EDAN INSTRUMENTS LX9EDAN User Manual
1
About This Manual
P/N:01.54.458126
MPN: 01.54.458126010
Release Date: March, 2019
© Copyright EDAN INSTRUMENTS, INC. 2019
This User Manual applies to 1.0X 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: 01.54.458127)
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 touch screen.
<Bold>: bold texts in angular brackets indicate buttons, knobs and other controls on the console
or on the keyboard.
->: Arrow indicates operations following the path.
Contact Information:
For sales or service information please contact your local distributor or the EDAN service department
at: support@edan.com.cn
I
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 ..................................................................................................................... 13
3.2.1. Main Unit........................................................................................................................ 13
3.2.2. Control Panel ................................................................................................................. 17
3.2.3. Screen Layout ................................................................................................................ 21
3.2.1. Touch Screen ................................................................................................................... 24
3.2.4. Trackball ........................................................................................................................ 26
3.3 System Preparation .................................................................................................................. 27
3.3.1. Battery Use ....................................................................................................................... 27
3.3.2. AC Power Use .................................................................................................................. 29
3.3.3. Transducer Connection .................................................................................................... 29
3.3.4. Powering on/ off ............................................................................................................... 30
3.4 Monitor Position Adjustment ..................................................................................................... 31
3.5 Control Panel Position Adjustment ........................................................................................... 34
4 Exam Operation ......................................................................................................................... 36
4.1 How to Start an Exam ............................................................................................................... 36
4.2 How to End an Exam ................................................................................................................ 37
4.3 How to Restart an Exam ........................................................................................................... 37
4.4 The Patient Information Page ................................................................................................... 37
4.5 Modality Worklist ...................................................................................................................... 39
5 Imaging ....................................................................................................................................... 41
5.1 B-mode ..................................................................................................................................... 41
5.1.1. Using B-mode ................................................................................................................... 41
5.1.2. B-mode Image Optimization ............................................................................................. 41
5.2 Color Mode ............................................................................................................................... 45
5.2.1. Color Mode Variants ......................................................................................................... 45
5.2.2. Using Color Mode ............................................................................................................. 45
5.2.3. Color Image Optimization ................................................................................................. 45
5.3 PW Mode .................................................................................................................................. 48
5.3.1. Using PW Mode ............................................................................................................... 48
II
5.3.2. PW Image Optimization ................................ ................................ .................................... 48
5.3.3. HPRF ............................................................................................................................... 51
5.4 CW Mode ................................................................................................................................. 51
5.4.1. Using CW Mode ............................................................................................................... 51
5.4.2. CW Image Optimization.................................................................................................... 51
5.5 M Mode .................................................................................................................................... 53
5.5.1. Using M Mode .................................................................................................................. 53
5.5.2. M-mode Image Optimization ............................................................................................ 53
5.6 Anatomic M Mode ..................................................................................................................... 55
5.6.1. Using Anatomic M Mode................................................................................................... 55
5.6.2. Anatomic M Image Optimization ....................................................................................... 55
5.7 Color M Mode ........................................................................................................................... 56
5.7.1. Using Color M Mode ......................................................................................................... 56
5.7.2. Color M Image Optimization ............................................................................................. 56
5.8 TDI Mode .................................................................................................................................. 57
5.8.1. TDI Mode Operations ....................................................................................................... 57
5.8.2. TDI Touch Screen Controls .............................................................................................. 57
5.9 3D/4D Mode ............................................................................................................................. 58
5.9.1. Pre-3D/Pre-4D .................................................................................................................. 58
5.9.2. 3D Volume Sweeping ....................................................................................................... 59
5.9.3. 3D Image Review ............................................................................................................. 60
5.9.4. 4D Volume Acquisition ...................................................................................................... 64
5.9.5. 4D Live Volume ................................................................................................................ 64
5.9.6. 4D Cine ............................................................................................................................ 65
5.9.7. Knobs and Buttons on Control Panel ............................................................................... 66
5.10 Panorama ............................................................................................................................... 67
5.11 Elastography ........................................................................................................................... 68
5.11.1. Using Elastography Mode ............................................................................................... 68
5.11.2. Elastography Image Optimization ................................................................................... 69
5.12 Contrast Imaging .................................................................................................................... 70
5.12.1. Using Contrast Imaging .................................................................................................. 71
5.12.2. Touch Screen Controls ................................................................................................... 71
5.12.3. Time Intensity Curve (TIC) Analysis ............................................................................... 73
5.13 ECG ........................................................................................................................................ 76
5.13.1. ECG Touch Screen Controls .......................................................................................... 77
5.13.2. ECG Basic Operations ................................................................................................... 77
5.13.3. ECG Review ................................................................................................................... 78
6 Transducers and Biopsy ........................................................................................................... 79
6.1 Transducer Model ..................................................................................................................... 79
6.2 Using Transducers.................................................................................................................... 81
III
6.3 Transducer Cleaning and Disinfecting ...................................................................................... 84
6.3.1. Cleaning ........................................................................................................................... 84
6.3.2. Disinfection ....................................................................................................................... 84
6.3.3. Sterilization ....................................................................................................................... 87
6.3.4. Storage ................................ ................................................................ ............................. 87
6.4 Needle Biopsy Guide ................................................................................................................ 88
6.4.1. Installing Needle Guide Bracket ....................................................................................... 88
6.4.2. Activating Needle Guide Function .................................................................................... 94
6.4.3. To Adjust the Needle Guide Line ...................................................................................... 94
6.5 Needle Visualization ................................................................................................................. 95
6.6 Center Line ............................................................................................................................... 96
6.7 Needle Guide Bracket Cleaning and Sterilization ..................................................................... 96
6.7.1. Cleaning ........................................................................................................................... 97
6.7.2. Sterilization ....................................................................................................................... 97
6.7.3. Storage ................................ ................................................................ ............................. 97
7 Features ...................................................................................................................................... 98
7.1 Comments ................................................................................................................................ 98
7.2 Body Mark .............................................................................................................................. 100
7.3 Split Display ............................................................................................................................ 101
7.3.1. Dual Imaging .................................................................................................................. 101
7.3.2. Quad Imaging ................................................................................................................. 101
7.4 Zoom ...................................................................................................................................... 102
7.4.1. Pan Zoom ....................................................................................................................... 102
7.4.2. Spot Zoom ...................................................................................................................... 102
8 Measurements and Reports .................................................................................................... 103
8.1 Generic Measurements .......................................................................................................... 107
8.1.1. B-mode Generic Measurements ..................................................................................... 107
8.1.2. M-mode Generic Measurements .................................................................................... 110
8.1.3. Strip Doppler Generic Measurements ............................................................................ 112
8.2 Application Measurements ..................................................................................................... 116
8.2.1. Abdomen Measurements................................................................................................ 117
8.2.2. Gynecology Measurements ............................................................................................ 118
8.2.3. Obstetrics Measurements............................................................................................... 119
8.2.4. Cardiac Measurements .................................................................................................. 123
8.2.5. Small Parts Measurements ............................................................................................ 127
8.2.6. Urology Measurements .................................................................................................. 128
8.2.7. Vascular Measurements ................................ ................................ ................................. 129
8.2.8. Pediatric Measurements ................................................................................................. 132
8.3 Worksheet and Report ............................................................................................................ 134
8.3.1. Worksheet ...................................................................................................................... 134
IV
8.3.2. Report ............................................................................................................................ 139
8.4 Measurement Accuracy .......................................................................................................... 140
9 Exam Data Management .......................................................................................................... 141
9.1 Storing Images ....................................................................................................................... 141
9.2 Reviewing Images .................................................................................................................. 142
9.3 Exam Database ...................................................................................................................... 143
9.4 Archiving Studies .................................................................................................................... 146
9.5 Structured Report ................................................................................................................... 146
10 Presets ...................................................................................................................................... 147
10.1 Preset Organization .............................................................................................................. 147
10.2 Selecting a Preset ................................................................................................................ 148
10.3 Storing and Editing a Preset ................................................................................................. 148
10.3.1. Exam Preset ................................................................................................................. 149
10.3.2. Comment Preset .......................................................................................................... 151
10.3.3. Body Mark Preset ......................................................................................................... 152
10.4 Measure Presets .................................................................................................................. 154
10.4.1. General Set-up ............................................................................................................. 154
10.4.2. Application Parameter .................................................................................................. 155
10.4.3. Measure Presets .......................................................................................................... 156
10.4.4. Report Set-up ............................................................................................................... 157
11 Utilities ...................................................................................................................................... 158
11.1 System Set-up ...................................................................................................................... 158
11.1.1. General Set-up ............................................................................................................. 158
11.1.2. Patient Set-up ............................................................................................................... 160
11.1.3. Store/Print Set-up ......................................................................................................... 161
11.1.4. Miscellaneous Set-up ................................................................................................... 162
11.1.5. User Set-up .................................................................................................................. 163
11.2 Connectivity .......................................................................................................................... 164
11.2.1. TCP/IP .......................................................................................................................... 165
11.2.2. DICOM .......................................................................................................................... 166
11.2.3. Network Store ............................................................................................................... 170
11.3 Maintenance ......................................................................................................................... 171
11.3.1. License ......................................................................................................................... 171
11.3.2. Version .......................................................................................................................... 171
11.3.3. Demo ................................................................................................ ............................ 172
11.3.4. Export/Import ................................................................................................................ 172
11.4 Screen Adjust........................................................................................................................ 173
12 In Between Exams ................................................................................................................... 174
12.1 Unpacking ............................................................................................................................ 174
12.2 Transport .............................................................................................................................. 174
V
12.3 Storage ................................................................................................................................. 174
13 Troubleshooting and Maintenance ......................................................................................... 175
13.1 Daily Checklist ...................................................................................................................... 175
13.2 Troubleshooting .................................................................................................................... 175
13.3 Cleaning and Disinfecting the System .................................................................................. 176
13.3.1. Cleaning and Disinfecting the System Surface ............................................................. 177
13.3.2. Cleaning and Disinfecting the ECG Cable .................................................................... 179
13.4 Maintenance ......................................................................................................................... 180
Appendix A Specifications ............................................................................................................ 181
A.1 Electrical Safety Classifications ........................................................................................... 181
A.2 Power Supply ...................................................................................................................... 181
A.3 Battery ................................................................................................................................. 181
A.4 Machine Specifications ........................................................................................................ 182
A.5 Display Specifications ......................................................................................................... 182
A.6 Technical Specifications ...................................................................................................... 182
A.7 Operating, Storage and Transportation Environment .......................................................... 184
A.7.1 Operating Environment ................................................................................................ 184
A.7.2 Storage and Transportation Environment .................................................................... 184
A.8 Transducer Specifications ................................................................................................... 184
A.9 Configuration Difference ...................................................................................................... 185
Appendix B Ultrasound Intensity and Safety ............................................................................... 186
B.1 Ultrasound in Medicine ........................................................................................................ 186
B.2 Ultrasound Safety and the ALARA Principle ........................................................................ 186
B.3 Explanation of MI/TI ............................................................................................................ 187
B.3.1 MI (Mechanical Index) ................................................................................................. 187
B.3.2 TI (Thermal Index) ....................................................................................................... 187
B.3.3 Display of MI/TI ............................................................................................................ 188
B.4 Acoustic Output ................................................................................................................... 188
B.4.1 Factors that Contribute to Uncertainty in the Output Display ....................................... 188
B.4.2 Differences between Actual and Displayed MI/TI ......................................................... 188
B.4.3 Measurement Uncertainty ............................................................................................ 188
B.4.4 Acoustic Power Default Settings .................................................................................. 189
B.5 Operator Control Features ................................................................................................... 189
B.6 Prudent Use Statement ....................................................................................................... 189
B.7 References for Acoustic Output and Safety ......................................................................... 189
B.8 Transducer Acoustic Output Data ........................................................................................ 190
Appendix C Order List ................................................................................................................... 191
Appendix D EMC Information ........................................................................................................ 193
Appendix E Ultrasound Gel Warmer ................................ ................................ ............................. 198
VI
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Introduction
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
Adult Cephalic
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-specific functions.
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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 a procedure.
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 connectors dry.
Do not use in a wet environment or when the relative humidity exceeds 95%.
Do not reverse the positive and negative poles when installing the battery.
Do not use the battery near heat sources or when the ambient temperature is over 40oC. Do
not heat or dispose of in fire.
Do not destroy the battery; do not pierce or cause a strong impact to the battery.
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 (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.
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
World Health Organization: WHO/CDS/APH/2000/3, WHO Infection Control Guidelines for
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Safety
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 messages carefully.
Do not touch accessible contacts of electrical equipment and the patient simultaneously.
This device is not suitable for intra-cardiac use or direct cardiac contact.
The system shall not be serviced or maintained while in use with a patient.
Install the system according the EMC guidance provided in Appendix D
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 the system.
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 isolation transformer.
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
electrical equipment.
Always use sterile technique during a biopsy procedure. Sterilize the needle guide assembly
between uses.
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Safety
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 surgical equipment.
Remove the battery from the device when the device is not used for a long time.
Transducer Warnings
To avoid infection, always use protective gloves when cleaning or disinfecting
Read and follow all manufacturer instructions for disinfection agents.
To avoid infection, ensure that expiration date of the disinfecting solution has not passed.
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 or disinfecting.
Do not immerse the transducer beyond the point indicated in Figure 6-3.
Do not allow the transducer connector to get wet.
"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 service life.
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 the environment.
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.
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
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
Appendix B.2 Ultrasound Safety and the ALARA Principle
- 4 -
before
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Safety
without compromising the image quality.
Do not use in the presence of a flammable anesthetic.
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.
Verify measurement 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 to use.
Please read and understand maintenance instructions prior to use.
Please read and understand instructions for system operation prior to use.
Studies stored on the system hard drive should be archived regularly. The system is not
intended for long term storage of patient information. Confirm successful archiving before
deleting a study from the hard drive.
Ensure that the system vents are clear and unobstructed.
Confirm patient identification information prior to storing or printing any exam information.
If you have any question about maintenance, technical specifications, or system functionality,
please contact your local distributor or Edan Service at: support@edan.com.cn
Ultrasound images occasionally have artifacts, and should only be used as one part of an
overall clinical assessment.
To avoid 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
regulation.
The system does not need calibration as part of routine maintenance.
The format of U disk should be FAT32.
Do NOT 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.
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Safety
To ensure 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°C or 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 unauthorized disassembly.
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 physically secure.
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 ultrasound system.
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.
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,
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:
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Safety
No.
Symbol
Definition
1 Serial Number
2
P/N
Part Number
3 Date of Manufacture
4 Manufacturer
5 Consult operating instructions
6
Warning
(Background: Yellow; Symbol & outline: Black )
7
Refer to User Manual
(Background: Blue; Symbol: White)
8
Caution
9 Biological Risks
10
CE Marking
11
Authorized Representative in the European Community
12
Disposal method. Indicates that the equipment should be sent to
special agencies according to local regulations for separate
collection after its useful life.
- 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 for help.
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:
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Safety
13
General Symbol for Recovery / Recyclable
14
Caution: Federal (U.S.) law restricts this device to sale by or on the
order of a physician.
15
IPX7
No harm for short time immersion
16
Type BF Applied Part
17
Transducer connector
18
Pencil Transducer connector (reserved)
19
ECG connector
21
Transducer lock
22
Transducer unlock
23
Equipotential grounding
24
Network port
25
Trademark
26
Video Output port
27
USB 2.0 port
28
USB 3.0 port
29
HDMI
HDMI port
30
Microphone input
- 8 -
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Safety
31
Audio output
32
AC power indicator
33
Batter charging indicator
34
Up/Down button, to move the control panel up or down
35
Non-ionizing electromagnetic radiation.
36
FCC
ID:SMQLX9EDAN
Federal Communications Commission:
FCC ID:SMQLX9EDAN
37
Type CF Applied Part with Defibrillation-proof protection
38
Non-sterile. Indicates a medical that has not been subjected to a
sterilization process.
39
IP68
Dust-tight (No ingress of dust); No harm for continuous immersion
in water
- 9 -
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Safety
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 monitored equipment.
The following labels are used on the wooden packaging:
NOTE:
The user manual is printed in black and white.
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
Model
Angle/Depth
Description
BGK-C5-2
20°, 28°, 40°
For use with the C7-2XQ/C5-2Q,
Supports: 14G-23G
BGK-L40UB
34°, 43°, 53°, 66°
For use with the L17-7HQ,
Supports: 14G-23G
BGK-CR10UA
2°
For use with the E8-4Q,
Supports: 16G, 18G
BGK-R15UB
12°, 20°, 35°
For use with the MC8-4Q,
Supports: 14G-23G
BGK-001
1.0cm, 1.5cm, 2.0cm
For use with the L17-7HQ,
Supports: 21G
BGK-004
12°, 20°
For use with the MC9-3TQ,
Supports: 14G-23G
BGK-005
0°
For use with the E10-3BQ,
Supports: 16G, 18G
BGK-006
1°
For use with the E10-3HQ,
Supports: 16G, 18G
BGK-007
18°, 25°, 35°
For use with the C5-1Q,
Supports: 14G-23G
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 user manual
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
Needle Guide Bracket Kit
Footswitch
Ultrasound gel warmer
USB disk
Table 3-1 Needle Guide Bracket Kits
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
Printer Type
Printer Model
Interface
Color Video Printer
SONY UP-25MD
S-Video
SONY UP-D25MD
USB
B/W Video Printer
SONY UP-X898MD
USB
Report Printer
HP Officejet Pro 251dw
USB
HP LaserJet Pro 200 color M251n
USB
HP LaserJet CP1525n Color
USB
HP Deskjet Ink Advantage 2010
USB
HP Deskjet 1010
USB
HP Deskjet 1510
USB
HP LaserJet 400 M401d
USB
HP DeskJet Ink Advantage Ultra 2029
USB
HP DeskJet 1112
USB
Canon E518
USB
Canon iP2780
USB
HP LaserJet Pro MFP M126nw
USB
HP DeskJet 1050
USB
HP DeskJet 2050
USB
HP LaserJet M252n
USB
Two batteries
Wifi module
ECG module
Supported Peripheral Accessories:
The recommended printers are listed as follows:
Many other printers may also work with Acclarix systems. To check if your printer works, connect it to
the system, go to Set-up->Store/Print, and click the Add button. Once it is added, confirm correct
operation by clicking the Test button.
If that does not work, you may need to download a printer ppd file from the printer supplier. In that
case download the ppd file to your local computer, and then copy it to a USB stick inside a directory
named “ppd”. Insert that USB stick into the Acclarix system along with the printer and try again. Most,
but not all, printers will work with the Acclarix systems. A list of printers that should be compatible can
be found at https://developers.hp.com/hp-linux-imaging-and-printing/supported_devices/index, or at
http://gimp-print.sourceforge.net/p_Supported_Printers.php.
Table 3-2 Printer List
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
2
8
9
6 3 18
10
7
5
1
15
16 4 11
13
14
17
12
19
WARNING
Only the recommended printers listed above are verified by EDAN. Therefore, it is suggested to only
use these printers. Use of other printers should comply with IEC 60950 or IEC 60601-1. Edan is not
responsible for the accuracy of other printers.
Recommended DVD drives: LITEON
3.2 System Overview
3.2.1. Main Unit
Figure 3-1 Main Unit
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
No.
Description
No.
Description
1
Monitor
11
Monitor Support Arm
2
Touch Screen
12
Speaker
3
Control Panel
13
Coupling Gel Holder
4
Handle
14
Transducer Holders
5
Control Panel Height Adjusting
Lever
15
Video Printer /DVD
Drive(optional)
6
Physical Keyboard
16
USB Port(two)
7
Cable Holder
17
System Vents
8
ECG Connector
18
Wheels(four)
9
Pencil Transducer Connector
(Reserved)
19
Battery Compartment
10
Transducer Sockets(five)
Table 3-3 Main Unit Description
Press down the keyboard case on figure 3-1 to open the keyboard for editing. Push it back after
usage.
Figure 3-2 System Keyboard
CAUTION
1. Ensure system vents are clear and unobstructed.
- 14 -
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
No.
Description
No.
Description
1
Coupling Gel Holder/
Gel Warmer(Optional)
2
I/O Ports
3
Video Printer/DVD Drive(Optional)
4
Air Switch
5
Equipotential Terminal
6
AC Power Socket
4
1
2 3 5
6
1. To facilitate the disconnection from power supply, please do not cover the AC power socket with
any object.
Figure 3-3 Rear View
Table 3-4 Rear View Description
CAUTION
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
No.
Description
No.
Description
1
S-Video output port
2
Audio output port
3
DVI port
4
USB port
5
Microphone port
6
VGA port
7
Network Port
8
HDMI port
Equipotential terminal Rear panel Potential equalization conductor
Equipotential Connection
The equipotential terminal is used for balancing the protective earth potentials between the ultrasound
system and other electrical devices. Perform the equipotential connection as the following illustration.
WARNING
1. When you connect another device to the ultrasound system, a potential equalization conductor
should be used to connect each of the equipotential terminals. Otherwise, electric shock may
result.
2. Any device connected to the ultrasound system 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.
I/O Ports on the Rear Panel
Figure 3-5 I/O ports
Table 3-5 I/O ports description
- 16 -
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
No.
Key
Name
Description
1.
Power Switch
Press to power on/off the system.
: AC power supply indicator. It illuminates in green
when the system is connected to AC power supply.
: Battery charging indicator. It illuminates in green
when the battery is charging.
2.
Patient
Invokes the Patient Information Screen typically used to
start/end exams or to modify patient information during
an exam.
3.
Transducer
Press to switch transducer or exam presets.
4.
Review
Press to enter exam database or image review mode.
See section 9.2 for details.
5.
Print
Press to print images via the connected USB video
printer.
Caution
1. The resolution of the external display which connects to DVI port or HDMI port should be 1080P,
otherwise the display will be abnormal.
3.2.2. Control Panel
Figure 3-6 Control Panel
- 17 -
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
6.
Report
Press to display the report page.
7.
F1
User-defined button. See section 11.1.1 for configuring
the user-defined button.
8.
F2
9.
Steer
The Steer knob control is only available for linear
transducers. It can steer B-mode image, Color ROI, PW
sample line, etc. Specific operations thereof are
described throughout the user manual.
10.
Angle
Adjusts the angle of comment, body marks, needle, M
sample line, etc. Specific operations thereof are
described throughout the user manual.
11.
Body Mark
Enters or exits the Body Mark function.
12.
Comment
Enters or exits the Comment function.
13.
Cursor
Press to hide or display the mouse cursor.
When pressing Cursor while using the Comments
function, the system will display a green cursor in the
image field that can be used to point to anatomical
structures.
14.
Clear
Press to clear all the measurements, calculations,
comments, and body marks displayed on the current
image.
15.
B
Press to return to B-mode imaging from any other
imaging mode and rotate to adjust the gain in B Mode.
16.
Color
Press to enter or exit Color Mode and rotate to adjust the
gain in Color Mode.
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
17.
PW
Press to get the sample line. Use the trackball to adjust
the position of the sample line. Press it again or press
<Update> key to display the Doppler strip. Rotate this
knob to adjust the gain in PW Mode.
In 3D/4D mode, rotating it can rotate the image by the
X-axis of the activated window.
18.
CW
Press to get the sample line. Use the trackball to adjust
the position of the sample line. Press it again or press
<Update> key to display the Doppler strip.
This knob is only available when the current active
transducer is a phased transducer .
In 3D/4D mode, rotating it can rotate the image by the
Y-axis of the activated window.
19.
M
Press to enter or exit M Mode and rotate to adjust the
gain in M Mode. Use the trackball to adjust the M sample
line.
In 3D/4D mode, rotating it can rotate the image by the
Z-axis of the activated window.
20.
3D
Press to enter or exit 3D Mode. It is only available when
the current active transducer is a wobble transducer.
21.
4D
Press to enter or exit 4D Mode. It is only available when
the current active transducer is a wobble transducer.
22.
Quad
Enters quad split screen. Each single press on it toggles
between four image windows.
23.
Dual
Enters dual split screen. Each single press on it toggles
between two image windows.
24.
Single
Press to display the currently active side of Dual image
as a single image.
25.
Update
In measurement, pressing <Update> switches the active
side of calipers. See section 8.1 for details.
In Pre-Doppler mode, pressing <Update> invokes
Spectral Doppler mode. When Spectral Doppler strip is
displayed, pressing Update allows switching between
live acquisition of the Doppler strip or the reference
image.
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Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
26.
Caliper
Invokes generic measurements. See section 8.1 for
details.
27.
Measure
Invokes application measurements. See section 8.2 for
details.
28.
Trackball
Keys
Two trackball keys provide a wide variety of functions
depending on the system state (e.g., selects a start or
end point of a measurement, selects menu items on the
screen, etc). For the convenience of introduction, we call
them <Set> throughout this user manual.
29.
Trackball
Move the trackball to change the cursor position, adjust
M mark position in M mode, adjust sample line position
in PW mode, etc.
30.
Store Clip
Press to store clips.
31.
Store Image
Press to store static images.
32.
Freeze
Press to switch between the frozen and real-time states.
33.
Depth
Rotate to adjust the depth of the image displayed.
Rotate counterclockwise to decrease the depth and
rotate clockwise to increase.
34.
Zoom
Rotate to use Pan Zoom function, and press to use
Spot Zoom function. See section 7.4 for details.
35.
TGC
The Time Gain Compensation control (TGC) adjusts the
gain of the image at different depths. Each slider can be
adjusted separately.
Glide the slide controls to adjust the TGC. Glide the
upper segments to adjust the near field gain, and the
lower segments to adjust the far field gain; glide
rightward to increase TGC, and glide leftward to
decrease.
- 20 -
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
36.
Auto
In B mode, the Auto push button automatically updates
the Overall Gain and TGC.
In PW mode, the Auto push button automatically
updates the PW gain, DR, baseline and scale.
In Color mode, this Auto push button automatically
updates the gain and scale.
Each single press of the button renews the automatic
optimization. Whether Gain, DR or Scale/Baseline is
optimized when pressing Auto button in PW mode can
be configured in Set-up. See section 11.1.4 for detail.
37.
Touch screen
paddle
Knob(Six)
Each of these six knobs adjusts the setting value of one
corresponding paddle control above it on the touch
screen.
①
④
②
③ ⑤ ⑥
Table 3-6 Buttons on Control Panel
3.2.3. Screen Layout
Figure 3-7 Main Screen Display
① Information Field
The top line of this field contains your hospital/institution name. Please see Section
Set-up
The second line of this field contains the patient name, gender, age and ID, as entered through the
Patient Information screen.
This field also contains data fields for:
The currently active transducer
The currently active preset
System date and time.
for information on customization.
11.1.1 General
- 21 -
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
No.
Shortcut Keys
Description
1 Select All
Selects all the displayed static images and clips.
2 Delete
Deletes the selected static images and clips.
3 Export
Exports the selected static images and clips to removable
storage devices.
4
Previous/Next
Images
Views previous or next images when more than one page of
images are displayed.
No.
Icons
Description
1
Image Store
icon
Displays the number of static images and clips stored in the
current exam.
2
USB icon
USB available.
3
Printer icon
Printer available.
② Image Field
The ultrasound image appears in the Image field, under the Information field. The Image field also
contains information typically associated with the image, such as depth, TGC, maps, image
parameters, MI and TI.
③ Measurements Display Field
The left side of the screen displays available generic and application measurement items for current
exam preset.
④Thumbnail Field
The right side of the screen displays thumbnail images of all statics and clips captured for currently
active exam or when in Review. This field also contains several shortcut keys for selecting, viewing,
deleting, exporting images. See the below for details:
⑤ User Feedback Field
The user feedback filed is displayed below image field and above status bar. This field displays:
The illustration of trackball and trackball keys.
Cine bar when the system is frozen.
The active function of user custom key F1 and F2.
⑥ Status Bar
The bottom of the screen is used to display icons that provide system status. These include:
- 22 -
Acclarix LX9 Series Diagnostic Ultrasound System User Manual Getting Started
4
Wi-Fi icon
Wi-Fi function is enabled, but no WI-FI network is
connected.
No WI-FI icon will be displayed when Wi-Fi function is
disabled in Connectivity setup.
Wi-Fi network is connected.
Clicking on this icon shows a list of available Wi-Fi networks.
Selecting an available network displays a dialog box for
entering password. Clicking on the "WiFi: Turn off" button
above the list will disconnect the currently connected WI-FI
network.
WI-FI network is disconnected.
Clicking on this icon shows a "WiFi: Turn on" button. Clicking
on this button shows a list of available Wi-Fi networks.
Selecting an available network displays a dialog box for
entering password.
5
Network
status icon
The network status icon shows the connection status of the
Network Server. If no Network Server is defined, then the
icon is not displayed.
Outline in grey color: Successful connection with a
Server.
Outline in green color: Data exchange with a Server.
Outline in red color: Failure to connect with a configured
Server
Clicking on this icon displays a queue of exam or image
transfers and as well as the transfer status of each exam or
image including refuse, pending, active, success and fail.
For a failed transfer, the system will automatically retry the
transfer when the transfer task is available, or user can
manually retry transfer. User can manually delete a transfer
from the queue.
6
Hard Drive
icon
Hard drive available.
Hard drive data exchange, symbol in green.
Hard drive 95% full, symbol in red.
Hard drive 95% full with data exchange, symbol in red.
7
Battery icon
Battery fully charged, symbol in green.
Battery more than 80% charged.
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