SSD-α10 Measurement E1 Manual Number MN1-5207 Rev13 ver 7.1

MN1-5207 Rev.13

VS-FlexGrid Pro Copyright(C)1999 Videosoft Corporation Portions of this software are based in part on the work of the Independent JPEG Group.

MN1-5207 Rev.13 Safety alert symbols

Safety alert symbols The four indications [Danger], [Warning], [Caution] and [Note] used on this instrument and in this instruction manual have the following meaning.

Danger Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. A warning message is inserted here.

Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. A warning message is inserted here.

Caution Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. A caution message is inserted here.

Note Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the instrument and also to ensure that it is used efficiently. An explanatory text is inserted here.

Classification of SSD-α10 • Protection against electric shock: Class I medical electrical equipment • Applied parts:Type BF applied parts • Protection against defibrillator emissions: Not compatible with defibrillator-proof applied parts • Protection against harmful ingress of water or particulate matter: Ordinary protection (IPX0) • Level of safety for use in air and flammable anesthetic gas, or in oxygen/nitrous oxide and flammable anesthetic gas: This instrument is not suitable for use in air and flammable anesthetic gas, or in oxygen/nitrous oxide and flammable anesthetic gas. • Operation mode: Continuous operation

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MN1-5207 Rev.13

CONTENTS This book consists of two separate volumes. These two volumes have the same table of contents and the index respectively.

1. Measurement Functions 1-1. 1-2. 1-3. 1-4. 1-5.

1-6. 1-7.

1-8. 1-9.

1-10.

1-11. 1-12.

Preface... 1-1 Flow of Measurement Operations... 1-2 Switches Used for Measurement... 1-3 1-3-1. The function of the panel switch used by the measurement operation ... 1-3 Basic Operation Procedure for Measurement ... 1-4 1-4-1. Method of starting measurement... 1-4 Explanation of the Measurement Menus ... 1-9 1-5-1. When the measurement Study is changed... 1-9 1-5-2. When the measurement application is changed ... 1-10 Executing the Application Measurement Using the Transfer Function... 1-11 Measurement Mark and Measurement Method ... 1-13 1-7-1. Basic types of marks ... 1-13 1-7-2. Auxiliary line type marks... 1-13 1-7-3. Display mark ... 1-14 1-7-4. The basic operating method for each mark type ... 1-15 Basic Measurement Functional Outline... 1-22 1-8-1. Basic Measurement Functional List... 1-22 Measurement operation procedure... 1-25 1-9-1. B mode ... 1-25 1-9-2. M mode ... 1-44 1-9-3. D mode ... 1-49 1-9-4. B/D mode ... 1-63 1-9-5. B (Flow) mode ... 1-68 1-9-6. VCR Calibration... 1-72 Preset Function... 1-77 1-10-1. Composition of the preset function ... 1-77 1-10-2. Basic operations and function of each button ... 1-78 1-10-3. Initializing Preset ... 1-79 1-10-4. Create Measurement Tools ... 1-80 1-10-5. Application Measurement Tools ... 1-85 1-10-6. Study Assignment ... 1-94 1-10-7. SW Assignment... 1-98 Calculation Formula & Reference ... 1-102 1-11-1. Calculation ... 1-102 Abbreviation... 1-106

2. Cardiac Measurement 2-1. 2-2.

Preface... 2-1 Cardiac Measurement Functional Outline ... 2-2 2-2-1. Cardiac Measurement Functional List ... 2-2 2

MN1-5207 Rev.13

2-3.

2-4.

2-5.

2-6.

2-7.

2-2-2. Items of Special Note... 2-7 2-2-3. Measurement Views for Measuring Cardiac Functions ... 2-8 Measurement operation procedure ... 2-10 2-3-1. B mode... 2-11 2-3-2. M mode... 2-32 2-3-3. D mode... 2-41 2-3-4. Flow mode ... 2-73 Report function ... 2-92 2-4-1. Basic Operation of a Report ... 2-92 2-4-2. Report Block...2-93 2-4-3. Description of Various Data Displayed in a Report ... 2-97 2-4-4. Function that Attaches an Ultrasound Image to a Report... 2-99 2-4-5. Printing Function ... 2-102 2-4-6. Output to a Personal Computer... 2-104 2-4-7. Output to a CSV file ... 2-105 Preset function ... 2-106 2-5-1. Preset Settings(Cardiac Measurement)... 2-106 2-5-2. PRESET list ... 2-107 Calculation Formula & Reference...2-115 2-6-1. Calculation... 2-115 2-6-2. Clinical References... 2-125 Abbreviation ... 2-133

3. Vascular Measurement 3-1. 3-2.

3-3.

3-4.

3-5.

3-6.

Preface ... 3-1 Vascular Measurement Functional Outline ... 3-2 3-2-1. Vascular Measurement Functional List ... 3-2 3-2-2. Items of Special Note... 3-3 Measurement operation procedure ... 3-4 3-3-1. B mode... 3-6 3-3-2. D mode... 3-12 Report function ... 3-24 3-4-1. Basic Operation of a Report ... 3-24 3-4-2. Report Block...3-25 3-4-3. Description of Various Data Displayed in a Report ... 3-29 3-4-4. W. Trace Function ... 3-36 3-4-5. Function that Attaches an Ultrasound Image to a Report... 3-38 3-4-6. Printing Function ... 3-41 3-4-7. Output to a Personal Computer... 3-43 3-4-8. Output to a CSV file ... 3-44 Preset function ... 3-45 3-5-1. Preset Settings... 3-45 3-5-2. PRESET list ... 3-46 Calculation Formula & Reference...3-52 3-6-1. Calculation... 3-52 3-6-2. Anatomy Check List ... 3-53 3

MN1-5207 Rev.13

3-7.

3-6-3. Clinical References ... 3-55 Abbreviation... 3-57

4. Abdominal measurement 4-1. 4-2.

4-3.

4-4.

4-5.

4-6.

4-7.

Preface... 4-1 Abdominal Measurement Functional Outline... 4-2 4-2-1. Abdominal Measurement Functional List... 4-2 4-2-2. Items of Particular Note ... 4-4 Measurement operation procedure... 4-5 4-3-1. B mode ... 4-6 4-3-2. D mode ... 4-14 Report function ... 4-22 4-4-1. Basic Operation of a Report... 4-22 4-4-2. Report Block ... 4-23 4-4-3. Description of Various Data Displayed in a Report... 4-27 4-4-4. Graph... 4-30 4-4-5. W. Trace... 4-31 4-4-6. Function that Attaches an Ultrasound Image to a Report ... 4-33 4-4-7. Printing Function... 4-36 4-4-8. Output to a Personal Computer ... 4-38 4-4-9. Output to a CSV file... 4-39 Preset function... 4-40 4-5-1. Preset Settings ... 4-40 4-5-2. PRESET list ... 4-41 Calculation Formula & Reference ... 4-47 4-6-1. Calculation ... 4-47 4-6-2. Clinical References ... 4-47 Abbreviation... 4-48

5. Obstetrical Measurement 5-1. 5-2.

5-3.

5-4.

Preface... 5-1 Obstetrical Measurement Functional Outline ... 5-2 5-2-1. Obstetrical Measurement Functional List ... 5-2 5-2-2. List of obstetrical measurement name built into system... 5-5 5-2-3. Items of Special Note ... 5-9 Measurement operation procedure... 5-10 5-3-1. B mode ... 5-11 5-3-2. M mode ... 5-25 5-3-3. D mode ... 5-27 5-3-4. Multiple pregnancies... 5-32 5-3-5. Interval Growth Rate... 5-34 Report function ... 5-35 5-4-1. Basic Operation of a Report... 5-35 5-4-2. Report Block ... 5-36 5-4-3. Description of Various Data Displayed in a Report... 5-40

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MN1-5207 Rev.13

5-5.

5-6.

5-7.

5-4-4. Function that Attaches an Ultrasound Image to a Report... 5-54 5-4-5. Printing Function ... 5-57 5-4-6. Output to a Personal Computer... 5-59 5-4-7. Output to a CSV file ... 5-60 Preset function ... 5-61 5-5-1. Preset Settings... 5-61 5-5-2. PRESET list ... 5-63 Calculation Formula & Reference & Table...5-72 5-6-1. Calculation... 5-72 5-6-2. Anatomy Check List ... 5-78 5-6-3. BPP Scoring... 5-80 5-6-4. References... 5-82 5-6-5. Data in the fetal growth table inside the system ... 5-96 Abbreviation ... 5-137

6. Gynecological Measurement 6-1. 6-2.

6-3.

6-4.

6-5.

6-6.

6-7.

Preface ... 6-1 Gynecological Measurement Functional Outline ... 6-2 6-2-1. Gynecological Measurement Functional List... 6-2 6-2-2. Items of Special Note... 6-3 Measurement operation procedure ... 6-4 6-3-1. B mode... 6-6 6-3-2. D mode... 6-13 Report function ... 6-15 6-4-1. Basic Operation of a Report ... 6-15 6-4-2. Report Block...6-16 6-4-3. Description of Various Data Displayed in a Report ... 6-20 6-4-4. Function that Attaches an Ultrasound Image to a Report... 6-27 6-4-5. Printing Function ... 6-30 6-4-6. Output to a Personal Computer... 6-32 6-4-7. Output to a CSV file ... 6-33 Preset function ... 6-34 6-5-1. Preset Settings... 6-34 6-5-2. PRESET list ... 6-35 Calculation Formula & Reference...6-40 6-6-1. Calculation... 6-40 6-6-2. Anatomy Check List ... 6-40 6-6-3. Clinical References... 6-41 Abbreviation ... 6-43

7. Urological Measurement 7-1. 7-2.

Preface ... 7-1 Urological Measurement Functional Outline ... 7-2 7-2-1. Urological Measurement Functional List ... 7-2 7-2-2. Items of Particular Note... 7-3

5

MN1-5207 Rev.13

7-3.

7-4.

7-5.

7-6.

7-7.

Measurement operation procedure... 7-4 7-3-1. B mode ... 7-6 7-3-2. D mode ... 7-18 Report function ... 7-20 7-4-1. Basic Operation of a Report... 7-20 7-4-2. Report Block ... 7-21 7-4-3. Description of Various Data Displayed in a Report... 7-25 7-4-4. Graph function ... 7-30 7-4-5. Function that Attaches an Ultrasound Image to a Report ... 7-31 7-4-6. Printing Function... 7-34 7-4-7. Output to a Personal Computer ... 7-36 7-4-8. Output to a CSV file... 7-37 Preset function... 7-38 7-5-1. Preset Settings ... 7-38 7-5-2. PRESET list ... 7-39 Calculation Formula & Reference ... 7-43 7-6-1. Calculation ... 7-43 7-6-2. References ... 7-44 Abbreviation... 7-46

8. eTRACKING Measurement 8-1. 8-2.

8-3.

8-4.

Preface... 8-1 eTRACKING Measurement Functional Outline ... 8-1 8-2-1. Outline of Function ... 8-1 8-2-2. Measurement operation procedure... 8-1 Report function ... 8-2 8-3-1. Basic Operation of a Report... 8-2 8-3-2. Report Block ... 8-3 8-3-3. Description of Various Data Displayed in a Report... 8-5 8-3-4. Function that Attaches an Ultrasound Image to a Report ... 8-6 8-3-5. Printing Function... 8-9 8-3-6. Output to a Personal Computer ... 8-11 8-3-7. Output to a CSV file... 8-12 Preset function... 8-13 8-4-1. Preset Settings ... 8-13 8-4-2. PRESET list ... 8-14

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MN1-5207 Rev.13 1-1.Preface

1. MEASUREMENT FUNCTIONS 1-1.

Preface The measurement functions of the SSD-ALPHA10 are divided by application (clinical area) into Abdomen, OB, GYN, Cardio, Vascular, URO, eTRACKING, and Small Parts. The measurement values found in ultrasonic examination are recorded and managed for each patient. They are effective for evaluation of observation over time. In addition to selecting a measurement from the menu, you can also transfer the results of a basic measurement to an applied measurement and compute the results of applied measurement. Also, the available measurements depend on the application, so there are ultrasonic studies that bring together the measurement items for each application. (Examples of studies for each application)

Application

Ultrasonic Study

Remark

Cardio

Cardiac Func.

Coronary

TDI

Vascular

Carotid Artery

Lower Ext Artery Lower Ext Vein

Upper Ext Vein

TCD

Asynchrony

Refer to Section 2

Upper Ext Artery

Refer to Section 3

Abdom

Basic

Refer to Section 4

OB

Basic

Early

Twin Basic

GYN

GYN

Follicles

Bladder

Refer to Section 6

URO

Prostate&SV

Bladder&Testis

Kidney

Refer to Section 7

eTRACKING

eTRACKING

FMD

Wave Intensity

Refer to Section 8

Twin Early

Refer to Section 5

[Remark] These application measurement functions are based on documents that indicate the clinical effectiveness of the measurements concerned. Consequently, they use measurement conditions and special computation formulas. The abovementioned documents are listed at the end of the section for each application measurement function, so refer to the relevant documents. [Remark] The application measurement functions of the SSD-ALPHA10 include a function called EXAM. HISTORY for performing a progress observation (development evaluation, treatment evaluation, and so on.). This function records and manages measurement values and operation index values obtained during various ultrasonic examinations, and displays the results as numerical values and/or graphs. For this reason, in order to use this function correctly, be sure to enter the patient data using the ID screen before performing an ultrasonic examination. The various measurement functions of the SSD-ALPHA10 ultrasonic diagnostic instrument are described in the following sections. Section1 Section2 Section3 Section4

Basic Measurement Functions Cardiac Measurement Functions Vascular Measurement Functions Abdominal Measurement Functions

Section5 Section6 Section7 Section8

This section describes the basic measurement method. This section consists of 108 pages. 1-1

Obstetric Measurement Functions Gynecological Measurement Functions Urological Measurement Functions eTRACKING

MN1-5207 Rev.13 1-2.Flow of Measurement Operations

1-2.

Flow of Measurement Operations Select the application.

(1)

Input the patient information.

(2)

Select the ultrasonic study.

(3)

Execute the measurement.

→

Input the patient information with the New Patient (ID) screen in order to correctly operate the patient management functions effectively for evaluating observations over time. For details, refer to Section 1 How to Use.

Select the ultrasonic study. →

(4)

In order to obtain correct ultrasonic measurement results, the computation equations and patient management database are decided according to the application selected.

Input the patient information. →

The measurement functions that can be executed are determined by the selected ultrasonic examination study. Refer to Section 1-5-1. “When the measurement Study is changed”

Execute the measurement. →

(5)

Report

Select the preset application (clinical area).

The measurement values are updated in real time until the measurement operation is finalized. Up to 10 caliper marks can be displayed in the measurement results display area. Section 1-4-1-1. “Starting from the + switch”. Section 1-4-1-3. “Starting from the MEASUREMENT switch”. Section 1-4-1-4. “Starting from a Hot key”.

Report →

The measurement values displayed on the report screen can be set with the preset function to either the most recent values or an average. Also, up to six of these measurement values can be preset for each measurement item. (For an explanation of each item, see the pages for each application.)

[Remark] The SSD-ALPHA10 has the following three functions for recording the results of examinations. a.

When operation (4) above is performed and a report is displayed, it is recorded by the recording device (thermal printer) connected to the SSD-ALPHA10.

b.

The report can be printed on paper using to Printer in the Output function of the Report screen.

c.

The measurement results can be transmitted to the application software of an external personal computer using to PC in the Output function of the Report screen.

1-2

MN1-5207 Rev.13 1-3.Switches Used for Measurement

1-3.

Switches Used for Measurement

1-3-1. The function of the panel switch used by the measurement operation (1) - (2) are switches for starting measurement, and (3) - (9) are switches related to measurement operations. (7)

-

+

(8)

(9)

NEW PATIENT

(3)

(5) (9)

(1) (2)

(1)

(4)

(9)

(6)

: The measurement menu corresponding to the display mode is displayed. MEASUREMENT switch

(2)

+ switch

: Directly starts the basic measurement corresponding to each display mode registered in a preset. Also, displays a new mark if pressed during measurement.

(3) (4)

Trackball ENTER switch

(5)

CANCEL switch

: Used to move a measurement mark. : Press this switch to separate marks or to change over the mark to be moved by the trackball. : Returns the system to the immediately preceding (or initial) mark display condition.

(6)

SEND switch

: Press to finalize the measurement operation presently taking place.

(7)

Touch panel

: Measurement menu is displayed.

(8) (9)

Rotary encoder 4 USER 1, 2, 3 switch

: The trace line is deleted little by little. : Directly starts the function or measurement registered using a preset.

1-3

MN1-5207 Rev.13 1-4.Basic Operation Procedure for Measurement

1-4.

Basic Operation Procedure for Measurement

1-4-1. Method of starting measurement You can use one of the following three methods to start a measurement. (1)

Display the measurement menu, and start the selected measurement.

(2)

Press the + switch to perform (basic) measurement.

[Remark] You can transfer the results obtained here to each parameter of the application measurement. Refer to Section 1-6. “Executing the Application Measurement Using the Transfer Function”. (3)

Start measurement directly. →

1-4-1-1. (1)

Press the hot key (alphabet key) on the full keyboard to start the measurement.

Starting from the + switch Press the + switch. →

The preset measurement is started.

Control menu

Measurements set in Preset

[Remark] Up to eight frequently used basic measurement items can be preset to the + switch for each display mode. Control menu: Clear VCR Calib Trace Manual Locate Mark Display Report

: Measurement function is finished. : Calibration for VCR playback measurement can be performed. : It is switched to a manual trace directly from an auto trace of a doppler waveform. : Change the position of (move) the measurement results display area. : On/Off of displaying caliper mark is made. : Report of application measurement is displayed.

[Remark] Control menu is different with each an application.

1-4

MN1-5207 Rev.13 1-4.Basic Operation Procedure for Measurement

(2)

Select the basic measurement item which is carried out on the touch panel, and perform the measurement.

(3)

After measurement, to measure again, press the + switch. →

The last measurement is started.

[Remark] Pressing the CANCEL switch returns the system to the status before separation without finalizing the measured caliper mark. If the CANCEL switch is pressed before the caliper mark is separated, the mark is erased.

1-4-1-2.

Starting measurement with a compound mode image

When pressing the + switch on hybrid modes (B/M and B/D modes), the measurement corresponding to each ultrasound image (B, M, and D) is performed. For example, for B/M mode as in the figure below, when the + switch is pressed, the caliper mark is displayed on the M image with a priority order (D → M → B). The caliper mark is moved to the B mode image side with the trackball. The moment at which the caliper mark is moved into the B mode image it becomes Dist. The measurement items and control menu display at the bottom of the screen also change to the B mode image. Moving the + mark to the B (M) image with the trackball

M.VEL

DIST

1-5

MN1-5207 Rev.13 1-4.Basic Operation Procedure for Measurement

1-4-1-3. (1)

Starting from the MEASUREMENT switch Press the →

switch.

The preset measurement menu and control menu are displayed.

Measurement menu

[Remark] Pressing the (2)

switch on the operation panel erases the measurement menu.

Select the measurement item displayed on the touch panel. →

The selected measurement starts.

Example: Uterus measurement

The proceeding order of the measurements can be selected voluntarily.

1-6

MN1-5207 Rev.13 1-4.Basic Operation Procedure for Measurement

1-4-1-4.

Starting from a Hot key

Pressing a letter key starts the measurement item or control function allocated to that key directly without passing through the measurement menu. Here is an explanation using an example in which the GYN measurement Uterus (Volume) is assigned to the Q key. (1)

Press the Q key. →

The system starts Uterus measurement and measures each position.

[Remark] Measurement items can be assigned to letter keys on the keyboard with the preset function.

1-7

MN1-5207 Rev.13 1-4.Basic Operation Procedure for Measurement

1-4-1-5.

Erasing individual marks

By performing the following operation, measurement values corresponding to the measurement marks which were fixed can be erased individually. (1)

Select the ch with the same number as the measurement results for erasing from the touch panel.

ch which corresponds to the number of measured times is displayed.

(2)

For example, press the ch1 switch once. →

(3)

The caliper mark becomes ready for re-measurement.

Once again, press the ch switch which was pressed in (2). →

The caliper mark with the number of 1 and the measurement results are erased.

[Remark] When the Clear switch on the control menu is pressed, the caliper mark and the measurement results are erased. To erase only the executed mark press the CANCEL switch on the operation panel twice. If the measurement has not yet been carried out (when there is one mark), pressing the CANCEL switch ends the measurement function.

1-4-1-6.

Ending a measurement function

The measurement marks and results on the screen are erased in the following cases. • When you press (select) the Clear switch. • When you press the MEASUREMENT switch. • When you cancel a freeze status [Remark] The above applies only when the Caliper auto off function in the Preset menu is ON.

1-8

MN1-5207 Rev.13 1-5.Explanation of the Measurement Menus

1-5.

Explanation of the Measurement Menus (1)

Press the →

switch.

The measurement menu is displayed on the touch panel. The preset of the measurement is displayed.

Basic : The menu is displayed.

The measurement having multiple measurement methods is displayed on the lower row.

The application which is currently on

The basic measurement results are copied to the application measurement results.

1-5-1. When the measurement Study is changed (1)

Select the Study & Application on the touch panel. →

The measurement Study that is changeable is displayed

Measurement Study

(2)

Select the Study to change. →

The Study is changed.

1-9

MN1-5207 Rev.13 1-5.Explanation of the Measurement Menus

1-5-2. When the measurement application is changed You can change the measurement menu from one to another clinical field during measurement, and perform an application measurement. (1)

Select the Study & Application on the touch panel. →

(2)

The Application which can be changed is displayed on the Change Application.

Select the Application and Study to change. →

The Application is changed. After selecting the Application, select the Study.

1-10

MN1-5207 Rev.13 1-6.Executing the Application Measurement Using the Transfer Function

1-6.

Executing the Application Measurement Using the Transfer Function The copying function is a function to transcribe fundamental measurement results to various application measurements and to register the report. Various application measurements can be completed without executing the application measurement through the measurement menu by carrying out the basic measurement with the + switch and using the transfer function. The case that was transcribed of basic measurement results that was transferred to an Uterus measurement of a gynecologic measurement is explained as an example. (1)

Measure with the Distance of the basic measurement, and select the Transfer on the touch panel. →

(2)

The measurement menu of GYN (Gynecologic measurement) is displayed.

Select the Uterus on the menu. →

A list of transferred items is displayed on the touch panel and the measurement results that can be transferred are displayed with white space on a colored background on the basic measurement.

Measurement results that can be transferred

1-11

List of transferred items

MN1-5207 Rev.13 1-6.Executing the Application Measurement Using the Transfer Function

(3)

Select the Length. →

The measurement results of (1) are transferred to the Length of an Uterus measurement. After these operations are repeated for A-P and Width, the Uterus measurements can be finished.

[Remark] When there are multiple measurement results, move the arrow to the measurement results that are wanted for transfer, and select the transfer address on the touch panel. [Remark] The number displayed, on the list of transferred items is the number of reports which were registered. [Remark] When a transferred item different from the measurement method of the basic measurement results is selected, it cannot be transferred. In that case, when a message is displayed, select the transferred item once again.

<Already measured value reuse function> The value measured at one location can be used for other application measurement. The explanation below uses an example in which gynecological uterus measurements of Length and A-P have already been measured. (1)

Select the Uterus on the touch panel. →

(2)

The already measured length and A-P measurement values are displayed in the measurement results area.

Measure the Width, then press the →

switch.

The measurement results are registered in the report.

[Remark] Whether or not to reuse already measured values can be set with the preset function.

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