NemioXG Model SSA-580A Fundamentals Operation Manual Rev A March 2006

Introduction This operation manual describes the operating procedures for the diagnostic ultrasound system. 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.

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REVISION RECORD REV.

DATE (MM/YY)

INI.

02/'06

*A

03/'06

REASON /AUTHOR

Support of V1.1

PAGE CHANGED

Mr. Ueki

-------

Mr. Goto

All pages

SER. No.

DOC. PRODUCT.

TM-WI2

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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.

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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: • 2B730-818EN (Application volume) • 2B730-821EN (Acoustic power data)

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3.

Entry Keys

In this manual, the keys on the keyboard are represented as shown below. Description

Actual key operation

Press Z .

Press

Press Shift .

Press

Press Shift

Z .

Press Enter .

Press

Z

.

.

Shift

Z

while holding down

.

Shift

.

Press

In addition, switches on the main panel are represented as shown below. Description

Actual switch operation

Press the SET switch.

SELECT

Press

. SET

Press the NEXT switch.

SELECT

Press

. NEXT

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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 System 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 Optional Software ... 2-2

2.4

List of Available Transducers ... 2-3

3.

System Overview ... 3-1

3.1

Name of Each Part ... 3-1

3.2

Subpanel ... 3-2

3.3

Main Panel... 3-3

3.4

Keyboard ... 3-8

3.5

Side Panel ... 3-9

3.6

Front Panel ... 3-10

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3.7

Rear Panel ... 3-11

3.8

Power Panel ... 3-12

3.9

Symbols ... 3-13

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

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

8.3

Security Functions ... 8-4

9.

Entering the Patient ID ... 9-1

9.1

Entering and Saving Data on the Patient ID Registration Screen ... 9-1 No. 2B730-815EN*A -b-

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9.2

Patient ID List Screen ... 9-4

9.3

Sorting and Calling a Patient ID... 9-5

9.4

Deleting Saved Patient IDs ... 9-6

9.5

Saving the Patient IDs Saved in the System on External Media ... 9-7

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

2D Mode ... 11-1

11.2

M Mode ... 11-6

11.3

CDI Mode ... 11-8

11.4

POWER Mode ... 11-13

11.5

Doppler Mode ... 11-15

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

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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

Addition of Position Comment ... 14-2

14.6

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

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

Deletion of the Selected Comment ... 15-3

15.7

Deletion of All Comments ... 15-3

15.8

Initial Cursor Display Position Setting ... 15-3

16.

Needle Mark Display ... 16-1

16.1

Display Method ... 16-1

16.2

Adjustment of the Needle Mark Angle ... 16-2

16.3

Display/Hiding of Biopsy Range Marks ... 16-2

16.4

Selection of the Biopsy Guide Size ... 16-2

16.5

Selection of the Biopsy Adapter ... 16-2

17.

DVD Drive ... 17-1

17.1

Name and Function of Each Part of the DVD Drive ... 17-1

17.2

Recommended Media ... 17-1 No. 2B730-815EN*A -d-

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17.3

Basic Operation ... 17-2

17.3.1

How to use the disk tray ... 17-2

17.3.2

If the tray cannot be ejected by pressing the eject button ... 17-3

17.4

Handling Disks... 17-4

17.4.1

Handling disks ... 17-4

17.4.2

Cleaning disks ... 17-4

17.5

Troubleshooting ... 17-5

17.5.1

Data cannot be written or a write error occurs ... 17-5

17.5.2

Data cannot be written on a media at the rated writing speed ... 17-5

17.5.3

The disk cannot be read, the disk is not recognized by the unit, or the reading speed does not increase ... 17-5

17.5.4

Abnormal noise is heard during reading ... 17-6

Measurements 18.

Measurement ... 18-1

18.1

Basic Operation ... 18-1

18.2

2D-Mode Measurements ... 18-3

18.3

M-Mode Measurements ... 18-4

18.4

CDI-Mode Measurements... 18-4

18.5

Doppler-Mode Measurements ... 18-5

General Information 19.

Using MI/TI ... 19-1

19.1

Basic Knowledge of MI/TI ... 19-1

19.2

MI/TI Display Description ... 19-3

19.3

Parameters Affecting the MI/TI Values ... 19-3

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19.4

Operating Procedures for MI/TI ... 19-4

19.5

References for MI/TI ... 19-5

20.

Maintenance Check ... 20-1

20.1

Maintenance Checks to Be Carried Out by Customers ... 20-1

20.2

Maintenance Checks to Be Carried Out by Service Personnel... 20-1

20.3

Consumable Parts and Parts Requiring Periodic Replacement ... 20-1

21.

Checks Before the System Is Judged Defective ... 21-1

22.

Accuracy of Measurement ... 22-1

23.

Conformance Standards ... 23-1

24.

Safety Classification ... 24-1

25.

Guidance and Manufacturer's Declaration ... 25-1

26.

Indication of Year of Manufacture ... 26-1

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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

Meaning

DANGER

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

WARNING

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

CAUTION

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

CAUTION

2.

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 and PCG microphone can be connected to this system are Type-BF applied part.

"Attention" (Refer to the operation manual.)

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3.

Safety Precautions

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

DANGER:

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

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

):

To use another medical device in combination with this system, an equipotential wire for connecting to an equipotential bus must be supplied. For more information, contact your TOSHIBA representative. * Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle. Also, be sure to remove the equipment power plug from the receptacle before disconnecting the wire to avoid electrical shock. 3. Information concerning the functional earth terminal ( ): Use of the functional earth terminal is not allowed in Europe. The system should be connected according to local requirements. 4. Connect the earth conductor only before turning ON the system. Disconnect the grounding cable only after turning OFF the system. Otherwise, electric shock may result. 5. Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as 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 fire.

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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 (UJUR-580A). (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 or PCG microphones to come into contact with the patient. The patient may be burned or receive an electric shock. 13. 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. 14. Confirm that the selected needle mark angle matches the angle indicated on the biopsy adapter to be used. 15. The use of transducers and cables other than those specified, with the exception of transducers and cables sold by Toshiba Medical Systems Corporation as replacement parts, may result in increased emissions or reduced system performance.

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CAUTION: 1. 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. 2. 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. 3. Move the system forward or backward only. If the system is moved to the left or right, it may fall, causing injury. 4. When the system is moved over a sloped surface, it must be moved by two persons. Otherwise, the system may slide unexpectedly and cause a serious injury. 5. Do not sit on the system. The system may move, causing you to lose your balance and fall. 6. Do not place any objects on top of the monitor. They may fall, causing injury. 7. When returning the LCD monitor to its home position, do not place your hands on the monitor arm. Your fingers may be caught by the monitor arm, possibly resulting in hand injury. 8. To prevent electric shock, do not connect the peripheral units (video printer, VCR, etc.) to an external outlet. Peripheral units should be connected to the service outlet of the system. For the connection procedures, contact your TOSHIBA representative. 9. 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. 10. Do not allow fluids such as water to contact the system or peripheral devices. Electric shock may result. 11. 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. 12. 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.

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CAUTION: 13. 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. Note that when the patient information is modified by pressing the F2 key, the patient information for the data already recorded in the image memory is also 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. 14. 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. 15. Restrictions on the optional reference signal inputs When external signals are input to AUX, the signal level that can be input is restricted. Contact your TOSHIBA representative for details. 16. Only medical equipment that conforms with the IEC60601-1 standards must be connected to AUX. Otherwise, an electric shock might result. 17. 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 while accessing external storage media may damage the media.

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CAUTION: 18. Malicious software (1) If this system is connected to a network for which any of the following conditions is true, the system can be infected with malware (malicious software, such as a computer virus or worm, that harms computers). The user must establish security measures to prevent the system from being infected. • Security control is not established for the network. • There is a risk of malware invasion in the network. • System for which any of the following conditions is true is connected to the network. (a) The security of the system is not controlled by the user. (b) The system can be accessed by persons not authorized by the user. (c) The system is capable of wireless communication. (2) The following instructions must be observed in order to prevent this system from being infected with malware (malicious software, such as a computer virus or worm, that harms computers). If the system is infected with malware, the data stored in the system may be lost, tampered with, or accessed by unauthorized persons; the system may operate incorrectly; or the system may become a source of malware infection. • Do not connect this system to a network for which security control is not established. • Do not connect this system to the Internet. • When an external storage media (such as a CD or DVD) is to be used, confirm in advance that the media is not infected with malware. • Do not perform any other actions that may result in infection. 19. The displayed reference signals should be used for reference only. They should not be used for diagnosis or monitoring. In patients with cardiac pacemakers, a implantable electro stimulator, or arrhythmias, the heart rate or other parameters may not be displayed correctly.

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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 in the following locations: • Exposed to direct sunlight • Subject to sudden changes in temperature • Dusty • Subject to vibration • Near heat generators • High humidity 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 sub switch or stop transmission by setting [Transducer] in the [Other] menu to OFF 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. When moving the LCD monitor, be careful to avoid hitting the monitor against the cable arm or TEE transducer hanger. The components may be damaged. 9. Do not press or use force on the main panel. It may damage the system. 10. If this system is used in a small room, it may cause the room temperature to rise. Proper ventilation must be provided. 11. The filters on both sides of the system must be cleaned once every 6 months. If the filters are 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.

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CAUTION:

14. When the DVD or MO disk is not being used, remove the disk from the drive. The disk may be damaged if the system fails. 15. Confirm that a core for preventing EMC problems is attached to the transducer cable. If a core is not attached, the system may affect other equipment. Contact your service representative for details.

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