EDAN Acclarix AX8 User manual

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文件名称(Document Name)：Acclarix AX8&AX7使用说明书基础册-英文
文件编号(Number)：01.54.002481
版本(Version)：2.1
产品型号(Product Model)：Acclarix AX7;Acclarix AX8
项目编码(Project Code)：2908G000
签批信息(Signature):
作者(Originator) : 谢 菊艳 (xiejuyan) 2019-07-31 09:33:08
审核人(Reviewers) : 李 娟 (lijuan) 2019-07-31 16:23:29
审核人(Reviewers) : 鲁 应君 (luyingjun) 2019-07-31 09:53:23
审核人(Reviewers) : 陈 云飞 (chenyunfei) 2019-08-02 17:59:54
批准人(Approvers) : 郭 伟娟 (guoweijuan) 2019-08-06 13:48:03
批准人(Approvers) : 冀 伟 (jiwei) 2019-08-07 00:24:14
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

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About This Manual
P/N:01.54.002481
MPN: 01.54.002481021
Release Date: June, 2019
© Copyright EDAN INSTRUMENTS, INC. 2015-2019
This User Manual applies to 2.0X releases for Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound
Systems.
This User Manual Basic Volume together with the User Manual Advanced Volume (P/N: 01.54.002482)
contain necessary and sufficient information to use the Acclarix AX8/Acclarix AX7 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: [email protected].cn

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Regulatory Approval Remarks
AcclarixAX7 model IS NOT available in CE region.
The following features are not available in the USAand its territories at the time of release of this
user manual. Consult your local representatives for the availability of these features.
Auto OB measurement;
Elastography mode;
ECG module;
C7-2XQ transducer;
C5-1Q transducer;
E10-3BQ transducer;
E10-3HQ transducer;
Auto NT measurement;
Color M mode.
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.
C5-1Q transducer;
E10-3BQ transducer;
E10-3HQ transducer;
Auto NT measurement;
Color M mode.

II
Contents
1Introduction.................................................................................................................................... 1
1.1 Intended Use/ Indications for Use................................................................................................ 1
1.2 Contra-indications ........................................................................................................................ 1
1.3 Device Description ....................................................................................................................... 1
2Safety .............................................................................................................................................. 2
2.1 Warnings ...................................................................................................................................... 2
2.2 Cautions ....................................................................................................................................... 4
2.3 Labeling Symbols......................................................................................................................... 6
3Getting Started............................................................................................................................. 10
3.1 System Configuration................................................................................................................. 10
3.2 System Overview ....................................................................................................................... 12
3.2.1. Main Unit ......................................................................................................................... 12
3.2.2. Control Panel................................................................................................................... 14
3.2.3. Screen Layout ................................................................................................................. 17
3.2.4. Touch Screen................................................................................................................... 20
3.2.5. Trackpad.......................................................................................................................... 21
3.3 System Preparation.................................................................................................................... 22
3.3.1. Battery Use ........................................................................................................................ 22
3.3.2. AC Power Use.................................................................................................................... 23
3.3.3. Transducer Connection...................................................................................................... 23
3.3.4. Powering on/ off ................................................................................................................. 25
4Exam Operation ........................................................................................................................... 27
4.1 How to Start an Exam ................................................................................................................ 27
4.2 How to End an Exam ................................................................................................................. 28
4.3 How to Restart an Exam ............................................................................................................ 28
4.4 The Patient Information Page .................................................................................................... 29
4.5 Modality Worklist........................................................................................................................ 30
5Imaging ......................................................................................................................................... 32
5.1 B-mode....................................................................................................................................... 32
5.1.1. Using B-mode .................................................................................................................... 32
5.1.2. B-mode Image Optimization .............................................................................................. 32
5.2 Color Mode................................................................................................................................. 35
5.2.1. Color Mode Variants .......................................................................................................... 35
5.2.2. Using Color Mode .............................................................................................................. 36
5.2.3. Color Image Optimization .................................................................................................. 36
5.3 PW Mode.................................................................................................................................... 39
5.3.1. Using PW Mode................................................................................................................. 39
5.3.2. PW Image Optimization..................................................................................................... 39
5.3.3. HPRF.................................................................................................................................. 42

III
5.4 CW Mode.................................................................................................................................... 42
5.4.1. Using CW Mode................................................................................................................. 42
5.4.2. CW Image Optimization..................................................................................................... 42
5.5 M Mode....................................................................................................................................... 44
5.5.1. Using M Mode.................................................................................................................... 44
5.5.2. M-mode Image Optimization.............................................................................................. 45
5.6Anatomic M Mode....................................................................................................................... 46
5.6.1. Using Anatomic M Mode.................................................................................................... 46
5.6.2. Anatomic M Image Optimization........................................................................................ 46
5.7 Color M Mode............................................................................................................................. 47
5.7.1. Using Color M Mode .......................................................................................................... 47
5.7.2. Color M Image Optimization .............................................................................................. 47
5.8 TDI Mode.................................................................................................................................... 48
5.8.1. TDI Mode Operations......................................................................................................... 48
5.8.2. TDITouch Screen Controls................................................................................................ 48
5.9 3D/4D Mode ............................................................................................................................... 49
5.9.1. Pre-3D/Pre-4D ................................................................................................................... 49
5.9.2. 3D Volume Sweeping......................................................................................................... 50
5.9.3. 3D Image Review............................................................................................................... 51
5.9.4. 4D Volume Acquisition....................................................................................................... 56
5.9.5. 4D Live Volume.................................................................................................................. 57
5.9.6. 4D Cine.............................................................................................................................. 57
5.10 Panorama................................................................................................................................. 58
5.11 Elastography............................................................................................................................. 59
5.11.1. Using Elastography Mode................................................................................................ 59
5.11.2. Elastography Image Optimization.................................................................................... 60
5.12 ECG.......................................................................................................................................... 61
5.12.1. ECG Touch Screen Controls............................................................................................ 62
5.12.2. ECG Basic Operations..................................................................................................... 62
5.12.3. ECG Review..................................................................................................................... 63
6Transducers and Biopsy............................................................................................................. 64
6.1 Transducer Model....................................................................................................................... 64
6.2 Using Transducers..................................................................................................................... 66
6.3 Transducer Cleaning and Disinfecting....................................................................................... 69
6.3.1. Cleaning............................................................................................................................. 69
6.3.2. Disinfection......................................................................................................................... 69
6.3.3. Sterilization......................................................................................................................... 72
6.3.4. Storage............................................................................................................................... 72
6.4 Needle Biopsy Guide ................................................................................................................. 73
6.4.1. Installing Needle Guide Bracket ........................................................................................ 73

IV
6.4.2. Activating Needle Guide Function...................................................................................... 79
6.4.3. ToAdjust the Needle Guide Line ....................................................................................... 79
6.5 Needle Visualization................................................................................................................... 80
6.6 Center Line................................................................................................................................. 81
6.7 Needle Guide Bracket Cleaning and Sterilization...................................................................... 81
6.7.1. Cleaning............................................................................................................................. 82
6.7.2. Sterilization......................................................................................................................... 82
6.7.3. Storage............................................................................................................................... 82
7Features ........................................................................................................................................ 83
7.1 Comments.................................................................................................................................. 83
7.2 Body Mark .................................................................................................................................. 85
7.3 Split Display................................................................................................................................ 86
7.3.1. Dual Imaging...................................................................................................................... 86
7.3.2. Quad Imaging..................................................................................................................... 86
7.4 Zoom .......................................................................................................................................... 87
7.4.1. Pan Zoom........................................................................................................................... 87
7.4.2. Spot Zoom.......................................................................................................................... 87
8Measurements and Reports........................................................................................................ 88
8.1 Generic Measurements.............................................................................................................. 92
8.1.1. B-mode Generic Measurements........................................................................................ 92
8.1.2. M-mode Generic Measurements....................................................................................... 96
8.1.3. Strip Doppler Generic Measurements ............................................................................... 97
8.2Application Measurements....................................................................................................... 102
8.2.1. Abdomen Measurements.................................................................................................103
8.2.2. Gynecology Measurements............................................................................................. 104
8.2.3. Obstetrics Measurements................................................................................................105
8.2.4. Cardiac Measurements.................................................................................................... 109
8.2.5. Small Parts Measurements...............................................................................................116
8.2.6. Urology Measurements.....................................................................................................117
8.2.7. Vascular Measurements ...................................................................................................118
8.2.8. Pediatric Measurements.................................................................................................. 121
8.3 Worksheet and Report ............................................................................................................. 123
8.3.1. Worksheet........................................................................................................................ 123
8.3.2. Report .............................................................................................................................. 128
8.4 Measurement Accuracy ........................................................................................................... 129
9Exam Data Management............................................................................................................ 130
9.1 Storing Images ......................................................................................................................... 130
9.2 Reviewing Images....................................................................................................................131
9.3 Exam Database........................................................................................................................ 132
9.4Archiving Studies......................................................................................................................135

V
9.5 Structured Report..................................................................................................................... 136
10 Presets ........................................................................................................................................ 137
10.1 Preset Organization ............................................................................................................... 137
10.2 Selecting a Preset.................................................................................................................. 138
10.3 Storing and Editing a Preset ..................................................................................................138
10.3.1. Exam Preset................................................................................................................... 139
10.3.2. Comment Preset............................................................................................................ 141
10.3.3. Body Mark Preset ..........................................................................................................142
10.4 Measure Presets.................................................................................................................... 144
10.4.1. General Set-up............................................................................................................... 144
10.4.2. Application Parameter....................................................................................................146
10.4.3. Measure Presets............................................................................................................146
10.4.4. Report Set-up................................................................................................................. 147
11 Utilities ........................................................................................................................................ 148
11.1 System Set-up........................................................................................................................ 148
11.1.1. General Set-up............................................................................................................... 148
11.1.2. Patient Set-up.................................................................................................................150
11.1.3. Store/Print Set-up........................................................................................................... 151
11.1.4. Miscellaneous Set-up..................................................................................................... 152
11.1.5. User Set-up .................................................................................................................... 153
11.2 Connectivity............................................................................................................................ 154
11.2.1. TCP/IP............................................................................................................................ 155
11.2.2. DICOM............................................................................................................................ 156
11.2.3. Network Store................................................................................................................. 160
11.3 Maintenance........................................................................................................................... 161
11.3.1. License........................................................................................................................... 161
11.3.2. Version............................................................................................................................161
11.3.3. Demo.............................................................................................................................. 162
11.3.4. Export/Import.................................................................................................................. 162
11.4 Screen Adjust ......................................................................................................................... 163
12 In Between Exams ..................................................................................................................... 164
12.1 Unpacking .............................................................................................................................. 164
12.2 Transport ................................................................................................................................164
12.3 Storage................................................................................................................................... 164
13 Troubleshooting and Maintenance.......................................................................................... 165
13.1 Daily Checklist........................................................................................................................ 165
13.2 Troubleshooting...................................................................................................................... 165
13.3 Cleaning and Disinfecting the System ...................................................................................166
13.3.1. Cleaning and Disinfecting the System Surface ............................................................. 167
13.3.2. Cleaning and Disinfecting the ECG Module and Cable ................................................168

VI
13.4 Maintenance........................................................................................................................... 169
Appendix A Specifications .............................................................................................................. 170
A.1 Electrical Safety Classifications............................................................................................ 170
A.2 Power Supply........................................................................................................................ 170
A.3 Battery................................................................................................................................... 170
A.4 Machine Specifications......................................................................................................... 171
A.5 Display Specifications...........................................................................................................171
A.6 Technical Specifications........................................................................................................ 171
A.7 Operating, Storage and Transportation Environment........................................................... 173
A.7.1 Operating Environment .................................................................................................173
A.7.2 Storage and Transportation Environment .....................................................................173
A.8 Transducer Specifications..................................................................................................... 173
Appendix B Ultrasound Intensity and Safety................................................................................ 174
B.1 Ultrasound in Medicine ......................................................................................................... 174
B.2 Ultrasound Safety and the ALARAPrinciple......................................................................... 174
B.3 Explanation of MI/TI.............................................................................................................. 175
B.3.1 MI (Mechanical Index)................................................................................................... 175
B.3.2 TI (Thermal Index).........................................................................................................175
B.3.3 Display of MI/TI .............................................................................................................176
B.4 Acoustic Output.....................................................................................................................176
B.4.1 Factors that Contribute to Uncertainty in the Output Display .......................................176
B.4.2 Differences between Actual and Displayed MI/TI .........................................................176
B.4.3 Measurement Uncertainty............................................................................................. 176
B.4.4 Acoustic Power Default Settings................................................................................... 177
B.5 Operator Control Features.................................................................................................... 177
B.6 Prudent Use Statement.........................................................................................................177
B.7 References forAcoustic Output and Safety.......................................................................... 177
B.8 Transducer Acoustic Output Data......................................................................................... 178
Appendix C Order List ..................................................................................................................... 179
Appendix D EMC Information.......................................................................................................... 181

AcclarixAX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Introduction
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1 Introduction
1.1 Intended Use/ Indications for Use
The Acclarix AX8/Acclarix AX7 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 AX8/Acclarix AX7 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.

Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety
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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 adapter and 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). However, the
system console panel including touch screen, track pad and hard keys are IPX1 certified. 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

Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety
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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 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-medical 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

Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety
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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 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.
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 flammable anesthetic.

Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety
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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: sup[email protected].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.
It is recommended to use an USB stick of FAT32 format.
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

Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety
- 6 -
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:
-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.
2.3 Labeling Symbols
The following labels are used on the system:

Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety
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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 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.
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
Conforms to AAMI Std. ES 60601-1, IEC Std. 60601-2-37
Certified to CSA Std. No. 60601-1, No 60601-2-37

Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety
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16
IPX7
No harm for short time immersion
17
Type BF Applied Part
18
Transducer connector
19
Pencil Transducer connector (reserved)
20
Signal input connector (reserved)
21
Transducer lock
22
Transducer unlock
23
Network port
24
Trademark
25
Direct current
26
Video Output port
27
USB 2.0 port
28
USB 3.0 port
29
Display port
30
Microphone input
31
Headphones
32
Non-ionizing electromagnetic radiation

Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety
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33
FCC ID:SMQAX8EDAN
Federal Communications Commission:
FCC ID:SMQAX8EDAN
34
Type CF Applied Part with Defibrillation-proof protection
The following labels are used on the packaging:
No.
Symbol
Definition
1
This way up
2
Fragile, handle with care
3
Keep dry
4
General Symbol for Recovery / Recyclable
5
Stacking limit by number
6
Do not step on!
7
Handle with care
NOTE:
The user manual is printed in black and white.

AcclarixAX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started
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3 Getting Started
3.1 System Configuration
Standard Configuration:
1 main unit
1 rechargeable lithium battery
1AC adapter
1 power cord
1 bottle of coupling gel
1 basic user manual and 1 advanced user manual
Options:
Transducers: C5-2XQ, C5-2Q, L10-4Q, L12-5Q, L17-7HQ, E8-4Q, MC8-4Q, P5-1XQ,
L17-7SQ, C5-2MQ, P5-1Q, MC9-3TQ, P7-3Q, C7-2XQ, E10-3BQ, E10-3HQ, C5-1Q
Needle Guide Bracket Kit
Model
Angle/Depth
Description
BGK-C5-2
20°, 28°, 40°
For use with the C7-2XQ/C5-2Q/C5-2XQ,
Supports: 14G-23G
BGK-L40UB
34°, 43°, 53°, 66°
For use with the L10-4Q/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-P5-1X
15°, 25°
For use with the P5-1XQ
Supports: 14G-23G
BGK-001
1.0cm, 1.5cm, 2.0cm
For use with the L10-4Q/L17-7HQ,
Supports: 21G
BGK-002
38°, 46°, 58°
For use with the L12-5Q,
Supports: 14G-23G
BGK-003
1.0cm, 1.5cm, 2.0cm
For use with the L12-5Q,
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
Table 3-1 Needle Guide Bracket Kits

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Mobile Trolley
Footswitch
Suitcase
Multi-Transducer Connector (MTC)
ECG module
Supported Peripheral Accessories:
The recommended printers are listed as follows:
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
Table 3-2 Printer List
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