DP-20 series Advanced Operation Manual Ver 1.0

Content Content ...i Intellectual Property Statement ... I Preface ... II Product Differences ... II Safety Precautions ... III

1

Overview ... 1-1 1.1 1.2

Basic Operations and Buttons... 1-1 Measurement Menu ... 1-2 1.2.1 Menu Title ... 1-2 1.2.2 Location Tags ... 1-3 1.2.3 Measurement Tools ... 1-3 1.2.4 Other ... 1-4 1.3 Measurement, Calculation and Study ... 1-4 1.4 Measure Caliper ... 1-5 1.5 Result Window ... 1-5 1.5.1 Result Display ... 1-5 1.5.2 Moving Result Window ... 1-5 1.5.3 Result Assignment ... 1-6 1.6 Cross-window Measurement... 1-7 1.7 Exam Report ... 1-7 1.7.1 Viewing Report ... 1-7 1.7.2 Editing Report ... 1-8 1.7.3 Viewing History Report ... 1-10 1.7.4 Printing Report ... 1-10 1.7.5 Exporting Report ... 1-11 1.7.6 Fetal Growth Curve... 1-11

2

Preset ... 2-1 2.1 2.2 2.3

Basic Preset Procedures ... 2-1 Measurement Parameters ... 2-1 Obstetric Preset... 2-2 2.3.1 Obstetric Formulae ... 2-2 2.3.2 Obstetric Preset Operations ... 2-7 2.4 Measure Preset ... 2-9 2.4.1 Preset of General Measurement ... 2-10 2.4.2 Application Measurement Preset... 2-11 2.5 Fast OB Measurement ... 2-14

3

General Measurement ... 3-1 3.1 3.2

Basic Procedures of General Measurement ... 3-1 2D General Measurements ... 3-1 3.2.1 Depth ... 3-1 3.2.2 Distance ... 3-1 3.2.3 Angle ... 3-2 3.2.4 Area&Circ ... 3-2 3.2.5 Volume ... 3-3 3.2.6 Cross ... 3-4

i

3.2.7 Parallel ... 3-5 3.2.8 Trace Length ... 3-5 3.2.9 Ratio (D) ... 3-5 3.2.10 Ratio (A)... 3-6 3.2.11 B-Profile ... 3-6 3.2.12 B-Hist ... 3-6 3.3 M General Measurements ... 3-7 3.3.1 Distance ... 3-7 3.3.2 Time ... 3-7 3.3.3 Slope ... 3-8 3.3.4 Velocity ... 3-8 3.3.5 HR ... 3-8 3.4 References ... 3-9

4

Abdomen ... 4-1 4.1 4.2 4.3 4.4 4.5

5

Abdomen Exam Preparations ... 4-1 Basic Abdomen Measurement Procedures ... 4-1 Abdomen Measurement Tools ... 4-1 Abdomen Measurement Operations ... 4-3 Abdomen Exam Report ... 4-3

Obstetrics ... 5-1 5.1 5.2 5.3

Obstetric Exam Preparations ... 5-1 Basic Measurement Procedures ... 5-1 GA ... 5-1 5.3.1 Clinical GA ... 5-1 5.3.2 Ultrasound GA ... 5-2 5.4 Obstetric Measurement Tools ... 5-4 5.5 Obstetric Measurement Operations ... 5-8 5.5.1 Measurement Tool Operations ... 5-8 5.5.2 Calculation Tool Operations ... 5-8 5.5.3 Study Tool Operations... 5-8 5.6 Multi-fetus Exam... 5-8 5.7 Obstetric Exam Report ... 5-9 5.7.1 Fetal Biophysical Profile ... 5-9 5.7.2 Fetal Growth Curve... 5-10 5.8 References ... 5-11

6

Cardiology ... 6-1 6.1 6.2 6.3

Cardiac Exam Preparations ... 6-1 Basic Cardiac Measurement Procedures ... 6-1 Cardiac Measurement Tools ... 6-1 6.3.1 2D Cardiac Measurements ... 6-2 6.3.2 M Cardiac Measurements ... 6-4 6.4 Cardiac Measurement Operations ... 6-6 6.4.1 Measurement Tool Operations ... 6-6 6.4.2 Calculation Tool Operations ... 6-6 6.4.3 Study Tool Operations... 6-6 6.5 Cardiac Exam Report ... 6-22 6.6 References ... 6-22

7

Vascular ... 7-1 7.1

ii

Vascular Exam Preparations ... 7-1

7.2 7.3 7.4

Basic Vascular Measurement Procedures ... 7-1 Vascular Measurement Tools ... 7-1 Vascular Measurement Operations ... 7-2 7.4.1 Calculation Tool Operations ... 7-2 7.5 Vascular Exam Report... 7-2 7.6 References ... 7-2

8

Gynecology ... 8-1 8.1 8.2 8.3 8.4

Gynecology Exam Preparations ... 8-1 Basic Gynecology Measurement Procedures ... 8-1 Gynecology Measurement Tools ... 8-1 Gynecology Measurement Operations... 8-2 8.4.1 Measurement Tool Operations ... 8-2 8.4.2 Calculation Tool Operations ... 8-3 8.4.3 Study Tool Operations... 8-3 8.5 Gynecology Exam Report ... 8-4 8.6 References ... 8-4

9

Urology ... 9-1 9.1 9.2 9.3 9.4

Urology Exam Preparations ... 9-1 Basic Urology Measurement Procedures ... 9-1 Urology Measurement Tools ... 9-1 Urology Measurement Operations ... 9-3 9.4.1 Measurement Tool Operations ... 9-3 9.4.2 Calculation Tool Operations ... 9-3 9.4.3 Study Tool Operations... 9-4 9.5 Urology Exam Report ... 9-6 9.6 References ... 9-6

10 Small Parts ... 10-1 10.1 Small Parts Exam Preparations ... 10-1 10.2 Basic Small Parts Measurement Procedures ... 10-1 10.3 Small Parts Measurement Tools... 10-1 10.4 Small Parts Measurement Operations ... 10-2 10.4.1 Measurement Tool Operations ... 10-2 10.4.2 Calculation Tool Operations ... 10-2 10.4.3 Study Tool Operations... 10-3 10.5 Small Parts Exam Report ... 10-3 10.6 References ... 10-4

11 Orthopedics...11-1 11.1 11.2 11.3 11.4 11.5 11.6

Orthopedics Exam Preparations ... 11-1 Basic Orthopedics Measurement Procedures ... 11-1 Orthopedics Measurement Tools ... 11-1 HIP Measurement Operations ... 11-3 Orthopedics Exam Report ... 11-3 References ... 11-3

iii

© 2013 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All Rights Reserved. For this Operator’s Manual, the issue date is 2013-01.

Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

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.

I

Preface This manual details the procedures for operating the DP-20/DP-20T/DP-21/DP-25/DP-28 Digital Ultrasonic Diagnostic Imaging System. Carefully read and understand the manual before using the system to ensure its safe and correct operation. NOTE:

When you operate the system, you can refer to the following manuals: „

Operator’s Manual (Basic Volume)

„

Acoustic output data

Depending on the software version, the preset settings, and optional configuration, the actual interfaces may appear different from those shown in this manual. NOTE:

The functions described in this manual are not provided for all systems sold in all regions. Functions that are available dependents on the specific system you purchased.

All the menus and screens in this manual take the system in full configuration as an example.

Product Differences DP-20T, DP-21, DP-25 and DP-28: not sold in FDA region.

II

Safety Precautions 1. Meanings of Signal Words In this manual, the signal words Danger, WARNING, CAUTION and NOTE 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

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

WARNING

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

CAUTION

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

NOTE

Indicates a potentially hazardous situation that, if not avoided, may result in property damage.

2. Meaning of Safety Symbols Symbol

Description General warning, caution, risk of danger.

3. Safety Precautions Please observe the following precautions to ensure patient and operator’s safety when using this system.

CAUTION:

1.

Select the proper patient image and measurement tools. Only the professionals can decide the appropriate measurements and results.

2.

Confine measurement calipers to the actual Region of Interest (ROI). Measurements that extend beyond the ROI will be incorrect.

3.

Before examining a new patient, it is necessary to press the < End Exam> key to end the current scan and delete the patient information and data. Otherwise, new patient data will be combined with the previous patient.

4.

When the system is turned OFF or the < End Exam> key is pressed, all the data that have not been saved are lost.

5.

Changing modes during a measurement will delete the General Measurement data.

6.

Pressing the < Freeze> key to unfreeze the image during a measurement will clear the General Measurement data.

7.

Pressing the < Measure> key during a measurement will clear the General Measurement data.

III

IV

8.

Pressing the < Clear> key will clear the measurement caliper, all data in the result window, comments and body mark.

9.

In dual-B imaging mode, the measurement results of the merged image can be inaccurate. Therefore, the results are provided for reference only, not for confirming a diagnosis.

10.

Ensure that measurement data correctly corresponds to the fetus during the Obstetric Measurement.

11.

The auto measurement might not be accurate when the result doesn’t match the image exactly, please make the measurement manually.

12.

Fully understand the functionality of this system by referring to the Operator’s Manual - Basic Volume.

1

Overview

1.1

Basic Operations and Buttons

Tips:

The following descriptions for buttons and keys are used in this manual: „

< >: Denotes key/ button on the control panel or keyboard. E.g. <Set>.

„

[ ]: Denotes button/item on the screen menu. E.g. [OK].

Click/Select [item/button]: to move the cursor over the item/button and press <Set>.

Basic Measurement Procedures 1. Press <End Exam> to start a new exam. 2. Press <Patient> and input the patient information. It includes patient ID, name, height, weight etc. Type in manually for a new patient, or load an existing patient from iStation or Worklist. The patient information entered is used for measurement data storage, analysis and exam report. For more details, refer to "Exam Preparation -> Patient Information" in the Operator's Manual [Basic Volume]. 3. Press <Probe> and select a proper exam mode. For more details, refer to "Exam Preparation" in the Operator's Manual [Basic Volume]. 4. Measure preset. To preset measurement parameters, obstetric formula, general/ application measurement packages etc. For details, refer to “2 Preset”. 5. Press <Measure> to start measurement. 6. Select an item in the measure menu. For general and application measurement items (tools), see "3 General Measurement " and the chapter of specified application measurements for details. 7. Press <Report> to view the exam report. For report editing and browsing, see “1.7 Exam Report”.

Button Functions Key Caliper Measure Update

Basic operations Enters/exits general measurement. Press <Esc> to exit measurement status. To enter/exit the application measurement. Press <Esc> to exit measurement status. Press <Update> to switch between the fixed end and active end of the caliper during a measurement.

1-1 Overview

Key

Basic operations To select an item on the measurement menu and press <Set> to activate it.

Set

Press <Set> confirm and end the current operation during measurement.

Back

To return to the previous measurement step, or delete the caliper backwards.

Clear

To clear all measurement calipers on the screen and data in the result window.

Report

To enter/ exit the report page.

Cursor

To show the cursor.

Palm Switch

To move the cursor.

Multifunction knob

To enable the commonly used measure function or used for selecting measurement item by rotating.

For details on key functions, see “System Overview” in the Operator's Manual [Basic Volume].

1.2

Measurement Menu

Menus of General and Application measurement are different. measurement menu, refer to "3 General Measurement" and the specified application measurement chapter. Measurement menu items are as follows:

Menu title Location Tags

Tools

Other

1.2.1

Menu Title

It displays the name of the measure menu, i.e. name of the measurement package

Overview 1-2

„

To switch to other measurement menus 1.

Move cursor to the menu title and the submenu pops up displaying other measure packages available.

2.

Move the cursor to an item and press <Set>.

1.2.2

Location Tags

The location widgets are used to select locations of the measurement. Side (Left/Right): Used to the item (e.g. kidney) that contains measurement of left/ right side parameters respectively. z Location (Prox/Mid/Dist): Used to items (e.g. vascular) contains measurement of Proximal, Middle or Distal parameters. To Select the Measurement Location: z

„

1.

Move the cursor to the location widgets (e.g. Side).

2.

Press <Set> to select the Measurement location.

Tips:

The location widgets are applicable only in application measurement.

1.2.3

Measurement Tools

There are two kinds of measurement tools. „

General tool: Basic measure tool in General Measurement, such as the "distance" and "Area".

„

Application tools: The measurement tools in Application Measurement. These items are classified and combined in clinical application package such as Abdomen, Obstetric, etc. E.g. HC (head circumference) in the Obstetric measurement is one of the application tools.

Tips:

1.

Actually, most application tools use the general measurement method while measuring, e.g. an "Area" tool is used when measuring the HC. Only the application measurement results are recorded in the report.

2.

For definition of the measurement, calculation and study, refer to "1.3 Measurement, Calculation and Study".

Supported application measurement categories: z z z z z z z z

Note:

Abdomen Obstetric Cardiology Gynecology Urology Small Parts Orthopedics (ORTH) Nerve Wherein the Nerve is intended to observe nerve structures during anesthesia. It includes no specific tools, however, you can preset the tools included in nerve package. See "2.4.2.2 Measurement Package Preset" for package preset.

1-3 Overview

To Active the Measurement Tools The procedures are as follows: 1.

Move the cursor to the item and press <Set>.

2.

A ">>" displays on the right side of the item if a submenu exists.

3.

Click on the >> and enter the submenu.

4.

Start the measurement by clicking an item on the menu.

5.

Click [Return] to return to the upper menu after measurement.

Other Features Feature Current tool/item

Description measurement

Highlighted.

Measured item

Performed application item/tool are marked with a "√". (If one or some items in a submenu (extended menu) of a study are already performed, this study will be marked as measured.)

Page up/down

A scroll bar displays if the items can not be displayed in one page.

Item unavailable

1.2.4

Greyed out. Need switch to the proper imaging mode to enable it.

Other

During application measurement in multiple modes, the [Other] item appears at the bottom of the menu is used to switch to other available measure menu.

1.3

Measurement, Calculation and Study

There are three kinds of measurement items.

Measurement Results of measurements are directly obtained via the measurement tools, which are indicated by “ ”.

Calculation Results of calculations are automatically derived by the system, using other measured or calculated values as parameters, they are indicated by “ ”. If all measurement tools related to a calculation tool are completed, the system will automatically complete the calculation result. If some measurement tools are performed again, the system will automatically update the calculation result using the latest measurement results.

Study A group of measurements and / or calculations for a specific clinical application. Fold/ unfold the study to hide/show the measurement or calculation items included.

Overview 1-4

1.4

Measure Caliper

A measurement caliper is a graphics consists of several points and straight line or curve drawn on the ultrasound image.

Fixed/ Active End The ends of calipers can be active or fixed. The active end is called a Cursor.

Caliper Color An active caliper appears in green, and a fixed caliper appears in white.

Symbols of the Caliper Ends 8 symbols are used as the caliper ends circularly, as shown in figure below.

These symbols display in calipers as well as in the result window to indentify different measurements. NOTE:

1.5

You can preset the cursor type in [System Preset] -> [Application], see "2.2 Measurement Parameters" for more information.

Result Window

Two types of result windows are used to display results numerically or graphically.

1.5.1

Result Display

Set [Result] to "ON" and the latest results display in the result window. When viewing the results: „

If the result window is full, the oldest value will be replaced according to the "first in, first out" rule. A maximum of 8 results display in the result window, and a maximum of 2 graphical result windows can appear in the screen.

„

To indentify the measurement results, symbols or numbers are used in the numerical result window while "No:1" or "No:2" is used in the graphical result window.

The results can display in the following type: „

No result displays when a measurement item/tool is activated but without the start point fixed.

„

The result displays as numbers when the value obtained is within the clinical range.

„

The result displays as "value!" when it's out of the clinical range but is still within the ultrasound range.

„

The result displays as "?" when it is out of the ultrasonic range.

1.5.2

Moving Result Window

To move the result window, 1.

Place the cursor to the result window title and press <Set>.

2.

Rotate the trackball to place the result window in a desired position.

3.

Press the <Set> key to fix the result window.

1-5 Overview

1.5.3

Result Assignment

A general measurement result can be assigned to an application measurement item in the result window.

System-defined Application Item Assignment The procedures are as follows: 1. Move the cursor to a general measurement result in the result window, press <Set> when the item highlighted in green, the matching list pops up as shown below.

Matching application items that meet the following requirements are displayed: a) Preset in current application package. b) Use the same general measurement tool with the result. Application items in the Abdomen measurement that use the "Distance" method are listed as shown above. 2. Select an application item in the list, press <Set>. 3. The assigned value displays in the result window and is saved in the exam report. Tips:

You can perform an assignment directly to the latest general measurement result by: 1.

Enter an application measure menu (e.g. Abdomen), when a general measurement (e.g. "Distance") is completed.

2.

Click the desired application item in the menu. The selected application item also has to meet the matching rules in step 1.

3.

If the application item(s) is/are preset in the current report, the assignment results will be saved in the report.

Assigning a New Application Item When no (desired) item displays in the matching list, you can create a new application item. The procedures are as follows: 1. Select [new] at the bottom of the matching list. 2. The following dialog box pops up.

a) Type in the new name.

Overview 1-6

b) Select the application region. 3. Click [OK] to assign the general result to the new item. NOTE:

Re-assignment for the assigned general result is not available.

Exiting Result Assignment Press <Esc> in the keyboard, or select [Cancel] in the matching list to exit.

1.6

Cross-window Measurement

For linear probe, cross-window measurement is available in dual-B mode when the left and right windows are imaging with the same probe, depth and invert mode.

1.7

Exam Report

The report records measurement results, which are automatically saved by system after each measurement. „

Press <Report> to enter the report dialog box.

„

The default report of the current exam appears.

„

After viewing, press <Report> or <Esc> key, or select [OK] or [Cancel] to exit the report page.

1.7.1

Viewing Report

Contains in the report page are described as follows (taking Obstetric report as an example):

1-7 Overview

„

Each measurement contains three latest values and a final value.

„

The report only displays results of the tools in the report template and completed.

„

Select [Previous] or [Next] to display the previous or next page if the report is more than one page. Click [Previous] or [Next] to display the previous or next page.

1.7.2

Editing Report

Available operations of report editing are as follows: „

Editing Measurement Data

„

Entering Ultrasound Remarks

„

Adding/ Removing Images

„

Analyzing Report Data

Editing Measurement Data

CAUTION: Input appropriate data when editing the measurement values, otherwise misdiagnosis may occur.

Overview 1-8

„

The 3 measurement values in text boxes are editable, move the cursor to the text box and press <Set>.

„

Modified values are underlined.

„

The final value display in the [Value] column. Select an option ([Last], [Avg], [Max] or [Min]) from [Method] to determine the method in which the final value is calculated.

„

For result values used to calculate GA (Gestational Age) and SD (Standard Deviation), the formula used in this calculation can be selected from [Formula]. GA and SD value updates with the formula change. GA and EDD value updates with the formula change.

NOTE:

„

1.

Only measurement values are editable while calculation values are not.

2.

After a measurement value is modified, the average value of the tool and the corresponding calculation value will be updated automatically.

Clearing Data

To clear all data except the patient information in the report dialog box, select [Clear All].

Entering Ultrasound Remarks You can input corresponding information in the report dialog box.

Adding/ Removing Images Image(s) saved in current exam can be added to the report. 1. Select [Image Select] to pop up the following dialog box.

Left Column: Image(s) saved in current exam. Right Column: Images selected to add into the report. 2. Select the image. (1) Adding/ Removing the image by pressing: [>]

To add the selected image in the left column into the right column.

1-9 Overview

[>>]

Add all images in the left column into the right column.

[<]

To remove selected image in the right column.

[<<]

To remove all images in the right column.

(2) Adjust the image arrangement. Select an image in the right column and click [Up] or [Down] to adjust the image sequence, in which the images are arranged in the report. 3. Click [OK] to confirm.

Analyzing Report Data You can edit OB anatomy information in the report. 1. Click [Analyze]. Tltrasound anatomy (OB or vascular) items are listed in the page pop up. 2. Select or type in anatomy descriptions. Tips:

Descriptions of [Fetus Score] can only be selected from the drop-down list.

3. Input the corresponding comments in the report dialog box. 4. Click [OK] to confirm. Analysis information displays following the measurement values in the report.

CAUTION: Input appropriate data when editing the measurement values, otherwise misdiagnosis may occur.

1.7.3

Viewing History Report

If more than one exam is performed to a patient, a drop-down list of [Exam] appears in the report. 1. Select history exams from the [Exam] drop-down list. 2. According to the exam mode, select a proper template from the [Report Type]. Make sure the template matches the exam mode, otherwise the measurement result will not display correctly. E.g. an abdomen measurement result will not display in an OB report template that preset without any abdomen measurement items. 3. Viewing the history report. NOTE:

1.7.4

1.

History reports can be viewed, but cannot be edited.

2.

Also, you can view the patient information in iStation, see "Patient Data Management" in the Operator's Manual [Basic Volume] for details.

Printing Report

Click [Print] in the report page to print the report. Or, click [Print View] in the report page to preview. In preview page, you can: Print Report

Click [Print].

Page up/down:

Select [Prev Page] or [Next Page] to view the previous or next page.

Zoom in/out:

Select a zoom ratio from the drop-down list.

Exit preview:

Overview 1-10

the

Click [Close].

1.7.5

Exporting Report

The reports can be exported in PDF or RTF documents, which can be viewed and edited on a PC. 1. In the report dialog box, select [Export]. 2. Select the drive, directory and file name in the dialogbox popped up. 3. Select a file type. 4. Click [OK].

1.7.6

Fetal Growth Curve

You can view the fetal growth curve by clicking the [Growth] button in the report page. See “5.7.2 Fetal Growth Curve” for details.

1-11 Overview

2

Preset

Before measuring, preset the following parameters: z z z z

2.1

Measurement Parameters Preset Obstetric Preset General Measurement Preset Application Measurement Preset

Basic Preset Procedures

The basic measure preset procedures are as follows: 1. Enter the Setup menu by pressing <Setup> on the keyboard. 2. Preset the measurement parameters. Enter [Setup] -> [System Preset] -> [Application] to preset the Measure ruler etc. See "2.2 Measurement Parameters" for details. 3. Preset the Obstetric formula. Enter the [Setup] -> [System Preset] -> [OB] page. Preset the GA (Fetal Gestational Age), FG (Fetal Growth) and the Fetal Weight. See "2.3 Obstetric Preset" for details. 4. Measure preset. Enter [Setup] -> [Measure Preset] -> [Caliper] and [Measure] to preset the measurement menu, and items. See "2.4 Measure Preset" for details. 5. Return from the setup to make the settings taking effect. Click [Save] on the [Setup] menu to return from the setup.

2.2

Measurement Parameters

Basic operation steps: 1. Press <Setup> to show the setup menu. 2. Select [Setup] -> [System Preset] -> [Application] to preset the following parameters: z Measure Ruler z Left ventricular study z Follicle z Comment 3. Click [Save] to confirm.

The following are function descriptions of the parameters.

2-1 Preset