Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 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...
Page 3 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  Acclarix AX7 model IS NOT available in CE region.  The following features are not available in the USA and its territories at the time of release of this user manual. 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 ......................... 6 Getting Started ..........................10 3.1 System Configuration .........................
Page 6 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 5.6 Anatomic M Mode........................46 5.6.1. Using Anatomic M Mode ....................46 5.6.2.
Page 7 6.4.2. Activating Needle Guide Function..................79 6.4.3. To Adjust 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.
Page 8 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 ........................
Page 9 13.4 Maintenance ........................... 169 Appendix A Specifications ......................170 Electrical Safety Classifications .................... 170 Power Supply ........................170 Battery ........................... 170 Machine Specifications ......................171 Display Specifications ......................171 Technical Specifications ......................171 Operating, Storage and Transportation Environment ............173 A.7.1 Operating Environment ....................
Page 10: Introduction
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Introduction 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: ...
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  Do not stack the system on other electronic equipment.  The use of transducer and connecting cable not supplied by EDAN may result in increased emissions or decreased immunity of the equipment.  Refer to Appendix D for recommended separation distances from other equipment, including portable and RF communication devices.
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: Labeling Symbols
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 AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety Symbol Definition Serial Number Part Number Date of Manufacture Manufacturer Operating instructions Warning (Background: Yellow; Symbol & outline: Black ) Refer to User Manual (Background: Blue; Symbol: White) Caution Biological Risks...
Page 17 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety IPX7 No harm for short time immersion Type BF Applied Part Transducer connector Pencil Transducer connector (reserved) Signal input connector (reserved) Transducer lock Transducer unlock Network port Trademark Direct current Video Output port USB 2.0 port...
Page 18 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Safety Federal Communications Commission: FCC ID:SMQAX8EDAN FCC ID:SMQAX8EDAN Type CF Applied Part with Defibrillation-proof protection The following labels are used on the packaging: Symbol Definition This way up Fragile, handle with care...
Page 19: Getting Started
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started 3 Getting Started 3.1 System Configuration Standard Configuration:  1 main unit  1 rechargeable lithium battery  1 AC adapter  1 power cord  1 bottle of coupling gel ...
Page 20 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started  Mobile Trolley  Footswitch  Suitcase  Multi-Transducer Connector (MTC)  ECG module Supported Peripheral Accessories:  The recommended printers are listed as follows: Printer Type Printer Model Interface...
Page 21: System Overview
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 22 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started Name Description Monitor Display the images and parameters during scanning. Touch Screen Use to control operation and activate functions Control panel Use to control the operation Handle Used for carrying the system...
Page 23: Control Panel
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started Caution 1. If an external monitor is connected to the system via display port, configure the resolution to 1920x1080, other resolution may cause abnormal ultrasound machine display. 3.2.2. Control Panel...
Page 24 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started Press upper or lower part of this key to use Pan Zoom Zoom function, and press Zoom to use Spot Zoom function. See section 7.4 for details. Depth Press to adjust the depth of the image displayed.
Page 25 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started One of three keys that can be configured to store or print Store 2 images or clips, or to set video printers. See section 9.1 for details. Controls the overall gain for the active imaging mode that currently has the UI focus.
Page 26: Screen Layout
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started 3.2.3. Screen Layout ① ④ ③ ② ⑤ ⑥ Figure 3-4 Main Screen Display ① Information Field The top line of this field contains your hospital/institution name. Please see Section 11.1.1 General Set-up for information on customization.
Page 27 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started Shortcut Keys Description Select All Selects all the displayed static images and clips. Delete Deletes the selected static images and clips. Exports the selected static images and clips to removable Export storage devices.
Page 28 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started WI-FI network is disconnected. Clicking on this icon shows a "WiFi: Turn on" button. Clicking on this button shows a list of available Wi-Fi networks. Selecting an available network displays a dialog box for entering password.
Page 29: Touch Screen
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started Symbol in grey: DVD device is connected. DVD icon Symbol in green: DVD device is connected, disc is inserted and data transmission is available. 3.2.4. Touch Screen The Touch Screen contains controls that vary depending on the active imaging mode or function.
Page 30: Trackpad
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started Customizing the touch screen The touch screen can be customized to meet your needs. Press and hold any control for about a second to put the touch screen in customization mode. Continue pressing and drag the control to a new location.
Page 31: System Preparation
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started 3.3 System Preparation 3.3.1. Battery Use The system comes with one lithium-ion battery. When it is fully charged it can run the system for approximately 60 minutes, depending on use. It is automatically charged when the system is plugged...
Page 32: Ac Power Use
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started Figure 3-7 Battery Removal 3.3.2. AC Power Use When using AC power, position the system so that it is easy to disconnect it from AC power supply. To connect AC power: Connect the AC power cord with the power adapter.
Page 33 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started Align the connector with the transducer port and carefully push into place. Toggle the locking handle to the bottom position. Do not allow the transducer head to hang free. Impact to the transducer head could result in irreparable damage.
Page 34: Powering On/ Off
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started 3.3.4. Powering on/ off Please review and follow the steps described in the Section 13.1.Daily Checklist prior to powering on the system. To power on 1. Connect the AC power supply.
Page 35 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Getting Started To power off 1. Press the Power on/off key on the top left of control panel and the system displays a confirmation dialog box. 2. Select “Shut Down” from the confirmation dialog box.
Page 36: Exam Operation
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Exam Operation 4 Exam Operation 4.1 How to Start an Exam Press the <Patient> key and enter in 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 37: How To End An Exam
Acclarix AX8/Acclarix AX7 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 the New Exam. This both ends the exam and displays the Patient Information Page for the next exam.
Page 38: The Patient Information Page
Acclarix AX8/Acclarix AX7 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 39: Modality Worklist
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Exam Operation considered invalid.  GA: Gestational Age (xxWyD), it is auto-calculated when LMP or EDD is entered (only in OB Exam).  EDD: Estimated Date of Delivery (yyyy/mm/dd or mm/dd/yyyy), if EDD is entered then GA is calculated.
Page 40 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Exam Operation Figure 4-4 Modality Worklist Display The worklist is displayed at the left side of the Patient Information Page in two columns labeled patient name and patient ID. Clicking on the header of each column will sort the list for the corresponding column.
Page 41: Imaging
Acclarix AX8/Acclarix AX7 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 42 Tint activate it. The Left/Right invert control is indicated by a backward R and is used to toggle the left/right orientation of the image. The Edan E Left/Right orientation marker at the top of the image switches with the left/right invert to match the orientation marker on the transducer.
Page 43 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging The Up/Down invert control is indicated by an upside-down R and is used to toggle the up/down orientation of the image. The Up/Down TGC curve is also re-oriented with Invert On, so that the top of the TGC curve corresponds to the top of the image on the screen.
Page 44: Color Mode
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Press to activate 3D/4D imaging mode. Refer to section 5.9 3D/4D 3D/4D mode for details. Adjusts the acoustic output power of the activate transducer. It is only available in live imaging. Higher acoustic power numbers...
Page 45: Using Color Mode
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging 5.2.2. Using Color Mode Perform the image scanning to get a good image in B mode; Press <Color> to enter B+Color mode and display ROI box; Adjust the size and position of ROI box.
Page 46 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Adjusts the current map for the active color variation. Persistence determines the number of frames that are averaged together for display. Levels of Off, Low, Med and High are Persist available.
Page 47 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging To activate split screen with simultaneous live B/Color and live B. The live B image without color and the same live B image with color are simultaneously displayed on each side of the image field.
Page 48: Pw Mode
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging 5.3 PW Mode 5.3.1. Using PW Mode Perform the image scanning to get a good image in B mode or B+Color(DPI/DPDI) mode; Press <D> on the console to display sample line;...
Page 49 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging The Filter control removes excessive noise from movement of vessel walls. Options of Low, Med and High are available. Filter Higher wall filter level will suppress more strong single of the vessel walls, but low flow signal will be missing.
Page 50 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging This determines if the strip mode and reference image are imaging simultaneously or not. In Duplex mode, either the Duplex Doppler strip or the reference image is updated continuously. (Triplex) In Triplex mode, both the Doppler strip and reference image are updated simultaneously.
Page 51: Hprf
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging The Auto push button automatically updates the PW gain, DR, baseline and PRF scale. Each single press of the button renews the automatic optimization. Auto Optimization Whether Gain, DR or Scale/Baseline is optimized when pressing Auto button can be configured in Set-up.
Page 52 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Name Control Description Scale adjusts the range of velocities that are displayed. Upward Scale presses increase scale and downward presses decrease it. The Baseline control adjusts the Doppler baseline. Upward Baseline presses move the baseline up on the screen and downward presses move the baseline down.
Page 53: M Mode
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Gray Map Adjusts the current postprocessing, either grayscale or tinted. Tint The Dynamic Range, or log compression, adjusts how signal intensities are converted to brightness. A high dynamic range Dynamic will display more shades of gray, while a low dynamic range will...
Page 54: M-Mode Image Optimization
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging 5.5.2. M-mode Image Optimization The following touch controls can be used to optimize the M-mode image. Name Control Description Switches between grayscale and colorized (pseudo-color) Colorize postprocessing maps. Gray Map Adjusts the current postprocessing, either grayscale or tinted.
Page 55: Anatomic M Mode
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging The line Persistence determines how many M-mode lines are Line averaged together for the display (similar to persistence in Persistence B-Mode). Off, Low, Med and High settings are available. Frequency determines the transmit frequency used by M-Mode.
Page 56: Color M Mode
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Name Control Description Angle Adjusts the angle of M sample line. Displays only one M sample line. M sample lines Displays two M sample lines. Displays three M sample lines. Table 5-6 Anatomic M Mode Touch Screen Controls 5.7 Color M Mode...
Page 57: Tdi Mode
Acclarix AX8/Acclarix AX7 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 transducer supports TDI mode. There are two types of TDI modes available on this system: ...
Page 58: 4D Mode
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging 5.9 3D/4D Mode 3D/4D mode is only available on a Wobble transducer. There are two ways to activate pre-3D or Pre-4D mode: Press the 3D or 4D button on the touch screen in B-mode.
Page 59: Volume Sweeping
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Adjusts the angle of the volume acquisition. Upward presses Angle increment the angle. Downward presses decrement the angle. Surface/ These two radio buttons determine if the acquisition is Skeleton optimized for looking at Skeleton or Surface.
Page 60: Image Review
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging While scanning, the sector in the right bottom is filled gradually, and no buttons on the control panel and touch screen can be activated. 5.9.3. 3D Image Review The system will enter to the 3D review status after finishing one sweep.
Page 61 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Reset the operation of pan, rotate and zoom to the initial Reset condition. 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...
Page 62 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Inverts the grayscale of 3D image which helps to better Inversion observe the hypoechonic structure, for example, blood vessel, cyst, etc. Adjust the threshold of surface render mode, Upward presses increase threshold. Downward presses decrease Threshold threshold.
Page 63 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Rotation Z Rotate the image by the Z-axis of the activated window. End the 3D volume sweeping and return to the pre-3D New Volume interface Exit Exit 3D 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.
Page 64 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Image area and touch screen controls in multi-slice imaging mode: Figure 5-4 Multi-slice Imaging Mode In figure 5-4, the first image shows the basis slice, other images are orthogonal to the basis slice and parallel to each other.
Page 65: Volume Acquisition
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Distance Adjust the distance between slices. When there are more slices than can be displayed at once Next this control cycles through the subset of slices displayed. Tint Select multi-slice tint.
Page 66: Live Volume
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging 5.9.5. 4D Live Volume 4D Live volume continuously sweeps and displays successive 3D volumes. As shown in figure below, image in the left is A slice and image in the right is the live 4D volume rendering.
Page 67: Panorama
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging 5.10 Panorama Panorama constructs an extended field of view image as the user slides the transducer along its long axis. Panorama is available only with Linear and Convex transducers. This system also provides Color Panoramic imaging so that you can get color flow information on the panoramic image.
Page 68: Elastography
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging 5.11 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 69: Elastography Image Optimization
Acclarix AX8/Acclarix AX7 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 70: Ecg
The ECG module and electrodes are not intended for intra-cardiac use or direct cardiac contact. 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 71: Ecg Touch Screen Controls
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging 5.12.1. 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 72: Ecg Review
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Imaging Figure 5-9 3-lead Placement of AHA Standard The image area displays real-time ECG waveform and heart rate value. There is a red mark on the ECG waveform indicating the temporal position of ultrasound image in relation to the ECG waveform.
Page 73: Transducers And Biopsy
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Transducers and Biopsy 6 Transducers and Biopsy 6.1 Transducer Model Model Type Application Applied Region Abdominal Fetal / Obstetrics Urology C5-2Q/C5-2XQ Convex Body Surface Gynecology Musculoskeletal Fetal / Obstetrics Trans-vaginal Micro Trans-rectal...
Page 74 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Transducers and Biopsy Gynecology Adult Cardiac Pediatric Phased Abdominal P7-3Q Body Surface Array Pediatric Cardiac Neonatal Cephalic Pediatric Abdominal Micro Neonatal Cephalic MC9-3TQ Body Surface Convex Peripheral Vascular Musculoskeletal Abdominal Fetal / Obstetrics...
Page 75: Using Transducers
Acclarix AX8/Acclarix AX7 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 Transducer Converts electrical signals to sound waves, and then converts received head echoes back to electrical signals.
Page 76 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Transducers and Biopsy Image Orientation Mark The image orientation marks 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 77 Acclarix AX8/Acclarix AX7 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 78: Transducer Cleaning And Disinfecting
Acclarix AX8/Acclarix AX7 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 79 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Transducers and Biopsy Contact normally sterile tissue Intra-operative Sterilization Immersion Note: LLD=Low-level Disinfection; HLD=High-level disinfection 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%)
Page 80 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Transducers and Biopsy instructions provided by the disinfectant manufacturer for the concentration of the disinfection solution, method of dilution, method of disinfection, temperature and cautions during use. Place the cleaned and dried transducer in contact with the disinfectant (refers to figure 6-3 for the contacting area) for the time specified by the disinfectant manufacturer.
Page 81: Sterilization
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Transducers and Biopsy 7. Patient contact area should be immersed into the solution while using the immersion method, but should not exceed the depth shown in figure 6-3. 6.3.3. Sterilization Intra-operative transducers must be sterilized before the first use and after each subsequent use.
Page 82: Needle Biopsy Guide
The displayed needle guide pathway on the display 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 83 Acclarix AX8/Acclarix AX7 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 84 Acclarix AX8/Acclarix AX7 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 Structures: Needle Guide Path Locking Knob...
Page 85 Acclarix AX8/Acclarix AX7 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/BGK-006 The installation steps for these brackets are the same.
Page 86 Acclarix AX8/Acclarix AX7 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 87 Acclarix AX8/Acclarix AX7 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 88: Activating Needle Guide Function
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Transducers and Biopsy 6.4.2. Activating Needle Guide Function To enable the needle guide function: In the B mode imaging, press Needle button on touch screen, A needle touch screen UI is displayed, Press Enable button to active the Needle Guide function.
Page 89: Needle Visualization
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Transducers and Biopsy Figure 6-5 Needle Guide Calibration Touch Screen To calibrate the guide line Assemble the needle guide bracket on the transducer, and use the transducer to image a water bath or needle guide phantom.
Page 90: 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 91: Cleaning
Acclarix AX8/Acclarix AX7 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 92: Features
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Features 7 Features 7.1 Comments The Comments 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 touch screen for the Comment function.
Page 93 Acclarix AX8/Acclarix AX7 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 94: Body Mark
Acclarix AX8/Acclarix AX7 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 95: Split Display
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Features Deleting a body mark: There are two ways of deleting a body mark graphic:  Press Delete on the touch screen to delete the graphics on the image area.  Press the <Clear> hard key to delete all body marks, comments, and measurements.
Page 96: Zoom
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Features 7.4 Zoom The system supports two types of zoom: Pan Zoom: enlarges a full image and pans the enlarged image to view the desired area. Spot Zoom: focuses on processing the image of the selected area and enlarges the image with higher resolution.
Page 97: Measurements And Reports
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8 Measurements and Reports The Measurement 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. Pressing on the <Measure>...
Page 98 Acclarix AX8/Acclarix AX7 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 99 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Name Description Measurement Displays application and generic measurement labels. label Pressing on any label will display its associated measurements on the touch screen. Measurement Displays available measurement groups. Selecting one...
Page 100 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Understanding Measurement Result Window The measurement result window is displayed at the upper left corner of the image area by default. The following figure is an example of measurement result window.
Page 101: Generic Measurements
Acclarix AX8/Acclarix AX7 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 102 Acclarix AX8/Acclarix AX7 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 103 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8.1.1.4. Volume Volume can be measured with 3 Distances or 1 Ellipse+1 distance method. 3-Distance Method: 1. Invoke the generic measurement function. 2. Select Volume-> Volume 3 Dist. 3. Move the caliper to the start point.
Page 104 Acclarix AX8/Acclarix AX7 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 105: M-Mode Generic Measurements
Acclarix AX8/Acclarix AX7 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 2-point method Slope Generic Time 8.1.2.1. Distance The distance measurement measures the distance between two points at the vertical direction.
Page 106: Strip Doppler Generic Measurements
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports position of start point and end point. 6. Press the <Set> key to fix the end point and complete the measurement. 8.1.2.4. HR The HR measurement measures the time interval between two points, and calculates the heart rate.
Page 107 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Item Remark Group Only available for Cardiac Tei index exam 8.1.3.1. Velocity Multiple types of velocity measurements are supported on Doppler Strip, for example velocity at any point, at PS or ED.
Page 108 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8.1.3.2. Trace The Trace measurement can provide a wide range of results, as shown below. The actual results displayed will depend on Measure Setup(See section 10.4 for details). ...
Page 109 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Auto Trace Method: 1. Freeze the strip and invoke the generic measurement function. 2. Select Generic-> Auto Trace. 3. The trace waveform(s) automatically appear, and measurement result displays. NOTE: Auto trace measurement can only be activated on a frozen Doppler strip.
Page 110 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8.1.3.8. Volume Flow Volume Flow can be measured in Strip Doppler mode by the following methods: Manual Method: 1. In Vascular exams, freeze the strip and invoke the generic measurement function.
Page 111: Application Measurements
Acclarix AX8/Acclarix AX7 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 measurement packages, each with its own set of measurements, calculations and report: ...
Page 112: Abdomen Measurements
Acclarix AX8/Acclarix AX7 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 113: Gynecology Measurements
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item 2.12 Splenic V Splenic Vein 2.13 Superior Mesenteric Vein 2.14 Inferior Mesenteric Vein 8.2.2. Gynecology Measurements Measurement Measurement Description Method Group Item Section 1: B-mode Measurements...
Page 114: Obstetrics Measurements
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Spline Trace ** The measurement method including 1 Distance, 2 Distances and 3 Distances can be switched by the Tool Options paddle key.
Page 115 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Distance in Crown Rump Length B-mode generic measurements Biparietal Diameter Distance in B-mode generic Femur Length measurements; Humerus Length Auto(See 8.2.3.1) Distance in...
Page 116 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Left Ventricular Outflow LVOT Diam Tract Diameter Ao Asc Ascending Aorta Diameter LVOT/AO Ao Arch Aorta Arch Diameter Ao Isthmus Aorta Isthmus Diameter...
Page 117 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports the Tool Options paddle key. 8.2.3.1. Auto OB Measurement Auto OB is a method designed to measure BPD, HC, HUM and FL automatically. To use Auto OB measurement: Select OB exam preset and perform image scanning in B mode.
Page 118: Cardiac Measurements
Acclarix AX8/Acclarix AX7 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 119 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Left Ventricular Internal Diameter at LVIDd End-diastole Left Ventricular Internal Diameter at LVIDs End-systole Left Ventricular Posterior Wall LVPWd Thickness at End-diastole Left...
Page 120 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item section 8.2.4.2) Mitral Regurgitation Aliasing MR Als. Vel Maximum Velocity Aortic Valve Stenosis Radius AR Rad Aortic Regurgitation Aliasing AR Als. Vel Maximum Velocity...
Page 121 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Tricuspid Valve Velocity Time TV VTI Integral TV Vmax Tricuspid Valve Maximum Velocity Tricuspid Valve Close-Open TV C-O Dur Duration RV TEI RVET...
Page 122 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Left Ventricular Outflow Tract LVOT Vmax Maximum Velocity AV Vmax Aortic Valve Maximum Velocity Left Ventricular Outflow Tract LVOT Diam Diameter 2.10 CO(LVOT)
Page 123 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Hep D Vel Hepitic Vein diastole velocity Hepitic Vein A-wave reverse Hep. A Vel velocity Hep A Dur Hepitic Vein A-wave Duration Mitral Valve Trace...
Page 124 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Left Ventricular Posterior Wall LVPWs Thickness at End-systole E-F Slope Mitral Valve E-F slope EPSS E point septal separation MV D-E Exc Mitral Valve DE Wave Amplitude...
Page 125: Small Parts Measurements
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Pivot the Point D to a new desired position if necessary. Press <Set> key to complete the measurement. 8.2.4.2. PISA PISA (Proximal Isovelocity Surface Area) is a tool in Cardiac presets used for quantitative analysis of regurgitation.
Page 126: Urology Measurements
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Testis L Testis Length Testis Testis W Testis Width Testis H Testis Height Section 2: Doppler Measurements Superior Thyroid Artery PS,ED,RI,S/D Doppler generic...
Page 127: Vascular Measurements
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item Testis L Testis Length Testis Testis W Testis Width Testis H Testis Height Section 2: Doppler Measurements Renal A Renal Artery Arcuate A...
Page 128 Acclarix AX8/Acclarix AX7 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 129 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Measurement Measurement Description Method Group Item 2.32 CIV Common Iliac Vein 2.33 EIV External Iliac Vein 2.34 IIV Internal Iliac Vein 2.35 Saph V Great Saphenous Vein 2.36 Pop V Popliteal Vein 2.37 Peron V...
Page 130: Pediatric Measurements
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports WARNING Auto IMT measurement can only be activated on a frozen image. Select the Right or Left, Near or Far vessel wall, and vessel segment before generating IMT measurement, otherwise the measurement results may not be accurate.
Page 131 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports To use Hip Joint Angle measurement: Invoke the B-mode application measurement function. Select HIP-> HIP Angle on the touch screen and then select Left or Right on touch screen. A horizontal straight line will be displayed on the image field.
Page 132: Worksheet And Report
Acclarix AX8/Acclarix AX7 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 133 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports Figure 8-8 Worksheet Touch Screen Display Name Description Growth Press to access the fetal growth curves. It is only available in Obstetric Curve exams. See section 8.3.1.4 Growth Curve for details.
Page 134 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8.3.1.2. Editing Worksheet Move the cursor over an editable field such as a measurement result, and press the <Set> key. A touch QWERTY is automatically invoked. Or, you can used the physical keyboard of the system. Type in your changes and press the Enter key to save the changes.
Page 135 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8.3.1.4. Growth Curve Press the <Report> key to enter the Worksheet, and then press the Growth Curve button on the touch screen to display the Growth Curve Graph. Growth Curve is only available in Obstetric exams.
Page 136 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8.3.1.5. 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 current measure preset.
Page 137: Report
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8.3.2. Report A report includes: Header, Patient Information, Images, Measurement/Calculation data, Comments, Findings and Sonographer signature. If images are stored in current exam, selecting images displayed on the right side of main screen will add the selected images into the report.
Page 138: Measurement Accuracy
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Measurements and Reports 8.4 Measurement Accuracy Parameter Range Accuracy 1.B Mode Measurement Distance Full Screen < ±5% Circumference (Ellipse) Full Screen < ±5% Circumference (Trace) Full Screen < ±5% Area (Ellipse) Full Screen <...
Page 139: Exam Data Management
Acclarix AX8/Acclarix AX7 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 140: Reviewing Images
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Exam Data Management 9.2 Reviewing Images 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 141: Exam Database
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Exam Data Management Select Select an image. Select All Select all the images in the current exam. Slideshow Play all the images as a slideshow. Export selected images to USB disk. Plug in a USB disk, select...
Page 142 Acclarix AX8/Acclarix AX7 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 143 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Exam Data Management  Working with one study: 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 editing report, reviewing, deleting and restarting of the selected study can be accessed on the touch screen.
Page 144: Archiving Studies
Use your mobile device to scan this QR code, and you will get a website link. Copy this link and open it in a browser. A "EDAN Remote Transmission" website is opened, and click the Download key. - 135 -...
Page 145: Structured Report
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Exam Data Management All the images/clips of this exam will be viewed on your mobile device. Press the images/clips to save them to your mobile device. 9.5 Structured Report Structured Reports are supported for OB, Gynecology, Cardiac and Vascular exams on this system.
Page 146: Presets
Acclarix AX8/Acclarix AX7 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 147: Selecting A Preset
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets 10.2 Selecting a Preset There are two ways to select a preset The Preset Function: The preset function is invoked by pressing the <Preset> key on the console. See figure 10-2 for an example Transducer touch screen. The currently active transducer is shown at the top of the touch screen.
Page 148: Exam Preset
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets Figure 10-3 Top level Touch Screen for the Setup Function  Press System to edit overall system settings unrelated to presets. See section 11 for details.  Press Presets to do any of the following: Edit the imaging parameters of an exam preset.
Page 149 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets Transducer: Select one transducer from the list to configure its exam presets. Preset List: Select one exam preset to configure its associated Image, Comment, Measure, Body Mark or Patient info settings.
Page 150: Comment Preset
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets Patient Info: Open the patient information configuration page. This page allows you to configure which demographic fields are shown in the Patient Information Page for the selected exam preset. Or, you can select other exam preset you want to configure on the left side of the screen and configure it directly on this page.
Page 151: Body Mark Preset
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets Editing Comment Preset: Select a comment preset from the preset list on the left side of the screen, and then you can do the followings to edit the comment texts for the selected preset.
Page 152 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets Figure 10-8 Body Mark Preset Touch Screen Pre-defined graphics area Figure 10-9 Body Mark Preset Main Screen Editing Body Mark Preset: Select an Body Mark preset from the preset list on the left side of the screen, and then you can do the followings to edit the body mark preset for the selected preset.
Page 153: Measure Presets
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets  Deleting a Body Mark from a Preset: Move the cursor to a Body Mark graphic in pre-defined graphics area and press <Set> key. Press the Delete button on the touch screen to delete it.
Page 154 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets  Unit Settings The system supports following unit settings:  Distance: Set the default unit of distance measurement. "mm" and "cm" are available.  Area: Set the default unit of area measurement. "mm "...
Page 155: Application Parameter
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets 10.4.2. Application Parameter Figure 10-11 Application Parameter Set-up Screen On the Application Parameter page, you can configure the default measurement results of Doppler trace measurement for each exam application. Select one clinic application in the Application drop-down list, for example ABD, and then tick the measurement result items in the list below.
Page 156: Report Set-Up
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Presets On the Measure Preset page, you can configure the measurements for each exam preset in each imaging mode. Follow the steps below: Select exam application Select an exam application, for example ABD, in the Application drop-down list.
Page 157: Utilities
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities 11 Utilities Press <Utilities> key on the console to open Utilities screen. The Utilities screen provides access to System setup, Presets, Measure presets, Connectivity, Maintenance, Screen adjust, etc. Each of these is described in separate sections.
Page 158 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities Keyboard U.S International Set the keyboard layout Time Zone Select the time zone from the drop-down list. YYYY/MM/DD/ Date Format MM/DD/YYYY Set the date format DD/MM/YYYY Set the system date Note: If the license is invalidated because of...
Page 159: Patient Set-Up
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities Auto zoom image Set whether to zoom in the image automatically at shallow depth √/× when adjusting image depth to shallow depth on linear linear transducer. transducer Hide whether hide hint “non...
Page 160: Store/Print Set-Up
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities 11.1.3. Store/Print Set-up Figure 11-3 Store/Print Set-up Screen Item Options Description Store Image Store static image to internal hard disk Store Clip Store clip to internal hard disk Store1/Store2/ SONY-UP-D25MD, Connect the corresponding printer to print...
Page 161: Miscellaneous Set-Up
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities 11.1.4. Miscellaneous Set-up Figure 11-4 Miscellaneous Set-up Screen Item Options Description Default review layout 4*4, 2*2, 1*1, 2*3 Set the default review layout. √/× Overlay Show or hide overlay icons on thumbnail images.
Page 162: User Set-Up
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities 11.1.5. User Set-up Figure 11-5 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 163: Connectivity
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities Caution For security consideration, a password with high secure intensity is suggested for each user account, and the password should be changed periodically. Please keep your user name and password safe.
Page 164: Tcp/Ip
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities 11.2.1. TCP/IP This screen configures access to a network. Access can be either wired or wireless. Figure 11-6 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 165: Dicom
These settings determine how the system communicates with other DICOM devices. Local AE Title: Any 16 characters that uniquely identify this system on your DICOM network. The default “EDAN_STR_SCU” will work unless you have multiple Edan systems on your network.
Page 166 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities The server list displays all the configured servers. It starts off as an empty list, and grows as servers are added. Most sites will only use one server, but if the system is moved between locations then multiple servers may be entered.
Page 167 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities to the nature of DICOM, images that are already sent can not be deleted from the server from the system.  Auto Transfer when End Exam: Images, clips and structured reports are sent automatically when the exam is ended.
Page 168 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities 11.2.2.4. MPPS Service Settings Click MPPS key on the left side of main screen, and the right half screen switches to MPPS service setup, where you can configuring MPPS service. Enable: Turns MPPS(Modality Performing Procedure Step) service on/off. If MPPS service is on, the ultrasound system will send the exam status to Worklist server automatically when starting or ending an exam.
Page 169: Network Store
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities  Server: Selects a configured server from the drop-down list to confirm whether the DICOM transfer to this server is successful. The confirmation is undergoing in the background. When an exam's transfer to the DICOM server is confirmed successfully, a small red disk icon appears next to this exam on the Exam Database screen, indicating that it has been saved successfully on the DICOM server.
Page 170: Maintenance
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, Import Config and Show Config button. Any released upgrade will include instructions regarding use of this button.
Page 171: Demo
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities Do not connect an USB device with unknown provenance to the ultrasound system. To avoid loss of patient data, please backup the patient data prior to software upgrade. 11.3.3. Demo A Demo exam is a special exam with a patient name of “Demo”. It allows you to collect any set of images from multiple exams.
Page 172: Screen Adjust
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Utilities were also exported/imported. To import user data: Press <Utilities> key on the console, select Maintenance Export/ImportImport. Select an external USB storage device. All the presets on it will be loaded and displayed. The Presets must have been previously exported from a system.
Page 173: 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.cn.
Page 174: Troubleshooting And Maintenance
13.1 Daily Checklist 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. Do not use any damaged transducer.
Page 175: Cleaning And Disinfecting The System
2. Clean the button 13.3 Cleaning and Disinfecting the System 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 176: Cleaning And Disinfecting The System Surface
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance 13.3.1. Cleaning and Disinfecting the System Surface System Surface Cleaning The validated cleaning agents for cleaning the system are:  Ethanol (75%)  Isopropanol (70%) To clean the system surface: Switch off the system and unplug it.
Page 177: Cleaning And Disinfecting The Ecg Module And Cable
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance Inspect the system to ensure that there is no damage. 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: ...
Page 178: Maintenance
Acclarix AX8/Acclarix AX7 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 179: Appendix A Specifications
Acclarix AX8/Acclarix AX7 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 180: Machine Specifications
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Specifications A.4 Machine Specifications Main unit dimensions 38.8cm(W)x 40.7cm(D)x 7.7cm(H) Net weight 9.25kg including battery (not including power adaptor or transducer) A.5 Display Specifications Display TFT-LCD Diagonal Size 15.6 inches View Angle Right 80°...
Page 181 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Specifications 3D/4D: 3D Rendering, 3 Sectional Planes Elastography: E, B+E(Display layout: Up/down, Left/right, 1:1); 120GB (SSD, Standard) Hard Drive Storage 500 GB (HHD, Optional) Abdomen, Obstetrics, Small Parts, Vascular, Cardiac, Gynecology, Report Packages...
Page 182: Operating, Storage And Transportation Environment
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Specifications Resolution: 1 bpm Accuracy: ±1% or 1 bpm, whichever is greater. Range: 40 ms~120 ms QRS Detection Amplitude:0.5 mV~5 mV Patient Leakage < 10 μA Current Supply Voltage USB-supply (5V, 300mA) A.7 Operating, Storage and Transportation Environment...
Page 183: Appendix B Ultrasound Intensity And Safety
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety Ultrasound Intensity and Safety Appendix B 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 184: Explanation Of Mi/Ti
Acclarix AX8/Acclarix AX7 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 185: Display Of Mi/Ti
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety TIC (Cranial Bone Thermal Index): It provides an estimate of potential temperature rise in the cranial bones or superficial bones. 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 186: Acoustic Power Default Settings
Acclarix AX8/Acclarix AX7 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 187: Transducer Acoustic Output Data
Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety Roy C. Preston, David R. Bacon, and Robert A. Smith, Calibration of Medical Ultrasonic Equipment - Procedures and Accuracy Assessment, IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, Vol. 35, No. 2, page110, March 1988.
Page 188: 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 transducers of EDAN can be only used on EDAN’s systems. Otherwise, the performance and electric shock protection cannot be guaranteed.
Page 189 Acclarix AX8/Acclarix AX7 Diagnostic Ultrasound System User Manual Order List 02.01.210618 BGK-R15UB Needle Guide Bracket Kit 02.01.210985 BGK-P5-1X Needle Guide Bracket Kit 02.01.215191 BGK-001 Needle Guide Bracket Kit 02.01.215192 BGK-002 Needle Guide Bracket Kit 02.01.215193 BGK-003 Needle Guide Bracket Kit 02.01.215194...
Page 190: Appendix D Emc Information
Acclarix AX8/Acclarix AX7 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 191 Acclarix AX8/Acclarix AX7 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 192 Acclarix AX8/Acclarix AX7 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 193 Acclarix AX8/Acclarix AX7 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 194 Acclarix AX8/Acclarix AX7 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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Acclarix ax7

EDAN Acclarix AX8 User Manual

1 Introduction

2 Safety

3 Getting Started

4 Exam Operation

5 Imaging

6 Transducers and Biopsy

7 Features

8 Measurements and Reports

9 Exam Data Management

10 Presets

11 Utilities

12 In between Exams

13 Troubleshooting and Maintenance

Appendix A Specifications

Appendix B Ultrasound Intensity and Safety

Appendix C Order List

Appendix D EMC Information

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