Model UIDM-580A Data Management Board Operation Manual Rev D June 2007

Introduction This operation manual describes the operating procedures for the Data Management Board Model UIDM-580A. To ensure safe and correct operation of the system, carefully read this manual before operating the system.

Trademarks Windows XP is a registered trademark of Microsoft Corporation, U.S.A. Other product names are generally trademarks or registered trademarks of the corresponding manufacturers. Note that the trademark symbol "™" and the registered trademark symbol "®" are not used in this manual.

IMPORTANT! 1. No part of this manual may be copied or reprinted, in whole or in part, without written permission. 2. The contents of this manual are subject to change without prior notice and without our legal obligation.

No. 2B708-500EN*D C-1

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REVISION RECORD REV.

DATE (MM/YY)

REASON /AUTHOR

PAGE CHANGED

Mr. Kikuchi

-------

INI.

02/'06

*A

03/'06

Support of V1.1

Mr. Kikuchi

All pages

*B

05/'06

Support of V1.5

Mr. Kikuchi

All pages

*C

11/'06

Support of V2.0

Mr. Kikuchi

All pages

*D

06'07

Support of V3.0

Mr. Kikuchi

All pages

SER. No.

DOC. PRODUCT.

TM-WI2

No. 2B708-500EN*D R-1

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Safety Precautions 1.

Meanings 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 "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 a danger of explosion.

WARNING: 1. Connect this system to outlets with different circuit breakers and fuses from those that control current to devices such as a lifesupport system. If the system malfunctions and generates an overcurrent or when there is an instantaneous current surge at power ON, this may trip the circuit breakers and fuses of the supply circuit of the building. 2. Do not allow the diagnostic ultrasound system or other equipment to come into contact with the patient. If the diagnostic ultrasound system or other equipment is defective, the patient may receive an electric shock. 3. To prevent electric shock, do not remove the covers of the system. 4. Repeated use of the keyboard for a prolonged period of time may possibly result in nervous dysfunction of the hand or arm, depending on the individual. Be careful to observe all local regulations concerning labor safety/health in each institution to avoid extended, uninterrupted use of the keyboard. 5. This system is provided with a lossy data compression function for images. Although this function helps increase the number of images that can be stored, it can cause image deterioration, which can result in measurement errors. The amount of compression, therefore, must be restricted so that the image quality is maintained at a level which does not adversely affect measurements and the resulting diagnoses. 6. Handling the cord on this product will expose you to lead, a chemical known to the State of California to cause birth defects or other reproductive harm. Wash hands after handling.

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CAUTION: 1. Malfunctions due to radiowaves (1) The use of radiowave-emitting devices near this type of medical electronic equipment may interfere with its operation. Do not bring in or use devices which generate radio waves, such as cellular telephones, transceivers, and radio-controlled toys, within the room where the equipment is installed. (2) If devices which generate radio waves are brought near the equipment, instruct the user to immediately turn off the radiowave-emitting device. This is necessary to ensure proper operation of the equipment. 2. To avoid electric shock, do not allow fluids such as water to spill over the system or peripheral devices. 3. Before starting image acquisition, confirm that the patient information on the screen is correct. If images are acquired with the incorrect patient information registered, mistaken diagnosis my result. 4. When acquiring images from a peripheral device, perform setting to ensure that the patient information does not change. Acquiring images with incorrect patient information may result in mistaken diagnosis. 5. This system provides a function which restarts the study. The study can be restarted only on that day. When restarting the study on the next day or later, the study is identified as a different study. Restarting the study on a day other than the current day is not intended. 6. Measurements must be performed using images appropriate for the specific measurement. For details of appropriate images for each measurement, refer to the operation manual, applications volume. 7. Be sure to verify that the date and time are correct when changes are made. 8. 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.

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CAUTION:

(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-R, DVD, or MO) 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.

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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 may malfunction or adversely affect such devices. 3. To prevent damage to the system, do not use it in the following locations: • Exposed to direct sunlight • Subject to sudden changes in temperature • Excessive dust • Subject to vibration • Near heat generators • High humidity • Fluids such as water or chemicals may be spilled on the system 4. MO disks used in the system must not be used in other PCs which do not support the DICOM format. If CD-R, DVD, or MO disks are used in such PCs, the stored data may not be read. 5. Non-compliance with the following precautions can result in a disk or data being destroyed. • The shutdown process must always be performed correctly. • The power must not be turned OFF while the hard disk unit or magnetooptical disk unit is being accessed. • The system must not be moved while the power is ON. • Excessive vibration and impact to the system should be avoided during movement. 6. Be sure to back up important data such as the system data. The data may be destroyed if the power fails or an accident occurs. 7. Make sure that no CD-R, DVD, or MO disk is present in the corresponding drives before the system power is turned ON. Otherwise, the disk may be damaged or a malfunction may result.

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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 a 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, floppy disks, or magnetic tapes.

8.

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

9.

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

10. TOSHIBA shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions contained in this operation manual. 11. On the occasion of change of the administrator or manager for this system, be sure to hand over this operation manual.

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

1. This system is designed to provide functions that aid functional diagnosis and morphological diagnosis in hospitals. The provided functions include stress echo. 2. If images for display are acquired from a device which is not intended for use with this system, the spatial resolution and gradations will be degraded. Correct measurement results also may not be obtained. 3. If image data acquired by this system is displayed by an external device not specified by TOSHIBA (via online transfer, using storage media, etc.), the image information may not be displayed correctly. 4. Do not press switches not intended for use with this system or press switches continuously. A malfunction may occur. 5. Before attempting to save data onto an MO, be sure to unprotect the MO. 6. To acquire and save cine images, a lossy data compression function (MJPEG standard) can be used. The image quality parameter, which determines the image quality level, can be specified in the range of 1 to 100 with this function. Note that 100 indicates the highest quality. The utility function can be used to determine whether the lossy data compression function was used and the image quality parameter employed if the function was used. 7. Displaying image-related information The items listed below can be displayed at the upper left of the image as related information. <Display items> Item Study Type Patient ID Patient Name

Description Study type can be selected or entered manually. Patient ID is entered manually. Patient name is entered manually.

No. 2B708-500EN*D W-2

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Intellectual Property Availability of This Software and Related Documents is Restricted. The software used for this system includes software owned by Toshiba Medical Systems Corporation and licensed to Toshiba Medical Systems Corporation by a Licensor. (1) The software and related documents must be used only for this system. (2) The intellectual property of this software and related documents is not assigned to you. (3) You must not copy the software or documents, or 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 U.S. and Japanese Export Administration laws and regulations. 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 and programs in the software are subject to change without notice.

No. 2B708-500EN*D L-1

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How to Use This Operation Manual 1. Operation Manuals The basic operating procedures for this system are explained by a TOSHIBA service engineer or instructor at the time of installation of the system. Refer to the operation manuals before using the system in order to fully understand the detailed operating procedures, functions, and performance, as well as how to maintain optimal system performance. The organization of the operation manuals related to this system is shown below.

Operation manual for the main unit of the ultrasound system Fundamentals volume

... Describes basic information concerning the system, such as preparation for examination, operation, inspection, and functional descriptions of the system.

Applications volume

... Describes the operating procedures for each application and system setting procedures.

No. 2B708-500EN*D U-1

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Table of Contents Safety Precautions ...S-1 Important Information ...W-1 Intellectual Property ... L-1 How to Use This Operation Manual ... U-1

1.

Applications/Specifications ... 1-1

1.1

Applications ... 1-1

1.2

Standard Configuration... 1-1

1.3

Optional Items ... 1-1

1.4

Recommended Media ... 1-1

2.

Power ON/OFF ... 2-1

2.1

Power ON Procedure ... 2-1

2.2

Power OFF Procedure ... 2-1

3.

Pre- and Post-Operation Checks ... 3-1

3.1

Operational Check ... 3-1

3.2

Checking the Image ... 3-1

4.

Operation Screen and Switch Operation... 4-1

4.1

Operating the Diagnostic Ultrasound System Using the Operating Panel ... 4-1

4.2

Operating the Diagnostic Ultrasound System from the Keyboard ... 4-2

4.3

Main Operation Toolbar ... 4-3 No. 2B708-500EN*D -a-

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4.4

Examination Flowchart... 4-7

4.5

Acquiring Images... 4-8

4.5.1

Acquiring still images ... 4-8

4.5.2

Acquiring cine images (dynamic images) ... 4-8

4.6

Operation Flow ... 4-10

4.7

Menu Tree ... 4-11

5.

Operation Screen and Switch Operation (Details) ... 5-1

5.1

Entering the Patient Information ... 5-2

5.2

Patient List Interface ... 5-5

5.2.1

Sending studies from the patient list ... 5-7

5.2.2

Retrieving studies from the Patient List screen ... 5-8

5.2.3

Image index ... 5-9

5.2.4

Retrieving patients from the Patient List screen... 5-12

5.3

Changing Acquisition Parameters for Cine Images ... 5-15

5.4

Review Mode ... 5-17

5.4.1

Reviewing images ... 5-17

5.4.2

Image index ... 5-18

5.4.3

Formatted Printing ... 5-19

5.5

Drop-Down Operation Menu in the Image Display Area ... 5-20

6.

Utility ... 6-1

6.1

Displaying the Utility Screen... 6-1

6.2

Compression Setup ... 6-3

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6.3

Acquisition Setup [Initial] ... 6-4

6.4

New Patient Screen Setup... 6-6

6.5

Protocol Edit for Stress Echo Application... 6-8

6.5.1

Starting the protocol editor ... 6-8

6.5.2

Creating a protocol ... 6-8

6.5.3

Editing a protocol ... 6-10

6.6

Setting of the Windows Printer ... 6-11

7.

Maintenance and Inspection ... 7-1

7.1

Maintenance/Inspections to Be Performed by the Customer ... 7-1

7.2

Maintenance/Inspections to Be Performed by the Service Engineer ... 7-1

7.3

Parts to Be Replaced Periodically and Consumable Parts... 7-1

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1. Applications/Specifications 1.1

Applications This system is an ultrasound data management unit which acquires dynamic or still images output from a diagnostic ultrasound system to support functional diagnosis by performing display, processing, measurement, and analysis of images.

1.2

Standard Configuration Name

1.3

Remarks

1

Main unit

Board main unit and options

2

OS (operating system) Windows XP

CD-ROM, manual

3

System disk (backup disk)

CD-ROM

4

Operation manual (Fundamentals volume)

2B708-500EN

5

Operation manual (Applications volume)

2B708-501EN

6

Installation manual

2C708-734EN

7

Installation quality check sheet

2J708-610EN

8

Label

Nameplate

Optional Items Name

1.4

Product Number

1

DICOM-supported software

UDDS-580A

2

Stress Echo software

UDSE-580A

3

Panoramic View software

UDPA-580A

Note

Recommended Media This unit cannot write data correctly on media manufactured by some companies. Toshiba has confirmed that this unit can write data correctly on media manufactured by the companies listed in the table below. Disk

Manufacturer

CD-R

TAIYO YUDEN CO., LTD.

CD-RW*

MITSUBISHI KAGAKU MEDIA CO., LTD.

DVD-R

TAIYO YUDEN CO., LTD.

DVD-RAM

Hitachi Maxell, Ltd.

* : Data can be written only one time in this system, even if CD-RW is used. Format the media before use.

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2. Power ON/OFF 2.1

Power ON Procedure (1) Turn ON the power of the diagnostic ultrasound system. Because the power supply of this unit is interlocked with the power supply of the diagnostic ultrasound system, the power of this unit is turned ON automatically when the power of the diagnostic ultrasound system is turned ON.

2.2

Power OFF Procedure CAUTION: 1. The power supply of this unit is interlocked with the power supply of the diagnostic ultrasound system. Therefore, when the diagnostic ultrasound system is turned OFF, this unit performs shutdown processing and then automatically turns the power OFF. 2. Do not turn the power OFF while the hard disk unit or magneto-optical disk unit is being accessed. If the power is turned OFF, disk damage or data loss may occur.

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3. Pre- and Post-Operation Checks 3.1

Operational Check (1) Confirm that there are no abnormal sounds or malfunctions after the power is turned ON.

3.2

Checking the Image (1) Display ultrasound images on the diagnostic ultrasound system. (2) Compare the Review images on the diagnostic ultrasound system against those on this unit and confirm that • the color balance is comparable, • the density resolution is comparable, and • the images are synchronized.

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4. Operation Screen and Switch Operation 4.1

Operating the Diagnostic Ultrasound System Using the Operating Panel In this system, the SET and NEXT switches are used together with the leftmost trackball to operate this unit. Pressing the SET switch is the same as clicking the left mouse button, and pressing the NEXT switch is the same as clicking the right mouse button. To move the cursor, use the trackball. To capture image data, use the two switches of the operating panel of the diagnostic ultrasound system. SET

NEXT

CINE (capturing dynamic images) * Used as the ACCEPT switch for optional Stress Echo operation.

STILL (capturing still images) * Used as the SKIP switch for optional Stress Echo operation.

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4.2

Operating the Diagnostic Ultrasound System from the Keyboard The keyboard is installed below the main panel. To use the keyboard, pull it out. Backspace key Moves the cursor to the previous character.

Enter key

Shift

key

Cursor keys

Space key Del

key

<<Character entry>> Key operation

Result

Shift + alphabetic character keys (with Caps Lock OFF)

Uppercase letters can be entered.

Shift + keys other than alphabetic

The symbol in the upper row can be entered.

character keys (such as

+ =

)

<<Short-cut key input>> Key operation

Result

F1

Displays the Patient List.

F2

Displays the Patient Registration screen.

F5

Transfers the application measurement results available in the Nemio XG.

F10

Starts up Stress Echo. (UDSE-580A must be installed.)

F13

Sets an emergency patient name and patient ID automatically, allowing an urgent examination to be started.

No. 2B708-500EN*D 4-2

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