No. 2B730-670E
OPERATION MANUAL FOR DIAGNOSTIC ULTRASOUND SYSTEM
MODEL SSA-530A [FUNDAMENTALS] (2B730-670E)
IMPORTANT! Read and understand this manual before operating the equipment. After reading, keep this manual in an easily accessible place.
TOSHIBA MEDICAL SYSTEMS CORPORATION 2004 ALL RIGHTS RESERVED
Introduction This operation manual describes the operating procedures for the diagnostic ultrasound system SSA-530A. To ensure safe and correct operation of the system, carefully read and understand the manual before operating the system.
IMPORTANT! 1. No part of this manual may be copied or reprinted, in whole or in part, without written permission. 2. The contents of this manual are subject to change without prior notice and without our legal obligation.
No. 2B730-670E C-1
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REVISION RECORD REV.
INI.
DATE (MM/YY)
04/'04
REASON /AUTHOR Mr. Matsumoto
PAGE CHANGED -------
SER. No.
DOC. PRODUCT.
TM-WI2
No. 2B730-670E R-1
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Intellectual Property Availability of This Software and Related Documents is Restricted. The software used for this system is licensed to Toshiba Medical Systems Corporation by a Licensor. (1) The software and related documents must be used only for this system. (2) The intellectual property of this software and related documents is not assigned to you. (3) You must not copy the software or documents, nor modify the software in whole or in part. (4) You must not recompile or reassemble the software. (5) You must not assign, disclose, transfer, or sublicense the software or documents to a third party. (6) The software is subject to the U.S. and Japanese Export Administration Laws and Regulations and you must not export or re-export the software in whole or in part unless properly authorized by the U.S. or Japanese government. (7) The information in the documents, or programs in the software are subject to change without notice.
No. 2B730-670E L-1
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Organization of the Operation Manuals 1.
Notation Conventions
In this operation manual, the following words are used in addition to the signal words related to the safety precautions (refer to "Safety Precautions"). Please read this operation manual before using the system. NOTE:
2.
Indicates information of interest to users of system as to exceptional conditions or operating procedures.
Operation Manuals
A TOSHIBA service person or instructor will explain the basic operating procedures for this system at the time of delivery. However, read this operation manual carefully before using the system in order to understand the detailed operating procedures, functions, performance, and maintenance procedures. The organization of the documents supplied with this system is shown below:
Main unit operation manual
Describes detailed system information on preparation, operating procedures, maintenance checks, and functions.
Transducer operation manuals
Describe the operating and sterilization procedures for transducers.
NOTE:
For certain applications, the following manuals are available in English: • 2B730-672E (Application volume) • 2B730-674E (Acoustic power data)
No. 2B730-670E U-1
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Table of Contents Introduction ......................................................................................................................C-1 Intellectual Property ................................................................................................... L-1 Organization of the Operation Manuals ......................................................U-1 Safety Precautions ......................................................................................................S-1 Important Information ..............................................................................................W-1
Outline of the SSA-530A 1.
Intended Use and Specifications ........................... 1-1
1.1
Intended Use ............................................................................................... 1-1
1.2
Specifications ............................................................................................. 1-1
2.
System Configuration ........................................................... 2-1
2.1
Standard Configuration....................................................................... 2-1
2.2
List of Optional Devices ..................................................................... 2-1
2.3
List of Available Transducers ........................................................ 2-2
3.
System Overview ......................................................................... 3-1
3.1
Name of Each Part .................................................................................. 3-1
3.2
Main Panel..................................................................................................... 3-2
3.3
Side Panel ..................................................................................................... 3-4
3.4
Rear Panel ..................................................................................................... 3-5
3.5
Power Panel ................................................................................................. 3-6
3.6
Symbols .......................................................................................................... 3-7
No. 2B730-670E -a-
Operation 4.
Preparation for Examination ........................................ 4-1
4.1
Moving the System ................................................................................. 4-1
4.2
Connecting the Transducer ............................................................. 4-2
5.
Connecting the Power Cable and Protective Earth ................................................................ 5-1
6.
Power ON/OFF ................................................................................. 6-1
6.1
Power ON ....................................................................................................... 6-1
6.2
Power OFF .................................................................................................... 6-1
6.3
Preparation for Use During an Operation or for Emergency Cases ........................................... 6-2
7.
Checks Before and After Use ..................................... 7-1
7.1
Check Before Turning ON the Power ....................................... 7-1
7.2
Check After Turning ON the Power ............................................ 7-2
8.
Basic Screen and Menu ...................................................... 8-1
8.1
Display of Various Data Items ........................................................ 8-1
8.2
Display and Operation of the Menu ........................................... 8-2
9.
Entering the Patient ID ......................................................... 9-1
9.1
Entering and Saving Data on the Patient ID Registration Screen ...................................................... 9-2
9.2
Sorting and Calling a Patient ID.................................................... 9-4
9.3
Deleting Saved Patient IDs ............................................................... 9-4
No. 2B730-670E -b-
10.
Selecting Presets ....................................................................... 10-1
10.1
Introduction................................................................................................ 10-1
10.2
Procedure for Selecting Presets ................................................ 10-1
11.
Display and Operation in Each Mode ............ 11-1
11.1
B Mode ........................................................................................................... 11-1
11.2
M Mode .......................................................................................................... 11-5
12.
Cine Function.................................................................................. 12-1
12.1
Introduction................................................................................................ 12-1
12.2
Cine Playback ........................................................................................... 12-1
13.
Display of Reference Signals.................................... 13-1
13.1
Display Procedures .............................................................................. 13-1
13.2
Adjustment of Reference Signals .............................................. 13-2
14.
Body Mark Entry and Deletion ................................ 14-1
14.1
Display of a Body Mark ..................................................................... 14-1
14.2
Selection of a Body Mark ................................................................. 14-1
14.3
Movement of the Transducer Mark........................................... 14-2
14.4
Movement of the Body Mark.......................................................... 14-2
14.5
Deletion of the Body Mark............................................................... 14-2
15.
Entry and Deletion of Comments ........................ 15-1
15.1
Entry from the Keyboard .................................................................. 15-1
15.2
Entry of Registered Comments ................................................... 15-1
No. 2B730-670E -c-
15.3
Entry of the Arrow Mark .................................................................... 15-2
15.4
Entry of Gender Symbols ( , ) ................................................... 15-2
15.5
Moving the Selected Comment ................................................... 15-3
15.6
Correcting the Comments ............................................................... 15-3
15.7
Deletion of the Selected Comment ........................................... 15-3
15.8
Deletion of All Comments ............................................................... 15-4
15.9
Initial Cursor Display Position Setting .................................. 15-4
16.
Needle Mark Display .............................................................. 16-1
16.1
Display Method ........................................................................................ 16-3
16.2
Adjustment of the Needle Mark Angle ................................... 16-4
16.3
Display/Hiding of Biopsy Range Marks ................................ 16-4
16.4
Selection of the Biopsy Guide Size .......................................... 16-4
16.5
Selection of the Biopsy Adaptor ................................................ 16-4
Measurements 17.
Measurement ................................................................................... 17-1
17.1
Basic Operation ...................................................................................... 17-1
17.2
B-mode Measurements ..................................................................... 17-2
17.3
M-mode Measurements ..................................................................... 17-3
General Information 18.
Output/Saving of Image Data .................................... 18-1
18.1
Data Archive to a CD-R...................................................................... 18-1
18.2
Data Archive to the DICOM Server ........................................... 18-2
18.3
Loading the Archived Data ............................................................. 18-3 No. 2B730-670E -d-
19.
Other Function .............................................................................. 19-1
19.1
Beep Tone Adjustment ...................................................................... 19-1
19.2
Adjustment of the Panel Backlight ........................................... 19-1
20.
Using MI/TI .......................................................................................... 20-1
20.1
Basic Knowledge of MI/TI ................................................................ 20-1
20.2
MI/TI Display Description ................................................................. 20-3
20.3
Parameters Affecting the MI/TI Values .................................. 20-3
20.4
Operating Procedures for MI/TI ................................................... 20-4
20.5
References for MI/TI ............................................................................. 20-5
21.
Maintenance Check ................................................................ 21-1
21.1
Maintenance Checks to Be Carried Out by Customers ................................................................................. 21-1
21.2
Maintenance Checks to Be Carried Out by Service Personnel ................................................................ 21-3
21.3
Consumable Parts and Parts Requiring Periodic Replacement ............................................... 21-3
22.
Checks Before the System Is Judged Defective ................................................................ 22-1
23.
Accuracy of Measurement ............................................ 23-1
24.
Conformance Standards ................................................. 24-1
25.
Safety Classification ............................................................. 25-1
No. 2B730-670E -e-
26.
Guidance and Manufacturer's Declaration.......................................................................................... 26-1
27.
Indication of Year of Manufacture ...................... 27-1
No. 2B730-670E -f-
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Safety Precautions 1.
Meaning of Signal Words
In this operation manual, the signal words DANGER, WARNING, and CAUTION are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.
Signal word
DANGER
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Indicates a potentially hazardous situation which, if not avoided, may result in property damage.
CAUTION
2.
Meaning
Meaning of Safety Symbols Symbol
Description Type-BF applied part ECG
:
Others :
Type-BF equipment Type-BF when Type-BF applied part is connected. All ultrasound transducers can be connected to this system are Type-BF applied part.
"Attention" (Refer to the operation manual.)
No. 2B730-670E S-1
3.
Safety Precautions
Please observe the following precautions to ensure patient and operator safety when using this system.
DANGER:
WARNING:
Do not use flammable gasses such as anesthetics, or flammable liquids such as ethanol, near this product, because there is danger of explosion.
1. Be sure to connect the power plug to a two-pin (with dual earth terminal) outlet meeting the ratings indicated on the rating nameplate. If this type of outlet is not available, contact your TOSHIBA representative. 2. Information concerning the terminal to which the potential equalization conductor is to be connected (
):
To use another medical device in combination with this system, an equipotential wire for connecting to an equipotential bus must be supplied. For more information, contact your TOSHIBA representative. *
Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle. Also, be sure to remove the equipment power plug from the receptacle before disconnecting the wire to avoid electrical shock.
3. Information concerning the functional earth terminal ( ): Use of the functional earth terminal is not allowed in Europe. The system should be connected according to local requirements. 4. Connect the earth conductor only before turning ON the system. Disconnect the grounding cable only after turning OFF the system. Otherwise, electric shock may result. 5. Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as lifesupport systems. If this system malfunctions and generates an overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped. 6. Do not allow this system or other equipment to come into contact with the patient. If this system or other equipment is defective, the patient may receive an electric shock. 7. Do not connect to the system transducers other than those specified by TOSHIBA, to prevent accidents such as burns, electrical shock, or fire.
No. 2B730-670E S-2
WARNING:
8. Do not subject the transducers to knocks. Use of defective transducers may cause an electric shock. 9. Do not remove the covers or panels of the system, or electric shock may result. 10. Prolonged and repeated use of keyboards can result in hand or arm nerve disorders in some individuals. Observe the local institution work safety/health regulations on keyboard use. 11. When the optional ECG cable is used, the following measures are required. (1) To prevent electric shock, check the following items before operation. • There must be no abnormality of the ECG cable. • The ECG cable must be connected correctly. (2) Connect the ECG cable to the system before attaching the pick-up of the ECG to the patient. If the connector of the ECG cable comes into contact with live parts, the patient may receive an electric shock. (3) Do not place the ECG electrodes in direct contact with the patient's heart. Cardiac arrest may occur. *
The ECG electrodes are of the BF type and are not designed to be placed in direct contact with the heart.
(4) To reduce the risk of electric shock or burns, use only the cable and patient leads supplied with the reference signal unit . (5) The ECG electrodes used should be commercially available products provided by the customer. 12. Before using equipment such as an electric scalpel, highfrequency therapy equipment, a defibrillator, etc., remove the ECG electrodes from the patient. In addition, do not allow ultrasound transducers to come into contact with the patient. The patient may be burned or receive an electric shock. 13. Prepare a backup system when an urgent examination is to be performed, for example during an operation or for an emergency case. If a severe problem should occur with the system, the normal operation of the system may not be recovered by resetting the system and the examination may not be able to continue.
No. 2B730-670E S-3
CAUTION: 1. Precautions concerning clinical examination techniques (1) This system must be used only by medical personnel fully trained in clinical examination techniques. (2) This operation manual does not describe clinical examination techniques. Selection of the proper clinical examination technique must be based on specialized training and clinical experience. 2. Malfunctions due to radiowaves (1) Use of radiowave-emitting devices in the proximity of this kind of medical electronic system may interfere with its operation. Do not bring or use devices which generate radio waves, such as cellular telephones, transceivers, and radio controlled toys, in the room where the system is installed. (2) If a user brings a device which generates radio waves near the system, they must be instructed to immediately turn OFF the device. This is necessary to ensure the proper operation of the system. 3. Precautions concerning installation and movement of the system (1) Be sure to install the system on a level floor and lock the casters. If this is not done, the system may move, injuring the patient. (2) Do not push the system from the side. If the system is pushed from the side, it may fall down and cause injury. (3) When the system is moved over a sloped surface, it must be moved slowly by two persons. Otherwise, the system may slide unexpectedly and cause a serious injury. (4) Do not sit on the system. The system may move, causing you to lose your balance and fall. (5) Do not place any objects on top of the monitor. They may fall, causing injury. (6) Confirm that the peripheral units are secured before moving the system. Otherwise, the peripheral units may fall and cause injury. (7) If the ECG cable is connected, disconnect it before moving the system. Otherwise, the cable may get caught in the casters or someone may trip over the cable and injury may result. (8) When the system is moved over a step, be careful not to allow the system to fall. When holding the system at the bottom to help move it over a step, take special care to prevent hand injuries.
No. 2B730-670E S-4
CAUTION: 4. To prevent electric shock, do not connect the peripheral units (video printer, VCR, etc.) to an external outlet (except for Deskjet series printers). Peripheral units should be connected to the service outlet of the system. For the connection procedures, contact your TOSHIBA representative. In addition, be sure to use the cable supplied with the system to connect a Deskjet series printer. If a different cable is used, there is a risk of electric shock. 5. Before cleaning the system, be sure to disconnect the power cable from the outlet. If the system is defective, there is a risk of electric shock. 6. Do not allow fluids such as water to contact the system or peripheral devices. Electric shock may result. 7. Terminals and switches on the system rear panel (1) Only equipment that conforms to the safety standards must be connected to the ETHERNET terminal on the rear panel. Otherwise, smoke or an electric shock may result. (2) Turn OFF the system power before connecting or disconnecting the cable from the ETHERNET terminal. If the cable is connected or disconnected with the system power ON, the system may not operate properly. (3) When a HUB is used, turn ON the system power only after tuning ON the power to the HUB. (4) Do not press the RESET switch when the system is operating normally. Data loss or damage to the system may result. 8. In normal diagnostic ultrasound mode, there is no danger of a lowtemperature burn; however, keeping the transducer on the same region of the patient may cause such a burn. 9. If there is any possibility of secondary infection, cover the entire system with a sterile cover. To obtain a sterile cover, contact your TOSHIBA representative.
No. 2B730-670E S-5
CAUTION: 10. Precautions regarding patient information entry (1) Before examining a new patient, press
to delete the
patient information and data recorded in the image memory for the previous patient. Otherwise, the new data may be confused with the data of the previous patient. (2) If the patient information is modified by pressing
PATIENT ID
, the
patient information for the data already recorded in the image memory is not modified (the data recorded in the image memory is not deleted). Thus, if the data recorded in the image memory is that for the previous patient, images for the different patients will have the same patient information, and this may cause confusion. It a patient ID is to be changed, press
to delete the patient
information and data recorded in the image memory for the previous patient. Otherwise, the data belonging to the current patient may be confused with the data for the previous patient. (3) Confirm that the patient to be examined is the same as the patient ID. There is a possibility of recording images with incorrect patient IDs. (4) Enter the patient's height and weight correctly in the patient ID registration screen. If the entered height and weight are not correct, the BSA will be calculated incorrectly. (5) Enter the patient information including LMP and IVF correctly in the patient ID registration screen. Otherwise, the fetal growth data will be calculated incorrectly. 11. Do not turn OFF the power supply of the system during printing, data saving, or invoking. Doing so may cause these processes to not operate correctly. In addition, doing so during access to a CD-R or an HDD may damage these media. 12. When discarding any part of this system, follow all applicable local regulations.
No. 2B730-670E S-6
CAUTION: 1. Do not use this system in locations subject to intense electric or magnetic fields (near transformers, for example). In such locations, the monitor will be adversely affected. 2. Do not use this system near devices generating high frequencies (such as medical telemeters and cordless telephones). The system can malfunction or adversely affect such devices. 3. To prevent damage to the system, do not use it in: • • • • • • •
Locations where it may be exposed to direct sunlight Locations where it may be subject to sudden changes in temperature Locations that are dusty Locations where it may be subjected to vibrations Locations near heat generators Locations where the humidity may be high Locations where the air filter of the system is blocked (for example, near a wall or another unit)
4. Turn ON the system only after the power has been OFF for more than 5 seconds. If the system is turned ON immediately after being turned OFF, the system may malfunction. 5. Turn OFF the system subswitch or stop transmission by FREEZE switch before connecting or disconnecting a transducer. If a transducer is connected or disconnected with an image displayed, the system and/or the transducer may malfunction. 6. The user can record ID registration and user registrations (with a function to permit user-specific items such as the hospital name to be registered). Be sure to back up such information on external storage media. Data stored in the system may be lost due to improper operation or an accident. 7. Move the system by the handle. If the user pushes or pulls other sections, the system may be damaged. 8. Do not press or use force on the main panel. It may damage the system. 9. If this system is used in a small room, it may cause the room temperature to rise. Proper ventilation must be provided. 10. Do not connect or disconnect a printer from the Deskjet series when the system power is ON. The printer may become defective. 11. The air filter at the left of the system must be cleaned once every 6 months. If the air filter is clogged, the internal temperature will rise, shortening the service life of the system. For inspection and cleaning by service personnel, contact your TOSHIBA representative. 12. Deterioration of electrical and mechanical safety characteristics (such as generation of a leakage current or deformation/abrasion of mechanical parts) and of image sensitivity and resolution may occur over a period of time. A maintenance service contract is recommended to avoid accidents and erroneous diagnosis and to maintain system performance. 13. Manage the system properly to prevent it from being infected with computer viruses.
No. 2B730-670E S-7
4.
Warning Labels
Various warning labels are attached to this system in order to call the user's attention to potential hazards. on the warning labels attached to the system indicates safety precautions. * The symbol The warning labels use the same signal words as used in the descriptions in the operation manuals. * Detailed information about the warning labels is given in the main body of this operation manual. Read the operation manual carefully before using the system. The name, appearance, indication, and location of each warning label is as follows. <>
<3>
<1> <2>
No.
Label
Meaning
<1>
(a) Cautions against sitting on the system. (b) Precautions regarding the registration of panel switches (a)
(b)
<2>
(a) Urges caution related to handling of the transducers. For handling of the transducers, refer to the transducers’ operation manual. (a)
(b)
<3>
(b) Cautions that the system must not be used around flammable gasses. (a) Cautions that the system must be placed on a horizontal surface. (b) Cautions that the cover must not be removed in order to prevent electric shock.
(a)
(b)
No. 2B730-670E S-8
<>
<3>
<1> <2>
No. <1>
Label
Meaning (a) Cautions against sitting on the system.
(b) Precautions regarding the registration of panel switches
<2>
(a) Cautions that the system must not be used around flammable gasses.
(b) Urges caution related to handling of the transducers. For handling of the transducers, refer to the transducers’ operation manual. <3>
(a) Cautions that the system must be placed on a horizontal surface.
(b) Cautions that the cover must not be removed in order to prevent electric shock.
No. 2B730-670E S-9
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Important Information 1.
The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product.
2.
The warranty does not cover the following items, even during the warranty period: (1) Damage or loss due to misuse or abuse. (2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc. (3) Damage or loss caused by failure to meet the specified conditions for this system, such as inadequate power supply, improper installation, or unacceptable environmental conditions. (4) Damage or loss due to mobile use in a vehicle which is not authorized by TOSHIBA. (5) Damage or loss due to use outside the territory in which the system was originally sold. (6) Damage or loss involving system purchased from a source other than TOSHIBA or its authorized distributors or agents.
3.
This system shall not be used by persons other than fully qualified and certified medical personnel.
4.
Do not make changes or modifications to the software or hardware of this product.
5.
In no event shall TOSHIBA be liable for problems, damage, or loss caused by relocation, modification, or repair performed by personnel other than those designated by TOSHIBA.
6.
The purpose of this system is to provide physicians with data for clinical diagnosis. The responsibility for diagnostic procedures lies with the physicians involved. TOSHIBA shall not be liable for the results of diagnostic procedures.
7.
Important data must be backed up on external recording media such as clinical records, notebooks, or CD-R.
8.
TOSHIBA shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents.
9.
This manual contains warnings regarding foreseeable potential dangers. Be alert at all times to dangers other than those indicated.
10.
TOSHIBA shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions contained in this operation manual.
11.
On the occasion of change of the administrator or manager for this system, be sure to hand over this operation manual.
12.
When disposing of this system, contact your TOSHIBA representative. Do not dispose of this system without consulting TOSHIBA representative first. TOSHIBA does not assume any responsibility for damage resulting from disposal of this system without consulting TOSHIBA.
No. 2B730-670E W-1
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1. Intended Use and Specifications 1.1
Intended Use (1) This system provides high-quality ultrasound images in B mode and M mode. (2) Transducers have their own characteristic applications. However, this system allows transducers to be used for regions other than those specified as applicable, because this system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment. For the transducers that can be used with this system and their applications, refer to subsection 2.3 "List of Available Transducers".
1.2
Specifications (1) Power (a) Line voltage
:
100 VAC ±10% 120 VAC ±10% 100 VAC to 127 VAC ±10% 220 VAC to 240 VAC ±10%
(b) Line frequency
:
47 Hz to 63 Hz
(c) Power consumption
:
Maximum 600 VA (including external devices) (100 V, 120 V, and 100 V to 127 V system) Maximum 580 VA (including external devices) (220 V to 240 V system)
(2) Operating environmental conditions (a) Ambient temperature :
10°C to 35°C
(b) Relative humidity
35% to 85% (no condensation)
:
(c) Atmospheric pressure :
700 hPa to 1060 hPa
(3) Storage and transportation conditions (a) Ambient temperature :
-10°C to 55°C
(b) Relative humidity
30% to 85% (no condensation)
:
(c) Atmospheric pressure : NOTE:
700 hPa to 1060 hPa
The line voltage differs depending on the area.
(4) External dimensions and mass (not including optional units) (a) External dimensions :
420 mm wide × 630 mm deep × 1260 or 1300 mm high
(b) Mass
Approx. 73 kg
:
No. 2B730-670E 1-1
*
2. System Configuration 2.1
Standard Configuration (1) Main unit (2) Monitor (3) Accessories • Transducer cable hanger • Transducer holder • Operation manual
2.2
List of Optional Devices The following list is accurate and complete at the time of printing. Due to constant developments, certain products may change or be no longer available at a later stage. For an up-to-date overview of available options, please consult your TOSHIBA representative. The following optional devices are available with this system. No.
Item
Model
1
Reference signal unit
UJUR-530A
2
VCR installation kit
UZRI-530A
3
DICOM kit
USDI-530A
4
Footswitch
UZFS002A
5
VCR
SVO-9500MD (SONY/NTSC) SVO-9500MDP (SONY/PAL)
6
Black-and-white printer
UP-895MD (SONY) P91W (MITSUBISHI) TP-8010 (MITSUBISHI)
7
Printer
Deskjet 5650/5652 (HP)
* It may not be possible to use some of the peripheral devices listed above depending on the power conditions of the country. For details, contact your Toshiba representative.
No. 2B730-670E 2-1
2.3
List of Available Transducers Transducer name
Indications for use
PLF-308P
Abdominal, intraoperative, pediatric
PLQ-805A
Peripheral vascular, small organ, musculoskeletal
PLQ-1203A
Peripheral vascular, small organ, musculoskeletal
PVQ-375A
Abdominal, fetal, pediatric
PVQ-381A
Abdominal, fetal, pediatric cardiac, neonatal cephalic
PVQ-641V
Endocavitary
PVQ-662A
Abdominal, pediatric, neonatal cephalic
PVF-738F
Abdominal, small organ, intraoperative
PVF-738H
Abdominal, small organ, intraoperative
PVF-745V
Abdominal, small organ, intraoperative
PVF-715R
Endorectal
No. 2B730-670E 2-2
*
3. System Overview 3.1
Name of Each Part
Monitor Transducer cable hanger Transducer holder
Main panel
CD-R drive Transducer connector
Side panel
Caster
Handle
Subswitch Rear panel
Power panel
* Before disconnecting the power cable of the system from the commercial power supply, turn OFF the sub switch, wait until the screen display disappears, and then turn OFF the main switch on the power panel.
No. 2B730-670E 3-1
3.2
Main Panel <1>
<2>
<3>
<4>
<5>
PRESET PATIENT ID
A
<6>
TRANSDUCER
B
C
STANDBY
A/B
HDD
<7>
ACOUSTIC POWER
1
2
3
Q A
<8> Ctrl
W S
Z
Shift
4
5
E D
X
6
R F
C
7
T
Y
G V
8
H B
9
U J
N
BS
0
I
O
K
P
L
M
Alt
Alt
<11>
Ins
Del
<12> <13> <14> <17>
<10>
<19>
THI / FREQ
IP
F-POSI
<15> <16>
<9>
<26> <22>
<20>
<23>
<24> <25>
<21> B
No.
<18>
<27> <28>
GAIN
Name
Function
<1> ACOUSTIC POWER Adjusts the ultrasonic beam output. <2> NEW PATIENT
Deletes the data for the previous patient, including the ID and measured values, and resets the system.
<3> PATIENT ID
The patient ID registration screen appears.
<4> PRESET
Invokes the registered initial settings (presets).
<5> TRANSDUCER
Selects a transducer.
<6> STANDBY/HDD
The STANDBY LED blinks when the main switch is ON and the subswitch is OFF (standby status). The HDD LED blinks when the HDD is being accessed.
<7> STC
Adjusts the ultrasound echo reception sensitivity according to the depth from the body surface.
<8> Keyboard
Used to enter characters and symbols Shift
+ alphabetic character keys;
Lowercase letters can be entered. Shift
+ keys other than alphabetic character keys );
(such as
The symbol in the upper row can be entered. <9> MENU
Displays a menu according to the system status.
<10> Body mark
Permits entry of body marks.
No. 2B730-670E 3-2
No.
Name
Function
<11> Multifunctional dial
Used for editing measurements. Also used to adjust the angle of the needle mark, input auto annotation, and rotate the transducer mark on the body mark.
<12> IP
Adjusts the image quality according to the registered image conditions.
<13> M+B
Displays B-mode and M-mode simultaneously.
<14> M
Displays M-mode images in full screen mode.
<15> B single
Displays a standard (single) B-mode image.
<16> B dual
Displays two B-mode images side by side.
<17> THI/FREQ
Switches the transmission/reception frequencies. When a transducer that supports THI mode is used, this switch is also used to set the system in THI mode.
<18> DEPTH/ZOOM
Adjusts the viewing depth for display of the ultrasound images. Every time this dial is pressed, the function is switched between DEPTH and ZOOM.
<19> F-POSI
Adjusts the focus position.
<20> OUTPUT B
Controls assigned output device (such as VCR or blackand-white printer).
<21> OUTPUT A
Controls assigned output device (such as VCR or blackand-white printer).
<22> CINE
Sets the trackball to image memory control mode.
<23> SET
Determines the cursor position for measurement, and determines the selected items, etc.
<24> Trackball
Moves the cursor or mark during image movement or measurement.
<25> GAIN
Adjusts the sensitivity of black/white images. Also used to play back the cine loop.
<26> NEXT
Moves the cursor to the next position during measurement, selected items, etc.
<27> STILL REVIEW
No function is registered to this switch at the time of shipment.
<28> FREEZE
Freezes and unfreezes the image.
NOTE:
User function switches User function switches are switches to which other functions can be registered. These include switches to which functions have already been assigned and switches to which no functions are registered, such as the switch. For details, contact your TOSHIBA representative. * To check the functions registered to the user function switches, select [Panel View] from the [Other] menu.
No. 2B730-670E 3-3
3.3
Side Panel NOTE:
The ECG input is optional.
ECG
GAIN
ECG gain
POSI.
ECG position
PATIENT
Input terminal for ECG lead
FOOT SW
A
For connection of the footswitches B
No. 2B730-670E 3-4
3.4
Rear Panel CAUTION: 1. Only equipment that conforms to the safety standards must be connected to the ETHERNET terminal on the rear panel. Otherwise, smoke or an electric shock may result. 2. Turn OFF the system power before connecting or disconnecting the cable from the ETHERNET terminal. If the cable is connected or disconnected with the system power ON, the system may not operate properly. 3. When a HUB is used, turn ON the system power only after tuning ON the power to the HUB.
<1> VIDEO
<2>
<3>
PARALLEL
REMOTE
<5> SERIAL
OUT
<4> RESET
<6> ETHERNET
IN
No.
Name
Functions
<1>
VIDEO
External video device input/output terminals
<2>
PARALLEL
Parallel ports
<3>
REMOTE
Printer connection terminals
<4>
RESET
System reset switch
<5>
SERIAL
Serial ports
<6>
ETHERNET
Terminal for digital data transfer
No. 2B730-670E 3-5
3.5
Power Panel NOTE:
The voltage and current indications of the AC line differ depending on the area.
<1>
<2>
<3>
<4>
FUSE 250V T4.0A
100V TOTAL MAX. 264VA (ISOLATED/SWITCHED)
100V 50/60Hz 600VA
<5>
No.
<6>
Name
Functions
<1>
FUSE
Fuse
<2>
Main switch
This is a circuit breaker.
<3>
Functional earth terminal
Terminal for the functional earth cable.
<4>
Equipotential terminal
Terminal for the potential equalization conductor.
<5>
Outlet
Connector for peripheral devices.
<6>
Inlet
Connector for the power cable.
No. 2B730-670E 3-6
3.6
Symbols This system uses the following symbols. For safety symbols, refer to page S-1. Symbol
Description Functional grounding Equipotentiality Main switch OFF (The AC power is turned OFF.) Main switch ON (The AC power is turned ON.) Subswitch OFF (The power to electronic circuits is turned OFF: Standby status) Subswitch ON (The power to electronic circuits is turned ON.)
TRANSDUCER A TRANSDUCER B
ECG FOOT SW
Transducer connector A Transducer connector B Electrocardiogram (option) Footswitch AC (Alternating current) The device fully complies with European Directive 93/42/EEC.
No. 2B730-670E 3-7
*
4. Preparation for Examination 4.1
Moving the System CAUTION: 1. Be sure to install the system on a level floor and lock the casters. If this is not done, the system may move, injuring the patient. 2. Do not push the system from the side. If the system is pushed from the side, it may fall down and cause injury. 3. When the system is moved over a sloped surface, it must be moved slowly by two persons. Otherwise, the system may slide unexpectedly and cause a serious injury. 4. Do not sit on the system. The system may move, causing you to lose your balance and fall. 5. Do not place any objects on top of the monitor. They may fall, causing injury. 6. Confirm that the peripheral units are secured before moving the system. Otherwise, the peripheral units may fall and cause injury. 7. If the ECG cable is connected, disconnect it before moving the system. Otherwise, the cable may get caught in the casters or someone may trip over the cable and injury may result. 8. When the system is moved over a step, be careful not to allow the system to fall. When holding the system at the bottom to help move it over a step, take special care to prevent hand injuries.
CAUTION: Observe the following precautions before moving the system to prevent system malfunctions. 1. Turn OFF the subswitch and the main switch on the power panel on the rear of the system. 2. Store the transducer in the transducer holder and hang the cable on the transducer cable hanger. 3. When moving the system, use the handle. Do not push weak sections such as the panel. (1) Unlock the four casters. (2) Move the system using the handle. (3) When the system is in the desired position, lock the four casters.
No. 2B730-670E 4-1
4.2
Connecting the Transducer CAUTION:
Turn OFF the system subswitch or stop transmission by FREEZE switch before connecting or disconnecting a transducer. If a transducer is connected or disconnected with an image displayed, the system and/or the transducer may malfunction.
(1) Connect the transducer and turn the lock handle clockwise to lock the connector. (2) When disconnecting the transducer, turn the lock handle counterclockwise to unlock the connector and then hold the connector and pull it straight out.
Lock Lock handle
No. 2B730-670E 4-2
*
5. Connecting the Power Cable and Protective Earth WARNING:
1. Be sure to connect the power plug to a two-pin (with dual earth terminal) outlet meeting the ratings indicated on the rating nameplate. If this type of outlet is not available, contact your TOSHIBA representative. 2. Information concerning the terminal to which the potential equalization conductor is to be connected (
):
To use another medical device in combination with this system, an equipotential wire for connecting to an equipotential bus must be supplied. For more information, contact your TOSHIBA representative. *
Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle. Also, be sure to remove the equipment power plug from the receptacle before disconnecting the wire to avoid electrical shock.
3. Information concerning the functional earth terminal (
):
Use of the functional earth terminal is not allowed in Europe. The system should be connected according the local requirements. 4. Connect the earth conductor only before turning ON the system. Disconnect the grounding cable only after turning OFF the system. Otherwise, electric shock may result. 5. Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life-support systems. If this system malfunctions and generates an overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped. Connect the power plug to an outlet for medical equipment. By doing this, the protective earth line is connected.
Protective earth terminal
No. 2B730-670E 5-1
*
6. Power ON/OFF 6.1
Power ON (1) Check the items below before turning the power ON. • The power cable should be connected. • One or more transducer should be connected. (2) Turn ON the main switch on the power panel on the rear of the system. The STANDBY LED blinks. (3) Turn ON the subswitch. Some time after the setup screen is displayed, the B-mode screen appears. (4) If required, adjust the brightness ( corresponding knobs on the monitor. (a) Set the contrast (
) and contrast (
) using the
) to minimum. The image disappears.
) so that the brightness level of the screen is the (b) Adjust the brightness ( same as in the examination room. (c) Then adjust the contrast ( NOTE:
6.2
) to set the maximum luminance.
When this system is started up or another transducer is selected, you may hear a click. This does not indicate abnormality.
Power OFF CAUTION: Do not turn the system power OFF while a CD-R disk or HDD is being accessed. If the system power is turned OFF during access to the CD-R disk or HDD, the disk may be damaged and recorded data may be lost. (1) Before turning OFF the system, confirm that the CD-R or HDD is not being accessed. (2) Turn OFF the subswitch. The STANDBY LED blinks. (3) When the system is not going to be used for an extended period of time, turn OFF the main switch on the power panel and disconnect the power plug.
No. 2B730-670E 6-1
6.3
Preparation for Use During an Operation or for Emergency Cases WARNING:
Prepare a backup system when an urgent examination is to be performed, for example during an operation or for an emergency case. If a severe problem should occur with the system, the normal operation of the system may not be recovered by resetting the system and the examination may not be able to continue.
6.3.1 Preparation of a backup system Prepare a backup system when an urgent examination is to be performed, for example during an operation or for an emergency case.
6.3.2 Power OFF/ON in the case of system failure When any of the following abnormalities occurs with the system, the system may be able to recover from the abnormality by pressing the RESET switch. • An error message is displayed and does not disappear. • The screen display is abnormal. • The system operations are disabled. Follow the steps below to reset the system. (1) Press the main switch on the power panel. (2) Wait at least 5 seconds, and then turn ON the main switch. The system is restarted. (3) If the system is still abnormal even after power OFF/ON, use the backup system.
No. 2B730-670E 6-2
*
7. Checks Before and After Use In the interests of safety, it is the user's responsibility to carry out the following checks before and after using the system.
7.1
Checks Before Turning ON the Power Before turning ON the power, perform the following checks.
No.
Check item
Check column
1
The temperature, humidity, and atmospheric pressure should meet the conditions of use.
2
There should be no condensation.
3
There should be no deformation, damage, or stains to the system and peripheral units.
* If any stains are present, perform cleaning referring to subsection 21.1.1 "Cleaning the system". 4
There should not backlash or loose screws in the casters, monitor, panel, etc.
5
Caster locks should function correctly.
6
There should be no damage to cables (power cable, ECG cable etc.) and no looseness in the connectors.
7
There should be no damage or stains to the transducer and transducer cables.
* If any stains are present, perform cleaning, disinfection, or sterilization referring to the operation manual provided with the transducer. 8
No clips etc. are placed on the main panel.
9
There should be no obstacles near the movable sections and air filter of the system.
No. 2B730-670E 7-1
7.2
Checks After Turning ON the Power After turning ON the power, perform the following checks.
No.
Check item
Check column
1
There should be no abnormal sound, unusual smells, or overheating.
2
No error message is displayed.
3
There should be no obviously abnormal noise, discontinuous display, or dark areas for B-mode images.
4
There should be no abnormality in the date and time.
5
The acoustic lens surface of the transducer should not be unusually hot. (Perform check by hand.)
6
Switches and knobs on the panel should function normally.
7
There should be no abnormality in the color or display position of images output on a printer or recorded on a VCR.
No. 2B730-670E 7-2
*
8. Basic Screen and Menu 8.1
Display of Various Data Items In addition to ultrasound images, various data items are displayed on the monitor. This section describes the screen display common to all modes. Refer to section 11 "Display and Operation in Each Mode" for the display specific to each mode. Patient ID
Scanning direction
Heart rate Preset name
Hospital name
TOSHIBA
123456789012 ABCDEF
999
Abdominal 9.9C9.9 100%
Date Time 2004/03/16 PM 07:05:43
0
Transducer frequency Acoustic power 5
Focus mark Image Process (1) MI (2) TIS (3) TIB (4) TIC
IP MI 10 9.9 TIS 9.9 TIB 9.9 TIC 9.9 9.9M
999 fps
BG99
DR99
B frequency Current B gain Dynamic frame rate range value
0:00:00
VCR
(1) MI (Mechanical Index) This is a measure of the mechanical effects such as cavitation. (2) TIS (Thermal Index Soft Tissue) This is a measure of the calculated/estimated rise in temperature of soft tissues. (3) TIB (Thermal Index Bone) This is a measure of the calculated/estimated rise in temperature of the cranial bone of fetuses/infants. (4) TIC (Thermal Index Cranial) This is a measure of the calculated/estimated rise in temperature of the cranial bone of children/adults.
No. 2B730-670E 8-1
8.2
Display and Operation of the Menu The functions not available on the panel are displayed in the menu. The menu should be displayed when required. (1) Press
MENU
. The menu appropriate for the current display mode is displayed.
Functions that cannot be selected or switched in the menu are displayed in gray. (a) Movement of the menu display position The menu can be moved to the left or right by operating the trackball to the left or right. (b) Display of other menus Move the cursor to the top of the menu and then move the trackball slightly to the left or right, depending on the position in which the menu is displayed. A pull-down menu, which can be used to select other menus, is displayed. Select the menu to be displayed and press
SET
.
Top of the menu B Focal Ptn Density DR Time Smth Axial Smth LateralSmth Mid Filter E.Enhance AGC PostProcess Reject L/R U/D Rotation Scan Rang High Frame
B M Other
Needle
(2) Operate the trackball up and down to move the cursor to the desired item.
No. 2B730-670E 8-2
(3) Press
on the main panel.
SET
• For an item with only ON and OFF options The item toggles between ON and OFF each time
SET
is pressed.
• For an item with several options When
SET
is pressed or the trackball is slightly moved laterally, a pull-down
menu appears next to the menu. Select the desired item by operating the trackball and then press
.
SET
mark on the right of an item indicates that other pull-down menus or pages exist. (4) To close the menu, press
MENU
.
No. 2B730-670E 8-3
*
9. Entering the Patient ID CAUTION: Observe the following precautions to avoid erroneous diagnosis. 1. Before examining a new patient, press
to delete the
patient information and data recorded in the image memory for the previous patient. Otherwise, the new data may be confused with the data of the previous patient. 2. If the patient information is modified by pressing
PATIENT ID
, the
patient information for the data already recorded in the image memory is not modified (the data recorded in the image memory is not deleted). Thus, if the data recorded in the image memory is that for the previous patient, images for the different patients will have the same patient information, and this may cause confusion. It a patient ID is to be changed, press
to delete the
patient information and data recorded in the image memory for the previous patient. Otherwise, the data belonging to the current patient may be confused with the data for the previous patient. 3. Confirm that the patient to be examined is the same as the patient ID. There is a possibility of recording images with incorrect patient IDs. 4. Enter the patient's height and weight correctly in the patient ID registration screen. If the entered height and weight are not correct, the BSA will be calculated incorrectly. 5. Enter the patient information including LMP and IVF correctly in the patient ID registration screen. Otherwise, the fetal growth data will be calculated incorrectly.
No. 2B730-670E 9-1
9.1
Entering and Saving Data on the Patient ID Registration Screen (1) Press (2) Press
to initialize the system. PATIENT ID
. The patient ID registration screen appears. Patient Data Input 2004/03/16
ID Number
AM06:54:47
Name Date of Birth Sex
(YYYY/MM/DD) Male
Female
Height
cm
Weight
kg
BSA
m2
Blood Pressure High/Low LMP
PRV
EDD
IVF
Age
Unknown
ADULT /
mmHg
CLN
Comment ABC
ID List Used:
10
Free:
ID Save
1990 Total:
2000
Close
(3) Enter the appropriate patient information in the fields. • In the "Date of Birth" field, enter the date using the same format as the current date displayed at the top right of the screen. When the date of birth is entered, the age is calculated automatically and displayed in the "Age" field. It is also possible to type a value directly in the "Age" field. • When the height and weight are entered, the BSA (body surface area) field is automatically filled with a calculated value. • Depending on the preset menu setting, the BP fields and options for obstetric data may not be displayed. • When one of [LMP], [PRV], [EDD], [IVF], or [CLN] is selected and the Enter key is pressed, the screen for entering the date and the number of weeks appears. On this screen, enter the date. (4) After the data has been entered, press [ID Save]. A confirmation dialog is displayed. Select [OK] to save the data. (5) When [Close] is selected, the system returns to normal ultrasound image display.
No. 2B730-670E 9-2
NOTE:
(1) Units of height and weight The units of height and weight differ depending on the setting of "Entry System" in the preset menu. (a) Metric ............ "cm" and "kg" (b) English .......... "feet", "inch", "lb", or "cm", "kg" (2) Formula for body surface area The formula differs depending on the setting of "Calculation" in the preset menu. (a) Oriental • ADULT
:
BSA = WT0.425 * HT0.725 * 73.58 / 10000
• PEDI 12-14 :
BSA = WT0.423 * HT0.651 * 102.65 / 10000
• PEDI 6-11
:
BSA = WT0.444 * HT0.663 * 88.83 / 10000
• PEDI 1-5
:
BSA = WT0.423 * HT0.362 * 381.89 / 10000
• PEDI 0
:
BSA = WT0.473 * HT0.655 * 95.68 / 10000
:
BSA = WT0.425 * HT0.725 * 71.84 / 10000
(b) Occidental • ADULT HT : WT :
Height (cm) Weight (kg)
No. 2B730-670E 9-3
9.2
Sorting and Calling a Patient ID (1) Press [ID List] on the patient ID registration screen. The list of patient IDs saved in the system is displayed in ascending order of ID number. ID List No. 1 2 3
ID 111 123 222
Select
Name AAA BBB CCC
Delete
Delete All
Sort key ID:
Name:
EDD (YYYY/MM/DD)
EDD
Used:
3
Free:
1997
Total:
2000 Close
(2) When the button for "ID", "Name", or "EDD" is selected in the [Sort Key] field, the patient ID numbers are sorted according to the selected condition. (3) Select the desired patient data item and select [Select] or move the cursor to the desired patient data and press
SET
twice. The patient data is displayed on the
Patient ID Registration screen.
9.3
Deleting Saved Patient IDs (1) To delete a patient ID (a) Using the trackball, select the patient ID to be deleted. (b) Press [Delete]. (c) Select [OK] on the deletion confirmation screen. The patient ID data is deleted. (2) To delete all the saved patient IDs (a) Press [Delete All]. (b) Select [OK] on the deletion confirmation screen. All the saved patient ID data is deleted.
No. 2B730-670E 9-4
*
10. Selecting Presets 10.1 Introduction In this system, 12 types of initial settings can be saved for examinations. These initial settings are called presets. The examination presets can be selected by pressing the PRESET switch on the main panel.
10.2 Procedure for Selecting Presets When * When
or
A
C
B
is pressed, the corresponding preset is selected.
is pressed, the Exam Select menu is displayed. The desired preset can
be selected from the displayed list by using the trackball and
SET
.
Exam Select ABDOMINAL1 ABDOMINAL2 OB/GY1 OB/GY2 S-PARTS1 S-PARTS2 PV Cardiac PROSTATE 10 11 12
PRESET
Display example
No. 2B730-670E 10-1
*
11. Display and Operation in Each Mode 11.1 B Mode (1) Entering B single mode Press
B
.
(2) Entering B dual display mode Press
DUAL
.
No. 2B730-670E 11-1
(3) Adjustment on the panel
PRESET PATIENT ID
A
TRANSDUCER
B
C
A/B
STANDBY HDD
ACOUSTIC POWER
1
2
3
Q A Shift
Ctrl
4
W S
Z
5
E D
X
6
R F
C
7
T G
V
8
Y H
B
Alt
9
U J
N
BS
0
I
O
K
P
<3>
L
M Alt
Ins
Del
<4>
<2>, <6> <5> THI /FREQ
IP
F-POSI
<7>
<1> <8> B
GAIN
Adjustment items <1>
Procedures Use the GAIN dial of the palm controller.
Sensitivity of the entire image Gain 2D
<2>
GAIN
Field depth
Use the DEPTH/ZOOM dial. * When the ZOOM LED is lit, hold down the dial to light the DEPTH LED. DEPTH ZOOM
<3>
Sensitivity according to the depth
Use the STC slide controls.
<4>
Calls up registered image-quality conditions.
Use IP to select the desired image-quality conditions.
IP
<5>
Switches the focus position.
Use F-POSI to switch the focus position.
F.POSI
No. 2B730-670E 11-2
Adjustment items <6>
Procedures Use the DEPTH/ZOOM dial and the trackball.
Magnification, reduction, and movement of the image (PAN/ZOOM)
(1) When the DEPTH LED is lit, hold down the dial to light the ZOOM LED. (2) When the dial is turned, the image is magnified/reduced. When the trackball is operated, the image moves.
DEPTH ZOOM
<7>
(3) When the dial is held down again, the system quits PAN/ZOOM and the DEPTH function is selected.
Switches the transmission/reception frequencies or switches to THI mode
Switches the transmission/reception frequencies. When a transducer that supports THI mode is used, this switch is also used to set the system in THI mode.
THI/FREQ
<8>
Freeze the image (to a still image). FRZ
Press
FRZ
. When it is pressed again, the
frozen image is restored to a real-time image.
No. 2B730-670E 11-3
(4) Adjustment using the menu When
MENU
is pressed, the B menu is displayed.
Automatically sets the focus of the ultrasound beam. Increases image sharpness. Adjust the dynamic range. B Focal Ptn Density DR Time Smth Axial Smth LateralSmth Mid Filter E.Enhance AGC PostProcess Reject L/R U/D Rotation Scan Rang High Frame
Adjusts the image smoothness. Adjusts the image smoothness in the axial direction. Adjusts the image smoothness in the lateral direction. Selects the filter type. Enhances the edge of the image. Suppresses comet-tail and reduces noise. Adjusts the image display intensity. Reduces noise at the low brightness level. Displays the image right-left reversed. Displays the image top-bottom inverted. Rotates the image in 90° steps. Sets the field angle (field width).
Needle
Sets the High Frame function ON/OFF. Displays the needle mark for biopsy procedures.
No. 2B730-670E 11-4
11.2 M Mode (1) Entering M mode Press
M
.
(2) Entering M + B mode Press
B M+B
.
(3) Setting the M mark (a) Enter M + B mode. The M mark is displayed on the B-mode image. (b) Move the M mark display position using the trackball. (4) Adjustment on the panel Refer to page 11-2.
No. 2B730-670E 11-5
(5) Adjustment using the menu When
MENU
is pressed, the M menu is displayed.
Adjusts the sweep speed of the M-mode image. Adjusts the dynamic range. M M Speed M DR M Gain Cmp M E.Enhance M AxialSmth M Time Mark M Time Smth M Post Proc M AGC M Max Smple
Adjusts the sensitivity of the M-mode image. Enhances the edge of the image. Adjusts the image smoothness in the axial direction. Turns ON/OFF the Time mark display for the M image area. Adjusts the image smoothness. Adjusts the image display intensity. Suppresses comet-tail and reduces noise. Selects the Max Sampling pattern.
No. 2B730-670E 11-6
*
12. Cine Function 12.1 Introduction CAUTION: When performing examination of a new patient, press
to
delete the recorded data in the image memory. Otherwise, the new data may be confused with the data of the previous patient. When an image is frozen, the images immediately before the frozen image can be played back and edited. This function is called Cine. Cine images are cleared by turning OFF the power or unfreezing the frozen image.
12.2 Cine Playback (1) Press
to freeze the image.
FRZ
(2) When the trackball is operated, the system enters frame-advance playback mode. • Operate the trackball to the right for forward playback. • Operate the trackball to the left for reverse playback. * For M-mode images, the trackball operation is opposite to the above. (3) When the trackball dial (the dial around the trackball) is turned during frameadvance playback, the system enters continuous playback mode. The playback speed can be changed using the dial. • Operate the dial clockwise to increase the playback speed. • Operate the dial counterclockwise to decrease the playback speed. When the trackball is operated, the system returns to frame-advance playback mode. (4) Continuous playback edit function (setting of the playback range) It is possible to set the start frame and end frame for continuous playback in frameadvance playback mode. (a) Operate the trackball to display the start frame of the playback range and press
SET
.
(b) Operate the trackball to display the end frame and press
NEXT
.
(c) Turn the trackball dial. The images between the specified start and end frames are played back continuously.
No. 2B730-670E 12-1
*
13. Display of Reference Signals Electrocardiographic (ECG) reference signals can be displayed during B-mode display, B Dual mode display, M-mode display, and M+B mode display. This function is optional.
WARNING:
1. To prevent electric shock, check the following items before operation. • There must be no abnormality of the ECG cable. • The ECG cable must be connected correctly. 2. Connect the ECG cable to the system before attaching the pick-up of the ECG to the patient. If the connector of the ECG cable is in contact with live parts, the patient may suffer an electric shock. 3. Do not place the ECG electrodes in direct contact with the patient's heart. Cardiac arrest may occur. *
The ECG electrodes are of the BF type and are not designed to be placed in direct contact with the heart.
4. To reduce the risk of electric shock or burns, use only the cable and patient leads supplied with the reference signal unit . 5. The ECG electrodes used should be commercially available products provided by the customer. 6. Before using equipment such as an electric scalpel, highfrequency therapy equipment, a defibrillator, etc., remove the ECG electrodes from the patient. In addition, do not allow ultrasound transducers to come into contact with the patient. The patient may be burned or receive an electric shock.
13.1 Display Procedures (1) Turn OFF the power of the system and connect the pick-up cable etc. to the side panel. (2) Turn ON the power of the system. (3) Attach the ECG electrodes to the patient. (4) Set the mode to M mode in which reference signals can be displayed. * If the signals need to be displayed in B-mode and B dual mode, it is necessary to preset the display setting to ON.
No. 2B730-670E 13-1
13.2 Adjustment of Reference Signals (1) Adjustment of the ECG waveform Use the ECG dial on the side panel to adjust the ECG waveform. • GAIN: Adjusts the sensitivity. • POSI: Adjusts the display position. (2) Adjustment using the menu When [ECG] is selected from the [Other] menu, the following menu is displayed. The settings can be changed using the trackball and
SET
.
Sets ECG synchronization mode. ECG Sync Mod Sync+Real CH1 Delay Interval
Displays ECG-gating images and live images simultaneously (for dual-display mode). Performs ECG-gating at the delay time set. Sets the delay time from detection of the R wave to refereshing of the B screen. Sets the interval before the B screen is updated in internal gating mode.
No. 2B730-670E 13-2
*
14. Body Mark Entry and Deletion A body mark, which indicates the anatomical region for the current examination, can be displayed on the screen.
14.1 Display of a Body Mark (1) Press the body mark switch on the main panel. The preset body mark for the current examination region is displayed.
14.2 Selection of a Body Mark (1) To display another body mark for the same examination region Press
SET
and then
NEXT
. The body mark is switched.
(2) To display a body mark for another examination region (a) Press
MENU
. The body mark menu is displayed.
(b) Move the cursor to the upper part of the menu and move the trackball slightly to the left or right, depending on the position in which the menu is displayed. A pull-down menu is displayed. (c) Select the desired examination region and press
(d) Select the body mark to be displayed and press mark is displayed on the screen.
No. 2B730-670E 14-1
SET
SET
.
. The selected body
14.3 Movement of the Transducer Mark (1) Operate the trackball to move the transducer mark.
Transducer mark
(2) The transducer mark rotates as the multifunctional dial is turned.
14.4 Movement of the Body Mark (1) Select [Mark Move] in the menu. (2) Press
SET
.
(3) The body mark moves as the trackball is operated. (4) When
SET
is pressed again, the body mark position is set.
14.5 Deletion of the Body Mark (1) Select [Mark Disp] in the menu. (2) Press
SET
. The body mark disappears.
* While the body mark is displayed, set the body mark switch on the panel to OFF, and turn ON/OFF the body mark switch again. The body mark disappears.
No. 2B730-670E 14-2
*
15. Entry and Deletion of Comments Two methods of comment entry are available; characters can be entered from the keyboard or already registered characters can be displayed. * The comment entry switch function must have been registered on the main panel. Contact your TOSHIBA representative for the registration procedure.
15.1 Entry from the Keyboard (1) Press the comment entry switch on the main panel. A cursor is displayed on the screen. (2) Operate the trackball to move the cursor to the position where characters are to be displayed. (3) Enter characters using the keyboard. (4) Press the comment entry switch to quit comment entry mode.
15.2 Entry of Registered Comments (1) Press the comment entry switch on the main panel. A cursor appears on the screen. (2) Enter characters. There are two input methods. • When the multifunctional dial is used (a) Operate the trackball to move the cursor to the position where characters are to be displayed. (b) When the multifunctional dial is rotated, the comment is switched. (c) Press
SET
.
• When the menu is used (a) Operate the trackball to move the cursor to the position where characters are to be displayed. (b) Press
MENU
. The menu for comment entry appears.
(c) Select the characters to be displayed from the menu. (d) Press
SET
.
(3) Press the comment entry switch to quit comment entry mode.
No. 2B730-670E 15-1
15.3 Entry of the Arrow Mark (1) In comment entry mode, operate the trackball to move the cursor to the position where characters are to be displayed. (2) Enter the arrow mark. There are two input methods. • When the menu is used (a) Press
MENU
. The menu for comment entry appears.
(b) Select [Arrow] in the menu. The arrow mark is displayed. (c) When the multifunctional dial is rotated, the arrow mark is rotated. (d) Press
SET
to determine the position.
• When the menu is not used (a) Press
NEXT
. The arrow mark is displayed on the screen.
(b) When the multifunctional dial is rotated, the arrow mark is rotated. (c) Press
SET
to determine the position.
15.4 Entry of Gender Symbols ( , ) (1)
In comment entry mode, operate the trackball to move the cursor to the position where the gender symbol is to be displayed.
(2)
Press the following keys on the keyboard. :
Alt
+ W
To display :
Alt
+ Q
To display
No. 2B730-670E 15-2
15.5 Moving the Selected Comment (1)
In comment entry mode, place the cursor at the entered comment and press . The comment is enclosed by a box.
SET
(2)
Move the comment to the desired position using the trackball.
(3)
Press
SET
to determine the new position.
15.6 Correcting the Comments (1)
Operate the trackball to move the cursor to the string to be corrected.
(2)
Press
(3)
, , , and Using the characters to be corrected.
(4)
Enter the characters from the keyboard.
SET
twice. The cursor appears.
keys on the keyboard, move the cursor to the
* Pressing the Ins key on the keyboard toggles the system between insert mode and overwrite mode. (5)
After correction, press
.
SET
15.7 Deletion of the Selected Comment (1) In comment entry mode, place the cursor at the entered comment and press SET
. The comment is enclosed by a box.
(2) After correction, press
SET
.
No. 2B730-670E 15-3
15.8 Deletion of All Comments Delete all comments. There are two deletion methods. Comment deletion is possible in comment entry mode. (1) When the menu is used (a) Press
MENU
. The menu for comment entry appears.
(b) Select [Comment All Clear] in the menu. (c) Press
SET
. All comment are cleared.
(2) When the menu is not used (a) Press the Del key on the keyboard. All comments are cleared. (b) Use the BS key to clear the input comments sequentially, starting from the most recently input comment.
15.9 Initial Cursor Display Position Setting (1)
In comment entry mode, move the cursor to the desired display position for comment entry.
(2)
Press
SET
. The cursor changes to .
(3)
Press
SET
again. The cursor will be displayed at this position when the
comment entry switch is pressed.
No. 2B730-670E 15-4
*
16. Needle Mark Display This system can display the needle mark for the specified biopsy adapter on the screen. Biopsy procedures must be performed with extreme care to prevent the induction of tissue necrosis, neurological disorders, infectious diseases, and other such problems. The clinical technique should be determined after consultation with the specialists concerned.
WARNING:
1. To perform biopsy procedures while observing ultrasound images, a thorough understanding of ultrasound diagnosis and adequate training in biopsy procedures are required. Biopsy procedures are safer when performed using image observation than when performed without images. However, 100% safety and reliability cannot be assured even when performing biopsy procedures using image observation. If biopsy procedures are performed without proper knowledge or training, they may be performed incorrectly and cause various patient side effects. 2. In the situations listed below, the biopsy needle may fail to reach the target. Incorrect biopsy may cause various patient side effects. • A biopsy procedure is performed without adequate skills. • A biopsy adapter other than that specified is used. • The biopsy adapter is mounted at an incorrect position. • A biopsy needle that is unsuitable for the purpose of the biopsy is used. • A biopsy needle that is unsuitable for the biopsy adapter is used. • The image is frozen but it goes unnoticed, and the biopsy procedure is continued. • The position of the biopsy needle end is misinterpreted on the image. 3. Before and after a biopsy procedure is performed, confirm that there are no abnormalities with the biopsy adapter. If an abnormal biopsy adapter is used, the patient may be injured.
No. 2B730-670E 16-1
WARNING:
4. During a biopsy procedure, the needle may deviate from the desired course due to the tissue characteristics or the type of needle. In particular, needles with small diameters may deviate to a greater degree. Always monitor the target region and the needle end while performing a biopsy procedure. 5. Sterilize the transducer and biopsy adapter before and after an ultrasound-guided biopsy procedure. Failure to do so may result in the transducer and adapter becoming a source of infection. 6. The needle mark displayed on the ultrasound image does not indicate the actual position of the biopsy needle. It should only be used as a reference. 7. Do not freeze the image when performing a biopsy procedure. Biopsy procedures may be performed incorrectly on frozen images. 8. Confirm that the selected needle mark angle matches the angle indicated on the biopsy adapter to be used.
CAUTION: Position of the biopsy target on the image and the biopsy needle Even though the biopsy target and the biopsy needle are identified on the image, a biopsy may not always be successful due to dispersion of the ultrasound beam. This is especially relevant when a biopsy procedure is to be performed for a tubule or a very small region. To avoid biopsy failure, follow the instructions below. 1. Do not rely solely on the echo of the needle end on the image. Pay careful attention to the target, which should shift slightly when the biopsy needle comes into contact with it. 2. Perform biopsy only after confirming the size of the target and the likelihood of biopsy success.
No. 2B730-670E 16-2
16.1 Display Method The needle mark can be displayed on B mode images only. (1) Press
MENU
. The B mode menu is displayed.
(2) Select [Needle] from the menu and press
SET
.
A confirmation dialog is displayed. (3) Select [OK] to display the Needle menu.
(4) Select [G Display] and press
Needle Guide G Angle G Display G Size Range Disp Adapt Sel
. A needle mark is displayed.
SET
If the needle mark angle is adjustable, the needle mark can be rotated at this time. When
SET
is pressed again, the needle mark disappears.
• Example of needle mark display Needle mark
Biopsy range marks Name of the biopsy adaptor Angle of the needle mark BG Adap
NA 99
No. 2B730-670E 16-3
16.2 Adjustment of the Needle Mark Angle The angle of the needle mark can be adjusted within the specified range depending on the transducer and biopsy adaptor used. * The needle mark cannot be changed (angle fixed) for some biopsy adapters. (1) Select [G Angle] in the menu and press
.
SET
([G Angle] is automatically set to ON when [G Display] is set to ON. This step is not required unless [G Angle] has been set to OFF intentionally.) (2) The angle of the needle mark changes as the multifunctional dial is turned. (3) Select [G Angle] from the menu and press
SET
. The needle mark angle is fixed.
16.3 Display/Hiding of Biopsy Range Marks Select [Range Disp] in the menu and press
.
SET
The biopsy range marks are toggled between displayed and hidden.
16.4 Selection of the Biopsy Guide Size (1) Select [G Size] in the menu. (2) Select the guide size in the pull-down menu and press
SET
.
The size of the dots that make up the needle mark is changed.
16.5 Selection of the Biopsy Adaptor Multiple biopsy adaptors may be selectable depending on the type of transducer used. (1) Select [Adapt Sel] in the menu and press
SET
. A dialog is displayed.
(2) Select an item from the dialog and press [OK].
No. 2B730-670E 16-4
*
17. Measurement 17.1 Basic Operation The basic operating procedures are common to all measurements.
CAUTION: 1. The measured data is lost when image freeze is released during measurement. (In the case of application measurements, the data loss depends on the preset settings.) 2. The measured data is lost when the system is turned OFF or is pressed. * The measurement switch function must have been registered on the main panel. Contact your TOSHIBA representative for the registration procedure. (1) After freezing the image, press the measurement switch. The registered measurement function starts. * To select other measurement functions, press
MENU
. The measurement menu
appears. Select the desired measurement from the menu and press
SET
.
(2) Operate the trackball to move the mark on the screen to the start point of the measurement region. (3) Press
SET
.
(4) If necessary, place the cursor at the end point of the measurement region and press
SET
. The measurement result is displayed on the screen.
(5) To perform another measurement using the same measurement function, press NEXT
.
(6) After measurement is completed, press the measurement switch. The system returns to normal ultrasound image display and the measurement results are cleared.
No. 2B730-670E 17-1
17.2 B-mode Measurements The measurements listed below can be performed in B mode. Measurement item
Description
Distance
The distance between two points is measured.
Trace length
The length of the traced portion of the curve is measured.
Angle
The angle between two lines is measured in addition to the distance between two points.
Area/circumference
The area/circumference can be measured by the following methods. • The approximate value for the tracing along the external circumference is obtained. • An ellipse is created along the external circumference to obtain the approximate value. • A rectangle is created along the external circumference to obtain the approximate value.
Volume
The volume is measured.
Cross measurement
Measures the distances on two perpendicular lines.
Parallel measurement
Measures the distances between 4 points set along the same straight line.
Joint measurement
Measures the angle formed by two lines.
Left ventricular function measurement
The left ventricular function can be measured by the calculation methods listed below. • Single-plane ellipse method • Biplane ellipse method • Bullet method • Modified Simpson method • Simpson SP method • Simpson BP method • Cube method • Teichholz method • Gibson method
Stenosis ratio measurement
The stenosis ratio is measured (% Stenosis).
Volume measurement
Measures the volume.
Prostate measurement
Measures the volume and mass of the prostate.
B-mode profile
The intensity of the echo on a line arbitrarily set on an image can be projected and displayed.
Histogram measurement
The distribution of the intensity of the B-mode echoes within the traced area can be displayed graphically.
OB measurement
Evaluates fetal growth.
No. 2B730-670E 17-2
17.3 M-mode Measurements The measurements listed below can be performed in M mode. Measurement item
Description
Distance
The distance (amplitude) between two points in the M mode is measured.
Time
The elapsed time between two points is measured.
Slope
The slope between two points is measured.
Heart rate
The number of heartbeats for one minute is calculated based on the heart rate displayed on the screen.
Left ventricular function measurement
The left ventricular function can be measured by the calculation methods listed below. • Cube method • Teichholz method • Gibson method
Mitral valve measurement
Amplitude/velocity measurements are performed for the mitral valve.
Aortic valve measurement
Diameter/time measurements are performed for the aortic valve.
Stenosis ratio measurement
The stenosis ratio is measured (% Stenosis).
OB measurement
Fetal growth is evaluated.
No. 2B730-670E 17-3
*
18. Output/Saving of Image Data 18.1 Data Archive to a CD-R (1) Place a blank CD-R in the CD-R drive. (2) Select [Copy to CDR] from the [Other] menu. The screen below is displayed. Copy to CDR HDD
CD-R
12345 123
Used: 0
Free: 600 Total: 600
Backup Close
(3) Select the desired data in the "HDD" area and press [>>]. The selected data is displayed in the "CD-R" area. (4) When data selection is complete, select [Backup]. The selected data is archived onto the CD-R. (5) When data archiving is complete, the message "Record success!" is displayed and the CD-R is ejected automatically. (6) Remove the CD-R and push the CD-R tray back into the drive. NOTE:
The maximum image data volume that can be stored on a CD-R is 600 MB.
No. 2B730-670E 18-1
18.2 Data Archive to the DICOM Server * The optional DICOM kit is required to use this function. (1) Select [Open File] from the [Other] menu. The screen below is displayed. Load File Drive: Folders 12345 123
HDD
File Type
ALL
File List Name AAAA.DCM
OK
To Server
Modify Time 2003-12-10 14:45
Cancel
(2) Select the desired data from the "File List" area and then select [To Server]. The selected data is transferred to the DICOM server. * It is possible to set the system to transfer the data automatically to the DICOM server at the same time the data is saved on the HDD. Consult your Toshiba service representative. * Although files with extensions other than "DCM" are also displayed in the File List area, only files with the extension "DCM" can be archived to the DICOM server. * Only a single item can be selected in the Folders area or File List area.
No. 2B730-670E 18-2
18.3 Loading the Archived Data * It is not possible to load the data that was archived to the DICOM server. NOTE:
When data in CIN or FRM format is loaded, the currently displayed patient information is cleared.
(1) Select [Open File] from the [Other] menu. The screen below is displayed. Load File Drive:
HDD
Folders 12345 123
File Type
ALL
File List Name AAAA.BMP BBBB.CIN
OK
To Server
Modify Time 2003-12-10 14:45 2003-12-11 13:15
Cancel
(2) Select the desired folder in the Folders area, select the desired data file in the File List area, and then select [OK]. The loaded data is displayed on the monitor. (3) To close the data file, follow the steps below. (a) For a BMP file Press [Exit] at the bottom right of the screen. (b) For CIN or FRM data Press
FRZ
.
No. 2B730-670E 18-3
*
19. Other Function 19.1 Beep Tone Adjustment The tone of the beep (generated when a switch of the main panel is pressed) can be adjusted. (1) Select [Buzzer] from the [Other] menu. (2) Select the desired volume from the pull-down menu.
19.2 Adjustment of the Panel Backlight The brightness of the backlight of the main panel can be adjusted. (1) Select [Light] from the [Other] menu. (2) Select the desired brightness from the pull-down menu.
No. 2B730-670E 19-1
*
20. Using MI/TI 20.1 Basic Knowledge of MI/TI (1) Concerns with bioeffects Diagnostic ultrasound is recognized as being safe. In fact, there have been no reports of injuries to patients caused by diagnostic ultrasound. It cannot be stated categorically that ultrasound is 100% safe. Studies have revealed that ultrasound with extremely high intensity is harmful to body tissues. This rapid advance has generated concerns about the potential risk of bioeffects when new applications or diagnostic technologies become available. (2) Mechanical effects and thermal effects Studies have revealed that two different kinds of ultrasound characteristics affect human bodies: one is the mechanical effects due to cavitation generated when the negative pressure of ultrasound exceeds a certain limit, and the other is the effects due to thermal energy generated when tissues absorb ultrasound. The levels of these two kinds of effects are represented by indices: the MI (Mechanical Index) and the TI (Thermal Index), respectively. (3) MI/TI values The smaller the MI/TI values, the less the bioeffects.
No. 2B730-670E 20-1
(4) Controlling the ultrasound output In 1976, the FDA in the U.S.A. established limits to the acoustic output level for diagnostic ultrasound equipment (TRACK1), along with the rapid advance in diagnostic ultrasound technology, and the versatile proliferation of its applications, in order to ensure the safety of patients. Thereinafter, manufacturers were required to control the acoustic output level below the limits, when releasing new diagnostic ultrasound systems on the market. Maximum acoustic power specified by FDA (TRACK1) Ispta.3 (mW/cm2)
Isppa.3 (W/cm2)
Peripheral blood vessels
720
190
1.9
Cardiovascular systems
430
190
1.9
Fetal and other
94
190
1.9
Eyes
17
28
0.23
Application
MI
The idea of MI/TI has been introduced recently to increase the diagnostic capability, promoting relaxation of these acoustic power limits (TRACK3). Maximum limit for MI/TI display (TRACK3) Application All regions (except eyes)
Ispta.3 (mW/cm2)
Isppa.3 (W/cm2)
720
<190
MI or
<1.9
With this trend, control of the level of acoustic power has been transferred from manufacturers to users. This means that users have a higher degree of responsibility for safety than manufacturers. Against this background, users are required to understand the ultrasound bioeffects and their causes. (5) ALARA (As Low As Reasonably Achievable) It is required to practice ALARA when using ultrasound energy. Practicing ALARA ensures that the total energy level is controlled below a low enough level at which bioeffects are not generated while diagnostic information is being accumulated. The total energy is controlled by output intensity and total radiation time. The output intensity necessary for examinations differs depending on the patient and the clinical case. Not all examinations can be performed with an extremely low level of acoustic energy. Controlling the acoustic level at an extremely low level leads to low-quality images or insufficient Doppler signals, adversely affecting the reliability of the diagnosis. However, increasing the acoustic power more than necessary does not always contribute to an increase in quality of information required for diagnosis, rather increasing the risk of generating bioeffects. Users must take responsibility for the safety of patients and utilize ultrasound deliberately. Deliberate use of ultrasound means that output power of ultrasound must be selected based on ALARA.
No. 2B730-670E 20-2
20.2 MI/TI Display Description Mechanical Index (MI) formula is the spatial peak value of the peak rarefactional pressure Pr.3 (Zsp), derated by 0.3 dB/cm-MHz at each point along the beam axis, divided by the square root of the center frequency fc (in MHz). That is: MI =
Pr.3 (Z sp ) fc
Thermal Index (TI) is a quantity related to calculated or estimated temperature rise under certain defined assumptions. TI is the ratio of total acoustic power to the acoustic power required to raise tissue temperature by 1 degree centigrade under defined assumptions. TIS (Thermal Index Soft Tissue) is related to heating in abdominal, cardiac and peripheral vascular applications. TIB (Thermal Index Bone) is related to bone heating, which may be of particular importance in fetal applications. TIC (Thermal Index Cranial) is related to heating in adult cephalic applications. Display Accuracy is a manufacturer's specification as to how closely the displayed values correspond to actual measured values. The display accuracy for acoustic output indices is +/-0.1. Display Precision is rounded in units of 0.1.
20.3 Parameters Affecting the MI/TI Values The MI/TI values are affected by transmission conditions (focus, drive frequency, voltage applied to piezoelectric elements, etc.), scan conditions, and settings of the main panel, and preset menu.
No. 2B730-670E 20-3
20.4 Operating Procedures for MI/TI The control of ultrasound output and the most useful switches for this purpose are described below. (1) ACOUSTIC POWER knob The output intensity is one of the available ultrasound output control parameters. It can be adjusted with the ACOUSTIC POWER knob at the right end of the main panel. To decrease ultrasound output, turn the knob counterclockwise and to increase ultrasound output, turn the knob clockwise.
High
Low ACOUSTIC POWER
(2) Setting the defaults for ACOUSTIC POWER Selection of diagnostic applications is the most important factor for controlling ultrasound output. The permissible level of intensity of ultrasound differs depending on the region of interest. For fetal examinations, in particular, much care must be exercised. For this reason, the
switch must be used to reset the parameters for each new
patient, and the Preset menu must be used to select the settings appropriate for each new region of interest. This system allows defaults to be set for MI, TIS, TIB, and TIC using the preset menu. The defaults automatically adjust the ACOUSTIC POWER level so that MI, TIS, TIB, and TIC do not exceed their own settings at the time of power ON,
, switching of the transducer, and other initializations. Default choices Initial power
20% to 100%*
* Definition of 100%: The maximum acoustic power of a transducer determined by the increase in transducer surface temperature in the selected mode and the acoustic power restrictions specified by the FDA. When 100% is set as the default setting value, the default function does not operate. Any changes to the default setting value are the responsibility of the user.
No. 2B730-670E 20-4
20.5 References for MI/TI For further information on measurement methods and MI/TI, refer to the followings: (1) "510 (K) Guide For Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices" issued by FDA in 1993 (2) "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 2" issued by AIUM/NEMA in 1998 (3) "Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment" issued by AIUM/NEMA in 1998 (4) "Bioeffects and Safety of Diagnostic Ultrasound" issued by AIUM in 1993 (5) "Medical Ultrasound Safety" issued by AIUM in 1994 (6) "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued by FDA in 1997
No. 2B730-670E 20-5
*
21. Maintenance Check TOSHIBA strives to ensure consistent product quality from manufacturing to installation in order to ensure that the customers receive products with the best possible safety and reliability characteristics. The customer is responsible for maintaining and operating the products after purchase. TOSHIBA representatives provide after-sales service for products out of warranty on a pay-for-service basis.
21.1 Maintenance Checks to Be Carried Out by Customers 21.1.1 Cleaning the system CAUTION: 1. Before cleaning the system, be sure to disconnect the system power cable from the outlet of the facility. If the system has been defective, an electric shock may occur. 2. Do not spill or spray liquids such as water onto the system or peripheral units. If a liquid such as water enters the system or peripheral units, an electric shock may occur.
CAUTION:
Do not use solvents (such as paint thinner or benzine) or abrasive cleansers for cleaning the system. These substances may cause deterioration in the monitor.
(1) Cleaning the transducer Clean, disinfect, and sterilize the transducer referring to the operation manual provided with the transducer. (2) Cleaning the transducer holder (a) Wipe off any stains on the transducer holder using a soft dry cloth. (b) If it is difficult to remove stains, wipe off stains using a soft cloth moistened with mild detergent and then tightly wrung out. (3) Cleaning the transducer connector (a) Wipe off any stains on the transducer connector using a soft dry cloth. (b) If it is difficult to remove stains, wipe off stains using a soft cloth moistened with water and then tightly wrung out. (4) Cleaning the monitor Wipe the monitor using a soft cloth moistened with glass cleaner and then tightly wrung out. CAUTION:
Do not use hydrocarbon glass cleaner or cleaner for the OA equipment to clean the monitor. This substance may cause deterioration in the monitor. No. 2B730-670E 21-1
(5) Cleaning the system, monitor cover, and panel (a) Wipe off stains using a soft cloth moistened with mild detergent and then tightly wrung out. (b) Clean around the switches or keys on the main panel using cotton buds. (6) Cleaning the air filters (a) Press down the tabs of the air filter to remove the air filter cover.
Air filter cover
Tabs
(b) Press the tabs to separate the dust-proof net from the air filter cover.
Tabs
Dust-proof net
(c) Vacuum dust from the air filter cover and dust-proof net at least once a month.
21.1.2 Creating a backup copy of the system hard disk To take precautions for any deterioration or loss of data stored on the system hard disk, create a backup copy of the hard disk at appropriate times.
No. 2B730-670E 21-2
21.2 Maintenance Checks to Be Carried Out by Service Personnel The following checks are required to ensure the performance and safety of the system. Contact your TOSHIBA representative when carrying out these checks, because they require special techniques. Check category
Check item
Check interval
Cleaning
Filter Interior of the system Peripheral units
1 year
Electric safety
Protective conductor resistance Ground line leakage current Enclosure leakage current Patient leakage current I Patient leakage current III Patient auxiliary current
1 year
Mechanical safety
Check of the casters Check of the caster mounting sections Check of the monitor mounting mechanism Operating panel Mounting mechanism for the peripheral devices Other mechanical parts External appearance of the transducer
1 year
Image recording
Images in each mode Image recording using the standard transducer
1 year
21.3 Consumable Parts and Parts Requiring Periodic Replacement This system contains some parts requiring periodic replacement and some consumable parts. The consumable parts include the casters, fuses, monitor, lamp at the bottom of the monitor, etc. For replacement, special techniques are required. Contact your TOSHIBA representative.
No. 2B730-670E 21-3
*
22. Checks Before the System Is Judged Defective If no images are displayed while the power is ON, or characters are displayed but no images are displayed, etc., check the items listed below before determining that the system is defective. Problems
What to do
The system cannot be Confirm that the power cable is connected to the outlet correctly. turned ON. Check the main switch. The system can be • Adjust the "CONTRAST" "BRIGHTNESS" knobs on the monitor. turned ON, but no • Check whether the equipment is in external video signal input images are displayed. mode. Characters are First, set the ACOUSTIC POWER dial, GAIN dial, and STC slide displayed but no controls to their maximum positions. If still no images are displayed, images are displayed. confirm that the transducer is connected to the transducer connector correctly, or use a different transducer. If the system cannot be turned ON, or problems are not resolved, or the system seems abnormal after checking the above items, contact your TOSHIBA representative. CAUTION: If the main switch is tripped, be sure to consult your TOSHIBA representative. If the main switch is turned ON again without checking the problem, the system or the device may be damaged more seriously.
No. 2B730-670E 22-1
*
23. Accuracy of Measurement Accuracy of Each Clinical Measurement Parameter Parameter - Image Depth Scale - ECG/Image Time Scales
Ranges
Error
20 to 240 mm 1, 2, 4, 8 s
< +/- 4% of full scale 1 s: 2 s: 4 s: 8 s:
3 ms (max.) 6 ms (max.) 12 ms (max.) 24 ms (max.)
Two-dimensional Measurements - Distance / Depth
Up to 240 mm
< +/- 3% or < 1.5 mm, if below 40 mm
- Area
2
Up to 720 cm
< +/- 7% or < 120 mm2, if below 16 cm2
- Trace(Ellipse, Circle)
Up to 560 cm2
< +/- 7% or < 120 mm2, if below 16 cm2
- Angle
0 – 180 degrees < +/- 3%
- Ratio (A/B) Result B/A & (A-B)/A
Up to 1.0
< +/- 10% of A
Result A/B
1.0 – 99.9
< +/- 10% of A
Time Motion (TM) Measurements - Depth
Up to 240 mm
- Time
Up to 8 s
< +/- 2%
15 – 999 bpm
< +/- 5%
Up to 999 mm/s
< +/- 5%
- Heart Rate - Velocity
< +/- 3% or < 1.5 mm, if below 40 mm
Volume Measurements - Volume (Area, Length, Diameter)
Up to 999 cm3
< +/- 10% or < 6.4 cm3, if below 64 cm3
- Prostate Volume
Up to 999 cm3
< +/- 10% or < 6.4 cm3, if below 64 cm3
Range of Accuracy These measurements will hold the accuracies stated above over the entire selected field of view. The accuracy stated is either the measured value or calculated for worst case conditions.
No. 2B730-670E 23-1
*
24. Conformance Standards (1) General
:
IEC60601-1 (1988), AMD No. 1 (1991), AMD No. 2 (1995) (IEC60601-1-1, IEC60601-1-2 (2001)/UL/CSA/SDA)
(2) Flammability
:
UL544 (1998), UL94, UL746C, UL796
(3) Acoustic power :
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (1997) IEC60601-2-37
No. 2B730-670E 24-1
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25. Safety Classification This system is classified with respect to safety characteristics. (1) According to the type of protection against electric shock: • CLASS I EQUIPMENT (2) According to the degree of protection against electric shock: • EQUIPMENT WITH TYPE-BF APPLIED PARTS (3) According to the degree of protection against harmful ingress of water: • IPX0 (enclosed EQUIPMENT without protection against ingress of water) • The optional footswitch is classified as IPX8. (4) According to the degree of safety of application in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE: • EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE (5) According to the mode of operation: • CONTINUOUS OPERATION
No. 2B730-670E 25-1
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26. Guidance and Manufacturer's Declaration This product complies with the EMC standard IEC60601-1-2: 2001. Guidance and manufacturer's declaration - electromagnetic emissions The SSA-530A is intended for use in the electromagnetic environment specified below. The customer or the user of the SSA-530A should assure that it is used in such an environment. Emissions test
Compliance Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The SSA-530A uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Class A
The SSA-530A is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Complies
No. 2B730-670E 26-1
Guidance and manufacturer's declaration - electromagnetic immunity The SSA-530A is intended for use in the electromagnetic environment specified below. The customer or the user of the SSA-530A should assure that it is used in such an environment. Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4
±2 kV for power supply lines ±1 kV for input/output lines
±2 kV for power Mains power quality should be supply lines that of a typical commercial or ±1 kV for input/output hospital environment. lines
Surge IEC 61000-4-5
±1 kV differential ±1 kV differential Mains power quality should be mode mode that of a typical commercial or ±2 kV common mode ±2 kV common mode hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s
<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s
Mains power quality should be that of a typical commercial or hospital environment. If the user of the SSA-530A requires continued operation during power mains interruptions, it is recommended for the SSA-530A to be powered from an uninterruptible power supply.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
No. 2B730-670E 26-2
Guidance and manufacturer's declaration - electromagnetic immunity The SSA-530A is intended for use in the electromagnetic environment specified below. The customer or the user of the SSA-530A should assure that it is used in such an environment. Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the SSA-530A, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3 Vrms
d = 1.2 P
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 Vrms
d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SSA-530A is used exceeds the applicable RF compliance level above, the SSA-530A should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SSA-530A.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
No. 2B730-670E 26-3
Recommended separation distances between portable and mobile RF communications equipment and the SSA-530A The SSA-530A is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SSA-530A can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SSA-530A as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W
Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.2 P
80 MHz to 800 MHz d = 1.2 P
800 MHz to 2.5 GHz d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
No. 2B730-670E 26-4
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27. Indication of Year of Manufacture The year of manufacture is shown on the label attached on the rear of the system.
No. 2B730-670E 27-1
E
For Europe: The equipment described in this manual is in accordance with the requirements of the Medical Device Directive 93/42/EEC. Authorized Representative in the EC: Toshiba Medical Systems Europe BV Zilverstraat 1 2718 RP, Zoetermeer The Netherlands Unauthorized modification of the product or configuration invalidates the CE Marking. For other countries, please contact your local distributor.
1385, SHIMOISHIGAMI, OTAWARA-SHI, TOCHIGI-KEN 324-8550, JAPAN
