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
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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.

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
2 Safety
Throughout this document the following terms are used:
Warning: Advises against certain actions or situations that could result in personal injury or
death.
Caution: Advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
Note: Provides useful information regarding a function or aprocedure.
Please read all warnings and cautions prior to using the system. For your convenience, all warnings
and cautions are provided in this section, but may be duplicated elsewhere in this document in the
context of the instructions for use.
2.1 Warnings
Only use Edan supplied power cord.
Only use Edan supplied battery.Read and understand the battery installation instructions prior
to changing the battery.
Only use Edan supplied transducer. Use of other transducers may result in electric shock or
system malfunction.
Only use a hospital grade, grounded, power outlet and plug. Do not use with an ungrounded
outlet.
The system is ordinary equipment (Sealed equipment without liquid proof). The transducers
(not including the transducer connector) are IPX7 certified. The footswitch is IP68 certified. Do
not immerse or expose any of the parts to extended moisture. Splash resistance does not
extend to transducer connectors. Please keep connectorsdry.
Do not use in a wet environment or when the relative humidity exceeds95%.
Do not reverse the positive and negative poles when installing thebattery.
Do not use the battery near heat sources or when the ambient temperature is over 40oC. Do
not heat or dispose of infire.
Do not destroy the battery; do not pierce or cause a strong impact to thebattery.
Do not touch the connector pins on the transducer port.
Parts and accessories used must meet the requirements of the applicable IEC/EN60601
series safety standards, and/or the system configuration must meet the requirements of the
IEC/EN60601-1.
Use protective barriers (FDA cleared/legally marketed gloves and transducer sheaths)
whenever possible. Follow sterile procedures when appropriate. Thoroughly clean
transducers and reusable accessories after each patient examination and disinfect or sterilize
as needed. Refer to transducer use and care instructions. Follow all infection control policies
established by your office, department or institution as they apply to personnel and equipment.
Not intended for Ophthalmic use or any use causing the acoustic beam to pass through the
eye.
If a sterile transducer cover becomes compromised during an intra-operative application
involving a patient with transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob
disease, follow the guidelines of the U.S. Disease Control Center and this document from the

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
World Health Organization: WHO/CDS/APH/2000/3, WHO Infection Control Guidelines for
Transmissible Spongiform Encephalopathies. The transducers for your system cannot be
decontaminated using a heat process.
Contact with natural rubber latex may lead to a severe anaphylactic reaction in persons
sensitive to the natural latex protein, Sensitive users and patients must avoid contact with
these items. EDAN strongly recommends that health-care professionals identify their latex-
sensitive patients, and refer to the March 29, 1991 Medical Alert on Latex products. Be
prepared to treat allergic reactions immediately.
Improper operation may cause the internal lithium battery (hereinafter called battery) to
become hot, ignited or possibly explode, and it may lead to decreased battery capacity. It is
necessary to read the user manual instructions and warning messagescarefully.
Do not touch accessible contacts of electrical equipment and the patientsimultaneously.
This device is not suitable for intra-cardiac use or direct cardiaccontact.
The system shall not be serviced or maintained while in use with apatient.
Install the system according the EMC guidance provided in AppendixD
Do not stack the system on other electronic equipment.
The use of transducer and connecting cable not supplied by EDAN may result in increased
emissions or decreased immunity of the equipment.
Refer to Appendix D for recommended separation distances from other equipment, including
portable and RF communication devices.
The mains plug is used to isolate the system from main power. Position the system so that it is
easy to disconnect it from the power supply.
No modification of this equipment is allowed.
The system should be maintained regularly, at least annually, by a qualified technician who
has adequate training, knowledge and experience. That person should be familiar with the
Service Manual, available from your Edan representative.
Keep non-medical equipment out of the vicinity of the patient.(1.5m/6ft.)
Use of an extension cord or multi-socket outlet setup to provide power to the ultrasound
system or to the system‟s peripheral devices, may compromise the system grounding and
cause the system to exceed current leakage limits.
It is not suggested to use a multiple socket-outlet with the device. If one is required, make sure
that the multi-socket complies with the requirement specified in Chapter 16 of IEC 60601-1, or
the multi-socket is with an isolation transformer. And the multi-socket shall not be placed on
the floor.
SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied as a part
of the system, to the multiple portable socket-outlet supplying thesystem.
SHOCK HAZARD - Don't connect non-electrical equipment, which has been supplied as a part
of the system, directly to the wall outlet when the non-medical equipment is intended to be
supplied by a multiple portable socket-outlet with an isolationtransformer.
SHOCK HAZARD –Do not connect non-isolated electrical equipment to the same circuit
being used to power the system.
Edan recommends the use of isolated connectors on any electrical equipment attached to the
system, and/or using isolation transformers that comply with IEC60601-1 to power that

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
electrical equipment.
Always use sterile technique during a biopsy procedure. Sterilize the needle guide assembly
between uses.
Use a sterile needle with each use.
The system may be interfered with by other equipment, even if that other equipment complies
with CISPR EMISSION requirements.
The system cannot be used together with high-frequency surgicalequipment.
Remove the battery from the device when the device is not used for a longtime.
Automated cleaning is prohibited for ultrasound system and itsaccessories.
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or
patient is established.
Transducer Warnings
Toavoid infection, always use protective gloves when cleaning or disinfecting
Read and follow all manufacturer instructions for disinfection agents.
Toavoid infection, ensure that expiration date of the disinfecting solution has notpassed.
Disinfect the transducer after each intra-cavity or intra-operative procedure. Use a new sterile
sheath for each such procedure.
Use a pyrogen-free transducer sheath for intra-operative procedures.
The system is not intended to come into contact with the central nervous system and central
cardiovascular system.
Unplug the transducer from the system prior to cleaning ordisinfecting.
Do not immerse the transducer beyond the point indicated in Figure6-3.
Do not allow the transducer connector to getwet.
"Intra-operation" exam preset must be used when doing intra-operative examination using
transducer L17-7SQ.
2.2 Cautions
Excessive dust and dirt could clog internal airflow and cause overheating. Do not use in a
dusty environment.
Do not use a battery that leaks, emits an odor, appears deformed, or discolored. Immediately
replace it with a new Edan-supplied battery and dispose of the old battery according to local
regulations. Replace a battery that has reached the end of its servicelife.
Use care when storing or disposing of batteries. Do not allow the leakage from one battery to
come in contact with other batteries. Batteries (including button cell on the main board) are
hazardous waste. Do not dispose of them together with household garbage. At the end of their
life hand the batteries over to the applicable collection points for the recycling of waste
batteries. Inappropriate disposal of waste may contaminate theenvironment.
Inspect the system regularly, at least weekly. Before use ensure there is no visible evidence of
damage to the equipment, cables, and transducers. If a component is damaged, replace it
before use.
Do not use in locations subject to vibration.

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
Do not exert excessive vibrations onto the system. Otherwise, it may damage the mechanical
components (such as wheels). If the system is required to move on an uneven surface
frequently, consult EDAN or authorized representatives for service.
Read and understand the Appendix B.2 Ultrasound Safety and the ALARA Principle before
using the system. Do not expose a patient to ultrasound energy longer than clinically
reasonable.
Practice ALARA principle when operating ultrasound system. Minimize the acoustic power
without compromising the image quality.
Do not use in the presence of a flammableanesthetic.
The system generates radio frequency energy, which may cause interference with other
devices in the vicinity. If interference is suspected, try re-orienting or relocating the equipment.
The use of electrosurgical units or other devices that generate radio frequency interference
may cause image distortion or other malfunctions.
The system should only be used by a qualified physician or allied health professional for
ultrasound evaluations.
Use only Edan supplied or recommended parts and accessories.
Verifymeasurement results prior to entering them into a report.
Contact your local distributor or Edan Service if there is excessive noise from the system
speaker or fans.
Please read and understand cleaning instructions prior touse.
Please read and understand maintenance instructions prior to use.
Please read and understand instructions for system operation prior touse.
The system is not intended for long term storage for patient data and image. Studies stored on
the system hard drive should be archived regularly, avoiding accident damage or loss. Confirm
successful archiving before deleting a study from the harddrive.
Ensure that the system vents are clear andunobstructed.
Confirm patient identification information prior to storing or printing any examinformation.
If you have any question about maintenance, technical specifications, or system functionality,
please contact your local distributor or Edan Service at:[email protected]
Ultrasound images occasionally have artifacts, and should only be used as one part of an
overall clinical assessment.
Toavoid electrical shock, turn off and disconnect the device from the AC power source before
cleaning and disinfecting.
No user serviceable parts are inside the system. All repairs on the system must be performed
by EDAN certified service personnel.
The device and accessories are to be disposed of according to local regulations after their
useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling
or proper disposal.
The packaging is to be disposed of according to local or hospital‟s regulations; otherwise, it
may cause environmental contamination. Place the packaging at the location that is
inaccessible to children.
Properly dispose of used cleaning agents or disinfectants according to your hospital's

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
regulation.
The system does not need calibration as part of routinemaintenance.
The format of U disk should be FAT32.
DoNOT place the device on slopes. It may suddenly slide, resulting in injury and/or equipment
damage.
Do NOT stand/sit on or bend over the device. It may move and make you lose your balance
and tumble.
Toensure safety, two persons are required to move the device across slopes.
Transducer Cautions
Do not use disinfection agents beyond their expiration date.
Do not use sterile sheaths beyond their expiration date.
Inspect the transducer connector, cable, and head periodically. Do not use if there is evidence
of excessive wear or damage.
Do not operate the transducer to temperatures in excess of 40°Cor store the transducer in
temperatures in excess of 55°C.
Do not kink or pull on the transducer cable.
Broken or bent connector pins can cause image artifacts. Do not use a transducer with broken
or bent pins.
Network Security Cautions
Keep your ultrasound system safe to protect the patient information and data from being
modified, damaged or disclosed caused by unauthorizeddisassembly.
Always ensure the privacy of patient information and data displayed/stored in the ultrasound
system or exported to external storage devices.
The software upgrade can only be performed by EDAN-qualified service professionals with
upgrade files of known provenance. Confirm that the system boots to imaging after an
upgrade.
Make sure the ultrasound system is used under secure network environment, and all the
approved devices connecting with the ultrasound system are physicallysecure.
Anti-virus measures such as USB device virus scanning should be carried out prior to using
the USB flash drive.
Do not connect an USB device with unknown provenance to the ultrasoundsystem.
When the ultrasound system is returned for maintenance, disposed of, or removed from the
medical institution for other reasons, ensure all patient data are removed from the ultrasound
system.
Always hide your password when entering it on the system, protecting it from being disclosed.
Federal Communications Commission (FCC)Statement:
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:
This device may not cause harmful interference,and
This device must accept any interference received, including interference that may cause
undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital device,

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver
is connected.
-Consult the dealer or an experienced radio/TV technician forhelp.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This equipment should be installed and operated with minimum distance 20cm between the radiator &
your body.
Any changes or modifications not expressly approved by the party responsible for compliance could
void the user's authority to operate the equipment.
2.3 Labeling Symbols
The following labels are used on the system:
No.
Symbol
Definition
1
Serial Number
2
P/N
Part Number
3
Date of Manufacture
4
Manufacturer
5
Operating instructions
6
Warning
(Background: Yellow; Symbol & outline: Black )
7
Refer to instruction manual/ booklet
(Background: Blue; Symbol: White)
8
Caution
9
CE Marking

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
10
Authorized Representative in the European Community
11
Disposal method. Indicates that the equipment should be sent to
special agencies according to local regulations for separate
collection after its useful life.
12
Caution: Federal (U.S.) law restricts this device to sale by or on the
order of a physician.
13
IPX7
Protected against the effects of temporary immersion
in water.
14
Type BF Applied Part
15
Probe for sector-shaped sound field
16
Pencil probe (reserved)
17
ECG connector
18
Locking, general
19
Unlocking
20
Equipotentiality
21
Computer Network
22
Trademark
23
Video Output
24
USB 2.0 port
25
USB 3.0 port
26
HDMI port

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
27
Microphone input
28
Headphones
29
Alternating Current
30
Battery check
31
Up/Down button, to move the control panel up or down
32
Non-ionizing electromagnetic radiation.
33
FCC
ID:SMQ-LX9EDAN
Federal Communications Commission:
FCC ID:SMQ-LX9EDAN
34
Defibrillation-proof type CF applied part
35
Non-sterile. Indicates a medical that has not been subjected to a
sterilization process.
36
IP68
Dust-tight (No ingress of dust); Protected against the effects of
continuous immersion in water.
37
No pushing.

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Safety
The following labels are used on the wooden packaging:
No.
Symbol
Definition
1
This way up
2
Fragile, handle with care
3
Keep dry
4
Stacking limit by number
5
Do Not Roll.
6
General Symbol for Recovery / Recyclable
7
Tilt Watch Indicator.
NOTE:
The user manual is printed in black and white.

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Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Getting Started
3 Getting Started
3.1 System Configuration
Standard Configuration:
1 main unit
1 power cord
1 potential equalization conductor
1 bottle of coupling gel
1 basic user manual and 1 advanced usermanual
Options:
Transducers: L17-7HQ, E8-4Q, C5-2Q, L12-5Q, L17-7SQ, MC8-4Q, P5-1Q, P7-3Q, MC9-
3TQ, C7-2XQ, E10-3BQ, E10-3HQ, C6-2MQ, C5-1Q, L12-5HQ, L12-5WQ, ECL12-3Q, P5-
1XQ
Needle Guide Bracket Kit
Model
Type
Angle/Depth
Description
BGK-C5-2
In-plane
20°, 28°, 40°
For use with the C7-2XQ,
Supports: 14G-23G
BGK-CR10UA
In-plane
2°
For use with the E8-4Q,
Supports: 16G, 18G
BGK-002
In-plane
38°, 46°, 58°
For use with the L12-5Q/L17-7HQ,
Supports: 14G-23G
BGK-003
Out-of-plane
1.0cm, 1.5cm,
2.0cm
For use with the L12-5Q/L17-7HQ,
Supports: 21G
BGK-004
In-plane
12°, 20°
For use with the MC9-3TQ,
Supports: 14G-23G
BGK-005
In-plane
0°
For use with the E10-3BQ,
Supports: 16G, 18G
BGK-006
In-plane
1°
For use with the E10-3HQ,
Supports: 16G, 18G
BGK-007
In-plane
18°, 25°, 35°
For use with the C5-2Q,
Supports: 14G-23G
BGK-008
In-plane
12°, 22°
For use with the P5-1Q
Supports: 14G-23G
BGK-009
In-plane
14°, 20°, 32°
For use with the C5-1Q
Supports:14G-23G