EDAN Acclarix LX4 User manual

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文件名称(Document Name)：Acclarix LX4(新显示器臂)使用说明书基础册_英文
文件编号(Number)：01.54.458402
版本(Version)：1.0
产品型号(Product Model)：Acclarix LX4
项目编码(Project Code)：2911G003
签批信息(Signature):
作者(Originator) : 谢 菊艳 (xiejuyan) 2019-08-19 14:34:48
审核人(Reviewers) : 李 娟 (lijuan) 2019-08-19 17:35:41
审核人(Reviewers) : 鲁 应君 (luyingjun) 2019-08-20 15:01:34
审核人(Reviewers) : 陈 云飞 (chenyunfei) 2019-08-19 17:34:03
审核人(Reviewers) : 赵 云兰 (zhaoyunlan) 2019-08-22 08:56:56
批准人(Approvers) : 郭 伟娟 (guoweijuan) 2019-08-26 10:27:51
批准人(Approvers) : 冀 伟 (jiwei) 2019-08-26 15:47:35
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

1

I
Preface
This User Manual Basic Volume together with the User Manual Advanced Volume (P/N:
01.54.458403) contain necessary and sufficient information to use the Acclarix LX4 Ultrasound
Imaging System safely for the intended purposes and approved clinical applications. This User
Manual applies to all 1.0X releases.
Read and understand all instructions in this manual prior to using the Acclarix LX4 ultrasound
system.
Disregarding instructions, particularly warnings and cautions, is considered abnormal use.
Caution: Federal law restricts this device to use by, or on the orders of, a physician.
Contact Information:
For sales or service information please contact your local distributor or the EDAN service
department at: [email protected]
P/N: 01.54. 458402
MPN: 01.54. 458402010
Release Date: August, 2019
© Copyright EDAN INSTRUMENTS, INC. 2019

II
RegulatoryApproval Remarks
Auto OB measurement IS NOT available in the USA and its territories.

III
Contents
1Introduction..............................................................................................................................1
1.1 Intended Use/ Indications for Use..........................................................................................1
1.2 Contra-indications..................................................................................................................1
1.3 Device Description.................................................................................................................1
1.4 Labeling Symbols ..................................................................................................................2
2Safety.........................................................................................................................................5
2.1 Warnings.................................................................................................................................5
2.2 Cautions .................................................................................................................................7
3Getting Started.......................................................................................................................10
3.1 System Configuration ..........................................................................................................10
3.2 System Overview.................................................................................................................12
3.2.1. Front View .................................................................................................................12
3.2.2. Rear View...................................................................................................................14
3.2.3. Left View ...................................................................................................................16
3.3 Connecting and Disconnecting a Transducer.......................................................................18
3.4 Powering on/ off...................................................................................................................21
3.5 Screen Layout.......................................................................................................................23
3.6 Control Panel........................................................................................................................26
3.7 Touch Screen........................................................................................................................30
3.8 Trackball...............................................................................................................................31
3.9 Monitor Position Adjustment..................................................................................................................32
4Exam Operation.....................................................................................................................36
4.1 How to Start an Exam..........................................................................................................36
4.2 How to End an Exam ...........................................................................................................36
4.3 How to Restart an Exam ......................................................................................................37
4.4 The Patient Information Page...............................................................................................37
4.5 Modality Worklist ................................................................................................................39
5Imaging...................................................................................................................................41
5.1 B-mode.................................................................................................................................41
5.1.1. B-mode Touch Screen Controls ...................................................................................41
5.1.2. Dual Imaging................................................................................................................44
5.1.3. Quad Imaging...............................................................................................................44
5.1.4. Panorama......................................................................................................................45
5.1.5. Zoom............................................................................................................................46
5.2 PW-mode..............................................................................................................................46
5.2.1. PW Touch Screen Controls ..........................................................................................46
5.2.2. HPRF............................................................................................................................48
5.2.3. Update..........................................................................................................................49
5.3 CW-mode .............................................................................................................................49
5.3.1. CW Touch Screen Controls..........................................................................................49
5.4 Color-mode ..........................................................................................................................51
5.4.1. Color Touch Screen Controls.......................................................................................51
5.4.2. Color Mode Variants ....................................................................................................53
5.5 M-mode................................................................................................................................53
5.5.1. M-mode Touch Screen Controls ..................................................................................53
5.6 Anatomic M Mode ...............................................................................................................55

IV
5.6.1. Anatomic M Touch Screen Controls............................................................................55
5.6.2. Anatomic M Mode Operations.....................................................................................55
5.7 TDI Mode.............................................................................................................................56
5.7.1. TDI Mode Operations ..................................................................................................56
5.7.2. TDI Touch Screen Controls..........................................................................................56
5.8 3D/4D Mode ........................................................................................................................57
5.8.1. Pre-3D/Pre-4D..............................................................................................................57
5.8.2. 3D Volume Sweeping...................................................................................................58
5.8.3. 3D Image Review.........................................................................................................59
5.8.4. 4D Volume Acquisition................................................................................................63
5.8.5. 4D Live Volume ...........................................................................................................64
5.8.6. 4D Cine ........................................................................................................................64
5.8.7. 3D/4D Dataset..............................................................................................................65
5.8.8. Knobs and Buttons on Control Panel...........................................................................66
6Transducers............................................................................................................................67
6.1 Transducer Model ................................................................................................................67
6.2 Name and Function of Each Part of the Transducer ............................................................68
6.3 Transducer Cleaning and Disinfecting.................................................................................68
6.3.1. Cleaning .......................................................................................................................68
6.3.2. Disinfection..................................................................................................................69
6.3.3. Sterilization..................................................................................................................72
6.3.4. Storage .........................................................................................................................72
6.3.5. Using Transducers........................................................................................................73
7Features...................................................................................................................................75
7.1 Comments ............................................................................................................................75
7.2 Body Mark ...........................................................................................................................77
7.3 Measurements ......................................................................................................................78
7.3.1. Generic Measurements.................................................................................................80
7.3.2. Application Measurements and Calculations...............................................................87
7.4 Patient Information Management.........................................................................................92
7.4.1. Storing Images .............................................................................................................92
7.4.2. Reviewing Images........................................................................................................93
7.4.3. Patient Database...........................................................................................................95
7.4.4. Archiving Studies.........................................................................................................97
7.4.5. Structured Report.........................................................................................................97
7.5 Needle Biopsy Guide ...........................................................................................................98
7.5.1. Installing Needle Guide Bracket..................................................................................98
7.5.2. Activating Needle Guide Function.............................................................................102
7.5.3. To Adjust the Needle Guide Line...............................................................................103
7.6 Needle Visualization ..........................................................................................................103
8Presets...................................................................................................................................105
8.1 Preset Organization............................................................................................................105
8.2 Selecting a Preset ...............................................................................................................105
8.3 Storing a Preset ..................................................................................................................106
8.3.1. Presets ........................................................................................................................107
8.3.2. Comments Presets......................................................................................................110
8.3.3. Bodymarker Presets ................................................................................................... 111
8.3.4. Measure Presets..........................................................................................................113

V
9Utilities.................................................................................................................................. 117
9.1 Set-up .................................................................................................................................117
9.1.1. General Set-up............................................................................................................118
9.1.2. Patient Set-up.............................................................................................................119
9.1.3. Store/Print Set-up.......................................................................................................120
9.1.4. Miscellaneous Set-up.................................................................................................122
9.1.5. User Set-up.................................................................................................................123
9.2 Connectivity.......................................................................................................................124
9.2.1. TCP/IP........................................................................................................................124
9.2.2. DICOM ......................................................................................................................126
9.2.3. Network Store ............................................................................................................128
9.3 Maintenance.......................................................................................................................130
9.3.1. License .......................................................................................................................130
9.3.2. Version........................................................................................................................130
9.3.3. Demo..........................................................................................................................131
9.3.4. Export/Import.............................................................................................................132
9.4 Screen Adjust .....................................................................................................................133
10 In Between Exams................................................................................................................135
10.1 Unpacking........................................................................................................................135
10.2 Transport ..........................................................................................................................135
10.3 Storage .............................................................................................................................135
11 Order List.............................................................................................................................136
12 Troubleshooting and Maintenance.....................................................................................137
12.1 Daily Checklist.................................................................................................................137
12.2 Troubleshooting ...............................................................................................................137
12.3 Cleaning the System.........................................................................................................138
12.3.1. Cleaning the System Surface ...................................................................................139
12.3.2. Cleaning Trackball ...................................................................................................139
12.3.3. Needle Guide Bracket Cleaning and Sterilization ...................................................140
12.4 Maintenance.....................................................................................................................141
13 Specifications........................................................................................................................142
13.1 Electrical Safety Classifications.......................................................................................142
13.2 Power Supply...................................................................................................................142
13.3 Machine Specifications....................................................................................................142
13.4 Display Specifications......................................................................................................142
13.5 General Technical Specifications.....................................................................................143
13.6 Operating, Storage and Transportation Environment.......................................................144
13.6.1. Operating Environment............................................................................................144
13.6.2. Storage and Transportation Environment.................................................................144
14 EMC Information................................................................................................................145
15 Ultrasound Gel Warmer......................................................................................................151

Acclarix LX4 Diagnostic Ultrasound System User Manual Introduction
- 1 -
1 Introduction
1.1 Intended Use/ Indications for Use
The Ultrasound system is intended for use by a qualified physician or allied health professional
for ultrasound evaluations. Specific clinical applications include:
Abdominal
Gynecology (including endovaginal)
Obstetric
Cardiac
Small parts (Breast, Testes, Thyroid, etc.)
Urology
Musculoskeletal
Peripheral vascular
Intra-operative
Pediatric
Neonatal (including abdominal and cephalic)
Adult Cephalic
1.2 Contra-indications
The Ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam
to pass the eye.
1.3 Device Description
The Acclarix Ultrasound Imaging 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 Acclarix system then analyzes the
returned signals and generates an ultrasound image or spectral Doppler display.
The Acclarix Ultrasound Imaging 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 LX4 Diagnostic Ultrasound System User Manual Introduction
- 2 -
1.4 Labeling Symbols
The following labels are used on the system:
No.
Symbol
Definition
1
Serial Number
2
P/N
Part Number
3
Date of Manufacture
4
Manufacturer
5
Operating instructions
6
Warning
(Background: Yellow; Symbol & outline: Black )
7
Refer to 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
IPX7
No harm for short time immersion
16
Type BF Applied Part

Acclarix LX4 Diagnostic Ultrasound System User Manual Introduction
- 3 -
17
Transducer connector
18
Transducer lock
19
Transducer unlock
20
Equipotential grounding
21
Network port
22
Trademark
23
Video Output port
24
USB 2.0 port
25
USB 3.0 port
26
Microphone input
27
Headphones
28
Up/Down button, to move the control panel up or down
29
Forbid to move the system by pushing the monitor.
30
The maximum load of the device is 15KG. Do not put heavy objects
on it or lean on it.
31
Non-ionizing electromagnetic radiation.