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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 *
REVISION RECORD

REV. DATE REASON PAGE SER. DOC.


(MM/YY) /AUTHOR CHANGED No. PRODUCT.

INI. 04/'04 Mr. Matsumoto ------- TM-WI2

No. 2B730-670E
R-1 *
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 *
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: Indicates information of interest to users of system as to exceptional conditions


or operating procedures.

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. 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 *
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- *
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 Meaning

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.

CAUTION Indicates a potentially hazardous situation which, if not avoided, may


result in property damage.

2. Meaning of Safety Symbols

Symbol Description
Type-BF applied part
ECG : Type-BF equipment
Others : 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: Do not use flammable gasses such as anesthetics, or flammable


liquids such as ethanol, near this product, because there is danger of
explosion.

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 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 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.

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, high-


frequency 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 low-


temperature 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.

PATIENT
(2) If the patient information is modified by pressing 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.

* The symbol on the warning labels attached to the system indicates safety precautions.
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.

<<System to which pictogram labels are attached>>

<1> <3>

<2>

No. Label Meaning


<1> (a) Cautions against sitting on the system.
(b) Precautions regarding the registration of panel
switches

(a) (b)

<2> (a) Urges caution related to handling of the


transducers.
For handling of the transducers, refer to the
transducers’ operation manual.
(b) Cautions that the system must not be used
(a) (b) around flammable gasses.

<3> (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
<<System to which labels containing pictogram and characters are attached>>

<1> <3>

<2>

No. Label Meaning


<1> (a) Cautions against sitting on the system.

(b) Precautions regarding the registration of panel


switches

<2> (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.
<3> (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 *
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 *
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 : 700 hPa to 1060 hPa

NOTE: 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 *
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

<1> <2> <3> <4> <5> <6>


PRESET TRANSDUCER

<7>
STANDBY
PATIENT
ID A B C A/B
HDD

ACOUSTIC POWER

BS
1 2 3 4 5 6 7 8 9 0

Q W E R T Y U I O P

A S D F G H J K L
<8>
Shift Z X C V B N M

Ctrl Alt Alt Ins Del

<12> <13> <14> <17> <18>


<11> <19>

<10>
IP THI / FREQ

F-POSI

<15> <16>
<9> <26>
<22>
<23>
<20> <24> <27>
<21> <25> <28>
B GAIN

No. Name Function


<1> ACOUSTIC POWER Adjusts the ultrasonic beam output.
<2> NEW PATIENT Deletes the data for the previous patient, including the ID
and measured values, and resets the system.
<3> PATIENT ID The patient ID registration screen appears.
<4> PRESET Invokes the registered initial settings (presets).
<5> TRANSDUCER Selects a transducer.
<6> 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.
<7> STC Adjusts the ultrasound echo reception sensitivity according
to the depth from the body surface.
<8> 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.


<9> MENU Displays a menu according to the system status.
<10> Body mark Permits entry of body marks.

No. 2B730-670E
3-2
No. Name Function
<11> 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.
<12> IP Adjusts the image quality according to the registered
image conditions.
<13> M+B Displays B-mode and M-mode simultaneously.
<14> M Displays M-mode images in full screen mode.
<15> B single Displays a standard (single) B-mode image.
<16> B dual Displays two B-mode images side by side.
<17> 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.
<18> 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.
<19> F-POSI Adjusts the focus position.
<20> OUTPUT B Controls assigned output device (such as VCR or black-
and-white printer).
<21> OUTPUT A Controls assigned output device (such as VCR or black-
and-white printer).
<22> CINE Sets the trackball to image memory control mode.
<23> SET Determines the cursor position for measurement, and
determines the selected items, etc.
<24> Trackball Moves the cursor or mark during image movement or
measurement.
<25> GAIN Adjusts the sensitivity of black/white images. Also used to
play back the cine loop.
<26> NEXT Moves the cursor to the next position during measurement,
selected items, etc.
<27> STILL REVIEW No function is registered to this switch at the time of
shipment.
<28> 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

For connection of the


footswitches

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.

<1> <2> <3> <4>


VIDEO PARALLEL REMOTE RESET

<5> <6>
OUT SERIAL ETHERNET

IN

No. Name Functions


<1> VIDEO External video device input/output terminals
<2> PARALLEL Parallel ports
<3> REMOTE Printer connection terminals
<4> RESET System reset switch
<5> SERIAL Serial ports
<6> 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.

<1> <2> <3>

FUSE <4>
250V T4.0A

100V TOTAL MAX. 264VA 100V 50/60Hz


(ISOLATED/SWITCHED) 600VA

<5> <6>

No. Name Functions


<1> FUSE Fuse
<2> Main switch This is a circuit breaker.
<3> Functional earth terminal Terminal for the functional earth cable.
<4> Equipotential terminal Terminal for the potential equalization conductor.
<5> Outlet Connector for peripheral devices.
<6> 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 connector A
TRANSDUCER A

Transducer connector B
TRANSDUCER B

ECG Electrocardiogram (option)


FOOT SW 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 ( ) and contrast ( ) using the


corresponding knobs on the monitor.

(a) Set the contrast ( ) to minimum. The image disappears.

(b) Adjust the brightness ( ) so that the brightness level of the screen is the
same as in the examination room.

(c) Then adjust the contrast ( ) to set the maximum luminance.

NOTE: When this system is started up or another transducer is selected, you


may hear a click. This does not indicate abnormality.

6.2 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.

<System OFF/ON procedure>

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 Heart rate Scanning direction


Preset name Date
Time
TOSHIBA 123456789012 Abdominal 2004/03/16
Hospital name ABCDEF 999 9.9C9.9 100% PM 07:05:43
0
Transducer
frequency

Acoustic power

Focus mark

Image Process IP

(1) MI MI
10
9.9
(2) TIS TIS
9.9
(3) TIB TIB
9.9
(4) TIC TIC
9.9
9.9M 999 fps BG99 DR99
0:00:00

B frequency Current B gain Dynamic VCR


frame rate range value

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

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

Needle

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

No. 2B730-670E
8-2
(3) Press SET on the main panel.

• 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.

PATIENT
2. If the patient information is modified by pressing 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 to initialize the system.

PATIENT
(2) Press ID . The patient ID registration screen appears.

Patient Data Input


ID Number 2004/03/16
AM06:54:47
Name

Date of Birth (YYYY/MM/DD) Age

Sex Male Female Unknown

Height cm

Weight kg

BSA m2 ADULT

Blood Pressure High/Low / mmHg


LMP PRV EDD IVF CLN

Comment
ABC

ID List ID Save

Used: 10 Free: 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

(b) Occidental

• ADULT : BSA = WT0.425 * HT0.725 * 71.84 / 10000

HT : Height (cm)
WT : 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. ID Name EDD


1 111 AAA
2 123 BBB
3 222 CCC

Select Delete Delete All


Used: 3
Sort key Free: 1997
ID: Name: EDD (YYYY/MM/DD)
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 A or B is pressed, the corresponding preset is selected.

* When C 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 TRANSDUCER

STANDBY
PATIENT
ID A B C A/B
HDD

ACOUSTIC POWER

BS
1 2 3 4 5 6 7 8 9 0

Q W E R T Y U I O P

A S D F G H J K L
<3>
Shift Z X C V B N M

Ctrl Alt Alt Ins Del

<4> <2>, <6>

<5>
IP THI /FREQ

F-POSI

<7>

<1>
<8>
B GAIN

Adjustment items Procedures


<1> Sensitivity of the entire image Use the GAIN dial of the palm controller.

Gain
2D GAIN

<2> Field depth Use the DEPTH/ZOOM dial.


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

<3> Sensitivity according to the depth Use the STC slide controls.

<4> Calls up registered image-quality Use IP to select the desired image-quality


conditions. conditions.

IP

<5> Switches the focus position. Use F-POSI to switch the focus position.

F.POSI

No. 2B730-670E
11-2
Adjustment items Procedures
<6> Magnification, reduction, and Use the DEPTH/ZOOM dial and the trackball.
movement of the image
(1) When the DEPTH LED is lit, hold down the dial
(PAN/ZOOM)
to light the ZOOM LED.
(2) When the dial is turned, the image is
magnified/reduced. When the trackball is
DEPTH operated, the image moves.
ZOOM
(3) When the dial is held down again, the system
quits PAN/ZOOM and the DEPTH function is
selected.
<7> Switches the Switches the transmission/reception frequencies.
transmission/reception frequencies When a transducer that supports THI mode is used,
or switches to THI mode this switch is also used to set the system in THI
mode.

THI/FREQ

<8> Freeze the image (to a still image).


Press FRZ . When it is pressed again, the
FRZ
frozen image is restored to a real-time image.

No. 2B730-670E
11-3
(4) Adjustment using the menu

When is pressed, the B menu is displayed.


MENU

Automatically sets the focus of the ultrasound beam.

Increases image sharpness.

Adjust the dynamic range.

Adjusts the image smoothness.


B
Focal Ptn Adjusts the image smoothness in the axial direction.
Density
DR Adjusts the image smoothness in the lateral direction.
Time Smth
Axial Smth Selects the filter type.
LateralSmth
Mid Filter Enhances the edge of the image.
E.Enhance
AGC Suppresses comet-tail and reduces noise.
PostProcess
Reject Adjusts the image display intensity.
L/R
U/D Reduces noise at the low brightness level.
Rotation
Scan Rang Displays the image right-left reversed.
High Frame
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 is pressed, the M menu is displayed.


MENU

Adjusts the sweep speed of the M-mode image.

Adjusts the dynamic range.


M
Adjusts the sensitivity of the M-mode image.
M Speed
M DR
Enhances the edge of the image.
M Gain Cmp
M E.Enhance
Adjusts the image smoothness in the axial direction.
M AxialSmth
M Time Mark
Turns ON/OFF the Time mark display for the M image area.
M Time Smth
M Post Proc
Adjusts the image smoothness.
M AGC
M Max Smple
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 FRZ to freeze the image.

(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 frame-
advance 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 frame-
advance 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, high-


frequency 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 Displays ECG-gating images and live images simultaneously


Sync Mod (for dual-display mode).
Sync+Real
CH1 Performs ECG-gating at the delay time set.
Delay
Interval 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 . The body mark menu is displayed.


MENU

(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 SET .

(d) Select the body mark to be displayed and press SET . The selected body

mark is displayed on the screen.

No. 2B730-670E
14-1
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 . The menu for comment entry appears.


MENU

(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 . The menu for comment entry appears.


MENU

(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.

To display : Alt + W

To display : Alt + Q

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

SET
. The comment is enclosed by a box.

(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 SET


twice. The cursor appears.

(3) Using the , , , and keys on the keyboard, move the cursor to the
characters to be corrected.

(4) Enter the characters from the keyboard.

* 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 . The menu for comment entry appears.


MENU

(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 . The B mode menu is displayed.


MENU

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


.

A confirmation dialog is displayed.

(3) Select [OK] to display the Needle menu. Needle Guide


G Angle
G Display
G Size
Range Disp
Adapt Sel

(4) Select [G Display] and press SET


. A needle mark is displayed.

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 . The measurement menu


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 The left ventricular function can be measured by the
measurement 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 The left ventricular function can be measured by the
measurement 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: HDD File Type ALL
Folders File List
12345 Name Modify Time
123 AAAA.DCM 2003-12-10 14:45

OK To Server 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 File Type ALL
Folders File List
12345 Name Modify Time
123 AAAA.BMP 2003-12-10 14:45
BBBB.CIN 2003-12-11 13:15

OK To Server 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)

Application Ispta.3 Isppa.3 MI


(mW/cm2) (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

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 Ispta.3 Isppa.3 MI


(mW/cm2) (W/cm2)
or
All regions 720 <190 <1.9
(except eyes)

With this trend, control of the level of acoustic power has been transferred from
manufacturers to users. This means that users have a higher degree of
responsibility for safety than manufacturers. Against this background, users are
required to understand the ultrasound bioeffects and their causes.

(5) ALARA (As Low As Reasonably Achievable)

It is required to practice ALARA when using ultrasound energy. Practicing ALARA


ensures that the total energy level is controlled below a low enough level at which
bioeffects are not generated while diagnostic information is being accumulated.
The total energy is controlled by output intensity and total radiation time. The
output intensity necessary for examinations differs depending on the patient and
the clinical case.
Not all examinations can be performed with an extremely low level of acoustic
energy. Controlling the acoustic level at an extremely low level leads to low-quality
images or insufficient Doppler signals, adversely affecting the reliability of the
diagnosis. However, increasing the acoustic power more than necessary does not
always contribute to an increase in quality of information required for diagnosis,
rather increasing the risk of generating bioeffects.
Users must take responsibility for the safety of patients and utilize ultrasound
deliberately. Deliberate use of ultrasound means that output power of ultrasound
must be selected based on ALARA.

No. 2B730-670E
20-2
20.2 MI/TI Display Description
Mechanical Index (MI) formula is the spatial peak value of the peak rarefactional
pressure Pr.3 (Zsp), derated by 0.3 dB/cm-MHz at each point along the beam axis,
divided by the square root of the center frequency fc (in MHz). That is:

Pr.3 (Z sp )
MI =
fc

Thermal Index (TI) is a quantity related to calculated or estimated temperature rise


under certain defined assumptions. TI is the ratio of total acoustic power to the acoustic
power required to raise tissue temperature by 1 degree centigrade under defined
assumptions.

TIS (Thermal Index Soft Tissue) is related to heating in abdominal, cardiac and
peripheral vascular applications.

TIB (Thermal Index Bone) is related to bone heating, which may be of particular
importance in fetal applications.

TIC (Thermal Index Cranial) is related to heating in adult cephalic applications.

Display Accuracy is a manufacturer's specification as to how closely the displayed


values correspond to actual measured values. The display accuracy for acoustic output
indices is +/-0.1.

Display Precision is rounded in units of 0.1.

20.3 Parameters Affecting the MI/TI Values


The MI/TI values are affected by transmission conditions (focus, drive frequency,
voltage applied to piezoelectric elements, etc.), scan conditions, and settings of the
main panel, and preset menu.

No. 2B730-670E
20-3
20.4 Operating Procedures for MI/TI
The control of ultrasound output and the most useful switches for this purpose are
described below.

(1) ACOUSTIC POWER knob

The output intensity is one of the available


ultrasound output control parameters. It
can be adjusted with the ACOUSTIC
POWER knob at the right end of the main Low High
panel. To decrease ultrasound output, turn
the knob counterclockwise and to increase ACOUSTIC POWER
ultrasound output, turn the knob clockwise.

(2) Setting the defaults for ACOUSTIC POWER

Selection of diagnostic applications is the most important factor for controlling


ultrasound output.
The permissible level of intensity of ultrasound differs depending on the region of
interest. For fetal examinations, in particular, much care must be exercised. For
this reason, the switch must be used to reset the parameters for each new
patient, and the Preset menu must be used to select the settings appropriate for
each new region of interest.
This system allows defaults to be set for MI, TIS, TIB, and TIC using the preset
menu. The defaults automatically adjust the ACOUSTIC POWER level so that
MI, TIS, TIB, and TIC do not exceed their own settings at the time of power
ON, , switching of the transducer, and other initializations.

Default choices

Initial power 20% to 100%*

* Definition of 100%:

The maximum acoustic power of a transducer determined by the


increase in transducer surface temperature in the selected mode and the
acoustic power restrictions specified by the FDA.

When 100% is set as the default setting value, the default function does not
operate.
Any changes to the default setting value are the responsibility of the user.

No. 2B730-670E
20-4
20.5 References for MI/TI
For further information on measurement methods and MI/TI, refer to the followings:

(1) "510 (K) Guide For Measuring and Reporting Acoustic Output of Diagnostic
Ultrasound Medical Devices" issued by FDA in 1993

(2) "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment,


Revision 2" issued by AIUM/NEMA in 1998

(3) "Standard for real-time display of thermal and mechanical acoustic output indices
on diagnostic ultrasound equipment" issued by AIUM/NEMA in 1998

(4) "Bioeffects and Safety of Diagnostic Ultrasound" issued by AIUM in 1993

(5) "Medical Ultrasound Safety" issued by AIUM in 1994

(6) "Information for Manufacturers Seeking Marketing Clearance of Diagnostic


Ultrasound Systems and Transducers" issued by FDA in 1997

No. 2B730-670E
20-5 *
21. Maintenance Check
TOSHIBA strives to ensure consistent product quality from manufacturing to installation
in order to ensure that the customers receive products with the best possible safety and
reliability characteristics. The customer is responsible for maintaining and operating the
products after purchase.
TOSHIBA representatives provide after-sales service for products out of warranty on a
pay-for-service basis.

21.1 Maintenance Checks to Be Carried Out by Customers


21.1.1 Cleaning the system

CAUTION: 1. Before cleaning the system, be sure to disconnect the


system power cable from the outlet of the facility.

If the system has been defective, an electric shock may


occur.

2. Do not spill or spray liquids such as water onto the system


or peripheral units. If a liquid such as water enters the
system or peripheral units, an electric shock may occur.

CAUTION: Do not use solvents (such as paint thinner or benzine) or abrasive


cleansers for cleaning the system. These substances may cause
deterioration in the monitor.

(1) Cleaning the transducer

Clean, disinfect, and sterilize the transducer referring to the operation manual
provided with the transducer.

(2) Cleaning the transducer holder

(a) Wipe off any stains on the transducer holder using a soft dry cloth.

(b) If it is difficult to remove stains, wipe off stains using a soft cloth moistened
with mild detergent and then tightly wrung out.

(3) Cleaning the transducer connector

(a) Wipe off any stains on the transducer connector using a soft dry cloth.

(b) If it is difficult to remove stains, wipe off stains using a soft cloth moistened
with water and then tightly wrung out.

(4) Cleaning the monitor

Wipe the monitor using a soft cloth moistened with glass cleaner and then tightly
wrung out.

CAUTION: Do not use hydrocarbon glass cleaner or cleaner for the OA


equipment to clean the monitor. This substance may cause
deterioration in the monitor.

No. 2B730-670E
21-1
(5) Cleaning the system, monitor cover, and panel

(a) Wipe off stains using a soft cloth moistened with mild detergent and then
tightly wrung out.

(b) Clean around the switches or keys on the main panel using cotton buds.

(6) Cleaning the air filters

(a) Press down the tabs of the air filter to remove the air filter cover.

Air filter cover

Tabs

(b) Press the tabs to separate the dust-proof net from the air filter cover.

Tabs

Dust-proof net

(c) Vacuum dust from the air filter cover and dust-proof net at least once a month.

21.1.2 Creating a backup copy of the system hard disk


To take precautions for any deterioration or loss of data stored on the system hard disk,
create a backup copy of the hard disk at appropriate times.

No. 2B730-670E
21-2
21.2 Maintenance Checks to Be Carried Out by Service
Personnel
The following checks are required to ensure the performance and safety of the system.
Contact your TOSHIBA representative when carrying out these checks, because they
require special techniques.

Check category Check item Check interval


Cleaning Filter 1 year
Interior of the system
Peripheral units
Electric safety Protective conductor resistance 1 year
Ground line leakage current
Enclosure leakage current
Patient leakage current I
Patient leakage current III
Patient auxiliary current
Mechanical safety Check of the casters 1 year
Check of the caster mounting sections
Check of the monitor mounting mechanism
Operating panel
Mounting mechanism for the peripheral devices
Other mechanical parts
External appearance of the transducer
Image recording Images in each mode 1 year
Image recording using the standard transducer

21.3 Consumable Parts and Parts Requiring Periodic


Replacement
This system contains some parts requiring periodic replacement and some consumable
parts.
The consumable parts include the casters, fuses, monitor, lamp at the bottom of the
monitor, etc. For replacement, special techniques are required. Contact your
TOSHIBA representative.

No. 2B730-670E
21-3 *
22. Checks Before the System Is
Judged Defective
If no images are displayed while the power is ON, or characters are displayed but no
images are displayed, etc., check the items listed below before determining that the
system is defective.

Problems What to do
The system cannot be Confirm that the power cable is connected to the outlet correctly.
turned ON. Check the main switch.
The system can be • Adjust the "CONTRAST" "BRIGHTNESS" knobs on the monitor.
turned ON, but no • Check whether the equipment is in external video signal input
images are displayed. mode.
Characters are First, set the ACOUSTIC POWER dial, GAIN dial, and STC slide
displayed but no controls to their maximum positions. If still no images are displayed,
images are displayed. confirm that the transducer is connected to the transducer connector
correctly, or use a different transducer.

If the system cannot be turned ON, or problems are not resolved, or the system seems
abnormal after checking the above items, contact your TOSHIBA representative.

CAUTION: If the main switch is tripped, be sure to consult your TOSHIBA


representative. If the main switch is turned ON again without checking the
problem, the system or the device may be damaged more seriously.

No. 2B730-670E
22-1 *
23. Accuracy of Measurement
Accuracy of Each Clinical Measurement Parameter

Parameter Ranges Error


- Image Depth Scale 20 to 240 mm < +/- 4% of full scale
- ECG/Image Time Scales 1, 2, 4, 8 s 1 s: 3 ms (max.)
2 s: 6 ms (max.)
4 s: 12 ms (max.)
8 s: 24 ms (max.)
Two-dimensional Measurements
- Distance / Depth Up to 240 mm < +/- 3% or < 1.5 mm, if below 40 mm
2
- Area Up to 720 cm < +/- 7% or < 120 mm2, if below 16 cm2
- Trace(Ellipse, Circle) Up to 560 cm2 < +/- 7% or < 120 mm2, if below 16 cm2
- Angle 0 – 180 degrees < +/- 3%
- Ratio (A/B)
Result B/A & (A-B)/A Up to 1.0 < +/- 10% of A
Result A/B 1.0 – 99.9 < +/- 10% of A
Time Motion (TM) Measurements
- Depth Up to 240 mm < +/- 3% or < 1.5 mm, if below 40 mm
- Time Up to 8 s < +/- 2%
- Heart Rate 15 – 999 bpm < +/- 5%
- Velocity Up to 999 mm/s < +/- 5%
Volume Measurements
- Volume (Area, Length, Diameter) Up to 999 cm3 < +/- 10% or < 6.4 cm3, if below 64 cm3
- Prostate Volume Up to 999 cm3 < +/- 10% or < 6.4 cm3, if below 64 cm3

Range of Accuracy
These measurements will hold the accuracies stated above over the entire selected
field of view. The accuracy stated is either the measured value or calculated for worst
case conditions.

No. 2B730-670E
23-1 *
24. Conformance Standards
(1) General : IEC60601-1 (1988), AMD No. 1 (1991), AMD No. 2 (1995)
(IEC60601-1-1, IEC60601-1-2 (2001)/UL/CSA/SDA)

(2) Flammability : UL544 (1998), UL94, UL746C, UL796

(3) Acoustic power : Information for Manufacturers Seeking Marketing Clearance of


Diagnostic Ultrasound Systems and Transducers (1997)
IEC60601-2-37

No. 2B730-670E
24-1 *
25. Safety Classification
This system is classified with respect to safety characteristics.

(1) According to the type of protection against electric shock:

• CLASS I EQUIPMENT

(2) According to the degree of protection against electric shock:

• EQUIPMENT WITH TYPE-BF APPLIED PARTS

(3) According to the degree of protection against harmful ingress of water:

• IPX0 (enclosed EQUIPMENT without protection against ingress of water)

• The optional footswitch is classified as IPX8.

(4) According to the degree of safety of application in the presence of FLAMMABLE


ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE:

• EQUIPMENT not suitable for use in the presence of a FLAMMABLE


ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE

(5) According to the mode of operation:

• CONTINUOUS OPERATION

No. 2B730-670E
25-1 *
26. Guidance and Manufacturer's
Declaration
This product complies with the EMC standard IEC60601-1-2: 2001.

Guidance and manufacturer's declaration - electromagnetic emissions


The SSA-530A is intended for use in the electromagnetic environment specified below. The
customer or the user of the SSA-530A should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The SSA-530A uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions Class B The SSA-530A is suitable for use in all establishments,
CISPR 11 including domestic establishments and those directly
connected to the public low-voltage power supply network
Harmonic emissions Class A
that supplies buildings used for domestic purposes.
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3

No. 2B730-670E
26-1
Guidance and manufacturer's declaration - electromagnetic immunity
The SSA-530A is intended for use in the electromagnetic environment specified below. The
customer or the user of the SSA-530A should assure that it is used in such an environment.
Electromagnetic
Immunity test IEC 60601 test level Compliance level
environment - guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,
discharge (ESD) ±8 kV air ±8 kV air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output hospital environment.
lines lines
Surge ±1 kV differential ±1 kV differential Mains power quality should be
IEC 61000-4-5 mode mode that of a typical commercial or
±2 kV common mode ±2 kV common mode hospital environment.
Voltage dips, <5 % UT <5 % UT Mains power quality should be
short interruptions (>95 % dip in UT) (>95 % dip in UT) that of a typical commercial or
and voltage for 0,5 cycle for 0.5 cycle hospital environment. If the
variations on 40 % UT 40 % UT user of the SSA-530A requires
power supply (60 % dip in UT) (60 % dip in UT) continued operation during
input lines for 5 cycles for 5 cycles power mains interruptions, it is
IEC 61000-4-11 70 % UT 70 % UT recommended for the
(30 % dip in UT) (30 % dip in UT) SSA-530A to be powered from
for 25 cycles for 25 cycles an uninterruptible power supply.
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 Hz) fields should be at levels
magnetic field characteristic of a typical
IEC 61000-4-8 location in a typical commercial
or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

No. 2B730-670E
26-2
Guidance and manufacturer's declaration - electromagnetic immunity
The SSA-530A is intended for use in the electromagnetic environment specified below. The
customer or the user of the SSA-530A should assure that it is used in such an environment.
Electromagnetic
Immunity test IEC 60601 test level Compliance level
environment - guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the SSA-530A, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
Conducted RF 3 Vrms 3 Vrms d = 1.2 P
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m 3 Vrms d = 1.2 P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz
d = 2.3 P 800 MHz to 2.5
GHz
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m). Field
strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the SSA-530A is used exceeds the
applicable RF compliance level above, the SSA-530A should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the SSA-530A.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

No. 2B730-670E
26-3
Recommended separation distances between portable
and mobile RF communications equipment and the SSA-530A
The SSA-530A is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SSA-530A can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the SSA-530A as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output m
power of transmitter
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

No. 2B730-670E
26-4 *
27. Indication of Year of Manufacture
The year of manufacture is shown on the label attached on the rear of the system.

No. 2B730-670E
27-1 E
For Europe:
The equipment described in this manual is in accordance with the requirements of the Medical
Device Directive 93/42/EEC.

Authorized Representative in the EC:


Toshiba Medical Systems Europe BV
Zilverstraat 1
2718 RP, Zoetermeer
The Netherlands

Unauthorized modification of the product or configuration invalidates the CE Marking.

For other countries, please contact your local distributor.

1385, SHIMOISHIGAMI, OTAWARA-SHI, TOCHIGI-KEN 324-8550, JAPAN

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