BK ProFocus 2202 User manual
Pro Focus 2202
Extended User Guide
English
BB1279-A
June 2005
•
NOT FAULT TOLERANT
HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE,
AND MS HAS RELIED UPON B-K Medical TO CONDUCT SUFFICIENT TESTING TO
DETERMINE THAT THE SOFTWARE IS SUITABLE FOR USE.
•
EXPORT RESTRICTIONS
You agree to comply with all applicable international and national laws that apply to Windo ws XP
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 Wi ndows XP Embedded, see http://www.microsoft.com/exporting/
•
The Pro Focus 2202 Ultrasound Scanner 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 from B-K Medical will immediately void any
warranty supplied by B-K Medical. Such changes will also void any service contract and result in
charges to the customer for restoration of the original Pro Focus 2202 system.
Trademarks:
DICOM is the registered trademark of the National Electrical Manufacturers Association for its
standards publications relating to digital communications of medical information.
TEH and Pro Package are trademarks of B-K Medical.
Microsoft and Windows are re gistered trademarks of Microsoft Corporation in the United States and
other countries.
SonoVue is a registered trademark of Bracco S.p.A.
FireWire is a trademark of Apple Computer, Inc.
CIV-Flex is a trademark of CIVCO Medical Instruments Co., Inc.
. THE SOFTWARE IS NOT FAULT TOLERANT. B-K Medical
. You acknowledge that Windows XP Embedded is of US-origin.
WORLD HEADQUARTERS
Mileparken 34
DK-2730 Herlev
Tel.:+45 44528100
Fax:+45 44528199
Website: www.bkmed.com
© 2005 B-K Medical
Information in this document may be subject to change without notice.
Contents
Part 1 Basics
Chapter 1 General and Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
About this User Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Typographical Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Terminology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
About the Scanner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Scanning Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Pro Packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Safety Symbols on the Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
CE Marks on Electrical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
General Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Explosion Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Other Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Connecting Other Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Computer Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Acoustic Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Monitor Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Thermal and Mechanical Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Acoustic Output Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Functions Affecting Acoustic Output . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Default Acoustic Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Chapter 2 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Adjusting the Keyboard Panel and Monitor . . . . . . . . . . . . . . . . . . . . . . . . . 34
Turning the Scanner On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Checking the Date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Adjusting the Brightness of the Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Adjusting the Reading Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Setting up a New Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Opening the Patient Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Changing Pro Package or Diagnostic Setup in the Patient Window . . . 37
3
New Patient Information from a DICOM Worklist . . . . . . . . . . . . . . . . 37
Entering Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Keeping Image Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Keeping Patient-Related Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Connecting and Selecting Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Connecting a Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Selecting a Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Selecting the Scanning Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Pro Packages and Diagnostic Setups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Selecting a Pro Package or Diagnostic Setup. . . . . . . . . . . . . . . . . . . . . 42
Saving a Diagnostic Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Selecting or Changing the Scanning Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Performing a Biopsy or Puncture Procedure (including Brachytherapy) . . . 43
Using the PCU (Palm Control Unit) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Attaching the PCU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Checking the PCU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Putting Sterile Covers on the PCU. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Part 2 Working with the Image
Chapter 3 The User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Keyboard Panel Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
The Control Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
The Trackball and Trackball Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Basic Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
B-Mode Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
B-Mode Adjustment Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Power and Color Mode Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Doppler and M-Mode Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Doppler Adjustment Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
User-Defined Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Image Annotation Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Miscellaneous Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
TGC Sliders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Controls on the Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Point and Click . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Foot Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Palm Control Unit (PCU) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Chapter 4 Working with the Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Image Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Freezing the Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
4
Update - Partial Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Split Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Simultaneous Scanning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Labelling Parts of the Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Placing Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Moving Labels and Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Creating and Editing Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Removing Labels and Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Using Bodymarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Adding a Bodymark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Moving a Bodymark. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Replacing a Bodymark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Setting a Default Position for Bodymarks . . . . . . . . . . . . . . . . . . . . . . . 80
Removing a Bodymark. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Adding New Bodymarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Cine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Using Cine in M-Mode or Doppler Mode . . . . . . . . . . . . . . . . . . . . . . . 81
Cine Play. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
The Video Window and Picture in Picture (PiP). . . . . . . . . . . . . . . . . . . . . . 82
Using the Video Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Using PiP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Chapter 5 Making Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Measurements and Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Making a Measurement – General Procedure . . . . . . . . . . . . . . . . . . . . 87
Clearing a Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Clearing All Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
B-Mode and Color Mode Measuring Tools . . . . . . . . . . . . . . . . . . . . . . 88
Doppler Mode Measuring Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Chapter 6 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
What are documents? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Patient Archiving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
The Document Browser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Saving Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Viewing Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
The Archive Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Examination Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Patient and Document Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Deleting Patients or Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Externally Stored Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Copying and Archiving Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Copying and Archiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
5
Copying Documents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Archiving Documents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Format of Saved Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Using CDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Using Flash Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Using the DICOM System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Printing Documents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Printing on a DICOM Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Printing on a Local Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Displaying a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Printing a Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Saving a Report to the Patient Archiving System . . . . . . . . . . . . . . . . 115
Password Protection of the Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Part 3 Imaging Modes
Chapter 7 B-Mode – 2D Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Adjusting MI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Adjusting the Scan Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Focus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Autofocus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Dynamic Range (Contrast). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Zoom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Panning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Persistence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Edge Enhancement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Auto . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Line Density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Multibeam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Resolution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Extended Resolution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
B-Mode Frequency – MFI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
B-Mode Gray Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
B Color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Combination Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Harmonic Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Tissue Harmonic Imaging (True Echo Harmonics – TEH) . . . . . . . . . 128
Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
6
Chapter 8 M-Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
The M-mode image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Adjusting the Scan Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
M-Mode Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
M-Mode Image Ruler. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Sweep Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Focus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Autofocus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Dynamic Range (Contrast). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Zoom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Panning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Edge Enhancement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
M-mode Frequency – MFI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
M-Mode Gray Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Chapter 9 Color Mode – Color Flow Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Color Flow Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Submodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Adjusting the Thermal Index Limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Adjusting MI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Turning Color Mode On or Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Adjusting the Color Mode Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Color Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Wall Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Color Mode Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Persistence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Auto . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Line Density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Color Quality – Shots per Estimate . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
2D Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Color Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Invert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Color Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Multibeam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Steering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Chapter 10 Power Mode – Power Doppler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Submodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
7
Adjusting the Thermal Index Limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Adjusting MI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Turning Power Mode On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Adjusting the Power Mode Image. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Color Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Wall Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Power Mode Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Persistence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Auto . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Line Density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Color Quality – Shots per Estimate . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
2D Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Color Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Invert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Color Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Multibeam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Steering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Chapter 11 Doppler Mode – Spectral Doppler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Pulsed Wave Doppler (PW) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Adjusting the Thermal Index Limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Adjusting MI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Turning Doppler Mode On or Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Audio Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Adjusting the Doppler Mode Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Doppler Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Trace Overlay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Steering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Angle Correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Wall Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Invert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Sweep Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Chapter 12 Continuous Wave Doppler Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Adjusting the Thermal Index Limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Adjusting MI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Turning CW Doppler Mode On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
8
CW Doppler Sample Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Audio Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Adjusting the Doppler Mode Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
CW Doppler Sample Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Trace Overlay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Wall Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Invert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Sweep Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Part 4 Setting up and Maintaining Your System
Chapter 13 Setting Up and Customizing Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Pro Package and Diagnostic Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Importing or Exporting Diagnostic Setups. . . . . . . . . . . . . . . . . . . . . . 168
Doppler and M-Mode Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
User-Defined Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Assigning User-Defined Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Customizing Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
General Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Clip Storage and Cine Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
3D Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Printer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Password Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
User-Defined Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Measurement Group Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Curves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Miscellaneous Measurement Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Marks (Bodymarks, Labels, Puncture Guides) . . . . . . . . . . . . . . . . . . . . . . 189
Bodymark Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Label Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Brachy Matrix Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Miscellaneous Marks Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Patient Window Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Licenses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Importing or Exporting Pro Packages and System Settings . . . . . . . . . . . . 197
DICOM Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Chapter 14 Care of the Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201
Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Scanner Unit and Keyboard Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Palm Control Unit (PCU) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
9
Transducers and Puncture Attachments . . . . . . . . . . . . . . . . . . . . . . . . 202
Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Palm Control Unit (PCU) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Transducers and Puncture Attachments . . . . . . . . . . . . . . . . . . . . . . . . 204
3D Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Scanner Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Palm Control Unit Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Transducer Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
Alignment of the Brachy Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
Disposing of the Scanner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
Part 5 Pro Packages
Chapter 15 General Pro Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
Transducers and Diagnostic Setups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
Patient Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Labels and Bodymarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
General Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
B-Mode Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
D-Mode (Doppler) Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
Doppler Spectra. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
Stenosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
VF (Volume Flow) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
TAM (Time Average Mean). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
RI and PI (Resistance Index and Pulsatility Index) . . . . . . . . . . . . . . . 219
Real-Time Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
Noise Limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
Carotid Velocities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
Calculations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Calculation Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Calculation Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Chapter 16 Urology Pro Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .227
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Transducers and Diagnostic Setups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Patient Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
Labels and Bodymarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
B-Mode Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
10
D-mode (Doppler) Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
Calculating Volumes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
HWL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Planimetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Empirical Method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
Calculating PSAD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Urology Calculation Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Volume Formulas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
PSA Density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Accuracy of Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
Chapter 17 Surgery Pro Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .239
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
Palm Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
Surgical Rack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
Transducers and Diagnostic Setups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
Patient Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
Labels and Bodymarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
B-Mode Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
Doppler Mode Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
Real-Time Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
Surgery Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
Labels and Bodymarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
Chapter 18 OB/Gyn Pro Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Transducers and Diagnostic Setups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Gestational Age and Expected Date of Confinement . . . . . . . . . . . . . . . . . 244
Patient Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Labels and Bodymarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Making Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Calculation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Obstetrics Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
Other OB Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Gynecology Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
IVF Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
Obstetrics Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Editing a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Curves in Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Calculation Tables and Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
Campbell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
11
DSOG (Danish Society of Obstetrics and Gynaecology). . . . . . . . . . . 255
Eik-Nes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
Hadlock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257
Hansmann. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260
Hellman . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
Hobbins. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
Jeanty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Kurtz. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
Persson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
Robinson. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
Shepard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
Tokyo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Warsof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274
Calculation Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
Chapter 19 Cardiac Pro Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
Transducers and Diagnostic Setups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
Patient Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Labels and Bodymarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Cine (Image Review). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Making Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
B-Mode Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
Doppler Mode Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
M-Mode Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285
Connecting the Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285
Checking the Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Using ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Reviewing ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287
Chapter 20 3D Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .289
Introduction to 3D Ultrasound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289
3D on the Pro Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289
Controlling Transducer Movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
Computer-Controlled Positioning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
Anorectal Transducer 2050 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
The Pullback Mover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
Endocavity Rotational Mover (ECRM) . . . . . . . . . . . . . . . . . . . . . . . . 291
Untracked Freehand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293
3D Scanning Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293
Turning 3D On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
Setting Up the Image Capture Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
12
Viewing a 3D Data Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299
3D – New, Close, Save. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300
Changing the View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300
Enhancing a 3D View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300
3D Layout Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
Manipulating the Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
Annotating a 3D View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303
Cube View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304
Making Measurements in a Cube View . . . . . . . . . . . . . . . . . . . . . . . . 305
Render View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307
Render Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308
Sculpting Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308
MIP View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 309
Transparency View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310
Render Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311
4-Up View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311
6-Up View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312
Part 6 Appendixes
Appendix A Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .315
Appendix B Technical Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .321
Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321
The Rear of the Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321
Cables Types and Lengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323
Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324
Audio Input and Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324
Documentation Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
Connecting to a Surgical Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326
Foot-Switch Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
Electrical Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
Power Supply Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
Connecting Other Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 332
Dismantling the Scanner for Transportation . . . . . . . . . . . . . . . . . . . . . . . . 333
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334
Appendix C Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .335
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343
Index 345
13
14
Part 1: Basics
Chapter 1
General and Safety Information
This user guide is for the Pro Focus 2202 Ultrasound Scanner from B-K Medical.
The scanner is a 2D and 3D ultrasound echo and flow imaging system fo r diagnosis,
data processing and transfer, guidance of puncture and biopsy, and ECG signal
superposition. It is not for continuous operation (mode of operation is not
continuous).
Before using the scanner, please make yourself familiar with the operating
instructions in this guide and in the
manual.
Make sure that you also read the transducer user guide and specifications for each
transducer that you use. The transducer user guides contain specific information
about operating and caring for each transducer. Acoustic output data and data about
EMC (electromagnetic compatibility) for all transducers used with this scanner are
on a CD (BZ2100) that accompanies this user guide.
This chapter contains important safety information that you should be aware of
before you use the scanner. The remaining chapters also contain safety information.
General Transducer Information
(BB0555)
About this User Guide
The chapters in this user guide are divided into Parts.
•
Part 1 – Basics
scanning.
•
Part 2 – Working with the Image
with it. It also contains general information about adjusting and working with
the scanned image as well as how to make basic measurements.
•
Part 3 – Imaging Modes
each of the scanning modes.
•
Part 4 – Setting Up and Maintaining Your System
scanner and how to set up and customize your system if you do not w ant to use
the predefined setups.
•
Part 5 – Pro P ackages
and 3D.
•
Part 6 – Appendixes
containing technical information (including important information about
electrical safety and about dismantling the scanner for transportation). Finally,
there is an appendix listing the specifications for the scanner.
contains information you need to know before you start
describes the user interface and how to work
contains chapters dealing with information specific to
tells you how to care for your
contains chapters for the various clinical application areas
– The appendixes include a glossary of terms and a chapter
General and Safety I nformation
17
Safety Inf ormation
This user guide contains cautions, warnings and other information about what you
must do to ensure the safe and proper performance of the ultrasound scanner. You
must also follow local government rules and guidelines at all times.
Important safety information is indicated in the user guide by means of special
formatting.
WARNING Warnings contain information that is important for a voiding persona l injury .
Caution: Cautions contain information and instructions that must be followed to avoid
damaging equipment, data or software.
NOTE:
Notes contain information that you should be aware of.
Typographical Conventions
The following typographical conventions are used in this manual:
F
REEZE
– a function, something you can do by using the keyboard panel or the
graphical user interface on the screen
Freq.
– text that can be selected or clicked on the screen
[
Power
Book T itles
[1] References. Literature references are found at the end of the chapter.
]
– a key on the keyboard panel
– names of books and scientific journals
Terminology
Many of the terms and abbreviations used in this user guide are defined in the
Glossary starting on page 315.
Instructions
You control the scanner by using the graphical user interface on the screen, pressing
keys on the control panel, or typing on the keyboard. Instructions in this user guide
tell you what sort of action to take.
18
Chapter 1
When the instructions say It means
Click
Power
[
Press
Press
Type
Table 1-1. Click, Press and Type.
Power
[
Sound
Power
About the Scanner
The Pro Focus 2202 Ultrasound Scanner is easy to use. You can perform most
scanner operations using just the trackball and the trackball keys to interact with
controls on the screen. Dedicated keys on the control panel make other operations
quick and easy.
Scanning Modes
The Pro Focus lets you use various scanning modes:
Use the trackball to point at the word “Power”
[A]
(
on the screen, and then press
on the control panel.
]
B
]
Press the
Press the
Type the word “Power” on the keyboard.
Power
Sound
key on the control panel.
key on the control panel.
Select
)
•
B-mode (brightness mode) for real-time imaging of soft tissues: includes
harmonic imaging
•
Color mode (CFM, color flow mapping, color Doppler mode) for information
about flow direction and velocity
•
Power mode (power Doppler mode) for higher sensitivity to flow information:
includes directional Power Doppler
•
Doppler mode (spectral Doppler mode) for information about the spectrum of
flow velocities as a function of time
•
CW Doppler mode (continuous wave Doppler) for information about highvelocity flow
•
M-mode for information about tissue motion as a function of time
Pro Packages
Pro Packages contain default Diagnostic Setups and calculation formulas that make
it quick and convenient to use the scanner for specific applications.
Safety Symbols on the Scanner
Important safety information is indicated in the user guide and on the scanner itself
by means of special symbols and formatting.
General and Safety I nformation
19
T able 1-2 contains brief e xplanations of the safety symbols used to label the scanner .
(Some labels in the table may appear on the transducer rather than the scanner itself.)
NOTE
especially the following:
!
When you encounter this sign on the scanner, consult the user guide for important
safety information.
B-K Medical disclaims all responsibility for the operating safety, reliability and
performance of the equipment if these symbols and warnings are disregarded in any
way.
Symbol Name Description
Caution or Warning Consult accompanying user guide (BB1279) when
you encounter this sign on the instrument, to a void
reducing its safety.
Potential
Equalization
Ground (earth) Additional protective ground (earth).
Type BF BF: Isolated from ground.
Type B B: Maximum patient leakage current under
Sealing Dust- and immersion-protected according to EN
Standby Standby switch on front of scanner – used to turn
Non-ionizing radiation Ultrasound scanner emits acoustic radiation.
Ter m in al conn ected to the chassis. Should be
connected to corresponding terminals on other
equipment to eliminate potential differences.
Maximum patient leakage current under
• Normal condition ≤100µA
• Single-fault condition ≤500µA
• Normal condition ≤100µA
• Single-fault condition ≤500µA
60529 [1].
scanner on and off.
20
Chapter 1
STERILE Device is in a sterile condition.
Not watertight
ESD (electrostatic
discharge)
Ta ble 1-2. Warning symbols on the scanner.
Plug may not be immersed (unless it is covered
with a special watertight plug cover).
Do not touch pins in connectors with this symbol
unless you follow ESD precautionary procedures.
CE Marks on Electrical Devices
The European Union has introduced directives requiring b marks on devices.
Non-medical devices marked with b comply with relevant directives, for example
EEC Council Directive 89/336/EEC of 3 May 1989 concerning Electromagnetic
Compatibility.
B-K Medical devices marked with b or
93/42/EEC of 14 June 1993 concerning Medical Devices. b applies to Class I
medical devices.
c
applies to Classes Im, IIa, IIb and III. B-K Medical defines
classes assuming scanning duration for individual patients does not exceed 60
minutes.
General Safety Precautions
The ultrasound scanner is designed and tested in accordance with EN/IEC 60601-1
[2] and EN 60601–2–37 [3]. It complies with requirements for Class 1 (protective
earth) devices of EN/IEC 60601-1 [2]. It also complies with UL 2601-1 [4] and CSA
C22.2 No. 601.1–M90 [5]. It fulfills the requirements for dust protection (IP20) for
ordinary equipment specified in EN 60529 [1].
WARNING Federal law in North America restricts this device to sale to, or on the order
of, a physician.
Equipment
failure
WARNING If at any time the scanner malfunctions , or the image is severely distorted
or degraded, or y ou suspect in any way that the scanner is not functioning correctly:
• Remove all transducers from contact with the patient.
• Turn off the scanner. Unplug the scanner from the wall and mak e sure it ca nnot be
used until it has been checked.
• Do not remove the scanner cover.
• Contact your B-K Medical representative or hospital technician.
c
comply with EEC Council Directive
Isolating the
scanner
Condensation
WARNING The power supply cord connects the scan ner to the line volt age. To isolate
the scanner, you must unplug the po wer supply cord from the wa ll outlet. Do this befor e
you try to make any repairs to the system.
Caution: Large variations in temperature or humidity may cause water to condense
inside the scanner . If this happ ens , the scanner m ay fail to oper ate p roperly. Always let
the scanner come to room temperature before you plug it in.
• Wait at least 2 hours after the scanner has been subjected to major changes in
temperature or humidity.
• If there is visible evidence of condensation, wait at least 8 hours.
Before you use the scanner, make sure that all the safety requirements described in
this chapter have been satisfied.
General and Safety I nformation
21
Explosion Hazards
Explosion
hazards
Electrical Safety
Do not use a
power strip
WARNING The ultrasound scanner is not designed to be used in potentially explosiv e
environments. It shou ld not be operated in the presence of fla mmable liquids or gases,
or in oxygen-enriched atmospheres.
There is a possible e xplosion hazard if the scanner is used in the presence of
flammable anesthetic. The scan ner should be placed at least 25cm (10 inches) from
the patient.
The ultrasound scanner contains a lithium battery. Never remove or replace this
battery. The lithium battery must not be removed except by a B-K Medical service
representative.
WARNING Do not plug the scanner into an ordinary power strip. If the ground
connection fails, this is dangerous because
• the total leakage current for all the conn ected equipment can exceed the limits
specified in EN/IEC60601-1 [2].
• the impedance of the ground connection will probably also exceed the limits
specified in EN/IEC 60601-1.
Leakage
current
Electrical
shock
ESD
WARNING When the equipment is used with 230V (and you believe the leakage
current would be within the UL limit if you were using 120V), power to the equipment
must come from an installation or supply unit with a center-tapp ed, 240V single-phase
circuit. This will make sure that chassis leakage current during single fault condition
fulfills the requirements specified in UL2601-1 [4] (limit of 300µA). If power is not
supplied in the way specified, the leakage current can be as high as 500µA, the limit
specified in EN/IEC60601-1. [2]
WARNING Never remove the cover to get access to the inside of the scanner. You
risk electrical shock if you do so. Do not allow anyone but qualified service personnel
to service the scanner.
WARNING Do not touch pins in connectors that have this symbol. Do not connect
anything to them unless you follow these ESD (electrostatic discharge) precautionary
procedures:
• Discharge your body to ground before you touch the pins with your hand or a tool.
For example, touch an unpainted metal part of the scanner cover.
• You can use a wrist strap connected to the additional protectiv e ground or potential
equalization terminal on the scanner if that is more convenient.
Anyone using the equipment should be taught to recognize the ESD symbol and to
take the necessary precautionary procedures.
22
Chapter 1
Interference
Electrical Noise
Electrical
noise
Other
equipment
nearby
WARNING Electrical noise from nearby devices such as electrosurgical devices – or
from devices that can tran smit electrical noise to the AC line – ma y cause disturbances
in ultrasound images. This could increase the risk during diagnostic or interventional
procedures.
Electromagnetic Interference
Medical electrical equipment requires special precautions regarding EMC
(electromagnetic compatibility). You must follow the instructions in this chapter
when you install the scanner and put it into service.
If the image is distorted, it may be necessary to position the scanner further from
sources of electromagnetic interference or to install magnetic shielding.
WARNING Do not use this equipment adjacent to oth er equipment . If you must place
it next to or stacked with other equipment, verify that it operates normally there and
neither causes nor is affected by electromagnetic interference.
EMC noise can reduce the usable image depth. Therefore, in order to avoid having
to repeat an ultrasound examination, you must make sure beforehand that the
ultrasound system can be used for the examination. Repeating an examination can be
regarded as a potential risk that should be avoided, especially if the examination
involves transducers used intracorporeally or transducers used for puncture.
RF (Radio Frequency) Interference
Portable and mobile RF (radio frequency) communication equipment can affect the
scanner, but the scanner will remain safe and meet essential performance
requirements.
An ultrasound scanner intentionally receives RF electromagnetic energy for the
purpose of its operation. The transducers are very sensitive to frequencies withi n
their signal frequency range (0.5MHz to 35MHz). Therefore RF equipment
operating in this frequency range can affect the ultrasound image. However, if
disturbances occur, they will appear as white lines in the ultrasound picture and
cannot be confused with physiological signals.
WARNING Other equipment may interfere with the scanner, even if that other
equipment complies with CISPR (International Special Committee on Radio
Interference) emission requirements.
WARNING If you use accessories, transducers or cables with the scanner, other than
those specified, increased emission or decreased immunity of the system may result.
General and Safety I nformation
23
Installation
Installation
safety
requirements
Secure the
power cord
Transducers
Electrical
shock
WARNING To ensure safe performance, a qualified electrical engineer or hospital
safety personnel mu st v erify that the ultra sound scann er is correctly in stalled and that
it complies with the safety requirements described below:
• Use only the original power supply cord. This must be fitted with a hospitalapproved three-prong grounded power plug. See “P ower Supply Cord” on
page 331.
• The equipment must only be connected to a grounded AC power supply (or wall
outlet) that meets EN/IEC/NEC requirements or applicab le local regulatio ns. The
examination room’s grounding system should be checked regularly by a qualif ied
electronics engineer or hospital safety personnel.
• Never use ex tension cables. The increased length of the cable will increase the
resistance of the protective ground conductor beyond an acceptable level.
• Keep power supply cords, sockets and plugs clean and dry at all times.
WARNING Make sure that the power cord cannot be accidentally disconnected from
the wall or the scanner.
WARNING The transducer sockets contain terminals with 5V. To avoid coming in
contact with these voltages, alwa ys connect tr ansducers to co ve r empty soc kets while
you use the scanner.
transducers
Electrical
24
Chapter 1
Type B
burns
WARNING When using Type B (non-isolated) transducers, carefully check all
electrical equipment within the patient area. Also, consider using additional protective
grounding.
WARNING Do not leave transducers in contact with the patient when using HF
electrosurgical equipment.
B-K Medical transducers fulfill EMC requirements when they are outside as well as
inside the patient’s body.
Care
Please refer to the
General Transducer Information
information about caring for transducers.
Other Safety Considerations
Mechanical failure or unintended use of ultrasound equipment can result in physical
injury to patients or operators.
(BB0555) manual for
Mechanical
injury
Service and Repair
WARNING Be careful to avoid the following potential sources of injury:
• Parts of the body can be pinched by moveable parts of the scanner, such as the
keyboard panel and the monitor.
• Tilting the scanner can cause it to be unstable and injure someone.
• Do not lean or sit on the keyboard. The keyboard panel or monitor can break if
subjected to heavy weights or impact.
Authorized
personnel
WARNING Service and repair of B-K Medical electromedical equipment must be
carried out only by the manufacturer or its authorized representatives. B-K Medical
reserves the right to disclaim all responsibility for the operating safety, reliability and
performance of equipment serviced or repaired by other parties. After repairs have
been carried out, a qualified electrical engineer or hospital technician should verify the
safety of all equipment.
Connecting Other Equipment
!
WARNING Consult this user guide before connecting other equipm en t to terminals
marked with .
!
To fulfill EMC requirements, do not attach cables to the scanner unless they are the
same type as listed in T able B-2 on page 324 and do not exceed the maximum length
given in the table. Do not attach transducers and other accessories unless the user
guide for the transducer or accessory states that it can be used with this scanner.
Attaching other equipment may cause an increase in electromagnetic emissions or
may cause the scanner to be more sensitive to electromagnetic interference.
The scanner must not be galvanically connected to a computer network (DICOM)
that has not been isolated. If the network is not isolated, the scanner must be
connected via a network isolator DP0925 (see “Accessories”, starting on page 341).
Medical
equipment
WARNING Equipment that complies with the requireme nts of EN/IEC 60601–1 [2], UL
2601-1 [4] or CSA C22.2 No. 601.1–M90 [5] can be connect ed to the scanner, but the
power for the equipment m ust come from the auxiliary power output on the scanner or
from an independent wall power outlet. You can use the isolated auxiliary power outlets
on the scanner to connect equipment such as a monito r or video printer requiring a
total of 350VA or less. Otherwise, you can plug the scanner and othe r eq uipm ent int o
an external common isolation transf ormer in order to control the leakage current during
a ground connection fault. Follow the guidelines in EN60601–1–1 [6]. If in doubt,
contact your local B-K Medical representative.
General and Safety I nformation
25
Non-medical
equipment:
location,
standards and
power supply
WARNING If you connect non-medical equipment (instruments that do not comply
with safety requirements for medical equipment), this equipment must be placed
outside the patient environment (1.5m from the bed, for example). The equipment
must fulfill the relevant EN standard or other applicable national or international
standard.
The power for the equipment must come from the auxiliary power output on the
scanner. You can use the isolated auxiliary power outlets on the scanner to connect
equipment such as a monitor or video printer requiring a total of 350VA or less.
Otherwise, you can plug the scanner and other equipment into an external common
isolation transformer in order to control the leakage current during a ground connection
fault. Follow the guidelines in EN60601–1–1 [6]. If in doubt, contact your local B-K
Medical representative.
Computer Security
When the Pro Focus is connected to a hospital network, B-K Medical does not take
any responsibility for computer viruses from the network that may infect the Pro
Focus.
Acoustic Output
General
Medical research has yet to prove whether or not ultrasound causes biological
effects. Therefore, prudent use considerations require you to follow certain
guidelines [3].
26
Chapter 1
Prudent Use
Exposure
level
Training
requirements
WARNING Always keep the exposure level (the acoustic output level and the
exposure time) as low as possible.
•
Scan patients only when clinical reasons make it necessary.
•
Keep exposure time as short as possible.
•
Be careful to prepare the patient correctly so that you get the best possible
image.
•
Start scanning at a low acoustic output level (see “Thermal and Mechanical
Indices” on page 28) and increase the level only as much as necessary to obtain
a satisfactory image.
•
If you switch from an application requiring high acoustic output levels (see
“Functions Affecting Acoustic Output” on page 29), to one that requires lower
levels (fetal scanning, for example), be sure to reset the levels before you scan.
(For example, start in B-mode.)
•
T ake into account all the types of tissue that may be affected. F or example, when
scanning a breast, it may be appropriate to monitor the TI in bone rather than in
soft tissue because the ribs will be subjected to ultrasound.
WARNING Before attempting to use B-K Medical equipment, y ou should be tr ained in
ultrasonography or be under the supervision of someone who is trained in
ultrasonography. You should also be thoroughly familiar with the safe operation of your
ultrasound system and should always use the transducer best suited to the
examination.
Acoustic output data for transducers used with the scanner are given on a CD
(BZ2100) that accompanies this user guide. The uncertainty level for each parameter
measured is listed in the user guide for each transducer. For definitions of the
parameters, refer to the Food and Drug Administration (FDA) Guide [7] as well as
EN 60601-2-37 [3] and AIUM/NEMA standards [8,9].
In North America, the FDA requires all ultrasound equipmen t to be cleared before it
is marketed in the United States.
The routes (or tracks) available for clearance by the FDA are well-defined. Track 3
is for diagnostic ultrasound systems that follow the Output Display Standard. Under
Track 3, acoustic output will not be evaluated on an application-specif ic basis, but
the maximum derated Spatial Peak–Temporal Average Intensity (I
≤
720mW/cm2, the maximum Mechanical Index (MI) must be ≤1.9, and the
) must be
SPTA
maximum Thermal Index (TI) must be ≤6. All B-K Medical transducers for use with
the Pro Focus 2202 Ultrasound Scanner are T rack 3.
General and Safety I nformation
27
Monitor Display
g
The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all scanning
modes.
Thermal and Mechanical Indices
The MI and TI indices are intended to allo w users to implement the ALARA [10, 11]
(As Low As Reasonably Achievable) principle using an indicator related to a
potential bioeffect.
The full details of the indices are given in references [3] an d [9], but the formulas are
given below.
MI Formula
P
()
MI
where the variables are defined in the table below.
Variable Definition
r0.3zsp
----------------------- -=
f
c
Blood
perfusion and
TI
P
r0.3(zsp
f
c
) Peak Rarefactional Pressure (MPa), derated by 0.3dB/cm·MHz,
measured at z
) is maximum
(PII
0.3
measured center frequency (in MHz)
, the point on the beam axis where pulse intensity integral
sp
TI Formula
W
-------------=
W
0
de
TI
where the variables are defined in the table below.
Variable Definition
W
W
0
deg
time-averaged acoustic power of the source or other power parameter (W)
estimated power necessary to raise the temper ature of the target tissue one
degree Celsius (W/°C)
As a rule of thumb, the Thermal Index (TI) indicates the highest expected
temperature increase in degrees Celsius. It is based on an average level of blood
perfusion. The displayed TI may underestimate the temperature rise in poorly
perfused tissues; you must take this into account when deciding on the maximum TI
you will allow. Conversely, in areas with a rich perfusion of blood the temperature
increase will be less than the displayed TI indicates.
28
Chapter 1
Fever
A temperature increase of one degree Celsius increase in a patient with fever may
cause complications in certain circumstances; it may be safer to delay the
investigation.
Acoustic Output Measurement
All values are measured in water according to the EN and AIUM/NEMA display
standards [3, 8, 9]. For the some of the acoustic parameters, an estimated in situ
derated value is given. This is derived assuming a tissue attenuation of
0.3dB/cm·MHz when the estimated in situ derated value (I) is described by the
following equation:
I formula
Fetal
scanning
IIwexp 0.069fz–()=
where the variables are defined in the table below.
Variable Definition
I
W
f transducer frequency (in MHz)
z distance (in cm) from the transducer face to the position where I is maximum
Intensity in water at the position where I is maximum
It should be stressed that the in situ values given are only applicable when there is
attenuating tissue between the transducer face and the focal point.
Possibility of Adverse Effects
Although it is believed that diagnostic ultrasound causes no significant biological
effects in mammalian tissue [3, 9], the user should be aware of the hypothetical
possibilities of adverse effects [10, 12, 13].
Current scientific and clinical concern over possible adverse effects is particularly
focused on fetal ultrasound scanning. It is due to the increased sensitivity of
mammalian cells and organs at this phase of their de velopment and the f act that such
a risk could have profound implications on public health. If you use high acoustic
output levels for some reason (see “Functions Affecting Acoustic Output”, below),
be sure to return to B-mode alone and turn down the power level before you do any
fetal scanning.
Functions Affecting Acoustic Output
The scanner has a control function that ensures that neither the I
value exceeds the maximum allowable value. When necessary, the scanner will
reduce the output voltage and/or PRF (pulse repetition frequency) to the transducer
in order to comply with requirements.
General and Safety I nformation
nor MI nor TI
SPTA
29
Some of the scanner functions can affect the acoustic output, as listed here.
(Instructions for using these functions are given in the relevant sections of this user
guide.)
•
Sizing functions such as ROI (region of interest) – in general, smaller size
results in higher acoustic intensity because the pulse repetition frequency (PRF)
is higher or the ultrasound beam is more strongly focused.
•
Focus – in general, strongly focusing the beam makes the acoustic intensity
higher.
•
Frame rate – higher frame rate results in higher acoustic intensity.
•
Range – increasing the Doppler range increases the acoustic intensity by
increasing the PRF.
•
CFM Resolution – higher resolution increases the acoustic output.
•
Color box size – narrowing the color box generally increases the acoustic output
within it.
The user can set a Thermal Index limit. This will provide an upper limit for acoustic
output.
Default Acoustic Output
After the scanner has been turned off, the transducers will start in the default setup
when the scanner is turned on again. The default setup may be factory-defined or
defined by the user.
Fetal
scanning
References
The factory-defined default setup values of acoustic output for each transducer are
listed in the
General Transducer Information
(BB0555) manual.
These setups have been optimized to gi ve the best compromise between low acoustic
output and enough power to obtain the image features as quickly as possible. This is
part of the ALARA principle. The factory default setup for all transducers is B-Mode
to ensure the lowest acoustic output when you start scanning.
To change the default setup to another that satisfies the ALARA principle, see
Chapter 13, “Setting Up and Customizing Your System”.
When you enter a new patient ID, the transducer setup will be reset to the default
setup. You can prevent this from happening – see “Keeping Image Settings” on
page 40.
When you use transducers intended for fetal scanning, it is important to make sure
that the default settings are appropriate and to reset to the default setting before
scanning a new patient.
[1] EN 60529:1991+A1:2000. Specification for degrees of protection provided by enclosures
(IP code).
30
Chapter 1
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