EDAN Acclarix LX9 Series User manual

Acclarix LX9 Series
Diagnostic Ultrasound System
Version 1.0
User Manual
BasicVolume

I
About This Manual
P/N: 01.54.458942
MPN: 01.54.458942010
Release Date: February 2022
© Copyright EDAN INSTRUMENTS, INC. 2022
This User Manual applies to V2.0X releases for Acclarix LX9 series Diagnostic Ultrasound Systems
including Acclarix LX9, Acclarix LX9 Exp, Acclarix LX9 Super, Acclarix LX85 and Acclarix LX88. See
Appendix A.9 for the difference between these models.
This User Manual Basic Volume together with the User Manual Advanced Volume (P/N: 01.54.458943)
contain necessary and sufficient information to use the Acclarix LX9 Series Diagnostic Ultrasound
Systems safely for the intended purposes and approved clinical applications.
Please read and make sure you understand all of the instructions in this manual prior to using the
system. Disregarding instructions, particularly warnings and cautions, is considered abnormal use.
Not all measurements and features are available for all system models and configurations. This
manual is based on the complete set of transducers and features available. Therefore, some of the
contents may not apply to your product. If you have any questions, please contact your local EDAN
representative. The pictures and interfaces in this manual are for reference only.
Conventions
In this manual, the following conventions are used to describe the system for better understanding:
Bold: bold texts indicate keys or items on main screen or touchscreen.
<Bold>: bold texts in angular brackets indicate buttons, knobs and other controls on the console
or on the keyboard.
->: Arrow indicates operations following thepath.
Contact Information:
For sales or service information please contact your local distributor or the EDAN service department
at: [e-mail]

II
Regulatory Approval Remarks:
The following features are not available in the CE region at the time of release of this user manual.
Consult your local representatives for the availability of these features.
eHIP Measurement
L12-5HQ Transducer
L12-5WQ Transducer
ECL12-3Q Transducer
The following features are not available in the USA and its territories at the time of release of this user
manual in FDA territory. Consult your local representatives for the availability of these features.
eHIP Measurement
eFollicle Measurement
eLVCardiac Measurement
L12-5HQ Transducer
L12-5WQTransducer
ECL12-3QTransducer

III
Contents
1 Introduction.................................................................................................................................... 1
1.1 Intended Use/ Indications for Use................................................................................................ 1
1.2 Contra-indications........................................................................................................................ 1
1.3 Device Description....................................................................................................................... 1
2 Safety.............................................................................................................................................. 2
2.1 Warnings...................................................................................................................................... 2
2.2 Cautions....................................................................................................................................... 4
2.3 Labeling Symbols......................................................................................................................... 7
3 Getting Started..............................................................................................................................11
3.1 System Configuration..................................................................................................................11
3.2 System Overview....................................................................................................................... 14
3.2.1. Main Unit ......................................................................................................................... 14
3.2.2. Control Panel................................................................................................................... 19
3.2.3. Screen Layout................................................................................................................. 23
3.2.4. Touch Screen................................................................................................................... 27
3.2.5. Trackball.......................................................................................................................... 28
3.3 System Preparation.................................................................................................................... 29
3.3.1. Battery Use ........................................................................................................................ 29
3.3.2. AC Power Use.................................................................................................................... 31
3.3.3. Transducer Connection...................................................................................................... 31
3.3.4. Powering on/ off......................................................................................................................32
3.4 Monitor Position Adjustment....................................................................................................... 33
3.5 Control Panel Position Adjustment............................................................................................. 36
4 Exam Operation ............................................................................................................................38
4.1 How to Start an Exam ................................................................................................................ 38
4.2 How to End an Exam.................................................................................................................. 39
4.3 How to Restart an Exam............................................................................................................ 39
4.4 The Patient Information Page .................................................................................................... 40
4.5 ModalityWorklist........................................................................................................................ 42
5 Imaging..........................................................................................................................................43
5.1 B-mode....................................................................................................................................... 43
5.1.1. Using B-mode .................................................................................................................... 43
5.1.2. B-mode Image Optimization.............................................................................................. 43
5.2 Color Mode................................................................................................................................. 48
5.2.1. Color Mode Variants ............................................................................................................... 48
5.2.2. Using Color Mode .............................................................................................................. 48
5.2.3. Color Image Optimization.................................................................................................. 48
5.3 PW Mode.................................................................................................................................... 52
5.3.1. Using PW Mode................................................................................................................. 52

IV
5.3.2. PW Image Optimization..................................................................................................... 52
5.3.3. HPRF ................................................................................................................................. 55
5.4 CW Mode ................................................................................................................................... 56
5.4.1. Using CW Mode................................................................................................................. 56
5.4.2. CW Image Optimization..................................................................................................... 56
5.5 M Mode....................................................................................................................................... 59
5.5.1. Using M Mode.................................................................................................................... 59
5.5.2. M-mode Image Optimization.............................................................................................. 59
5.6 Anatomic M Mode ...................................................................................................................... 61
5.6.1. Linear AnatomicM Mode................................................................................................... 61
5.6.2. Curved AnatomicM Mode.................................................................................................. 62
5.7 Color M Mode............................................................................................................................. 63
5.7.1. Using Color M Mode.......................................................................................................... 63
5.7.2. Color M Image Optimization.............................................................................................. 63
5.8 TDI Mode.................................................................................................................................... 64
5.8.1. TDI Mode Operations......................................................................................................... 64
5.8.2. TDI TouchScreen Controls................................................................................................ 64
5.9 3D/4D Mode............................................................................................................................... 65
5.9.1. Pre-3D/Pre-4D................................................................................................................... 65
5.9.2. 3D Volume Sweeping......................................................................................................... 67
5.9.3. 3D Image Review............................................................................................................... 67
5.9.4. 4D VolumeAcquisition ....................................................................................................... 74
5.9.5. 4D Live Volume.............................................................................................................................74
5.9.6. 4D Cine.............................................................................................................................. 74
5.9.7. Knobs and Buttons on Control Panel................................................................................. 75
5.10 Panorama................................................................................................................................. 76
5.11Elastography............................................................................................................................. 77
5.11.1. Using Elastography Mode................................................................................................ 77
5.11.2. Elastography Image Optimization.................................................................................... 78
5.12 Contrast Imaging...................................................................................................................... 84
5.12.1. Using Contrast Imaging ................................................................................................... 85
5.12.2. Touch Screen Controls..................................................................................................... 85
5.12.3. Time Intensity Curve (TIC)Analysis ................................................................................ 87
5.13 ECG.......................................................................................................................................... 79
5.13.1. ECG TouchScreen Controls............................................................................................ 80
5.13.2. ECG Basic Operations..................................................................................................... 81
5.13.3. ECG Review..................................................................................................................... 81
5.14 Stress Echo.............................................................................................................................. 82
6 Transducers and Biopsy..............................................................................................................90
6.1 Transducer Model ...................................................................................................................... 90

V
6.2 Using Transducers..................................................................................................................... 93
6.3 Transducer Cleaning and Disinfecting....................................................................................... 96
6.3.1. Cleaning............................................................................................................................. 96
6.3.2. Disinfection......................................................................................................................... 96
6.3.3. Sterilization......................................................................................................................... 99
6.3.4. Storage............................................................................................................................... 99
6.4 Needle Biopsy Guide ............................................................................................................... 100
6.4.1. Installing Needle Guide Bracket ...................................................................................... 100
6.4.2. Activating Needle Guide Function.................................................................................... 107
6.4.3. ToAdjust the Needle Guide Line...................................................................................... 108
6.5 Needle Visualization................................................................................................................. 108
6.6 Center Line............................................................................................................................... 109
6.7 Needle Guide Bracket Cleaningand Sterilization.....................................................................110
6.7.1. Cleaning............................................................................................................................110
6.7.2. Sterilization........................................................................................................................110
6.7.3. Storage..............................................................................................................................111
7 Features.......................................................................................................................................112
7.1 Comments.................................................................................................................................112
7.2 Body Mark.................................................................................................................................114
7.3 Split Display...............................................................................................................................115
7.3.1. Dual Imaging.....................................................................................................................115
7.3.2. Quad Imaging....................................................................................................................115
7.4 Zoom .........................................................................................................................................116
7.4.1. Pan Zoom..........................................................................................................................116
7.4.2. Spot Zoom.........................................................................................................................116
7.4.3. Full Screen Zoom..............................................................................................................117
7.5 Cine Review..............................................................................................................................117
8 Measurements and Reports ......................................................................................................119
8.1 Generic Measurements............................................................................................................ 123
8.1.1. B-mode Generic Measurements...................................................................................... 123
8.1.2. M-mode Generic Measurements..................................................................................... 127
8.1.3. Strip Doppler Generic Measurements ............................................................................. 128
8.2 Application Measurements....................................................................................................... 133
8.2.1. Abdomen Measurements................................................................................................. 134
8.2.2. Gynecology Measurements............................................................................................. 135
8.2.3. Obstetrics Measurements................................................................................................ 138
8.2.4. Cardiac Measurements.................................................................................................... 143
8.2.5. Small Parts Measurements.............................................................................................. 157
8.2.6. Urology Measurements.................................................................................................... 158
8.2.7. Vascular Measurements................................................................................................... 159

VI
8.2.8. Pediatric Measurements.................................................................................................. 164
8.3 Worksheet and Report............................................................................................................. 167
8.3.1. Worksheet........................................................................................................................ 167
8.3.2. Report .............................................................................................................................. 172
8.4 Measurement Accuracy ........................................................................................................... 173
9 Exam Data Management ........................................................................................................... 175
9.1 Storing Images......................................................................................................................... 175
9.2 Reviewing Images.................................................................................................................... 176
9.3 Exam Database........................................................................................................................ 178
9.4 Archiving Studies...................................................................................................................... 180
9.5 Structured Report..................................................................................................................... 181
9.6 Image Compare........................................................................................................................ 182
10 Utilities........................................................................................................................................ 183
10.1 System Set-up........................................................................................................................ 183
10.1.1. General Set-up............................................................................................................... 183
10.1.2. Button Set-up................................................................................................................. 185
10.1.3. Store Set-up................................................................................................................... 185
10.1.4. Device Set-up ................................................................................................................ 186
10.1.5. Patient Set-up ................................................................................................................ 186
10.1.6. User Set-up.................................................................................................................... 187
10.1.7. Miscellaneous Set-up..................................................................................................... 188
10.2 Exam Preset........................................................................................................................... 188
10.2.1. General Preset............................................................................................................... 189
10.2.2. Exam Preset................................................................................................................... 190
10.2.3. Image Preset.................................................................................................................. 191
10.3 Comment Preset.................................................................................................................... 193
10.4 Body Mark Preset................................................................................................................... 194
10.5 Measure Set-up...................................................................................................................... 195
10.5.1. General Set-up............................................................................................................... 195
10.5.2. Application Parameters.................................................................................................. 197
10.5.3. Measure Preset.............................................................................................................. 197
10.5.4. Report Set-up................................................................................................................. 197
10.6 Connectivity............................................................................................................................ 198
10.6.1. TCP/IP............................................................................................................................ 199
10.6.2. DICOM........................................................................................................................... 200
10.6.3. Network Store................................................................................................................ 204
10.7 Maintenance........................................................................................................................... 205
10.7.1. License........................................................................................................................... 205
10.7.2. Version.................................................................................................................................205
10.7.3. Export/Import ................................................................................................................. 206

VII
10.7.4. Demo.............................................................................................................................. 206
10.7.5. Transducer Element Check ........................................................................................... 207
10.8 Screen Adjust......................................................................................................................... 208
10.9 Stress Echo Set-up................................................................................................................ 209
11 eVocal.......................................................................................................................................................210
12 In Between Exams......................................................................................................................211
12.1 Unpacking ...............................................................................................................................211
12.2 Transport.................................................................................................................................211
12.3 Storage....................................................................................................................................211
13 Troubleshooting and Maintenance.......................................................................................... 212
13.1 Daily Checklist........................................................................................................................ 212
13.2 Troubleshooting ..................................................................................................................... 212
13.3 Cleaning and Disinfecting the System................................................................................... 213
13.3.1. Cleaning and Disinfecting the System Surface ............................................................. 214
13.3.2. Cleaning and Disinfecting the ECG Cable..................................................................... 216
13.4 Maintenance........................................................................................................................... 217
Appendix ASpecifications.............................................................................................................. 218
A.1 Electrical Safety Classifications............................................................................................ 218
A.2 Power Supply........................................................................................................................ 218
A.3 Battery................................................................................................................................... 218
A.4 Machine Specifications ......................................................................................................... 218
A.5 Display Specifications........................................................................................................... 219
A.6 Technical Specifications........................................................................................................ 219
A.7 Operating, Storage and Transportation Environment........................................................... 221
A.7.1 Operating Environment................................................................................................. 221
A.7.2 Storage and Transportation Environment..................................................................... 221
A.8 Transducer Specifications..................................................................................................... 221
A.9 Configuration Difference....................................................................................................... 222
Appendix B Ultrasound Intensity and Safety................................................................................ 223
B.1 Ultrasound in Medicine ......................................................................................................... 223
B.2 Ultrasound Safety and theALARAPrinciple......................................................................... 223
B.3 Explanation of MI/TI.............................................................................................................. 224
B.3.1 MI (Mechanical Index)................................................................................................... 224
B.3.2 TI (Thermal Index)......................................................................................................... 224
B.3.3 Display of MI/TI ............................................................................................................. 225
B.4 Acoustic Output..................................................................................................................... 225
B.4.1 Factors that Contribute to Uncertainty in the Output Display........................................ 225
B.4.2 Differences between Actual andDisplayed MI/TI......................................................... 225
B.4.3 Measurement Uncertainty............................................................................................. 225
B.4.4 Acoustic Power Default Settings................................................................................... 226

VIII
B.4.5 Limits ofAcoustic Output............................................................................................... 226
B.5 Operator Control Features.................................................................................................... 226
B.6 Prudent Use Statement......................................................................................................... 226
B.7 References for Acoustic Outputand Safety.......................................................................... 227
B.8 Transducer AcousticOutput Data......................................................................................... 227
Appendix C Order List..................................................................................................................... 228
Appendix D EMC Information ......................................................................................................... 231
Appendix E Ultrasound Gel Warmer................................................................................................... 236

Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Introduction
- 1 -
1 Introduction
1.1 Intended Use/ Indications for Use
The Acclarix LX9 series Diagnostic Ultrasound System is intended for use by a qualified physician or
allied health professional for ultrasound evaluations in hospitals and clinics. Clinical applications
include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral
vascular, Intra-operative, Pediatric, Neonatal and Adult Cephalic.
The Modes of Operation for Acclarix LX9 series include B mode, M mode, Doppler mode, Harmonic
Imaging, Elastography Imaging, Contrast imaging and their combination modes.
1.2 Contra-indications
The Acclarix LX9 series Diagnostic Ultrasound System is not intended for ophthalmic use or any use
causing the acoustic beam to pass through the eye.
1.3 Device Description
The Diagnostic Ultrasound System consists of a main system and associated ultrasound transducers.
The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In
the transducer, a piezoelectric array converts the electronic pulse into an ultrasonic pressure wave.
When coupled to the body, the pressure wave transmits through body tissues. The waves are then
reflected within the body and detected by the transducer, which then converts the waves back to an
electrical signal. The system then analyzes the returned signals and generates an ultrasound image
or spectral Doppler display.
The Diagnostic Ultrasound System provides the operator the ability to measure anatomical structures,
and offers analysis packages that provide information used by competent health care professionals to
make a diagnosis.
The system‟s user interface provides both hard keys for functions frequently used throughout an exam
and touch screen controls for mode-specificfunctions.