Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 文件名称：Acclarix AX3 系列使用说明书基础册_英文文件编号：01.54.458117 版本：2.0 产品型号：Acclarix AX3 VET;Acclarix AX3 项目编码(Project Code)：00001G001 签批信息: 作者 : 钟晓婷 (zhongxiaoting) 2021-09-23 09:50:56 审核人 : 李姣 (lijiao) 2021-09-23 10:01:18 审核人...
Page 3: About This Manual
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.
Page 4 Regulatory Approval Remarks The following feature is not available at the time of release of this user manual in CE and USA territories. Consult your local representatives for the availability of the feature.  Fetus Score The following features are not available at the time of release of this user manual in Canada territory. Consult your local representatives for the availability of these features.
Page 5: Table Of Contents
Contents Introduction ............................ 1 1.1 Intended Use/ Indications for Use ....................1 1.2 Contra-indications ........................1 1.3 Device Description ........................1 Safety .............................. 2 2.1 Warnings ............................2 2.2 Cautions ............................4 2.3 Labeling Symbols ......................... 8 Getting Started ..........................11 3.1 System Configuration ........................
Page 6 5.4 CW Mode ........................... 45 5.4.1. Using CW Mode ......................... 45 5.4.2. CW Image Optimization ..................... 45 5.5 M-mode ............................47 5.5.1. Using M-mode ........................47 5.5.2. M-mode Image Optimization ....................47 5.6 Anatomic M Mode ........................49 5.6.1. Using Anatomic M Mode ....................49 5.6.2.
Page 7 6.4.3. Calibrating the Needle Guide Line ..................81 6.5 Needle Visualization ........................82 6.6 Center Line ..........................83 6.7 Needle Guide Bracket Cleaning and Sterilization ..............83 6.7.1. Cleaning ..........................84 6.7.2. Sterilization......................... 84 6.7.3. Storage ..........................84 Features ............................85 7.1 Comment ............................
Page 8 9.2 Reviewing Images ........................136 9.3 Exam Database ........................137 9.4 Archiving Studies ........................139 9.5 Structured Report ........................140 10 Presets ............................141 10.1 Preset Organization ....................... 141 10.2 Selecting a Preset ........................142 10.3 Storing and Editing a Preset ....................142 10.3.1.
Page 9 13.1 Daily Checklist ........................171 13.2 Troubleshooting ........................171 13.3 System Cleaning and Disinfection ..................172 13.3.1. Cleaning and Disinfecting the System Surface ............. 173 13.3.2. Cleaning and Disinfecting the ECG Module and Cable ..........175 13.4 Maintenance ........................... 176 Appendix A Specifications ......................
Page 10: Introduction
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Introduction 1 Introduction 1.1 Intended Use/ Indications for Use The Acclarix AX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics. General clinical applications include:...
Page 11: Safety
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.
Page 12 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.
Page 13: Cautions
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.
Page 14  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.
Page 15 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.
Page 16 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety Federal Communications Commission (FCC) Statement: 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.
Page 17: Labeling Symbols
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety 2.3 Labeling Symbols The following labels are used on the system: Symbol Definition Serial Number Part Number Date of Manufacture Manufacturer Operating instructions Warning (Background: Yellow; Symbol & outline: Black ) Refer to instruction manual/ booklet (Background: Blue;...
Page 18 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety Pencil Probe(reserved) Locking, general Unlocking Computer network Trademark Current: Direct Video Output USB 2.0 port USB 3.0 port HDMI HDMI port Alternating Current Electric Energy Battery Check Non-ionizing electromagnetic radiation Federal Communications Commission:...
Page 19 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety Conforms to AAMI Std. ES60601-1, IEC Std. 60601-2-37, IEC Std. 60601-1-6. Certified to CSA Std. C22.2 No. 60601-1, No 60601-2-37, IEC Std. 60601-1-6. DEFIBRILLATION-PROOF TYPE CF APPLIED PART Probe Version. The following labels are used on the packaging:...
Page 20: Getting Started
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 3 Getting Started 3.1 System Configuration Standard Configuration: The system is shipped with the following components:  1 main unit  1 AC adapter  1 power cord  1 rechargeable lithium battery ...
Page 21 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started For use with the E10-3BQ, In-plane 0° BGK-005 Supports: 16G, 18G For use with the E10-3HQ, In-plane 1° BGK-006 Supports: 16G, 18G For use with the C5-2Q, In-plane 18°, 25°, 35°...
Page 22 Only the recommended printers listed above are verified by EDAN. Therefore, it is suggested to only use these printers. Use of other printers should comply with IEC 60950 or IEC 60601-1. Edan is not responsible for the accuracy of other printers.
Page 23: System Overview
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 3.2 System Overview 3.2.1. Main Unit This manual takes the illustrations of a dual-transducer-port ultrasound system as an example to introduce the appearances of the ultrasound system. All illustrations in this manual are for reference only.
Page 24 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Name Description Display the images and parameters during 15.6 inch Monitor scanning. Power Switch Power on/off the system. control operation activate 10.1 inch Touch Screen functions. Control Panel Use to control the operation.
Page 25 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started CAUTION Bad ventilation will result in high system temperature. To ensure good ventilation for the system, please use the system as follows: Operate the system in the environment temperature between 0° and 40°.
Page 26: Control Panel
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 3.2.2. Control Panel Figure 3-3 Control Panel Name Description Power switch Press to power on/off the system Invokes the Patient Information Screen typically used to Patient start/end exams or to modify patient information during an exam.
Page 27 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Report Press to display the report page. User-defined button User-defined button Press to clear all the measurements, calculations, Clear comments, and body marks displayed on the current image. Enters or exits the Body Mark function. See section 7.2 for Body Mark details.
Page 28 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Press to display the currently active side of Dual image as Single a single image. See section 7.3 for details. Enters dual split screen. Each single press on it toggles Dual between two images.
Page 29: Screen Layout
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started illuminates. Rotating the knob will adjust the angle of comment arrow or the transducer icon. Depth Rotate to adjust the depth of the image displayed. Press to optimize B image or PW Doppler strip automatically.
Page 30 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started ② Image Field The ultrasound image appears in the Image field, under the Information field. The Image field also contains information typically associated with the image, such as depth, TGC, maps, image parameters, MI and TI.
Page 31 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Icons Description Provides access to system setup, screen adjust, connectivity, Utility icon maintenance, etc. Image Store Displays the number of static images and clips stored in the icon current exam.
Page 32: Touch Screen
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Hard drive 95% full with data exchange, symbol in red. Battery fully charged, symbol in green. Battery more than 80% charged. Battery 60%-80% charged. Battery 40%-60% charged. Battery icon Battery low, symbol in red.
Page 33: Trackball
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started A. Tabs: Each imaging mode that is active has a tab at the top of the touch screen. Usually, the imaging mode that was most recently activated is the top tab and has priority. Pressing on any other tab will bring it to the top and provide access to the controls available for that imaging mode.
Page 34: System Preparation
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 3.3 System Preparation 3.3.1. Battery Use The system may come with two lithium-ion batteries depending on your order. The batteries are automatically charged when the system is plugged in. The system has two battery compartments which are identified by letter A and B respectively. The...
Page 35: Ac Power Use
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Figure 3-7 Installation of the Battery 5. Close the battery door and screw the three screws. To remove a battery: 1. Turn off and unplug the system. 2. Close the monitor, turn the system upside down and rest it on a flat stable surface.
Page 36: Transducer Connection
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 3.3.3. Transducer Connection To connect a transducer: Figure 3-8 Tansducer Locking Handle 1. Align the connector with the transducer port and carefully push into place. 2. Toggle the locking handle to the top position.
Page 37: Powering On/ Off
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Multi-Transducer Connector (MTC) The Multi-Transducer Connector (MTC) is an optional addition to the system that allows up to four transducers to be connected to the system simultaneously. The MTC can be mounted to the optional cart, or lie flat on an adjacent table.
Page 38 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started To Switch Users If Password Protection is enabled, switching users is allowed without restarting the system. Press Power on/off key, and the system will display a confirmation dialog box. Select User from the confirmation dialog box. A login information dialog box will be displayed providing access to change user.
Page 39: Exam Operation
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation 4 Exam Operation 4.1 How to Start an Exam Press the <Patient> key and enter patient information, or select a scheduled patient from the modality worklist. If there is no previous exam, pressing the <Patient> key will bring you directly to the Patient Information Page (see figure 4-3 below).
Page 40: How To End An Exam
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation Figure 4-2 Example of Transducer Touch Screen 4.2 How to End an Exam There are two ways to end an exam:  Pressing the <Patient> key, as described above, and then selecting New Exam. This both ends the exam and displays the Patient Information Page for the next exam.
Page 41: The Patient Information Page
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation 4.4 The Patient Information Page The Patient Information Page is used to enter or modify patient demographic data. The following figure is an example: Figure 4-3 Patient Information Page(OB Exam) The top three lines are for entering the patient last name, first name, ID, exam accession number, and DOB (Date-of-Birth) or age.
Page 42 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation  Fetus: Enter 1 up to 4 for multiple gestations.  G/P/A: G stands for Gravida, P stands for Para and A stands for Aborta. Enter values for each in the fields separated by slashes.
Page 43: Modality Worklist
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation 4.5 Modality Worklist Modality worklist provides a list of scheduled patients derived from a DICOM server. It is available only when a DICOM server is configured and worklist is enabled.
Page 44: Imaging
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5 Imaging 5.1 B-mode 5.1.1. Using B-mode Press <B> on the console to enter B mode. Perform the image scanning. Adjust Image parameters to optimize the image. 5.1.2. B-mode Image Optimization The following touch controls can be used to optimize the B-mode image.
Page 45 The Left/Right invert control is indicated by a backward R and is used to toggle the left/right orientation of the image. Left/Right The Edan E orientation marker at the top of the image switches with the left/right invert to match the orientation marker on the transducer.
Page 46 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging The Field of View control adjusts the image width. Full, Large, Med. and Small settings are available. As the image becomes narrower, the frame rate increases. The Steer control is only available for linear transducers and steers the B-mode image left or right, without moving the transducer.
Page 47: Color Mode
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Lateral Gain Control (LGC) adjusts the gain along the scan line to improve the lateral resolution of the image. Press LGC touch screen key to display 8 gain control sliders. Move the slider downwards to decrease the gain, while move the slider upwards to increase the gain.
Page 48: Color Image Optimization
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.2.3. Color Image Optimization The following touch controls can be used to optimize the Color image. Name Control Description A set of radio-buttons display the color modes that are available Color Mode on the current transducer, and let you switch between them.
Page 49 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Persistence determines the number of frames that are Persist averaged together for display. Levels of Off, Low, Med. and High are available. The smoothness filter determines the spatial filtering that is applied to the Color image.
Page 50: Pw Mode
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging The Dynamic Range, or log compression, adjusts how echo intensities are converted to brightness. A high dynamic range Dynamic presents a flatter, less contrasty color display, while a low Range dynamic range presents a more contrasty color display. Only available in PDI/DPDI mode.
Page 51: Pw Image Optimization
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.3.2. PW Image Optimization The following touch controls can be used to optimize the PW image. Name Control Description Scale adjusts the range of velocities that are displayed. Upward presses increase scale and downward presses Scale decrease scale.
Page 52 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Gate adjusts the size of the sample volume gate. Upward Gate Size presses increase the gate size. Downward presses decrease the gate size. Sweep adjusts the sweep speed of the Doppler strip. Options Sweep of Slow, Low, Med., High and Fast are available.
Page 53: Hprf
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging This determines the Doppler transmit frequency used for Frequency imaging. Press to activate the Auto Trace function on a real-time or frozen PW Doppler strip. Auto Trace The Auto Trace function automatically traces the spectral Doppler waveform and records several measurements on selected waveforms.
Page 54: Cw Mode
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.4 CW Mode 5.4.1. Using CW Mode CW mode is only available on phased array transducer. Perform the image scanning to get a good image in B mode or B+Color(DPI/DPDI) mode;...
Page 55 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Quick-Angle Adjusts the angle correct quickly to one of 60°/0°/-60°. The Filter control removes excessive noise from movement of vessel walls. Options of Low, Med. and High are Filter available. Higher wall filter level will suppress more strong single of the vessel walls, but low flow signal will be missing.
Page 56: M-Mode
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.5 M-mode 5.5.1. Using M-mode Perform image scanning to get a good image in B mode; Press <M> to display M strip and sample line; Move the trackball to adjust the sample line;...
Page 57 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Changes the relative size of the M-mode strip compared to Strip Size the reference image. Full, large, Med. and small are available. This is an on/off control. When On, the M-Mode strip is Side-by-side displayed side-by-side with the B-mode image.
Page 58: Anatomic M Mode
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.6 Anatomic M Mode Anatomic M mode allows you to manipulate the position and angle of M sample line and displays real-time M strip image. Only phased array transducer supports Anatomic M mode.
Page 59: Color M Mode
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.7 Color M Mode Color M mode superimposes color encoded information on M mode strip to indicate the direction, velocity and timing of cardiac flow and tissue movements. The direction of cardiac tissue movements can be identified by color changes.
Page 60: Tdi Mode
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.8 TDI Mode Tissue Doppler Imaging (TDI) mode shows information about low-velocity and high-amplitude tissue motion, usually used to evaluate cardiac tissue motion. Only Phased array transducer supports TDI mode. There are four types of TDI modes available on this system: ...
Page 61: 4D Mode
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.9 3D/4D Mode 3D/4D mode is only available on a Wobble transducer. To activate pre-3D or Pre-4D mode: press the 3D or 4D button on the touch screen in B-mode. 5.9.1. Pre-3D/Pre-4D The Pre-3D and Pre-4D mode supports defining the 3D and 4D acquisition location and settings.
Page 62: Volume Sweeping
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Surface/ These two radio buttons determine if the acquisition is Skeleton optimized for looking at Skeleton or Surface. Press to switch to Pre-3D. Press to switch to Pre-4D. Start Start an acquisition.
Page 63: Image Review
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.9.3. 3D Image Review The system will enter to the 3D review status after finishing one sweep. Figure 5-3 3D Image Review There are two image modes: Volume imaging mode and multi-slice imaging mode. Figure 5-3 shows Volume Imaging Mode in quad screen with a Baby Face volume rendering.
Page 64 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging These three radio buttons switch the display to show 1, 2, or Single, Dual, 4 images at once. Single shows the 3D image, dual shows Quad the A slice and 3D image, Quad shows three MPR slices and 3D image.
Page 65 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Brightness Adjust the brightness of 3D image. Contrast Adjust the contrast of 3D image. 3D Smooth Adjust smoothness of A\B\C slices and 3D images. Higher filter levels create a smoother image. Upward presses increase the filter.
Page 66 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging End the 3D volume sweeping and return to the pre-3D New Volume interface MPR (multi-planar reconstruction) review function. After this button is activated, the 3D volume is hidden and two perpendicular lines appear on the selected quadrant. These...
Page 67 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Control Name Description These three radio buttons determine which slice is the A/B/C required parallel slice. These three choices are the same as on the Volume display in quad mode. These three radio buttons determine the layout of the 3*3, 2*2, 3*2 display.
Page 68: Volume Acquisition
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Rotate the basis slice by the X-axis of the activated Rotation X window. Parallel slices change with the rotation operation. Rotate the basis slice by the Y-axis of the activated Rotation Y window.
Page 69: Cine
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.9.6. 4D Cine During the process of 4D live volume imaging, press the <Freeze> button on the control panel to enter the 4D cine mode. A cine replay scroll bar appears below the images. Use the trackball to replay the images.
Page 70: Elastography
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.10 Elastography Elastography imaging maps the elastic properties of soft tissue with different colors in a region of interest by estimating the strain before and after tissue distortion caused by external or internal forces.
Page 71: Elastography Image Optimization
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging The Elastography image is for reference only. The image quality and measured results in Elastography mode always depend on the accuracy of the procedure performed. Any clinic diagnosis should be verified with other effective diagnosis methods.
Page 72: Ecg
Do not use the ECG function on the patient with pacemaker. Only the ECG module, patient cable and electrodes supplied by EDAN can be used. Only authorized service personnel can service the ECG module.
Page 73: Ecg Touch Screen Controls
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.11.1. ECG Touch Screen Controls The following touchscreen controls impact the ECG function: Name Control Description Displays or hides ECG waveforms and heart rate value on the main screen. Gain Adjusts the gain of ECG waveform.
Page 74: Ecg Basic Operations
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.11.2. ECG Basic Operations Invoke ECG function. Invoke a phased array transducer as the currently active transducer, and select Cardiac exam preset. Connect the ECG module to the system and the system will display a Physio tab, press the tab to enter ECG page and adjust ECG controls on the touch screen.
Page 75: Transducers And Biopsy
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy 6 Transducers and Biopsy 6.1 Transducers No. Model Type Application Applied Region Abdominal Fetal / Obstetrics C5-2Q Convex Urology Body Surface Gynecology Musculoskeletal Fetal / Obstetrics Gyncecology E8-4Q Micro Convex...
Page 76 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Pediatric Abdominal MC8-4Q Micro Convex Neonatal Cephalic Body Surface Musculoskeletal Peripheral Vascular Fetal / Obstetrics Abdominal Body Surface C6-2MQ Convex Gynecology Pediatric Abdominal Neonatal Cephalic MC9-3TQ Micro Convex Body Surface...
Page 77: Using Transducers
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy 6.2 Using Transducers Understanding a Transducer: Figure 6-1 takes L12-5Q transducer to show an example of a transducer. Figure 6-1 Typical transducer Name Function Converts electrical signals to sound waves, and then converts received Transducer head echoes back to electrical signals.
Page 78 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Image Orientation Mark The image orientation mark on the display screen and on the transducer are shown as below. The side of orientation mark on the transducer corresponds to the side of orientation mark on the display screen.
Page 79 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Use of Transducer sheath CAUTION Always wear gloves to perform the following steps. To minimize disease transmission, legally marketed, sterile transducer sheath is required to use for intra-cavitary and intra-operative procedures.
Page 80: Transducer Cleaning And Disinfecting
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy 6.3 Transducer Cleaning and Disinfecting Transducers should be cleaned and/or disinfected as necessary or between use with a recommended cleanser or disinfectant. Disconnect the transducer from the system prior to cleaning and disinfecting.
Page 81 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy The validated disinfectants for transducer are: Disinfectants Disinfecting Intensity Disinfecting Method Ethanol (75%) Spraying or wiping Isopropanol (70%) Spraying or wiping Cidex OPA (0.55%) Immersion Cidex Glutaraldehyde(2.4%) HLD, Sterilization...
Page 82 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy 6. Rinse the transducer thoroughly with sterile water to remove all chemical residues. For example, it is required to flush the transducer after soaking in Cidex Glutaraldehyde(2.4%) with plenty of sterile water (about 2 gallons) at least one time.
Page 83: Sterilization
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy 6.3.3. Sterilization Intra-operative transducers must be sterilized after each exam. Sterilizing the transducers: 1. Disconnect the transducer from the system. 2. Wear protective gloves to prevent infection. 3. Clean and dry the transducer according to the methods in section 6.3.1 Cleaning.
Page 84: Needle Biopsy Guide
If previous use has shown some drift of the needle from the center of the guidelines. 4. The displayed needle guide pathway on the EDAN video monitor is intended for reference during biopsy procedures. A variety of factors outside EDAN’s control, such as changing tissue density, bending of the needle, off-axis pressure by the person holding the transducer, etc., may cause...
Page 85 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Structures: Angle Knob Clamp Tab Release Locking Knob Adjusting Knob Needle Guide Path Installation and Use Steps: Place an appropriate amount of gel on transducer surface, and insert transducer into the sheath.
Page 86 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy After biopsy, press the tab release to remove the needle, and loosen the locking knob to remove the bracket from the transducer.  BGK-CR10UA/BGK-006 The installation steps for these brackets are the same. Here we take one bracket for illustration.
Page 87 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Properly secure the clamp of bracket with the locking knob. Ensure the backet is firmly attached, and then place the biopsy needle into the needle guide path.  BGK-005...
Page 88 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Press the left and right side of the clamp as the figure below to attach the bracket to the transducer firmly. Ensure the bracket is firmly attached, and then place the biopsy needle into the needle guide path.
Page 89: Activating Needle Guide Function
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Installation and Use Steps: Place an appropriate amount of gel on transducer surface, and insert transducer into the sheath. Loosen the locking knob to open the clamp bracket. Attach the bracket to the transducer by aligning the locating markers on the bracket and the transducer.
Page 90: Calibrating The Needle Guide Line
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Figure 6-4 Needle Guide Touch Screen There is a depth and length mark on the guide line. The depth indicates the position of the mark in the image and the length indicates the distance along the guide line between the mark and the patient’s skin surface.
Page 91: Needle Visualization
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy To calibrate the guide line 1. Assemble the needle guide bracket on the transducer, and use the transducer to image a water bath or needle guide phantom. 2. From the Needle function on the B-mode touch screen, press the Line paddle key to select a guide line.
Page 92: Center Line
Inspect the bracket for damage such as cracks or breakage. If damage is evident, discontinue use of bracket and contact your Edan representative for disposal guidance. Sterilize the bracket before disposal or sending back to manufacturer for repair.
Page 93: Cleaning
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy 6.7.1. Cleaning 1. Wear sterile protective gloves to prevent infection. 2. Disconnect the needle guide bracket from the transducer after each use, and remove all visible residues from the needle guide bracket using a small and soft-bristled brush or other similar devices.
Page 94: Features
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features 7 Features 7.1 Comment The Comment function allows you add annotation to an image. The Comment function is invoked by pressing the <Comment> hard key on the console. Figure 7-1 shows an example touchscreen for the Comment function.
Page 95 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features Adding comments You can add either pre-defined comments or use a keyboard.  Adding comments using the keyboard Invoke the Comment function. Press the “Keyboard” touch screen key to display a keyboard on the touch screen.
Page 96: Body Mark
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features 7.2 Body Mark Body Mark allows you add a body mark graphic to an image and indicate the location of the transducer using a transducer icon on that graphic. The Body Mark function is invoked by pressing the <Body Mark>...
Page 97: Split Display
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features 7.3 Split Display 7.3.1. Dual Imaging Dual Imaging displays images side by side on the screen. During real-time imaging when Dual imaging is enabled, the active image is displayed in real-time and the other image is frozen.
Page 98: Zoom
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features 7.4 Zoom Zoom mode is available on the live or frozen image in B mode and Color mode. When the indicator of zoom function illuminates, rotate the physical Zoom knob on the console, as shown below, to zoom an image.
Page 99 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features The cine can be reviewed manually or automatically. Manual Review: Move the trackball to review the cine frame by frame. As the trackball moves, the current cine number is displayed on the right of the cine bar.
Page 100: Measurements And Reports
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8 Measurements and Reports The Measure function lets you perform measurements on a live or frozen image. The Measurement function is invoked by pressing the <Measure> hard key on the console. When measurement function is invoked, generic and application could be switched by the tabs on the main screen or touch screen.
Page 101 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement main screen display is divided into three fields: Field 1: Displays measurement labels and attributes:  The first line displays labels of Application Measurements and Generic Measurements. Clicking on each of them displays its associated measurement items.
Page 102 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Name Description Measurement Displays application and generic measurement labels. Pressing label on any label will display its associated measurements on the touch screen. Measurement Displays available measurement groups. Selecting one...
Page 103: Generic Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.1 Generic Measurements Each imaging mode supports different types of generic measurements. This chapter describes all the generic measurements supported in each imaging mode. 8.1.1. B-mode Generic Measurements The generic measurements supported in B-mode are listed in the table below.
Page 104 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.1.1.2. Circumference/Area Circumference/Area measurement can measure the circumference and area of a closed region. There are Ellipse, Trace and Spline methods. Ellipse Method: 1. Invoke the generic measurement function.
Page 105 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 6. Press the <Set> key to fix the third point and complete the angle measurement. 8.1.1.4. Volume Volume can be measured with 3 Distances or 1 Ellipse+1 distance method.
Page 106 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Spline Method: 1. Invoke the generic measurement function. 2. Select Circ/Area-> Stenosis% Spline 3. Perform two spline measurements following the Spline method in section 8.1.1.2 Circumference/Area measurement. 4. Then the Stenosis measurement result displays.
Page 107: M-Mode Generic Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.1.2. M-mode Generic Measurements The generic measurements supported in M-mode are listed in the table below. Measurement Measurement Item Remark Group Distance Slope Generic 2-point method Time Only available for...
Page 108 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 5. Move the caliper to the end point. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the position of start point and end point.
Page 109: Strip Doppler Generic Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.1.3. Strip Doppler Generic Measurements The generic measurements supported in strip Doppler mode are listed in the table below. Measurement Measurement Item Remark Group PS,ED,RI,S/D Generic Time Manual Trace...
Page 110 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports PS/ED: measures the velocity at PS and ED points. 1. Invoke the generic measurement function. 2. Select Generic-> PS or ED. 3. Move the caliper to the PS or ED point on the strip.
Page 111 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Trace measurement is only available on a frozen strip. There are Manual Trace, Spline Trace and Auto Trace methods. Manual Trace Method: 1. Freeze the strip and invoke the generic measurement function.
Page 112: Volume Flow
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.1.3.5. PI (Pulse Index) PI measurement can be measured with manual trace method. To measure PI: 1. Freeze the strip and invoke the generic measurement function. 2. Select Generic-> PI.
Page 113: Application Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2 Application Measurements Application Measurements have a pre-defined meaning and can be entered into a report. The system supports the following application packages, each with its own set of measurements, calculations and report: ...
Page 114: Abdomen Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.1. Abdomen Measurements Measurement Measurement Description Method Group Item Section 1: B-mode Measurements Liver L Liver Length Liver W Liver Width Liver Liver H Liver Height Portal Vein Portal Vein Diameter...
Page 115: Gynecology Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item generic Inferior Vena Cava measurements M Portal V Main Portal Vein 2.10 Hepatic V Hepatic Vein 2.11 M Hepatic V Middle Hepatic Vein 2.12...
Page 116: Obstetrics Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.3. Obstetrics Measurements Obstetric measurements are used to calculate the GA (Gestation Age), EDD (Estimated Delivery Date) and EFW (Estimated Fetus Weight). Multiple fetuses The Obstetric package supports measurements and reports on up to four fetuses. If you know the number of fetuses at the start of the exam then you can enter this in the Patient page (see section 4.4).
Page 117 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Yolk Sac Deepest Pocket Humerus Length ULNA Ulna Length Radius Length Lone Bones Tibia Length Fibula Length Foot Foot Length Nuchal Translucency Cerebellum Diameter...
Page 118: Section 3: M-Mode Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Trace in B-mode Area 1 generic measurements CTAR Cardio/Thorax area ratio Ellipse in B-mode Area 2 generic measurements Section 2: Doppler Measurements Middle Cerebral Artery Umb.
Page 119: Cardiac Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.4. Cardiac Measurements Measurement Measurement Description Method Group Item Section 1: B-mode Measurements Left Ventricular apical four-chamber A4C Dias. views at End-diastole Left Ventricular apical four-chamber A4C Sys. views at End-systole...
Page 120 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item PV Diam Pulmonary Valve Diameter Right Ventricular Diameter RVDs end-systole Right Atrium Length Diameter RA Length Right Atrium Width Diameter RA Width LA/RA...
Page 121 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Section 2: Doppler Measurements E-wave Velocity/ A-wave Velocity MV PHT Mitral Valve Pressure Half Time MV VTI Mitral Valve Velocity Time Integral IVRT...
Page 122 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item PV Vmax Pulmonic Valve maximum Velocity PV Accel Time Pulmonic Valve Acceleration Time Pulmonic Valve Regurgitation max PR Vmax velocity PVein S Vel...
Page 123 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Left Ventricular Posterior Wall LVPWs Thickness at End-systole Right Ventricular Anterior Wall RVAWd Thickness at End-diastole Right Ventricular Internal Diameter RVIDd at end-diastole...
Page 124 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item IVCmax Inferior Vena Cava max diam IVC-CI IVCmin Inferior Vena Cava min diam 8.2.4.1. Simpson’s Method of Disks (MOD) Simpson’s MOD is a method used to calculate LV diastolic and systolic volumes and ejection fraction.
Page 125 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports WARNING The Auto EF function is intended for use by the clinician who is qualified to use ultrasound for cardiac function evaluations. The measurement result is for reference only. The accuracy of the measurement result can be affected by the image quality, the cardiac image section and procedures performed.
Page 126: Small Parts Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.5. Small Parts Measurements Measurement Measurement Description Method Group Item Section 1: B-mode Measurements THY L Thyroid Length THY W Thyroid Width Thyroid THY H Thyroid Height Isthmus Thyroid Isthmus...
Page 127: Urology Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.6. Urology Measurements Measurement Measurement Description Method Group Item Section 1: B-mode Measurements Renal L Renal Length Renal W Renal Width Renal Renal H Renal Height Cortex Renal Cortex thickness...
Page 128: Vascular Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.7. Vascular Measurements Measurement Measurement Description Method Group Item Section 1: B-mode Measurements Common Carotid Artery IMT Far Intima-Media Thickness (Far vessel wall) Common Carotid Artery IMT Near Intima-Media...
Page 129 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Section 2: Doppler Measurements Common Carotid Artery External Carotid Artery Internal Carotid Artery Vert A Vert Artery SUBC A Subclavian Artery Axill A...
Page 130 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item 2.32 Common Iliac Vein 2.33 External Iliac Vein 2.34 Internal Iliac Vein 2.35 Saph V Great Saphenous Vein 2.36 Pop V Popliteal Vein 2.37...
Page 131: Pediatric Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8. If you are not satisfied with the measurement result, press Tool to switch to Distance tool and do the IMT measurement manually. 9. The IMT measurement can display the following result: ...
Page 132 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.8.1. Hip Joint Measurement Hip Joint Angle Measurement: Hip Joint Angle Measurement is intended to evaluate the development of acetabular roof and the subluxation of femoral head for pediatrics. This measurement is performed by adding three straight lines on the anatomic image, thereby calculating two angles.
Page 133: Emergency Measurements
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Dislocation Criteria type α β Patient Age ＜77° >=60° ＜77° ＜=3 months 50°- 59° 50°- 59° ＜77° ＞3 months 43°- 49° ＜=77° 43°- 49° ＞77° ＜43° ＞77° The angle cannot be performed.
Page 134: Worksheet And Report
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.3 Worksheet and Report Worksheet is available at any time during an exam, and is displayed as default on the main screen. Report contains the information from a worksheet but it is formatted in a slightly different manner.
Page 135 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports There is a group of radio button that includes: Report, Worksheet and Growth Curve. Note: Radio Buttons are buttons where only one is active at any time. Activating one will de-activate all others.
Page 136: Ob Worksheet
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.3.2. OB Worksheet Please see previous section for an overview of reports and worksheets. This section describes worksheet capabilities that are unique to OB. Figure 8-5 shows an example of the OB worksheet.
Page 137: Growth Curve
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.3.3. Growth Curve OB Growth Curve indicates predicted fetal growth patterns according to the selected reference for a measurement or calculation. A growth curve graph can display information acquired in the current exam.
Page 138 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Following controls are invoked by Growth Curve button.  Single/Quad: press to select the number of the growth curve graph for display. Figure 8-8 Quad Growth Curve Graph ...
Page 139: Fetus Score
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports  Print: At the left side of each growth curve graphic a Print checkbox is displayed for you to determine whether to print the growth curve graphic in the report.
Page 140: Findings
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.3.5. Findings The findings user interface allows you to quickly create a paragraph of findings for the current exam. It consists of three interactions:  Findings preset. It determines the pre-defined findings displayed. The default findings preset is auto linked to the measure preset of current exam mode.
Page 141: Report
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.3.6. Report Press the <Report> hard key to enter the Worksheet, and then press the Report button on the touch screen to display the Report screen. A report includes: Header, Patient Information, Images, Measurement/Calculation data, Comments, Sonographer signature, etc.
Page 142: Measurement Accuracy
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Save As: Press it to store the report as PDF file to external storage. Preview: Press it to invoke print preview before print. Then switching report pages and zooming in report are supported.
Page 143 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Table 2 Strain Elastography Imaging Performance and measurement accuracy Transducer Model L12-5Q L17-7HQ Max. Penetration ≥30mm ≥30mm Depth(cm) ≤10.5mm ≤10.5mm Spatial Resolution ≤±20% ≤±20% Error of Geometric Contract ratio of B ≤±10%...
Page 144: Exam Data Management
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management 9 Exam Data Management 9.1 Storing Images The system supports storing static images and cine clips. What is displayed in Information area, Image area and Image parameter area on the main screen will be stored.
Page 145: Reviewing Images
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management 9.2 Reviewing Images To enter image review: If Static or Clip images have been stored for the current exam, then they can be reviewed by pressing the <Review> hard key on the console. The review touch screen is shown as the figure below.
Page 146: Exam Database
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management Select all the images in the current exam. Toggle between showing all images and only showing the selected images. Delete the selected image. Export selected images to a removable media currently available. Plug in a...
Page 147 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management Figure 9-2 Exam Database Main Screen The main part of the display shows a list of studies. Clicking on the header of a field will sort the list by that field.
Page 148: Archiving Studies
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management A study is selected by clicking on it. When a study is selected thumbnail images from that study are shown on the right side of the screen. Operations such as reviewing and restarting of the selected study can be accessed on the touch screen.
Page 149: Structured Report
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management Sending images/clips to mobile device The images/clips stored on the ultrasound system can be sent to a mobile device, such as mobile phone and iPad. Follow the steps below to send images/clips to a mobile device: Connect the network for your ultrasound system (See 11.2).
Page 150: Presets
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets 10 Presets 10.1 Preset Organization The Presets are divided into two levels: the Exam Presets and Application Presets. Exam Preset: Each transducer has its own set of Exam Presets. Each Exam Preset contains: ...
Page 151: Selecting A Preset
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets 10.2 Selecting a Preset Pressing the <Transducer> key on the console will open the Transducer touch screen. See figure 10-2 for an example Transducer touch screen. The currently active transducer is shown at the top of the touch screen.
Page 152: Exam Preset
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets Figure 10-3 Preset Main Screen 10.3.1. Exam Preset Figure 10-4 shows an example of the exam preset page where you can configure which Comment, Measure, Body Mark or Patient info presets are associated with each exam preset, or adjust the display order of exam presets of each transducer.
Page 153 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets  Body Mark: Select one of the pre-defined body mark presets to be the default body mark preset for the selected exam preset.  Patient Info: Select one of the pre-defined patient information categories for the selected exam preset, which determines the patient information items displayed on the patient information page by default.
Page 154: Image Preset
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets 10.3.2. Image Preset Figure 10-6 shows an example set-up screen for Image Preset, where you can configure the imaging parameters for an exam preset. This example shows the screen for editing the B-mode settings for the C5-2Q OB exam preset.
Page 155: Comment Preset
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets 10.3.3. Comment Preset Figure 10-7 shows an example set-up screen for Comment Preset, where you can add or edit the comment texts of each Comment preset. Figure 10-7 Comment Preset Screen...
Page 156: Body Mark Preset
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets 10.3.4. Body Mark Preset Figure 10-8 shows an example set-up screen for Body Mark Preset, where you can configure which body mark graphics appear with each Body Mark preset. Figure 10-8 Body Mark Preset Screen...
Page 157: Measure Preset
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets 10.3.5. Measure Preset 10.3.5.1. General Set-up Figure 10-9 shows an example set-up screen for Measure Preset, where you can configure general measurement settings. Figure 10-9 Measure Preset Screen  Unit Settings The system supports following unit settings: ...
Page 158 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Presets  Worksheet Settings:  Calc. Method: set the calculation method for the finally displayed result in the report when multiple times of measurement operation were done for one measurement item. Available methods include Last, Average, Max.
Page 159: Utilities
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11 Utilities To open the Utility screen: Press <Cursor> key to display the cursor; Move the cursor to the Utility icon displayed at the lower left corner of the screen; Press <Set> key.
Page 160 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Item Options Description Set hospital name displayed on the top left of the Hospital Input freely screen and diagnosis report. Set the system language (new language is Language Chinese, English, etc.
Page 161: Patient Set-Up
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.1.2. Patient Set-up Figure 11-2 Patient Set-up Screen Item Options Description Weight Unit kg, lbs Set the weight unit of patients Height Unit cm, ft/in Set the height unit of patients...
Page 162: Store/Print Set-Up
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.1.3. Store/Print Set-up Figure 11-3 Store/Print Set-up Screen Item Description Set the cine length for prospective cine storing Duration for prospective in live scanning status. Set the default cine length for retrospective Duration for retrospective cine storing in the frozen status.
Page 163: Report Set-Up
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.1.4. Report Set-up Figure 11-4 Report Set-up Screen Item Description Import Import a bmp format logo from USB disk. Set the logo position to locating at the left or right side of Logo Position report header.
Page 164: Image Set-Up
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.1.5. Image Set-up Figure 11-5 Image Set-up Screen Item Options Description Set whether to hide the hint of “non Hide non intra-operative indicator for √/× while using intra-operative” L17-7SQ transducer L17-7SQ.
Page 165: Power Set-Up
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Optimize Dynamic Range or not when √/× press Auto button on the control panel in PW mode. Optimize Scale/Baseline or not when √/× Scale /Baseline press Auto button on the control panel in PW mode.
Page 166: User Set-Up
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.1.7. User Set-up Figure 11-7 User Set-up Screen Item Options Description Enable Show or hide the login dialog when booting up the √/× Password system. Password is required to enable password Protection protection function.
Page 167: Connectivity
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities There’s a couple of buttons for different user edit operation. It includes Add User, Delete User, Edit User, and Change Password.  Add User: Click it to add user in the user list.
Page 168: Tcp/Ip
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.2.1. TCP/IP This screen configures access to a network. Figure 11-8 TCP/IP settings Wired Settings: The following settings apply when connecting a system to a wired network via the network port on the side of the system.
Page 169: Dicom
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Add: Clicking on this button brings you a window for connecting a hidden WiFi network by entering its network name, security protocol, and password. The following controls require that a wireless network has been selected from the network list.
Page 170 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities default “EDAN_STR_SCU” will work unless you have multiple Edan systems on your network. Time Out: This determines the time after which this system will stop trying to establish a connection to the DICOM server.
Page 171: Ftp Server
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities  Service: Shows the service type of this DICOM server, including Storage, Worklist, and Storage&Worklist. Test the server: There are two tests to ensure that the server information is entered correctly.
Page 172 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Studies are sent to the configured folder, where each study appears in a separate folder with particular name (a combination of the patient’s name and ID, the study time and the transfer time).
Page 173 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities  Connect: A successful Connect means that the system can communicate with the FTP server, and FTP transfers will work. If this fails but Ping works it could mean: The destination computer is not correctly configured as an FTP server.
Page 174: Maintenance
 Press Import button to import a license file from a USB external storage device. Please contact your distributor or Edan service engineer to obtain a new license key.  Press Revert button to restore the previous license if the imported license is not correct.
Page 175: Version
11.3.2. Version The Version screen shows the current version of software, firmware, and selected hardware for the system. This information is only needed if requested by an Edan service engineer. This page also includes an Upgrade and Export Logs button.
Page 176: Export/Import
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.3.3. Export/Import The Export/Import screen provides access for you to export/import user-configured presets, settings and Findings using an external storage device. Figure 11-12 Export/Import Screen To export user data: Select an external USB storage device.
Page 177: Demo
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.3.4. Demo The Demo screen provides access for you to show a set of images you collected for demonstration purpose. Import: Imports a collection of images to the ultrasound system. Before import, you need create any a folder in USB disk and put the images inside.
Page 178: Transducer Element Check
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.3.7. Transducer Element Check Proper performance of the transducer is the prerequisites for acquiring images or signals that provide the intended information for the users. To ensure the proper performance of a transducer, it is suggested to implement the transducer element check each time a transducer is activated for use or at regular transducer performance check.
Page 179: In Between Exams
After unpacking the device, you should follow the packing list to check the product carefully and to make sure that no damage has occurred during transportation. For installation, please contact your local distributor or the EDAN service department at: support@edan.com.
Page 180: Troubleshooting And Maintenance
Check before the system is switched on, if any system malfunction is experienced, eliminate the malfunction before use, or contact EDAN or authorized representatives for service if needed.  Visually inspect all the transducers for unintended rough surfaces, sharp edges or protrusions.
Page 181: System Cleaning And Disinfection
Service. 13.3 System Cleaning and Disinfection Use only the EDAN-approved substances and methods listed in this chapter to clean the system. The warranty does not cover damage caused by using unapproved substances or methods. Edan Instruments has validated the cleaning and disinfection instructions included in this User Manual.
Page 182: Cleaning And Disinfecting The System Surface
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance  Do not pour liquid onto the system.  Do not allow liquid to enter the case.  Never use abrasive material (such as steel wool or silver polish).
Page 183 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance 7. Assemble the trackball and front panel bezel after the assembly parts completely dry. Rotate clockwise to remove the fixing ring Rotate counterclockwise to mount the fixing ring Figure 13-1 Assembling and Disassembling Trackball...
Page 184: Cleaning And Disinfecting The Ecg Module And Cable
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance 13.3.2. Cleaning and Disinfecting the ECG Module and Cable ECG module and cable cleaning The validated cleaning agents for cleaning the ECG module and cable are:  Ethanol (75%) ...
Page 185: Maintenance
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance 13.4 Maintenance 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.
Page 186: Appendix A Specifications
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Specifications Appendix A Specifications A.1 Electrical Safety Classifications Internally powered equipment, According to the type of protection against electric shock Class I equipment Type BF According to the degree of protection against electric shock...
Page 187: Machine Specifications
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Specifications A.3 Machine Specifications Main unit dimensions 375 mm×380 mm×64mm Weight ≤4.5kg ( without battery and any other accessory) A.4 Display Specifications Display TFT-LCD Diagonal Size 15.6 inches Open Angle 0°-180° Pixel Number...
Page 188: Wi-Fi Specifications
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Specifications Hard Drive Storage 120GB or 512GB or 1TB Abdomen, Obstetrics, Small Parts, Vascular, Cardiac, Gynecology, Report Packages Urology, Pediatrics. A.6 Wi-Fi Specifications Standard Conformance 802.11b, 802.11g ,802.11n Frequency Band 2.412-2.484GHz(@2.4GHz band)
Page 189: Ecg Specifications
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Specifications A.7 ECG Specifications Patient Cable IEC, AHA Lead Mode 3-Lead: I, II, III AC Filter 50 Hz, 60 Hz Adult: 15 bpm to 300 bpm Pediatric: 15 bpm to 350 bpm...
Page 190: Transducer Specifications
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Specifications A.9 Transducer Specifications Transducer Center Frequency Transducer Center Frequency L17-7HQ 12.0MHz E8-4Q 6.2MHz C6-2MQ 3.9MHz C5-1Q 3.25MHz C5-2Q 3.5MHz L12-5Q 8.0MHz L17-7SQ 12.0MHz MC8-4Q 6.2MHz P5-1Q 2.7MHz P7-3Q 5.0MHz MC9-3TQ 6.4MHz C7-2XQ 3.3MHz...
Page 191: Appendix B Ultrasound Intensity And Safety
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety Appendix B Ultrasound Intensity and Safety B.1 Ultrasound in Medicine The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises.
Page 192: Explanation Of Mi/Ti
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety The acoustic output will be changed with the change of the number of the Line density scanning line (line density). The acoustic power will be changed with the change of PRF.
Page 193: Display Of Mi/Ti
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety B.3.3 Display of MI/TI The system provides real-time display of MI/TI values in the upper right part of the screen. The start point of MI/TI value is 0.0.
Page 194: Acoustic Power Default Settings
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety B.4.4 Acoustic Power Default Settings The ultrasound system allows direct control of acoustic power by the Power paddle key on the touch screen. The range can be adjusted is 10% to 100%. The higher the acoustic power number, the greater the acoustic output.
Page 195: References For Acoustic Output And Safety
Acclarix AX3 Series Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety B.7 References for Acoustic Output and Safety “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993 “Medical Ultrasound Safety” issued by AIUM in 1994 IEC 62359:2017, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.
Page 196: Appendix C Order List
The following accessories are recommended for use on the system. WARNING Only accessories supplied or recommended by EDAN can be used, the battery and transducers of EDAN can be only used on EDAN’s systems. Otherwise, the performance and electric shock protection cannot be guaranteed.
Page 197 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Order List 02.01.215192 BGK-002 02.01.215193 BGK-003 02.01.215194 BGK-004 02.01.215372 BGK-005 02.01.215373 BGK-006 02.01.215514 BGK-007 02.01.215468 BGK-008 02.01.215834 BGK-009 02.01.216312 BGK-012 Power Cable, European Standard FG-L23X-003-04 01.13.036638 Power Cable, American Standard 01.13.037122 FG-L23X-20150323-001...
Page 198 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Order List ECG patient cable, 3-lead, IEC, 01.57.471379 EC03DIS121 Defib, Snap ECG patient cable, 3-lead, AHA, 01.57.471380 EC03DAS121 Defib, Snap ECG electrodes, disposable H99SG 01.57.471858 NOTE: The part name may vary depending on context, but the part number is constant.
Page 199: Appendix Demc Information
Acclarix AX3 Series Diagnostic Ultrasound System User Manual EMC Information Appendix D EMC Information Electromagnetic emissions Guidance and manufacture’s declaration – electromagnetic emission The system is intended for use in the electromagnetic environment specified below; The customer or the user of the system should assure that it is used in such an environment.
Page 200 Acclarix AX3 Series Diagnostic Ultrasound System User Manual EMC Information Electromagnetic immunity Guidance and manufacture’s declaration – electromagnetic immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that they are used in such an environment.
Page 201 Acclarix AX3 Series Diagnostic Ultrasound System User Manual EMC Information Electromagnetic immunity Guidance and manufacture’s declaration – electromagnetic immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that they are used in such an environment.
Page 202 Acclarix AX3 Series Diagnostic Ultrasound System User Manual EMC Information NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Page 203 Acclarix AX3 Series Diagnostic Ultrasound System User Manual EMC Information 2450 2400-2570 Bluetooth, Pulse WLAN, 802.11 modulation b/g/n, RFID 217 Hz 2450, LTE Band 7 5240 5100-5800 WLAN 802.11 Pulse modulation 5500 217 Hz 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
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