

.

. The selected body

14.3 Movement of the Transducer Mark (1) Operate the trackball to move the transducer mark.

Transducer mark

(2) The transducer mark rotates as the multifunctional dial is turned.

14.4 Movement of the Body Mark (1) Select [Mark Move] in the menu. (2) Press

SET

.

(3) The body mark moves as the trackball is operated. (4) When

SET

is pressed again, the body mark position is set.

14.5 Deletion of the Body Mark (1) Select [Mark Disp] in the menu. (2) Press

SET

. The body mark disappears.

* While the body mark is displayed, set the body mark switch on the panel to OFF, and turn ON/OFF the body mark switch again. The body mark disappears.

No. 2B730-670E 14-2

*

15. Entry and Deletion of Comments Two methods of comment entry are available; characters can be entered from the keyboard or already registered characters can be displayed. * The comment entry switch function must have been registered on the main panel. Contact your TOSHIBA representative for the registration procedure.

15.1 Entry from the Keyboard (1) Press the comment entry switch on the main panel. A cursor is displayed on the screen. (2) Operate the trackball to move the cursor to the position where characters are to be displayed. (3) Enter characters using the keyboard. (4) Press the comment entry switch to quit comment entry mode.

15.2 Entry of Registered Comments (1) Press the comment entry switch on the main panel. A cursor appears on the screen. (2) Enter characters. There are two input methods. • When the multifunctional dial is used (a) Operate the trackball to move the cursor to the position where characters are to be displayed. (b) When the multifunctional dial is rotated, the comment is switched. (c) Press

SET

.

• When the menu is used (a) Operate the trackball to move the cursor to the position where characters are to be displayed. (b) Press

MENU

. The menu for comment entry appears.

(c) Select the characters to be displayed from the menu. (d) Press

SET

.

(3) Press the comment entry switch to quit comment entry mode.

No. 2B730-670E 15-1

15.3 Entry of the Arrow Mark (1) In comment entry mode, operate the trackball to move the cursor to the position where characters are to be displayed. (2) Enter the arrow mark. There are two input methods. • When the menu is used (a) Press

MENU

. The menu for comment entry appears.

(b) Select [Arrow] in the menu. The arrow mark is displayed. (c) When the multifunctional dial is rotated, the arrow mark is rotated. (d) Press

SET

to determine the position.

• When the menu is not used (a) Press

NEXT

. The arrow mark is displayed on the screen.

(b) When the multifunctional dial is rotated, the arrow mark is rotated. (c) Press

SET

to determine the position.

15.4 Entry of Gender Symbols ( , ) (1)

In comment entry mode, operate the trackball to move the cursor to the position where the gender symbol is to be displayed.

(2)

Press the following keys on the keyboard. :

Alt

+ W

To display :

Alt

+ Q

To display

No. 2B730-670E 15-2

15.5 Moving the Selected Comment (1)

In comment entry mode, place the cursor at the entered comment and press . The comment is enclosed by a box.

SET

(2)

Move the comment to the desired position using the trackball.

(3)

Press

SET

to determine the new position.

15.6 Correcting the Comments (1)

Operate the trackball to move the cursor to the string to be corrected.

(2)

Press

(3)

, , , and Using the characters to be corrected.

(4)

Enter the characters from the keyboard.

SET

twice. The cursor appears.

keys on the keyboard, move the cursor to the

* Pressing the Ins key on the keyboard toggles the system between insert mode and overwrite mode. (5)

After correction, press

.

SET

15.7 Deletion of the Selected Comment (1) In comment entry mode, place the cursor at the entered comment and press SET

. The comment is enclosed by a box.

(2) After correction, press

SET

.

No. 2B730-670E 15-3

15.8 Deletion of All Comments Delete all comments. There are two deletion methods. Comment deletion is possible in comment entry mode. (1) When the menu is used (a) Press

MENU

. The menu for comment entry appears.

(b) Select [Comment All Clear] in the menu. (c) Press

SET

. All comment are cleared.

(2) When the menu is not used (a) Press the Del key on the keyboard. All comments are cleared. (b) Use the BS key to clear the input comments sequentially, starting from the most recently input comment.

15.9 Initial Cursor Display Position Setting (1)

In comment entry mode, move the cursor to the desired display position for comment entry.

(2)

Press

SET

. The cursor changes to †.

(3)

Press

SET

again. The cursor will be displayed at this position when the

comment entry switch is pressed.

No. 2B730-670E 15-4

*

16. Needle Mark Display This system can display the needle mark for the specified biopsy adapter on the screen. Biopsy procedures must be performed with extreme care to prevent the induction of tissue necrosis, neurological disorders, infectious diseases, and other such problems. The clinical technique should be determined after consultation with the specialists concerned.

WARNING:

1. To perform biopsy procedures while observing ultrasound images, a thorough understanding of ultrasound diagnosis and adequate training in biopsy procedures are required. Biopsy procedures are safer when performed using image observation than when performed without images. However, 100% safety and reliability cannot be assured even when performing biopsy procedures using image observation. If biopsy procedures are performed without proper knowledge or training, they may be performed incorrectly and cause various patient side effects. 2. In the situations listed below, the biopsy needle may fail to reach the target. Incorrect biopsy may cause various patient side effects. • A biopsy procedure is performed without adequate skills. • A biopsy adapter other than that specified is used. • The biopsy adapter is mounted at an incorrect position. • A biopsy needle that is unsuitable for the purpose of the biopsy is used. • A biopsy needle that is unsuitable for the biopsy adapter is used. • The image is frozen but it goes unnoticed, and the biopsy procedure is continued. • The position of the biopsy needle end is misinterpreted on the image. 3. Before and after a biopsy procedure is performed, confirm that there are no abnormalities with the biopsy adapter. If an abnormal biopsy adapter is used, the patient may be injured.

No. 2B730-670E 16-1

WARNING:

4. During a biopsy procedure, the needle may deviate from the desired course due to the tissue characteristics or the type of needle. In particular, needles with small diameters may deviate to a greater degree. Always monitor the target region and the needle end while performing a biopsy procedure. 5. Sterilize the transducer and biopsy adapter before and after an ultrasound-guided biopsy procedure. Failure to do so may result in the transducer and adapter becoming a source of infection. 6. The needle mark displayed on the ultrasound image does not indicate the actual position of the biopsy needle. It should only be used as a reference. 7. Do not freeze the image when performing a biopsy procedure. Biopsy procedures may be performed incorrectly on frozen images. 8. Confirm that the selected needle mark angle matches the angle indicated on the biopsy adapter to be used.

CAUTION: Position of the biopsy target on the image and the biopsy needle Even though the biopsy target and the biopsy needle are identified on the image, a biopsy may not always be successful due to dispersion of the ultrasound beam. This is especially relevant when a biopsy procedure is to be performed for a tubule or a very small region. To avoid biopsy failure, follow the instructions below. 1. Do not rely solely on the echo of the needle end on the image. Pay careful attention to the target, which should shift slightly when the biopsy needle comes into contact with it. 2. Perform biopsy only after confirming the size of the target and the likelihood of biopsy success.

No. 2B730-670E 16-2

16.1 Display Method The needle mark can be displayed on B mode images only. (1) Press

MENU

. The B mode menu is displayed.

(2) Select [Needle] from the menu and press

SET

.

A confirmation dialog is displayed. (3) Select [OK] to display the Needle menu.

(4) Select [G Display] and press

Needle Guide G Angle G Display G Size Range Disp Adapt Sel

. A needle mark is displayed.

SET

If the needle mark angle is adjustable, the needle mark can be rotated at this time. When

SET

is pressed again, the needle mark disappears.

• Example of needle mark display Needle mark

Biopsy range marks Name of the biopsy adaptor Angle of the needle mark BG Adap

NA 99

No. 2B730-670E 16-3

16.2 Adjustment of the Needle Mark Angle The angle of the needle mark can be adjusted within the specified range depending on the transducer and biopsy adaptor used. * The needle mark cannot be changed (angle fixed) for some biopsy adapters. (1) Select [G Angle] in the menu and press

.

SET

([G Angle] is automatically set to ON when [G Display] is set to ON. This step is not required unless [G Angle] has been set to OFF intentionally.) (2) The angle of the needle mark changes as the multifunctional dial is turned. (3) Select [G Angle] from the menu and press

SET

. The needle mark angle is fixed.

16.3 Display/Hiding of Biopsy Range Marks Select [Range Disp] in the menu and press

.

SET

The biopsy range marks are toggled between displayed and hidden.

16.4 Selection of the Biopsy Guide Size (1) Select [G Size] in the menu. (2) Select the guide size in the pull-down menu and press

SET

.

The size of the dots that make up the needle mark is changed.

16.5 Selection of the Biopsy Adaptor Multiple biopsy adaptors may be selectable depending on the type of transducer used. (1) Select [Adapt Sel] in the menu and press

SET

. A dialog is displayed.

(2) Select an item from the dialog and press [OK].

No. 2B730-670E 16-4

*

17. Measurement 17.1 Basic Operation The basic operating procedures are common to all measurements.

CAUTION: 1. The measured data is lost when image freeze is released during measurement. (In the case of application measurements, the data loss depends on the preset settings.) 2. The measured data is lost when the system is turned OFF or is pressed. * The measurement switch function must have been registered on the main panel. Contact your TOSHIBA representative for the registration procedure. (1) After freezing the image, press the measurement switch. The registered measurement function starts. * To select other measurement functions, press

MENU

. The measurement menu

appears. Select the desired measurement from the menu and press

SET

.

(2) Operate the trackball to move the mark on the screen to the start point of the measurement region. (3) Press

SET

.

(4) If necessary, place the cursor at the end point of the measurement region and press

SET

. The measurement result is displayed on the screen.

(5) To perform another measurement using the same measurement function, press NEXT

.

(6) After measurement is completed, press the measurement switch. The system returns to normal ultrasound image display and the measurement results are cleared.

No. 2B730-670E 17-1

17.2 B-mode Measurements The measurements listed below can be performed in B mode. Measurement item

Description

Distance

The distance between two points is measured.

Trace length

The length of the traced portion of the curve is measured.

Angle

The angle between two lines is measured in addition to the distance between two points.

Area/circumference

The area/circumference can be measured by the following methods. • The approximate value for the tracing along the external circumference is obtained. • An ellipse is created along the external circumference to obtain the approximate value. • A rectangle is created along the external circumference to obtain the approximate value.

Volume

The volume is measured.

Cross measurement

Measures the distances on two perpendicular lines.

Parallel measurement

Measures the distances between 4 points set along the same straight line.

Joint measurement

Measures the angle formed by two lines.

Left ventricular function measurement

The left ventricular function can be measured by the calculation methods listed below. • Single-plane ellipse method • Biplane ellipse method • Bullet method • Modified Simpson method • Simpson SP method • Simpson BP method • Cube method • Teichholz method • Gibson method

Stenosis ratio measurement

The stenosis ratio is measured (% Stenosis).

Volume measurement

Measures the volume.

Prostate measurement

Measures the volume and mass of the prostate.

B-mode profile

The intensity of the echo on a line arbitrarily set on an image can be projected and displayed.

Histogram measurement

The distribution of the intensity of the B-mode echoes within the traced area can be displayed graphically.

OB measurement

Evaluates fetal growth.

No. 2B730-670E 17-2

17.3 M-mode Measurements The measurements listed below can be performed in M mode. Measurement item

Description

Distance

The distance (amplitude) between two points in the M mode is measured.

Time

The elapsed time between two points is measured.

Slope

The slope between two points is measured.

Heart rate

The number of heartbeats for one minute is calculated based on the heart rate displayed on the screen.

Left ventricular function measurement

The left ventricular function can be measured by the calculation methods listed below. • Cube method • Teichholz method • Gibson method

Mitral valve measurement

Amplitude/velocity measurements are performed for the mitral valve.

Aortic valve measurement

Diameter/time measurements are performed for the aortic valve.

Stenosis ratio measurement

The stenosis ratio is measured (% Stenosis).

OB measurement

Fetal growth is evaluated.

No. 2B730-670E 17-3

*

18. Output/Saving of Image Data 18.1 Data Archive to a CD-R (1) Place a blank CD-R in the CD-R drive. (2) Select [Copy to CDR] from the [Other] menu. The screen below is displayed. Copy to CDR HDD

CD-R

12345 123

Used: 0

Free: 600 Total: 600

Backup Close

(3) Select the desired data in the "HDD" area and press [>>]. The selected data is displayed in the "CD-R" area. (4) When data selection is complete, select [Backup]. The selected data is archived onto the CD-R. (5) When data archiving is complete, the message "Record success!" is displayed and the CD-R is ejected automatically. (6) Remove the CD-R and push the CD-R tray back into the drive. NOTE:

The maximum image data volume that can be stored on a CD-R is 600 MB.

No. 2B730-670E 18-1

18.2 Data Archive to the DICOM Server * The optional DICOM kit is required to use this function. (1) Select [Open File] from the [Other] menu. The screen below is displayed. Load File Drive: Folders 12345 123

HDD

File Type

ALL

File List Name AAAA.DCM

OK

To Server

Modify Time 2003-12-10 14:45

Cancel

(2) Select the desired data from the "File List" area and then select [To Server]. The selected data is transferred to the DICOM server. * It is possible to set the system to transfer the data automatically to the DICOM server at the same time the data is saved on the HDD. Consult your Toshiba service representative. * Although files with extensions other than "DCM" are also displayed in the File List area, only files with the extension "DCM" can be archived to the DICOM server. * Only a single item can be selected in the Folders area or File List area.

No. 2B730-670E 18-2

18.3 Loading the Archived Data * It is not possible to load the data that was archived to the DICOM server. NOTE:

When data in CIN or FRM format is loaded, the currently displayed patient information is cleared.

(1) Select [Open File] from the [Other] menu. The screen below is displayed. Load File Drive:

HDD

Folders 12345 123

File Type

ALL

File List Name AAAA.BMP BBBB.CIN

OK

To Server

Modify Time 2003-12-10 14:45 2003-12-11 13:15

Cancel

(2) Select the desired folder in the Folders area, select the desired data file in the File List area, and then select [OK]. The loaded data is displayed on the monitor. (3) To close the data file, follow the steps below. (a) For a BMP file Press [Exit] at the bottom right of the screen. (b) For CIN or FRM data Press

FRZ

.

No. 2B730-670E 18-3

*

19. Other Function 19.1 Beep Tone Adjustment The tone of the beep (generated when a switch of the main panel is pressed) can be adjusted. (1) Select [Buzzer] from the [Other] menu. (2) Select the desired volume from the pull-down menu.

19.2 Adjustment of the Panel Backlight The brightness of the backlight of the main panel can be adjusted. (1) Select [Light] from the [Other] menu. (2) Select the desired brightness from the pull-down menu.

No. 2B730-670E 19-1

*

20. Using MI/TI 20.1 Basic Knowledge of MI/TI (1) Concerns with bioeffects Diagnostic ultrasound is recognized as being safe. In fact, there have been no reports of injuries to patients caused by diagnostic ultrasound. It cannot be stated categorically that ultrasound is 100% safe. Studies have revealed that ultrasound with extremely high intensity is harmful to body tissues. This rapid advance has generated concerns about the potential risk of bioeffects when new applications or diagnostic technologies become available. (2) Mechanical effects and thermal effects Studies have revealed that two different kinds of ultrasound characteristics affect human bodies: one is the mechanical effects due to cavitation generated when the negative pressure of ultrasound exceeds a certain limit, and the other is the effects due to thermal energy generated when tissues absorb ultrasound. The levels of these two kinds of effects are represented by indices: the MI (Mechanical Index) and the TI (Thermal Index), respectively. (3) MI/TI values The smaller the MI/TI values, the less the bioeffects.

No. 2B730-670E 20-1

(4) Controlling the ultrasound output In 1976, the FDA in the U.S.A. established limits to the acoustic output level for diagnostic ultrasound equipment (TRACK1), along with the rapid advance in diagnostic ultrasound technology, and the versatile proliferation of its applications, in order to ensure the safety of patients. Thereinafter, manufacturers were required to control the acoustic output level below the limits, when releasing new diagnostic ultrasound systems on the market. Maximum acoustic power specified by FDA (TRACK1) Ispta.3 (mW/cm2)

Isppa.3 (W/cm2)

Peripheral blood vessels

720

190

1.9

Cardiovascular systems

430

190

1.9

Fetal and other

94

190

1.9

Eyes

17

28

0.23

Application

MI

The idea of MI/TI has been introduced recently to increase the diagnostic capability, promoting relaxation of these acoustic power limits (TRACK3). Maximum limit for MI/TI display (TRACK3) Application All regions (except eyes)

Ispta.3 (mW/cm2)

Isppa.3 (W/cm2)

720