BK Medical

bk3000 Ultrasound System Advanced User Guide Aug 2014

Advanced User Guide

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Advanced User Guide

bk3000 Ultrasound System

16-01255-EN-00 August 2014

For Professional Users Only

LEGAL MANUFACTURER BK Medical Aps Mileparken 34 DK-2730 Herlev Denmark Tel.:+45 4452 8100/Fax:+45 4452 8199 www.analogicultrasound.com Email: [email protected]

The serial number label on a BK Medical product contains information about the year of manufacture.

BK Medical Customer Satisfaction

Input from our customers helps us improve our products and services. As part of our customer satisfaction program, we contact a sample of our customers a few months after they receive their orders. If you receive an email message from us asking for your feedback, we hope you will be willing to answer some questions about your experience buying and using our products. Your opinions are important to us. You are of course always welcome to contact us via your BK Medical representative or by contacting us directly. If you have comments about the user documentation, please write to us at the email address above. We would like to hear from you. •

•

Scanner Software NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. BK Medical HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED UPON BK Medical TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR USE. EXPORT RESTRICTIONS. You acknowledge that Windows 8 Embedded is of US-origin. You agree to comply with all applicable international and national laws that apply to Windows 8 Embedded, including the U.S. Export Administration Regulations, as well as end-user, end-use and country destination restrictions issued by U.S. and other governments. For additional information on exporting Windows 8 Embedded, see http:// www.microsoft.com/exporting/ The bk3000 Ultrasound System is closed. Any modification of or installation of software to the system may compromise safety and function of the system. Any modification of or installation of software without written permission fromBK Medical will immediately void any warranty supplied by BK Medical. Such changes will also void any service contract and result in charges to the customer for restoration of the original bk3000 Ultrasound System.

Trademarks: DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. FireWire is a trademark of Apple Computer, Inc. Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries. Pro Package is a trademark of BK Medical.

Contents Chapter 1

Before You Begin... 11

Chapter 2

The User Interface... 13 Working with the Monitor... 13 Selecting a Transducer... 13 Selecting an Examination Type... 14 Patient Information... 15 Document Browser... 15 Measurements and Image Data... 15 Workflow Tabs... 15 Keyboard Control Panel... 17

Chapter 3

Controls on the Monitor... 19

Chapter 4

Working with the Image... 27 Selecting the Imaging Plane... 27 Freezing the Image... 27 Partial Freeze and the Update Key... 27 Split Screen... 28 Simultaneous Imaging... 28 Linked Split/Dual... 29 Labels and Bodymarks... 29 Labels... 29 Bodymarks... 30 Cine... 31 Using Cine... 31 Using Cine in M-Mode or Doppler Mode... 32 Video Display... 33 The Video Window and Picture in Picture (PiP)... 33 Using the Video Window... 33 Using PiP... 34

Chapter 5

Making Measurements... 37 Measurements and Calculations... 37 Making a Measurement – General Procedure... 37 B-Mode and Color Mode Measuring Tools... 38 Doppler Mode Measuring Tools... 45

Chapter 6

Documentation... 49 What are Documents?... 49 HIPAA Compliance... 49 Saving Documents – Capturing Images and Video Clips... 49 Capturing 2D Images... 50 Video Clips – Capturing while Imaging... 50 Capturing 3D Data Sets... 50

Saving Reports... 50 Local Patient Archiving System... 51 Reviewing Documents... 51 The Document Browser... 51 Viewing and Editing Video Clips... 53 Viewing Exported Documents on the System... 53 Viewing Exported Documents on an External Computer... 54 Exporting Data... 55 HIPAA Compliance and Exporting Data... 55 Copying to a CD/DVD or USB Storage Device... 55 Archiving to a CD/DVD or Network Drive... 55 Using CD/DVDs... 56 Using USB Storage Devices... 58 Using a Network Drive... 58 The Archive Window (Examination List and Patient Information)... 59 Patient Information... 60 Examination List... 60 Deleting Documents or Exams from the System... 62 Starting a New Examination from the Examination List... 63 Pausing and Later Resuming an Examination... 63 Password Protection of the Patient Archiving System... 64 Hard Disk Quota... 65 Reports... 65 Creating a Report... 65 Editing a Report... 67 Printing a Report... 67 Saving a Report to the Local Patient Archiving System... 67 Printing Documents or Images on the Monitor... 67 Printing Thumbnail Images... 67 Printing Images Displayed on the Monitor... 68 Using a Transducer Button... 68 ... 68

Chapter 7

Imaging Modes... 69 Imaging Modes... 69 Adjusting the Thermal Index Limit... 69 B-Mode... 70 Focus... 70 Gain... 71 Zoom... 72 Depth... 72 Gray Scales... 73 Combination Modes... 73 Tissue Harmonic Imaging (True Echo Harmonics – TEH)... 74 Contrast Imaging1... 75 Color Mode and Power Mode... 78 Color Submodes... 78 Color Coding of Flow... 78 Independent D-Mode/C-Mode Steering... 79

Color Box... 79 Color Scales... 79 Elastography... 80 Color Box... 81 Color Map... 82 Quality Indicator... 82 Strain Ratio Measurement... 82 Diameter Comparison Measurement... 82 Vector Flow Imaging (VFI)1... 83 Using VFI... 85 Arrow Flow Indicators for VFI... 86 Streamlined VFI Workflow... 87 Assisted Doppler Gate Placement... 87 Angle Correction... 88 Assisted Doppler Steering... 88 Inverting the Doppler Spectrum... 88 Selecting the Appropriate Scale/PRF... 88 Assisted Volume Flow Rate Estimation... 88 Asymmetric Doppler Gate Cross... 89 Outline of VFI Workflow... 89 Doppler Mode – Spectral Doppler... 90 Turning Doppler Mode On or Off... 90 Adjusting the Doppler Mode Image... 91 Doppler Indicator... 91 Independent D-Mode/C-Mode Steering... 92 Doppler Trace (Automatic Curve Tracing)... 92 Sweep Speed... 92 M-Mode... 92 The M-Mode Image... 93 M-Mode Line... 94 M-Mode Image Ruler... 94 Saving a Preset... 94

Chapter 8

Continuous Wave Doppler Mode... 95 Overview... 95 Adjusting the Thermal Index Limit... 95 Adjusting MI... 95 Turning CW Doppler Mode On or Off... 95 CW Doppler Line... 96 Audio Volume... 97 Adjusting the Doppler Mode Image... 97 Doppler Trace (Automatic Curve Tracing)... 97 Auto... 97 Gain... 97 Scale... 98 Smooth... 98 Wall Filter... 98 Invert... 98 Baseline... 99

Sweep Speed... 99

Chapter 9

Pro Packages...101 Before You Begin... 101 If You Perform a Puncture Procedure... 101 What Is a Pro Package?... 101 Presets... 101 Measurements... 102 Doppler Measurements... 102 Stenosis... 104 VF (Volume Flow)... 104 TAM (Time Average Mean) and TAMX (Time Average Max)... 105 RI and PI (Resistance Index and Pulsatility Index)... 106 Real-Time Measurements... 107 Noise Limit... 108 Carotid Velocities... 108 Calculations... 108 Using the Brachy Pro Package... 108 Patient Setup... 108 Calculating Volumes... 109 Performing a Biopsy or Puncture Procedure (including Brachytherapy). . 111 Using the OB, Gyn, and Gyn Follicles Pro Packages... 113 Gestational Age and Expected Date of Confinement... 113 Patient Setup... 113 Making Measurements... 113 Calculation Methods... 114 Obstetrics Reports... 114

Chapter 10

Vascular Pro Package...119 Contents... 119 Presets... 119 Setting up the Patient – Patient ID... 120 Imaging Controls... 120 B-Mode (2D)... 120 Color Mode (CFM)... 121 Doppler Mode... 121 Annotations – Labels and Bodymarks... 122 Labels... 122 Bodymarks... 123 Measurements and Calculations... 124 Using the Calculation Package... 124 Using Reports... 126 Capturing and Documenting Images... 127 Cine Review... 127 Capturing Images... 127 Copying and Archiving... 128 Printing... 128 Customization Examples... 129 New Presets... 129

Default Pro Packages and Presets... 129 Making a New Screen Key... 130 Vascular Measurement Abbreviations... 132 Leg Vein Measurements... 132 Artery Measurements... 133 Where to Find More Information... 135

Chapter 11

Cardiac Pro Package...137 Contents... 137 Presets... 137 Setting up the Patient – Patient ID... 138 Imaging Controls... 138 B Mode (2D)... 138 M-Mode... 138 Color Mode (CFM)... 139 Doppler Mode... 139 Annotations... 139 Labels... 140 Bodymarks... 141 Measurements and Calculations... 141 Basic Cardiac Measurements... 141 LV V (Left Ventricular Volume)... 141 Doppler Measurements... 143 HR (Heart Rate)... 144 Using Reports... 145 Capturing and Documenting Images... 145 Cine Review... 145 Capturing Images... 145 Copying and Archiving... 146 Printing Images... 146 Customization Examples... 147 Creating a Custom Keyboard Key for M-Mode... 147 Customizing Labels and Bodymarks Using Advanced Mode... 147 FATE (Focus Assessed Transthoracic Echocardiography)... 148 Preset... 148 FATE Measurements... 148 Where to Find More Information... 150

Chapter 12

Urology Prostate Pro Package...151 Contents... 151 Diagnostic Presets... 151 Setting up the Patient – Patient ID... 152 Imaging Controls... 152 B Mode (2D)... 152 Annotations – Labels and Bodymarks... 154 Labels... 154 Customizing Labels and Bodymarks Using Advanced Mode... 155 Bodymarks... 156 Measurements and Calculations... 157

Automatic Measurement of Prostate Volume... 157 User Reports... 158 Capturing and Documenting Images... 158 Cine Review... 158 Capturing Images... 158 Copying and Archiving... 159 Printing Images... 159 Customization Examples... 160 New Presets... 160 Default Pro Packages and Presets... 160 Where to Find More Information... 161 ... 161

Chapter 13

3D Imaging1...163 Introduction to 3D Ultrasound... 163 3D License... 163 Controlling Transducer Movement... 164 Untracked Freehand Acquisition... 164 3D Imaging Overview... 164 Preparations... 165 Adjusting the Image Capture Settings... 166 ROI (3D Region of Interest)... 166 3D Capture Settings... 166 Acquisition... 167 Viewing a 3D Data Set... 167 Enhancing a 3D View... 168 3D Layout Options... 168 Working with the 3D Image... 168 Manipulating the Volume... 168 Annotating a 3D View... 170 User Views... 171 The 6 Data Presentation Views... 171 Cube View... 171 Render View... 174 MIP View... 175 Transparency View... 175 4-Up View... 176 6-Up View... 176 Save, Capture and Close... 176

Chapter 14

DICOM...177 DICOM on the System... 177 New Patient Information from a DICOM Worklist... 177 Saving or Printing to a DICOM Network... 177 Filenames of Documents Exported in DICOM Format... 177 Archiving to a PACS... 178 Reports... 178 Deleting a Document... 179 Discontinuing an Examination with an MPPS Server... 179

Appendix A

Glossary... 181

Appendix B

Measurement Abbreviations... 187

Appendix C

Setting Up and Customizing Your System... 207 Pro Package and Presets... 208 Doppler and M-Mode Monitor Layout... 209 User-Defined Keys... 209 Assigning User-Defined Keys... 211 Customizing Key Brightness, Mouse Controls and Depth Control... 211 System Setup... 212 General Setup... 212 Clip Storage and Cine Setup... 214 3D Setup... 217 Printer Setup... 217 Password Setup... 219 Network Archiving... 220 Version Information... 220 Video I/O Setup... 221 Miscellaneous System Setup... 222 Measurements... 224 User-Defined Measurements... 225 Curves... 229 Miscellaneous Measurement Setup... 232 Marks (Bodymarks, Labels, Puncture Guides)... 234 Bodymark Setup... 234 Label Setup... 234 Transperineal Matrix, Brachy Matrix and Ruler, and Programmable Puncture Guide Setup... 235 Miscellaneous Marks Setup... 241 Licenses... 241 Importing and Exporting System Configurations... 242 Importing or Exporting Presets... 244 DICOM Setup... 247

Appendix D

Redefining Screen Keys – Label, Bodymark, and Measurement... 249 Other Settings... 250

Appendix E

Configuring the bk3000... 253 Before You Begin... 253 Configuration Mode... 253 Key Definitions (Redefining an Existing Key)... 253 Unavailable Spaces... 255 The Imaging Tabs... 255 Special 3D Mode Tab... 256 Measure and Mark Tabs... 256 Documentation Tab... 256 Patient Dialog... 257 Display Areas and Info Boxes... 257

Prioritizing the Display of Measurements and Settings... 259 Creating a New Pro Package in Configuration Mode... 259 Index

261

Chapter 1 Before You Begin This is the advanced user guide for the bk3000 Ultrasound System. The bk3000 User Guide includes an overview of all the documentation available for the system, including different user guides. NOTE: You must read the Safety chapter in the bk3000 User Guide before working

with the system. About this guide

This guide takes you deeper into the functionality and potential of the bk3000 Ultrasound System. NOTE: Some of the functionality and options described in this guide may not be

available with your version of the system. Questions About the System

Where to Find the Answers

What are the various parts of the monitor display?

“The User Interface” on page 13

Is there an alphabetical list of all the controls on the system?

“Controls on the Monitor” on page 19

How do you make measurements and calculations for an image, and what measurement tools are available?

“Making Measurements” on page 37

How do you manage the images, clips, 3D data sets, and reports that are made on the system?

“Documentation” on page 49

What imaging modes are available on the bk3000?

“Imaging Modes” on page 69 and “3D Imaging1” on page 163

What is an examination type, and how does it help with imaging?

“Pro Packages” on page 101

How does DICOM® work with the bk3000?

“DICOM” on page 177

What do various abbreviations mean?

“Glossary” on page 181

Can the bk3000 be customized and how?

“Setting Up and Customizing Your System” on page 207, and “Redefining Screen Keys – Label, Bodymark, and Measurement” on page 249,

How do you configure the system?

“Configuring the bk3000” on page 253

bk3000 Advanced User Guide (16-01255-EN-00)

Before You Begin

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Chapter 2 The User Interface Working with the Monitor This chapter introduces you to each part of the monitor (Fig 2-1). Keyboard functionality

For a description of the keyboard, see Getting Started with bk3000. The first 3 steps for imaging are: 1 Select a transducer. 2 Select an examination type. 3 Enter the patient information. You work in the upper part of the monitor to perform these step, as shown in Fig 2-1. Select exam type

Enter patient information

Select transducer

Documentation panel or browser

Measurement data

Image data

Imaging mode tabs

Advanced key

Workflow tabs

Figure 2-1. The monitor user interface for the bk3000.

Selecting a Transducer From the drop-down list, select the transducer that you will use for imaging. Only transducers properly connected to the system appear on the list.

bk3000 Advanced User Guide (16-01255-EN-00)

The User Interface

Selecting an Examination Type The examination type configures your monitor for imaging. An examination type consists of a Pro Package (predefined monitor settings) and a preset (predefined image processing settings). The names of the examination types indicate where they are best suited: urology, gynecology, and so on. NOTE: Pro Packages are indicated by brighter white text. Yellow text indicates the selected Pro Package and preset (Uro Prostate and Prostate M in this picture). Pro Package Defines monitor setup such as tabs, screen controls, measurements, labels, bodymarks, reports. Yellow (Uro Prostate) indicates the chosen Pro Package.

preset Defines settings for image processing such as transducer frequency, gain, etc.

NOTE: A measurement that is set up for one preset in a Pro Package will be available

in all presets for that Pro Package. Accessing other Pro Packages

If you need access to measurements or functions available in other Pro Packages, you can click the Pro Package name instead of a preset name. This will not affect the image setup itself. The list of Pro Packages displayed depends on which transducers are connected to the system. If the Pro Package you need is not listed, click Pro Package...

2. Choose from the list of other Pro Packages for additional measurements, labels, etc.

1. Click Pro Package...

Figure 2-2. Finding a Pro Package from the list of all Pro Packages.

For information about examination types, see Chapter 9, “Pro Packages” on page 101.

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Patient Information After you select the transducer and exam type for your imaging, click the patient information area at the top of the monitor. (It might say Enter Patient or contain a patient name or the current time and date). You can also press the Patient key on the keyboard. A window opens where you can enter patient information. The fields that are available for entering patient information depend on the examination type. NOTE: If you are capturing an image or clip, or using 3D, you must enter a patient

name and ID. You can configure the patient information area to show the information you want. See Appendix E, “Configuring the bk3000”.

Document Browser For information about using the Document Browser, see Chapter 6, “Documentation” on page 49.

Measurements and Image Data For information about making and using measurements on the system, see Chapter 5, “Making Measurements” on page 37. For information about working with the image, see Chapter 4, “Working with the Image” on page 27. If measurement data are covered by workflow tabs, minimize the tabs by clicking the top tab. Customizing

You can customize which measurement and image data are displayed, where they are displayed on the monitor, and the font size for measurements. For more information about this customization, see Appendix E, “” on page 253 or consult your BK Medical representative.

Workflow Tabs Workflow tabs follow a typical workflow of a patient examination. The workflow tabs open automatically as needed so that only relevant controls are displayed. The tabs are at the bottom of the monitor and are often minimized when you start the system. Click to open them up. • • •

The Image tab is on top when you are imaging. When you freeze an image, the Measure and Mark tab opens so you can make measurements or annotations. When you want to copy, print, or archive documents, or make a report, open the Documentation tab.

Minimize all tabs by clicking the top workflow tab. Maximize all tabs by clicking any tab. To open a workflow tab that is not on top, click it. Most on-screen controls are grouped and displayed as screen keys on the appropriate workflow tabs. You can always click a tab to see its controls.

bk3000 Advanced User Guide (16-01255-EN-00)

The User Interface

Advanced By default, only the controls relevant for the situation are displayed. Click Advanced to display all available controls for any of the tabs. NOTE: Advanced must be on to access Customize, which is where you configure

settings as described in “Setting Up and Customizing Your System” on page 207.

The Image Tab The Image tab is on top when you start to image. Imaging mode subtabs for the Image tab

Screen keys on the Image workflow tab are grouped on various imaging mode tabs, visible at the top of the workflow tab. Click on an imaging mode tab to open it and see and use its keys. NOTE: If an imaging mode tab is active, but its tab is not on top, click the tab to open

it and use its keys. If you click the imaging mode tab that is on top, you turn off that imaging mode. The imaging mode subtabs for Image are • • • •

General: controls for B-mode Color: controls for color mode and power mode Doppler: controls for spectral Doppler mode M-mode: controls for M-mode.

NOTE: An imaging mode tab (for example, M-mode) is available only when the

examination type is set up to include that mode. Capturing a 3D data set is initiated by the 3D key on the keyboard or by the 3D controls on the Image tab.

3D Tab 3D images

Viewing and manipulating a 3D data set can be considered virtual imaging – an additional step in the workflow. When you have captured or recalled a 3D data set, a 3D workflow tab appears. It may be divided into 2 subtabs, which appear at the top of the tab area, similar to imaging mode tabs. For information about 3D imaging, see Chapter 13, “3D Imaging1” on page 163.

Measure and Mark Tab The Measure and Mark tab opens when you freeze the image. It contains controls for the measurements and annotations that are set up for the examination type. More

Click More Meas., More Bodymarks or More Labels to see more measurements or annotations than are immediately shown on individual screen keys.

Down arrows indicate lists

The down arrow on the right of a screen key indicates that clicking the key opens a menu to choose from. NOTE: The More screen keys are only visible when Advanced is on.

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Figure 2-3. The More screen keys on the Measure and Mark tab. Redefining Screen Keys

Accessing any measurement label, or bodymark screen key

If the Measure and Mark tab does not contain a screen key you need, you can redefine one of the screen keys. (See Appendix D, “Redefining Screen Keys – Label, Bodymark, and Measurement”.) You can access any measurement from any measurement screen key. To access any measurement: 1 Click Advanced. 2 Click the circle in the top right corner of a key to open the Key Definition Menu and click the word(s) that name the measurement, not the circle next to it. (See Appendix D, “Redefining Screen Keys – Label, Bodymark, and Measurement”.) This is handy for a measurement that is used only occasionally. You can do the same thing for label and bodymark screen keys.

Documentation Tab After acquiring the image and making measurements, use the Documentation tab for saving, reviewing, or deleting the images and reports you made.

Keyboard Tab Keyboard panel opens when you need it

You can press any active button or slider on the monitor as needed. When a box opens that requires you to enter text, for example Patient ID information, the keyboard panel opens automatically. Type the information that is required, and then press another workflow tab to close the keyboard panel.

Using two keys at the same time

When using a physical keyboard, you may need to use two keys at one time for certain results. For example, pressing Shift and A results in an upper-case A. For the same result on the on-screen keyboard, you press the keys one at a time: first Shift, then A. This method applies to the Ctrl, Alt, Shift, and Fn keys. When you press one of these keys, it lights up and remains lit until you press another key to complete the typing.

Keyboard Control Panel The keyboard control keys are described in Getting Started with bk3000.

Typing Special Letters or Accents Some special letters are available as keys on the keyboard. In addition, 4 accents are available on the Accent key.

bk3000 Advanced User Guide (16-01255-EN-00)

The User Interface

Figure 2-4. The Accent key.

To use the Accent key, press the key and THEN press the letter that is to be accented. Examples:

18 Chapter 2

To write this

Press this

Then press this

➶ (or ↔)

Accent

o (or Shift + o, for O)

è or (È)

Shift + Accent

e (or Shift + e, for E)

ñ (or Ñ)

fn+ Accent

n (or Shift + n, for N)

ê (or Ê)

Shift + fn+ Accent

e (or Shift + e, for E)

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Chapter 3 Controls on the Monitor This chapter contains a list of all on-screen controls in alphabetical order for easy reference. Some on-screen controls only appear when Advanced is turned on or when the system has been set up to display them. See Appendix C, “Setting Up and Customizing Your System” and Appendix D, “Redefining Screen Keys – Label, Bodymark, and Measurement”. Not all of the controls in the list can be configured by the user. Monitor Control

Function

%d ]

Set the frame number for the end of a cine loop.

[ %d

Set the frame number for the beginning of a cine loop.

2D Filter

Set amount of color information smoothing in Color or Power mode.

Turn 3D imaging on or off.

3D Frames

Display the number of frames.

ACI

Turn Angular Compound Imaging on or off to reduce speckle and optimize the ultrasound image. ACI is only supported for some transducers. NOTE: If ACI is turned on, you cannot select number of focal zones.

Advanced

Make all available controls on a tab visible.

All

Select all documents in the browser.

Angle

In Doppler mode, correct the Doppler angle. In 3D, measurement of angle.