2b771 - 050en - G - TOSHIBA XARIO - ENGLISH - OPERATION MANUAL

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No.

2B771-050EN*G

OPERATION MANUAL
FOR
DIAGNOSTIC ULTRASOUND SYSTEM

MODEL SSA-660A
[FUNDAMENTALS]
(2B771-050EN*G)

CAUTION:

In the USA, federal law restricts this device to sale by


or on the order of a physician.

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

 TOSHIBA MEDICAL SYSTEMS CORPORATION 2011-2015


ALL RIGHTS RESERVED
Introduction

This operation manual describes the operating procedures for the diagnostic ultrasound system
SSA-660A. To ensure safe and correct operation of the system, carefully read and understand
the manual before operating the system.

Trademarks
® ®
Microsoft Windows 2000 is a trademark of Microsoft Corporation in the U.S.A and other
countries.

Xario, ApliPure, DYNAMIC FLOW, and IASSIST are trademarks of Toshiba Medical Systems
Corporation.
This manual may include trademarks or registered trademarks of other companies.

Note that the trademark symbol "" and the registered trademark symbol "" are not used in
this manual.

IMPORTANT!

1. No part of this manual may be copied or reprinted, in whole or in part,


without prior written permission.

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

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

No. 2B771-050EN*G
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-B applied part
* Type B when Type-B applied part is connected.
The PCG sensor and pulse sensor that can be connected
to this system are Type-B applied parts.
Type-BF applied part
* Type BF when Type-BF applied part is connected.
Reference signal cables that can be connected to this
system are Type-BF applied parts.
"Attention" (Refer to the operation manual.)

No. 2B771-050EN*G
S-1
3. Safety Precautions

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

3.1 Safety precautions in the operation manual


<<Fundamentals volume>>
The following four precautions are related to EMC.
 WARNING No. 10 on page S-4

 CAUTION No. 2 on page S-7


 CAUTION No. 1 on page S-17
 CAUTION No. 2 on page S-17

DANGER: Do not use flammable gases such as anesthetics or flammable


liquids such as ethanol near this product. Doing so may cause an
explosion.
This product is not intended for use with oxygen or in an oxygen
enriched atmosphere.

WARNING: 1. Warnings concerning electric shock, fire, and burns

(1) If an abnormal smell or noise, or smoke occurs, immediately


turn the system breaker OFF and disconnect the plug from
the power outlet. Continuing to use the system with such an
abnormality may result in a fire etc. When using the system,
ensure that there is enough space for access to the breaker.

(2) To prevent fire or electric shock, observe the following


instructions regarding the power cable and plug.

 Do not forcibly bend the cable.


 Do not modify the power cable or plug.
 Do not damage the power cable or plug.
 Do not pull the power cable to disconnect the plug from
the outlet.
 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.

(3) 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.

(4) Do not connect to the system transducers other than those


specified by TOSHIBA, to prevent accidents such as fire.

(5) Do not use a defective transducer.

No. 2B771-050EN*G
S-2
WARNING: (6) Do not remove the covers or panels of the system.

(7) When in the patient environment, the operator must not


touch any exposed connectors. In addition, if the system
covers have been removed for some reason, the operator
must be extremely careful not to touch any part where the
voltage exceeds 25 VAC or 60 VDC and the patient at the
same time.

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 as protective earth is not


allowed. The system should be connected according to local
requirements and should not conflict with IEC60601-1
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. A separate power outlet of the specified rating must be provided


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

7. Do not push the system from the side. If the system is pushed
from the side, it may fall down and cause injury.

No. 2B771-050EN*G
S-3
WARNING: 8. When the optional reference signal 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 reference signal


cable.
 The reference signal cable must be connected correctly.

(2) Connect the reference signal cable to the system before


attaching the ECG electrodes to the patient. After the
electrodes are attached to the patient, be careful not to allow
them to come into contact with ground or other electrically
live parts. If the reference signal cable connector or an
electrode comes into contact with ground or other
electrically 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 (UJUR-660A).

(5) The ECG electrodes used should be commercially available


products provided by the customer.

9. Before using equipment such as an electric scalpel, high-


frequency therapy equipment, an electro stimulator, or a
defibrillator, remove the ECG electrodes from the patient. In
addition, do not allow ultrasound transducers, a PCG
microphone, a respiratory sensor, or a pulse sensor to come into
contact with the patient. The patient may be burned or receive an
electric shock.

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

No. 2B771-050EN*G
S-4
WARNING: 11. Cautions regarding the biopsy procedures

(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.

(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.

No. 2B771-050EN*G
S-5
WARNING: (8) Confirm that the selected needle mark angle matches the
angle indicated on the biopsy adapter to be used.

(9) The biopsy target may shift due to unexpected patient


motion when the biopsy needle is inserted, or else due to
respiratory movement. Always monitor the target region and
the needle tip while performing a biopsy procedure.

12. When a transducer is applied to a patient with a high body


temperature, the rate of heat dissipation from the transducer may
be lower than normal. Take care not to cause a burn during
examination (especially during surgery or an intracavitary
examination).
If the surface temperature of the transducer becomes abnormally
high, stop using the transducer and contact your service
representative.

13. 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.

14. This system is provided with a lossy data compression function


for images. Although this function helps reduce the size of
stored images, it can cause image deterioration. The amount of
compression, therefore, must be limited so that the image quality
is maintained at a level which does not adversely affect image
viewing.

15. For the safety precautions regarding the use of contrast medium
etc. in CHI mode, refer to the operation manual, Application
volume.

16. Prepare a backup system when an urgent examination is to be


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

17. Handling the cord on this product will expose you to lead, a
chemical known to the State of California to cause birth defects
or other reproductive harm.
Wash hands after handling.

18. This device is contraindicated for ophthalmic use or any


application that causes the acoustic beam to pass through the
eye.

19. Do not use the controls, adjusters, or operating sections of the


DVD/CD unit in a manner other than specified. Incorrect use may
cause hazardous beams to be radiated.

No. 2B771-050EN*G
S-6
CAUTION: 1. Precautions concerning clinical examination techniques
(1) This operation manual is intended for users who are well-
versed in the principles and basic techniques of ultrasound.
(2) This system must be used only by medical personnel fully
trained in clinical examination techniques.
(3) This operation manual does not describe clinical examination
techniques. Selection of the proper clinical examination
technique must be based on specialized training and clinical
experience.
2. Malfunctions due to radiowaves

(1) This system may malfunction due to electromagnetic influence


from electric scalpels, high-frequency therapy equipment, or
other devices that generate high frequencies.
(2) 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.
(3) 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) When the system is moved over a sloped surface, it must be
moved by two persons. Otherwise, the system may slide
unexpectedly and cause a serious injury.
(3) Do not sit on the system.
The system may move, causing you to lose your balance and
fall.
(4) Do not place any objects on top of the monitor. They may fall,
causing injury.
(5) Confirm that movable sections such as the LCD monitor and
operating panel are locked before moving the system.
Otherwise, the movable sections may move unexpectedly and
cause 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 reference signal 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.

No. 2B771-050EN*G
S-7
CAUTION: (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.

4. 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.

5. Do not rub the LCD surface with a hard material or apply strong
pressure to the LCD surface. Doing so may cause scratches on the
LCD surface or result in damage to the monitor.

6. Terminals and connectors on the system side panel

(1) Only the specified device must be connected to the USB


connector or other connectors. Otherwise, smoke or an electric
shock may result.

(2) Only equipment that conforms to the safety standards must be


connected to the ETHERNET terminal on the side panel.
Otherwise, smoke or an electric shock may result.

(3) 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.

(4) When a HUB is used, turn ON the system power only after
tuning ON the power to the HUB.

7. Physio panel (option)

(1) Only medical equipment that conforms with the IEC60601-1


standards must be connected to DC IN and AUX. Otherwise, an
electric shock may result.

(2) When external signals are input to DC IN and AUX of the Physio
panel, the signal level that can be input is restricted. Contact
your TOSHIBA representative for details.

8. Main panel switch configuration

(1) The switch configuration on the main panel of this system can
be changed. The switch settings may therefore differ
depending on the system. When pattern U is set, the functions
of the switches may differ depending on the system even if the
same labels are attached to the switches. Confirm the switch
configuration of your system before use.
In particular, confirm the locations of the OUTPUT, STORE, and
FREEZE switches.
For details, refer to subsection 3.2 "Main Panel".

No. 2B771-050EN*G
S-8
CAUTION: (2) The descriptions in this operation manual are based on the
standard switch configuration. If the switch configuration has
been changed, the differences between the current
configuration and the standard configuration must be
understood before use.

9. Back up the stored data (image data and exam history) periodically
and delete unnecessary data. If there is a limited amount of free
space on the hard disk, the time required to display the ultrasound
image after the system power is turned ON increases.

10. Do not turn OFF the power supply of the system during printing,
data saving, or invoking. Doing so may result in failure of saving or
printing or damage to the data. In addition, doing so during access
to media may damage the media.

11. Standby mode

(1) Before setting the system to Standby mode, be sure to save or


print the necessary data. Otherwise, the data will be lost.

(2) Do not set the system to Standby mode during printing, data
saving, or invoking. Doing so may cause an error in these
processes.

(3) In addition, if the system is set to Standby mode during access


to media, the media may be damaged. Furthermore, when used
the next time, the printer or DVD/CD drive will not operate
correctly.

12. Precautions regarding patient information entry

(1) Be sure to register and save the patient ID before starting an


examination for a new patient. If measurement is performed for
a new patient for whom the patient ID is not registered or saved,
the measurement results and other data cannot be saved in the
system. In addition, the data for the two patients are mixed
together, which may result in incorrect diagnosis.

(2) 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.

(3) 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.

(4) Enter the patient information including LMP and IVF correctly in
the patient ID registration screen. Otherwise, the fetal growth
data will be calculated incorrectly.

(5) Do not enter a patient ID consisting of spaces only. Doing so


will result in reading/writing of data to/from media and DICOM
transfer to other systems being performed incorrectly.

No. 2B771-050EN*G
S-9
CAUTION: 13. Cautions regarding the presets
(1) When a new imaging preset is to be created, the Exam Type is
displayed automatically as the imaging preset name in the
dialog. Be sure to change it. Otherwise, the examination may
not be started with the factory setting even when "Factory" is
selected in Exam Type registration in the system preset setting
menu (refer to subsection 10.7).

(2) If a change has been made to the system presets, be sure to


turn OFF/ON the system power. Otherwise, the change will not
go into effect.

14. 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.

15. Precautions regarding the measurements

(1) For basic measurements, the measured data is lost when image
freeze is released or the image mode is changed during
measurement.

(2) The measurement data is lost when the system is turned OFF.
However, the measurement data saved for application
measurements is not lost.

(3) The basic measurement result is not displayed on the report.

(4) On the application measurement result screen, some


calculation results are displayed. To check all the
measurement results (calculation results), perform checks on
the report screen.

(5) The results edited on the report screen are not reflected in the
measurement results on the image display.

(6) When measurement is to be performed in M-mode or Doppler


mode, confirm that the entire screen has been refreshed after
changing the mode or settings. Otherwise, measurement may
not be performed correctly.

No. 2B771-050EN*G
S-10
CAUTION: 16. Do not display or print the data imported from other devices in this
system. Such data may not be able to be displayed or printed
correctly.

17. Peripheral units

(1) To prevent electric shock, do not connect the peripheral units


(video printer, VCR, etc.) to an external outlet. Peripheral units
should be connected to the service outlet of the system. For
the connection procedures, contact your TOSHIBA
representative.

(2) Some printers cannot detect print errors. Use the actual
printout to confirm whether the data is printed correctly.

(3) Do not turn OFF the power to the printer during printing. This
may result in system malfunction.

(4) Do not turn the power to peripheral devices ON or OFF during


the system startup or shutdown process. This may result in
system malfunction.

(5) When the system is in Standby mode, do not disconnect any


peripheral unit or turn the power ON/OFF. A malfunction of the
peripheral unit may result.

(6) When printing is executed, do not turn the system power OFF
before all the images are printed. The data in the print queue
may be lost.

(7) When the color printer is to be used for printing, make sure that
its power is ON. If printing is executed when the printer power
is OFF, a system malfunction may result.

18. When an attempt is made to archive images on media or transfer


them with the DICOM protocol, the following dialog may be
displayed.

Sorry. DVD/CD and DICOM storage are not available now.


Please store important images to hard disk.
Please power off and then power on to make them available.

In this case, archiving to media and DICOM transfer cannot be


performed. Store the important images on the hard disk.
If you wish to archive images on media or transfer them with the
DICOM protocol immediately, reboot the system.

19. The free space on the hard disk is displayed at the bottom of the
screen in the format "HDD: xx% Free". Data cannot be saved if the
free space is insufficient. Ensure the required free space before
saving the images.

No. 2B771-050EN*G
S-11
CAUTION: 20. Frame missing error in recording with the Snapshot Clips function
(1) If the system detects that 4 or more consecutive image frames
are missing, the error message below is displayed and the
images are not recorded. Release the freeze status and acquire
the image again.
"System busy. Failed in Storing the image."

(2) If the system detects that less than 4 consecutive image frames
are missing, the message below is displayed at the bottom of
the monitor. In this case, the images are recorded.
"System busy. Some frames were missing."

21. Acoustic power

(1) The FDA allows ultrasound equipment to output acoustic power


level TRACK3, which is higher than TRACK1, provided that
MI/TI values are displayed on the system. This means that
users have a higher degree of responsibility for safety than
manufacturers. Against this background, users are required to
understand the ultrasound bioeffects and their causes.

(2) It is strictly required that acoustic output be set based on the


ALARA (As Low As Reasonably Achievable) principle.
However, 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.

(3) Set the ultrasound output as low as possible when a fetus is to


be exposed to ultrasound.

(4) Note that there are switches on the operation panel, the pop up
menu and the touch panel other than the ACOUSTIC POWER,
the MI/TI value may change in a direction not intended for those
switches.

22. If preventive maintenance is performed by the user, special care


must be taken to ensure safety.

23. If any abnormality of the system is found as a result of inspection,


stop using the system and contact your TOSHIBA representative for
repair.

24. In no event shall TOSHIBA be liable for problems, damage, or loss


caused by inspection performed by personnel other than TOSHIBA
service personnel or those designated by TOSHIBA.

No. 2B771-050EN*G
S-12
CAUTION: 25. This system uses Windows 2000 as the OS. Do not change the
settings of the OS.

26. Problems that typically occur in personal computers may also occur
in this system. Important data must be stored on external storage
media.

27. Only software authorized by TOSHIBA should be installed in this


system. Otherwise, system failure or malfunction may result.
Contact your TOSHIBA representative for details.

28. The doctor's judgement should be used when using contrast


medium.
For the procedures for using contrast medium, contact the
manufacturer of the contrast medium.

29. Refer to the operation manual Measurement volume and Application


volume for precautions regarding the use of measurement
functions, optional software, etc.

30. 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.

31. 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.

32. Clean the reference signal cable regularly.

(1) Do not allow clips to wet. The ECG is not displayed correctly.

(2) Do not soak the connector in the water.


Wipe the connector with dry cloth only.
The water may enter the connector inside, possibly resulting in
failure.

(3) Do not use solvents (such as paint thinner, benzine, or alcohol)


for cleaning the reference signal cable.

33. Cleaning the LCD monitor

(1) Do not hit or apply strong pressure to the LCD surface during
cleaning. Doing so may damage the monitor.

(2) Never use a stiff or hard cloth to clean the LCD monitor.
Doing so may damage the monitor cover or LCD surface.

(3) If stains on the LCD surface are difficult to remove, wipe it


gently with a soft cloth slightly moistened with water.
Detergents or chemical agents should not be used because
they may damage the monitor.

No. 2B771-050EN*G
S-13
CAUTION: (4) Do not attempt to clean the LCD monitor with organic solvents
such as benzine, paint thinner, and alcohol or abrasive
cleaners.
Such agents may damage the monitor cover or LCD surface.
Also, do not use mild detergent to clean the LCD surface.

(5) Do not allow liquid droplets to remain on the LCD surface.


The droplets may cause small stains when they dry or may
enter the LCD surface, possibly resulting in failure.

34. Cleaning the trackball

(1) Be extremely careful when removing dial.

(2) Do not touch the encoding rollers. If foreign matter has


adhered to the encoding rollers, contact your Toshiba service
representative.

(3) Set the dial so that it is seated securely. If the ring is locked
with the dial not seated securely, the palm switch may be
damaged.

35. 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.

36. Malicious software

(1) If this system is connected to a network for which any of the


following conditions is true, the system can be infected with
malware (malicious software, such as a computer virus or
worm, that harms computers). The user must establish security
measures to prevent the system from being infected.

 Security control is not established for the network.

 There is a risk of malware invasion in the network.

 System for which any of the following conditions is true is


connected to the network.

(a) The security of the system is not controlled by the user.

(b) The system can be accessed by persons not authorized by


the user.

(c) The system is capable of wireless communication.

No. 2B771-050EN*G
S-14
CAUTION: (2) The following instructions must be observed in order to prevent
this system from being infected with malware (malicious
software, such as a computer virus or worm, that harms
computers).
If the system is infected with malware, the data stored in the
system may be lost, tampered with, or accessed by
unauthorized persons; the system may operate incorrectly; or
the system may become a source of malware infection.

 Do not connect this system to a network for which security


control is not established.

 Do not connect this system to the Internet.

 When an external storage media (such as a CD or USB flash


memory) is to be used, confirm in advance that the media is
not infected with malware.

 Do not perform any other actions that may result in


infection.

37. When discarding any part of this system, follow all applicable local
regulations.

38. When this system is used to examine an elderly patient or an infant,


an attendant should be present as required.

39. The displayed reference signals should be used for reference only.
They should not be used for diagnosis or monitoring. In patients
with cardiac pacemakers, an implantable electro stimulator, or
arrhythmia, the heart rate or other parameters may not be displayed
correctly.

40. Confirm that the LCD monitor arm is locked before moving the
system. Otherwise, the LCD monitor arm may move unexpectedly,
resulting in personal injury.

41. Do not place your hand on the LCD monitor arm or under the LCD
monitor when adjusting the monitor angle. There is a risk of hand
injury.

42. DVD/CD unit

(1) Do not use lens cleaner to clean the disk. Lens cleaner will
damage the drive.

(2) Do not place adhesive labels on the disk. They may cause read
errors or scratches on the disk.

(3) Do not eject the media by pressing the [Eject] button during
writing to the media. The data on the media may be damaged.

No. 2B771-050EN*G
S-15
CAUTION: (4) A disk that has been purchased in a spindle package may have
protective sponge material applied to its surface. If such
sponge material enters the internal mechanism of this unit, a
malfunction may result. Confirm that there are no traces of
sponge material on the disk before loading it into the unit.

(5) The tray slides out approximately 15 cm when it is ejected.


Keep the area in front of the tray clear. If the tray hits an
obstacle, the tray may be damaged.

(6) Do not leave the tray open. Dust may enter the unit and cause a
malfunction, or a person may hit the tray and be injured. Open
the tray only when necessary.

43. Do not connect any device to the USB connector other than a USB
flash memory for storing and reviewing image data.

44. Do not press two or more switches on the system simultaneously.


System malfunction may result.

45. During the system startup or shutdown process (or in standby


status), do not attempt to operate the system (for example, turning a
peripheral device ON/OFF, placing media into or removing media
from the drive, or pressing a switch on the system). System
malfunction may result.

No. 2B771-050EN*G
S-16
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 by walls, etc. (a
space at least 10 cm wide and 20 cm deep is required.)

4. Turn ON the system only after the power has been OFF for more than 15
seconds. If the system is turned ON immediately after being turned OFF, the
system may malfunction.

5. 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.

6. Move the system by the handle. If the user pushes or pulls other sections
such as the panel, the system may be damaged.

7. Do not press or use force on the main panel. It may damage the system.

8. The service outlet on the main unit provides power to recommended external
options only. (Refer to subsection 2.3 "Compatible Peripheral Devices".) Do
not connect other devices or the power capacity may be exceeded, and the
system may malfunction.

9. The cooling fan must be cleaned once every 1 year. If the cooling fan is
clogged, the internal temperature will rise, shortening the service life of the
system. For inspection and cleaning by service personnel, contact your
TOSHIBA representative.

10. 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.

No. 2B771-050EN*G
S-17
CAUTION: 11. Observe the following precautions before moving the system to prevent
system malfunctions.

(a) Turn the power OFF and then turn OFF the breaker on the power supply
panel at the rear of the system.

(b) Store the transducer in the transducer holder and hang the cable on the
transducer cable hanger.

(c) When moving the system, use the handle. Do not push delicate sections
such as the panel.

12. Do not stop the moving system using the total lock function except in
emergencies. The casters can be damaged and abnormal operation can
result.

13. Before connecting or disconnecting a transducer, deselect the transducer or


turn the power OFF. If a transducer is connected or disconnected with an
image displayed, the system and/or the transducer may malfunction.

14. Do not connect or disconnect a transducer during the system startup or


shutdown process. This may result in system malfunction.

15. When lowering the main panel, take care not to apply a load to the cable hook
or transducer holder. The cable hook or transducer holder may be damaged.

16. If the power cannot be turned OFF by the normal procedure, press and hold
down POWER for at least 5 seconds. If the power is still not turned OFF, turn
OFF the breaker of the power supply panel at the rear of the system.
These methods should not be used under normal conditions. They may
damage the system.

17. If the power is not turned OFF by following the normal procedures, 2D mode
images may not be displayed when the system power is turned ON again.
This does not indicate system failure. Turn OFF the breaker on the power
supply panel on the rear of the system, wait at least 15 seconds, and then turn
ON the breaker again. When the STANDBY LED lights, turn ON the power
switch.

18. When the message "Printing" is displayed at the bottom-left corner of the
monitor, it indicates that the system is ready to output images to the printer.
Check the printer output for completion of the actual printing.
Note that if the next print operation is executed while "Printing" is displayed,
the next image is not printed. Confirm that the message "Printing" is cleared
before executing the print operation.

19. When you wish to change an application preset, confirm that the application
preset is displayed on the screen.
Only changes to the displayed application preset can be saved.

20. When the measurement data displayed on the report screen is edited, the
original data is overwritten by the edited data. The original data is not saved.

No. 2B771-050EN*G
S-18
CAUTION: 21. If a result for a measurement item is deleted on the report edit screen, the
measurement item, the mean of the item, and the calculation results obtained
using the measurement value (or mean) are all deleted automatically. To
redisplay these values, the item must be measured again. Before saving the
contents of the report edit window, confirm that the necessary data has not
been deleted.

22. Do not use hydrocarbon glass cleaner or cleaner for the OA equipment to
clean the monitor. This substance may cause deterioration in the monitor.

23. Do not use solvents (such as paint thinner, benzine, or alcohol) or abrasive
cleansers for cleaning the system. These substances may cause
deterioration in the monitor.

24. Do not boot the system while the air filters are removed. The system may
malfunction.

25. Do not use the maintenance menu during an examination. The maintenance
menu must be started before a patient ID is registered after system power ON,
or after an examination is terminated by pressing twice.

26. Do not mount/remove the transducers during remote maintenance. Doing so


may damage data in the system.

27. If the main switch or circuit protector 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.

28. DVD/CD unit

(a) Do not remove the DVD/CD unit from the system. The performance of
the DVD/CD unit cannot be guaranteed if it has been removed from the
system.

(b) Do not use the software CD supplied with the DVD/CD unit in this
system.

(c) Data writing to media other than the recommended media cannot be
guaranteed.

29. USB flash memory

Do not remove the USB flash memory without following the proper [Eject]
procedure. Otherwise, data on the memory may be damaged.

30. Manage the system properly to prevent it from being infected with computer
viruses.

31. Refer to the Operation Manual (Measurement Volume and Application


Volume) for precautions regarding the use of measurement functions, optional
software, etc.

No. 2B771-050EN*G
S-19
3.2 Safety precautions in the operation manual
<<Applications volume>>

WARNING: 1. This system is provided with a lossy data compression function


for images. Although this function helps reduce the size of
stored images, it can cause image deterioration. The amount of
compression, therefore, must be limited so that the image quality
is maintained at a level which does not adversely affect image
viewing.

2. Using a contrast medium

(1) Handle the contrast medium as described in the operation


manual supplied with the contrast medium. TOSHIBA is not
liable for any damage or injury resulting from misuse of
contrast media.

(2) Check the side effects of the contrast medium used with the
manufacturer of the contrast medium.

(3) If there is an abnormality with the patient during use of the


contrast medium, stop the examination and perform
appropriate treatment.

(4) Cavitation may occur due to interactions between the


ultrasonic waves and the contrast medium. Always perform
examination using the ALARA (as low as reasonably
achievable) principle. The acoustic power can be changed
using the ACOUSTIC POWER dial on the main panel.

3. Pharmaceutical loading in stress echo examinations

(1) Handle the loading pharmaceutical such as Dobutamin as


described in the instructions supplied with the
pharmaceutical. TOSHIBA is not liable for any damage or
injury to the patient resulting from misuse of
pharmaceutical.

(2) Check the side effects of the pharmaceutical used with the
manufacturer of the pharmaceutical.

(3) If there is any abnormality with the patient during use of the
pharmaceutical, stop the examination and perform
appropriate treatment.

(4) If there is any abnormality with the patient during an


exercise test such as a treadmill exercise test, stop the
examination and perform appropriate treatment. TOSHIBA is
not liable for any damage or injury to the patient resulting
from an exercise test.

No. 2B771-050EN*G
S-20
WARNING: 4. IASSIST controller

(1) The IASSIST controller may cause cardiac pacemakers that


are in the vicinity to malfunction.
Do not use the IASSIST controller within 25 cm of persons
who use a cardiac pacemaker.

(2) Do not use the IASSIST controller in locations where


precision instruments that may affect human life are
installed, such as an operating room. Malfunction in the
instruments may occur.

5. TEE transducer

(1) If the temperature detection function of the TEE transducer


becomes abnormal, the message below is displayed.

In this case, stop the examination immediately, make the


angle free, return the transducer to a neutral angle, and then
withdraw the transducer carefully. Then, contact your
Toshiba service representative.

(2) During scanning using the TEE transducer, the following


message is displayed if the temperature at the transducer
end exceeds 43°C for two minutes or more.

In this case, stop the examination immediately, make the


angle free, return the transducer to a neutral angle, and then
withdraw the transducer carefully. The diagnostic
ultrasound system must be restarted in order to perform
examination again.

No. 2B771-050EN*G
S-21
WARNING: 6. 4D Biopsy

(1) Before starting a biopsy procedure, confirm that the biopsy


target is clearly visible on the image displayed in 4D Biopsy
mode.

(2) When the volume rate setting is low, movement of the


biopsy needle and organs cannot be observed while the
image is being refreshed. In such cases, extra caution is
required during biopsy procedures.

(3) For the general safety precautions and other important


information for biopsy procedures, refer to safety
precautions in section 16 "Needle Mark Display" of the
operation manual <<Fundamentals>> volume.

CAUTION: 1. Patient ID registration

(1) Be sure to register and save the patient ID before starting an


examination for a new patient. If measurement is performed
for a new patient for whom the patient ID is not registered or
saved, the measurement results and other data cannot be
saved in the system. In addition, the data for the two patients
are mixed together, which may result in incorrect diagnosis.

(2) Before starting an examination for a new patient, confirm that


the patient ID matches the patent to be examined. Images can
be recorded with an incorrect patient ID.

(3) Enter height, weight, LMP (Last Menstrual Period), IVF (In
Vitro Fertilization date), and other information correctly.
When the function for reusing the information entered for the
immediately preceding examination (described in subsection
1.8 of <<Applications volume>>) is used, confirm that these
data items are entered correctly. Otherwise, BSA and fetal
growth data will be calculated incorrectly.

(4) Check the date format before entering the date of birth, LMP
(Last Menstrual Period), or EDD (Estimated Date of Delivery).

2. Back up the saved data (image data and exam history) periodically
and delete unnecessary data from the hard disk to ensure free
space on the hard disk. New data cannot be stored if the free
space on the hard disk is insufficient.

3. The free space on the hard disk is displayed at the bottom of the
screen in the format "HDD: xx% Free". Images cannot be saved if
the free space is insufficient.

When the free space becomes lower than 20%, the message
display color is changed to yellow.
When the free space becomes lower than 10%, the message
display color is changed to red.

Ensure the required free space before saving the images.

No. 2B771-050EN*G
S-22
CAUTION: 4. If the message "HDD is Full" is displayed, back up the stored data
(image data) to removable media using the Copy function etc. of
the Patient Browser. Then, delete unnecessary examinations and
images using the Patient Browser.

5. If the message "Database for OB/Gyn examination is full." is


displayed, back up the stored data (previous obstetric data) to
removable media using the Export function of the OB Browser.
Then, delete unnecessary obstetric examination history using the
OB Browser.

6. If the message "History Database is full." is displayed, back up the


stored data (previous examination data) to media using the Export
function of the History Browser. Then, delete unnecessary
examination history using the History Browser.

7. Confirm the dates, patient IDs, and patient names before deleting
the data.

8. 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
media may damage these media.

9. Do not set the system to Standby mode during printing, data


saving, or invoking. Doing so may cause these processes to not
operate correctly. In addition, doing so during access to media
may damage these media. Furthermore, when used the next time,
the printer, and DVD/CD drive will not operate correctly.

10. When an attempt is made to archive images on DVD/CD or transfer


them with the DICOM protocol, the following dialog may be
displayed.

Sorry. DVD/CD and DICOM storage is not available now.


Please store important images on the hard disk.
Please power off and then power on to make them available.

In this case, archiving to media and DICOM transfer cannot be


performed. Store the important images on the hard disk.
If you wish to archive images on media or transfer them with the
DICOM protocol immediately, reboot the system.

11. Do not load examination data acquired by non-Xario systems into


this system. If data including more than one series acquired by
non-Xario systems is loaded, the series may not be displayed
correctly in a list.

12. Do not display or print data imported from other devices in this
system. Such data may not be displayed or printed correctly.

13. Some printers cannot detect print errors. Examine the actual
printout to confirm that the data has been printed correctly.

No. 2B771-050EN*G
S-23
CAUTION: 14. Exam review
(1) When using a previously acquired image for diagnosis, be
sure to verify the patient ID, the patient name, and the date
and time of image acquisition that are displayed above the
image.

The displayed patient ID and name may not match the


registered ones if the image has been stored in the HDD and
the corresponding patient information has then been edited
using the patient/exam information edit form.

(2) Do not display or print data imported from other devices in


this system. Such data may not be displayed or printed
correctly.

(3) A rather long time may be required to display acquired images


using the Exam Review function. It is recommended that this
function be used when time allows after the patient
examination is completed.

15. 3D display

(1) The horizontal (X-axis direction) and vertical (Y-axis direction)


lengths of the displayed 3D image are based on the body
dimensions calculated in the diagnostic ultrasound system.

(2) The depth (Z-axis direction) of the displayed 3D image is


calculated based on the transducer movement data entered
manually by the operator.

(3) The USFR-770A is not provided with a 3D position sensor.

Quantitative evaluation functions such as measurement


functions are not available for 3D images.

(4) If the manually entered sweep distance or fan angle does not
match the data obtained by actual scanning with the
transducer, 3D image distortion will result. Image distortion
will also occur if scanning using the transducer is not
performed in the same direction at constant speed.

In particular, if 3D acquisition is to be performed with ECG


Sync set to ON, select the timing so that the patient's heart
rate is as stable as possible. In this case, the scan time
becomes longer, and as a result the transducer must be
moved in the same direction at constant speed for a longer
time.

The user can easily identify image distortion due to the above
causes. However, in other cases, it may be difficult to
determine whether the image is distorted.

Therefore, to ensure accurate diagnosis, 3D images must be


used in combination with other types of images.

No. 2B771-050EN*G
S-24
CAUTION: (5) Be sure to enter the scanning conditions for the transducer
for each examination correctly.

Enter the values for Distance and Angle referring to the


direction of the transducer position marker. If a value with an
incorrect sign (+ or -) is entered, a mirror image will be
generated, possibly leading to misidentification of the region
examined.

(6) The scale mark displayed on a 3D image is for reference only.


Do not use it for measurement.

(7) The color map for CDI or POWER ANGIO VR images is


independent of the color map for other types of CDI or
POWER ANGIO images. Therefore, the coloring may appear
different between these images.

16. Precautions regarding IASSIST

The activities may not operate as intended due to mismatch


between the Work Flow contents and the system operating
conditions (for example, if an attempt is made to perform a mode
transition that is not allowed for the target region or the transducer
used or if an attempt is made to record the data or control the
drive, or VCR unit with no storage media set in the recording
device). In this case, the menu text for the failed activity is
displayed in yellow. Confirm that the proper operating conditions
(target region, transducer to be used, storage media setting, etc.)
have been set before starting a Work Flow.

17. IASSIST controller

(1) The transmission output power of the IASSIST controller uses


weak radiowaves(*) that may affect other electronic
equipment. Avoid using the IASSIST controller within 25 cm
of other electronic equipment.
(*Reference) PHS: 80 mW > Wireless LAN: 20 mW >>
Bluetooth: 2.5 mW

(2) It is possible to change the functions registered to the


switches of the IASSIST controller.

The functions of the switches may therefore differ between


IASSIST controllers. Be sure to confirm the switch functions
before use.

No. 2B771-050EN*G
S-25
CAUTION: 18. Panoramic View
(1) Quantitative evaluations such as measurements are not
supported in Panoramic View.

(2) Perform scanning in the specified direction using the


transducer. If the transducer scanning direction is changed,
image distortion will result. In addition, image distortion may
be created by deviating from the appropriate scan path.

Panoramic View images must not be used to establish a


definitive diagnosis. They should only be used in
combination with other types of images in order to ensure
accurate diagnosis.

(3) The image to be displayed is a scan line image generated by


passing through the transducer. Note that a curved image is
displayed on the flat surface if the scan line is curved.

(4) When scanning is performed by moving the transducer in a


circular motion (for example, when scanning around the neck
and the Panoramic View display is performed), if there are
overlapped parts in the image field depth, the overlapped
parts cannot be displayed correctly. To prevent image
overlap from occurring, set DEPTH for the image.

(5) When measurement is started in Panoramic View mode, or


is displayed on the screen. These symbols alert the user
that the accuracy of the measurement results obtained in this
mode cannot be ensured. The data obtained for
measurements in Panoramic View mode must be used only
for reference.

19. If the temperature at the transducer end exceeds 43°C while the
TEE transducer is being used, this system operates as follows.

 The system freezes. When the temperature decreases,


scanning is started automatically.

 If after 2 minutes the temperature remains at 43°C or higher, the


system must be restarted.

 While the warning message related to temperature control is


displayed, all switches other than the New Patient, transducer
selection switch, and power switches are disabled.

No. 2B771-050EN*G
S-26
CAUTION: 20. To prevent the temperature of the head of the transesophageal
transducer from increasing, follow the instructions below.

(1) Keep the transducer end in contact with the walls of


esophagus or stomach.

(2) When images are not being observed, reduce the


transmission power (acoustic power) or freeze the images.

(3) When the transducer is used for a long period of time, set the
minimum transmission power needed to obtain the required
diagnostic information.

21. Video recording devices

(1) When recording diagnostic images, confirm that the displayed


patient ID and patient name are correct. Recording diagnostic
images with an incorrect patient ID may result in incorrect
diagnosis.

(2) In this system, recording is stopped when one of the following


operations is performed.

 [PIMS]  [VIDEO]

  [CONFIRM Start]

(If recording is required, press .)

  [Shutdown], [Standby], or [Log Off]

(3) Do not subject the video recording device to vibration or


shock during recording. The media may be damaged.

(4) Do not move the video recording device with media in the
device. Vibration or shock during movement may damage the
media.

No. 2B771-050EN*G
S-27
CAUTION: 22. 4D
(1) Image distortion may occur depending on the manner in
which the transducer is applied or due to hand instability or
fetal movement. 3D images obtained with 4D must not be
used to establish a definitive diagnosis. In order to ensure
accurate diagnosis, such images should only be used in
combination with other types of images.

(2) When the free space on the hard disk is insufficient, the
following error message is displayed on the monitor and the
data is not saved.
Ensure the required free space before saving the images.

Error message : Data saving is failed. Because of disk full.

(3) The heart rates calculated in STIC mode are estimated values
based on the acquired image data. Do not perform definitive
diagnosis solely using the calculated cardiac rate.

(4) When measurement is started up in STIC mode, or is


displayed on the screen. This alerts the user that the
accuracy of the measurement results obtained in STIC mode
cannot be guaranteed. Use the measurement results only for
reference.

(5) CTAR measurement

<1> When the thoracic area is to be measured in CTAR


measurement, set the measurement start point on the
spine.
If measurement is performed with the start point set at a
location other than the spine, correct measurement
results cannot be obtained.

<2> Do not perform CTAR measurement using a horizontally


flipped image. Correct measurement results cannot be
obtained.

23. Do not create a body mark by reproducing (in whole or in part) or


modifying an image created by another person without
permission. Doing so may result in copyright infringement.

No. 2B771-050EN*G
S-28
CAUTION: 1. 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.

2. Media

(a) Do not remove the media by pressing the Eject button on the DVD/CD
drive except in cases where the system does not recognize the media.
The system may malfunction. To remove the media from the drive, select
[Eject] from the Tools menu on the Patient Browser screen.

(b) Do not use media for which writing has been discontinued. The data on
the media is corrupted.

3. DICOM transfer

Confirm that the images transmitted from the system to the DICOM server
have been received correctly by the DICOM server before turning the system
power OFF (refer to subsection 2.2.8 of <<Applications volume>>).

4. When obstetric examination information or examination history is to be


deleted, confirm the patient ID and patient name displayed in the dialog.

5. When obstetric examination information is to be edited, confirm the patient ID


and patient name displayed in the dialog.

6. In the Windows File Browser window, files with .tiff, .tif, .bmp, .jpg, .jpeg, .avi,
and .wmv extensions can be copied or moved.

When files used by the system (such as index.us etc.) are present in a folder
in which images are stored, the message "Some files and/or folders were not
copied" may be displayed when all the files in the folder are selected and then
copied or moved.

This message does not indicate an error; it is displayed because the system
differentiates between files that can be copied and those that cannot. If the
message is displayed, press [OK] and continue with the operation.

7. In the Windows File Browser window, files with an extension other


than .jpg, .jpeg, .tif, .tiff, .bmp, .avi, or .wmv such as DICOM files, cannot be
deleted.
Before attempting to delete a folder, confirm that the folder does not include
files with an extension other than .jpg, .jpeg, .tif, .tiff, .bmp, .avi, or .wmv.
Cut, paste and copy are also not possible for such files. To delete or edit a
DICOM file, use the Patient Browser window.

8. When image display is switched between "Current" (current image) and


"Previous" (previous image) using the Exam Review function, confirm the
patient ID, patient name, and exam date for the displayed image.

No. 2B771-050EN*G
S-29
CAUTION: 9. IASSIST

(a) Operation of the Visual Editor

<1> In addition to using the Visual Editor, the parameters and attributes
of each activity can be edited using the Work Flow menu (open the
pop-up menu by pressing NE
XT , select "Parameters" or
"Attributes", and make changes). However, the changes made
using the Work Flow menu are only temporary. It is necessary to
save the edited Work Flow using the pop-up menu (SAVE WF) to
apply the changes to the original Work Flow.

<2> The currently loaded Work Flow can be edited and saved using the
Visual Editor. However, the changes are not applied to the currently
loaded Work Flow. To apply the changes, the Work Flow must be
loaded from "NewWF" again.

<3> If a large number of objects are selected at one time and cut, copy,
paste, or delete is performed, a long time may be required for
processing (depending on the number of objects selected). In this
case, wait until processing is completed before performing the next
operation.

(b) Work Flow creation using the Visual Editor

<1> Various application measurement items are provided for each


application preset. Confirm that the measurement to be performed
matches the application preset.

<2> Before starting measurement of an item, specify the method for


displaying the measurement tab page of the touch panel on which
the measurement item is displayed.

<3> Some measurements require operation of more than one switch.


For such measurements, create a Work Flow that executes the
switch operations.

<4> In the LV measurements in the Cardiac measurement application,


confirm that the methods for the measurement items to be executed
in the Work Flow match the methods set in the system.

<5> The created Work Flow may not operate, depending on the system
conditions. Be sure to confirm that the Work Flow operates correctly
before clinical use.

No. 2B771-050EN*G
S-30
CAUTION: 10. IASSIST controller

(a) The IASSIST controller is a piece of high-precision equipment. If the


controller is subjected to strong shock such as falling on the floor, failure
may result. Be sure to attach the provided strap and loop it over the
user's neck to prevent it from falling.

(b) Do not modify or disassemble the controller. Failure may result.

(c) Do not immerse the controller in water or spill water onto the controller.
Failure may result.

(d) The provided charger is dedicated to the controller. Do not use this
charger for charging other equipment.

(e) Do not use the charger for purposes other than charging.

(f) Do not move the system while the controller is being charged.
In addition, do not move the system while the controller is being inserted
into the charger. Otherwise, the controller may come off, resulting in
failure.

11. Bluetooth-USB adaptor

(a) Do not connect/disconnect the Bluetooth-USB adaptor during system


startup/shutdown. The system may not start up correctly.

(b) Do not remove the Bluetooth-USB adaptor during communication.


Communication cannot be established. If so, turn OFF the power supply
of the controller, insert the adaptor, and then perform connection again.

(c) Do not apply excessive force to the Bluetooth-USB adaptor from the
above when it is inserted into the USB port. The Bluetooth-USB adaptor
may be damaged.

12. Do not place the TEE transducer end in water exceeding 60°C. The
transducer may be damaged.

13. Be sure to select another transducer before disconnecting the currently used
transducer. Disconnecting the currently selected transducer can damage the
system or the transducer.

14. When using the jog search function for VCR playback, operate the trackball
slowly while confirming that frames advance one by one. If the trackball is
rotated fast in this mode, the response to later switch operations may be
slowed.

15. Refer to the operation manuals (<<Fundamentals volume>> and


<<Measurements volume>>) for precautions regarding the use of this system.

16. A Stress Echo acquisition cannot be paused in some cases if a large number
of images are being acquired.

No. 2B771-050EN*G
S-31
CAUTION: 17. 4D mode

(a) In order to extend the service life of the PVT-575MV used for 4D, post-
operational treatment of the PVT-575MV is automatically carried out
when the power of the diagnostic ultrasound system main unit is turned
OFF. Do not disconnect the PVT-575MV before the power goes OFF
completely.

(b) Do not start 4D mode while copying image data to media. Doing so
results in the response in 4D mode becoming slow.

18. When security mode is enabled, immediately set the users and their
authorities according to subsection 17.2 "Account Management" of
<<Applications volume>> so that each user can use the diagnostic ultrasound
system only within the scope of his/her own authority. The user name that
has been used to log into the system cannot be deleted.

19. When security mode is enabled, special care is required when handling audit
logs, because they include personal information (the same level of care as for
image files is required).

20. When security mode is enabled, back up the audit log files periodically using
the Export function of the audit log tool. In addition, delete the oldest audit log
files periodically using the Delete function. If the disk becomes full, the
subsequent operations cannot be recorded.

21. Body mark

Up to 300 body marks can be created. If is pressed after


300 body marks have been created, the following message is displayed.

"The number of custom bodymarks is over limit. Please delete one or more
custom bodymark (s) and retry."

No. 2B771-050EN*G
S-32
3.3 Safety precautions in the operation manual
<<Measurements volume>>

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

CAUTION: 1. Display the most suitable image and select the most suitable
measurement tool for the intended measurement. The appropriate
measurement methods and results must be determined by a
specialist.

2. Patient ID registration

(1) Be sure to register and save the patient ID before starting an


examination for a new patient. If measurement is performed for
a new patient for whom the patient ID is not registered or saved,
the measurement results and other data cannot be saved in the
system. In addition, the data for the two patients are mixed
together, which may result in incorrect diagnosis.

(2) Before starting an examination for a new patient, confirm that


the patient ID matches the patent to be examined. Images can
be recorded with an incorrect patient ID.

(3) Enter height, weight, LMP (Last Menstrual Period), IVF (In Vitro
Fertilization date), and other information correctly. When the
function for reusing the information entered for the immediately
preceding examination is used, confirm that these data items
are entered correctly. Otherwise, BSA and fetal growth data will
be calculated incorrectly.

(4) Check the date format before entering the date of birth, LMP
(Last Menstrual Period), or EDD (Estimated Date of Delivery).

(5) Do not enter a patient ID consisting of spaces only. Doing so


will result in reading/writing of data to/from media and DICOM
transfer to other systems being performed incorrectly.

No. 2B771-050EN*G
S-33
CAUTION: 3. Press SE
T
to fix the data during measurement or during
measurement modification.
Note, however, that the following operations may also fix the
measurement data.

NE
XT

 is pressed.

 One of the following measurement-related switches is pressed.

- [Copy]
- In TIC measurement, [Start], [Copy], [Move], [Drop],
[1Frame Move], [Part Move], and [ROI A] to [ROI H]
- Another measurement item switch (except [Velocity] in the
basic measurements)
- The switch for the current measurement item

Confirm that the measurement is performed correctly.

4. If the measurement data is not fixed for an application


measurement, the measurement results are not displayed in the
Report.

5. If [Delete] on the touch panel is pressed immediately after


measurement data is fixed, the result for the item that has been
measured most recently is deleted and the item is not displayed on
the Report screen.

6. The basic measurement results are not displayed in the report.

7. Be sure to perform measurement within images. If the area outside


an image is included in a measurement, incorrect diagnosis may
result.

8. Display of heart rate values

(1) In Dual display mode, the heart rate for the most recently frozen
image is displayed. For example, when the image on the left is
frozen most recently, the heart rate for that image is also
displayed on the image on the right.

(2) When a patient with an unstable heartbeat, such as a patient


with atrial fibrillation, is to be examined, enter a heart rate value
using the Manual Input screen.

(3) The heart rate value displayed on the 2D (including color etc.) +
PW/CW screen represents the heart rate obtained at the instant
the PW/CW image is stopped.

For example, when the PW/CW image is stopped by pressing


and then the 2D image is frozen, the displayed heart rate
2D

UPDATE

value represents the heart rate at the time the PW/CW image is
stopped, not at the time the Freeze switch is pressed.

No. 2B771-050EN*G
S-34
CAUTION: (4) Confirm that the ECG waveform is displayed correctly. If the
ECG waveform is not displayed correctly, an incorrect heart
rate value may be displayed due to noise.

(5) When ECG is not used, turn OFF the ECG monitor. Otherwise,
an incorrect heart rate value may be displayed due to noise
from the ECG monitor.

9. Vascular measurements

The values obtained in Velocity measurement and Velocity Trace


measurement can be deleted but cannot be changed to other
values. In Velocity Trace measurement, more than one value is
obtained in a single tracing procedure. If any one of these values is
deleted by pressing the [Backspace] key followed by the [Enter] key,
the values obtained together with the deleted value are also deleted.

10. TIC measurement

Exercise extreme care when managing data, especially when the


files of two or more patients are stored on a single disk.

11. Precautions regarding ACT measurement

(1) ACT measurement can be performed only when the following


conditions are met.

 2D single display (except for R-wave synchronous images


and images recorded in CHI mode)
 Cine playback images (including at least 3 frames)
(2) The Modified Simpson method is used for volume measurement
calculation. For this measurement, it is necessary to display a
long-axis long-cross sectional image from the cardiac apex
(two-chamber/four-chamber cross-sectional image). (Refer to
subsection 7.2.1 of <<Measurements volume>>).

(3) ACT measurement is assumed to be performed for evaluating


the left ventricular contraction ability.

Depending on the application, perform appropriate setting for


the image to be displayed and use the appropriate transducer.

(4) Noise near the cardiac apex may disable correct automatic
tracing. After automatic tracing, correct the trace line if
required.

(5) Under the influence of the valve and valve underneath


structure, automatic tracing exceeding the target heart chamber
may be performed. After automatic tracing, correct the trace
line if required.

(6) If the frame rate is low, an end-diastole image and end-systole


image may not be acquired within the start and end of
measurement. It is recommended that the frame rate be set to
30 fps or more.

No. 2B771-050EN*G
S-35
CAUTION: (7) If the valve ring, cardiac apex, and inner wall are not included in
the displayed image, the contour may not be extracted
correctly. Perform adjustment using the DEPTH/ZOOM dial,
GAIN dial, STC volume, and each image quality setting function.

(8) In ACT measurement, the frame range to be measured is


calculated from the heart rate. Obtain the patient's heart rate
correctly from the ECG.

* If the heart rate is not input from the ECG, the calculations
are performed with the heart rate fixed at 60 (bpm).
* If the heart rate is not input from the ECG or the input heart
rate is changed manually, an asterisk (*) is displayed at the
upper right of the heart rate value and cardiac output value.
* Confirm that the ECG waveform is displayed correctly. If the
ECG waveform is not displayed correctly, an incorrect heart
rate value may be displayed due to noise.
(9) The difference between the R-R interval in the two-chamber
cross-sectional image and that in the four-chamber cross-
sectional image is displayed as "ED_ED Diff".

ED_ED Diff = |(R-R interval in the 2-chamber cross-sectional


image)  (R-R interval in the 4-chamber cross-sectional image)|
/ (value of whichever R-R interval is longer)  100 [%]

A caution message is displayed if the calculated value is


greater than the preset "RR Interval Differential Time Limit".

The factory setting for "RR Interval Differential Time Limit" is


10%. The setting should be changed according to the objective
of the examination.

If the ED_ED Diff value is extremely large, it may affect the EDV,
ESV, and EF values that are calculated and displayed as the
Biplane Volume results. The decision as to whether to accept
these values or to perform measurement again should be based
on the results for all of the other items.

12. Obstetric calculations

(1) Enter the correct data for LMP (last menstrual period), IVF (in
vitro fertilization date), CLIN (current date and current
gestational age), and PREV (date of previous examination and
gestational age on that date). Incorrect entry of these
parameters will result in incorrect EDD (estimated date of
delivery) calculation.
The date and GA entered for CLIN or PREV are used to
calculate LMP and GA, which are then used for measurement.

(2) Be sure to record the EDD (Estimated Date of Delivery) and the
measurement data in the patient's medical records.
Although these data can be stored in the system together with
the patient ID and name using the SAVE function, they should
also be stored in the patient's medical records because data
stored in the system may be lost if there is a system failure.

No. 2B771-050EN*G
S-36
CAUTION: (3) Obstetric calculation data cannot be stored in the system or
updated unless the patient ID is entered.

(4) Use the correct Exam Type (OB, Endo-Vaginal, or Fetal Heart) to
perform the obstetric calculations. If an incorrect Exam Type is
used, the obstetric calculation data cannot be stored in the
system or updated.

(5) Do not reach a diagnosis based only on the current measured


data and calculation results displayed on the report screen.
The diagnosis must always be based on an overall clinical
evaluation of the patient including past examination results
recorded on the patient's medical record.

(6) When the system date is changed, be sure to enter the patient
information again in the patient ID registration window.
Otherwise, the gestational ages and the trend graphs cannot be
displayed correctly.

(7) Measurements may be incorrect depending on the fetal


position. Do not reach a diagnosis based only on the measured
data and calculation results obtained using the measured data.
The diagnosis must always be based on an overall clinical
evaluation of the patient.

(8) Several fetal growth measurement methods are available.


Select the most appropriate method for the patient based on the
clinical judgment of a specialist.

(9) OB measurement for up to quadruplets is possible. Be careful


not to confuse the fetuses when measuring the fetal growth.

(10) The Fetus ID is displayed in the measurement window, on the


report screen, and on the Trend Graph. Confirm the fetus ID
when performing diagnosis.

(11) For items that are calculated based on two or more


measurement results, the item label and the calculation result
are not displayed on the screen or in the report, unless all the
items required for calculation are measured. The measurement
items required for calculation and the calculation result display
range of some items differ according to the author. Therefore,
if another author is selected after measurement, the result may
not be displayed.

(12) The results of the last three measurements are stored in the OB
calculations. When more than three measurements have been
executed, the oldest result is overwritten with the new one.
These results can be checked using the report function.

(13) If "Mean of Measurements" is selected for the "Measurement


Value Display Method" in Meas Report in Application Preset,
the mean of the last three measurement is displayed in the
report. If only one measurement has been executed, the result
of the measurement is displayed in the Mean field.

No. 2B771-050EN*G
S-37
CAUTION: (14) If "Most Recent Measurement" is selected for the
"Measurement Value Display Method" in Meas Report in
Application Preset, only the most recent measurement result is
displayed in the report.

(15) When two or more measurements have been executed for a


single item, be sure to check each measurement result using
the report function. If an unexpected value is measured, it will
affect the mean.

(16) Deviations from the normal values of the measurement results


must be judged based on the trend graphs and literature.

(17) To calculate the gestational age and estimated fetal weight


correctly from the measurement result, it is necessary to
specify the author of the GA calculation method to be used and
the EFW calculation method. Refer to section 2 "Setting the
Presets" of <<Measurements volume>> for details.
When performing OB measurement for multiple pregnancies, be
sure to confirm the fetus ID on the touch panel, measurement
window, Report screen, and Trend Graph to prevent confusion
between fetuses.

(18) The maximum GA that can be handled by the system is 45


weeks and 0 days. If GA exceeds 45 weeks and 0 days, it is not
displayed on the report or trend graph.

(19) CTAR measurement

<1> When the thoracic area is to be measured in CTAR


measurement, set the measurement start point on the
spine.
If measurement is performed with the start point set at a
location other than the spine, correct measurement results
cannot be obtained.

<2> Do not perform CTAR measurement using a horizontally


flipped image. Correct measurement results cannot be
obtained.

(20) When the "Weeks of Pregnancy" function is used, LMP is not


calculated if GA has not been calculated in the most recent
measurement.
If IVF etc. is entered as obstetrical date information, LMP is
calculated based on the GA and the entered date is replaced
with the calculated LMP.
EDD is calculated by adding 280 days to LMP. If GA exceeds 40
weeks and 0 days, EDD is displayed as a date earlier than the
examination date.

No. 2B771-050EN*G
S-38
CAUTION: (21) If a result for a measurement item is deleted in the report edit
window with "Most Recent" selected, the result of the directly
preceding measurement is displayed.
If all the results for a measurement item are deleted in the
report edit window, the measurement item and the calculation
results obtained using the measured value are all deleted
automatically.
To redisplay the deleted values, the item must be measured
again. Before saving the contents of the report edit window,
confirm that the necessary data has not been deleted.

(22) Check the date format to be displayed on the report screen.

(23) If a result for a measurement item is deleted in the report edit


window, the measurement item, the mean of the item, and the
calculation results obtained using the measurement value (or
mean) are all deleted automatically.
To redisplay these values, the item must be measured again.
Before saving the contents of the report edit window, confirm
that the necessary data has not been deleted.
When entering calculation items or editing the measurement
data, be sure to enter the values and units correctly.

(24) The OB Doppler measurement results can be deleted using the


[BS] and [Enter] keys but cannot be edited. Since more than
one measurement value is obtained in a single tracing
procedure, deleting a single value also deletes the values
measured at the same time as the deleted one.

(25) If a result for a measurement item is deleted in the report edit


window, the result of the directly preceding measurement is
displayed.
If all the results for a measurement item are deleted in the
report edit window, the measurement item and the calculation
results obtained using the measured value are all deleted
automatically.
To redisplay the deleted values, the item must be measured
again. Before saving the contents of the report edit window,
confirm that the necessary data has not been deleted.

(26) Measurement or calculation data cannot be saved unless a


patient ID is registered for the patient. Be sure to register the
patient ID before starting measurement.

(27) Make sure that no unexpected value is displayed on the report


screen before saving the data.

(28) The measured value for some items displayed on the Report
screen can be edited, provided that the examination has not yet
been completed. Once the examination for the patient is
completed, however, editing of measured values is impossible.
Confirm the results on the report before saving the data. The
values displayed in black in the gray boxes are editable.

(29) When data saving is repeated on the report screen for the same
examination, the previously saved data is overwritten. Check
the data before overwriting the previous data.

No. 2B771-050EN*G
S-39
CAUTION: (30) If the patient information (patient ID, patient name, birth date, or
sex) for previously saved exam data is changed, the system
cannot identify the exam data for the patient and it displays a
confirmation dialog before plotting the past exam data in the
trend graph.
Confirm that the input data is correct before starting
examination.

If it is obvious that the patient information has been edited,


select [OK] to plot the data in the trend graph.
The exam data itself cannot be edited and this confirmation
dialog will therefore appear each time an attempt is made to
plot the exam data for which patient information has been
changed in the trend graph.

(31) If the EFW calculation method used for the previous data is
different from the EFW calculation method used for the current
data, the previous data is not plotted on the graph.
Even though the previous data can be plotted by changing the
author of the graph to match the author used for the previous
data, the EFW for the current data is not plotted if this done.
Do not change the EFW calculation method in examinations for
the same patient.

(32) Three curves are displayed on the Trend Graph screen for fetal
growth measurement. The middle curve corresponds to the
mean, while the other two curves represent ±percentiles or ±SD.
When five curves are displayed, the middle curve corresponds
to the mean, while the other four curves represent ±SD.
When only one curve is displayed, it is the mean curve. The
legend for the displayed curves is shown on the screen.

(33) When the report is displayed in Mean mode, the mean value is
plotted for the current examination data (CURRENT).
When the report is displayed in Most Recent mode, the most
recent value displayed in the report is plotted for the current
examination data (CURRENT).

(34) When Mean mode is selected, the label "Averaged" is displayed


below "CURRENT" in the legend for the plotted data. This label
is not displayed in Most Recent mode.
Whether "Averaged" is displayed or not depends on the mode
of the current examination. This label does not represent the
mode in which the previous data (PREV) was saved.

13. User-registered measurement functions

(1) Toshiba shall not be held liable for results obtained with user-
registered functions.
(2) The data registered in the user-programmed measurements will
not be included in future upgraded systems or subsequent
models.
(3) Use the user-registered measurements only after
understanding the contents. Refer to subsection 13.4 of
<<Measurements volume>> for the procedure for checking the
contents of the user-registered measurements.

No. 2B771-050EN*G
S-40
CAUTION: 14. OB measurement user chart registration
(1) Toshiba shall not be held liable for results obtained with the OB
measurement user chart registration function.

(2) The data registered in the OB measurement user chart will not
be included in future upgraded systems or subsequent models.

(3) Use the OB measurement packages only after understanding


the registered data.

* Refer to subsection 14.2 of <<Measurements volume>> for


details.

(4) Use the OB measurement user charts only after understanding


the registered data.

* Refer to subsection 14.9 of <<Measurements volume>> for


details.

15. Measurements on a stored image

(1) Display the most suitable image and select the most suitable
measurement tool for the intended measurement. The
appropriate measurement methods and results must be
determined by a specialist.

(2) It is also possible to perform measurement using an image on


which measurement has been performed during examination
and to print the image with the results of the two
measurements. In the case of black-and-white printing, the
caliper and measurement results for the first measurement may
be confused with those for the second measurement. To
prevent such confusion in later image viewing on printed
images, take appropriate measures such as placing an
identification mark at the head of the results of the first
measurement.

(3) Do not use 3D images or panoramic View images for


measurement.

(4) In manual calibration, the information on the stored image is


used to set the information required for measurement.
Accordingly, the measurement results will depend on the
values set on the stored image. Errors in the settings will affect
the measurement results and the measurement accuracy is
lower than in measurements using images acquired during
examination. Accordingly, the accuracy of measurement
results may be lower than that of standard measurements. In
the worst case, the error after calibration can be 5% for an
object that is 100 mm in length in measurements using ER
images and 10% in measurements using images recorded in
the video recording unit. For details, refer to subsection 15.6 of
<<Measurements volume>>. Use the manual calibration
function only after understanding its characteristics
thoroughly.

No. 2B771-050EN*G
S-41
CAUTION: (5) In manual calibration, the accuracy of the scale setting used for
measurement affects the accuracy of the measurement results
as described in (4) above. To increase the accuracy of the
scale setting, the calibration marker should be set using the
scale graduations as reference. For example, align the center
lines of the calibration marker handles with the graduations.

(6) Do not perform measurements on images recorded in the video


recording unit that were acquired with a system other than
Xario.

(7) The scale and graduations may not be seen clearly depending
on when the playback is paused. In this case, pause the
playback again at a timing at which the scale and graduations
are clearly seen and then start calibration.

(8) Confirm the unit before entering the value of the calibration
marker.

16. Auto Range function for Doppler waveform tracing

The Doppler waveform tracing result may be unsatisfactory,


depending on the conditions (for example, the Doppler waveform
displayed on the monitor may not be stable or may contain
significant noise).

Before pressing [SET] on the operating panel to accept the


measurement results, confirm that Doppler waveform tracing has
been performed correctly.

If the automatic trace results are not satisfactory, select [Range],


specify the trace range, and perform measurement again. Or, select
[Continuous Trace], trace the waveform manually, and perform
measurement again.

No. 2B771-050EN*G
S-42
CAUTION: 1. 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.

2. Only some of the measurement results are displayed on the application


measurement result screen. To display all of the measurement results including
calculation results, use the report screen.

3. Display of measurement results obtained using the IMT tool or Thickness tool

(1) When "Double Digits" is selected for Thickness [IMT] Precision in the
preset menu and measurement is performed using the IMT tool or
Thickness tool, the measurement value is displayed to two decimal places.
However, it may not be possible to obtain a value that is accurate to two
decimal places depending on the characteristics of the image.

(2) Keeping the above point in mind, use the measurement and calculation
values displayed to two decimal places only for reference purposes.

(3) In the MDA, a single quotation mark (') is added to the measurement
values and the calculation results obtained based on the measurement
values.

Limitations: Marks can be moved in steps of 1 pixel on the screen. Due


to the resolution of ultrasound images, this does not
correspond to an indicated value change of 0.01. Thus, the
indicated value changes in increments of greater than 0.01
as a mark is moved.

4. Time Intensity Curve (TIC) measurements

(1) If the measurement ROI is set including the area outside the image, the
correct measurement result cannot be obtained.

(2) When TIC measurement is performed in Dynamic Flow mode or Power


Angio mode, only the intensity data for blood flow is used for calculation.
The intensity data for tissue is not used for calculation.

(3) To perform TIC measurement, it is necessary to specify the start and end
frames for acquiring the intensity information of the cine image.

If the number of cine image frames exceeds 1024, the message "Memory
is insufficient to measure. Please measure within 1024 image frame." is
displayed and TIC measurement cannot be performed. If the number of
frames is 1024 or less but the volume of data corresponding to the
specified frames exceeds the available system memory, the message
"Memory allocate error" is displayed and TIC measurement cannot be
performed.

In these cases, reduce the number of frames for performing TIC


measurement.

The amount of memory available varies depending on the system status.


When TIC measurement is performed for the first time, approximately 1000
frames can be set.

No. 2B771-050EN*G
S-43
CAUTION: (4) If the image is reduced after measurement, color image quality adjustment
functions such as Power-DR are disabled. When ROI operation is started,
the image returns to the normal display size and color image quality
adjustment becomes possible.

When the color image quality has been adjusted, the intensity data is
changed, and therefore measurement must be performed again by
pressing [Start] on the touch panel.

(5) When the TIC measurement graph is output using a monochrome printer, it
may be difficult to identify the TIC curve.

5. User-registered measurement functions

(1) Setting the unit here does not set the unit to be used for calculation.
Set the unit when entering the calculation formula so that the unit to be
used for calculation matches the displayed unit.

(2) A dialog is displayed during registration of a user-registered measurement.


Do not operate the panel while this dialog is displayed.

(3) When an OB measurement user chart is registered to a 2D measurement


item using a table and data is to be set on both the Type (FG) and Type
(GA) pages, the same value must be set for the same GA. If the value for
a GA differs between these two pages and the Week function is used to
calculate GA based on the data set on the Type (GA) page, the calculated
GA is not plotted at the Mean position on the trend graph that is created
based on the data set on the Type (FG) page.

6. Saving of measurement data

(1) When [Send (DICOM)] is selected, the data is saved onto the HDD and at
the same time can be transferred to the server or media.

(2) If data transfer fails, a warning message is displayed in a blue window on


the monitor. In this case, transfer the data again using the Job Status
function of the Patient Browser after the examination is completed.

(3) The patient ID must be entered to save the measurement data. Be sure to
enter the patient ID on the Patient Information screen before starting
examination.

(4) When measurement is performed on saved images (such as video images


and Exam Review images), it is not possible to save the measurement
data in the DICOM format.
In such cases, [Send (DICOM)] is not displayed on the Report screen.

7. When the measurement data is to be stored in the server as DICOM SR, leave
the unit field blank or select one of the existing units in the Manual Input tool
and also for the calculation items.
* Items for which an arbitrary unit is set cannot be stored in the server.

No. 2B771-050EN*G
S-44
CAUTION: 8. Auto-IMT measurement display

(1) When Double Digits is selected for Auto IMT Precision in the preset menu
and measurement is performed using the Auto-IMT tool, the measurement
value is displayed to two decimal places. However, depending on the
characteristics of the image, it may not be possible to obtain an accurate
value within 1/100.

(2) When Three Digits is selected for Auto IMT Precision in the preset menu
and measurement is performed using the Auto-IMT tool, the measurement
value is displayed to three decimal places. However, depending on the
characteristics of the image, it may not be possible to obtain an accurate
value within 1/1000.

(3) Keeping the above points (1) and (2) in mind, use the measurement and
calculation values only for reference purposes.

(4) In the MDA, a single quotation mark (') is added to the measurement
values and calculation results obtained based on the measurement values.

Limitations: Marks can be moved in steps of 1 pixel on the screen.


Due to the resolution of ultrasound images, this does not
correspond to an indicated value change of 0.01/0.001.
Thus, the indicated value changes in increments of greater
than 0.01/0.001 as a mark is moved.

9. Read the precautions regarding the use of this system described in the
<<Fundamentals>> and <<Applications>> volumes.

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.

No. 2B771-050EN*G
S-45
 Warning labels on systems complying with the European Directive 93/42/EEC

No. Label Meaning


<1> Cautions that the system must not be used around
flammable gases.

<2> Cautions that MI and TI must be controlled so that


they are as low as reasonably achievable.

<3> (a) Cautions against sitting on the system.

(b) Urges caution related to the switches on the main


panel.

<4> Urges caution related to handling of the transducers.


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

<5> Cautions regarding handling of the monitor arm.

<6> (a) Cautions that the system must be placed on a


horizontal surface.
(b) Cautions that the cover must not be removed,
(a) (b) because doing so increases the risk of electric
shock.

No. 2B771-050EN*G
S-46
 Warning labels on other systems

No. Label Meaning


<1> Cautions that the system must not be used around
flammable gases.
EXPLOSION RISK IF USED WITH
FLAMMABLE ANESTHETICS.

<2> (a) Cautions that MI and TI must be controlled so


that they are as low as reasonably achievable.
(b) Cautions that the displayed MI and TI are mean
values (as per requirements in the USA and
Canada). Refer to subsection 21.2.2.
<3> (a) Cautions against sitting or leaning on the system.

(b) Urges caution related to the switches on the main


panel.

<4> Urges caution related to handling of the transducers.


THE PROBE IS HIGHLY SENSITIVE TO
SHOCK;ALWAYS HANDLE CAREFULLY;
REFER TO THE OPERATION MANUAL
FOR HANDLING AND CLEANING
INSTRUCTIONS.

<5> Cautions that hands may be caught when the height


of the main panel is adjusted.

<6> <a> (a) Cautions that the system must be placed on a


horizontal surface.
Do not place the system on a sloped surface.
The system may slide unexpectedly, resulting
in crush injury. The system should be moved
over a sloped surface by two persons to ensure
safety.

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


High voltages inside may cause electric shock.
Only service engineers should remove covers.
because doing so increases the risk of electric
shock.

<b>

No. 2B771-050EN*G
S-47
 Warning labels on systems complying with the European Directive 93/42/EEC

No. Label Meaning


<1> Cautions that the system must not be used around
flammable gases.

<2> (a) Cautions that MI and TI must be controlled so


that they are as low as reasonably achievable.
(Before serial No. LGI*******, 15D*******,
LCI******* )
(b) Cautions that MI and TI must be controlled so
that they are as low as reasonably achievable.
(After serial No. LGJ*******, 15E*******,
LCJ******* )
<3> (a) Cautions against sitting on the system.

(b) Urges caution related to the switches on the


main panel.

<4> Urges caution related to handling of the transducers.


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

<5> Cautions regarding handling of the monitor arm.

No. 2B771-050EN*G
S-48
No. Label Meaning
<6> (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.

(c) Cautions that the system must not be leaned


on nor pushed from the side.
(After serial No. LGJ*******, 15E*******,
LCJ******* )

 Warning labels on other systems

No. Label Meaning


<1> Cautions that the system must not be used around
flammable gases.
EXPLOSION RISK IF USED WITH
FLAMMABLE ANESTHETICS.

<2> (a) Cautions that MI and TI must be controlled so


that they are as low as reasonably achievable.
(b) Cautions that the displayed MI and TI are mean
values (as per requirements in the USA and
Canada). Refer to subsection 21.2.2.
<3> (a) Cautions against sitting or leaning on the
system.
(b) Urges caution related to the switches on the
main panel.

No. 2B771-050EN*G
S-49
No. Label Meaning
<4> Urges caution related to handling of the transducers.
THE PROBE IS HIGHLY SENSITIVE TO
SHOCK;ALWAYS HANDLE CAREFULLY;
REFER TO THE OPERATION MANUAL
FOR HANDLING AND CLEANING
INSTRUCTIONS.

<5> Cautions that hands may be caught when the height


of the main panel is adjusted.

<6>-1 Cautions that the system must be placed on a


horizontal surface.

<6>-2 Cautions that the cover must not be removed,


because doing so increases the risk of electric
shock.

5. Regulatory Labels
Label Meaning
This label indicates this device complies with European
Directive 93/42/EEC.

No. 2B771-050EN*G
S-50 *
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.

This system shall be used only by persons conversant with the basic principles and
techniques of ultrasound examinations and adequately trained in clinical procedures.

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

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

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

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

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

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

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

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

No. 2B771-050EN*G
W-1
11. Ultrasound transducers are precision equipment and should be handled with proper care.
If they are not handled according to the instructions in the operation manual, problems
such as scratches, holes, defects in the acoustic lens surface, twisting of the transducer
cable, or degradation of the ultrasound images may result.
Note that the warranty does not cover problems caused by improper handling of the
transducers.
12. TOSHIBA shall not be liable for any error or malfunction that results from use of a
transducer other than that specified by TOSHIBA.
13. On the occasion of change of the administrator or manager for this system, be sure to hand
over this operation manual.
14. When this system is to be transported, be sure to contact your TOSHIBA representative
first. Special packaging must be performed by a TOSHIBA service engineer or a service
engineer authorized by TOSHIBA. TOSHIBA does not assume any responsibility for
damage resulting from transportation of this system without consulting TOSHIBA.
15. When disposing of this system, contact your TOSHIBA 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.

NOTE: Concerning the WEEE label

The following information is only for EU member states:


The use of this symbol indicates that this product should not
be treated as household waste.
By ensuring that this product is disposed of correctly, you will
help prevent potential negative consequences for the
environment and human health, which could otherwise be
caused by inappropriate waste-handling of this product.
For more detailed information concerning the return and
recycling of this product, please consult the supplier from
whom you purchased the product.

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

NOTE: Concerning BATTERIES

The following information is only for EEA countries:


The directive 2006/66/EC requires separate collection and
appropriate disposal of spent batteries.

This product also contains batteries that are not intended to


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

NOTE: Regulatory information

The high-efficiency LCD backlights used in this product contain 5 mg or less of


mercury, the disposal of which may be regulated due to environmental
considerations.
For disposal or recycling information, please contact your local authorities or the
Electronic Industries Alliance (www.eiae.org).

This information is only for the U.S.A.

No. 2B771-050EN*G
W-2
NOTE: Perchlorate Material - special handling may apply.
See http://www.dtsc.ca.gov/hazardouswaste/perchlorate/

This is applicable to California, U.S.A. only.

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

17. Expected service life

The expected service life is 7 years if the specified maintenance and inspection procedures
are performed.
However, the service life depends on usage conditions, and individually specified periods,
if any, take precedence.

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

No. 2B771-050EN*G
W-3 *
Intellectual Property

1. Availability of This Software and Related Documents Is


Restricted.

The software used for this system includes software owned by Toshiba Medical Systems
Corporation and 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.

(8) The licensor shall have no liability for any express or implied warranties or any indirect,
incidental, special, punitive, or consequential damages related to the software and related
documents.

2. Agreement for Microsoft Software

Read the end-user license agreement for Microsoft software on the following pages.

No. 2B771-050EN*G
L-1
MICROSOFT SOFTWARE LICENSE TERMS FOR:
MICROSOFT® WINDOWS® 2000 PROFESSIONAL FOR EMBEDDED SYSTEMS (1-2 CPU
VERSION)
MICROSOFT® WINDOWS® XP PROFESSIONAL 64 BIT EDITION FOR EMBEDDED SYSTEMS
(1-2 CPU)
MICROSOFT® WINDOWS® XP PROFESSIONAL FOR EMBEDDED SYSTEMS (1-2 CPU
VERSION)
MICROSOFT® WINDOWS® XP PROFESSIONAL FOR EMBEDDED SYSTEMS—RUSSIAN
VERSION (1-2 CPU VERSION)
MICROSOFT® WINDOWS® XP PROFESSIONAL FOR EMBEDDED SYSTEMS—SIMPLIFIED
CHINESE VERSION (1-2 CPU VERSION)
These license terms are an agreement between you and Toshiba Medical Systems Corporation.
Please read them. They apply to the software included on this device. The software also includes
any separate media on which you received the software.
The software on this device includes software licensed from Microsoft Corporation or its affiliate.
The terms also apply to any Microsoft
 updates,
 supplements,
 Internet-based services, and
 support services
for this software, unless other terms accompany those items. If so, those terms apply. If you obtain
updates or supplements directly from Microsoft, then Microsoft, and not Toshiba Medical Systems
Corporation, licenses those to you.
As described below, using some features also operates as your consent to the transmission
of certain standard computer information for Internet-based services.
By using the software, you accept these terms. If you do not accept them, do not use the
software. Instead, contact Toshiba Medical Systems Corporation to determine its return
policy for a refund or credit.
If you comply with these license terms, you have the rights below.
1. USE RIGHTS.
You may use the software on the device with which you acquired the software.
Processor Limit. You may use the software with no more than two (2) processors at any one time.
2. ADDITIONAL LICENSING REQUIREMENTS AND/OR USE RIGHTS.
a. Specific Use. Toshiba Medical Systems Corporation designed this device for a specific use.
You may only use the software for that use.
b. Other Software. You may use other programs with the software as long as the other
programs
 directly support the manufacturer’s specific use for the device, or
 provide system utilities, resource management, or anti-virus or similar protection.
Software that provides consumer or business tasks or processes may not run on the device.
This includes email, word processing, spreadsheet, database, scheduling and personal
finance software. The device may use terminal services protocols to access such software
running on a server.
c. Device Connections. You may not use the software as server software. In other words,
more than one device may not access, display, run, share or use the software at the same
time. You may allow up to ten other devices to access the software to use
 File Services,
 Print Services,
 Internet Information Services, and
 Internet Connection Sharing and Telephony Services.

No. 2B771-050EN*G
L-2
The ten connection limit applies to devices that access the software indirectly through
"multiplexing" or other software or hardware that pools connections. You may use unlimited
inbound connections at any time via TCP/IP.
3. SCOPE OF LICENSE. The software is licensed, not sold. This agreement only gives you some
rights to use the software. Toshiba Medical Systems Corporation and Microsoft reserve all other
rights. Unless applicable law gives you more rights despite this limitation, you may use the
software only as expressly permitted in this agreement. In doing so, you must comply with any
technical limitations in the software that allow you to use it only in certain ways. For more
information, see the software documentation or contact Toshiba Medical Systems Corporation.
Except and only to the extent permitted by applicable law despite these limitations, you may not:
 work around any technical limitations in the software;
 reverse engineer, decompile or disassemble the software;
 make more copies of the software than specified in this agreement;
 publish the software for others to copy;
 rent, lease or lend the software; or
 use the software for commercial software hosting services.
Except as expressly provided in this agreement, rights to access the software on this device do
not give you any right to implement Microsoft patents or other Microsoft intellectual property in
software or devices that access this device.
 INTERNET-BASED SERVICES. Microsoft provides Internet-based services with the
software. Microsoft may change or cancel them at any time.
a. Consent for Internet-Based Services. The software features described below connect
to Microsoft or service provider computer systems over the Internet. In some cases, you
will not receive a separate notice when they connect. You may switch off these features
or not use them. For more information about these features, visit
http://www.microsoft.com/windowsxp/downloads/updates/sp2/docs/privacy.mspx. By
using these features, you consent to the transmission of this information.
Microsoft does not use the information to identify or contact you.
b. Computer Information. The following feature uses Internet protocols, which send to
the appropriate systems computer information, such as your Internet protocol address,
the type of operating system, browser and name and version of the software you are
using, and the language code of the device where you installed the software. Microsoft
uses this information to make the Internet-based services available to you.
 Web Content Features. Features in the software can retrieve related content from
Microsoft and provide it to you. To provide the content, these features send to
Microsoft the type of operating system, name and version of the software you are
using, type of browser and language code of the device where the software was
installed. Examples of these features are clip art, templates, online training, online
assistance and Appshelp. You may choose not to use these web content features.
 Windows Media Digital Rights Management. Content owners use Windows
Media digital rights management technology (WMDRM) to protect their intellectual
property, including copyrights. This software and third party software use WMDRM
to play and copy WMDRM-protected content. If the software fails to protect the
content, content owners may ask Microsoft to revoke the software’s ability to use
WMDRM to play or copy protected content. Revocation does not affect other
content. When you download licenses for protected content, you agree that
Microsoft may include a revocation list with the licenses. Content owners may
require you to upgrade WMDRM to access their content. Microsoft software that
includes WMDRM will ask for your consent prior to the upgrade. If you decline an
upgrade, you will not be able to access content that requires the upgrade. You may
switch off WMDRM features that access the Internet. When these features are off,
you can still play content for which you have a valid license.
c. Misuse of Internet-based Services. You may not use these services in any way that
could harm them or impair anyone else’s use of them. You may not use the services to
try to gain unauthorized access to any service, data, account or network by any means.

No. 2B771-050EN*G
L-3
 NOTICES ABOUT THE MPEG-4 VISUAL STANDARD. The software may include MPEG-4
visual decoding technology. This technology is a format for data compression of video
information. MPEG LA, L.L.C. requires this notice:
USE OF THIS PRODUCT IN ANY MANNER THAT COMPLIES WITH THE MPEG-4
VISUAL STANDARD IS PROHIBITED, EXCEPT FOR USE DIRECTLY RELATED TO
(A) DATA OR INFORMATION (i) GENERATED BY AND OBTAINED WITHOUT
CHARGE FROM A CONSUMER NOT THEREBY ENGAGED IN A BUSINESS
ENTERPRISE, AND (ii) FOR PERSONAL USE ONLY; AND (B) OTHER USES
SPECIFICALLY AND SEPARATELY LICENSED BY MPEG LA, L.L.C.
If you have questions about the MPEG-4 visual standard, please contact MPEG LA, L.L.C.,
250 Steele Street, Suite 300, Denver, CO 80206; www.mpegla.com.
4. PRODUCT SUPPORT. Contact Toshiba Medical Systems Corporation for support options.
Refer to the support number provided with the device.
5. BACKUP COPY. You may make one backup copy of the software. You may use it only to
reinstall the software on the device.
6. PROOF OF LICENSE. If you acquired the software on the device, or on a disc or other media, a
genuine Certificate of Authenticity label with a genuine copy of the software identifies licensed
software. To be valid, this label must be affixed to the device, or included on or in Toshiba
Medical Systems Corporation's software packaging. If you receive the label separately, it is not
valid. You should keep the label on the device or packaging to prove that you are licensed to
use the software. To identify genuine Microsoft software, see http://www.howtotell.com.
7. TRANSFER TO A THIRD PARTY. You may transfer the software only with the device, the
Certificate of Authenticity label, and these license terms directly to a third party. Before the
transfer, that party must agree that these license terms apply to the transfer and use of the
software. You may not retain any copies of the software including the backup copy.
8. NOT FAULT TOLERANT. The software is not fault tolerant. Toshiba Medical Systems
Corporation installed the software on the device and is responsible for how it operates on
the device.
9. RESTRICTED USE. The Microsoft software was designed for systems that do not require fail-
safe performance. You may not use the Microsoft software in any device or system in which a
malfunction of the software would result in foreseeable risk of injury or death to any person. This
includes operation of nuclear facilities, aircraft navigation or communication systems and air
traffic control.
10. NO WARRANTIES FOR THE SOFTWARE. The software is provided “as is”. You bear all
risks of using it. Microsoft gives no express warranties, guarantees or conditions. Any
warranties you receive regarding the device or the software do not originate from, and are
not binding on, Microsoft or its affiliates. When allowed by your local laws, Toshiba
Medical Systems Corporation and Microsoft exclude implied warranties of merchantability,
fitness for a particular purpose and non-infringement.
11. LIABILITY LIMITATIONS. You can recover from Microsoft and its affiliates only direct damages
up to two hundred fifty U.S. Dollars (U.S. $250.00), or equivalent in local currency. You cannot
recover any other damages, including consequential, lost profits, special, indirect or incidental
damages.
This limitation applies to:
 anything related to the software, services, content (including code) on third party internet
sites, or third party programs, and
 claims for breach of contract, breach of warranty, guarantee or condition, strict liability,
negligence, or other tort to the extent permitted by applicable law.
It also applies even if Microsoft should have been aware of the possibility of the damages. The
above limitation may not apply to you because your country may not allow the exclusion or
limitation of incidental, consequential or other damages.
12. EXPORT RESTRICTIONS. The software is subject to United States export laws and regulations.
You must comply with all domestic and international export laws and regulations that apply to
the software. These laws include restrictions on destinations, end users and end use. For
additional information, see www.microsoft.com/exporting.
[20070125]

No. 2B771-050EN*G
L-4
3. Others

Patents

This product is licensed under the MPEG-4 visual patent portfolio license for the personal and
non-commercial use of a consumer for (i) encoding video in compliance with the MPEG-4 visual
standard ("MPEG-4 VIDEO") and/or (ii) decoding MPEG-4 video that was encoded by a
consumer engaged in a personal and non-commercial activity and/or was obtained from a video
provider licensed by MPEG-LA to provide MPEG-4 video. No license is granted or shall be
implied for any other use. Additional information including that relating to promotional, internal
and commercial uses and licensing may be obtained from MPEG LA, LLC.
See http://www.mpegla.com.

END USER LICENSE AGREEMENT PROVISIONS

The PIC Code may be made available by LICENSEE to third parties only pursuant to an end
user license agreement. Each end user license agreement shall, at a minimum, contain terms
that:
a. Prohibit the end user to disassembly, decompile or reverse engineer the Integrated
Products;
b. Reserve to LICENSEE and PIC all rights, title and interest in and to the Integrated Products;
c. Restrict transfer of the Integrated Product only to third parties who agree to be bound by the
terms of the end user license agreement, and prohibit lending, leasing, sublicensing or
pledging of the Integrated Products by end user;
d. Include a statement substantially similar to the following:
"Product(s) provided under this Agreement contain portions of program code owned and
copyrighted by Pegasus Imaging Corporation, Tampa, Florida, [email protected] 2003,
ALL RIGHTS RESERVED and provided under license to [LICENSEE] by Pegasus Imaging
Corporation. [LICENSEE] has assumed responsibility for the selection of such code and its
use in production of the Products(s). Pegasus Imaging Corporation DISCLAIMS ALL
WARRANTIES WITH RESPECT TO THE USE OF SUCH CODE IN THE PRODUCT(S),
INCLUDING (WITHOUT LIMITATION) ANY WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. In no event shall [LICENSEE] or Pegasus
Imaging Corporation be liable for indirect, incidental, consequential or exemplary damages
arising from use, or inability to use the Product(s), even if they knew of the possibility of
such damages. Some states/countries do not allow the exclusion or limitation of liability for
consequential or incidental damages so the above limitation may not apply to you."
e. The end user license agreement and all rights to use or maintain possession of the
Integrated Product shall terminate immediately upon the sublicensee's breach of any
material provision of such agreement.

No. 2B771-050EN*G
L-5
Intel License Agreement
For Open Source Computer Vision Library

Copyright (C) 2000-2006, Intel Corporation, all rights reserved.


Third party copyrights are property of their respective owners.

Redistribution and use in source and binary forms, with or without modification, are permitted
provided that the following conditions are met:

* Redistribution's of source code must retain the above copyright notice, this list of conditions
and the following disclaimer.
* Redistribution's in binary form must reproduce the above copyright notice, this list of
conditions and the following disclaimer in the documentation and/or other materials provided
with the distribution.
* The name of Intel Corporation may not be used to endorse or promote products derived
from this software without specific prior written permission.
This software is provided by the copyright holders and contributors "as is" and any express or
implied warranties, including, but not limited to, the implied warranties of merchantability and
fitness for a particular purpose are disclaimed. In no event shall the Intel Corporation or
contributors be liable for any direct, indirect, incidental, special, exemplary, or consequential
damages (including, but not limited to, procurement of substitute goods or services; loss of use,
data, or profits; or business interruption) however caused and on any theory of liability, whether
in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the
use of this software, even if advised of the possibility of such damage.

No. 2B771-050EN*G
L-6 *
Organization of the Operation
Manuals

1. Notation Conventions
In this operation manual, the following word is used in addition to the signal words related to the
safety precautions (refer to "Safety Precautions"). Please read this operation manual before
using the system.

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

2. Operation Manuals
A TOSHIBA service person or instructor will explain the basic operating procedures for this
system at the time of delivery. However, read this operation manual carefully before using the
system in order to understand the detailed operating procedures, functions, performance, and
maintenance procedures. The organization of the documents supplied with this system is
shown below:

Operation manual for the main unit of the ultrasound system

Contains basic information about the system, including


Fundamentals
descriptions concerning preparation, operation,
inspection, and functions.

Contains descriptions of preset operations for various


Applications
types of registration (Preset) and methods of
measurement.

Acoustic power and Contains descriptions of acoustic power generated by


surface temperature data the ultrasound transducer.

Describe the operating and sterilization procedures for


Transducer operation manuals
transducers.

NOTE: For certain applications, the following manuals are available in English:
 2B730-682EN (Applications volume)
 2B730-684EN (Measurements volume)
 2B730-686EN (Acoustic power and surface temperature data) (For regions other
than the USA)
 2B730-687EN (Acoustic power and surface temperature data) (For the USA only)
 2B730-963EN (Operation card)

NOTE: The operation manuals <<Applications volume>> and <<Measurements volume>>


may be supplied on electronic media.

No. 2B771-050EN*G
U-1
3. Technical Descriptions
For technical descriptions about this system, refer to the following manuals.

 Installation manual
 Maintenance manual
 Disposal manual

4. Entry Keys
In this manual, the keys on the keyboard are represented as shown below.

Description Actual key operation

Press the Z key. Z


Press .

Press the Shift key.


Press Shift .

Press the Shift Z keys. Z


Press while holding down Shift .

Press the Enter key.


Press .

No. 2B771-050EN*G
U-2 *
Table of Contents

Safety Precautions ..................................................................................................... S-1


Important Information ............................................................................................. W-1
Intellectual Property .................................................................................................. L-1
Organization of the Operation Manuals ......................................................U-1

Outline of the SSA-660A

1. Intended Use, Operating Principles,


and Specifications..................................................................... 1-1
1.1 Intended Use .............................................................................................. 1-1

1.2 Operating Principles............................................................................. 1-1

1.3 Specifications ............................................................................................ 1-3

1.4 Patient Environment ............................................................................. 1-4

1.5 Environmentally Friendly Usage and


Maintenance Management ............................................................... 1-4

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


2.1 Standard Configuration ...................................................................... 2-1

2.2 List of Optional Units ........................................................................... 2-1

2.3 Compatible Peripheral Devices .................................................... 2-2

2.4 External Storage Devices ................................................................. 2-2

2.5 List of Optional Software .................................................................. 2-3

2.6 List of Available Transducers ........................................................ 2-4

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


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

No. 2B771-050EN*G
-a-
3.2 Main Panel ................................................................................................... 3-3

3.3 Keyboard....................................................................................................... 3-8

3.4 Monitor ........................................................................................................... 3-9


3.4.1 CRT monitor .................................................................................................... 3-9

3.4.2 LCD monitor .................................................................................................. 3-10

3.5 Transducer Connectors


and Footswitch Connectors.......................................................... 3-11

3.6 Side Panel .................................................................................................. 3-12

3.7 Physio Panel ............................................................................................ 3-13

3.8 Power Supply Panel ............................................................................ 3-14

3.9 Symbols ....................................................................................................... 3-15

Operation

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


4.1 Moving and Stopping the System............................................... 4-1

4.2 Handling and Connecting/Disconnecting


the Transducer ......................................................................................... 4-3
4.2.1 Handling the transducer ............................................................................ 4-3

4.2.2 Connecting/Disconnecting the transducer ........................................ 4-3

4.3 Positional Adjustment of the Main Panel .............................. 4-4

4.4 Adjustment of the CRT Monitor Angle .................................... 4-5

4.5 Adjustment of the LCD Monitor.................................................... 4-6


4.5.1 Locking and unlocking the 17-inch LCD monitor arm................... 4-6

4.5.2 Locking and unlocking the 15-inch LCD monitor arm................... 4-7

4.5.3 Locking the LCD monitor (for 17-inch monitor only) ..................... 4-8

4.5.4 Adjusting the LCD monitor angle (for both 17-inch and
15-inch monitors).......................................................................................... 4-8

No. 2B771-050EN*G
-b-
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 ................................................................................................... 6-2

6.3 Standby Mode ........................................................................................... 6-4


6.3.1 Setting standby mode ................................................................................. 6-4

6.3.2 Recovery from the standby status ........................................................ 6-6

6.4 Preparation for Use During an


Operation or for Emergency Cases ........................................... 6-6
6.4.1 Preparation of a backup system ............................................................. 6-6

6.4.2 Power OFF/ON in the case of system failure..................................... 6-6

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


7.1 Checks Before Turning ON the Power .................................... 7-1

7.2 Checks 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 Displaying the Acoustic Power Data ........................................ 8-2

8.3 Display of Scanning Direction....................................................... 8-4

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


9.1 Entering and Saving Data on the
Patient ID Registration Screen ...................................................... 9-1

10. Common Operation for Each Mode ................. 10-1

No. 2B771-050EN*G
-c-
10.1 Touch Panel Operation ..................................................................... 10-1

10.2 Pop-Up Menu Operation .................................................................. 10-1

10.3 Trackball Operations .......................................................................... 10-2


10.3.1 Operations in real-time display mode ................................................ 10-2

10.3.2 Operations after freezing ......................................................................... 10-3

10.4 Selecting an Imaging Preset During Examination ........ 10-4

10.5 Selecting an Application


Preset During Examination............................................................ 10-5

10.6 Changing the Transducer During Examination .............. 10-6

10.7 Creating the Imaging Preset ......................................................... 10-7

10.8 Deleting the Imaging Preset.......................................................... 10-8

10.9 Changing the System Preset/Application Preset .......... 10-9

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


11.1 2D Mode ....................................................................................................... 11-1

11.2 M Mode ......................................................................................................... 11-7

11.3 CDI Mode................................................................................................... 11-12

11.4 Power Angio Mode............................................................................. 11-18

11.5 Doppler Mode ........................................................................................ 11-22

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


12.1 Overview ..................................................................................................... 12-1

12.2 Cine Operations ..................................................................................... 12-1

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


13.1 Display Procedures ............................................................................. 13-4

No. 2B771-050EN*G
-d-
13.2 Reference Signal Adjustment Procedure ............................ 13-4

13.3 Channel Selection ................................................................................ 13-6

14. Body Mark ........................................................................................... 14-1


14.1 Displaying the Body Mark .............................................................. 14-1

14.2 Moving and Rotating the Transducer Mark ....................... 14-2

14.3 Moving the Body Mark ...................................................................... 14-2

14.4 Deleting the Body Mark .................................................................... 14-2

15. Entering Comments .............................................................. 15-1


15.1 Entering Characters and Arrow Marks.................................. 15-1

15.2 Correcting a Comment or an Arrow ........................................ 15-3

15.3 Moving a Selected Comment ....................................................... 15-3

15.4 Moving a Selected Arrow ................................................................ 15-3

15.5 Deleting a Comment ........................................................................... 15-4

15.6 Deleting All Comments ..................................................................... 15-4

15.7 Entering Comments in Saved Images ................................... 15-5

15.8 Manipulating the Menu ..................................................................... 15-6


15.8.1 Procedures for adding menu switches .............................................. 15-6

15.8.2 Procedures for changing and deleting menu switches .............. 15-8

15.8.3 Exporting the registered data ................................................................ 15-9

15.8.4 Importing the registered data .............................................................. 15-10

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


16.1 Applicable Transducers and Biopsy Adapters ............... 16-3

16.2 Displaying the Needle Mark .......................................................... 16-5

No. 2B771-050EN*G
-e-
16.3 Deleting the Needle Mark ................................................................ 16-7

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

18. Report Function .......................................................................... 18-1

19. Output/Saving of Image Data.................................... 19-1


19.1 Output to the Printer........................................................................... 19-3
19.1.1 Operations using the panel switches ................................................. 19-3

19.1.2 Operations using the touch panel ....................................................... 19-4

19.1.3 Action for the "Check the printer cables." message .................... 19-4

19.1.4 Clearing a paper jam ................................................................................. 19-4

19.1.5 Replacing the ink sheet and printer sheets ..................................... 19-5

19.2 Recording to the Video Recording Unit ............................... 19-7

19.3 Saving Still Images .............................................................................. 19-8


19.3.1 Operations using the panel switches ................................................. 19-8

19.3.2 Operations using the touch panel ....................................................... 19-8

19.4 Saving Live Images to the HDD (Clips) ................................. 19-9


19.4.1 Snapshot Clips (retrospective storage)............................................. 19-9

19.4.2 Operating procedure for Snapshot Clips ........................................ 19-11

19.4.3 Cine Clips (cine image data storage function) ............................. 19-13

19.4.4 Operating procedure for Cine Clips .................................................. 19-13

19.4.5 Presetting of Cine Clips ......................................................................... 19-14

19.5 Saving Data to the DICOM Server ........................................... 19-15


19.5.1 Operation from the main panel ........................................................... 19-15

19.5.2 Operation from the touch panel .......................................................... 19-15

19.6 Outputting Data to the DICOM Printer ................................. 19-16

No. 2B771-050EN*G
-f-
20. Other Function ............................................................................. 20-1
20.1 DVD/CD Unit ............................................................................................. 20-1
20.1.1 Name and function of each part of the DVD/CD drive ................. 20-1

20.1.2 Recommended media ............................................................................... 20-1

20.1.3 Basic operation ........................................................................................... 20-2

20.1.4 Handling disks ............................................................................................. 20-4

20.1.5 Troubleshooting .......................................................................................... 20-5

20.2 Handling of USB Flash Memory ................................................. 20-6


20.2.1 Basic operations ......................................................................................... 20-6

20.3 Checking the Free Space of the Removable Media ..... 20-7

20.4 Beep Volume Adjustment ............................................................... 20-7

20.5 Beep Tone Adjustment ..................................................................... 20-8

20.6 Adjusting the Brightness of the Touch Panel .................. 20-8

20.7 File Handling for Image Data ........................................................ 20-8

20.8 Display of Saved Images ................................................................. 20-8

20.9 Changing the System Time ........................................................... 20-9

20.10 Display/Non-Display of the Patient ID.................................... 20-9

21. Using MI/TI ......................................................................................... 21-1


21.1 Using MI/TI (Outside the USA and Canada) ....................... 21-1
21.1.1 Basic knowledge of MI/TI......................................................................... 21-1

21.1.2 MI/TI display description.......................................................................... 21-3

21.1.3 Parameters affecting the MI/TI values ................................................ 21-3

21.1.4 Operating procedures for MI/TI ............................................................. 21-4

21.1.5 Output display.............................................................................................. 21-5

21.1.6 Parameters affecting MI/TI display ...................................................... 21-6

No. 2B771-050EN*G
-g-
21.1.7 Reminder ........................................................................................................ 21-7

21.1.8 Ultrasonic output power and acoustic output ................................ 21-8

21.1.9 References for MI/TI................................................................................... 21-9

21.2 Using MI/TI (in the USA and Canada) ................................... 21-10
21.2.1 Basic knowledge of MI/TI....................................................................... 21-10

21.2.2 MI/TI display description........................................................................ 21-12

21.2.3 Parameters affecting the MI/TI values .............................................. 21-12

21.2.4 Operating procedures for MI/TI ........................................................... 21-13

21.2.5 Output display............................................................................................ 21-14

21.2.6 Information contained in the system documentation ................ 21-15

21.2.7 Parameters affecting MI/TI display .................................................... 21-15

21.2.8 Measurement uncertainty and precision ........................................ 21-17

21.2.9 Reminder ...................................................................................................... 21-17

21.2.10 Ultrasonic output power and acoustic output .............................. 21-18

21.2.11 References for MI/TI................................................................................. 21-20

22. Preventive Maintenance .................................................. 22-1


22.1 Preventive Maintenance Performed by User .................... 22-2
22.1.1 Cleaning the system .................................................................................. 22-2

22.1.2 Creating a backup copy of the system hard disk .......................... 22-9

22.1.3 Maintenance menu ..................................................................................... 22-9

22.1.4 Backup of the HDD (Archiving Preset Data) .................................. 22-10

22.1.5 Recording/printing the daily check result


(System Maintenance) ............................................................................ 22-11

22.1.6 Remote Maintenance ............................................................................... 22-14

22.2 Preventive Maintenance Performed


by Service Personnel...................................................................... 22-15

No. 2B771-050EN*G
-h-
22.3 Periodically Replaced Parts
and Consumable Parts ................................................................... 22-15

22.4 Repair .......................................................................................................... 22-15

22.5 Check During Storage ..................................................................... 22-15

22.6 Disposal ..................................................................................................... 22-16

23. Checks Before the System


Is Judged Defective ............................................................... 23-1

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

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

26. Indication of Year of Manufacture...................... 26-1

27. Accuracy of Measurement ........................................... 27-1

28. Guidance and


Manufacturer's Declaration ......................................... 28-1

No. 2B771-050EN*G
-i- *
1. Intended Use, Operating
Principles, and Specifications
1.1 Intended Use
(1) The intended use of this system is to visualize structures, characteristics, and
dynamic processes within the human body using ultrasound and to provide image
information for diagnosis.

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

(3) This system is a general-purpose diagnostic ultrasound imaging system. This


system conforms to Real Time Display of Thermal and Mechanical Output Indices
on Diagnostic Ultrasound Equipment. Transducers have their own characteristic
applications. For the transducers that can be used with this system and their
applications, refer to subsection 2.6 "List of Available Transducers".

1.2 Operating Principles


The SSA-660A transmits ultrasound signals into the human body from a transducer and
receives the reflected echoes from the human body using the same transducer. It then
processes the received signals and displays them as images on a display screen (CRT
monitor or LCD monitor).

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

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

The SSA-660A supports convex, sector, linear, and some other scanning techniques.

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

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

An M-mode image (cross-sectional image) can be displayed together with a 2D-mode


image on the same screen through time-sharing control, allowing the user to perform
M-mode diagnosis while observing a 2D-mode image.

No. 2B771-050EN*G
1-1
In color Doppler imaging, phase detection is performed in a receive signal processing
circuit to obtain I and Q signals. These signals undergo frequency analysis with the
correlational method in a color Doppler imaging circuit to produce the mean velocity,
variance, and power information of the blood flow. These information items are
assigned color signals and represented as real-time two-dimensional color Doppler
images.

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

The SSA-660A supports basic measurements including distance, time, angle, and trace,
as well as combinations of some basic measurements. In addition, calculations based
on the measurement values can be performed for each region (circulatory organ, OB,
etc.) using widely accepted expressions. The calculation results can be displayed in
values, tables, or graphs.

No. 2B771-050EN*G
1-2
1.3 Specifications

Item Specifications
Power Line voltage USA 120 VAC 10%
Europe 220 to 240 VAC 10%
Other 1 100 to 120 VAC 10%
Other 2 220 to 240 VAC 10%
Line frequency 50 Hz to 60 Hz 1 Hz
Power consumption USA 1.44 kVA
Europe 1.5 kVA
Other 1 1.44 kVA
Other 2 1.5 kVA
Operating Ambient temperature 10°C to 35°C *
environmental
Relative humidity 35% to 80% (no condensation)
conditions
Atmospheric pressure 700 hPa to 1060 hPa
Storage and Ambient temperature -10°C to 50°C
transportation
Relative humidity 30% to 85% (no condensation)
conditions
50% or less if ambient temperature exceeds 40°C
(for systems with LCD monitor)
Atmospheric pressure 700 hPa to 1060 hPa
External For systems with CRT 540 20 mm (width)  1455 30 to
dimensions (not monitor 1550 50 mm (height)  814 30 mm (depth)
including optional
units) For systems with 540 20 mm (width)  1402 30 to
15-inch LCD monitor 1638 50 mm (height)  814 30 mm (depth)
For systems with 540 20 mm (width)  1375 30 to
17-inch LCD monitor 1610 50 mm (height)  814 30 mm (depth)
Mass (not including For systems with CRT 150 kg or less
optional units) monitor
For systems with 133 kg or less
15-inch LCD monitor
For systems with 136 kg or less
17-inch LCD monitor

* On systems complying with European Directive 93/42/EEC, the ambient temperature


should be 10°C to 30°C for the following transducers.
PVT-375MV (Serial No. A*******)
PVT-675MV (Serial No. AEA*******)
PVT-681MV (Serial No. A*******)

NOTE: The line voltage differs depending on the area.

No. 2B771-050EN*G
1-3
1.4 Patient Environment
This system is designed to be used in the environment specified in the figure below.

2.5 m
1.5 m 1.5 m

1.5 m

1.5 Environmentally Friendly Usage and Maintenance


Management
Observe the following to keep environmental impact to a minimum.

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

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

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

performed.

No. 2B771-050EN*G
1-4 *
2. System Configuration
2.1 Standard Configuration
(1) Main unit of the SSA-660A/LG

(2) Accessories

 Grounding cable (differs depending on the region)


 Transducer cable hanger
 Operation manuals

2.2 List of Optional Units


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 units are available with this system.

No. Item Model


1 CW unit UICW-660A
2 Reference signal unit UJUR-660B (Except for USA)
3 Reference signal unit UJUR-661B (only for USA)
4 Reference signal transducer UJUR-772A
5 Video processor kit UIVP-660A
6 Mounting kit for video unit UZRI-660A
7 Mounting kit for B&W printer unit (for mounting in the UZRI-661A
transverse orientation)
8 Mounting kit for B&W printer unit (for mounting in the UZRI-662A
longitudinal orientation)
9 IASSIST kit UIIA-661A
10 Footswitch UZFS002A
11 Footswitch kit UZFS-003A
12 Motor Drive M-TEE hanger kit UAEH-002A
13 M-TEE hanger kit UAEH-770A
14 Gel warmer UZGW-001A (100 to 120 V) *
15 Gel warmer UZGW-002A (220 to 240 V) *
16 Gel warmer UZGW-007A
17 4D unit UIMV-661A
18 4D unit UIMV-662A
19 4D unit UIMV-663A
20 LCD kit UILM-660A
21 IO panel kit UIIO-780A

* Systems complying with European Directive 93/42/EEC (serial No. LGJ*******,


15E*******, LCJ*******, and later) are not supported.

No. 2B771-050EN*G
2-1
2.3 Compatible Peripheral 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 devices, please consult your TOSHIBA
representative.

The following devices are available with this system.

No. Item Model


1 Black-and-white printer UP-D897 (SONY)
UP-D898MD (SONY)
P93DW (MITSUBISHI)
P95DW (MITSUBISHI)
2 Digital color printer CP900DW (MITSUBISHI)
CP30DW (MITSUBISHI)
UP-D23MD (SONY)
UP-D25MD (SONY)
3 VCR HS-MD3000E-T (PAL: MITSUBISHI)
HS-MD3000U-T (NTSC: MITSUBISHI)
4 DVD video recorder BD-X201M (NTSC: JVC, outside Europe)
BD-X201ME (PAL: JVC, for Europe)
LQ-MD800E (PAL: Panasonic, for Europe)
LQ-MD800P (NTSC: Panasonic, outside Europe)

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

2.4 External Storage Devices


A USB flash memory can be connected to this system. Contact your Toshiba
representative for the recommended models.

No. 2B771-050EN*G
2-2
2.5 List of Optional Software
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 software is available with this system.

No. Item Model


1 Contrast Harmonic Imaging kit USHI-770A, USHI-770A/EL
2 3D System kit USFR-770A, USFR-770A/EL
3 DYNAMIC FLOW kit USDF-770A, USDF-770A/EL
4 DICOM kit USDI-770A, USDI-770A/EL
5 DICOM Advanced kit (upgrade) USDI-772B, USDI-772B/EL
6 Stress Echo kit USSE-770A, USSE-770A/EL
7 IASSIST kit USIA-770A, USIA-770A/EL
8 ACT (Automated Contour Tracking) kit USAT-770A, USAT-770A/EL
*1
9 ApliPure kit USAP-770A, USAP-770A/EL
10 Panoramic View kit USPV-770A, USPV-770A/EL
11 Measurement Registration kit USMR-680A
12 TRAPEZOID scan kit USTS-770A, USTS-770A/EL
13 Quick scan kit USQI-770A, USQI-770A/EL
*2
14 STIC Imaging kit USST-680A, USST-680A/EL
*2, *3
15 Precision Imaging kit USPI-680A, USPI-680A/EL
*3
16 Auto-IMT kit USAI-680A, USAI-680A/EL

*1: The ApliPure migration kit USMG-660A is required.


*2: Options marked *2 are not available in China.
*3: Options marked *3 are not available in Canada.

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


license.

No. 2B771-050EN*G
2-3
2.6 List of Available Transducers
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 transducers are available with this system.
Transducer name Indications for use
PST-20CT Cardiac, adult cephalic, neonatal cephalic, pediatric, abdominal
PST-25BT Cardiac, pediatric, abdominal, adult cephalic, neonatal cephalic
PST-30BT Cardiac, abdominal, adult cephalic, neonatal cephalic
PST-50AT Cardiac, neonatal cephalic, pediatric
PST-65AT Cardiac, neonatal cephalic, pediatric
*1
PVT-350BTP Abdominal
PVT-375BT Abdominal, fetal, pediatric
PVT-375MV Abdominal, fetal, pediatric
PVT-382BT Abdominal, fetal, pediatric
PVT-575MV Fetal
PVT-661VT Transrectal, transvaginal
PVT-674BT Abdominal, fetal
PVT-675MV Fetal
PVT-681MV Transvaginal, transrectal
PVT-712BT Neonatal cephalic, abdominal
PVT-745BTH Abdominal, small organs, intraoperative
PVT-745BTF Abdominal, small organs, intraoperative
PVT-745BTV Abdominal, small organs, intraoperative
PVT-770RT Transrectal
*1
PLT-308P Abdominal
PLT-604AT Peripheral vascular, small organ, musculoskeletal
PLT-704AT Peripheral vascular, small organ, musculoskeletal
PLT-704SBT Small organ, peripheral vascular, musculoskeletal
PLT-705BTH Abdominal
PLT-705BTF Abdominal
PLT-1202S Peripheral vascular, small organ, musculoskeletal, intraoperative
PLT-805AT Peripheral vascular, small organ, musculoskeletal
PLT-1204AT Peripheral vascular, small organ, musculoskeletal
PLT-1204BT Peripheral vascular, small organ, musculoskeletal
PET-508MA Cardiac (transesophageal)
*2
PET-510MA Cardiac (transesophageal)
*3
PET-510MB Cardiac (transesophageal)
*2
PET-511BTM Cardiac (transesophageal)
*4
PET-512MC Cardiac (transesophageal)
PC-20M Cardiac, pediatric
PC-50M Cardiac, Peripheral vascular, pediatric
*1: This transducer is not available in the USA and Canada.
*2: This transducer is not available in the USA.
*3: This transducer is available in the USA only.
*4: This transducer is not available in Canada.
The table on the next page shows the modes each transducer supports.

No. 2B771-050EN*G
2-4
2D mode POWER DYNAMIC CHI mode*1
Transducer M CDI TDI PW CW Precision
Pulse Subtract Pulse Subtract ANGIO FLOW DYNAMIC ApliPure*1
name Fund. mode mode mode mode mode 2D POWER Imaging*1
ON OFF mode mode*1 FLOW*1
PST-20CT o o x o o o o x o o x x x x x
PST-25BT o o o o o o/x *2 o/x *2 o o o o x x x x
PST-30BT o o o o o o/x *2 o/x *2 o o o o x x x x
PST-50AT o o o o o x x o o o x x x x x
PST-65AT o o o/x *2 o o o/x *2 o/x *2 o o o x x x x x
PVT-350BTP o o x o o o o x o x o *3 x o *3 o o
PVT-375BT o o x o o o o x o x o *3 x o *3 o o
PVT-375MV o o x o o o o x o x x x x o o
PVT-382BT o o x o o o o x o x o *3 x o *3 o o
PVT-575MV o o x o o o o x o x x x x o o
PVT-661VT o o x o o o o o o x x x x o o
PVT-674BT o o x o o o o x o x x x x o o
PVT-675MV o o x o o o o x o x x x x o o
PVT-681MV o o x o o o o o o x x x x o o
No. 2B771-050EN*G

PVT-712BT o o x o o o o x o x x x x o o
PVT-745BTH o o x o o o o x o x o x x o o
PVT-745BTF o o x o o o o x o x o x x o o
2-5

PVT-745BTV o o x o o o o x o x x x x o o
PVT-770RT o o x o o o o x o x x x x o o
PLT-308P o o x o o o x x o x x x x o o
PLT-604AT o o x o o o o x o x x x x o o
PLT-704AT o o x o o o o x o x x x x o o
PLT-704SBT o o x o o o o x o x x x x o o
PLT-705BTH o o x o o o o x o x x o *3 x o o
PLT-705BTF o o x o o o o x o x x o *3 x o o
PLT-1202S o o x o o o x o o x x x x o o
PLT-805AT o o x o o o o o o x x x x o o
PLT-1204AT o o x o o o o o o x x x x o o
PLT-1204BT o o x o o o o o o x x x x o o
PET-508MA o o o o o x x o o o x x x x x
PET-510MA/MB o o o o o x x o o o x x x x x
PET-511BTM o o o o o x x o o o x x x x x
PET-512MC o o o o o x x o o o x x x x x
PC-20M x x x x x x x x x o x x x x x
PC-50M x x x x x x x x x o x x x x x

*1) Optional software is required. *3) Not available in the USA. o: Available x: Not available
*2) Depends on the preset.
4D Live mode Single Sweep mode
Transducer STIC*1 Volume
Pulse Subtract Pulse Subtract Pulse Subtract Pulse Subtract STIC*1 4D Biopsy
name Fund. Fund. color color
ON OFF ON OFF
PVT-375MV o x o o o x o/x *2 o/x *2 o o
*2
PVT-575MV o x o o o x o/x x x x
*2 *2
PVT-675MV o x o o o x o/x o/x o x
PVT-681MV o x x o o x x x o o

*1) Optional software is required. *3) Not available in the USA. o: Available x: Not available
*2) Depends on the preset.
No. 2B771-050EN*G
2-6
*
3. System Overview
3.1 Name of Each Part
 System with CRT monitor

No. 2B771-050EN*G
3-1
 System with LCD monitor

No. 2B771-050EN*G
3-2
3.2 Main Panel
The standard switch configuration on the main panel is as shown in the figure below.

(5)
(1) POW ER

(6)
(2) STANDBY

(4) (7)

(8)
(3)

(9) (10)
VOLUME
(24) (25) (26) (27) (28)
(55)
BALANCE

ACOUSTIC POWER AUDIO


(11) (59) (12) (30) (31) (32)
TDI
(29) (33)
(13) (14) (15) (16) BASE LINE SCALE
C/D FREQ
C/D FILTER

ER
MENU
ABC
ANGLE COR
(36) (37) (38) 2D FREQ
POWER
(35) PW CDI
(39)
REPORT TRACE CALC CALIPER
(42)
(17) (18) (19) (20) (34) (40)
CW DYNAMIC

(41)
FLOW

(43)
(21) VIDEO REC M SE
T NE
XT 2D (56) (57)
(47) (50) CLIPS
STORE

(22) C
OUTPUT
(44) (45) CALIPER (52) (53) (58)
DEPTH
2D

FULL UPDATE MEAS EDIT DUAL SINGLE


ZOOM STILL

(48) (49) (51)


STORE

(23) OUTPUT
B
(46) (54)
A
OUTPUT FRZ

2D GAIN

CAUTION: 1. The switch configuration on the main panel of this system can
be changed. The switch settings may therefore differ
depending on the system. When pattern U is set, the functions
of the switches may differ depending on the system even if the
same labels are attached to the switches. Confirm the switch
configuration of your system before use.
In particular, confirm the locations of the OUTPUT, STORE, and
FREEZE switches.
2. The descriptions in this operation manual are based on the
standard switch configuration. If the switch configuration has
been changed, the differences between the current
configuration and the standard configuration must be
understood before use.
3. Do not press two or more switches on the main panel
simultaneously. System malfunction may result.

The locations of the user function switches (switches for measurement, mode selection,
output to peripheral units) on the main panel can be changed according to user
preference. The change should be performed by service personnel. Contact your
Toshiba service representative.

No. 2B771-050EN*G
3-3
No. Switch Function
(1) Turns the system power ON/OFF.
POWER

(2) STANDBY
Lights when the system is in Standby mode.

(3) Clears the ID, measurement data, etc., of the current patient and
returns the system to the initial status.

(4) Touch panel The switches (for image quality adjustment, related
measurements, etc.) are displayed according to the selected
mode.
Use this screen by touching it with your fingers.
(5) Selects a transducer.

(6) Turns ECG gating ON/OFF. The dial can be used to select the
cardiac phase (delay from the R wave) for ECG gating.

(7) Used to adjust the display position and display size of the ECG
waveform. The specified display size is applied both for ECG and
PCG waveforms.
(8) Used to adjust the display position of the PCG waveform and the
volume of the heart-sound headphone.

(9) Used to set the ultrasound output.

ACOUSTIC POWER

(10) Used to adjust the volume of the Doppler sound etc.


AUDIO

(11) User function keys Used to register some of the functions of the touch panel to the
1 to 3 user function keys.
(12) Activates the TDI function.
TDI

(13) Opens Exam Review.


ER

(14) Opens the pop-up menu.


MENU

(15) Used to enter a body mark.

(16) Used to enter characters within the image.


ABC

(17) Opens the Report screen.


REPORT

(18) Starts basic measurement mode.


TRACE

No. 2B771-050EN*G
3-4
No. Switch Function
(19) Starts application measurement mode.
CALC

(20) Starts basic measurement mode.


CALIPER

(21) Switches between recording and pausing of the video recording


VIDEO REC
unit.

(22) C
Outputs the data to the specified data recording unit.
OUTPUT
The default recording destination is CD-R.
(23) B
Outputs the data to the specified data recording unit.
OUTPUT
The default recording destination is color printer.
(24) Used to set the sampling width in PW mode.

(25) Used to set the CDI (color mode) or PW Doppler independent


oblique scan angle with a linear transducer.
(26) Used to set the 2D (B mode) independent oblique scan angle with
a linear transducer.
(27) Used to set 2D IP (Image Process).

(28) Used to set the focal position for 2D acquisition.

(29) Used to turn the angle mark ON/OFF in Doppler mode and to set
the angle correction function.
ANGLE COR

(30) Used to change the reference value in PW/CW or color (CDI,


POWER, etc.) mode.
BASE LINE

(31) Used to set the velocity scale or multiple frequencies in PW/CW


or color (CDI, POWER, etc.) mode.
SCALE
C/D FREQ

(32) Used to set the filter value in PW/CW or color (CDI, POWER,
etc.) mode.
CDI FILTER

(33) Used to set the frequency for 2D acquisition.

2D FREQ

(34) When pressed, this switch sets the system to M mode.


M
When rotated, this switch allows adjustment of the M-mode gain.
(35) Sets the system to CW mode.
CW

No. 2B771-050EN*G
3-5
No. Switch Function
(36) When pressed, this switch sets the system to PW mode.
PW
When rotated, this switch allows adjustment of the gain in PW
(pulsed-wave Doppler) or CW (continuous-wave Doppler) mode.
(37) When pressed, this switch sets the system to POWER (ANGIO)
POWER
mode (one of the vascular imaging modes).

(38) When pressed, this switch sets the system to CDI mode.
CDI
When rotated, this switch allows adjustment of the gain in color
(CDI, POWER, etc.) mode.
(39) Activates the DYNAMIC FLOW function.
DYNAMIC
FLOW

(40) When pressed, this switch sets the system to 2D display mode.
2D
When rotated, this switch allows adjustment of the gain in 2D
mode.
(41) T
Changes the functions of the trackball and sets the position of the
SE
cursor etc.

(42) When the wheel is pressed while cine display is paused due to
(Wheel) body mark display, annotation display, or measurement, cine
display is resumed.
When the wheel is rolled in cine mode, the image is played back
in frame-by-frame mode. When the wheel is rolled in Exam
Review, image feeding is performed.
(43) NE
Changes the functions of the trackball and sets the movement of
XT
the cursor etc.

(44) Sets Trace (M or Doppler mode) display in full-screen mode.


FULL

(45) 2D
Sets the simultaneous display of 2D-mode images and M-mode
UPDATE or Doppler-mode images.
When this switch is pressed, the 2D-mode image is frozen. When
this switch is pressed again, the 2D-mode image returns to real-
time display.
(46) A Outputs the data to the specified data recording unit.
OUTPUT
The default setting is B/W printer.
(47) Used to change the following application examination functions.
Measurement : Measurement edit function (correction of the
MEAS EDIT
ellipse or trace)
Body mark : Rotation of the transducer mark
Annotation : Rotation of the arrow mark
Cine review : Frame-by-frame playback
(48) Used to enter the body mark.

No. 2B771-050EN*G
3-6
No. Switch Function
(49) Trackball : Moves the cursor or marker during measurement.
Palm dial :
During real-time display: Used to adjust the gain in 2D mode.
During freezing: Starts loop playback and adjusts the
2D GAIN

playback speed during Cine Review mode.


Rotates the transducer mark in body mark
mode.
Rotates the arrow mark in annotation mode.
(50) Starts the application measurement supported in the current
CALIPER mode.

(51) Turns ON/OFF the sampling gate mark for M mode or Doppler
mode (PW/CW) in 2D single or color single display mode.

(52) Sets dual display mode.


DUAL

(53) Sets single display mode.


SINGLE

(54) Freezes the displayed image.


FRZ

(55) Used to set the ultrasound echo reception sensitivity according to


the depth from the body surface.

(56) Sets the depth and zoom.

DEPTH
ZOOM

(57) CLIPS Stores the dynamic image clip.


STORE

(58) STILL Stores the still image.


STORE

(59) Used to start simultaneous realtime display of black-and-white


and color images in DUAL mode.

NOTE: 2D and SINGLE

2D is pressed to return to 2D single display mode directly from another


imaging or display mode.
Even if the image is frozen, when this switch is pressed, the image is unfrozen
and displayed in 2D single mode.

SINGLE is pressed to return to single display mode from dual display mode,
update display mode, or full display mode.

No. 2B771-050EN*G
3-7
3.3 Keyboard
The keyboard is installed below the main panel.
The keyboard can be slid out by pulling the lever under the Space key.
When returning the keyboard to the storage position, push it in until it is locked with a click.

Lever

Backspace key
Moves the cursor to the
previous character.
Delete key

Enter key

Shift key Space key Cursor keys

<<Character entry>>

Key operation Result


Shift + alphabetic character keys Lowercase letters can be entered.

Shift + keys other than alphabetic The symbol in the upper row can be
+ entered.
character keys (such as =
)

NOTE: If the cursor is not displayed on the screen, the [Tab] key can be used to
select the desired switch.

No. 2B771-050EN*G
3-8
3.4 Monitor
For the monitor adjustment procedures, refer to section 6 "Power ON/OFF".

3.4.1 CRT monitor

<1> <2> <3>

No. Name Functions


<1> Monitor power LED When power is supplied to the monitor, this LED lights
in green.
<2> Brightness Adjusts the screen brightness.
<3> Contrast Adjusts the screen contrast.

No. 2B771-050EN*G
3-9
3.4.2 LCD monitor

<3> <1> <2>

No. Name Functions


<1> MENU buttons Displays the adjustment menu and select menu items.
<2> [], [+] buttons Adjusts the values in the adjustment menu.
<3> LED for the LCD Displays the LCD monitor status.
monitor

CAUTION: Do not rub the LCD surface with a hard material or apply strong
pressure to the LCD surface. Doing so may cause scratches on
the LCD surface or result in damage to the monitor.

NOTE: Dead dots or light-emitting dots

A small number of dots may be dead or emit light. This is due to the inherent
characteristics of the design and therefore not a problem with the monitor.

No. 2B771-050EN*G
3-10
3.5 Transducer Connectors and Footswitch Connectors

Transducer connector

Transducer holder
* Used for transportation
or storage

Footswitch connector Battery status LED (green)


(Option) During charging: This LED blinks.
When charging is completed: The LED stops
blinking and lights constantly.
Approximately 2 hours is required to charge a
fully discharged battery to the fully charged status.
* If the LED does not blink or light, contact your
Toshiba service representative.

No. 2B771-050EN*G
3-11
3.6 Side Panel

CAUTION: 1. Only the specified device must be connected to the USB


connector or other connectors. Otherwise, smoke or an
electric shock may result.

2. Only equipment that conforms to the safety standards must


be connected to the ETHERNET terminal on the side panel.
Otherwise, smoke or an electric shock may result.

3. 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.

4. When a HUB is used, turn ON the system power only after


tuning ON the power to the HUB.

NOTE: Cables for the VCR, printer, and other peripheral devices are connected within
the system. Contact your Toshiba service representative to connect an
additional peripheral device.

Ethernet
(digital image transfer terminal)

USB connector

S output terminal
(output terminal for an
external video recording unit) Color composite terminal
(output terminal for an
external video recording unit)
RGB output terminal
(output terminal for an
external video recording unit)

No. 2B771-050EN*G
3-12
3.7 Physio Panel
* The Physio panel is an option.

CAUTION: 1. Only medical equipment that conforms with the IEC60601-1


standards must be connected to DC IN and AUX. Otherwise,
an electric shock might result.

2. When external signals are input to DC IN and AUX of the


Physio panel, the signal level that can be input is restricted.
Contact your TOSHIBA representative for details.

No. Name Functions


<1> ECG (PATIENT) Input terminal for the ECG lead cord (A respiration
sensor can be connected to this terminal when the
impedance method is used.)
<2> ECG (DC IN) External input terminal
For inputting the ECG from an external ECG monitor etc.
<3> AUX External input terminal
For inputting signals from an external device
<4> PULSE Pulse sensor input terminal
<5> PCG (INPUT) PCG sensor input terminal

No. 2B771-050EN*G
3-13
3.8 Power Supply Panel

Power cable connector


Power circuit breaker

Circuit protector Functional grounding


terminal

No. 2B771-050EN*G
3-14
3.9 Symbols
This system uses the following symbols. For safety symbols, refer to page S-1.

Symbol Description
Functional grounding

Equipotentiality

Breaker OFF (The AC power is turned OFF.)


Breaker ON (The AC power is turned ON.)
Power OFF (The power to electronic circuits is turned OFF:
Standby status)
Power ON (The power to electronic circuits is turned ON.)

TRANSDUCER A
Transducer connector A

TRANSDUCER B
Transducer connector B

TRANSDUCER C
Transducer connector C

Pencil transducer connector

DC IN
ECG (Electrocardiogram)
ECG

PCG (Phonocardiogram)
PCG
External input terminal
AUX
AC (Alternating current)
Footswitch
Manufacturer

Date of manufacture

Serial number

Authorized representative in the EC (on systems complying


with European Directive 93/42/EEC)

No. 2B771-050EN*G
3-15 *
4. Preparation for Examination
4.1 Moving and Stopping the System

WARNING: Do not push the system from the side. If the system is
pushed from the side, it may fall down and cause injury.

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. 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.

3. Do not sit on the system.


The system may move, causing you to lose your balance
and fall.

4. Do not place any objects on top of the monitor. They may


fall, causing injury.

5. Confirm that the movable sections such as the operating


panel are locked before moving the system. Otherwise, the
movable sections may move unexpectedly and cause 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 reference signal 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. 2B771-050EN*G
4-1
CAUTION: 1. Observe the following precautions before moving the system to
prevent system malfunctions.

(a) Turn the power OFF and then turn OFF the breaker on the power
supply panel at the rear of the system.

(b) Store the transducer in the transducer holder and hang the cable
on the transducer cable hanger.

(c) When moving the system, use the handle. Do not push delicate
sections such as the panel.

2. Do not stop the moving system using the total lock function except in
emergencies. The casters can be damaged and abnormal operation
can result.

(1) Unlock the caster locks. The caster locks are at the front and rear of the system
and each lock can prevent movement of the corresponding wheel.

<<Caster locking>>

Releases the lock


Locks rolling of the casters
Locks horizontal swiveling of the casters

(2) Move the system using the handle.

(3) When the system is in the desired position, lock the casters.

No. 2B771-050EN*G
4-2
4.2 Handling and Connecting/Disconnecting the Transducer
4.2.1 Handling the transducer
(1) When the transducer is not used or when the system is moved, place the
transducer in the transducer holder and hook the transducer cable on the cable
hanger.

(2) When moving the system, be careful not to allow the system casters to roll over the
transducer cable. Failure of the transducer may result.

(3) Do not subject the acoustic lens surface of the transducer to shock by hitting it
against a hard object or dropping it on the floor. A failure affecting the safety or
functionality of the transducer may result.

(4) Do not apply stress to the transducer cable (tension, twisting, bending, pinching,
etc.). The shield wire or signal wire inside the cable may break or short-circuit,
which could result in electric shock to the patient or operator, or abnormal
ultrasound images.

(5) Do not scratch or rub the acoustic lens surface of the transducer. This may cause
the transducer to fail.

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

4.2.2 Connecting/Disconnecting the transducer

CAUTION: 1. Be sure to turn OFF the power or select another transducer connector
before connecting a transducer to or disconnecting the transducer from
the currently selected transducer connector. Connecting a transducer
to or disconnecting the transducer from the currently selected
transducer connector can cause damage to the system or the
transducer.
2. Do not connect or disconnect a transducer during system startup or
shutdown. Doing so may cause a malfunction.

(1) Connect the transducer and turn the lock handle clockwise to lock the connector.

Lock handle

Lock

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

No. 2B771-050EN*G
4-3
4.3 Positional Adjustment of the Main Panel

CAUTION: When lowering the main panel, take care not to apply a load to the cable
hook or transducer holder. The cable hook or transducer holder may be
damaged.

(1) Hold the panel Up/Down lever. The lock is released.

(2) Adjust the height of the main panel and release the panel Up/Down lever.

No. 2B771-050EN*G
4-4
4.4 Adjustment of the CRT Monitor Angle
Hold both sides of the monitor and adjust the angle.

No. 2B771-050EN*G
4-5
4.5 Adjustment of the LCD Monitor

CAUTION: Confirm that the LCD monitor arm is locked before moving the
system. Otherwise, the LCD monitor arm may move
unexpectedly, resulting in personal injury.

4.5.1 Locking and unlocking the 17-inch LCD monitor arm

 To release the lock of the LCD monitor arm, fold the arm down fully and then press
the lever in and rotate it in the direction indicated by .

 To lock the LCD monitor arm, fold the arm down fully and then press the lever in and
rotate it in the direction indicated by .

Arm

Released

Lever
Locked

No. 2B771-050EN*G
4-6
4.5.2 Locking and unlocking the 15-inch LCD monitor arm

 To release the lock of the LCD monitor arm, fold the arm down fully and then press
the lever in and rotate it in the direction indicated by .

 To lock the LCD monitor arm, fold the arm down fully and then press the lever in and
rotate it in the direction indicated by .

No. 2B771-050EN*G
4-7
4.5.3 Locking the LCD monitor (for 17-inch monitor only)
(1) Carefully tilt the LCD monitor so that the LCD surface is facing up.

(2) Move the lever in the direction indicated by the arrow to lock the monitor.

LCD monitor

Lever

4.5.4 Adjusting the LCD monitor angle (for both 17-inch and 15-inch
monitors)

CAUTION: Do not place your hand on the LCD monitor arm or under the
LCD monitor when adjusting the monitor angle. There is a risk
of hand injury.

(1) To tilt the monitor up/down, hold the opposite corners of the LCD monitor.

(2) To swivel the monitor left/right, hold the monitor handles.

No. 2B771-050EN*G
4-8 *
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 as protective earth is


not allowed. The system should be connected according
to local requirements and should not conflict with
IEC60601-1 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.

No. 2B771-050EN*G
5-1
WARNING: 6. A separate power outlet of the specified rating must be
provided to supply power to the diagnostic ultrasound
system. Refer to the "Specifications" subsection for the
power requirements of the diagnostic ultrasound system.
Do not connect the diagnostic ultrasound system to the
same power outlet as another device. Doing so may
cause the power circuit breaker of the facility to trip, the
fuses to blow, or a fire or electric shock to occur.

Connect the power plug to an outlet for medical equipment. By doing this, the
protective earth line is connected.

Protective earth terminal

No. 2B771-050EN*G
5-2 *
6. Power ON/OFF
CAUTION: Back up the stored data (image data and exam history)
periodically and delete unnecessary data. If there is a limited
amount of free space on the hard disk, the time required to
display the ultrasound image after the system power is turned
ON increases.

6.1 Power ON
This section describes the security functions for protecting patient information and their
operation.

To use the security functions, enter the ID and password on the logon screen after
system power ON.

This system supports a function for recording the operator's certification and access log
in order to protect personal information. If this function is required, contact your Toshiba
service representative.

(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 breaker of the power supply panel on the rear of the system.

(3) Press POWER on the main panel. Some time after the setup screen is displayed, a
2D-mode image is displayed.

NOTE: 1. Some time is required before an ultrasound image is displayed on the


monitor after the power is turned ON. The time ranges from 3 to 6 minutes
and differs depending on the system conditions.

2. A 2D-mode image is displayed and then frozen automatically.

(4) If required, adjust the brightness ( ) and contrast ( ) using the


corresponding buttons on the monitor.

<When the CRT monitor is used>

(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.

No. 2B771-050EN*G
6-1
<When the LCD monitor is used>

(a) Display the adjustment menu using the MENU buttons. Select the desired
function (brightness/contrast/screen size/ characteristic).

100%
100%
1
MENU buttons [-], [+] buttons 
1

(b) Adjust the brightness ( ) using the [-], [+] buttons so that the brightness
level of the screen matches the lighting in the examination room.

(c) Set the desired contrast ( ) using the [-], [+] buttons.

(d) Select the desired screen size ( ) using the [-], [+] buttons.


(e) Select the desired  characteristic ( ) using the [-], [+] buttons.

(f) Each function setting can be returned to the default (initial value at the time of
shipment) by pressing the [+] button while holding down the [-] button.

(g) Image display on the LCD monitor can be switched ON/OFF by pressing the
[-] button while holding down the ▲ MENU button.

6.2 Power OFF

CAUTION: Do not turn OFF the power supply of the system during
printing, data saving, or invoking. Doing so may result in
failure of saving or printing or damage to the data. In addition,
doing so during access to media may damage the media.

(1) Press POWER . The confirmation message is displayed on the screen.

a. When the system is not in security mode b. When the system is in security mode

No. 2B771-050EN*G
6-2
(2) Move the cursor to Shutdown and press SE
T
. The power is turned OFF.

CAUTION: 1. Turn ON the system only after the power has been OFF for more
than 15 seconds. If the system is turned ON immediately after
being turned OFF, the system may malfunction.

2. If the power cannot be turned OFF by the normal procedure, press


and hold down POWER for at least 5 seconds. If the power is still not
turned OFF, turn OFF the breaker of the power supply panel at the
rear of the system.
These methods should not be used under normal conditions. They
may damage the system.

3. If the power is not turned OFF by following the normal procedures,


2D mode images may not be displayed when the system power is
turned ON again. This does not indicate system failure. Turn OFF
the breaker on the power supply panel on the rear of the system,
wait at least 15 seconds, and then turn ON the breaker again.
When the STANDBY LED lights, turn ON the power switch.

NOTE: 1. The power shutdown process may take approximately 1.5 to 3


minutes depending on the system conditions.

2. If an error dialog is displayed during the power shutdown process, turn


ON the system power again.

3. When POWER is pressed during data copying to media, during data


conversion, or during access to the database, the confirmation dialog
shown below is displayed.

(Example: Confirmation dialog displayed when the power switch is


pressed during data copying to a CD-R)

When the cursor is moved to Continue and SE


T
is pressed, the
dialog for selecting Standby or Shutdown is displayed.

No. 2B771-050EN*G
6-3
(3) If the system is not going to be used for an extended period of time, turn OFF the
breaker of the power supply panel at the rear of the system and disconnect the
power cable from the outlet.

6.3 Standby Mode


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

CAUTION: Do not set the system to Standby mode during printing, data
saving, or invoking. Doing so may result in failure of saving or
printing or damage to the data. In addition, if the system is set
to standby mode during access to media, the media may be
damaged. Furthermore, when used the next time, the printer or
DVD/CD drive will not operate correctly.

6.3.1 Setting standby mode

(1) Press POWER . A confirmation dialog is displayed on the monitor.

a. When the system is not in security mode b. When the system is in security mode

(2) Move the cursor to Standby and press SE


T
. After a short while, the system
power is turned OFF and the STANDBY LED lights in orange.

NOTE: 1. A message suggesting that the system power be turned OFF by pressing
[Shutdown] is displayed if [Standby] is selected in the following cases.
 The cumulative power ON time (the cumulative time for which the
system has been used without being shut down after normal power ON)
has exceeded 48 hours; or
The cumulative passed time (the cumulative time for which the system
has been operated in the standby OFF/ON sequence without being shut
down by the normal shutdown process) has exceeded 480 hours (20
days).
"Shutdown is recommended. After starting, it has passed for a long
time."
 The system has been turned ON from standby mode 60 times
continuously.
"Shutdown is recommended. There is too much number of times of
standby."

No. 2B771-050EN*G
6-4
NOTE: 2. Standby mode cannot be used in the following cases and the
corresponding messages shown below are displayed. In this case, turn
OFF the power by selecting [Shutdown].
 The cumulative power ON time (the cumulative time for which the
system has been used without being shut down after normal power ON)
has exceeded 96 hours; or
The cumulative passed time (the cumulative time for which the system
has not been turned OFF using the normal shutdown method after
normal power ON, including the period in which the system has not been
used) has exceeded 720 hours (30 days).
"Standby is halted. Select Shutdown or Cancel. After starting, it has
passed for a long time."
 The system has been turned ON in standby mode 120 times
continuously.
"Standby is halted. Select Shutdown or Cancel. There is too much
number of times of standby."

3. Approximately 3 minutes is normally required to shut down the system


power from standby mode; however, the actual time required varies
depending on the system status.

4. If the system power is turned OFF using a method other than the normal
shutdown procedure, the 2D-mode image may not be displayed when the
power is turned ON the next time. This is not a system failure. Turn OFF
the breaker on the power supply panel on the rear of the system, wait for at
least 15 seconds after the STANDBY LED lights, and then turn ON the
breaker again to turn the system power ON.

5. When the system is started from the standby status while the battery is
low, the system starts up in the same manner as in normal power ON
mode.
* The battery is charged automatically by keeping the breaker set to ON.
* The purpose of the battery is to maintain the memory that stores the
system information required for the standby function. The system cannot
be started using the battery only.
6. Standby mode cannot be used in the following cases and the
corresponding messages shown below are displayed. When the
corresponding operation is completed or terminated, standby mode
becomes effective again.
 During system setting operation
"Standby cannot be selected in the current system mode."
 During the data registration process
"Data registration is in progress. Standby cannot be selected."
 During use of an MTEE transducer
"A MTEE transducer is being used. Standby cannot be selected."
 When a caution message is displayed

No. 2B771-050EN*G
6-5
6.3.2 Recovery from the standby status

Press POWER on the main panel. A short while later, a 2D-mode image is displayed.

NOTE: Normally, the ultrasound image is displayed approximately 1 or 2 minutes


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

6.4 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 turning the power OFF/ON and the examination
may not be able to continue.

6.4.1 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.

6.4.2 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 turning OFF/ON the system power.

 An error message is displayed and does not disappear (except for messages
regarding TEE transducer temperature control).

 The screen display is abnormal.

 The system operations are disabled.

<System OFF/ON procedure>

(1) Follow the steps below to turn the system power OFF.

(a) Press POWER . The confirmation message is displayed on the screen.

(b) Move the cursor to Shutdown and press SE


T
. The power is turned OFF.

NOTE: The power shutdown process may take approximately 1.5 to 3 minutes
depending on the system conditions.

No. 2B771-050EN*G
6-6
(2) Wait at least 15 seconds, and then press POWER to turn the system power ON.

NOTE: Some time is required before an ultrasound image is displayed on the


monitor after the power is turned ON. The time ranges from 3 to 6
minutes and differs depending on the system conditions.

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

CAUTION: 1. Turn ON the system only after the power has been OFF for more
than 15 seconds. If the system is turned ON immediately after
being turned OFF, the system may malfunction.

2. If the power cannot be turned OFF by the normal procedure, press


and hold down POWER for at least 5 seconds. If the power is still not
turned OFF, turn OFF the breaker of the power supply panel at the
rear of the system.
These methods should not be used under normal conditions. They
may damage the system.

No. 2B771-050EN*G
6-7 *
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 22.1.1
"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, reference signal cable 
etc.) and no looseness in the connectors.
7 There should be no abnormalities or stains of the transducer surface, cable 
sheath, or connector, such as peeling, cracks, protruding parts, or loss of
firmness of the acoustic lens.
* If any stains are present, perform cleaning, disinfection, or sterilization
referring to the operation manual provided with the transducer.
8 No clips etc. are placed on the main panel or keyboard. 
9 There should be no obstacles near the movable sections and air filter of 
the system.

No. 2B771-050EN*G
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 2D-mode images.
4 There should be no abnormality in the date and time. 
* Refer to subsection 20.9 for the procedures for changing the system
time.
5 The acoustic lens surface of the transducer should not be unusually hot. 
(Perform check by hand.)
6 Switches and knobs on the panel should function normally. 
7 There should be no abnormality in the color or display position of images 
output on a printer or recorded on a video recording unit.
* When measurement is to be performed using video images, be sure to
check the image recording performance in advance. Refer to the
operation manual <<Measurements volume>> for details.
8 The temperature detection function should operate normally (when the 
multiplane transesophageal transducer is to be used).
* Refer to the operation manual <<Applications volume>>.

No. 2B771-050EN*G
7-2
NOTE: IQ Report function

When an error message or incorrect image is displayed, save the image and
system information using the IQ Report function

<<Easy operating procedures>>

(1) Freeze the screen.

(2) Press [IQ Report] on the touch panel [Other] menu. The image and
system information are saved.

(3) Stop using the system and contact your TOSHIBA representative for
repair.

Other
AP 49

Panel IQ
Setting Report

Special VIDEO
Appli. Menu Size

Stress Panoramic
Echo View

Biopsy Preset
3D
Guide

PIMS
TDI CHI 4D Physio

Other
2D-
Gate Size CDI/PW-Steer 2D-Steer 2D-IP Frequency

No. 2B771-050EN*G
7-3 *
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 and Patient name Examiner name Preset name VCR

Date
TOSHIBA 123456789012 0:00:00 2004/10/05
Hospital name ABCDEF -Y.M- Adult Heart 07:02:28 Time
0

10

Printing Storing HDD : 90% Free SELECT

The space available for image storage Trackball function icon


in the storage media is displayed.
The message "Storing" is displayed during data archiving to the HDD or MO or
when communication is in progress in the background.
Displayed when printing is performed.

CAUTION: The free space on the hard disk is displayed at the bottom of
the screen in the format "HDD: xx% Free". Data cannot be
saved if the free space is insufficient. Ensure the required free
space before saving the images.

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


operation manual, Application volume.

CAUTION: When the message "Printing" is displayed at the bottom-left corner of the
monitor, it indicates that the system is ready to output images to the printer.
Check the printer output for completion of the actual printing.
Note that if the next print operation is executed while "Printing" is
displayed, the next image is not printed. Confirm that the message
"Printing" is cleared before executing the print operation.

No. 2B771-050EN*G
8-1
8.2 Displaying the Acoustic Power Data
The acoustic power data transferred from the transducer is displayed on the touch panel.

NOTE: Whether or not the acoustic power data is displayed depends on the mode. If
the value is low, display is not performed.

<Except for USA and Canada>

No. Label Description Display location


<1> TIS Thermal index soft tissue Acoustic power
Displayed as the calculated/estimated value for display area
temperature increase in the soft tissues.
<2> TIB Thermal index bone
Displayed as the calculated/estimated value for
temperature increase in the cranial bones of a fetus
or newborn child.
<3> TIC Thermal index cranial
Displayed as calculated/estimated value for
temperature increase in the cranial bones of a child
or adult.
<4> AP Acoustic power
The current transmission value (%) is displayed.
<5> MI Mechanical index Image display area
Displayed as the value related to the mechanical
effectiveness such as cavitation.

No. 2B771-050EN*G
8-2
<Only for USA and Canada>

No. Label Description Display location


<1> TISm Thermal index soft tissue Acoustic power
Displayed as the calculated/estimated mean value display area
for temperature increase in the soft tissues.
<2> TIBm Thermal index bone
Displayed as the calculated/estimated mean value
for temperature increase in the cranial bones of a
fetus or newborn child.
<3> TICm Thermal index cranial
Displayed as calculated/estimated mean value for
temperature increase in the cranial bones of a child
or adult.
<4> AP Acoustic power
The current transmission value (%) is displayed.
<5> MIm Mechanical index Image display area
Displayed as the mean value related to the
mechanical effectiveness such as cavitation.

No. 2B771-050EN*G
8-3
8.3 Display of Scanning Direction
In this system, the T mark indicating the side of the transducer grip with a small bump is
displayed on the screen. In the standard configuration, the T mark is displayed as
shown below. The T mark display position can be changed. The change should be
made by a service engineer. If you wish to change the T mark display position, contact
your Toshiba service representative.

When the same region is to be examined repeatedly, the T mark can be used as a
guide to acquire the images at the same position by checking the relationship between
T mark position and the small bump on the grip of the transducer.

No. 2B771-050EN*G
8-4 *
9. Entering the Patient ID
This section describes the patient information input procedures. For details, refer to the
Operation Manual (Application Volume).

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


examination for a new patient. If measurement is performed
for a new patient for whom the patient ID is not registered or
saved, the measurement results and other data cannot be
saved in the system. In addition, the data for the two
patients are mixed together, which may result in incorrect
diagnosis.

2. 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.

3. 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.

4. Enter the patient information including LMP and IVF


correctly in the patient ID registration screen. Otherwise, the
fetal growth data will be calculated incorrectly.

9.1 Entering and Saving Data on the Patient ID Registration


Screen

(1) Press to display the patient ID registration screen.

Example of display

No. 2B771-050EN*G
9-1
(2) Enter the patient ID (essential).

CAUTION: Do not enter a patient ID consisting of spaces only. Doing


so will result in reading/writing of data to/from an media
and DICOM transfer to other systems being performed
incorrectly.

NOTE: For urgent cases, move the cursor to [Emergency] and press SE
T
.
The ID and name for urgent cases are automatically numbered.
The ID and name are displayed as "date + unique letter string". If more
than one system is used at the site, be sure to set a unique letter string
so that the system can be identified. For the letter string setting, contact
your TOSHIBA representative.

(3) Select the desired exam type. The items to be displayed on the Patient
Information screen may differ according to the selected exam type.

(4) Enter other patient information items.

 For fetal examinations, enter the data for the mother as the patient information.

 Confirm the BSA calculation method setting.

NOTE: Equations for calculating BSA (body surface area)


2
BSA (m ) is calculated when patient height (cm) and weight (kg) are
entered on the Patient Information screen.
The following expressions are available for calculating BSA. The desired
expression can be selected from a pull-down menu.

1. Occidental
0.725 0.425
BSA = 0.007184  Height  Weight

2. Oriental (Adult)
0.725 0.425
BSA = 0.007358  Height  Weight

3. Oriental (12-14)
0.651 0.423
BSA = 0.010265  Height  Weight

4. Oriental (6-11)
0.663 0.444
BSA = 0.008883  Height  Weight

5. Oriental (1-5)
0.362 0.423
BSA = 0.038189  Height  Weight

6. Oriental (0)
0.655 0.473
BSA = 0.009568  Height  Weight

No. 2B771-050EN*G
9-2
(5) Confirm that the patient information, including the ID, is entered correctly, and then
move the cursor to CONFIRM Start and press SE
T
. 2D-mode images are
displayed.

NOTE: 1. The following items cannot be changed once the patient information
has been registered. Confirm that these items are set correctly before
starting the examination.

* Exam Type
* All the patient information items when "OB" is selected for Exam
Type

2. If the patient's date of birth has not been entered on the Patient
Information screen, "November 18, 1858" is displayed for the date of
birth in the OB Browser, in the History Browser, in the Comment field
of the Patient Browser screen in Patient Info mode, and in the
patient/examination information modification form.

3. When settings are added or deleted for any of the following items, the
changes will be applied after the system is rebooted.

* Operator
* Physician
* Ref. Physician
* Department

No. 2B771-050EN*G
9-3 *
10. Common Operation for Each
Mode
10.1 Touch Panel Operation

CAUTION: Do not press two or more switches simultaneously. System


malfunction may result.

The menu is displayed on the touch panel according to the image mode.

* Acoustic power data display area is displayed as follows.

<Except for USA and Canada> <Only for USA and Canada>

TIS 0 TISm 0
TIB 0 TIBm 0

When the tab is pressed, the touch panel can be displayed in another mode.

For example, the CDI menu is displayed in CDI mode. If the 2D tab is pressed, the 2D
menu is displayed. 2D images in the background of CDI images can be adjusted.

10.2 Pop-Up Menu Operation


When MENU
is pressed, the pop-up menu corresponding to the image mode is
displayed on the monitor.

(1) Move the cursor to the desired item using the trackball and press SE
T
.

(2) Rotate the dial of the trackball to change the setting value.

No. 2B771-050EN*G
10-1
10.3 Trackball Operations
Functions appropriate to the system status are assigned to the trackball.

The assigned function can be changed by pressing SE


T
, NE
XT , , or a desired
function switch.

CINE REVIEW

NE
XT

Trackball

2D GAIN

10.3.1 Operations in real-time display mode


(1) To assign the functions shown on the monitor

The functions that can be controlled by the trackball are shown as trackball function
icons at the bottom of the screen.

10

15
# 1000

SELECT
Trackball function icons

When more than one function is activated, press SE


T
or NE
XT to select the
function to be used.

No. 2B771-050EN*G
10-2
(2) To assign a function that is not shown on the monitor

When the pop-up menu or body mark is displayed, SE


T
and NE
XT may not be
used to select a trackball function because these switches are used to operate
menus or the body mark. In this case, directly press the switch for the desired
function.

For example, when MENU


is pressed, the pop-up menu operation function is

assigned to the trackball. When CDI is then pressed, the ROI adjustment function
is assigned to the trackball and the pop-up menu remains displayed. In this status,
the trackball cannot be used for pop-up menu operation even when SE
T
or
NE
XT is pressed.

To operate the pop-up menu using the trackball, press MENU


.

10.3.2 Operations after freezing


(1) To assign the functions shown on the monitor

After freezing, up to two trackball functions are shown at the bottom of the monitor.
One of them is always the cine control function.

For example, when CALC


is pressed after freezing, the trackball is used to move
the measurement cursor. The icons for cine and measurement are shown at the
bottom of the monitor, with the measurement icon selected.

Pressing in this status changes the trackball function to cine control. To

change the trackball function back to measurement, press or CALC


and select
the measurement item from the touch panel menu. If the trackball is currently used
for cine control, directly select the measurement item from the touch panel menu to
change the trackball function back to measurement.

(2) To assign a function not shown on the monitor to the trackball

Press the switch for the desired function directly in the same manner as in real-time
display mode.

For example, when CALC


is pressed after freezing and measurement is performed

by moving the cursor with the trackball and then is pressed, the trackball is

assigned the body mark (transducer mark) function. When is then pressed,
the trackball function is changed to cine control. To use the trackball for moving
the measurement cursor again, press CALC
.

Thereafter, the trackball function is switched between cine and measurement every
time is pressed.

No. 2B771-050EN*G
10-3
10.4 Selecting an Imaging Preset During Examination
(1) Press the [Preset] of the touch panel. The following menu is displayed.

Imaging Appli.
Preset Preset

Factory Factory Factory Factory Factory Factory Factory

Endo PV
Abdomen Neo-Hip OB Prostate Digits
Vaginal Arterial

Factory Factory Factory Factory Factory Factory Factory

Neo Fetal
Neo-Head GYN Kidney Testes PV Venous
General Heart

Factory Factory Factory Factory Factory Factory Factory

Adult Pediatric
Coronary TCD Breast Thyroid Carotid
Heart Heart

Factory Factory Factory

MSK OTHER M-TEE

Delete Save

(2) Select the desired imaging preset.

* For 2D IP, Type A, B, C, D, or E can be selected for each imaging preset using
the pop-up menu. For example, for the imaging preset in which Type A is
selected, the same parameter value is set for all other imaging presets.
However, the value for each imaging preset can be changed later.

No. 2B771-050EN*G
10-4
10.5 Selecting an Application Preset During Examination
The application preset is for measurement, body mark, comment entry, and reporting.

(1) Press the [Preset] on the touch panel. The following menu is displayed.

(2) Press the [Appli. Preset] tab on the touch panel. The application preset menu is
displayed on the touch panel.

Imaging Appli.
Preset Preset

Abdomen2 Neo-Hip Abdomen1 Testes Prostate OB/Gyn1 PV Lower

Adult Pediatric Adult


Penile Pelvis PV Upper
Heart2 Heart Heart1

MSK TCD Breast Thyroid Carotid1 Carotid2 CHI

(3) Select the desired application preset.

No. 2B771-050EN*G
10-5
10.6 Changing the Transducer During Examination
(1) Press [Probe Menu] or the switch on its right on the touch panel. The connected
transducer selection switch is displayed on the touch panel.

Transducer

Transducer Name Transducer Name Transducer Name Transducer Name

(2) Select the desired transducer.

CAUTION: Be sure to turn the power OFF or select another transducer before
disconnecting the currently used transducer. Disconnecting the
currently selected transducer can cause damage to the system or the
transducer.

No. 2B771-050EN*G
10-6
10.7 Creating the Imaging Preset
By changing the image quality adjustment parameter, a new imaging preset can be
created.
Up to seven imaging presets can be created for each Exam Type.
To save/overwrite a new imaging preset, press [Save] in the touch panel [Imaging
Preset] menu. The following message is displayed.

Save the Imaging Preset


Saving Name (in Adult Heart Exam Type)

Enter the new


Custom 1
name in this field.

OK Cancel

(a) To save a new imaging preset, enter the imaging preset name and press [OK].

CAUTION: When a new imaging preset is to be created, the Exam


Type is displayed automatically as the imaging preset
name in the dialog. Be sure to change it. If "Abdomen" is
displayed, change it, for example, to "Abdomen 1". If you
fail to change the displayed preset name, the examination
may not be started with the factory setting even when
"Factory" is selected in Exam Type registration in the
system preset setting menu (refer to subsection 10.9).

(b) To perform overwriting, press [OK] without changing the imaging preset name.

NOTE: 1. Image preset 2D-IP can be saved independently by pressing [IP Save]
in the [2D] menu on the touch panel.
Note, however, that this procedure overwrites the factory setting.
In the factory setting, five types of 2D-IP combinations, A, B, C, D, and
E, are set as default. It is also possible to set and save the
parameters independently for 2D, THI, and CHI for each type.

2. When a new imaging preset that includes the following three


parameters is registered, the corresponding parameters in all other
imaging presets are changed to the values that have been set for the
new imaging preset.

 [PCG Filter] and [PCG Volume] in the [Physio] menu on the touch
panel

 [Video Size] in the [Other] menu on the touch panel

No. 2B771-050EN*G
10-7
10.8 Deleting the Imaging Preset
Imaging presets created by the user can be deleted.

(1) Press [Delete] in the touch panel [Imaging Preset] menu. The following message is
displayed. The name of the running imaging preset is displayed.

Delete the Imaging Preset


Delete Preset Name (in Adult Heart Exam Type)

Custom 1

OK Cancel

(2) When [OK] in the menu is pressed, the imaging preset is deleted.

No. 2B771-050EN*G
10-8
10.9 Changing the System Preset/Application Preset
When [System Settings] in the pop-up menu is selected, the following preset menus are
displayed. Select the desired preset menu, edit the parameters, and press [Save]. For
details, contact your Toshiba service representative.

Preset Function
General Setting Registration of a date format, ON/OFF of network
connection, etc.
Peripheral System Registration of a peripheral device such as a VCR
Output Selection of the dynamic image recording (Clips)
format (AVI or DICOM)
System Exam Information Registration of an examiner name
Preset
Transducer Setting for use of a TEE transducer, etc.
External This menu is provided for the service engineer.
Report This menu is provided for the service engineer.
Other Setting This menu is provided for the service engineer.
Work Order This menu is provided for the service engineer.
Body mark Customize Creation of body marks, editing of touch panel
layout, etc.
Annotation Customize Registration, modification, etc. of the annotation
(comment) menu
Meas. Registration Registration of user-defined measurements
OB Registration Registration of user-defined OB measurements
Application Meas. Auto Active Confirmation of the measurement item to be
Preset started automatically.
* The setting is to be performed by a service
engineer.
Exam Type Registration of an imaging preset to be called in
Exam Type, registration of an application preset,
and registration of a transducer.
Specification of the application preset items

CAUTION: If a change has been made to the system presets, be sure to


turn OFF/ON the system power. Otherwise, the change will not
go into effect.

CAUTION: 1. When you wish to change an application preset, confirm that the
application preset is displayed on the screen.
Only changes to the displayed application preset can be saved.

2. If the date format or the height or weight unit is changed on the General
Setting screen, the change will be applied after the system is rebooted.

3. If the time is set back in the General Setting screen, images stored with
a time stamp later than the time after the change cannot be printed for
some time. Wait until the system time advances past the time stamp of
the image and then print the image.

No. 2B771-050EN*G
10-9 *
11. Display and Operation in Each
Mode
11.1 2D Mode
(1) Entering 2D single mode

Press 2D .

(2) Entering 2D dual display mode

Press DUAL .

NOTE: 2D and SINGLE

2D is pressed to return to 2D single display mode directly from another


imaging or display mode.

Even if the image is frozen, when this switch is pressed, the image is unfrozen
and displayed in 2D single mode.

SINGLE is pressed to return to single display mode from dual display mode,
update display mode, or full display mode.

No. 2B771-050EN*G
11-1
(3) Display layout

<<Display example>>

TOSHIBA 0001 TARO TOSHIBA 0:00:00:00 2004/09/16


Toshiba -Y.M- Adult Heart 00:00:00:PM
0

Gray scale bar


MI:1.2 MI value*3
5 2DG
60
2D gain
DR
60
2D dynamic range
Focus mark
Information on the 10
transducer being
used*1
5S2
Current frequency*2 T2.5
999 fps
Frame rate Body mark
15
2D cine icon
# 1000
IP7 IP
SELECT

Depth scale mark


The scale mark intervals change according to the depth.

*1: 2D-multi frequency upper limit/Transducer type/2D-multi frequency lower limit


Transducer type: S: Sector transducer, C: Convex transducer,
L: Linear transducer, P: Pencil transducer.

*2: 2D transmission/reception frequencies

* T : THI
H : CHI

*3: When the MI value is displayed with the % symbol, the value indicates the
percentage of the current acoustic power.

No. 2B771-050EN*G
11-2
(4) Adjustment on the main panel

Adjustment items Switch Operating procedure


<1> Sensitivity of the entire image Use the palm dial around the trackball.
The overall sensitivity can also be
adjusted using the 2D mode dial: 2D .
2D GAIN

Gain can be changed using the 2D


mode dial after freezing (post gain).(*1)
<2> Depth Use the DEPTH/ZOOM dial.
* When the ZOOM LED is lit, press the
DEPTH
ZOOM
dial to light the DEPTH LED.
<3> Sensitivity according to the Use the STC slide controls.
depth

<4> Invoking the registered image


quality condition IP Use for to select the
desired image quality conditions.
<5> Focus position selection
Use for to select the
focus position.
<6> 2D steering
Use for to adjust the
steering angle during oblique scanning.
<7> Image zooming/panning Use the DEPTH/ZOOM dial and the
trackball.
DEPTH
ZOOM
(1) If the DEPTH LED is lit, press the
dial to light the ZOOM LED.
(2) Rotate the dial to magnify or reduce
the image. Operate the trackball to
pan the image.
(3) Press the dial again to terminate
PAN/ZOOM control.
<8> Frequency selection Use this switch to select the
transmission and reception frequencies.
2D FREQ

<9> Image freezing


FRZ Press FRZ . When it is pressed
again, real-time display mode is
restored.

*1: In this system, gain for 2D mode and M mode can be changed after freezing
(post gain). It can be changed using the 2D mode dial. It cannot be changed
using the palm dial around the trackball because the loop playback function is
assigned to the palm dial. When the gain is changed after freezing, the gain
value is displayed in brackets on the image, indicating that the value is for
reference only. The brackets disappear when the gain is reset to the initial
value.

No. 2B771-050EN*G
11-3
(5) Adjustment using the touch panel

2D-IP menu, page 1/2 2D-IP menu, page 2/2

No. Switch Function


<1> 2D Size Switches the 2D image size.
<2> 2D-Scan Range Sets the scan range.
<3> 2D-Map Adjusts the image hue.
<4> Upside/Down Flips the image upside down.
<5> Reverse Flips the image left to right.
<6> QuickScan Update Automatically adjusts the 2D image quality.
<7> QuickScan Quit Turns OFF Quick Scan.
<8> Trapezoid Linear Switches image display between standard mode and
trapezoid mode.
When the image display is switched, all the parameter
settings other than the size and position of Color ROI
and the Doppler gate position are maintained.
<9> IQ Enhance Reduces residual multiple artifacts and adjusts the
sensitivity.
<10> 2D-PSel Adjusts the image quality and number of frames.
<11> M/D Cursor Turns ON/OFF the M/D cursor display in single display
mode.
<12> Focal No. Sets the focus of the ultrasound beam.
<13> IP Save Registers the IP image quality conditions.
<14> Next/Prev Switches the pages of the 2D-IP menu.
<15> Precision Adjusts the image quality using the Precision Imaging
function.
<16> ApliPure Adjusts the image quality using the ApliPure function.
<17> 2D-Time Smooth Adjusts the image smoothness.
<18> 2D-Edge Enhance Enhances the edge of the image.
<19> 2D-DR Adjusts the dynamic range of the image.
<20> 2D-Post Process Adjusts the enhancement for image display.
<21> 2D-AGC Suppresses comet-tail and reduces noise.
<22> THI Mode Selects the mode of the THI scan (the setting differs
depending on the transducer used).
<23> 2D-THI Turns ON/OFF THI.
* Some of these switches may not be displayed depending on the transducer
connected, the options installed, or the mode used.

No. 2B771-050EN*G
11-4
(6) Adjustment using the pop-up menu

When MENU
is pressed, the 2D menu is displayed on the monitor. Press
and to switch the pages.

2D menu 2D menu 2D menu 2D menu 2D menu 2D menu


(1/6) (2/6) (3/6) (4/6) (5/6) (6/6)

No. 2B771-050EN*G
11-5
No. Menu Function
<1> 2D-Frequency Switches the transmission/reception frequencies.
<2> 2D-Steer Adjusts the steering angle for oblique scanning.
<3> 2D-IP Calls up the image quality conditions.
<4> 2D-IP Type Selects an IP type.
<5> 2D-Focal Position Sets the focal position.
<6> IP Save Registers the IP image quality conditions.
<7> ApliPure Adjusts the image quality using the ApliPure function
(option).
<8> 2D-Post Process Adjusts the gamma curve.
<9> 2D-AGC Suppresses comet-tail and reduces noise.
<10> 2D-Time Smooth Adjusts the image smoothness.
<11> 2D-Edge Enhance Enhances the edge of the image.
<12> 2D-DR Adjusts the dynamic range.
<13> 2D-THI Turns ON/OFF THI.
<14> THI-Mode Selects the mode of the THI scan (the setting differs
depending on the transducer used).
<15> 2D-Map Adjusts the image hue.
<16> QuickScan Update Automatically adjusts the 2D image quality.
<17> QuickScan Quit Turns OFF Quick Scan.
<18> IQ Enhance Reduces residual multiple artifacts and adjusts the
sensitivity.
<19> 2D-PSel Adjusts the image quality and number of frames.
<20> Focal No. Sets the focus of the ultrasound beam.
<21> General Switches the 2D image size. (Standard)
<22> Large Switches the 2D image size. (Large)
<23> Image U/D Flips the image from top to bottom.
<24> Image L/R Flips the image from left to right.
<25> Trapezoid Linear Switches image display between standard mode and
trapezoid mode.
<26> M/D Cursor Turns ON/OFF the M/D cursor display in single
display mode.
<27> MI/AP(%) Display Switches the transmission power display mode
between MI value and percentage (%).
<28> Mode Change Sets display mode after releasing freeze status in
single/dual display mode.
<29> Precision Adjusts the image quality using the Precision
Imaging function.
<30> ClipsStore Specifies the behavior of Cine Clips (cine image data
Behavior storage function).
Refer to subsection 19.4.5 for details.

No. 2B771-050EN*G
11-6
11.2 M Mode
(1) To enter M mode

Press M .

(2) To display the M-mode image in full screen

Press FULL .

(3) To enter M+2D mode

Press .
2D

UPDATE

(4) To set the M cursor

(a) Enter M+2D mode. The M cursor is displayed on the 2D-mode image.

(b) Adjust the position of the M mark using the trackball.

No. 2B771-050EN*G
11-7
(5) Display layout

<<Display example>>

TOSHIBA 0001 TARO TOSHIBA 0:00:00:00 2004/09/16


Toshiba -Y.M- Adult Heart 00:00:00:PM
# 1000 5C2
0
T2.5

999 fps
5

MI:1.2
10 2DG:60
DR:60

15
0
MG:60/MDR60/MF2.5M M gain, M dynamic range,
M transmission/
5
reception frequencies

10
M depth scale mark
15
-2 -1.5 -1 -0.5
IP7
SELECT

Time scale

NOTE: Auto-data display for CDI/MCDI dual display

In CDI/MCDI mode, the values related to images are automatically


displayed on both the CDI image and the MCDI image (auto-data
display).
The most recently adjusted settings of the image are reflected in this
value.
For example, when the CDI image is a real-time image and the MCDI
image is a frozen image, if the settings of the CDI image are changed,
the auto-data for the frozen MCDI image is also changed. The value
differs from the setting value at the time of freezing the MCDI image.
When saving images, pay attention to this.

The data change is reflected


Auto-data for the MCDI image in the CDI image settings.
This changes automatically
Auto-data for the CDI image
according to the settings.

Frozen Frozen
MCDI images Real-time MCDI images Real-time
CDI image CDI image

When the settings of the CDI image are changed

No. 2B771-050EN*G
11-8
(6) Adjustment using the main panel

Refer to page 11-3.

(7) Adjustment using the touch panel

2D M CDI PW/CW

<1> M
Size
<2> <3> <4>
M-Sweep M-
M-Map Speed Frequency

3 2 7.4

M-Post
<6> <7> <8>M-Edge <9>
M-AGC M-Gain M-DR
<5> Process Enhance

3 2 14 1 55

No. Switch Function


<1> M Size Selects the M+2D mode image size.
<2> M-Map Adjusts the image hue.
<3> M-Sweep Speed Adjusts the sweep speed of the M-mode image.
<4> M-Frequency Switches the transmission/reception frequencies.
<5> M-Post Process Adjusts the gamma curve.
<6> M-AGC Suppresses comet-tail and reduces noise.
<7> M-Gain Adjusts the sensitivity of the M-mode image.
<8> M-Edge Enhance Enhances the edge of the image.
<9> M-DR Adjusts the dynamic range.

* Some of these switches may not be displayed depending on the transducer


connected, the options installed, or the mode used.

No. 2B771-050EN*G
11-9
(8) Adjustment using the pop-up menu

When MENU
is pressed, the M menu is displayed on the monitor. Press
and to switch the pages.

M M M
M-Post M-Sweep
<1> Process <7> Speed

<2> M-AGC <8> M-Frequency

M-Gain 2D + M(Small)
<3> <9>

M-Edge 2D + M(Middle)
<4> Enhance <10>

M-DR 2D + M(Large)
<5> <11>

M-Map Side by Side


<6> <12>

1/3 2/3 3/3

System Setting System Setting System Setting


Maintenance Maintenance Maintenance

M menu (1/3) M menu (2/3) M menu (3/3)

No. 2B771-050EN*G
11-10
No. Menu Function
<1> M-Post Process Adjusts the gamma curve.
<2> M-AGC Suppresses comet-tail and reduces noise.
<3> M-Gain Adjusts the sensitivity of the M-mode image.
<4> M-Edge Enhance Enhances the edge of the image.
<5> M-DR Adjusts the dynamic range.
<6> M-Map Adjusts the image hue.
<7> M-Sweep Speed Adjusts the sweep speed of the M-mode image.
<8> M-Frequency Switches the transmission/reception frequencies.
<9> 2D+M (Small) Changes the 2D+M image size. (M-mode: Small)
<10> 2D+M (Middle) Changes the 2D+M image size. (M-mode: Middle)
<11> 2D+M (Large) Changes the 2D+M image size. (M-mode: Large)
<12> Side by Side Displays M-mode image and 2D image side by
side.

No. 2B771-050EN*G
11-11
11.3 CDI Mode
(1) Entering CDI mode

Press CDI .

(2) Relocating and resizing the ROI

(a) To move the ROI

In CDI mode, the ROI can be moved using the trackball. (The icon
appears orange.)

(b) To resize the ROI

Use SE
T
or NE
XT to change the color of the icon to orange.

The ROI can be resized using the trackball.

No. 2B771-050EN*G
11-12
(3) Display layout

<<Display example>>

TOSHIBA 0001 TARO TOSHIBA 0:00:00:00 2004/09/16


Toshiba -Y.M- Adult Heart 00:00:00:PM
Color flow 80.0 0
velocity range

Color bar
MI:1.2
5 2DG
Color flow -80.0 60
velocity range cm/s DR
60
CG Color gain
Color focus mark 80
10 PRF
3.5k
Color PRF
5C2 Filter
T2.5 I Color filter
Color transmission/ CFH2.5
reception frequencies 999 fps

15
# 1000
IP7
SELECT

No. 2B771-050EN*G
11-13
(4) Adjustment on the main panel

Adjustment items Switch Operating procedure


Sensitivity of the entire Use the CDI/POWER GAIN dial.
CDI
image

Depth Use the DEPTH/ZOOM dial.


* When the ZOOM LED is lit, press the dial
DEPTH
ZOOM to light the DEPTH LED.
Low-cut filter
Use to set the filter.
CDI FILTER

CDI FILTER

CDI steering
Use for to adjust the
steering angle during oblique scanning.
Switching between velocity Press this switch to shift between SCALE
scale and frequency and C/D FREQ.
SCALE
C/D FREQ

Color baseline Use the BASE LINE switch.

BASE LINE

Image zooming/panning Use the DEPTH/ZOOM dial and the trackball.


(1) If the DEPTH LED is lit, press the dial to
DEPTH
ZOOM light the ZOOM LED.
(2) Rotate the dial to magnify or reduce the
image. Operate the trackball to pan the
image.
(3) Press the dial again to terminate
PAN/ZOOM control.
Image freezing
FRZ Press FRZ . When it is pressed again,
real-time display mode is restored.
Twin View Use this switch to start up Twin View mode,
in which a black-and-white image and a color
image are displayed in real time
simultaneously.

No. 2B771-050EN*G
11-14
(5) Adjustment using the touch panel

No. Switch Function


<1> Indep. Oblique Changes operation settings for CDI steering and PW
steering.
ON : Operation settings for either CDI steering or
PW steering can be made.
OFF : Operation settings for both CDI steering and
PW steering can be made.
<2> CDI-Map Type Selects the color mode display type.
<3> Reverse Reverses coloring.
<4> FIO Turns ON/OFF the color-display FIO.
<5> M/D Cursor Turns the M/D cursor display ON/OFF in single
display mode.
<6> CDI-Map Adjusts the image hue.
<7> Data No. Adjusts the sensitivity for low-velocity blood flow.
<8> M.A.E Adjusts for reducing motion artifacts.
<9> M-Sweep Speed Adjusts the sweep speed for the MCDI-mode images.
* This switch is displayed only when an M-mode
image is displayed in MCDI mode.
<10> CDI-PSel Adjusts the color image quality and number of
frames.
<11> CDI-Focal Position Adjusts the color focal position.
<12> Frame Interpolat Adjusts the frame interpolation.
<13> CDI-Time Smooth Adjusts the smoothness of the image movement.
<14> Spatial Smooth Adjusts the smoothness of the image in the spatial
direction.
<15> Balance Adjusts the balance between color and black/white.
<16> CDI Frequency Switches the transmission/reception frequencies.

* Some of these switches may not be displayed depending on the transducer


connected, the options installed, or the mode used.

No. 2B771-050EN*G
11-15
(6) Adjustment using the pop-up menu

When MENU
is pressed, the CDI menu is displayed on the monitor. Press
and to switch the pages.

CDI CDI CDI CDI


CDI-Time
CDI-Steer M.A.E. FIO
<1> <5> Smooth <10> <15>

M-Sweep
CDI-Filter Spatial Smooth
<2> <6> <11> Speed

CDI-Frequency Balance CDI-PSel


<3> <7> <12>

Frame CDI-Focal
M/D Cursor
<4> Interpolat <13> Position <16>

CDI-Map Reverse Variance Curve


<8> <14> <17>

Data No.
<9>

1/4 2/4 3/4 4/4

System Setting System Setting System Setting System Setting


Maintenance Maintenance Maintenance Maintenance

CDI menu (1/4) CDI menu (2/4) CDI menu (3/4) CDI menu (4/4)

No. 2B771-050EN*G
11-16
No. Menu Function
<1> CDI-Steer Adjusts the steering angle for oblique scanning.
<2> CDI-Filter Adjusts the low-cut filter.
<3> CDI-Frequency Switches the transmission/reception frequencies.
<4> Frame Interpolat Adjusts the frame interpolation.
<5> CDI-Time Smooth Adjusts the smoothness of the image motion.
<6> Spatial Smooth Adjusts the smoothness of the image in the
spatial direction.
<7> Balance Adjusts the balance between color and
black/white.
<8> CDI-Map Adjusts the image hue.
<9> Data No. Adjusts the sensitivity for low-velocity blood flow.
<10> M.A.E Adjusts for reduction in motion artifacts.
<11> M-Sweep Speed Adjusts the sweep speed for the MCDI-mode
images.
* This switch is displayed only when an M-mode
image is displayed in MCDI mode.
<12> CDI-PSel Adjusts the color image quality and number of
frames.
<13> CDI-Focal Position Adjusts the color focal position.
<14> Reverse Reverses the coloring.
<15> FIO Turns ON/OFF the color-display optimization
function.
<16> M/D Cursor Turns the M/D cursor display ON/OFF in single
display mode.
<17> Variance Curve Adjusts the color variance component.
* This is effective when CDI-Map Type is set to
Vel-Variance.

No. 2B771-050EN*G
11-17
11.4 Power Angio Mode
(1) Entering Power Angio display mode

Press POWER .

(2) Relocating and resizing the ROI

(a) To move the ROI

In Power Angio mode, the ROI can be moved using the trackball. (The
icon appears orange.)

(b) To resize the ROI

Use SE
T
or NE
XT to change the color of the icon to orange.

(3) Display layout

Refer to (3) of subsection 11.3 "CDI Mode".

No. 2B771-050EN*G
11-18
(4) Adjustment on the main panel

Refer to (4) of subsection 11.3 "CDI Mode".

(5) Adjustment using the touch panel

No. Switch Function


<1> Indep. Oblique Changes operation settings for CDI steering and PW
steering.
ON : Operation settings for either CDI steering or
PW steering can be made.
OFF : Operation settings for both CDI steering and
PW steering can be made.
<2> Reverse Reverses color.
<3> Back Disp Sets black-and-white display ON/OFF within the ROI.
<4> FIO Turns ON/OFF the color-display FIO.
<5> M/D Cursor Turns the M/D cursor display ON/OFF in single
display mode.
<6> CDI-Map Adjusts the image hue.
<7> Data No. Adjusts the sensitivity for low-velocity blood flow.
<8> M.A.E Adjusts for reducing motion artifacts.
<9> CDI-PSel Adjusts the color image quality and number of
frames.
<10> CDI-Focal Position Adjusts the color focal position.
<11> Frame Interpolat Adjusts the frame interpolation.
<12> Cut off Adjusts the Power Angio image coloring.
<13> CDI-Time Smooth Adjusts the smoothness of the image movement.
<14> Spatial Smooth Adjusts the smoothness of the image in the spatial
direction.
<15> POWER-DR Adjusts the dynamic range.
<16> CDI-Frequency Switches the transmission/reception frequencies.

* Some of these switches may not be displayed depending on the transducer


connected, the options installed, or the mode used.

No. 2B771-050EN*G
11-19
(6) Adjustment using the pop-up menu

When MENU
is pressed, the POWER menu is displayed on the monitor. Press
and to switch the pages.

POWER POWER POWER POWER


CDI-Steer CDI-Time M.A.E FIO
<1> <6> Smooth <11> <16>

CDI-Filter Spatial Smooth


<2> <7>

CDI-Frequency CDI-PSel
<3> <12>

Frame CDI-Focal
Power-DR M/D Cursor
<4> Interpolat <8> <13> Position <17>

Cut Off CDI-Map Reverse


<5> <9> <14>

Data No. Back Disp


<10> <15>

1/4 2/4 3/4 4/4

System Setting System Setting System Setting System Setting


Maintenance Maintenance Maintenance Maintenance

POWER menu (1/4) POWER menu (2/4) POWER menu (3/4) POWER menu (4/4)

No. 2B771-050EN*G
11-20
No. Menu Function
<1> CDI-Steer Adjusts the steering angle for oblique scanning.
<2> CDI-Filter Adjusts the low-cut filter.
<3> CDI-Frequency Switches the transmission/reception frequencies.
<4> Frame Interpolat Adjusts the frame interpolation.
<5> Cut Off Adjusts the POWER image coloring.
<6> CDI-Time Smooth Adjusts the smoothness of the image motion.
<7> Spatial Smooth Adjusts the smoothness of the image in the
spatial direction.
<8> Power-DR Adjusts the dynamic range.
<9> CDI-Map Adjusts the image hue.
<10> Data No. Adjusts the sensitivity for low-velocity blood flow.
<11> M.A.E Adjusts for reduction in motion artifacts.
<12> CDI-PSel Adjusts the color image quality and number of
frames.
<13> CDI-Focal Position Adjusts the color focal position.
<14> Reverse Reverses the coloring.
<15> Back Disp Turns ON/OFF the black/white display within the
ROI.
<16> FIO Turns ON/OFF the color-display optimization
function.
<17> M/D Cursor Turns the M/D cursor display ON/OFF in single
display mode.

No. 2B771-050EN*G
11-21
11.5 Doppler Mode
(1) Entering PW (Pulsed Wave) Doppler display mode

Press PW . The system enters 2D + PW display.

To display PW mode only, press PW to enter PW mode and then press FULL .

(2) Entering CW (Continuous Wave) Doppler mode

Press CW . The system enters 2D + CW display (except when a pencil


transducer is used).

To display CW mode only, press CW to enter CW mode and then press FULL .

No. 2B771-050EN*G
11-22
(3) Display layout

TOSHIBA 0001 TARO TOSHIBA 0:00:00:00 2004/09/16


Toshiba -Y.M- Adult Heart 00:00:00:PM
# 1000 5C2
0
T2.5

999 fps
5
MI:1.2
Gate size (mm)
2DG:60
10 DR:60 Depth and angle correction
value of sampling gate and
11.5 45°
12.4 cm PW/CW Doppler
15
80.0
DG:50/PRF:52k/Filter:2000 Doppler gain, PRF, and
filter of the PW/CW Doppler
40.0

cm/s Velocity scale of the


-40.0 PW/CW Doppler

-80.0
-2 -1.5 -1 -0.5 0 Time scale
IP7
SELECT

No. 2B771-050EN*G
11-23
(4) Adjustment on the main panel

Adjustment items Switch Operating procedure


Sensitivity of the Doppler Use the Doppler GAIN knob.
PW
waveform

Sampling gate width Use this switch to change the sampling gate
width.
Low-velocity noise
Use to reduce the low-velocity noise.
CDI FILTER

CDI FILTER

PW steering
Use for to adjust the
steering angle during oblique scanning.
Velocity scale
Use to select the desired velocity
SCALE
SCALE C/D FREQ

C/D FREQ scale.


Angle correction for Rotate the ANGLE COR knob to correct the
Doppler beams angle.
ANGLE COR
Press this knob to turn the angle mark
display ON/OFF.
Doppler baseline Use this switch to move the baseline (0-Hz
line) vertically.
BASE LINE

VOLUME
Doppler sound BALANCE
Use the outer dial (BALANCE) to adjust the
right-to-left balance.

AUDIO
Use the inner dial (VOLUME) to adjust the
volume.
Image freezing
FRZ Press FRZ . When it is pressed again,
real-time display mode is restored.

No. 2B771-050EN*G
11-24
(5) Adjustment using the touch panel

No. Switch Function


<1> DOP Size Switches the image size in PW/CW + 2D mode
display.
<2> Reverse Reverses the waveform.
<3> Steer Reverse Reverses the steering angle for oblique scanning.
<4> Bi-plane E/Tr Switches the display between Endfire and Transverse
when a biplane transducer is used.
<5> CDI/PW Simult Turns ON/OFF the simultaneous display of the CDI
and PW images at the time of mode transition from
CDI to PW.
<6> Indep. Oblique Changes operation settings for PW steering and CDI
steering.
ON : Operation settings for either PW steering or
CDI steering can be made.
OFF : Operation settings for both PW steering and
CDI steering can be made.
<7> DOP-Map Adjusts the image hue.
<8> DOP-Sweep Speed Adjusts the sweep speed of the D-mode image.
<9> DOP-Pixel Ratio Adjusts the time/frequency resolution.
<10> DOP-Frequency Switches the transmission/reception frequencies.
<11> IQ Balance BD Selects the image quality of 2D-mode and D-mode
images in 2D+D display mode.
* This switch is displayed only when [DOP-High
Velocity] is set to ON on the PW/CW page of the
pop-up menu and blood flowing at a high velocity is
depicted.
<12> DOP-Post Process Adjusts the image display intensity.
<13> DOP-DR Adjusts the dynamic range.
<14> Auto Trace Turns ON/OFF the Real-time Doppler Auto Trace
function.
<15> Trace Adjust Displays the trace line adjustment menu.
<16> QuickScan Update Adjusts the scale and baseline automatically.
* Some of these switches may not be displayed depending on the transducer
connected, the options installed, or the mode used.

No. 2B771-050EN*G
11-25
(6) Real-time Doppler Auto Trace

When the Real-time Doppler Auto Trace function starts up, the Doppler waveform
tracing is performed as shown in the screen below. Measurement values and
calculated values for the recognized Doppler waveform are displayed. The
markers are also displayed at the positions of maximum flow velocity value,
minimum flow velocity value, and end-diastolic flow velocity value. Real-time
Doppler Auto Trace is enabled during both spectrum Doppler image acquisition
and freezing.

Refer to subsection 2.2.5 "D-Mode Meas.2" in the operation manual


<<Measurement>> volume for the setting which determines whether or not the
measurement values and calculated values are displayed.

* Example of Real-time Doppler Auto Trace display

No. 2B771-050EN*G
11-26
When "D>>C" is set in [High Velocity BCD] of the pop-up menu and color mode
and Doppler mode are set to ON, the touch panel is displayed as shown below.

No. Switch Function


<1> IQ Balance BCD Selects the image quality of 2D-mode, CDI-mode,
and D-mode images in 2D+CDI+D display mode.
* This switch is displayed only when "D>>C" is set in
[High Velocity BCD] of the PW/CW page of the
pop-up menu and high-velocity blood flow is
depicted. This switch is not displayed when "D>C"
or "D=C" is set.

No. 2B771-050EN*G
11-27
When [Auto Trace] or [Trace Adjust] is set to ON, the menu below is displayed.

No. Switch Function


<1> Forward/Reverse Selects the trace range for Real-time Doppler auto
trace.
Forward : The Doppler waveform above the
baseline is traced.
Reverse : The Doppler waveform below the
baseline is traced.
All : The entire Doppler waveform is traced.
Auto :  When the baseline is at or below the
center, the waveform above the
baseline is traced.
 When the baseline is above the
center, the waveform below the
baseline is traced.
<2> Peak/Mean Selects the Doppler auto trace display type.
Peak : Only the trace of the maximum velocity
is displayed.
Both : Both the peak velocity trace and mean
velocity trace are displayed.
<3> Beat Sets the number of heartbeat waveforms used for
performing auto measurement for Doppler Auto Trace
line.
<4> Trace Smooth Adjusts the smoothness of the Doppler auto trace in
the temporal direction.
<5> Threshold Sets the threshold for the Doppler auto trace line with
respect to the waveform.
A higher threshold generates a trace closer to the
baseline.

No. 2B771-050EN*G
11-28
NOTE: Real-time Doppler Auto Trace function

1. Before using results of Real-time Doppler Auto Trace for diagnosis,


confirm that the auto-traced line and traced points such as maximum
point and minimum point are appropriate.

2. Make sure that no aliasing is present in the Doppler waveform before


Real-time Doppler auto tracing is performed. Aliasing can be
eliminated by adjusting the baseline and the Doppler scale.

3. The performance of the Real-time Doppler Auto Trace function


depends on the Doppler image quality. Tracing may not be performed
properly depending on the Doppler waveform.

4. The trace line is discontinued at the point where it crosses the


baseline, but it does not affect the measurement result.

5. Real-time Doppler Auto Trace detects the border between the noise
and the signal, not the displayed Doppler waveform. Accordingly, the
trace does not change even if post-processing such as change of the
dynamic range is performed after freezing.

6. If the number of Doppler waveforms recognized on the screen is lower


than that of the Beat setting, the maximum number of waveforms
displayed on the screen are used.

7. The following switches are effective during the Real-time Doppler Auto
Trace process.

 Main panel

ANGLE COR
BASE LINE

 Touch panel

DOP Size
CDI/PW Simult
DOP Map
DOP-Post Process
DOP-DR
Reverse
Auto Trace
Trace Adjust
Threshold
Trace Smooth
Beat
Forward/Reverse
Peak/Mean

No. 2B771-050EN*G
11-29
(7) Adjustment using the pop-up menu

When MENU
is pressed, the PW/CW menu is displayed on the monitor. Press
and to switch the pages.

PW/CW PW/CW PW/CW PW/CW PW/CW PW/CW


menu (1/6) menu (2/6) menu (3/6) menu (4/6) menu (5/6) menu (6/6)

No. 2B771-050EN*G
11-30
No. Menu Function
<1> Base Line Moves the baseline (0 Hz line) vertically.
<2> Angle Cor Rotate Corrects the angle relative to the Doppler beam.
<3> PW-Steer Adjusts the steering angle for oblique scanning.
<4> Gate Size Changes the width of the sampling gate.
<5> DOP-Filter Reduces the low-velocity noise.
<6> High Velocity BD Turns ON/OFF the high velocity support mode in
2D+D display mode.
<7> IQ Balance BD Selects the image quality of 2D-mode and
D-mode images in 2D+D display mode.
<8> DOP-Post Process Adjusts the gamma curve.
<9> DOP-DR Adjusts the dynamic range.
<10> Auto Trace Starts up the Real-time Doppler Auto Trace
function.
<11> DOP-Map Adjusts the image hue.
<12> DOP-Sweep Speed Adjusts the sweep speed of the D-mode image.
<13> DOP-Pixel Ratio Adjusts the pixel ratio of the image.
<14> DOP-Frequency Switches the transmission/reception frequencies.
<15> 2D+D (Small) Changes the 2D+D image size. (D Mode: Small)
<16> 2D+D (Middle) Changes the 2D+D image size. (D Mode: Middle)
<17> 2D+D (Large) Changes the 2D+D image size. (D Mode: Large)
<18> Side by Side Displays D-mode images and 2D images side by
side.
<19> Reverse Reverses the waveform.
<20> Steer Reverse Reverses the angle for oblique scanning.
<21> CDI/PW Simult Turns ON/OFF the simultaneous display of the
CDI and PW images at the time of mode
transition from CDI to PW.
<22> 2D Real/M/D Real Selects whether to display the 2D-mode image in
real time mode or to display M-mode or Doppler-
mode image in real time.
<23> Frequency Scale Switches the Doppler scale between velocity and
frequency.
<24> High Velocity BCD Sets Doppler high-velocity support mode in BCD
simultaneous display mode (Doppler/CDI
simultaneous real-time display mode).
OFF (D = C)
ON1 (D > C)
ON2 (D >> C)

No. 2B771-050EN*G
11-31
No. Menu Function
<25> Auto Invert Adjusts velocity direction automatically according
to the steering angle in CDI mode and Doppler
mode.
<26> Q. Scan Sel Specifies the mode or modes for which the
[Q. Scan] switch is effective.
<27> Obser. Time Specifies the observation period (response
speed) for determining the velocity range and
baseline value.
<28> Disp. Ratio Specifies the Doppler waveform display size with
respect to the velocity range.
<29> Indep. Oblique Changes operation settings for CDI steering and
PW steering.
ON : Operation settings for either CDI steering
or PW steering can be made.
OFF : Operation settings for both CDI steering
and PW steering can be made.
<30> 10 deg. skip* ON : PW steering angle settings
0°, ±20°, or ±30°
OFF : PW steering angle settings
0°, ±10°, ±20°, or ±30°

* This menu is displayed only when [Indep. Oblique] is turned ON.


The PW steering angle of some transducers cannot be set to ±20° and ±30°.

No. 2B771-050EN*G
11-32 *
12. Cine Function
CAUTION: Be sure to register and save the patient ID before starting an
examination for a new patient. If measurement is performed for
a new patient for whom the patient ID is not registered or saved,
the measurement results and other data cannot be saved in the
system. In addition, the data for the two patients are mixed
together, which may result in incorrect diagnosis.

12.1 Overview
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 Operations

(1) Press FRZ to freeze the image. The cine icon is displayed on the monitor.

(2) Operate the trackball, wheel, or MEAS EDIT dial to enable frame-advance
playback. When this operation is performed for the M-mode or Doppler-mode
image, scroll playback is enabled.

MEAS EDIT Forward playback Wheel

Reverse playback Forward playback SE


T NE
XT

Reverse playback
MEAS EDIT

Reverse playback Forward playback


(Roll to the left) (Roll to the right)

2D GAIN

Trackball

(a) Trackball

Use the trackball to play the image back in normal frame-advance mode.

(b) Wheel

Use the wheel to play the image back in frame-by-frame mode.

(c) MEAS EDIT dial

Use the MEAS EDIT dial to play the image back in frame-by-frame mode.
This dial cannot be operated when body mark, annotation, or measurement is
active.

No. 2B771-050EN*G
12-1
(3) When the dial around the trackball is rotated during frame-advance playback mode,
continuous playback (loop) mode is set. The playback speed can be adjusted
using the same dial. When the trackball is operated during loop playback mode,
frame-advance mode is set again.

Dial

Reducing the playback speed Increase the playback speed


(rotate counterclockwise) (rotate clockwise)

2D GAIN

(4) To specify the range of frames to be played back in continuous playback mode,
display the start frame using the trackball and press SE
T
. Then, display the

end frame and press SE


T
.

NOTE: 1. When both images are frozen in 2D-dual display mode, the cine
processing is applied to the image for which the cine icon and the
character "T" indicating the scanning direction are brighter. To
change the target, press DUAL .

2. Auto data displayed on the image played back from the cine memory

The auto data displayed on the image played back from the cine
memory reflects the settings for the timing at which the image has
been frozen. Note this when you save an image.

3. Images in the cine memory may be lost due to setting changes. The
necessary data should be recorded on storage media such as an
HDD using the Clips function etc. as needed.

No. 2B771-050EN*G
12-2 *
13. Display of Reference Signals
Electrocardiographic (ECG) and phonocardiographic (PCG) reference signals can be
displayed during 2D-mode display, M-mode display, and M+2D 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 reference signal


cable.
 The reference signal cable must be connected
correctly.

2. Connect the reference signal cable to the system before


attaching the ECG electrodes to the patient. After the
electrodes are attached to the patient, be careful not to
allow them to come into contact with ground or other
electrically live parts. If the reference signal cable
connector or an electrode comes into contact with
ground or other electrically 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 (UJUR-660A).

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, an electro stimulator, or a
defibrillator, remove the ECG electrodes from the patient.
In addition, do not allow ultrasound transducers, a PCG
microphone, a respiratory sensor, or a pulse sensor to
come into contact with the patient. The patient may be
burned or receive an electric shock.

CAUTION: The displayed reference signals should be used for reference


only. They should not be used for diagnosis or monitoring. In
patients with cardiac pacemakers, an implantable electro
stimulator, or arrhythmia, the heart rate or other parameters
may not be displayed correctly.

No. 2B771-050EN*G
13-1
Reference signal cable and electrode positions

The relationships between the lead wire colors of the reference signal cable and the
electrode positions are described below.

 In regions other than the USA

Electrode positions (lead I) Three electrode leads


Electrode positions

Lead color
R L Symbol Application position
(clip color)
(red) (yellow)
R Red Right infraclavicular fossa
L Yellow Left infraclavicular fossa
F Green Lowest rib on the left
anterior axillary line

F
(green)

To use lead II or lead III, connect the lead wires of the reference signal cable to the
electrodes as shown below.

Red Yellow Red Green Green Red


(N)
(N)
Green Yellow Yellow
(N)

NOTE: This system is designed to use ECG lead I. To use lead II or lead III, the
lead colors and the connection destinations differ from the standard
arrangement.
To display both the ECG waveform and the respiratory waveform (using the
reference signal cable), use lead I.

No. 2B771-050EN*G
13-2
 For the USA

Electrode positions (lead I) Three electrode leads


Electrode positions

Lead color
RA LA Symbol Application position
(clip color)
RA White Right infraclavicular fossa
LA Black Left infraclavicular fossa
LL Red Lowest rib on the left
anterior axillary line

LL

White Black White Red Red White


(N)
Red Black (N) Black
(N)

No. 2B771-050EN*G
13-3
13.1 Display Procedures
(1) When the system power is OFF, 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.

13.2 Reference Signal Adjustment Procedure


(1) Operation from the main panel (ECG/PCG)

Press [ECG] or [PCG] on the touch panel. The ECG or PCG waveform is
displayed on the screen.

Use the ECG Position/Gain control dial on the panel to adjust the display position
or size of the ECG waveform. Use the PCG position control dial to adjust the
display position of the PCG waveform.

To switch the function of the ECG Position/Gain control dial between position
adjustment and size (*) adjustment, press the dial.

The PCG waveform display position can be changed by pressing the dial.

(*) The specified display size is applied for both ECG and PCG waveforms.

Switching between CH1 and CH2

Switching the R-delay


2D M CDI PW/CW
AP 100
between CH1 and CH2
General

2D M/D
Size Cursor

2D-Map 2D-PSel Focal No.


ECG ON/OFF
2D-Scan QuickScan
Range Update

3 3 1

IP Save
QuickScan
ECG Posi/Gain
Quit

ApliPure 2D-Post Tissue 2D-Edge


1/2 Process Enhance Enhance 2D-DR

Next Preset
PCG Posi/Vol
0 1 0 1 60
PIMS

2D-THI

Gate Size CDI/PW-Steer 2D-Steer 2D-IP


2D-
Frequency
Other
PCG ON/OFF

No. 2B771-050EN*G
13-4
(2) Operation from the touch panel

Press [Physio] in the Other menu on the touch panel.

Other
AP 49

Panel IQ
Setting Report

Special VIDEO
Appli. Menu Size

Stress Panoramic
Echo View

Biopsy Preset
3D
Guide

PIMS
TDI CHI 4D Physio

Other
2D-
Gate Size CDI/PW-Steer 2D-Steer 2D-IP Frequency

The Physio menu is displayed on the touch panel. Use this menu to turn the
reference signals ON/OFF or to adjust the reference signals.

Physio

M <2> <3> <4> <5> <6>


PCG AUX PULSE RESP PCG ECG
<1> Filter Display Display Display Display Display

AUX PULSE RESP PCG ECG


Position Position Position Position Position
<11>

5 5 5 5 5

<7> <8> <9> <10> Gain


<12>

5
<13>
Quit

No. 2B771-050EN*G
13-5
No. Menu Function
<1> PCG Filter Adjusts the harmonics components of the phonocardiogram
(L, M, H).
<2> AUX Display Turns ON/OFF the display of the signals from the external
device.
<3> PULSE Display Turns the pulse signal display ON/OFF.
<4> RESP Display Turns the respiratory signal display ON/OFF.
<5> PCG Display Turns the PCG waveform display ON/OFF.
<6> ECG Display Turns the ECG waveform display ON/OFF.
<7> AUX Position Adjusts the display position of the signal from the external
device.
<8> PULSE Position Adjusts the display position of the pulse signals.
<9> RESP Position Adjusts the display position of the respiratory signals.
<10> PCG Position Adjusts the display position of the PCG waveform.
<11> ECG Position Adjusts the display position of the ECG waveform.
<12> Gain Adjusts the sensitivity of the displayed signal.
<13> Quit Closes the menu.

13.3 Channel Selection


Select CH1 or CH2 on the touch panel and adjust the R-delay for the selected channel
using the dial on the main panel.

No. 2B771-050EN*G
13-6 *
14. Body Mark
A body mark indicating the current examination region can be displayed.

NOTE: It is possible to preset the following items for each application preset.

For details, refer to section 2 "Setting the Presets" in the operation manual
<Measurement volume>.

1. Whether or not the body mark is deleted at the time of unfreezing.

2. Whether the body mark is set to the normal size or 1.5 times the normal
size.

3. Whether or not the position and orientation of the body mark and
transducer mark are maintained at the time of 2D Dual left/right switching.

14.1 Displaying the Body Mark

(1) Press or . The body mark menu is displayed on the touch panel.

<<Display example>>

Switch for deleting the


Abdomen General
displayed body mark

Initial
Mark

Mark
Move

Delete
All

(2) To display another body mark, press the switch displayed in the body mark menu.

* To change the diagnostic area in the body mark menu, switch the application
preset.

* If the menu has two or more tabs, press the tab for the desired page.

No. 2B771-050EN*G
14-1
14.2 Moving and Rotating the Transducer Mark
(1) Move the trackball to move the transducer mark.

(2) When the dial is rotated, the transducer Transducer mark


MEAS EDIT

mark rotates.

When the image is frozen, the transducer mark


can also be rotated using the palm dial around the
trackball.

14.3 Moving the Body Mark


(1) Press [Mark Move] on the touch panel to set it to ON.

(2) Use the trackball to move the body mark.

(3) To set the body mark position, set [Mark Move] to OFF.

14.4 Deleting the Body Mark

Press on the touch panel. In dual display mode, the body mark on the active
image is deleted.

To delete the body mark on both the images, press [Delete All]. All the displayed body
marks are deleted.

No. 2B771-050EN*G
14-2 *
15. Entering Comments
To enter comments, enter characters from the keyboard, or display the characters that
have already been registered.

NOTE: It is possible to preset the following items for each application preset.
For details, refer to section 2 "Setting the Presets" in the operation manual
<Measurement Volume>.

1. Whether or not the comments are deleted at the time of mode switching

2. Whether or not the comments are deleted at the time of unfreezing

3. Shape of the cursor in annotation input mode (I cursor or arrow cursor)

15.1 Entering Characters and Arrow Marks

(1) Press ABC or the F7 key of the keyboard. The cursor is displayed on the
screen and the annotation menu is displayed on the touch panel.

* When a 3D option is used, the annotation menu is not displayed even if the
F7 key is pressed.

* To change the diagnostic area in the annotation menu, switch the application
preset.

<<Display example>>

Abdomen 1 Abdomen 2 Abdomen 3 Abdomen 4 Abdomen 5 Abdomen 6 Abdomen 7 Selecting the menu

Small

Liver GB Pancreas R-Kidney Size


Selecting the
character size
Small
Spleen CBD PD L-Kidney

Arrow Size
Selecting the
arrow mark size
SOL Stone Polyp Cyst

Ascites Prostate Ut Bladder All Delete Deleting all comments

Delete
Deleting selected
comments
Arrow mark
input
Set Home Setting the initial display
position of the cursor

No. 2B771-050EN*G
15-1
(2) Move the cursor to the desired position using the trackball or the arrow keys of the
keyboard , , , and .

(3) To display the arrow mark, select the orientation and size of the arrow mark and
press SE
T
. The set arrow mark is displayed in white.

(a) Selection of the arrow mark orientation

Press the desired arrow mark switch (8 types). The selected arrow mark is
displayed on the screen.

* The arrow mark can be rotated using .


MEAS EDIT

* When the image is frozen, the arrow mark can also be rotated using the dial
around the trackball.

(b) Changing of the arrow mark size

Press [Arrow Size] on the touch panel to change the size of the arrow mark to
be displayed.

(4) To display characters, enter them from the keyboard.

When the trackball is moved after entry, the characters are set and displayed in
white. The new cursor (yellow) is then displayed.

* The character size can be changed by pressing [Size] on the touch panel.

(5) When [Set Home] is pressed, the cursor returns to its default display position. The
default position can be set for each display mode.

No. 2B771-050EN*G
15-2
15.2 Correcting a Comment or an Arrow

(1) Press ABC or F7 . The cursor is displayed on the screen.

(2) Move the cursor to the character string or arrow to be corrected using the trackball
or the arrow keys of the keyboard , , , and .

The color of the character string or the arrow is changed to yellow.

(3) Place the cursor on the character to be corrected using the arrow keys of the
keyboard , , , and .

(4) Enter the characters or arrow from the keyboard or touch panel.

* Pressing the Ins key of the keyboard toggles the input mode between insert
mode and overwrite mode.

(5) Move the cursor slightly using the trackball. The change becomes effective and
the new character string or body mark is displayed in white.

15.3 Moving a Selected Comment


(1) Place the cursor on an existing comment. The color of the comment is changed to
yellow.

(2) Press SE
T
. The comment is enclosed in a rectangular frame.

(3) Move the comment to the desired position using the trackball.

(4) Press and move the trackball slightly. The new position is set.

15.4 Moving a Selected Arrow


(1) Place the cursor on an existing arrow. The arrow is displayed in yellow.

(2) Press and hold down SE


T
, and move the arrow to the desired position using the
trackball or the arrow keys of the keyboard , , , and .

(3) Release and move the trackball slightly. The new position is set.

No. 2B771-050EN*G
15-3
15.5 Deleting a Comment

(1) Press ABC or F7 . The cursor is displayed on the screen.

(2) Place the cursor on the comment or arrow to be deleted using the trackball or the
arrow keys of the keyboard , , , and .

The color of the comment or the arrow is changed to yellow.

(3) Press [Delete] on the touch panel.

Or, move the cursor on the right end of the character string and press the Del
key of the keyboard. The comment is deleted.

(4) Press ABC or F7 to terminate comment/arrow input mode.

15.6 Deleting All Comments

(1) Press ABC or F7 . The cursor is displayed on the screen.

(2) Press [All Delete] on the touch panel or press the Shift Del keys of the
keyboard. All the displayed comments are deleted.

(3) Press ABC or F7 to terminate comment/arrow input mode.

No. 2B771-050EN*G
15-4
15.7 Entering Comments in Saved Images
Comments can be entered in still images or any one image (still image) of images
saved as dynamic images (clips) in HDD. Comments can be saved with the images.

Refer to section 19 "Output/Saving of Image Data" for saving image data.

Use Exam Review to display saved images.

To operate Exam Review, refer to section 3 "Exam Review" of the operation manual
<<Applications>> volume.

NOTE: 1. While multiple images are displayed in Exam Review, comments cannot be
entered. Display one image and then enter comments.

2. If the wheel in the main panel is operated while comments are being
entered, comment entering mode is terminated. The screen then returns to
the Exam Review.

3. If Exam Review starts up and comments are entered in an image while


comments have already been entered in another image, those in the image
selected before Exam Review was started up are automatically deleted.

(1) Entering characters or arrows in the saved image

(a) Select the saved image from Exam Review and press the or key.

The same cursor used in the general annotation function is displayed.

(b) Operations and editing are the same as for the annotation function.

* Depending on the operation, the following messages may be displayed. If one of


these messages is displayed, check the description.

Example of message Description


"This application is available on single
This message is displayed when
image only."
is pressed to enter comments after
startup of Exam Review with two or more
images displayed.
In this case, comments cannot be
entered.
"Measurement can not be started while This message is displayed when ,
ER Annotation is enabled."
, or is pressed to start up the
ER measurement. The ER measurement
cannot be performed while comments are
being entered in saved images.

No. 2B771-050EN*G
15-5
15.8 Manipulating the Menu
The annotation menu displayed on the touch panel can be changed and registered.

(1) Press MENU


. The pop-up menu is displayed.

(2) Select [System Setting]  [Annotation Customize] from the pop-up menu.

The following screen is displayed. The annotation menu can be changed and
registered on this screen.

Select application presets

Adds menus
Menu (tab)
Deletes menus

Characters and arrow


mark input field

Moves the position of the


current selection menu
Sets the current selection
menu as the initial display

Saves the configuration Quits the menu


Imports the annotation data stored on external media
Exports the registered data to external media

15.8.1 Procedures for adding menu switches


(1) Press [Add Menu]. The following window is displayed.

No. 2B771-050EN*G
15-6
(2) Press [OK]. The new page (tab) is added and the page name can be entered.

New page (tab)

Characters and arrow


mark input field

(3) Enter the page name from the keyboard.

(4) Move the cursor to [OK] and press SE


T
.

(5) Move the cursor to the switch where the comments (or arrow mark) are to be
registered and press SE
T
.

(6) Enter the comments or arrow mark.

(a) To enter the comments

Enter the comment name from the keyboard. Move the cursor to [OK] and
press SE
T
.

The entered
characters Arrow mark entry
are displayed.
Comment entry

No. 2B771-050EN*G
15-7
(b) To enter the arrow mark

Press [Arrow]. The following window is displayed. Select the desired arrow
mark. Then, move the cursor to [OK] and press SE
T
.

(7) When setting is completed, move the cursor to [Save] and press SE
T
. The
configuration is saved on the system.

15.8.2 Procedures for changing and deleting menu switches


(1) To delete a menu

(a) Select the menu to be deleted and press [Delete Menu]. A confirmation
message is displayed.

(b) After confirmation, move the cursor to [OK] and press SE


T
. When [OK] is
then pressed on the confirmation screen, the menu is deleted.

* The selected menu can also be deleted by pressing the Del key on the
keyboard.

(2) To delete a switch

(a) Select the switch to be deleted. Move the cursor to [OK] and press SE
T
.

(b) Delete all characters displayed in the input field using the BS key.

* This step is not required for an arrow mark.

(c) Move the cursor to [OK] and press SE


T
.

* The selected switch can also be deleted by pressing the Del key on the
keyboard.

No. 2B771-050EN*G
15-8
(3) Changing the menu name and switch name

(a) Select the menu tab or switch to be renamed. Move the cursor to [OK] and
press SE
T
.

(b) Change the characters displayed in the input field using the keyboard.

(c) Move the cursor to [OK] and press SE


T
.

15.8.3 Exporting the registered data


(1) Press [Export] at the bottom left of the screen. The screen below is displayed.

Refreshes the list of files on the media

Ejects the media

List of user-registered
data on the media

File name entry field

(2) Enter the name of the file to be deleted in the file name entry field.

(3) Press [OK]. The specified data is exported to the media.

No. 2B771-050EN*G
15-9
15.8.4 Importing the registered data
(1) Press [Import] at the bottom left of the screen. The screen below is displayed.

Refreshes the list of files on the media

List of user-registered
data on the media

(2) Select the data to be imported in the list.

(3) Press [OK].

(4) Move the cursor to [Save] and press SE


T
.
The registered data is saved on the system.

No. 2B771-050EN*G
15-10 *
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. 2B771-050EN*G
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.

9. The biopsy target may shift due to unexpected patient


motion when the biopsy needle is inserted, or else due to
respiratory movement. Always monitor the target region
and the needle tip while performing a biopsy procedure.

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. 2B771-050EN*G
16-2
16.1 Applicable Transducers and Biopsy Adapters
In this system, the needle mark for the specified biopsy adapter can be displayed on the
screen when one of the transducers listed in the table below is connected.

Displayed on the screen


Transducer Applicable biopsy adapter Biopsy Needle mark
adapter name angle
PVT-375BT Product name: Product name: TG-1 52, 64
TM
ToshibaTG-1 Ultra-ProII
1 *2
Bracket* Replacement Kit
Product No.: 680-085 Product No.: 610-608
*3
Product name : Reusable Starter Kits
Product No. : 680-105
PST-25BT Product name: Product name: TG-2 53, 65
TM
PST-30BT Toshiba TG-2 Ultra-ProII
1 *2
Bracket* Replacement Kit
Product No.: 680-086 Product No.: 610-608
*3
Product name : Reusable Starter Kits
Product No. : 680-106
PLT-604AT Product name: Product name: TG-3 39, 51
TM
PLT-704AT Toshiba TG-3 Ultra-ProII
1 2
Bracket* Replacement Kit*
PLT-704SBT
Product No.: 680-087 Product No.: 610-608
*3
Product name : Reusable Starter Kits
Product No. : 680-107
PLT-1204AT Product name: Product name: TG-4 37
TM
PLT-1204BT Toshiba TG-4 Ultra-ProII
1 2
Bracket* Replacement Kit*
Product No.: 680-088 Product No.: 610-608
*3
Product name : Reusable Starter Kits
Product No. : 680-102
PLT-805AT Product name: Product name: TG-6 34, 51
TM
Toshiba TG-6 Ultra-ProII
1 2
Bracket* Replacement Kit*
Product No.: 680-090 Product No.: 610-608
*3
Product name : Reusable Starter Kits
Product No. : 680-109
4
PLT-308P UAGL004A* UAGL004A 70, 80,
90, 100
PLT-705BTF UAGV020A UAGV020A The needle
PLT-705BTH mark is not
displayed for
these
transducers.
4
PVT-350BTP UAGV-030A* UAGV-030A 55, 75,85,
100

No. 2B771-050EN*G
16-3
Displayed on the screen
Transducer Applicable biopsy adapter Biopsy Needle mark
adapter name angle
PVT-382BT UAGV-027A UAGV-027A 67, 80
Product name: Product name:
TM *5 TM *6
BX2 Biopsy Bracket BX2 Needle Guide
Product No.: 680-110 Product No.: 680-112
*3
Product name : Biopsy Starter Kit
Product No. : 680-111
PVT-674BT UAGV-028A UAGV-028A 47, 70
PVT-661VT UAGV-024A UAGV-024A 90
PVT-745BTV UAGV-029A UAGV-029A 44, 75
*7
PVT-745BTH UAGV-034A UAGV-034A 60, -60
PVT-770RT UAGV-023A UAGV-023A 93
*9
Product name: Replacement Kit 680-093 91
*8
Reusable Bracket Product No.: 680-092
Product No.: 680-093
PVT-375MV UAGV-033A UAGV-033A 58, 69
PVT-681MV UAGV-031A UAGV-031A 87
*10
Product name : CIVCO Needle guide
Product No. : 680-114

*1, *2, *3, *5, *6, *8, *9, *10 : Manufactured by CIVCO Medical Instruments
*1 and *2, *5 and *6, and *8 and *9 must be used in
combination.
The kits marked *3 include the bracket and the sterile
procedure kit.
*4 : Biopsy adapter supplied with the transducer

*7 : Selection of the needle mark display angle differs


depending on the position in which the biopsy adapter
is mounted to the transducer. Refer to (6) of subsection
16.2 "Displaying the Needle Mark" for details.

No. 2B771-050EN*G
16-4
16.2 Displaying the Needle Mark
(1) Press [Biopsy Guide] in the Other menu on the touch panel.

* This switch is not displayed when "TCD" is selected for Imaging Preset.

Other
AP 49

Panel IQ
Setting Report

Special VIDEO
Appli. Menu Size

Stress Panoramic
Echo View

Biopsy Preset
3D
Guide

PIMS
TDI CHI 4D Physio

Other
2D-
Gate Size CDI/PW-Steer 2D-Steer 2D-IP Frequency

(2) The switch showing the needle mark display angle is displayed. Press this switch
to display the needle mark, biopsy adapter name, and needle mark angle on the
screen.
For transducers which have two types of biopsy angle, the angle selection switches
are displayed. Press the desired angle switch. The selected needle mark, biopsy
adapter name, and needle mark angle are displayed on the screen.

52.0
Angle switches Degree

64.0
Degree

<<Display example>>

No. 2B771-050EN*G
16-5
(3) Selecting the Needle Mark for PVT-770RT

* Two types of biopsy adapters are provided for the PVT-770RT transducer. The
preset must be changed according to the biopsy adapter to be used.

(a) Press MENU on the main panel. The pop-up menu is displayed.

(b) Select [System Setting]  [Transducer] from the pop-up menu.

The following screen is displayed.

Selection of the
biopsy adapter

(c) Select the biopsy adapter to be used in the [Adapter Select] area and press
[Save].

(4) The PVT-681MV supports two types of biopsy adapters, but the same needle mark
is displayed for both of them.
In addition, the biopsy adapter name that is displayed at the top of the screen when
the needle mark is displayed is "UAGV-031A" regardless of which biopsy adapter
is used.

(5) The PVT-382BT supports two types of biopsy adapters, but the same needle mark
is displayed for both of them.
In addition, the biopsy adapter name that is displayed at the top of the screen when
the needle mark is displayed is "UAGV-027A" regardless of which biopsy adapter
is used.

No. 2B771-050EN*G
16-6
(6) For the PVT-745BTH, the biopsy adapter (UAGV-034A) can be mounted on either
the right side (side with the  mark) or left side of the transducer. The needle
mark to be selected differs depending on the biopsy adapter mounting position.
Refer to the figure below for the biopsy adapter mounting position and the
corresponding needle mark display angle.

Angle selection
switches
Biopsy adapter mounting position displayed at Needle mark display
[Biopsy Guide]
ON

UAGV-034A 60°
T

The biopsy adapter is mounted so that


the needle guide is positioned on the
Needle mark
right side (side with the mark) of the
transducer
UAGV-034A -60°
T

The biopsy adapter is mounted so that


the needle guide is positioned on the
left side of the transducer
Needle mark

16.3 Deleting the Needle Mark


To delete the needle mark, press the selected angle switch again.

No. 2B771-050EN*G
16-7 *
17. Measurement
CAUTION: 1. For basic measurements, the measured data is lost when
image freeze is released or the image mode is changed
during measurement.

2. The measurement data is lost when the system is turned


OFF. However, the measurement data saved for application
measurements is not lost.

3. Be sure to register and save the patient ID before starting an


examination for a new patient. If measurement is performed
for a new patient for whom the patient ID is not registered or
saved, the measurement results and other data cannot be
saved in the system. In addition, the data for the two
patients are mixed together, which may result in incorrect
diagnosis

4. The basic measurement result is not displayed on the report.

5. On the application measurement result screen, some


calculation results are displayed. To check all the
measurement results (calculation results), perform checks
on the report screen.

6. The results edited on the report screen are not reflected in


the measurement results on the image display.

7. When measurement is to be performed in M-mode or


Doppler mode, confirm that the entire screen has been
refreshed after changing the mode or settings. Otherwise,
measurement may not be performed correctly.

When CALIPER , CALIPER


, or TRACE
on the main panel is pressed after an image is frozen,
one of the basic measurements in the table below is started. To start another
measurement, press the corresponding switch on the touch panel.

Pressing CALC
instead of CALIPER , CALIPER
, or TRACE
displays the application
measurement menu on the touch panel. To display other examination areas in the
application measurement menu, change the application preset (refer to section 10
"Common Operation for Each Mode"). Note that no application measurement menu is
provided for some examination areas.

Refer to the operation manual <Measurement Volume> for details of the measurement
procedures.

No. 2B771-050EN*G
17-1 *
18. Report Function
CAUTION: 1. The basic measurement result is not displayed on the report.
2. On the application measurement result screen, some
calculation results are displayed. To check all the
measurement results (calculation results), perform checks
on the report screen.

3. The results edited on the report screen are not reflected in


the measurement results on the image display.

(1) Press REPORT


. The report screen is displayed.

<<Display example>>

(2) Operate the trackball to move the cursor to for the item to be edited and press

SE
T
.

(3) The report edit screen is displayed . Edit the report using the keyboard.

* To cancel the changes made on the currently displayed edit screen, press the
[Esc] key of the keyboard.

(4) Press SE
T
to complete editing and check the displayed values.

No. 2B771-050EN*G
18-1
(5) Move the cursor to for the edited item and press SE
T
. The edit window is
closed.

(6) On the report screen, an asterisk "*" is displayed for the edited measurement result
and the calculation results obtained using the measurement result.

(7) Press REPORT


. The report screen is cleared and the screen returns to the previous
image display.

CAUTION: 1. When the measurement data displayed on the report screen is edited,
the original data is overwritten by the edited data. The original data is
not saved.

2. If a result for a measurement item is deleted on the report edit screen,


the measurement item, the mean of the item, and the calculation results
obtained using the measurement value (or mean) are all deleted
automatically. To redisplay these values, the item must be measured
again. Before saving the contents of the report edit window, confirm
that the necessary data has not been deleted.

No. 2B771-050EN*G
18-2 *
19. Output/Saving of Image Data
CAUTION: 1. Be sure to register and save the patient ID before starting an
examination for a new patient. If measurement is performed
for a new patient for whom the patient ID is not registered or
saved, the measurement results and other data cannot be
saved in the system. In addition, the data for the two
patients are mixed together, which may result in incorrect
diagnosis.

2. Do not display or print the data imported from other devices


in this system. Such data may not be able to be displayed or
printed correctly.

3. Some printers cannot detect print errors. Use the actual


printout to confirm whether the data is printed correctly.

4. Do not turn OFF the power to the printer during printing.


This may result in system malfunction.

5. When printing is executed, do not turn the system power


OFF before all the images are printed. The data in the print
queue may be lost.

6. When the color printer is to be used for printing, make sure


that its power is ON. If printing is executed when the printer
power is OFF, a system malfunction may result.

7. Do not turn the power to peripheral devices ON or OFF


during the system startup or shutdown process. This may
result in system malfunction.

8. When an attempt is made to archive images on media or


transfer them with the DICOM protocol, the following dialog
may be displayed.

Sorry. DVD/CD and DICOM storage are not available now.


Please store important images to hard disk.
Please power off and then power on to make them available.

In this case, archiving to media and DICOM transfer cannot


be performed. Store the important images on the hard disk.
If you wish to archive images on media or transfer them with
the DICOM protocol immediately, reboot the system.

9. The free space on the hard disk is displayed at the bottom of


the screen in the format "HDD: xx% Free". Images cannot be
saved if the free space is insufficient. Ensure the required
free space before saving the images.

10. Do not turn OFF the power supply of the system during
printing, data saving, or invoking. Doing so may result in
failure of saving or printing or damage to the data. In
addition, doing so during access to media may damage the
media.

No. 2B771-050EN*G
19-1
CAUTION: 11. Do not set the system to Standby mode during printing,
data saving, or invoking. Doing so may result in failure of
saving or printing or damage to the data. In addition, if the
system is set to standby mode during access to media, the
media may be damaged. Furthermore, when used the next
time, the printer or DVD/CD drive will not operate correctly.

CAUTION: When the message "Printing" is displayed at the bottom-left corner of the
monitor, it indicates that the system is ready to output images to the printer.
Check the printer output for completion of the actual printing.
Note that if the next print operation is executed while "Printing" is
displayed, the next image is not printed. Confirm that the message
"Printing" is cleared before executing the print operation.

When the image data is output (printed) or saved, use the switches on the main panel
or on the touch panel [PIMS Image] menu.

<< [PIMS Image] menu display example >>

Press [PIMS] on the touch panel to display the following menu.

No. 2B771-050EN*G
19-2
19.1 Output to the Printer

NOTE: When "Printing" is displayed at the bottom-left of the screen, the next image in
the print queue is not printed even if the print switch is pressed. Confirm that
the message "Printing" is cleared before pressing the print switch.

Images to be printed differ depending on the switch. If the system is set to the standard
switch configuration, the images are output as described in the table below.

19.1.1 Operations using the panel switches

Switch Data to be printed


A When [Print Size] on the touch panel is set to "Part", the screen,
OUTPUT
excluding the status bar etc. at the bottom of the screen, is
printed as follows:
 When a color image is displayed:
The color printer is automatically used for printing.
 When a black-and-white image is displayed:
The B/W printer is automatically used for printing.
When [Print Size] on the touch panel is set to "Full", the entire
screen is printed using the color printer.

B
The range of the image specified by [Print Size] is printed using
OUTPUT the B/W printer.

No. 2B771-050EN*G
19-3
19.1.2 Operations using the touch panel

Switch Data to be printed


[Print Size] The area of the screen to be printed can be selected.
 Part: Image, ID area, auto data, and measurement result
 Full : Entire display screen
[Auto Print] When [Print Size] on the touch panel is set to "Part", the image
is printed as follows:
 When a color image is displayed:
The color printer is automatically used for printing.
 When a black-and-white image is displayed:
The B/W printer is automatically used for printing.
When [Print Size] on the touch panel is set to "Full", the color
printer is automatically used for printing.
[B/W Print] The range of the image specified by [Print Size] is printed using
the B/W printer.
[Color Print]] The range of the image specified by [Print Size] is printed using
the color printer.
[DICOM Print] The range of the image specified by [Print Size] is printed using
the printer connected to the network server (the optional DICOM
kit is required).

19.1.3 Action for the "Check the printer cables." message


This message is displayed if the printer cable is disconnected or the printer power is
turned OFF during printing (the data in the print queue is not lost). Recover the system
from the error as follows.

(1) Confirm that the printer cable is connected correctly. Turn ON the power of the
printer.
The power switch on the side surface of P95DW cannot be reached. Therefore, to
reset the printer, hold down the [COPY] button on the front surface of the printer.

(2) The error message is cleared and printing is resumed.

19.1.4 Clearing a paper jam


When a paper jam occurs, an error message window is displayed. Follow the steps
below to clear the paper jam.

(1) Remove the jammed paper.

(2) Push the tray back in position. Paper feeding is performed twice automatically. If
paper feeding is not performed automatically, press [FEED & CUT] on the
operating panel of the printer.

(3) The error message disappears and printing is resumed.

No. 2B771-050EN*G
19-4
19.1.5 Replacing the ink sheet and printer sheets
To replace the ink sheet or printer sheets of the printer during use, use the following
procedure.

To replace the ink sheet or printer sheets of the printer during use, use the following
procedure. If an error message indicating that the printer sheets or the ink sheet have
run out during use is displayed, replace them by following the procedure below.
Replace them while the printer is turned ON.

(1) For the CP900DW

(a) If the printer sheets or the ink sheet run out during use, the "PAPER" or
"SHEET" LED on the front of the printer lights.

(b) Press [OPEN] on the CP900DW to open the tray, and replace the ink sheet or
printer sheets.

(c) Close the tray. Paper feeding is performed twice automatically.

(d) The error message disappears and the images in the print queue are printed.

(e) Examination can be resumed.

(2) For the UP-D23MD

(a) When the ink sheet or printer sheets have run out, the "PAPER" or "RIBBON"
LED on the front of the printer lights.

(b) Replace the ink sheet or printer sheets. The image for which printing was
discontinued is printed again. The images in the print queue are also printed.

(3) For the UP-D25MD

(a) When the ink sheet or printer sheets have run out, the "ALARM" LED on the
front of the printer lights and a message is displayed on the LCD display.

(b) Replace the ink sheet or printer sheets. The image for which printing was
discontinued is printed again. The images in the print queue are also printed.

(4) For the UP-D897/UP-D898MD

(a) When the printer sheets have run out, the LCD indicator on the front lights
orange and the message "EMPTY" is displayed.

(b) Add printer sheets. The image for which printing was discontinued is printed.
The remaining images in the printer queue are also printed.

(5) For the P93DW/P95DW

(a) When the printer sheets have run out, the message "EP" is displayed on the
indicator on the front.

(b) Add printer sheets. The image for which printing was discontinued is printed.
The remaining images in the printer queue are also printed.

No. 2B771-050EN*G
19-5
(6) For the CP30DW

(a) If the printer sheets or the ink sheet run out during use, the "PAPER" or
"RIBBON" LED on the front of the printer lights.

(b) Replace the ink sheet or printer sheets. The image for which printing was
discontinued is printed. The remaining images in the printer queue are also
printed.

NOTE: If an error message for the printer is displayed on the monitor, the print job
can be canceled and the error message can be cleared by following the
procedure below.

1. Press REPORT
.

2. Move the cursor to  in the pull-down menu and press SE


T
.

3. Move the cursor to [Cancel] in the error message box and press SE
T

(refer to the figure below).

4. Press REPORT
.

No. 2B771-050EN*G
19-6
19.2 Recording to the Video Recording Unit

(1) Press VIDEO REC . Recording (REC) starts. When VIDEO REC is pressed, the system
pauses (REC PAUSE). (For the standard switch configuration)

* During recording, in the patient information display area lights in orange

and the counter increments. In addition, VIDEO REC on the operating panel lights
in orange.

* To perform playback, use the touch panel. For the operating procedures, refer
to the operation manual <application volume>.

NOTE: 1. To operate a video recording unit using the main panel or touch panel, use
a recommended device.

2. The image size setting for recording to or playback from a video recording
unit can be changed using the Other menu on the touch panel.

(a) Press [VIDEO Size]. [Input] and [Output] are displayed.

Other

Panel IQ
Setting Report

Full-L Full-L

Special VIDEO
Appli. Menu Input Output Size

Stress Panoramic
Echo View

Biopsy
3D
Guide

TDI CHI 4D Physio

(b) Press [Input] or [Output] and set the image size.

* Full-S : Full-screen display

* Full-L : Full-screen display (recommended)

* Part : Image, ID area, Auto data, and measurement results

(c) Press [VIDEO Size] again to complete setting.

The VIDEO size setting is saved for each Imaging Preset.

No. 2B771-050EN*G
19-7
19.3 Saving Still Images
The data to be saved differs depending on the switch.

19.3.1 Operations using the panel switches

Switch Data to be saved


The still image is saved to the destination specified by [Still
STILL
STORE Destinat.] in the image format specified by [Still Size].

*: This switch is disabled while the video device is playing back images.

19.3.2 Operations using the touch panel


The switches in the Store area in the [PIMS Image] menu are used.

Switch Function
[Still Size] This switch is used to select the image size to save the still
*1
image.
Part : The still images are saved in DICOM format regardless
of the image size. The saved images can be used for
re-measurement in an offline device.
Full : The image is saved with "Full" (full screen) setting.
[Still Destinat.] This switch is used to select the destination to save the still
image.
HDD : Hard disk
DVD/CD
*2
: Compact disk on which data can be written only once
*2
Server : DICOM server (The optional DICOM kit is required.)
[Still Store] The still image is saved to the destination specified by [Still
Destinat.] in the image format specified by [Still Size].

*1: Some screens (Patient Browser, Worksheet, Report, and measurement display
screen, etc.) are saved as full screens, regardless of the setting of this switch.

*2: When data is saved on media, or server, the same data is automatically saved to
the HDD.

No. 2B771-050EN*G
19-8
19.4 Saving Live Images to the HDD (Clips)
The image data acquired by the system can be stored on the HDD.
There are two types of Clips function: Snapshot Clips and Cine Clips.
The images stored on the HDD can be displayed in the following formats. For details,
refer to the Operation Manual <<Applications Volume>>.

(1) DICOM format : Available in Exam Review


The DICOM multiframe format can be converted into
Windows file format.

(2) AVI format : Available in Image Viewer in Win Browser accessed from
Patient Browser.

19.4.1 Snapshot Clips (retrospective storage)


The live image for the period preceding the moment [Clips Store] is pressed is stored.

(1) Operations from the main panel

Switch Data to be saved

CLIPS The Clips image is saved to the destination specified by


STORE [Clips Destinat.].

*: This switch is disabled while the video device or DVD VSR is playing back images.

No. 2B771-050EN*G
19-9
(2) Operations from the touch panel

Switch Function
[Clips Mode] When [Retro] is set to ON, Snapshot Clips (retrospective
storage) is started.
[Quality] This switch is used to set the image quality (compression ratio).
"H" represents high image quality (low compression ratio), "M"
represents intermediate image quality, and "L" represents low
image quality.
[Capture Rate] This switch is used to set the image acquisition frame rate.
 60 Hz, 30 Hz, or 15 Hz can be selected (for NTSC).
 75 Hz, 37 Hz, or 18 Hz can be selected (for PAL).
[Range Select] This switch is used to toggle the setting for the image storing
period between "Time" and "R-R".
[Seconds]/ These switches are used to set the preceding period (in seconds
[Cycle] or as the number of cardiac cycles) for which the image is to be
stored when [Clips Store] is pressed after freezing or during real-
time display.
[Clips Store] When this switch is pressed, the image is stored to the HDD
using the conditions specified by [Quality] and [Capture Rate]
and in [Seconds] or [Cycle].

No. 2B771-050EN*G
19-10
19.4.2 Operating procedure for Snapshot Clips
(1) Specify the image compression ratio using [Quality] on the touch panel.

H : Low compression ratio (High image quality)


M : Intermediate image quality
L : High compression ratio (Low image quality)

(2) Specify the image acquisition frame rate using [Capture Rate] on the touch panel.

(3) Using [Range Select] on the touch panel, select whether the image storing period
is defined by time (Time) or by the number of cardiac cycles (R-R).

(4) Using [Seconds] or [Cycle] on the touch panel, specify the preceding period (in
seconds or as the number of cardiac cycles) for which the image is to be stored.

(5) Set [Clips Mode] ([Retro]) on the touch panel to ON.

CLIPS
(6) Press [Clips Store] on the touch panel or STORE . The image is stored on the
HDD for the following period with the specified compression rate and frame rate.

(a) When [Clips Store] is pressed during real-time display

For the period preceding the moment when [Clips Store] is pressed

[Clips Store] ON
Time

Image storing period

(b) When [Clips Store] is pressed during freezing

For the period preceding the moment when the image is frozen

FREEZE ON [Clips Store] ON


Time

Image storing period

CAUTION: Frame missing error in recording with the Snapshot Clips


function

1. If the system detects that 4 or more consecutive image


frames are missing, the error message below is displayed
and the images are not recorded. Release the freeze status
and acquire the image again.
"System busy. Failed in Storing the image."

2. If the system detects that less than 4 consecutive image


frames are missing, the message below is displayed at the
bottom of the monitor. In this case, the images are
recorded.
"System busy. Some frames were missing."

No. 2B771-050EN*G
19-11
NOTE: 1. When the [Clips Mode] switch is ON ([Retro]), mode transitions, ROI
movement, and sample mark movement become slower. Set the optimal
conditions before setting the [Clips Mode] switch to ON ([Retro]).

2. The "Storing" message is displayed at the bottom of the monitor while the
data is stored on the HDD. Panel operation is disabled during this period
(a maximum of approximately 5 seconds).

3. The image is saved on the HDD in the DICOM format or AVI format.
The format can be selected from Options in the Tools menu in the Patient
Browser or preset menu (Output).

 Patient Browser/Tools/
Option : The selected format is applied only to the
current examination. The default format will
be used for the next examination.

 Preset menu (Output) : The selected format is set as the default.

4. When storage with the AVI format is selected, the storage destination is
limited to the HDD regardless of the setting for [Clips Destinat.].

5. The image save time for Snapshot Clips defines the hard limit beyond
which image saving is not possible. However, for certain types of images,
the actual maximum time may be less than this value.

6. When the number of cardiac cycles is specified as the image storing period
but the R wave is not detected, the image is stored for the period (seconds)
corresponding to the specified number of cardiac cycles.

7. The [Cycle] setting when [Range Select] is set to [R-R] assumes that the
heart rate is 50 bpm or more. If the patient's heart rate is less than
50 bpm, the image may be stored for fewer cardiac cycles than specified.

In this case, the following message is displayed and the image for the
detected number of cardiac cycles is stored.

"Acquired ** cycle will be stored"


(** indicates the number of detected cardiac cycles.)

8. When the image is frozen, the loop range in the cine memory is specified,
CLIPS
and [Clips Store] or STORE is then pressed without playing back the
loop, the image is stored in Snapshot Clips mode, ignoring the specified
loop range. This is applicable only to the first attempt of clip storage
directly after freezing.

9. If the data related to the scale (depth, for example) is changed during the
image storage process in Snapshot Clips mode, calibration will be
necessary when the stored image data is used for measurement.

No. 2B771-050EN*G
19-12
19.4.3 Cine Clips (cine image data storage function)
The specified range of the image data recorded in the cine memory can be stored as
a dynamic image.
Cine Clips is disabled for some exam types before shipment. For these exam types,
setting on the pop-up menu is required to use Cine Clips. For details, refer to
subsection 19.4.5.

19.4.4 Operating procedure for Cine Clips


The following two types of operating procedures are available for Cine Clips.

* The image data is stored in the destination specified using [Clips Destinat.].
* Cine Clips does not work while video unit or DVD VSR is in playback status.

(1) To store the image data for the specified cine loop range

(a) Set [Clips Mode] to ON ([Retro]).

(b) Freeze the image and specify the cine loop range to be stored (refer to
subsection 12.2).

(c) Start playback of the specified loop by rotating the palm dial.

(d) Press [Clips Store]. The cine image for the specified loop is stored.

(e) When [Clips Store] is pressed for the second time or later, the specified loop
of the cine image data is played back automatically and then stored.

(2) To store the image data for which the gain or depth setting has been changed
after storage of the live image

(a) Store the live image by pressing [Clips Store] and then change the gain or
depth setting.

(b) Press [Clips Store] again. The cine image for the specified loop with the
new setting is played back automatically and stored.

NOTE: 1. This function cannot be used when [Clips Mode] is set to OFF.

2. The image is stored with the auto data (MI value, gain value, etc.)
immediately after the image is frozen.

3. Image playback after [Clips Store] is pressed can be discontinued using


the trackball. In this case, the portion of the data that has been played
back is stored as a dynamic image. However, when Caliper, Trace,
Annotation, or Body Mark is set to ON, it may not be possible to
discontinue playback using the trackball.

4. The dynamic image time range that can be stored is limited.


If the specified range of the cine data is longer than the limit, only the range
up to the limit is played back and stored. In such cases, divide the data.

5. The storage conditions are fixed and cannot be changed.


Quality: Low, Rate: Approx. 15 (for NTSC)
Quality: Low, Rate: Approx. 19 (for PAL)

No. 2B771-050EN*G
19-13
19.4.5 Presetting of Cine Clips
Whether Cine Clips is used or not can be preset using the pop-up menu that is
displayed by pressing MENU
in 2D mode or CHI mode.

Menu Function
Clips Store SC Cine Clips is enabled.
Behavior
S Cine Clips is disabled.

No. 2B771-050EN*G
19-14
19.5 Saving Data to the DICOM Server
* The optional DICOM kit is required to use this function.

19.5.1 Operation from the main panel


(1) Select "Server" for [Still destinat.] in the PIMS Image menu on the touch panel.

STILL
(2) Press STORE on the main panel.

19.5.2 Operation from the touch panel


(1) Select "Server" for [Still destinat.] in the PIMS Image menu on the touch panel.
Then, press [Still Store] (in the standard switch configuration).

(2) The currently displayed image is transferred to the DICOM server in the format
specified by [Still Size].

* When an image is transferred to the DICOM server, the same image is saved on
the HDD.

No. 2B771-050EN*G
19-15
19.6 Outputting Data to the DICOM Printer
* The optional DICOM kit is required to use this function.

(1) Press [DICOM Print] in the touch panel [PIMS Image] menu.

(2) The whole displayed screen is transferred to the DICOM printer.

The currently displayed image is output to the DICOM printer in the size specified
by [Print Size].

(3) If the multiple frame setting is selected, the status of multiple frames in the lower
part of the screen can be checked.

When the frames are filled with images, the images are output to the DICOM
printer.

* Images can be output only to printers for which the system settings are set to
DICOM printer.

No. 2B771-050EN*G
19-16 *
20. Other Function
20.1 DVD/CD Unit

WARNING: Do not use the controls, adjusters, or operating sections in a


manner other than specified. Incorrect use may cause
hazardous beams to be radiated.
Laser beams emitted by the optical pickup are hazardous to
humans (eyes). Do not look into the DVD/CD unit.

20.1.1 Name and function of each part of the DVD/CD drive

Disk tray Emergency eject hole

Disk/Busy indicator

Eject button

Name Function
Disk tray A disk is placed on this tray.
Emergency eject hole Use this hole to eject the disk tray if the tray cannot be ejected
by pressing the eject button.
Refer to subsection 20.1.3 (2) for details.
Disk/Busy indicator This indicator blinks when the media is being accessed.
Do not open the tray while this indicator is blinking.
Eject button Used to open and close the disk tray.

20.1.2 Recommended media


This unit cannot write data correctly on media manufactured by some companies.
Toshiba has confirmed that this unit can write data correctly on media manufactured
by the companies listed in the table below.

Disk Manufacturer
CD-R Hitachi Maxell, Ltd. START Lab Inc.
TDK Corporation
DVD +R Hitachi Maxell, Ltd. START Lab Inc.

No. 2B771-050EN*G
20-1
20.1.3 Basic operation
(1) How to use the disk tray

(a) Loading a disk

1) Press the eject button.

2) Place a disk in the depression in the tray.

3) Press the eject button or press the tray gently with your fingers.
The tray closes.

CAUTION: 1. Do not place adhesive labels on the disk. They


may cause read errors or scratches on the disk.

2. A disk that has been purchased in a spindle


package may have protective sponge material
applied to its surface. If such sponge material
enters the internal mechanism of this unit, a
malfunction may result. Confirm that there are no
traces of sponge material on the disk before
loading it into the unit.

3. The tray slides out approximately 15 cm when it is


ejected. Keep the area in front of the tray clear. If
the tray hits an obstacle, the tray may be
damaged.

No. 2B771-050EN*G
20-2
(b) Removing the disk

1) Press the eject button.

2) Confirm that the disk is stationary in the tray.

3) Remove the disk from the tray.

CAUTION: Do not leave the tray open. Dust may enter the unit
and cause a malfunction, or a person may hit the tray
and be injured. Open the tray only when necessary.

(2) If the tray cannot be ejected by pressing the eject button

If the tray is not ejected even when the eject button is pressed, use the
emergency stick.

(a) Turn the power OFF.

(b) Insert the emergency stick into the emergency eject hole. The disk tray is
ejected forcibly.

NOTE: <Accessory>
Emergency stick (used to eject the tray forcibly)

No. 2B771-050EN*G
20-3
20.1.4 Handling disks
(1) Handling disks

(a) When holding a disk, place one finger in the center hole of the disk and one
finger on the outer edge of the disk.

1) Do not drop the disk, stack multiple disks, place a heavy object on the
disk, or subject the disk to mechanical shock.

2) Do not touch the data-recording surface of the disk.

3) Do not place self-adhesive labels on the label side of the disk. Labels on
the disk may cause read/write errors or scratches on the disk.

4) Store the disk in its package or case for protection.

5) Scratches on the disk may cause read/write errors.

(2) Cleaning disks

To clean a disk, wipe the disk using an air spray and soft cloth in the radial
direction (from the center to the outer edge). Be very careful not to scratch the
disk surface.

CAUTION: Do not use lens cleaner to clean the disk. Lens cleaner
will damage the drive.

No. 2B771-050EN*G
20-4
20.1.5 Troubleshooting
If any problems occur in this unit, take appropriate measures referring to the tables
below.

(1) Data cannot be written or a write error occurs

Possible cause Action


A disk that is not one Use a disk recommended by Toshiba or one that has
of the recommended been confirmed to operate properly.
types is used. Refer to subsection 20.1.2 for details.
The disk is placed in Place the disk in the tray with the recording surface facing
the tray upside down.
down.
The disk is scratched Use another disk that is free of scratches and of good
or of poor quality. quality. If there is dust or fingerprints on the disk, clean
the disk.
Refer to subsection 20.1.4 (2) for the cleaning procedure.

(2) Data cannot be written on media at the rated writing speed

Possible cause Action


A disk that is not one Use a disk recommended by Toshiba or one that has
of the recommended been confirmed to operate properly.
types is used. Refer to subsection 20.1.2 for details.
The disk is scratched Use another disk that is free of scratches and of good
or of poor quality. quality. If there is dust or fingerprints on the disk, clean
the disk.
Refer to subsection 20.1.4 (2) for the cleaning procedure.
Data transfer is not When a buffer underrun occurs, the buffer underrun
fast enough to match prevention function is automatically actuated to prevent
the recording speed. recording error. In this case, however, the actual
recording speed is significantly slower than the specified
recording speed. This phenomenon does not indicate an
abnormality. The unit and the media can be used as is.

(3) The disk cannot be read, the disk is not recognized by the unit, or the reading
speed does not increase

Possible cause Action


The disk is placed in Place the disk in the tray with the recording surface facing
the tray upside down.
down.
The disk is scratched Use another disk that is free of scratches and of good
or of poor quality. quality. If there is dust or fingerprints on the disk, clean
the disk.
Refer to subsection 20.1.4 (2) for the cleaning procedure.

No. 2B771-050EN*G
20-5
(4) Abnormal noise is heard during reading

Possible cause Action


The disk is scratched Use another disk that is free of scratches and of good
or of poor quality. quality. If there is dust or fingerprints on the disk, clean
the disk.
Refer to subsection 20.1.4 (2) for the cleaning procedure.
(If a warped disk is used, abnormal noise is generated
even if the data can be read normally.)
A self-adhesive label If a self-adhesive label is placed on the disk, the weight of
is placed on the disk the label may unbalance the disk slightly, resulting in
surface. abnormal noise during disk rotation. In this case, remove
the label from the disk. Be careful not to damage the disk
when removing the label.

20.2 Handling of USB Flash Memory

CAUTION: Do not connect any device to the USB connector other than a
USB flash memory for storing and reviewing image data.

NOTE: 1. Contact your Toshiba service representative for the recommended


products.

2. Prepare a USB flash memory to be used only for this system. Store only
the data to be used in this system in the USB flash memory.

20.2.1 Basic operations

Figure 1 Inserted position of USB flash memory

No. 2B771-050EN*G
20-6
(1) Insert the USB flash memory into the position indicated in figure 1.

When it is recognized correctly, the USB icon is displayed in the lower part of the
screen.

(2) Save the data.

Save the data using the convert function in the Patient Browser, copy/paste
function in the Windows File Browser, or the save function in each application.

(3) Press [Media Eject] on the touch panel or click [Eject] on the Patient Browser or
Windows File Browser. After the message "The USB flash memory can now be
safely removed from the machine." is displayed, remove the USB flash memory.

CAUTION: Do not remove the USB flash memory without following the proper
[Eject] procedure. Otherwise, data on the memory may be damaged.

NOTE: 1. Even if the [Eject] procedure has been performed, the USB flash memory
cannot be removed if the confirmation message has not been displayed. In
that case, shut down the system, remove the USB flash memory, and
reboot the system.

2. After performing the [Eject] procedure, do not shut down the system or set
the system to standby mode with the USB flash memory inserted. The
USB flash memory may not be recognized the next time the system is
started up. If the USB flash memory is not recognized during startup,
remove it, shut down the system, and reboot the system.

3. Insert the USB flash memory after the system has started up. If it is
inserted before the system is started up, it may not be recognized. If the
USB flash memory is not recognized, disconnect it and insert it again.

4. Do not insert the USB flash memory while a CD/DVD or other media is
being mounted. The USB flash memory may not be recognized by the
system.

20.3 Checking the Free Space of the Removable Media


When [Media Space] on the touch panel [PIMS Image] menu is pressed, the free space
of the removable media (such as a CD-R, USB flash memory, etc.) is displayed after
several seconds, and cleared automatically.

* This function cannot be used if a menu, window, measurement marker, or cursor for
annotation entry is displayed overlapping the ultrasound image.

20.4 Beep Volume Adjustment


The volume of the beep (generated when a switch of the main panel is pressed) can be
adjusted.

(1) Press [Panel Setting] in the touch panel [Other] menu. The dialog box is displayed.

(2) Press touch panel [Beep Volume] to adjust the volume of the beep.

No. 2B771-050EN*G
20-7
20.5 Beep Tone Adjustment
The tone of the beep (generated when a switch of the main panel is pressed) can be
adjusted.

(1) Press [Panel Setting] in the touch panel [Other] menu. The dialog box is displayed.

(2) Press touch panel [Beep Tone] to adjust the tone of the beep.

NOTE: When the tone is changed, the volume of the beep is lower than the standard
volume.

20.6 Adjusting the Brightness of the Touch Panel


The brightness of the touch panel can be adjusted.

(1) Press [Panel Setting] in the Other menu on the touch panel. A dialog box is
displayed.

(2) Press [Brightness] in the dialog box to adjust the brightness.

20.7 File Handling for Image Data


Image data acquired with this system is in DICOM format as the standard. The Patient
Browser is provided for file handling for DICOM format image data.

The Patient Browser is also used to convert image data to a Windows format such as
JPEG. The image data converted to a Windows format is handled using the Win
Browser. Refer to the operation manual <Application Volume> for details.

20.8 Display of Saved Images


Use the Exam Review to display the saved images.

The Exam Review displays the images that are saved on the HDD, provided that the
patient information for those images has been entered in the patient ID registration
screen. It also displays the previous images selected using the Patient Browser (by
pressing the [Apply] switch). Refer to the operation manual <Application Volume> for
details.

CAUTION: Do not display or print data imported from other devices in this
system. Such data may not be able to be displayed or printed
correctly.

No. 2B771-050EN*G
20-8
20.9 Changing the System Time
The time (hour/minute/second) displayed in the upper right part of the screen can be
changed.

(1) Press [Menu] in the Other menu on the touch panel.

(2) Select [System Setting] from the [General Setting] pop-up menu.

(3) In the "Time" field of the General Setting screen, change the setting for
hour/minute/second.

(4) Press [Save] The changes are saved.

NOTE: Changing of the date display should be performed by a service engineer.


If the date needs to be changed, contact your Toshiba service
representative.

20.10 Display/Non-Display of the Patient ID


It is possible to set display or non-display of the patient ID, patient name, sex, and age
on the banner.

 Press [De-Identify] in the [PIMS Image] menu on the touch panel.

NOTE: The running number is displayed on the banner when the patient information
is set to non-display. The number is reset for every examination. However, if
the date is changed during an examination, the number is reset starting from
the next examination.

No. 2B771-050EN*G
20-9 *
21. Using MI/TI
21.1 Using MI/TI (Outside the USA and Canada)
21.1.1 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.

(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.

NOTE: Ispta.3 may be represented as Izpta, ( = 0.3dB/cm-MHz) or Ispta,


( = 0.3dB/cm-MHz) (IEC60601-2-37).

Maximum acoustic power specified by FDA (TRACK1)

Ispta.3 Isppa.3
Application 2 2 MI
(mW/cm ) (W/cm )
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

No. 2B771-050EN*G
21-1
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)

Ispta.3 Isppa.3
Application 2 2 MI
(mW/cm ) (W/cm )
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.

CAUTION: The FDA allows ultrasound equipment to output acoustic


power level TRACK3, which is higher than TRACK1,
provided that MI/TI values are displayed on the system.
This means that users 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.

CAUTION: It is strictly required that acoustic output be set based on


the ALARA (As Low As Reasonably Achievable) principle.
However, 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. 2B771-050EN*G
21-2
21.1.2 MI/TI display description
(1) Definition of MI

Mechanical Index (MI) is the peak-rarefactional acoustic pressure Pr, (calculated


considering the tissue attenuation;  = 0.3 dB/cm-MHz) divided by the square root
of the acoustic working frequency fawf (unit: MHz) and can be expressed as follows:

MI = Pr,  ,
fawf  CMI

where CMI = 1 (MPa / MHz )

(2) Definition of TI

Thermal Index (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.

(3) Displayed MI/TI values

Accuracy

The MI and TI values are determined and displayed based on the measured
acoustic power data. The displayed values contain errors due to the following
factors.

* Measurement error in acoustic power measurement


* Variation in the characteristics of the system and transducer
* Ultrasound propagation characteristics

Display Precision is rounded in units of 0.1.

The MI and TI values are displayed only when the value is 0.4 or higher.

In CHI mode, however, the MI value is displayed in steps of 0.01 irrespective of the
displayed value.

21.1.3 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. 2B771-050EN*G
21-3
21.1.4 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 panel. To Low High
decrease ultrasound output, turn the knob
counterclockwise and to increase ultrasound ACOUSTIC POWER
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.

In this system, imaging presets can be created using the ultrasound output set by
the user. At this time, the default function is disabled.
Any changes to the default setting value are the responsibility of the user.

Default choices

Initial power 0% 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.

* Any value less than 1% is displayed as 0%.

No. 2B771-050EN*G
21-4
(3) Default setting for acoustic power

High NOTE: This system automatically returns to the


preset default values whenever changes
*2 are made to the (*1) POWER ON,
*1 TRANSDUCER connector selection,
NEW PATIENT, or PRESET values in the
application menu. In the default status,
the acoustic output power is limited below
Acoustic preset values. Following the ALARA
power restrictions, the user is allowed to
level increase the acoustic power by turning
Default the (*2) ACOUSTIC POWER knob
conditions clockwise under Track3 limits and to save
it to user definable presets.

Low

21.1.5 Output display


This system displays thermal and mechanical indices in real-time. The display
conforms to IEC60601-2-37 "Particular requirements for the safety of ultrasonic medical
diagnostic and monitoring equipment."

The display is intended to give the user information related to the likelihood of bioeffects
from tissue/bone heating (TI) and cavitation (MI). The user should practice ALARA (As
Low As Reasonably Achievable) with respect to these indices.

The maximum acoustic intensity with any transducer/system combination will remain
2
below the FDA (Federal Food and Drug Administration) limit of 720 mW/cm , Ispta and
2
either 1.9 MI or 190 W/cm , Isppa.

For additional information on bioeffects beyond that contained in this labeling, contact
your Toshiba representative. As further information becomes available on the potential
for bioeffects, these displays may change.

No. 2B771-050EN*G
21-5
21.1.6 Parameters affecting MI/TI display
(1) Transmission conditions

 Transmission aperture
 Focus condition
 Drive frequency
 Pulse duration
 Voltage applied to the transducer (acoustic power control)

(2) Scan conditions

 Scan width
 Number of scanning lines
 Method for and selection of beam steering

(3) Parameters used for the calculation of MI/TI in the equipment

 PPC (probe (transducer) preset configuration)


 MI-value table
 TI-value table
 Table of correction values for beam deflection

(4) Control switches affecting MI/TI

(a) Main panel

 NEW PATIENT
 TRANSDUCER SELECTION
TRANSDUCER A
TRANSDUCER B
TRANSDUCER C
PENCIL
 MODE SELECTION
SINGLE/DUAL
UPDATE/FULL
2D
M
PW
CW
CDI
Power
TDI
Dynamic Flow(optional)
 2D FREQ
 2D FOCAL POSITION
 2D STEER
 C/D FREQ
 CDI/PW STEER
 CDI ROI POSI/ SIZE
 GATE POSI/ SIZE
 SCALE
 PAN/EXPAND
 DEPTH
 ACOUSTIC POWER*

No. 2B771-050EN*G
21-6
(b) POP UP MENU and touch panel

For all display modes

 PRESET

For 2D-mode display

 2D-Scan Range
 2D-PSEL
 2D-THI
 Focal No.

For M-mode display

 M-Frequency

For CDI mode (including POWER, TDI, Dynamic Flow mode)

 Data No.
 CDI-Psel
 CDI-Focal Position

For Doppler mode

 Dop-Frequency
 IQ Balance

CAUTION: Note that for switches other than those marked *, the MI/TI
value may change in a direction not intended for the above
parameters.

21.1.7 Reminder
As a reminder, Always Practice ALARA. The display gives information in real time
and therefore shows the current acoustic exposure rates to the tissue or structure being
insonated.

For inquiries and information, contact your Toshiba representative. Additionally, as


further information becomes available, we will do our utmost to keep you informed.

No. 2B771-050EN*G
21-7
21.1.8 Ultrasonic output power and acoustic output
(1) Derated Ultrasonic Output Parameters

In order to determine the relevant Ultrasonic Output Parameters, a method is used


which allows for the comparison of ultrasound systems which operate at different
frequencies and are focused at different depths. This approach, called "derating"
or "attenuating", adjusts the acoustic output as measured in a water tank to
account for the effect of ultrasound propagation through tissue. By convention, a
specific average intensity attenuation value is used, which corresponds to a loss of
0.3 dB/cm/MHz. That is, the intensity of ultrasound will be reduced by 0.3 dB/MHz
for every centimeter of travel from the transducer. This can be expressed by the
following equation:

Iatten  Iwater x 10( 0.3 / 10  fc  z )

Where Iatten is the attenuated intensity, Iwater is the intensity measured in a water tank
(at distance z), fc is the center frequency of the ultrasound wave (as measured in
water), and z is the distance from the transducer. The equation for attenuating
pressure values is similar except that the attenuation coefficient is 0.15 dB/cm/MHz,
or one-half the intensity coefficient. The intensity coefficient is double the pressure
coefficient because intensity is proportional to the square of pressure.

Although the attenuation coefficient chosen, 0.3 dB/cm/MHz, is significantly lower


than any specific solid tissue in the body, this value was chosen to account for fetal
examinations. In early trimester ultrasound fetal examinations, there may be a
significant fluid path between the transducer and the fetus, and the attenuation of
fluid is very small. Therefore the attenuation coefficient was lowered to account for
this case.

(2) Acoustic Output Limits

The derating (or attenuated) approach was incorporated into the FDA Acoustic
Output Limits, as listed below. The acoustic output level is designed to fall below
these limits.

FDA Maximum Acoustic Output Limits for Track 3 (Attenuated Values)

Ispta.3 Isppa.3
Application 2 2 MI
(mW/cm ) (W/cm )
or
All regions 720 <190 <1.9
(except eyes)

In addition, the TI (TIS, TIB and TIC) is designed not to exceed 6.0.

No. 2B771-050EN*G
21-8
(3) Differences between displayed and "actual" Thermal and Mechanical effects

In operation, the system will display to the operator the Acoustic Output
Parameters Thermal Index, TI, or Mechanical Index, MI (or sometimes both
parameters simultaneously). These parameters were developed as general
indicators of risk from either thermal or mechanical action of the ultrasound wave.
They serve to indicate to the operator whether a particular setting of the system
increases or decreases the possibility of Thermal or Mechanical effect. More
specifically, they were designed to assist in the implementation of the ALARA
principle (see subsection 21.1.7). As an operator changes a given system control
(see subsection 21.1.6), the potential effect of the change in output will be
indicated. However, the Thermal Index is not the same as temperature rise in the
body, for several reasons. First of all, in order to provide a single display index to
the user, a number of simplifying assumptions had to be made. The biggest
assumption was the use of the attenuating formula described above, which is much
lower that the actual value for most tissues within the body. Scanning through
muscle or organ tissue, for example, will produce much higher attenuation than
0.3 dB/cm/MHz. There were also significant simplifications made for the thermal
properties of tissue. Therefore, scanning through highly perfused tissue, such as
the heart or vasculature, will produce significantly less thermal effect than that
suggested by the Thermal Index.

Similarly, the Mechanical Index was derived to indicate the relative possibility of
mechanical (cavitation) effects. The MI is based on the derated peak rarefactional
pressure and the center frequency of the ultrasound wave (see subsection 21.2.2).
The actual peak rarefactional pressure is affected by the actual attenuation caused
by tissue in the path between the transducer and the focal point. Again, all solid
tissues within the body have higher attenuation than the proscribed 0.3 dB/cm/MHz
value, and therefore, the actual peak rarefactional pressure will be lower. Further,
the actual peak rarefactional pressure will change depending upon the region of
the body being scanned.

For these reasons, the TI and MI displays should only be used to assist the
operator in implementing ALARA at the time of the patient examination.

21.1.9 References for MI/TI


For further information on measurement methods and MI/TI, refer to the followings:

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


Revision 3" issued by AIUM/NEMA in 2004

(2) "Standard for real-time display of thermal and mechanical acoustic output indices
on diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004

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

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

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


Ultrasound Systems and Transducers" issued by FDA in 2008

(6) World Federation for Ultrasound in Medicine and Biology (WFUMB), Conclusions
and Recommendations on Thermal and Non-thermal Mechanisms for Biological
Effects of Ultrasound. Report of the 1996 WFUMB Symposium on Safety of
Ultrasound in Medicine. Barnett, S.B. (ed). Ultrasound in Medicine and Biology,
Vol 24, suppl 1, 1998.

No. 2B771-050EN*G
21-9
21.2 Using MI/TI (in the USA and Canada)
21.2.1 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.

(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.

NOTE: Ispta.3 may be represented as Izpta, ( = 0.3 dB/cm-MHz)


(IEC60601-2-37).

Maximum acoustic power specified by FDA (TRACK1)

Ispta.3 Isppa.3
Application 2 2 MI
(mW/cm ) (W/cm )
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

No. 2B771-050EN*G
21-10
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)

Ispta.3 Isppa.3
Application 2 2 MI
(mW/cm ) (W/cm )
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.

CAUTION: The FDA allows ultrasound equipment to output acoustic


power level TRACK3, which is higher than TRACK1,
provided that MI/TI values are displayed on the system.
This means that users 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.

CAUTION: It is strictly required that acoustic output be set based on


the ALARA (As Low As Reasonably Achievable) principle.
However, 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. 2B771-050EN*G
21-11
21.2.2 MI/TI display description
(1) Definition of MI

Mechanical Index (MI) is the peak-rarefactional acoustic pressure P.3 (calculated


considering the tissue attenuation) divided by the square root of the center
frequency fc (unit: MHz) and can be expressed as follows:

MI = P.3

fc

(2) Definition of TI

Thermal Index (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.

(3) Displayed MI/TI values

Accuracy

The MI and TI values are mean values that are determined and displayed based
on the measured acoustic power data.
The displayed label names have "m" as the last character (such as MIm and TISm).

The system also has other index values. They are called global maximum values
and internally control the ultrasound output. They are determined statistically,
based on the variation due to the following factors.

* Measurement error in acoustic power measurement


* Variation in the characteristics of the system and transducer
* Ultrasound propagation characteristics

Display Precision is rounded in units of 0.1.

The MI and TI values are displayed only when the value is 0.4 or higher.

In CHI mode, however, the MI value is displayed in steps of 0.01 irrespective of the
displayed value.

21.2.3 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. 2B771-050EN*G
21-12
21.2.4 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 panel. To Low High
decrease ultrasound output, turn the knob
counterclockwise and to increase ultrasound ACOUSTIC POWER
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.

In this system, imaging presets can be created using the ultrasound output set by
the user. At this time, the default function is disabled.
Any changes to the default setting value are the responsibility of the user.

Default choices

Initial power 0% 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.

* Any value less than 1% is displayed as 0%.

No. 2B771-050EN*G
21-13
(3) Default setting for acoustic power

High NOTE: This system automatically returns to the


preset default values whenever changes
*2 are made to the (*1) POWER ON,
*1 TRANSDUCER connector selection,
NEW PATIENT, or PRESET values in the
application menu. In the default status,
the acoustic output power is limited below
Acoustic preset values. Following the ALARA
power restrictions, the user is allowed to
level increase the acoustic power by turning
Default the (*2) ACOUSTIC POWER knob
conditions clockwise under Track3 limits and to save
it to user definable presets.

Low

21.2.5 Output display


This system displays thermal and mechanical indices in real-time. The display
conforms to the "Standard for Real-Time Display of Thermal and Mechanical Output
Indices on Diagnostic Ultrasound Equipment", which is the voluntary standard of AIUM
(American Institute of Ultrasound in Medicine) and NEMA (National Electrical
Manufacturers Association).

The display is intended to give the user information related to the likelihood of bioeffects
from tissue/bone heating (TI) and cavitation (MI). The user should practice ALARA (As
Low As Reasonably Achievable) with respect to these indices.

The absolute maximum acoustic intensity with any transducer/system combination will
remain below the FDA (Federal Food and Drug Administration) limit of 720 mW/cm2,
Ispta and either 1.9 MI or 190 W/cm2, Isppa.

For additional information on bioeffects beyond that contained in this labeling, contact
your Toshiba representative. As further information becomes available on the potential
for bioeffects, these displays may change.

Information from AIUM is included in the operational information for MI and TI. You are
strongly encouraged to become familiar with this information and to understand the
potential for bioeffects. Always practice ALARA and avoid unnecessary use of
ultrasound.

No. 2B771-050EN*G
21-14
21.2.6 Information contained in the system documentation
Information from AIUM and FDA is included in the system documentation. This
information details the basics of ultrasound, the mechanical and thermal indices, their
clinical and biological meaning, and information on the ALARA principal.

The included information is extremely important for the understanding and use of the
system. It will help yield effective diagnostic images while keeping acoustic exposure
as low as possible. You are strongly encouraged to read this information.

The information following this section describes the operational controls which affect the
MI/TI values and the acoustic exposure to the patient. These controls should be
understood by the user and their effects should be observed prior to the performance of
examinations.

21.2.7 Parameters affecting MI/TI display


(1) Transmission conditions

 Transmission aperture
 Focus condition
 Drive frequency
 Pulse duration
 Voltage applied to the transducer (acoustic power control)

(2) Scan conditions

 Scan width
 Number of scanning lines
 Method for and selection of beam steering

(3) Parameters used for the calculation of MI/TI in the equipment

 PPC (probe (transducer) preset configuration)


 MI-value table
 TI-value table
 Table of correction values for beam deflection

(4) Control switches affecting MI/TI

(a) Main panel

 NEW PATIENT
 TRANSDUCER SELECTION
TRANSDUCER A
TRANSDUCER B
TRANSDUCER C
PENCIL

No. 2B771-050EN*G
21-15
 MODE SELECTION
SINGLE/DUAL
UPDATE/FULL
2D
M
PW
CW
CDI
Power
TDI
Dynamic Flow(optional)
 2D FREQ
 2D FOCAL POSITION
 2D STEER
 C/D FREQ
 CDI/PW STEER
 CDI ROI POSI/ SIZE
 GATE POSI/ SIZE
 SCALE
 PAN/EXPAND
 DEPTH
 ACOUSTIC POWER*

(b) POP UP MENU and touch panel

For all display modes

 PRESET

For 2D-mode display

 2D-Scan Range
 2D-PSEL
 2D-THI
 Focal No.

For M-mode display

 M-Frequency

For CDI mode (including POWER, TDI, Dynamic Flow mode)

 Data No.
 CDI-Psel
 CDI-Focal Position

For Doppler mode

 Dop-Frequency
 IQ Balance

CAUTION: Note that for switches other than those marked *, the MI/TI
value may change in a direction not intended for the above
parameters.

No. 2B771-050EN*G
21-16
21.2.8 Measurement uncertainty and precision
The total estimated measurement uncertainty (where the total uncertainty includes the
uncertainties in hydrophone response, measurement, calculation, and positioning) are:

Expanded uncertainty
Ispta 19.8%
Isppa 19.8%
Center frequency (fc) 1.9%
Total power (W) 6.2%
Rarefactional pressure (pr) 9.8%
(k=2.132, C.I.=90%)

21.2.9 Reminder
As a reminder, Always Practice ALARA. The display gives information in real time
and therefore shows the current acoustic exposure rates to the tissue or structure being
insonated.

For inquiries and information, contact your Toshiba representative. Additionally, as


further information becomes available, we will do our utmost to keep you informed.

No. 2B771-050EN*G
21-17
21.2.10 Ultrasonic output power and acoustic output
(1) Derated Ultrasonic Output Parameters

In order to determine the relevant Ultrasonic Output Parameters, a method is used


which allows for the comparison of ultrasound systems which operate at different
frequencies and are focused at different depths. This approach, called "derating"
or "attenuating", adjusts the acoustic output as measured in a water tank to
account for the effect of ultrasound propagation through tissue. By convention, a
specific average intensity attenuation value is used, which corresponds to a loss of
0.3 dB/cm/MHz. That is, the intensity of ultrasound will be reduced by 0.3 dB/MHz
for every centimeter of travel from the transducer. This can be expressed by the
following equation:

Iatten  Iwater x 10( 0.3 / 10  fc  z )

Where Iatten is the attenuated intensity, Iwater is the intensity measured in a water tank
(at distance z), fc is the center frequency of the ultrasound wave (as measured in
water), and z is the distance from the transducer. The equation for attenuating
pressure values is similar except that the attenuation coefficient is 0.15 dB/cm/MHz,
or one-half the intensity coefficient. The intensity coefficient is double the pressure
coefficient because intensity is proportional to the square of pressure.

Although the attenuation coefficient chosen, 0.3 dB/cm/MHz, is significantly lower


than any specific solid tissue in the body, this value was chosen to account for fetal
examinations. In early trimester ultrasound fetal examinations, there may be a
significant fluid path between the transducer and the fetus, and the attenuation of
fluid is very small. Therefore the attenuation coefficient was lowered to account for
this case.

(2) Acoustic Output Limits

The derating (or attenuated) approach was incorporated into the FDA Acoustic
Output Limits, as listed below. The acoustic output level is designed to fall below
these limits.

FDA Maximum Acoustic Output Limits for Track 3 (Attenuated Values)

Ispta.3 Isppa.3
Application 2 2 MI
(mW/cm ) (W/cm )
or
All regions 720 <190 <1.9
(except eyes)

In addition, the TI (TIS, TIB and TIC) is designed not to exceed 6.0.

No. 2B771-050EN*G
21-18
(3) Differences between displayed and "actual" Thermal and Mechanical effects

In operation, the system will display to the operator the Acoustic Output
Parameters Thermal Index, TI, or Mechanical Index, MI (or sometimes both
parameters simultaneously). These parameters were developed as general
indicators of risk from either thermal or mechanical action of the ultrasound wave.
They serve to indicate to the operator whether a particular setting of the system
increases or decreases the possibility of Thermal or Mechanical effect. More
specifically, they were designed to assist in the implementation of the ALARA
principle (see section 21.2.9). As an operator changes a given system control (see
section 21.2.7), the potential effect of the change in output will be indicated.
However, the Thermal Index is not the same as temperature rise in the body, for
several reasons. First of all, in order to provide a single display index to the user, a
number of simplifying assumptions had to be made. The biggest assumption was
the use of the attenuating formula described above, which is much lower that the
actual value for most tissues within the body. Scanning through muscle or organ
tissue, for example, will produce much higher attenuation than 0.3 dB/cm/MHz.
There were also significant simplifications made for the thermal properties of tissue.
Therefore, scanning through highly perfused tissue, such as the heart or
vasculature, will produce significantly less thermal effect than that suggested by the
Thermal Index.

Similarly, the Mechanical Index was derived to indicate the relative possibility of
mechanical (cavitation) effects. The MI is based on the derated peak rarefactional
pressure and the center frequency of the ultrasound wave (see section 21.2.2).
The actual peak rarefactional pressure is affected by the actual attenuation caused
by tissue in the path between the transducer and the focal point. Again, all solid
tissues within the body have higher attenuation than the proscribed 0.3 dB/cm/MHz
value, and therefore, the actual peak rarefactional pressure will be lower. Further,
the actual peak rarefactional pressure will change depending upon the region of
the body being scanned.

For these reasons, the TI and MI displays should only be used to assist the
operator in implementing ALARA at the time of the patient examination.

No. 2B771-050EN*G
21-19
21.2.11 References for MI/TI
For further information on measurement methods and MI/TI, refer to the followings:

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


Revision 3" issued by AIUM/NEMA in 2004

(2) "Standard for real-time display of thermal and mechanical acoustic output indices
on diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004

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

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

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


Ultrasound Systems and Transducers" issued by FDA in 2008

(6) "Guide to the expression of uncertainty in measurement" issued by ISO in 1995

(7) World Federation for Ultrasound in Medicine and Biology (WFUMB), Conclusions
and Recommendations on Thermal and Non-thermal Mechanisms for Biological
Effects of Ultrasound. Report of the 1996 WFUMB Symposium on Safety of
Ultrasound in Medicine. Barnett, S.B. (ed). Ultrasound in Medicine and Biology,
Vol 24, suppl 1, 1998.

No. 2B771-050EN*G
21-20 *
22. Preventive Maintenance
Daily checks, periodic inspection, and replacement of consumable parts/periodically
replaced parts are included in preventive maintenance. For replacement of periodically
replaced parts, special techniques are required because special tools are used or there
are special risks involved.

TOSHIBA provides preventive maintenance services requiring special techniques on a


pay-for-service basis.

TOSHIBA requests that the user make a preventive maintenance contract and to have
periodic inspection and cleaning by TOSHIBA service personnel so that data reliability
can be improved.

If you have any questions concerning preventive maintenance or preventive


maintenance contracts, contact your TOSHIBA representative.

CAUTION: 1. If preventive maintenance is performed by the user, special


care must be taken to ensure safety.

2. If any abnormality of the system is found as a result of


inspection, stop using the system and contact your
TOSHIBA representative for repair.

3. In no event shall TOSHIBA be liable for problems, damage,


or loss caused by inspection performed by personnel other
than TOSHIBA service personnel or those designated by
TOSHIBA.

NOTE: The following message is displayed when the period of operation (factory
setting: 600 hours) set in the system has elapsed. When this message is
displayed, consider placing a request for inspection by a service engineer.
The interval for display of this message can be changed. Contact your service
representative.

The maintenance period coming.


Please contact your service representative.

No. 2B771-050EN*G
22-1
22.1 Preventive Maintenance Performed by User
22.1.1 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, benzine, or alcohol) 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 and gel holder

* The transducer holder and gel holder are removable.


When the gel bottle is removed from the gel holder, the gel holder may be
inadvertently removed together with the gel bottle in some cases.
Confirm that the gel holder is not removed when removing the gel bottle.

(a) Wipe off any stains on the transducer holder and gel 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.

No. 2B771-050EN*G
22-2
(4) Clean the reference signal cable regularly.

(a) Wipe off any stains using a soft cloth moistened with mild detergent and then
tightly wrung out. When the mild detergent is required for cleaning, please
contact your TOSHIBA representative.

(b) Wipe the reference signal cable with dry cloth and dry it well.

CAUTION: 1. Do not allow clips to wet. The ECG is not displayed


correctly.

2. Do not soak the connector in the water.


Wipe the connector with dry cloth only.
The water may enter the connector inside, possibly
resulting in failure.

3. Do not use solvents (such as paint thinner, benzine, or


alcohol) for cleaning the reference signal cable.

(5) Cleaning the CRT 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. 2B771-050EN*G
22-3
(6) Cleaning the LCD monitor

Use a clean, soft cloth to clean the LCD surface.

(a) Monitor cover

 Clean the monitor cover using a soft cloth moistened with mild detergent.

(b) LCD surface

 Use a soft cotton cloth or lens cleaning paper to clean the LCD surface.

 Do not hit or apply strong pressure to the LCD surface.

 If stains on the LCD surface are difficult to remove, wipe it gently with a soft
cloth slightly moistened with water and then wipe it with a soft, dry cloth.

CAUTION: 1. Do not hit or apply strong pressure to the LCD surface


during cleaning. Doing so may damage the monitor.

2. Never use a stiff or hard cloth to clean the LCD monitor.


Doing so may damage the monitor cover or LCD
surface.

3. If stains on the LCD surface are difficult to remove, wipe


it gently with a soft cloth slightly moistened with water.
Detergents or chemical agents should not be used
because they may damage the monitor.

4. Do not attempt to clean the LCD monitor with organic


solvents such as benzine, paint thinner, and alcohol or
abrasive cleaners.
Such agents may damage the monitor cover or LCD
surface.
Also, do not use mild detergent to clean the LCD
surface.

5. Do not allow liquid droplets to remain on the LCD


surface.
The droplets may cause small stains when they dry or
may enter the LCD surface, possibly resulting in failure.

(7) 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.

No. 2B771-050EN*G
22-4
(8) Cleaning the surface of the touch panel

(a) Clean the surface of the touch panel using a commercially available eyeglass
cleaning cloth (non-woven rayon cloth etc.).

(b) If necessary, use a piece of soft cloth moistened with water or neutral
detergent and then tightly wrung out.

(9) Cleaning the trackball

(a) Turn the ring on the trackball case in the direction indicated by the arrow to
remove the dial (the ring is unlocked and pushed up).

CAUTION: Be extremely careful when removing dial.

(b) Keep the ball in a clean box or other suitable place to ensure that it does not
fall.

No. 2B771-050EN*G
22-5
(c) Clean the ball and ball bearings, removing all dirt and foreign matter.

CAUTION: Do not touch the encoding rollers.


If foreign matter has adhered to the encoding rollers,
contact your Toshiba service representative.

CAUTION: Never use organic solvents such as benzin, paint thinner, or alcohol.
They may damage plastic parts.

(d) Confirm that no dirt or foreign matter is left in the trackball case. Place the ball
gently in the trackball main unit and place the dial on top of the trackball main
unit.

No. 2B771-050EN*G
22-6
(e) Set the arrowheads on the dial as shown below and confirm that the dial is
seated securely.

Arrowhead positions Confirm that the dial is seated securely.

CAUTION: Set the dial so that it is seated securely.


If the ring is locked with the dial not seated securely,
the palm switch may be damaged.

(f) Turn the ring in the indicated direction to tighten it.

(g) After assembling the trackball, move the ball with your finger to confirm that it
moves smoothly and that there is no noise.

Also, start the system and confirm that the trackball functions properly.

No. 2B771-050EN*G
22-7
(10) Cleaning the air filters

Check and clean the air filters to avoid overheating inside the system and a
reduction in system performance/reliability due to clogging of the filters.

CAUTION: Do not boot the system while the air filters are removed. The system
may malfunction.

(a) Cleaning the air filter in the peripheral unit rack

<1> Remove the air filters.

<2> Clean dust from the filters using a vacuum cleaner at a location away
from the system.

<3> Re-install the air filters to the system.

(b) Cleaning the air filter in the power supply unit

<1> Separate the Velcro fastener and then pull out the air filter.

<2> Clean dust from the filters using a vacuum cleaner at a location away
from the system.

<3> Re-install the air filter and secure it with the Velcro fastener.

Slot

Air filter for the


peripheral rack

Velcro fastener

Slot

Air filter for the power supply unit

No. 2B771-050EN*G
22-8
22.1.2 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. Refer to subsection 22.1.4
"Backup of the HDD (Archiving Preset Data)" for the detailed procedure.

22.1.3 Maintenance menu


This system provides a maintenance menu that supports maintenance and
management by the user. Use this maintenance menu if required.

CAUTION: Do not use the maintenance menu during an examination. The


maintenance menu must be started before a patient ID is registered after
system power ON, or after an examination is terminated by pressing
twice.

(1) Press MENU


.
Select [Maintenance] from the pop-up menu to display the submenu.

Archiving Preset Data


SystemMaintenance Submenu
System Setting RemoteMaintenance
Maintenance Return

Submenu name Function


Archiving Preset Data Backup of the HDD data to another medium can be
performed to protect data specific to the user, and for
moving specific data to another system.
System Maintenance The daily inspection record performed by the user is
provided as the template. The inspection result can be
printed.
Remote Maintenance Open this menu when remote maintenance is allowed.

(2) Select the desired item from the submenu.

Details of each submenu are described on the next page or later.

No. 2B771-050EN*G
22-9
22.1.4 Backup of the HDD (Archiving Preset Data)
(1) Prepare the media for the backup destination, insert it into the system, and then
open the [Archiving Preset Data] menu.

* If the backup destination media is inserted after opening the [Archiving Preset
Data] menu, press Refresh Drive List .

(2) Select a drive.

(3) When Go is clicked, the backup procedures start.

(4) After terminating the backup procedures, press Exit to terminate the menu.

Only the removable media is displayed.


The drive in which the removable media
has already been inserted is displayed.

The media to be written to is scanned


again.

The standard time required for backup


is displayed.

The backup progress is displayed.

NOTE: When data is to be backed up to media that has not previously been used for
data backup, press [Initialize Media] in the archiving menu first. The system
identification information such as the system serial number is written to the
media. After this operation, the media cannot be used to back up the data of
other systems.

No. 2B771-050EN*G
22-10
22.1.5 Recording/printing the daily check result (System Maintenance)
(1) Open the [System Maintenance] menu.

Check item

Select from No Execution, Pass, or Fail.

Check the
implementation date
(Automatic display)

Enter the name of


the checker
(if the check
manager has been
set, the name is
automatically
displayed.)

Closes the menu.

Displays the test pattern Boots the Panel Prints the test result
Returns to the
and saves the data to the
on the monitor. Operation Test. initial status.
hard disk.

No. 2B771-050EN*G
22-11
(2) Check the items listed in the table below.

Press No Exe and select the check result from among No Exe, Pass, and
Fail.

No. Check item Contents Check procedures


1. Power Supply Around the outlet Check the power cable and around the
Cable outlet.
2. Smell/Noise Checking for abnormal Check the sound and smell.
sounds and unusual smells
3. Air Filter Air filters Check the clogging of the air filters.
4. Fixture Checking the peripheral unit Confirm that peripheral units are
fixing status securely fixed.
5. Castor Checking the caster function Check the caster.
6. Probe Transducer Check the appearance of the
transducer.
7. Peripheral Peripheral units Check the status of the peripheral units.
Equipment
8. Image Quality Image quality Check images. (Judge whether or not
any abnormality exists by comparing
with images before starting this menu.)
9. Monitor CRT Monitor Press Display . Refer to *(a).

10. Operation Panel Operation panel Press Execute . Refer to *(b).

*(a) When Display is pressed, the test pattern is displayed in color on the
monitor for about 5 seconds. Check it visually.

No. 2B771-050EN*G
22-12
*(b) When Execute is pressed, the screen below is displayed and the operation
panel tests start automatically.

The message "Checking" is displayed in Button Test 1 to indicate that the test
is being executed. Press the switch which is lit on the maintenance panel
(normally is lit). The message "Pass" or "Failed" is displayed and the
test proceeds to Button Test 2. If no panel switch is lit, press Next >> .
The message "Not Executed" is displayed and the next test is started.

 Checking : The test is in progress.


 Pass : The test completed successfully.
 Failed : The test failed.
 Not Executed : The test is discontinued.

Switch test.
Each test proceeds in the
form of dialogs.
* Refer to <1>.

Enter characters from the


keyboard. On the keyboard-
entry character display
column shown below, when
the entered characters are
correctly displayed, check
"Pass". When the entered
characters are not correctly
displayed, check "Fail".
When the test is interrupted,
check "Not Executed".
* Refer to <2>.

<1> The window below is displayed during Button Tests 1 to 5.

When "Back" is clicked, the test is When "Next" is clicked, the test is
moved to the previous test. moved to the next test.
The status of the test is The status of the test is
"Not Executed". "Not Executed".

<2> The window below is displayed during Full Key Board test.

When "Back" is clicked, the test is


Disabled key. Nothing changes.
moved to "Button Test 5".

No. 2B771-050EN*G
22-13
(3) Enter the name of the checker in the Tester Name field.

(4) Press Print to output the test results to the printer.

(5) Press Exit to terminate the menu.

22.1.6 Remote Maintenance


(1) Open the [Remote Maintenance] menu. The following message is displayed.

(2) When remote maintenance is completed, the Toshiba Assistance Center (TAC) will
tell you to terminate the menu. Press Exit to terminate the Remote Maintenance
menu.

CAUTION: Do not mount/remove the transducers during remote maintenance. Doing


so may damage data in the system.

No. 2B771-050EN*G
22-14
22.2 Preventive Maintenance Performed by Service Personnel
To ensure safety and maintain system performance, the following checks must be
performed by service personnel who have the required expertise. Contact your
TOSHIBA representative.

Check contents Check items Check interval


Cleaning Transducer, transducer holder 1 year
Main body, peripheral units
Air filters
Electrical safety Protective conductor resistance 1 year
Leakage current
Patient auxiliary current
Mechanical safety Caster/monitor/panel operations, 1 year
mounting sections
Peripheral units
Appearance of the transducer
Checking/recording images Images in each mode 1 year
Images acquired by a standard transducer

22.3 Periodically Replaced Parts and Consumable Parts


The equipment has been designed with parts that have as long a service life as possible.
However, to maintain the safety, specifications, and performance of the system, the
periodic replacement of some parts (batteries for the system power backup, etc.) is
required.

To perform replacement of periodically replaced parts, special techniques are required.


Contact your TOSHIBA representative.

22.4 Repair
To perform repair, special techniques are required.
Contact your TOSHIBA representative.

22.5 Check During Storage


Perform preventive maintenance during storage of the system.

No. 2B771-050EN*G
22-15
22.6 Disposal
To meet environmental standards, the components inside the system need to be
classified and disposed of. As the system contains heavy components, precautions
must be followed when they are disassembled.

When the system is disposed of, contact your TOSHIBA representative.

When the battery of the IASSIST remote controller (option) needs to be changed,
contact your TOSHIBA representative. The local regulations must be followed when
disposing of the battery.

WARNING: This system and its parts should be disposed of as


industrial waste material. When disposing of them, all
applicable laws and regulations must be observed and a
certified waste disposal contractor must handle the disposal
work.

CAUTION: Be sure to delete all data stored on disks and other media
before disposal to ensure that personal information is not
disclosed.

No. 2B771-050EN*G
22-16 *
23. 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 turned  Adjust the "CONTRAST" "BRIGHTNESS" buttons on the monitor.
ON, but no images are
 Check whether the equipment is in external video signal input
displayed.
mode.
Characters are displayed  Confirm that the ACOUSTIC POWER dial, GAIN dial, and STC
but no images are slide controls are set to their maximum positions. If still no
displayed. images are displayed, confirm that the transducer is connected to
the transducer connector correctly, or use a different transducer.
An error dialog (error  Turn the power of the system OFF and then ON referring to
message) is displayed and section 6 "Power ON/OFF".
the operation is disabled.

NOTE: 1. Some time is required before an ultrasound image is displayed on the


monitor after the power is turned ON. The time differs depending on the
system conditions, ranging from 3 to 6 minutes.

2. The power shutdown process may take approximately 1.5 to 3 minutes


depending on the system conditions.

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 or circuit protector 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.

NOTE: Error codes


An error message such as "US_IMG **" may be displayed on the monitor.
This error is mainly caused by the hardware (or its control software).
When the error message is displayed and the system cannot be operated,
refer to section 6 "Power ON/OFF", and turn the system ON again. If the error
message is still displayed after rebooting, contact your Toshiba service
representative.
In the "**" of "US_IMG **", a one- or two-digit number is displayed.
This number identifies the location that has failed. When contacting the
service representative, provide this error code.

No. 2B771-050EN*G
23-1 *
24. Conformance Standards
Canada
(1) General : IEC60601-1 (1988), Amd. 1 (1991), Amd. 2 (1995)
CAN/CSA-C22.2 No. 601.1-M90
(2) Particular : IEC60601-2-37 (2001), Amd. 1 (2004), Amd. 2 (2005)
(3) Acoustic power : Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and
Transducers (2008) (FDA guidance)
(4) EMC : IEC60601-1-2 (2001), Amd. 1 (2004)

EU and other regions requiring compliance with European Directive 93/42/EEC and
subsequent amendments

 After serial No. LGJ*******, 15E*******, LCJ*******


(1) General : EN60601-1 (2006)
(2) Particular : EN60601-2-37 (2008)
(3) Acoustic power : Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and
Transducers (2008) (FDA guidance)
(4) EMC : EN60601-1-2 (2007)

 Before serial No. LGI*******, 15D*******, LCI*******


(1) General : EN60601-1 (1990), Amd. 1 (1993), Amd. 2 (1995)
(2) Particular : EN60601-2-37 (2001), Amd. 1 (2005), Amd. 2 (2005)
(3) Acoustic power : Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and
Transducers (2008) (FDA guidance)
(4) EMC : EN60601-1-2 (2001), Amd. 1 (2006)

USA
(1) General : IEC60601-1 (1988), Amd. 1 (1991), Amd. 2 (1995)
UL 60601-1(2003) R6.03
(2) Particular : IEC60601-2-37 (2001), Amd. 1 (2004), Amd. 2 (2005)
(3) Acoustic power : Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and
Transducers (2008) (FDA guidance)
(4) EMC : IEC60601-1-2 (2001), Amd. 1 (2004)

Other regions
(1) General : IEC60601-1 (1988), Amd. 1 (1991), Amd. 2 (1995)
(2) Particular : IEC60601-2-37 (2001), Amd. 1 (2004), Amd. 2 (2005)
(3) Acoustic power : Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and
Transducers (2008) (FDA guidance)
(4) EMC : IEC60601-1-2 (2001), Amd. 1 (2004)

No. 2B771-050EN*G
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

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

 EQUIPMENT WITH TYPE-BF APPLIED PARTS (reference signal cable)

 EQUIPMENT WITH TYPE-B APPLIED PARTS (PCG, pulse)

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

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

However, the footswitch is 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. 2B771-050EN*G
25-1 *
26. Indication of Year of Manufacture
The year of manufacture is shown on the label attached on the rear of the system.

No. 2B771-050EN*G
26-1 *
27. Accuracy of Measurement
Accuracy of Each Clinical Measurement Parameter

Parameter Ranges Accuracy


- Image Depth Scale Up to 280 mm < 5% or <1 mm, if below 20 mm
- Physio/Image Scales Up to 10 s < 3%
- Distance/Depth Up to 280 mm < 5% or < 1 mm, if below 20 mm
2
- Area Up to 999 cm < 10% or < 0.041 cm2, if below 4 cm2
- Circumference Up to 1800 mm < 5% or < 1 mm, if below 20 mm
- Angle 0 to 180 < 1
3
- Volume Up to 4200 cm < 16% or < 1.3 cm3, if below 8 cm3
- Velocity Up to 2000 cm/s < 5% of the full scale
- Time Up to 10 s < 3% of the full scale
- Heart Rate 20 to 600 bpm < 3%
2
- Accel Up to 20000 cm/s < 8%
- M distance Up to 280 mm < 5% or < 1 mm, if below 20 mm
- Slope Up to 1000 mm/s < 8%

Range of Applicability of the Accuracy Specifications

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

It should be noted, however, that the above values are not guaranteed for measurements
performed on stored images that use manual calibration or MPR images that have been created
based on data acquired using the 4D transducer. For details of manual calibration, refer to the
operation manual, <<Measurement>> volume. For details of the 4D transducer, refer to the
section describing the 4D function in the operation manual, <<Applications>> volume.

No. 2B771-050EN*G
27-1 *
28. Guidance and Manufacturer's
Declaration
This product is compliant with the following EMC standards.

 On systems complying with European Directive 93/42/EEC (after serial No.


LGJ*******, 15E*******, LCJ******* )
IEC60601-1-2:2007

 On systems complying with European Directive 93/42/EEC (before serial No.


LGI*******, 15D*******, LCI******* )
IEC60601-1-2 (2001), Amd.1 (2004)

 Other systems
IEC60601-1-2 (2001), Amd.1 (2004)

No. 2B771-050EN*G
28-1
(1) Guidance and manufacturer's declaration

 SSA-660A without IASSIST

Guidance and manufacturer's declaration - electromagnetic emissions


The SSA-660A is intended for use in the electromagnetic environment specified below. The
customer or the user of the SSA-660A should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The SSA-660A 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-660A 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
*: Not applicable to the regions classified as Other 1
Voltage fluctuations/ Complies*
(where a line voltage of 110 to 120 VAC is used).
flicker emissions
IEC 61000-3-3
NOTE: Do not use cables or parts other than those intended for this product.
If cables or parts other than those intended for this product are used, performance
related to electromagnetic emission may deteriorate.

 SSA-660A with IASSIST

Guidance and manufacturer's declaration - electromagnetic emissions


The SSA-660A is intended for use in the electromagnetic environment specified below. The
customer or the user of the SSA-660A should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 2 The SSA-660A must emit electromagnetic energy in order
CISPR 11 to perform its intended function.
Nearby electronic equipment may be effected.
RF emissions Class B The SSA-660A 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
*: Not applicable to the regions classified as Other 1
Voltage fluctuations/ Complies*
(where a line voltage of 110 to 120 VAC is used).
flicker emissions
IEC 61000-3-3
NOTE: Do not use cables or parts other than those intended for this product.
If cables or parts other than those intended for this product are used, performance
related to electromagnetic emission may deteriorate.

No. 2B771-050EN*G
28-2
Guidance and manufacturer's declaration - electromagnetic immunity
The SSA-660A is intended for use in the electromagnetic environment specified below. The
customer or the user of the SSA-660A 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-660A 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-660A 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 1: UT is the a.c. mains voltage prior to application of the test level.
NOTE 2: Do not use cables or parts other than those intended for this product.
If cables or parts other than those intended for this product are used, performance
related to electromagnetic immunity may deteriorate.

No. 2B771-050EN*G
28-3
Guidance and manufacturer's declaration - electromagnetic immunity
The SSA-660A is intended for use in the electromagnetic environment specified below. The
customer or the user of the SSA-660A 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-660A, 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 150 kHz to 80 MHz
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m 3 V/m 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.
NOTE 3: Do not use cables or parts other than those intended for this product.
If cables or parts other than those intended for this product are used, performance
related to electromagnetic immunity may deteriorate.
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-660A is used exceeds the
applicable RF compliance level above, the SSA-660A 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-660A.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

No. 2B771-050EN*G
28-4
Recommended separation distances between portable
and mobile RF communications equipment and the SSA-660A
The SSA-660A is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SSA-660A can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the SSA-660A 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.
NOTE 3: Do not use cables or parts other than those intended for this product.
If cables or parts other than those intended for this product are used, performance
related to recommended separation distances may deteriorate.

(2) Essential performance of this system

The essential performance of this system are described in sections 9, 11, 12, 16,
and 17.

No. 2B771-050EN*G
28-5 *
No. 2B771-050EN*G
A-1
For Europe:
The equipment described in this manual is in accordance with the requirements of the Medical
Device Directive 93/42/EEC.

Zilverstraat 1, 2718 RP
EC REP
Zoetermeer, The Netherlands
TOSHIBA MEDICAL SYSTEMS EUROPE B.V.

For other countries, please contact your local distributor.

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

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

No. 2B771-050EN*G
A-2 E

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