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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.
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!
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
No. 2B730-670E
R-1 *
Intellectual Property
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.
(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.
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:
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
No. 2B730-670E
-a-
Operation
No. 2B730-670E
-b-
10. Selecting Presets ....................................................................... 10-1
10.1 Introduction................................................................................................ 10-1
No. 2B730-670E
-c-
15.3 Entry of the Arrow Mark .................................................................... 15-2
Measurements
General Information
No. 2B730-670E
-d-
19. Other Function .............................................................................. 19-1
19.1 Beep Tone Adjustment ...................................................................... 19-1
No. 2B730-670E
-e-
26. Guidance and Manufacturer's
Declaration.......................................................................................... 26-1
No. 2B730-670E
-f- *
Safety Precautions
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.
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.
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.
No. 2B730-670E
S-2
WARNING: 8. Do not subject the transducers to knocks. Use of defective
transducers may cause an electric shock.
11. When the optional ECG cable is used, the following measures are
required.
(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.
(4) To reduce the risk of electric shock or burns, use only the
cable and patient leads supplied with the reference signal
unit .
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) 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.
(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.
(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.
(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.
(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.
No. 2B730-670E
S-5
CAUTION: 10. Precautions regarding patient information entry
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.
(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.
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.
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.
<1> <3>
<2>
(a) (b)
(a) (b)
No. 2B730-670E
S-8
<<System to which labels containing pictogram and characters are attached>>
<1> <3>
<2>
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:
(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.
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
No. 2B730-670E
1-1 *
2. System Configuration
2.1 Standard Configuration
(1) Main unit
(2) Monitor
(3) Accessories
* 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 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
<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
<10>
IP THI / FREQ
F-POSI
<15> <16>
<9> <26>
<22>
<23>
<20> <24> <27>
<21> <25> <28>
B GAIN
(such as );
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.
No. 2B730-670E
3-3
3.3 Side Panel
NOTE: The ECG input is optional.
ECG
PATIENT
FOOT SW
No. 2B730-670E
3-4
3.4 Rear Panel
<5> <6>
OUT SERIAL ETHERNET
IN
No. 2B730-670E
3-5
3.5 Power Panel
NOTE: The voltage and current indications of the AC line differ depending on the
area.
FUSE <4>
250V T4.0A
<5> <6>
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
Transducer connector A
TRANSDUCER A
Transducer connector B
TRANSDUCER B
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.
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.
(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.
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.
Connect the power plug to an outlet for medical equipment. By doing this, the
protective earth line is connected.
No. 2B730-670E
5-1 *
6. Power ON/OFF
6.1 Power ON
(1) Check the items below before turning the power ON.
(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.
(b) Adjust the brightness ( ) so that the brightness level of the screen is the
same as in the examination room.
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.
(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
(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.
No. 2B730-670E
7-1
7.2 Checks After Turning ON the Power
After turning ON the power, perform the following checks.
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.
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
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.
The menu can be moved to the left or right by operating the trackball to the left
or right.
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.
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.
The item toggles between ON and OFF each time SET is pressed.
menu appears next to the menu. Select the desired item by operating the
mark on the right of an item indicates that other pull-down menus or pages
exist.
No. 2B730-670E
8-3 *
9. Entering the Patient ID
CAUTION: Observe the following precautions to avoid erroneous
diagnosis.
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.
No. 2B730-670E
9-1
9.1 Entering and Saving Data on the Patient ID Registration
Screen
PATIENT
(2) Press ID . The patient ID registration screen appears.
Height cm
Weight kg
BSA m2 ADULT
Comment
ABC
ID List ID Save
• 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) Oriental
(b) Occidental
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
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
(c) Select [OK] on the deletion confirmation screen. The patient ID data is
deleted.
(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.
* 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 .
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
<5>
IP THI /FREQ
F-POSI
<7>
<1>
<8>
B GAIN
Gain
2D GAIN
<3> Sensitivity according to the depth Use the STC slide controls.
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
No. 2B730-670E
11-3
(4) Adjustment using the menu
No. 2B730-670E
11-4
11.2 M Mode
(1) Entering M mode
Press M
.
Press B
.
M+B
No. 2B730-670E
11-5
(5) Adjustment using the menu
No. 2B730-670E
11-6 *
12. Cine Function
12.1 Introduction
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.
(2) When the trackball is operated, the system enters frame-advance playback mode.
(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.
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.
(4) Set the mode to M mode in which reference signals can be displayed.
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.
When [ECG] is selected from the [Other] menu, the following menu is displayed.
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.
(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.
(d) Select the body mark to be displayed and press SET . The selected body
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.
(4) When SET is pressed again, the body mark position is set.
* 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.
(2) Operate the trackball to move the cursor to the position where characters are to be
displayed.
(4) Press the comment entry switch to quit comment entry mode.
(a) Operate the trackball to move the cursor to the position where characters are
to be displayed.
(a) Operate the trackball to move the cursor to the position where characters are
to be displayed.
(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.
(c) When the multifunctional dial is rotated, the arrow mark is rotated.
(b) When the multifunctional dial is rotated, the arrow mark is rotated.
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) Using the , , , and keys on the keyboard, move the cursor to the
characters to be corrected.
* Pressing the Ins key on the keyboard toggles the system between insert
mode and overwrite mode.
SET
. The comment is enclosed by a box.
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.
(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.
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.
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.
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.
No. 2B730-670E
16-2
16.1 Display Method
The needle mark can be displayed on B mode images only.
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.
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.
([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.
The biopsy range marks are toggled between displayed and hidden.
(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.
No. 2B730-670E
16-4 *
17. Measurement
17.1 Basic Operation
The basic operating procedures are common to all measurements.
* 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.
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.
(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.
No. 2B730-670E
17-2
17.3 M-mode Measurements
The measurements listed below can be performed in M mode.
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.
Copy to CDR
HDD CD-R
12345
123
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.
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.
No. 2B730-670E
19-1 *
20. Using MI/TI
20.1 Basic Knowledge of MI/TI
(1) Concerns with bioeffects
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.
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.
The idea of MI/TI has been introduced recently to increase the diagnostic capability,
promoting relaxation of these acoustic power limits (TRACK3).
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.
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
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.
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.
Default choices
* Definition of 100%:
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
(3) "Standard for real-time display of thermal and mechanical acoustic output indices
on diagnostic ultrasound equipment" issued by AIUM/NEMA in 1998
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.
Clean, disinfect, and sterilize the transducer referring to the operation manual
provided with the transducer.
(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.
(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.
Wipe the monitor using a soft cloth moistened with glass cleaner and then tightly
wrung out.
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.
(a) Press down the tabs of the air filter to remove the 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.
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.
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.
No. 2B730-670E
22-1 *
23. Accuracy of Measurement
Accuracy of Each Clinical Measurement Parameter
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)
No. 2B730-670E
24-1 *
25. Safety Classification
This system is classified with respect to safety characteristics.
• CLASS I EQUIPMENT
• CONTINUOUS OPERATION
No. 2B730-670E
25-1 *
26. Guidance and Manufacturer's
Declaration
This product complies with the EMC standard IEC60601-1-2: 2001.
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.