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.

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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

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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

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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

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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
- 1 -
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.