EDAN Acclarix AX3 User Manual

EDAN Acclarix AX3 User Manual

Diagnostic ultrasound system
Table of Contents

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Summary of Contents for EDAN Acclarix AX3

  • Page 2 Not all measurements and features are available for all system models and configurations. This manual is based on the complete set of transducers and features available. Therefore, some of the contents may not apply to your product. If you have any questions, please contact your local EDAN representative.
  • Page 3: 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 ........................7 Getting Started ........................... 10 3.1 System Configuration .......................
  • Page 4 5.4 CW Mode ..........................42 5.4.1. Using CW Mode ....................... 42 5.4.2. CW Image Optimization....................43 5.5 M-mode ............................ 45 5.5.1. Using M-mode ........................45 5.5.2. M-mode Image Optimization .................... 45 Transducers and Biopsy ......................47 6.1 Transducers ..........................47 6.2 Using Transducers........................
  • Page 5 8.3.2. OB Worksheet ........................90 8.3.3. Growth Curve ........................91 8.3.4. Report ..........................93 8.4 Measurement Accuracy ......................95 Exam Data Management ......................96 9.1 Storing Images ......................... 96 9.2 Reviewing Images ........................97 9.3 Exam Database ........................99 9.4 Archiving Studies ........................100 10 Presets ............................
  • Page 6 13.2 Troubleshooting ........................123 13.3 Cleaning the System ......................124 13.4 Maintenance ......................... 126 Appendix A Specifications ......................127 A.1 Electrical Safety Classifications ................... 127 A.2 Power Supply ........................127 A.3 Machine Specifications ......................128 A.4 Display Specifications ......................128 A.5 General Specifications ......................
  • Page 7: Introduction

    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 8: 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 9 SHOCK HAZARD – Do not connect non-isolated electrical equipment to the same circuit being used to power the system.  Edan recommends the use of isolated connectors on any electrical equipment attached to the system, and/or using isolation transformers that comply with IEC60601-1 to power that electrical equipment.
  • Page 10: 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 11 Confirm patient identification information prior to storing or printing any exam information.  If you have any questions about maintenance, technical specifications, or system functionality, please contact your local distributor or Edan Service at: support@edan.com.cn  Ultrasound images occasionally have artifacts, and should only be used as one part of an overall clinical assessment.
  • Page 12 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 13: 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 User Manual (Background: Blue;...
  • Page 14 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety Type BF Applied Part Transducer connector Pencil Transducer connector (reserved) Transducer lock Transducer unlock Network port Trademark Direct current S-Video Output port USB 2.0 port USB 3.0 port HDMI HDMI port...
  • Page 15 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety The following labels are used on the packaging: Symbol Definition This way up Fragile Keep away from rain General Symbol for Recovery / Recyclable Stacking limit by number Do not step on!
  • Page 16: 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 17 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 18: System Overview

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 3.2 System Overview 3.2.1. Main Unit Figure 3-1 Main Unit - 12 -...
  • Page 19 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Name Description Display the images and parameters during Monitor scanning. Power Switch Power on/off the system. control operation activate Touch Screen functions. Control Panel Use to control the operation .
  • Page 20 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started I/O Ports on the left panel: Figure 3-2 I/O ports Power supply Network port S-Video output port HDMI port USB 3.0 port USB 2.0 port USB 2.0 port Table 3-4 I/O Ports Caution 1.
  • Page 21: 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 22 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 23 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Enters dual split screen. Each single press on it toggles Dual between two images. See section 7.3 for details. Store Image Press to store static images. Store Clip Press to store clips.
  • Page 24: Screen Layout

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Depth Rotate to adjust the depth of the image displayed. Press to optimize B image automatically. Auto/Gain Rotate to change the gain of images. Table 3-5 Buttons on Control Panel 3.2.3.
  • Page 25 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started ③Mini Report The left side of the screen displays a “mini-report” which displays measurements performed during the current exam. ④Thumbnail Field The right side of the screen displays thumbnail images of all statics and clips captured for currently active exam or when in Review.
  • Page 26 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Wi-Fi function is enabled, but no WI-FI network is connected. No WI-FI icon will be displayed when Wi-Fi function is disabled in Connectivity setup. Wi-Fi network is connected. Clicking on this icon shows a list of available Wi-Fi networks.
  • Page 27: Touch Screen

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 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. Battery removed. Battery charging. 3.2.4. Touch Screen The Touch Screen contains controls that vary depending on the active imaging mode or function.
  • Page 28: Trackball

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started de-activate all others. E. TGC: The B-mode tab has a specialized control for TGC. Each slider can be dragged horizontally and individually. Dragging vertically down across the sliders will set all sliders.
  • Page 29: 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. One fully charged battery can run the system for approximately 1 hour and two fully charged batteries together can run the system for approximately 2 hours, depending on use.
  • Page 30: 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 31: Transducer Connection

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Direction Indicating Dot Push the power cord in firmly to ensure a secure connection. Connect the AC power cord to a hospital-grade power outlet. WARNING Make sure the AC power supply complies with the following specifications: 100V-240V~, 50Hz/60Hz.
  • Page 32 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started Figure 3-9 Lock the tansducer locking handle To disconnect a transducer: Toggle the locking handle to the bottom position to unlock the transducer connector. Firmly grasp the transducer connector and carefully remove it from the system port.
  • Page 33: Powering On/ Off

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 3.3.4. Powering on/ off To power on: 1. Connect the system to a hospital grade power supply, or use the battery as the power supply. 2. Press the Power on/off key on the top left of the control panel.
  • Page 34: 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 4-2 below).
  • Page 35: 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 36 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation 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. If date of birth is entered, the age is automatically calculated.
  • Page 37 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation  Weight: Enter the patient‟s weight. The units can be set in the Patient section of Setup.  BSA: Body Surface Area, it is auto-calculated and displayed when Height/Weight is entered.
  • Page 38: 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 39: 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 40 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 41 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 42: Color Mode

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.2 Color Mode 5.2.1. Color Mode Variants The system supports 3 types of Color Doppler imaging:  Color (Color Doppler): This is velocity Color Doppler that shows direction and velocity of flow.
  • Page 43 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging The Baseline control adjusts the Color baseline. Upward presses move the baseline up on the scale and downward Baseline presses move the baseline down. Baseline is not available in PDI mode.
  • Page 44 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Frequency determines the transmit frequency used by color Frequency Doppler. Upward presses increase the frequency. Downward presses decrease the frequency. This control is only available for linear transducers. It steers the Steer Color ROI box angle left or right.
  • Page 45: Pw Mode

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Acoustic Adjusts the acoustic output power of the activated transducer. It power is only available in live imaging. Higher acoustic power numbers correspond to increased color sensitivity and penetration, but the ALARA principle should be followed in actual clinical situations.
  • Page 46 Acclarix AX3 Series 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 47 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Volume adjusts the audio volume of the Doppler strip. This Volume can be adjusted in pre-Doppler to set the initial volume upon invoking Doppler acquisition. This determines if the strip mode and reference image are imaging simultaneously or not.
  • Page 48: Hprf

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Acoustic Adjusts the acoustic output power of the activated transducer. Power It is only available in live imaging. Higher acoustic power numbers correspond to increased sensitivity in the Doppler display and improved penetration, but the ALARA principle should be followed in actual clinical situations.
  • Page 49: Cw Image Optimization

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging 5.4.2. CW Image Optimization The following touch controls can be used to optimize the CW image. Name Control Description Scale adjusts the range of velocities that are displayed. Scale Upward presses increase scale and downward presses decrease it.
  • Page 50 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging Gray Adjusts the current post processing, either grayscale or Tint tinted. The Dynamic Range, or log compression, adjusts how signal intensities are converted to brightness. A high Dynamic dynamic range will display more shades of gray, while a...
  • Page 51: 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 52 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 53: 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 Abdomen Fetal / Obstetrics C5-2Q Convex Urology Surface Gynecology Musculoskeletal Fetal / Obstetrics Gyncecology E8-4Q Micro Convex...
  • Page 54: 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 Transducer Converts electrical signals to sound waves, and then converts received head echoes back to electrical signals.
  • Page 55 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 56 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 procedures.
  • Page 57: 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 58 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 Glutaraldehyde(1.8%-2.2%) Immersion WARNING Unplug the transducer from the system prior to cleaning or disinfecting.
  • Page 59 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy E8-4Q Disinfectant Figure 6-3 Depth of the Transducer Immerged into Disinfectant WARNING 1. Do not immerse the transducer connector. If the cable connector is immersed, do not plug the connector into the system.
  • Page 60: Needle Biopsy Guide

    If previous use has shown some drift of the needle from the center of the guidelines. 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 61 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 62 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 Structures: Needle Guide Path Locking Knob...
  • Page 63 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-001/BGK-003 The installation steps for BGK-001 and BGK-003 brackets are the same.
  • Page 64: Activating Needle Guide Function

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Install the disposable Needle Guide. Select appropriate disposable needle guide to achieve target depth from skin line: Specification Depth 21G(1.0cm) 0.8 - 1.2 cm 21G(1.5cm) 1.3 - 1.7 cm 21G(2.0cm)...
  • Page 65: Calibrating The Needle Guide Line

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy Figure 6-4 Needle Guide Touch Screen WARNING To avoid patient injury when using a multi-angle bracket, make sure that the same angle(A, B, C or D) is selected on both the bracket and the ultrasound system.
  • Page 66: Needle Visualization

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy  Use the Position paddle to adjust the line horizontally until the origin aligns with the actual needle.  Use the Angle paddle to adjust the angle of the line until the entire line aligns with the actual needle.
  • Page 67: Center Line

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy 6.6 Center Line The Center Line is a vertical dotted line displayed at the middle of the image field, representing the middle of ultrasound beam. The Center Line helps to locate the position and depth of a target disease focus for out-of-plane biopsy, lithotripsy and etc..
  • Page 68: 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 69 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 70: 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 71: Dual Image Display

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features 7.3 Dual Image Display 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 72: Cine Review

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features 7.5 Cine Review Press <Freeze> key on the console to freeze the image or select a stored cine clip, and the cine bar is displayed on the bottom of the screen, as shown below.
  • Page 73: 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 Measure function is invoked by pressing the <Measure> hard key on the console. Figure 8-1 shows an example touch screen for Measure.
  • Page 74: Generic Measurements

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Figure 8-2 Tool Options Touch Screen Moving the measurement result window The measurement result window is displayed on the top left corner of the image field by default, the system supports changing the display position of the result window by dragging it.
  • Page 75 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports  Stenosis Distance: The distance measurement is always done with a caliper pair. To measure Distance with a caliper pair: 1. Invoke the measure function on a B-mode image.
  • Page 76 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Presses of the <Update> key will toggle between active calipers, allowing you to adjust the position of the three points that make up the angle. 6. Press the <Set> key to fix the third point and complete the angle measurement.
  • Page 77: Strip Doppler Generic Measurements

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports To measure Stenosis with Traces: 1. Invoke the Measure Function on a B-mode image. 2. Select Stenosis from the touch screen. If Traces is not the default tool, press Tool Options to switch to Traces.
  • Page 78 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports the PS point or ED point. 6. Press the <Set> key to fix the ED point and complete the measurement. The S/D, PI, and PHT results assume that the first caliper is placed on the peak systolic point.
  • Page 79 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports  PGmean      Time    NOTE: Auto trace measurement can only be activated on a frozen Doppler strip.. Live Auto Trace is available as a separate feature on the Doppler touch screen. To activate Auto Trace in real time mode, press Auto Trace button on PW touch screen.
  • Page 80 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 5. Move the caliper to the ED point. Presses of the <Update> key will toggle between active calipers, allowing you to re-position the PS point or ED point. 6. Press the <Set> key to fix the ED point and complete RI measurement.
  • Page 81: M-Mode Generic Measurements

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.1.3. M-mode Generic Measurements The system supports the following types of generic M-mode measurements:  Caliper  HR (Heart Rate) Caliper: The Caliper measurement can provide a wide range of results, as shown below: ...
  • Page 82: 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 83: Abdomen Measurements

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.1. Abdomen Measurements Abdomen measurements include liver, gall bladder, pancreas, spleen, renal and Aorta Diam. Abdomen Measurement Description Tool Section 1: B-mode Measurements Liver L Liver Length Liver W...
  • Page 84: Gynecology Measurements

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Abdomen Measurement Description Tool 2.14 Inferior Mesenteric Vein Table 8-1 Abdomen Measurement * The tools can be switched by Tool Options in the touch screen after the Measurement is selected.
  • Page 85: 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 86 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports OB Measurement Description Tool 1.24 AF Deepest Pocket 1.25 AFI** Amniotic Fluid Index Caliper 1.26 RV Diam Right Ventricular Diameter 1.27 RA Diam Right Atrium Diameter Right Ventricular Outflow Tract 1.28 RVOT Diam...
  • Page 87: Cardiac Measurements

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports OB Measurement Description Tool Section 3: M-mode Measurements FHR*** Fetal Heart Rate Caliper Table 8-3: OB Measurements * The tools can be switched by Tool Options in the touch screen after the Measurement is selected.
  • Page 88 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Cardiac Measurement Description Tool LA Width Left Atrium Width Diameter Ao Asc Ascending Aorta Diameter 1.10 Aortic Root Diameter 1.11 LVOT Diam Left Ventricular Outflow Tract 1.12 RVOT Diam...
  • Page 89 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Cardiac Measurement Description Tool Thickness at End-diastole Interventricular Septal Thickness at IVSTs End-systole Left Ventricular Internal Diameter at LVIDs End-systole Left Ventricular Posterior Wall LVPWs Thickness at End-systole LVET...
  • Page 90: Small Parts Measurements

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports 8.2.5. Small Parts Measurements Small Parts measurements include thyroid and breast. Small Parts Measurement Description Tool Section 1: B-mode Measurements THY L Thyroid Length THY W Thyroid Width Thyroid...
  • Page 91: Vascular Measurements

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Urology Measurement Description Tool Pre-BL W Pre-void Bladder Width Pre-BL H Pre-void Bladder Height Post-BL L Post-void Bladder Length Post-BL W Post-void Bladder Width Post-BL H Post-void Bladder Height...
  • Page 92 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Vascular Description Tool Measurement Vert Artery SUBC A Subclavian Artery Axill A Axillary Artery Brach A Brachial Artery Ulnar A Ulnar Artery Radial A Radial Artery 2.10 CFA Common Femoral Artery 2.11 DFA...
  • Page 93 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Vascular Description Tool Measurement 2.39 ATV Anterior Tibial Vein 2.40 SSV Small Saphenous Vein 2.41 HR** Heart Rate 2.42 VF TAMean Volume Flow Time Average Mean Velocity Auto Trace 2.43 ACA...
  • Page 94: 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 95 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Figure 8-4 Worksheet Touch Screen Display(OB as Example) 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 96: Ob Worksheet

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports manually edited value. Figure 8-5 Editing a measurement in Worksheet 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 8-7 shows an example of the OB worksheet.
  • Page 97: Growth Curve

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports LMP: The LMP is displayed on the first page of the report. If the LMP was entered on the Patient page that date is transferred to here. GA: Two different versions of the GA are displayed: ...
  • Page 98 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports To view a growth curve graph: Press the <Report> hard key to enter the Worksheet, and then press the Growth Curve button on the touch screen to display the Growth Curve Graph.
  • Page 99: Report

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports data directly .It appears only in multiple fetus situations, and the fetus number is determined by which is entered in patient information. Figure 8-10 Comparing fetus in a growth curve graph ...
  • Page 100 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports Figure 8-11 Report Main Screen The middle part of the main screen is the general layout of a report. On the left side of the main screen, you can set the layout of the report: ...
  • Page 101: Measurement Accuracy

    Acclarix AX3 Series 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%...
  • Page 102: 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 103: 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 104 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management Delete the selected image. Export selected images to a removable media currently available. Plug in a USB disk, select an image, press this button and the following confirmation dialog pop-up: Select the export path from destination drop list menu, select the export format and click OK to export.
  • Page 105: Exam Database

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management 9.3 Exam Database The Exam Database provides a list of recently performed studies. It can be accessed by pressing the <Review> hard key on the console when there is no active exam.
  • Page 106: Archiving Studies

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Data Management Export Format: This location displays export format for static images and clips. BMP, Raw Data and DICOM formats are available for static images. AVI, Raw Data and DICOM formats are available for clips.
  • Page 107: Presets

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 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 108: Selecting A Preset

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 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 109: Exam Preset

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 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.
  • Page 110: Image Preset

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Comment: Select one of the pre-defined comment presets to be the default comment preset for the selected exam preset. Body Mark: Select one of the pre-defined body mark presets to be the default body mark preset for the selected exam preset.
  • Page 111: Comment Preset

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Image Type: Each imaging mode has a set of image types. For example in B-mode the types are Detail, General, and Penetration. While imaging, the image type lets you quickly change the aesthetic look of the image without changing settings like depth or invert status.
  • Page 112: Body Mark Preset

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 10.3.4. Body Mark Preset Figure 10-7 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 10-7 Body Mark Preset Screen...
  • Page 113: Measure Preset

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 10.3.5. Measure Preset Figure 10-8 shows an example set-up screen for Measure Preset, where you can configure general measurement settings. Figure 10-8 Measure Preset Screen  Unit Settings The system supports following unit settings: ...
  • Page 114 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities  OB Settings The system supports the following OB measurement settings:  Fetal Age: set equation for measurements which are used for calculating fetal age.  Fetal Growth: set equation for measurements which are used for calculating fetal growth.
  • Page 115: 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 116 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 effective after reboot the system).
  • Page 117: 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 118: 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. Store Clip Set the default cine length for retrospective Duration for retrospective cine storing in the frozen status.
  • Page 119: 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 Logo Position side of report header.
  • Page 120: 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 cm/s, kHz Set the velocity units of spectrum scale. Scale unit Auto zoom image on linear Set whether to auto zoom image at the shallow √/×...
  • Page 121: Connectivity

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 11.2 Connectivity Entering Connectivity Screen: Open Utility page. Press Set up touchscreen button, and then the Connectivity touchscreen button to access Connectivity screens. The Connectivity screens support configuration of network access and services. It is divided into 2 tabs: ...
  • Page 122: Dicom

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Wireless Settings: Enable Wireless: This will turn the wireless radio on/off. No wireless networks are displayed when this is disabled. Networks: When wireless is enabled the system will search for wireless networks that are available and display them in this list.
  • Page 123 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. Time Out: This determines the time after which this system will stop trying to establish a connection to the DICOM server.
  • Page 124: 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 125: 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 126: Tool

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Figure 11-9 Demo Screen 11.3.4. Tool The Tool screen provides access to system maintenance which must be performed by authorized service personnel. Please refer to the Service Manual for the details.
  • Page 127 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities Figure 11-10 Screen Adjust Screen - 121 -...
  • Page 128: 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 129: 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. Do not use any damaged transducer.
  • Page 130: Cleaning The System

    Service. 13.3 Cleaning 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 131 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance liquid.  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 132: Maintenance

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance Rotate clockwise to remove the fixing ring Rotate counterclockwise to mount the fixing ring Figure 13-1 Assembling and Disassembling Trackball X idler wheel Y idler wheel Auxiliary idler wheel...
  • Page 133: 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 According to the degree of Type BF protection against electric shock...
  • Page 134: Machine Specifications

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Specifications A.3 Machine Specifications Main unit dimensions 375 mm×380 mm×58 mm Weight Weight: 4.2kg (Including one transducer socket, not including battery, power adapter and transducers) Weight:4.35kg (Including two transducer sockets, not including battery, power adapter and transducers) A.4 Display Specifications...
  • Page 135: Wi-Fi Specifications

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Specifications A.6 Wi-Fi Specifications Standard 802.11a, 802.11b, 802.11g ,802.11n Conformance 2.412-2.484GHz(@2.4GHz band) Frequency Band OFDM Modulation DSSS Technique 2.4G Transmit 1MbpsDSSS :17.3dBm 2MbpsDSSS :17.3dBm 5.5MbpsCCK :17.3dBm 11MbpsCCK :17.3dBm 6MbpsOFDM: 17.1dBm 9MbpsOFDM :17.1dBm Typical Transmit Power(±2dBm)
  • Page 136: Transducer Specifications

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Specifications A.8 Transducer Specifications Transducer Center Frequency L17-7Q 12.0MHz E8-4Q 6.2MHz L12-5Q 8.0MHz C5-2Q 3.5MHz P5-1Q 2.7MHz A.9 Configuration Difference Configuration Difference Feature 1 Feature 2 Feature 3 Feature 4 Models Seminal...
  • Page 137: 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 138: 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 139: 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 140: Acoustic Power Default Settings

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety Table 1 The intensity and pressure measurement uncertainties table Total uncertainties Hydrophone Digitizer Sensitivity Intensity Pressure Intensity Pressure Intensity Pressure Uncertainty ± 23.68% ± 11.84% ± 14% ± 7% ±...
  • Page 141: Prudent Use Statement

    Acclarix AX3 Series Diagnostic Ultrasound System User Manual Ultrasound Intensity and Safety  Indirect Controls The acoustic output of the system can be controlled indirectly through many imaging parameters, including imaging modes, field of view, line density, probe frequency, focus number/position, depth and pulse repetition frequency (PRF).
  • Page 142: 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 143 Acclarix AX3 Series Diagnostic Ultrasound System User Manual Order List Fottswitch(double button) 01.10.027323 Suitcase 01.56.466572 NOTE: The part name may vary depending on context, but the part number is constant. - 137 -...
  • Page 144: 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 145 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 146 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 147 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 148 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.
  • Page 149 - 143 -...

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