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

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. 2B730-818EN*A C-1

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REVISION RECORD REV.

DATE (MM/YY)

REASON /AUTHOR

INI.

01/'06

Mr. Ueki

*A

03/'06

Mr. Ueki

PAGE CHANGED -------

SER. No.

DOC. PRODUCT.

TM-WI2

No. 2B730-818EN*A R-1

YEM55600C-1 *

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.)

No. 2B730-818EN*A S-1

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3.

Safety Precautions

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

WARNING: 1. Using a contrast medium (1) Handle the contrast medium as described in the operation manual supplied with the contrast medium. TOSHIBA is not liable for any damage or injury resulting from misuse of contrast media. (2) Check the side effects of the contrast medium used with the manufacturer of the contrast medium. (3) If there is an abnormality with the patient during use of the contrast medium, stop the examination and perform appropriate treatment. (4) Cavitation may occur due to interactions between the ultrasonic waves and the contrast medium. Always perform examination using the ALARA (as low as reasonably achievable) principle. The acoustic power can be changed using the ACOUSTIC POWER dial on the main panel. 2. If the temperature detection function of the transesophageal transducer becomes abnormal, the message below is displayed.

In this case, stop the examination immediately, make the angle free, return the transducer to a neutral angle, and then withdraw the transducer carefully. Then, contact your Toshiba service representative. 3. During scanning using the transesophageal transducer, the following message is displayed if the temperature at the transducer end exceeds 43°C for two minutes or more. "Shut down system immediately." In this case, stop the examination immediately, make the angle free, return the transducer to a neutral angle, and then withdraw the transducer carefully. The diagnostic ultrasound system must be restarted in order to perform examination again. 4. Refer to the Operation Manual (Basic Volume) for precautions regarding the use of this system.

No. 2B730-818EN*A S-2

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CAUTION: 1. Display the most suitable image and select the most suitable measurement tool for the intended measurement. The appropriate measurement methods and results must be determined by a specialist. 2. Press SET to fix the data during measurement or during measurement modification. Note, however, that the following operations may also fix the measurement. • Pressing the NEXT switch • Performing one of the following measurement-related operations -

Starting HR input

-

Selecting one of menu items [ROI A] to [ROI D] during TIC or ACM measurement

-

Selecting another measurement item on the menu

Confirm that the measurement is performed correctly. 3. If the measurement is not fixed for an application measurement, the measurement results are not displayed in the Report. 4. The basic measurement results are not displayed in the report. 5. Be sure to perform measurement within images. If the area outside an image is included in a measurement, incorrect diagnosis may result. 6. The detailed precautions for each measurement and function are described in the corresponding section. Read and understand these precautions before performing the measurement or using the function. 7. Data in temporary storage areas, such as the image memory, is deleted when the power supply is turned OFF or when the New Patient switch is pressed. Such data may also occasionally be deleted due to accidents. To minimize the possibility of reexamination being required as a result of unintended data deletion, back up the required images on external storage media such as DVDs, CDs, or videotapes. 8. Do not perform measurements on VCR images acquired with a system other than Nemio XG.

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CAUTION: 9. Before performing measurement on a VCR image, confirm that the code starting with "M" displayed at the bottom of the monitor matches the value that appears in the Playback Code field of the Playback Calibration dialog when the measurement button is pressed. If the code does not match the value displayed in the Playback Code field, make them match by entering the code displayed at the bottom of the monitor in the Playback Code field or by taking other appropriate actions. It should be noted that measurement cannot be performed on a VCR image if no code is displayed at the bottom of the monitor. Also confirm that the scale and graduations are displayed clearly. The scale and graduations may not be seen clearly depending on when the playback is paused. In this case, pause the playback again at a time when the scale and graduations are clearly seen. 10. Compared with normal measurements, measurement accuracy when using VCR images is lower. In the worst case, the error may be 8%. 11. It is also possible to perform measurement using an image on which measurement has been performed during examination and to print the image with the results of the two measurements. In the case of black-and-white printing, the caliper and measurement results for the first measurement may be confused with those for the second measurement. To prevent such confusion in later image viewing on printed images, take appropriate measures such as placing an identification mark at the head of the results of the first measurement. 12. There are two types of measurement results: measurement values that are measured directly by the user and calculation values that are calculated from measurement values. Measurement values are obtained by measurements performed by the user and are rounded off. Calculation values, on the other hand, are obtained by calculating measurement values (internal values) without rounding off in order to improve the accuracy of calculation and then rounding off the calculation results. Therefore, calculation values may differ from the values obtained by calculating displayed measurement values. 13. Refer to the Operation Manual (Basic Volume) for precautions regarding the use of this system.

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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.

No. 2B730-818EN*A U-1

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3.

Entry Keys

In this manual, keys on the keyboard are represented as shown in the table 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

The following switches on the main panel are represented as shown in the table below. Description

Actual switch operation

Press the SET switch.

SELECT

Press

. SET

Press the NEXT switch.

SELECT

Press

. NEXT

4.

Screens in This Operation Manual

Depending on the software version, the preset settings, and whether options are used or not, the actual screens may appear different from those shown in this manual.

No. 2B730-818EN*A U-2

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Table of Contents Safety Precautions ...S-1 Intellectual Property ... L-1 Organization of the Operation Manuals ... U-1

System Setting Changes 1.

Change and Registration of Standard Settings ... 1-1

1.1

Displaying the Preset Screen ... 1-1

1.2

Changing the System Environmental Settings (System Configuration) ... 1-2

1.3

Changing the Date and Time (Time Correction) ... 1-3

1.4

Changing Image Parameter Settings (Image Process) ... 1-4

1.5

Setting the Color Velocity Range (Scale Set) ... 1-5

1.6

Changing the Needle Mark (Needle Adapter) ... 1-6

1.7

Setting Parameters for Each Exam (Exam Preset) ... 1-7

1.7.1

Changing the region name (name of the anatomical region to be examined)... 1-8

1.7.2

Changing initial settings in each mode... 1-9

1.7.3

Changing display items in the measurement menu ... 1-10

1.7.4

Changing the functions assigned to measurement switches ... 1-11

1.7.5

Creating a user body mark menu... 1-12

1.7.6

Changing and registering the annotation menu... 1-15

1.7.7

Changing and registering measurements... 1-20

1.7.8

Changing items to be displayed in the menu ... 1-21

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1.7.9

Changing the hospital name and the examination department ... 1-22

1.8

Changing the Display Conditions for Markers and Other Items (Visual Customize) ... 1-23

Measurements 2.

2D-Mode Measurements ... 2-1

2.1

Distance Measurement (Distance) ... 2-1

2.1.1

Measurement procedures ... 2-1

2.1.2

Modifying measurements ... 2-2

2.2

Trace Length Measurement (Trace Length)... 2-3

2.2.1

Trace All ... 2-4

2.2.2

Trace Spline ... 2-5

2.3

Angle Measurement (Angle) ... 2-6

2.3.1

Measurement procedures ... 2-6

2.3.2

Modifying measurements ... 2-7

2.4

Area/Circumference Measurement (Area) ... 2-8

2.4.1

Trace All ... 2-9

2.4.2

Trace Spline ... 2-10

2.4.3

Elliptical approximation (Ellipse) ... 2-11

2.4.4

Cross ... 2-13

2.5

Volume Measurement (Volume)... 2-15

2.5.1

Measurement procedures ... 2-15

2.5.2

Modifying measurements ... 2-16

2.6

Cross Measurement (Cross)... 2-17

2.6.1

Measurement procedures ... 2-17

2.6.2

Modifying measurements ... 2-18

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2.7

Parallel Measurement (Parallel) ... 2-19

2.7.1

Measurement procedures ... 2-19

2.7.2

Modifying measurements ... 2-20

2.8

Joint Measurement (Joint) ... 2-21

2.8.1

Measurement procedures ... 2-21

2.9

Prostate Measurement (Prostate)... 2-23

2.10

Percent Stenosis (% STENOSIS)... 2-25

2.11

Left Ventricular Function Measurement (LV) ... 2-26

2.11.1

SINGLE PLANE ELLIPSE method ... 2-27

2.11.2

BIPLANE ELLIPSE method ... 2-29

2.11.3

BULLET method ... 2-31

2.11.4

SIMPSON'S method ... 2-32

2.11.5

SIMPSON'S SINGLE PLANE method ... 2-34

2.11.6

SIMPSON'S BIPLANE method ... 2-36

2.11.7

CUBE method ... 2-42

2.11.8

TEICHHOLZ method ... 2-48

2.11.9

GIBSON method ... 2-48

2.12

2D-Mode Profile (2D-Profile) ... 2-49

2.12.1

Measurement procedures ... 2-49

2.12.2

Modifying measurements ... 2-50

2.12.3

Copying measurements ... 2-50

2.13

Histogram Measurement (2D-Histogram) ... 2-51

2.13.1

Measurement procedures ... 2-51

2.13.2

Copying measurements ... 2-51

2.14

Mean IMT Measurement ... 2-52

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3.

M-Mode Measurements ... 3-1

3.1

Distance Measurement (Distance) ... 3-1

3.1.1

Measurement procedures ... 3-1

3.1.2

Display layout for measured values ... 3-1

3.2

Time Measurement (Time)... 3-2

3.3

Slope Measurement (Slope)... 3-3

3.3.1

Measurement procedures ... 3-3

3.3.2

Modifying measurements ... 3-4

3.4

Heart Rate Measurement (HR)... 3-5

3.5

Left Ventricular Function Measurement (LV) ... 3-6

3.5.1

CUBE method (M-mode) ... 3-7

3.5.2

TEICHHOLZ method ... 3-12

3.5.3

GIBSON method ... 3-12

3.6

Mitral Valve Measurement (MV) ... 3-13

3.7

Aortic Valve Measurement (Aortic) ... 3-14

3.8

Percent Stenosis Measurement (% STENOSIS)... 3-15

4.

CDI-Mode Measurements ... 4-1

4.1

Flow Velocity (Color Vel)... 4-1

4.1.1

Measurement procedures ... 4-1

4.1.2

Modifying measurements ... 4-2

4.2

Color-Mode Profile Measurement (Color Profile) ... 4-3

5.

Doppler-Mode Measurements ... 5-1

5.1

Flow Velocity Measurement (Velocity) ... 5-1

5.2

Acceleration Measurement (Accel) ... 5-2

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5.3

Time Measurement (Time)... 5-3

5.4

Heart Rate Measurement (HR)... 5-3

5.5

Velocity Trace Measurement (Vel Trace) ... 5-4

5.5.1

Trace All ... 5-4

5.5.2

Trace Spline ... 5-6

5.5.3

Trace Line ... 5-6

5.5.4

Auto-trace ... 5-7

5.6

VTI Measurement (Conti. Equation) ... 5-10

5.7

Doppler Flow Volume Measurement (F Vol VTI) ... 5-11

5.8

Velocity Measurement (F Vol Vel Trace) ... 5-13

5.9

Velocity Ratio Measurement ... 5-15

5.9.1

RATIO measurement ... 5-15

5.9.2

RI measurement (RI) ... 5-17

5.10

Mitral Valve Measurement (Mitral Valve) ... 5-18

5.11

Mitral Valve Regurgitation Measurement (Mitral Regurgitation: MR) ... 5-20

5.12

Aortic Valve Function Measurement (Aortic Valve) ... 5-22

5.13

Aortic Valve Regurgitation Measurement (Aortic Regurgitation: AR) ... 5-25

5.14

Tricuspid Valve Measurement (Tricuspid Valve) ... 5-26

5.15

Tricuspid Valve Regurgitation Measurement (Tricuspid Regurgitation: TR) ... 5-28

5.16

Pulmonary Valve Measurement (Pulmonary Valve)... 5-30

5.17

Pulmonary Vein Measurement (Pulmonary Vein)... 5-33

6.

Cardiac Report/Worksheet ... 6-1 No. 2B730-818EN*A -e-

YEM55600C-1

6.1

Report Function ... 6-2

6.2

Worksheet Function ... 6-3

6.3

List of Cardiac Report/Worksheet Measurement Titles ... 6-5

7.

Obstetric Calculations ... 7-1

7.1

Outline of Obstetric Calculations ... 7-1

7.1.1

Outline of operating procedures ... 7-3

7.1.2

Abbreviations used ... 7-3

7.1.3

Items measured ... 7-4

7.1.4

Items calculated ... 7-6

7.1.5

Gestational age calculation data ... 7-7

7.2

Fetal Growth Measurement Menu ... 7-12

7.2.1

2D-mode menu ... 7-12

7.2.2

Doppler-mode menu ... 7-13

7.3

Entry and Calculation of OB Dates... 7-14

7.3.1

LMP method ... 7-15

7.3.2

EDD method ... 7-16

7.3.3

PREV method ... 7-17

7.3.4

CLIN method ... 7-18

7.4

Measurement Methods ... 7-19

7.4.1

Operating procedures for obtaining the number of weeks ... 7-19

7.4.2

Amniotic fluid index measurements (AFI)... 7-20

7.5

Registering OB Calculation Data ... 7-21

7.5.1

Starting up the registration menu for OB Calculation data ... 7-23

7.5.2

Setting procedures... 7-26

7.6

Birth Registration ... 7-42 No. 2B730-818EN*A -f-

YEM55600C-1

7.7

OB Item Registration ... 7-45

7.7.1

Starting up the OB Item registration screen ... 7-45

7.7.2

OB Item (2D) screen... 7-46

7.7.3

OB Item (2D) Save screen ... 7-50

7.7.4

OB Item (2D) Load screen ... 7-51

7.8

OB Item D-Mode Registration ... 7-52

7.8.1

Starting up the OB Item D-mode registration screen ... 7-52

7.8.2

OB Item D-mode screen ... 7-53

7.8.3

OB Item (D Mode) Save screen ... 7-55

7.8.4

OB Item (D Mode) Load screen ... 7-56

8.

OB Report/Worksheet ... 8-1

8.1

Outline ... 8-1

8.2

OB Report Function ... 8-1

8.3

OB Worksheet Function ... 8-6

8.4

OB Datalist Function ... 8-11

8.5

OB Trend Graph Function ... 8-14

9.

User Registration of Measurements ... 9-1

9.1

What Is User Registration of Measurements ... 9-1

9.2

Invoking the Preset Screen ... 9-1

9.3

User Registration of Measurements (Measure Registration) ... 9-2

9.3.1

Adding a measurement to the user-registered measurements ... 9-3

9.3.2

Adding a calculation item ... 9-10

9.3.3

Setting a preset... 9-17

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9.3.4

Editing the measurement result display layout ... 9-18

9.3.5

Saving the user-registered measurements ... 9-23

9.4

Modifying a User-Registered Measurement (Modify) ... 9-24

9.5

Copying a User-Registered Measurement Sample (Sample Copy)... 9-25

9.6

Copying a Registered Measurement (Copy) ... 9-26

9.7

Loading a User-Registered Measurement from External Media (Upload) ... 9-27

9.8

Saving a User-Registered Measurement on External Media (Save) ... 9-28

9.9

Clearing All the User-Registered Measurement (All Clear) ... 9-29

9.10

Terminating Measure Registration (Exit) ... 9-29

9.11

Executing a User-Registered Measurement ... 9-29

Optional Unit Operation 10.

Recording Devices ... 10-1

10.1

VCR ... 10-2

10.1.1

Recording to the VCR ... 10-2

10.1.2

Operation using the menu ... 10-2

10.1.3

Operations from the main panel ... 10-4

10.1.4

Daily checks for VCR recording ... 10-5

10.1.5

Measurement using VCR playback images ... 10-7

10.2

Printer ... 10-10

10.3

HDD ... 10-11

10.3.1

Saving images ... 10-12

10.3.2

Procedures for displaying saved images ... 10-13

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10.4

TEAC MO Drive ... 10-15

11.

How to Use the Transducer ... 11-1

11.1

PEF-510MA ... 11-1

11.1.1

Icon display setting... 11-1

11.1.2

Indication of the rotation angle... 11-2

11.1.3

Temperature control ... 11-3

11.1.4

Temperature detection function check procedure ... 11-5

11.2

PVM-740RT ... 11-6

11.2.1

Selecting the scanning plane ... 11-6

11.2.2

Display example ... 11-7

Optional Software Operation 12.

THI (Tissue Harmonic Imaging) Display Mode ... 12-1

12.1

What Is THI Mode? ... 12-1

12.2

Operating Procedures ... 12-1

13.

TDI (Tissue Doppler Imaging) Display Mode ... 13-1

13.1

What Is TDI Mode? ... 13-1

13.2

Operating Procedures ... 13-1

14.

CI/FEI Mode ... 14-1

14.1

Outline of CI/FEI Modes ... 14-2

14.2

Display in CI/FEI Mode ... 14-3

14.3

Image Adjustment on the Main Panel... 14-6

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14.4

Image Adjustment Using the Menu ... 14-7

14.5

Cine Memory Operating Procedure ... 14-20

15.

Time Intensity Curve (TIC) Measurements ... 15-1

15.1

Features of the Time Intensity Curve (TIC) Measurement Function... 15-1

15.2

Operating Procedures ... 15-2

15.3

Display Format of the Time Intensity Curve ... 15-7

15.4

TIC Data File Output ... 15-10

16.

Dynamic Flow Mode ... 16-1

16.1

Features of Dynamic Flow Mode ... 16-1

16.2

Operating Procedure ... 16-1

17.

Automated Cardiac Flow Measurement (ACM) ... 17-1

17.1

Outline of ACM... 17-1

17.2

Features of ACM ... 17-2

17.3

Precautions for Measurement ... 17-3

17.4

Display of the Menus ... 17-5

17.5

Operating Procedure ... 17-7

17.6

Display Format for Measurement Results ... 17-9

17.7

Restrictions ... 17-10

17.8

Flow Volume Calculation Method ... 17-11

17.9

List of Related Documents ... 17-13

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