bk3000 & bk5000 Advanced User Guide Ref 2300 Nov 2018

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

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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 and bk5000 Ultrasound Systems are 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 or bk5000 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. Curve®, Kick® and Buzz® are registered trademarks of Brainlab. Microsoft® and Windows® are registered trademarks of Microsoft Corporation in the United States and other countries. Pro Package is a trademark of BK Medical. bk3000 & bk5000 = Ref. Type 2300 © 2018 BK Medical Information in this document may be subject to change without notice.

Contents Chapter 1

Before You Begin... 13

Chapter 2

The User Interface... 15 Working with the Monitor... 15 Selecting a Transducer... 15 Selecting an Examination Type... 16 Patient Information... 17 Document Browser... 17 Measurements and Image Data... 17 Workflow Tabs... 17 Keyboard Control Panel... 20

Chapter 3

Controls on the Monitor... 21

Chapter 4

Working with the Image... 29 Selecting the Imaging Plane... 29 Freezing the Image... 29 Partial Freeze and the Update Key... 30 Split Screen... 30 Simultaneous Imaging... 30 Linked Split/Dual... 31 Labels and Bodymarks... 31 Labels... 31 Bodymarks... 32 Cine... 33 Using Cine... 34 Using Cine in M-Mode or Doppler Mode... 34 Video Display... 35 The Video Window and Picture in Picture (PiP)... 35 Using the Video Window... 35 Using PiP... 36

Chapter 5

Making Measurements... 39 Measurements and Calculations... 39 Making a Measurement – General Procedure... 39 B-Mode and Color Mode Measuring Tools... 40 Doppler Mode Measuring Tools... 47

Chapter 6

Documentation... 51 What are Documents?... 51 HIPAA Compliance... 51 Saving Documents – Capturing Images and Video Clips... 51 Capturing 2D Images... 52 Video Clips – Capturing while Imaging... 52 Capturing 3D Data Sets... 52

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Saving Reports... 52 Local Patient Archiving System... 53 Reviewing Documents... 53 The Document Browser... 53 Viewing and Editing Video Clips... 55 Viewing Exported Documents on the System... 55 Viewing Exported Documents on an External Computer... 56 Exporting Data... 57 HIPAA Compliance and Exporting Data... 57 Copying to a CD/DVD or USB Storage Device... 57 Archiving to a CD/DVD or Network Drive... 58 Using CD/DVDs... 58 Using USB Storage Devices... 61 Using a Network Drive... 61 The Archive Window (Examination List and Patient Information)... 61 Patient Information... 62 Examination List... 62 Deleting Documents or Exams from the System... 64 Starting a New Examination from the Examination List... 65 Pausing and Later Resuming an Examination... 65 Password Protection of the Patient Archiving System... 66 Hard Disk Quota... 67 Reports... 67 Creating a Report... 68 Editing a Report... 69 Printing a Report... 69 Saving a Report to the Local Patient Archiving System... 69 Printing Documents or Images on the Monitor... 69 Printing Thumbnail Images... 70 Printing Images Displayed on the Monitor... 70 Using a Transducer Button... 70

Chapter 7

Imaging Modes... 71 Imaging Modes... 71 Adjusting the Thermal Index Limit... 71 B-Mode... 72 Focus... 72 Gain... 73 Auto Gain... 74 Zoom... 75 Depth... 76 Gray Scales... 76 Combination Modes... 77 Tissue Harmonic Imaging (True Echo Harmonics – TEH)... 77 Contrast Imaging... 78 X-Shine... 81 Activate X-Shine Imaging... 82 Adding Buttons to the Screen... 83 Color Mode and Power Mode... 84

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Color Submodes... 84 Color Coding of Flow... 84 Independent D-Mode/C-Mode Steering... 85 Color Box... 85 Color Scales... 85 Elastography... 86 Color Box... 87 Color Map... 87 Quality Indicator... 87 Strain Ratio Measurement... 87 Diameter Comparison Measurement... 88 Vector Flow Imaging (VFI)... 89 Using VFI... 91 Arrow Flow Indicators for VFI... 91 Streamlined VFI Workflow... 92 Assisted Doppler Gate Placement... 93 Angle Correction... 93 Assisted Doppler Steering... 93 Inverting the Doppler Spectrum... 93 Selecting the Appropriate Scale/PRF... 93 Assisted Volume Flow Rate Estimation... 94 Asymmetric Doppler Gate Cross... 95 Outline of VFI Workflow... 95 Doppler Mode – Spectral Doppler... 96 Turning Doppler Mode On or Off... 96 Adjusting the Doppler Mode Image... 97 Doppler Indicator... 97 Independent D-Mode/C-Mode Steering... 97 Doppler Trace (Automatic Curve Tracing)... 97 Sweep Speed... 98 M-Mode... 98 The M-Mode Image... 98 M-Mode Line... 99 M-Mode Image Ruler... 99 Saving a Preset... 99

Chapter 8

Continuous Wave Doppler Mode...101 Overview... 101 Adjusting the Thermal Index Limit... 101 Adjusting MI... 101 Turning CW Doppler Mode On or Off... 101 CW Doppler Line... 102 Audio Volume... 103 Adjusting the Doppler Mode Image... 103 Doppler Trace (Automatic Curve Tracing)... 103 Auto... 103 Gain... 103 Scale... 104 Smooth... 104

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Wall Filter... 104 Invert... 104 Baseline... 105 Sweep Speed... 105

Chapter 9

Pro Packages...107 Before You Begin... 107 If You Perform a Puncture Procedure... 107 What Is a Pro Package?... 107 Presets... 108 Measurements... 108 Doppler Measurements... 109 Stenosis... 110 VF (Volume Flow)... 111 TAM (Time Average Mean) and TAMX (Time Average Max)... 111 RI and PI (Resistance Index and Pulsatility Index)... 112 Real-Time Measurements... 113 Noise Limit... 114 Carotid Velocities... 114 Calculations... 115 Using the Brachy Pro Package... 115 Patient Setup... 116 Calculating Volumes... 116 Performing a Biopsy or Puncture Procedure (including Brachytherapy). . 118 Using the OB, Gyn, and Gyn Follicles Pro Packages... 120 Gestational Age and Expected Date of Confinement... 120 Patient Setup... 120 Making Measurements... 120 Calculation Methods... 121 Obstetrics Reports... 121

Chapter 10

Vascular Pro Package...125 Contents... 125 Presets... 125 Setting up the Patient – Patient ID... 126 Imaging Controls... 126 B-Mode (2D)... 126 Color Mode (CFM)... 127 Doppler Mode... 127 Volume Flow... 128 Annotations – Labels and Bodymarks... 128 Labels... 129 Bodymarks... 129 Measurements and Calculations... 130 Using the Calculation Package... 130 Using Reports... 132 Capturing and Documenting Images... 133 Cine Review... 133 Capturing Images... 134

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Copying and Archiving... 134 Printing... 135 Customization Examples... 135 New Presets... 135 Default Pro Packages and Presets... 136 Making a New Screen Key... 137 Vascular Measurement Abbreviations... 138 Leg Vein Measurements... 138 Artery Measurements... 139 Where to Find More Information... 141

Chapter 11

Cardiac Pro Package...143 Contents... 143 Presets... 143 Setting up the Patient – Patient ID... 144 Imaging Controls... 144 B Mode (2D)... 144 M-Mode... 144 Color Mode (CFM)... 145 Doppler Mode... 145 Spectral Doppler Mode... 145 Annotations... 146 Labels... 146 Bodymarks... 147 Measurements and Calculations... 147 Basic Cardiac Measurements... 147 LVV (Left Ventricular Volume)... 148 Doppler Measurements... 150 HR (Heart Rate)... 151 Cardiac Output... 152 Using Reports... 153 Capturing and Documenting Images... 153 Cine Review... 153 Capturing Images... 153 Copying and Archiving... 154 Printing Images... 154 Customization Examples... 155 Creating a Custom Keyboard Key for M-Mode... 155 Customizing Labels and Bodymarks Using Advanced Mode... 155 FATE (Focus Assessed Transthoracic Echocardiography)... 156 Preset... 156 FATE Measurements... 156 Where to Find More Information... 158

Chapter 12

Urology Prostate Pro Package...159 Contents... 159 Diagnostic Presets... 159 Setting up the Patient – Patient ID... 160 Imaging Controls... 160

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B Mode (2D)... 160 Annotations – Labels and Bodymarks... 162 Labels... 162 Customizing Labels and Bodymarks Using Advanced Mode... 163 Bodymarks... 164 Measurements and Calculations... 165 Automatic Measurement of Prostate Volume... 165 User Reports... 166 Capturing and Documenting Images... 166 Cine Review... 166 Capturing Images... 166 Copying and Archiving... 167 Printing Images... 167 Customization Examples... 168 New Presets... 168 Default Pro Packages and Presets... 168 Where to Find More Information... 169

Chapter 13

Surgery Pro Package...171 Contents... 171 Diagnostic Presets... 171 Setting up the Patient – Patient ID... 172 Imaging Controls... 172 B-Mode (2D)... 172 Color Mode (CFM)... 173 Doppler Mode... 174 Elastography... 174 Annotations – Labels and Bodymarks... 174 Labels... 175 Bodymarks... 176 Measurements and Calculations... 176 Distance... 176 Freehand Measurements – Area and Circumference... 176 Volume... 177 Using Reports... 177 Capturing and Documenting Images... 177 Cine Review... 177 The Document Browser... 178 Capturing Images... 178 Copying and Archiving... 178 Printing Images... 179 Customization Examples... 180 New Presets... 180 Default Pro Packages and Presets... 180 Making a New Screen Key... 180 Customizing Labels and Bodymarks Using Advanced Mode... 181 Where to Find More Information... 182

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Chapter 14

Neuro Pro Package...183 Contents... 183 Diagnostic Presets... 183 Setting up the Patient – Patient ID... 184 Imaging Controls... 184 B Mode (2D)... 184 Color Mode (CFM)... 185 Doppler Mode... 186 Elastography... 186 Annotations – Labels and Bodymarks... 186 Labels... 187 Bodymarks... 188 Measurements and Calculations... 189 Distance... 189 Freehand Measurements – Area and Circumference... 189 Volume... 189 Using Reports... 190 Capturing and Documenting Images... 190 Cine Review... 190 The Document Browser... 190 Capturing Images... 191 Copying and Archiving... 191 Printing Images... 191 Customization Examples... 192 New Presets... 192 Default Pro Packages and Presets... 192 Making a New Screen Key... 193 Customizing Labels and Bodymarks Using Advanced Mode... 193 Imaging with Brainlab... 194 Contact with the Company... 194 Installation and Setup... 194 Spinal Cord Pro Package... 195 Where to Find More Information... 195

Chapter 15

3D Imaging...197 Introduction to 3D Ultrasound... 197 3D License... 197 Controlling Transducer Movement... 198 System-Controlled Positioning... 198 The 20R3 Transducer... 198 The Magnetic Wheel Mover... 198 Untracked Freehand Acquisition... 198 3D Imaging Overview... 199 Preparations... 200 Adjusting the Image Capture Settings... 201 ROI (3D Region of Interest)... 201 3D Capture Settings... 201 Acquisition... 202 Viewing a 3D Data Set... 202

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Enhancing a 3D View... 203 3D Layout Options... 203 Working with the 3D Image... 204 Manipulating the Volume... 204 Annotating a 3D View... 205 User Views... 206 The 6 Data Presentation Views... 206 Cube View... 207 Render View... 209 MIP View... 211 Transparency View... 211 4-Up View... 211 6-Up View... 212 Save, Capture and Close... 212

Chapter 16

DICOM...213 DICOM on the System... 213 New Patient Information from a DICOM Worklist... 213 Saving or Printing to a DICOM Network... 213 Filenames of Documents Exported in DICOM Format... 213 Archiving to a PACS... 214 Reports... 214 Deleting a Document... 215 Discontinuing an Examination with an MPPS Server... 215

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Appendix A

Glossary... 217

Appendix B

Measurement Abbreviations... 223

Appendix C

Setting Up and Customizing Your System... 243 Pro Package and Presets... 244 Doppler and M-Mode Monitor Layout... 245 User-Defined Keys... 245 Assigning User-Defined Keys... 247 Customizing Key Brightness, Mouse Controls and Depth Control... 247 System Setup... 248 General Setup... 248 Clip Storage and Cine Setup... 250 3D Setup... 253 Printer Setup... 253 Password Setup... 255 Network Archiving... 256 Version Information... 256 Video I/O Setup... 258 Battery Support Setup... 259 Miscellaneous System Setup... 260 Measurements... 262 User-Defined Measurements... 263 Curves... 267

Miscellaneous Measurement Setup... 270 Marks (Bodymarks, Labels, Puncture Guides)... 272 Bodymark Setup... 272 Label Setup... 272 Transperineal Matrix, Brachy Matrix and Ruler, and Programmable Puncture Guide Setup... 273 Miscellaneous Marks Setup... 279 Licenses... 280 Importing and Exporting System Configurations... 280 Importing or Exporting Presets... 282 DICOM Setup... 285 Appendix D

Redefining Screen Keys – Label, Bodymark, and Measurement... 287 Other Settings... 288

Appendix E

Configuring the bk3000 and bk5000... 291 Before You Begin... 291 Configuration Mode... 291 Key Definitions (Redefining an Existing Key)... 291 Unavailable Spaces... 293 The Imaging Tabs... 293 Special 3D Mode Tab... 294 Measure and Mark Tabs... 294 Documentation Tab... 294 Patient Dialog... 295 Display Areas and Info Boxes... 295 Prioritizing the Display of Measurements and Settings... 297 Creating a New Pro Package in Configuration Mode... 297

Index

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Chapter 1 Before You Begin This is the advanced user guide for the bk3000 and bk5000 Ultrasound Systems. The bk3000 & bk5000 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 & bk5000 User Guide before

working with the system. This guide takes you deeper into the functionality and potential of the bk3000 and bk5000 Ultrasound Systems. 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 15

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

“Controls on the Monitor” on page 21

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

“Making Measurements” on page 39

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

“Documentation” on page 51

What imaging modes are available on the bk3000 and bk5000?

“Imaging Modes” on page 71 and “3D Imaging” on page 197

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

“Pro Packages” on page 107

How does DICOM® work with the bk3000 and bk5000?

“DICOM” on page 213

What do various abbreviations mean?

“Glossary” on page 217

Can the bk3000 and bk5000 be customized and how?

“Setting Up and Customizing Your System” on page 243, and “Redefining Screen Keys – Label, Bodymark, and Measurement” on page 287,

How do you configure the system?

“Configuring the bk3000 and bk5000” on page 291

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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). For a description of the keyboard, see Getting Started with bk3000 & bk5000. 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 steps, 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 and bk5000.

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

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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. 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 107.

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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 and bk5000”.

Document Browser For information about using the Document Browser, see Chapter 6, “Documentation” on page 51.

Measurements and Image Data For information about making and using measurements on the system, see Chapter 5, “Making Measurements” on page 39. For information about working with the image, see Chapter 4, “Working with the Image” on page 29. If measurement data are covered by workflow tabs, minimize the tabs by clicking the top tab. 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, “Configuring the bk3000 and bk5000” or consult your BK Medical representative.

Workflow Tabs Workflow tabs follow the 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 click a tab to see its controls.

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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 243.

The Image Tab The Image tab is on top when you start to image. 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 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 15, “3D Imaging” on page 197.

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

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.

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Keyboard Control Panel The keyboard control keys are described in Getting Started with bk3000 & bk5000.

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.

Figure 2-4. The Accent key.

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

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To write this

Press this

Then press this

ö or (Ö)

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. Some onscreen 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.

3D

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.

Archive

Send to PACS (DICOM), to a network drive, or to a staging area to be burned to a CD/DVD.

Area

3D area measurement.

Arrow

Display an arrow on the image.

Auto

In B-mode, reset overall gain and TGC curve to the default setup for the preset. NOTE: The TGC sliders do not move when you do this. Therefore, the shape of the TGC curve on the monitor may not correspond to the relative position of the sliders on the control panel. In Doppler mode, reset the range and baseline to prevent aliasing and to optimize the display of the Doppler spectrum. NOTE: The keyboard, except for the Freeze key, is disabled while the scale and baseline are being adjusted. This may take a few seconds.

Autofocus

Ensure that the focal range is centered in the displayed image.

Auto Scale

Automatic Scale/PRF adjustment.

B Color

Select a color to tint the B-mode image.

Biopsy

Display a puncture line or brachy matrix.

Bodymark

Place a bodymark on the image.

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