Preface This manual contains necessary and sufficient information to use the Acclarix AX8 system safely for the purposes for which it is intended. It applies to all 1.3X releases. Read and understand all instructions in this manual prior to using the Acclarix AX8 ultrasound system. Disregarding instructions, particularly warnings and cautions, is considered abnormal use. Caution: Federal law restricts this device to use by, or on the orders of, a physician.
Contents 1 Introduction................................................................................................................................ 1 1.1 Intended Use/ Indications for Use .......................................................................................... 1 1.2 Contra-indications .................................................................................................................. 1 1.3 Device Description ...............................................................
5.6.1. 5.6.2. 5.6.3. 5.6.4. 5.6.5. 5.6.6. 6 Pre-3D ........................................................................................................................ 45 3D Volume Sweeping ................................................................................................ 46 3D Image Review ...................................................................................................... 46 4D Volume Acquisition .........................................................................
9.3.3. Demo ........................................................................................................................ 109 9.3.4. Export/Import........................................................................................................... 109 9.4 Screen Adjust ..................................................................................................................... 111 10 In Between Exams ...................................................................................
Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction 1 Introduction 1.1 Intended Use/ Indications for Use For the United States of America The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology (including endovaginal) Obstetric Cardiac Small parts (Breast, Testes, Thyroid, etc.
Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction then converts back to an electrical signal. The Acclarix AX8 system then analyzes the returned signal to generate an image or conduct Doppler processing. The Acclarix AX8 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides both touch screen and hard buttons for the User Interface.
Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction 11 Authorized Representative in the European Community 12 Disposal method. Indicates that the equipment should be sent to special agencies according to local regulations for separate collection after its useful life. 13 General Symbol for Recovery / Recyclable 14 Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Conforms to AAMI Std. ES 60601-1, IEC Std.
Acclarix AX8 Diagnostic Ultrasound System User Manual 27 USB 2.0 port 28 USB 3.0 port 29 Display port 30 Microphone input 31 Headphones 32 FCC ID: SMQAX8EDAN Introduction Federal Communication Commission: FCC ID: SMQAX8EDAN NOTE: The user manual is printed in black and white.
Acclarix AX8 Diagnostic Ultrasound System User Manual Safety 2 Safety Throughout this document the following terms are used: Warning: Advises against certain actions or situations that could result in personal injury or death. Caution: Advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. Note: Provides useful information regarding a function or a procedure.
Acclarix AX8 Diagnostic Ultrasound System User Manual Safety Not intended for Ophthalmic use. If a sterile transducer cover becomes compromised during an intra-operative application involving a patient with transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Disease Control Center and this document from the World Health Organization: WHO/CDS/APH/2000/3, WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies.
Acclarix AX8 Diagnostic Ultrasound System User Manual Safety system grounding and cause the system to exceed leakage current limits. 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 complies with IEC60601-1 to power that electrical equipment.
Acclarix AX8 Diagnostic Ultrasound System User Manual Safety evidence of damage to the equipment, cables, and transducers. If a component is damaged replace it before use. Do not use in locations subject to vibration. Read and understand the section A1.2 Ultrasound Safety and the ALARA Principle of Acclarix AX8 Advanced User Manual before using the system. Do not expose a patient to ultrasound energy longer than clinically reasonable. Practice ALARA principle when operating ultrasound system.
Acclarix AX8 Diagnostic Ultrasound System User Manual Safety source before cleaning and disinfecting. The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Transducer Cautions Do not use disinfection agents beyond their expiration date. Do not use sterile sheaths beyond their expiration date.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started 3 Getting Started 3.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started Note: For more printer models, please see: http://hplipopensource.com/hplip-web/supported_devices/combined.html . Generally, printer models with driver version 3.14.3 or lower can be supported by Acclarix AX8, but some models cannot be perfectly supported.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started 10 Figure 3-1 Appearance of the System No. Name Description 1 Monitor Display the scanning.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started I/O Ports on the left panel: 1 2 3 4 5 6 7 8 Figure 3-2 I/O ports of the system 1. Power supply 5. USB 2.0 port 2. S-Video output port 6. Network port 3. Display port 7. Microphone input port 4. USB 3.0 port 8.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started To install the battery: 1. Turn off and unplug the Acclarix AX8 system. 2. Close the monitor, turn the system upside down and rest it on a flat stable surface. 3. Put the battery gently to battery compartment, and the button will lock the battery automatically. Figure 3-3 Installation of the Battery To remove a battery: 1. Turn off and unplug the Acclarix AX8 system. 2.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started 2. Take out the UPS battery from the package. 3. Put the UPS battery gently to the UPS battery compartment. Figure 3-5 Installation of the UPS Battery 3.4 Connecting and Disconnecting a Transducer To connect a transducer: Figure 3-6 Tansducer Locking Handle 1. Align the connector with the transducer port and carefully push into place. 2. Toggle the locking handle to the bottom position. 3.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started To disconnect a transducer: 1. Toggle the locking handle to the top position to unlock the connection of the Transducer. 2. Firmly grasp the transducer connector and carefully remove it from the system port. 3. Store transducer in its protective carrying case prior to transport. Figure 3-8 Unlock the Tansducer Locking Handle CAUTION 1. Do not touch the pins of the transducer connector. 2.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started 3.5 Powering on/ off Please review and follow the steps described in the Section 12.1.Daily Checklist prior to powering on the device. 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 control panel. To Login If Password Protection is enabled (see section 9.1.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started Close the cover of the system without powering-off the system. No user input for a configurable amount of time. Please see System Set-up to configure this time. Pressing the Sleep button on the confirmation dialog box when powering off. Figure 3-10 Confirmation Dialog Box When Power off 3.
Acclarix AX8 Diagnostic Ultrasound System User Manual The currently active preset MI, TI, current date and time. Getting Started ②Image Field: The ultrasound image appears in the Image Field, under the Information field. The image field also contains information typically associated with the image, such as scales, TGC, and maps. The system supports two different image sizes within the image field. See 9.1.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started : Outline in grey color: Successful connection with a Server. Outline in green color: Data exchange with a Server. Outline in red color: Failure to connect with a configured Server. Hard drive icon. : Hard drive available : Hard drive data exchange, symbol in green. : Hard drive 95% full, symbol in red. : Hard drive 95% full with data exchange, symbol in red.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started cause undesired operation. NOTE: 1. 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.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started 2. Preset Allows you to change the Preset being used. See section 8 for details. 3. End Exam Completes an exam without invoking the Patient Information Screen for the next exam. See section 4.2 4. Utilities Press this button to get the Set Up, Maintenance, Connectivity and Screen Adjust keys on the touch screen. 5. Alt Store One of three keys that can be configured to store images or clips, or to set video printers.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started 13. Update In Strip Doppler this switches between acquiring the Doppler strip and the reference image. See section 5.2.3 for details. 14. Cursor Press to hide or display the cursor 15. Measure Invokes the Measure function for Generic and Application Measurements. See section 7.3 for details. 16. Freeze/Cine Press this key to switch between the frozen and real-time states. 17.
Acclarix AX8 Diagnostic Ultrasound System User Manual 25. B Getting Started Press to return to B-mode imaging from any display or imaging mode. See section 5.1 for details. Table 3-4 Buttons on Control Panel 3.8 Touch Screen The Touch Screen contains controls that vary depending on the active function. There are several types of controls used by the touch screen, as illustrated below: Figure 3-13 Touch screen of the System A. Tabs: Each function that is active has a tab on the touch screen.
Acclarix AX8 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. Creating Folders: Dragging one control on top of another control will create a folder that contains both controls.
Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started generally equivalent to a double click on a mouse. For example: o In Measure it is used to enter a measurement into a report. The examples provided above are a subset of how the trackpad is used. Additional examples are provided in specific feature descriptions elsewhere in this manual.
Acclarix AX8 Diagnostic Ultrasound System User Manual Exam Operation 4 Exam Operation 4.1 How to Start an Exam To start a new exam, press the Patient key and enter in patient information for the exam, or select a scheduled patient from the modality worklist. If there is no previous exam this will bring you directly to the Patient Information Page (see figure 4-2 below).
Acclarix AX8 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 4-2 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 a date of birth is entered the age is automatically calculated.
Acclarix AX8 Diagnostic Ultrasound System User Manual Exam Operation exam and testis exam; is default for others exam. LMP: Last Menstrual Period (yyyy/mm/dd), If LMP is entered then GA and EDD are calculated. Entering EDD does not impact LMP. An LMP more than 300 days ago is considered invalid. GA: Gestational Age (xxWyD), it is auto-calculated when LMP or EDD is entered (only in OB Exam). A GA of more than 42W6D is considered invalid and not displayed.
Acclarix AX8 Diagnostic Ultrasound System User Manual Exam Operation Figure 4-3 Patient Information Touch Screen Press Start Exam to exit the Patient Page function and return to B-mode imaging with the newly entered demographic data entered for the active exam. Press Cancel to exit the Patient Information Page without storing any of the entered data. Press Clear All to clear all of the demographic fields except for name and ID.
Acclarix AX8 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 showing patient name and patient ID. Clicking on the header of each column will sort the list by the corresponding column. The worklist shows all scheduled ultrasound exams within the date-range specified in the Connectivity Utility (See 9.2.2).
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging 5 Imaging The imaging modes are entered and exited via dedicated hard keys along the right side of the console. Key Description The B-mode key behaves differently than the other mode keys. B-mode imaging is the baseline state of the system. Therefore, the B key returns to B-mode imaging at any time from any display on the system. See section 5.1 for B-mode controls. Invokes and exits strip Doppler mode.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging eSRI eSRI is Speckle Reduction Imaging. There are 4 levels: Off, Low, Med. and High. High level provides more aggressive speckle reduction. Persistence Persistence averages frames together in order to reduce random noise. There are 4 options: Low, Med., High and Off. The persistence level corresponds to the number of frames averaged. The frame rate is unchanged; as each new frame is acquired it is averaged with the preceding frames.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Up/Down The Up/Down invert control is indicated by an upside-down R. It toggles the up/down orientation of the image. The TGC also swaps so the top of the TGC corresponds to the top of the image on the screen. FOV The Field of View control adjusts the image width. Full, Large, Med. and Small are available. As the image becomes narrower the frame rate increases. Steer This control is only available for linear transducers.
Acclarix AX8 Diagnostic Ultrasound System User Manual Acoustic power* Imaging Adjusts the acoustic output power of the activated transducer. It is only available in live imaging. Higher acoustic power numbers correspond to more brightness and contrast in the image and more force of penetration, but the ALARA principle should be followed in actual situations. Table 5-2 B-mode Touch Screen Controls 5.1.2. Dual Imaging Dual Imaging displays images side by side on the screen.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Panorama is available in live B-mode imaging. To acquire a panoramic image: Press the Panorama button on the B-mode touch screen. Press the Set button on the trackpad to start acquisition. Slide the transducer along the long axis The B-mode image will extend to incorporate the newly imaged anatomy. When the full anatomy has been acquired, press the Enter button on the trackpad or press the Freeze hard key.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging 5.2 PW-mode 5.2.1. PW Touch Screen Controls The following touch screen controls impact the PW image. Touch screen controls can be located where you want them to be. See section 3.8 for details. Name Control Description Scale Scale adjusts the range of velocities that are displayed. Upward presses increase scale and downward presses decrease it.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging SV Size/Gate Size Gate adjusts the size of the sample volume gate. Upward presses increase the gate size. Downward presses decrease the gate size. Sweep Speed Sweep adjusts the sweep speed of the Doppler strip. Options of Slow, Low, Med., High and Fast are available. Upward presses increase sweep speed. Downward presses decrease sweep speed. Strip Size Format changes the relative size of the Doppler strip compared to the reference image.
Acclarix AX8 Diagnostic Ultrasound System User Manual Auto Trace Direction Acoustic power* Auto Optimization* Imaging Press to specify which side of the Doppler baseline to take measurements from. there are 3 options: Up: traces positive portion of waveform (above baseline). Down: traces negative portion of waveform (below baseline). Both: traces waveform on both sides of baseline. Adjusts the acoustic output power of the activated transducer. It is only available in live imaging.
Acclarix AX8 Diagnostic Ultrasound System User Manual Name Control Imaging Description Scale Scale adjusts the range of velocities that are displayed. Upward presses increase scale and downward presses decrease it. Baseline The Baseline control adjusts the Doppler baseline. Upward presses move the baseline up on the screen and downward presses move the baseline down. Image Type Strip Doppler supports image presets for Low Flow, Medium Flow, and High Flow.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Sweep Speed Sweep adjusts the sweep speed of the Doppler strip. Options of Slow, Low, Med., High and Fast are available. Upward presses increase sweep speed. Downward presses decrease sweep speed. Strip Size Format changes the relative size of the Doppler strip compared to the reference image. Full, Large, Med. and Small are available. Volume Volume adjusts the audio volume of the Doppler strip.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Wall Filter The Filter control removes excessive noise from movement of vessel walls. Options of Low, Med. and High are available. Map Adjusts the current map for the active color variation. Persist Persistence determines the number of frames that are averaged together for display. Levels of Off, Low, Med. and High are available. Smooth Filter The smoothness filter determines the spatial filtering that is applied to the Color image.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Dynamic Range The Dynamic Range, or log compression, adjusts how echo intensities are converted to brightness. A high dynamic range presents a flat image, while a low dynamic range present a large range of intensities. Only available in PDI/DPDI mode. Frame rate Adjusts the tradeoff between frame rate and spatial resolution. Higher settings provide more temporal resolution.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Dynamic Range The Dynamic Range, or log compression, adjusts how signal intensities are converted to brightness. A high dynamic range presents a flat spectrum, while a low dynamic range presents a large range of spectrum brightness. Focus Pos The focus position set in B-mode applies to M-mode as well. Upward presses move the focus shallower, regardless of the U/D invert status of the M-mode. Downward presses move the focus deeper.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging and 4D. NOTE: Measurement function is not available in 3D/4D. 5.6.1. Pre-3D The Pre-3D mode supports defining the 3D/4D acquisition location and settings. Figure 5-2 shows an example of the pre-3D image. The ROI (Region of Interest) indicates the portion of the image that will be used for 3D/4D. The position/size of the ROI can be adjusted using the trackpad and Set key.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging automatically. 3D/4D These two radio buttons determine if the acquisition will be 3D or 4D. Start Start an acquisition. If 3D was highlighted then a single volume is acquired. If 4D was highlighted then continuous acquisitions are started. Exit Exit 3D/4D Table 5-7 Pre-3D Touch Screen 5.6.2. 3D Volume Sweeping During the process of 3D volume sweeping, the images swept in ROI box are displayed in the image area.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Figure 5-4 3D Image Review There are two image modes: Volume imaging mode and multi-slice imaging mode. Figure 5-4 shows Volume Imaging Mode in quad screen with a Baby Face volume rendering. Quadrant A shows a slice through the data that mimics the original ultrasound image. Quadrant B is orthogonal to A, as if the transducer had been rotated 90 degrees.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging y-axis. Press to activate the function of adjusting VOI or clip VOI plane. Use the trackpad to adjust and press Set to switch between VOI and clip plane. Cut Function of cut. After activating this button, the 3D image is selected, press Set to locate the start point, use trackpad to trace and second press Set to locate the end point The region within these two points will be cut.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Rotation X Rotate the image by the X-axis of the activated window. Rotation Y Rotate the image by the Y-axis of the activated window. Rotation Z Rotate the image by the Z-axis of the activated window. New Volume End the 3D volume sweeping and return to the pre-3D interface Exit Exit 3D/4D MPR Review MPR (multi-planar reconstruction) review function.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging Figure 5-5 Multi-slice Imaging Mode In figure 5-5, the first image shows the basis slice, other images are orthogonal to the basis slice and parallel to each other. Lines on the basis slice indicate the locations of the parallel slices. If there are more slices than images then the un-displayed slices are shown with a dotted line. A number below each parallel slice shows the slice location in the basis slice, with 0 being the middle slice.
Acclarix AX8 Diagnostic Ultrasound System User Manual Distance Adjust the distance between slices. Next When there are more slices than can be displayed at once this control cycles through the subset of slices displayed. Tint Select multi-slice tint, options of Gold, Sepia, Blue, Ice and Clear are available. Smooth Adjust smoothness of A\B\C slices. Higher filter levels create a smoother image. Upward presses increase the filter. Downward presses decrease the filter.
Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging 5.6.5. 4D Live Volume 4D Live volume continuously sweeps and displays successive 3D volumes. During live 4D imaging the following controls are available: activate any window of A/B/C/3D, Single/Dual/Quad，VOI, Threshold, Bright, Contrast, 3D Smooth/ MPR Smooth, 3D Tint/ MPR Tint, Rotation, Rotation X, Rotation Y, Rotation Z , Zoom and Gain in B mode.
Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer 6 Transducers 6.1 Transducer Model No.
Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer 6.2 Name and Function of Each Part of the Transducer Figure 6-1 shows an example of a transducer. Transducer head Transducer cable Transducer connector Figure 6-1 Typical transducer Name Function Transducer head Converts electrical signals to sound waves, and then converts received echoes back to electrical signals. The tip of the transducer is the acoustic lens.
Acclarix AX8 Diagnostic Ultrasound System User Manual Isopropanol (70%) OPA (0.55%) Transducer If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required for the disinfection step. WARNING 1. Unplug the transducer from the system prior to cleaning or disinfecting. 2. To avoid infection, always use protective gloves when performing cleaning and disinfecting procedures. 3.
Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer There are two methods to disinfect the transducer (use the immersion method for the E8-4Q and L17-7SQ): Non-immersion: 1. Disconnect the transducer from the system. 2. Prepare the disinfectant solution (75% ethanol or 70% isopropanol). 3. Spray the solution to the transducer interface or wipe it with a soft cloth dampened with the disinfectant solution. 4. Rinse the transducer according to the disinfectant instructions.
Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer 2. Prohibit infiltration of any type of liquid into the device or the transducer. 3. Do not sterilize the transducer using techniques such as autoclave, ultraviolet, gamma radiation, gas, steam, or heat. Severe damage May result. 4. Use only ultrasound coupling gel that complies with local regulations. 5. Do not immerse the AC adapter and connector of the transducer into solutions.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 7 Features 7.1 Comments The Comments function lets 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 Comments. The top portion of the screen shows comments that are pre-defined in pre-sets. See section 8 for details on how to configure these. The bottom portion of the screen shows controls available while the Comment function is active.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Adding comments using pre-defined comments 1. Invoke the Comment function 2. Move the cursor to the desired location and press the desired pre-defined comment. Some of the pre-defined comments may be grouped together with a border surrounding them (such as „Rt‟ and „Lt‟ in figure 7.1). These are special keys that let you quickly replace one term with another, regardless of where the cursor is within a block of text.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Figure 7-2 Body Mark Touch Screen Button Description Delete Delete the graphics on the image area Angle Rotates the transducer icon on the bodymarker graphic. Table 7-2 Body Mark Touch Screen Description Adding a body mark: 1. Invoke the Body Mark function The default bodymarker graphic appears on the main screen, with the transducer icon shown in the default position. 2.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 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 7-3 shows an example touch screen for Measure. There are two types of measurements: Generic Measurements: These are simple tools like Distance or Area. There is no specific anatomy associated with these measurements and they do not appear in a report.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Figure 7-4 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. To change the display position of result window: 1. Press Cursor hard key to invoke a cursor after a measurement is done. 2.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Figure 7-5 Moving the Measurement Result Window 7.3.1. Generic Measurements A default generic measurement is automatically started when Measure is invoked. Each imaging mode supports several types of measurements, as described below. You can switch between these types using the touch screen buttons along the bottom of the touch screen. Some generic measurements have options, for the method to perform the measurement.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Further presses of the Set key toggle which side of the caliper can be moved. Pressing the Enter key completes the caliper and allows you to create another tool. Circ/Area: Area and Circumference can be measured with an Ellipse or Trace To measure Area or Circumference with an Ellipse: 1. Invoke the measure function on a B-mode image. 2. If Area is not the default measurement, select Area from the touch screen.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 3. Press the Set key to place that caliper and add the second half of the first caliper pair. 4. Further presses of the Set key toggle which side of the caliper can be moved. Pressing the Enter key completes the first caliper pair and creates the second caliper pair. 5. Repeat step 3~5 to complete the second caliper pair and create the third caliper pair. 6.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 7.3.1.2. Strip Doppler Generic Measurements The Acclarix AX8 supports the following types of generic strip Doppler measurements: Caliper Trace Auto Trace HR (Heart Rate) RI (Resistive Index) Caliper: The Caliper measurement can provide a wide range of results. To use the Caliper measurement: 1. Invoke the Measure Function on a Doppler strip. 2. If Caliper is not the default measurement, select Caliper from the touch screen.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 5. Press the Set key to place the start point and start drawing the trace. 6. Moving the caliper now leaves behind a trail of dots to mark the trace outline. Press the Set key to adjust the positions of the PS or ED points in the trace. 7. Press the Enter key to complete the trace. 8.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features HR NOTE: Measure Auto trace can only be active in image frozen status. Live auto trace is available as a separate feature from the Doppler touch screen. HR：The HR measurement can provide the heart rate calculation by measured the time of the heart beat cycles. To use the HR measurement： 1. Invoke the Measure Function on a Doppler strip. 2. If HR is not the default measurement, select HR from the touch screen. 3.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 3. Press the Set key to place that caliper and add the second half of the caliper pair. Further presses of the Set key toggle which side of the caliper can be moved. Pressing the Enter key completes the caliper and allows you to create another tool 4. The Caliper measurement can display the following results: Distance Time Slope HR：The HR measurement can provide the heart rate calculation by measured the time of the heart beat cycles.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features multiple variations you will see buttons on the touch screen that let you pick which variation you are measuring. 7.3.2.1. Auto IMT (Note: Auto-IMT is not available in the USA and some other countries.) Intima-media thickness (IMT) is a measurement of the thickness of tunica intima and tunica media. The system provides an automatic measurement of the Carotid IMT. Figure 7-6 IMT Touch Screen To measure IMT: 1.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Figure 7-7 ROI Box of Auto IMT Figure 7-8 Measure Result of Auto IMT 7.3.2.2. Simpson’s (Method of Disks) Simpson is a tool in Cardiac presets used to determine LV diastolic and systolic volumes, and from that derive an ejection fraction. To use the Simpson measurement: 1. Invoke the B-mode Measure function. 2. Select LV Simpson measurement on the touch screen and then select one measurement label from A4C Dias., A4C Sys., A2C Dias.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 4. Draw the trace along the endocardium of left ventricular. 5. Press Set key to fix the end point B and complete the trace. A new caliper positions automatically at the apex (Point D) of the trace, connecting the Point C (Midpoint of point A and B). This distance between point C and D is the longest detected by the system, as shown below: 6. Move the caliper(Point D) to a new desired position if necessary. 7.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 7.4 Patient Information Management 7.4.1. Storing Images The control panel has three store keys: Store 1, Store 2, and Alt Store. Each store key can be separately configurable to support any of the following functions: Store a static image. Store a clip. Video print function For details about the configuration of store keys, please refer to Section 8. Storing an image: 1.
Acclarix AX8 Diagnostic Ultrasound System User Manual Button Figure 7-9 Review Screen Description Page Change the display one page at a time. Speed Change the playing speed of the highlighted clip; the speed range is 12.5%-100%, in increments of 12.5%.The default speed is 50%. L.Margin Change the left margin of a highlighted clip R.Margin Change the right margin of a highlighted clip Frame Scroll the paused clip frame by frame Play Plays/Stops the highlighted clip.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Select the export path from destination drop list menu and click OK to confirm. If there is only one removable media then this field is a read-only field. Static images export as .bmp files. Clip images export as .avi files. While export in progress the dialog is displayed as bellow. Cancel button is used to stop the export. The dialog disappears when export finishes.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features screen shot from the Patient Database screen. Figure 7-10 Patient Database 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. Fields can be displayed or hidden. Filter: The database filter field at the top-left of the screen provides a powerful tool to find the study of interest. It filters the list based on whatever text is typed in this field.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 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. A study can also be send to a DICOM server, saved to a USB device or DVD drive, or deleted. If the study has been copied to either a server or to a USB device or DVD drive a small disk icon appears next to it, indicating that it has been saved.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features screen, select the exam(s) from the list shown, and select the device from the list of currently configured destinations. 7.5 Needle Biopsy Guide NOTE: Use proper sterile technique at all times when performing a biopsy. Always follow these basic precautions: WARNING 1. Disinfect the needle guide kit before the first use and after each subsequent use. 2. Calibrate the needle guide kit (see section 7.5.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Screw 旋钮1 Knob 1 螺钉 矩形卡槽 Rectangular slot Cone 圆锥台 Knob 2 旋钮2 Figure 7-12 Structure of Needle Guide Bracket Kit Step 2: Select the correct size guide for the gauge of needle to be used, and secure it to the needle guide holder by tightening knob 1. If the needle guide holder is loose tighten the screw with an allen wrench. Loosen knob 2 all the way prior to installing the bracket on the transducer.
Acclarix AX8 Diagnostic Ultrasound System User Manual Figure 7-15 Attaching Bracket Kit to Probe Features Figure 7-16 Turning Knob 2 Clockwise Step 4: Insert the needle into the rectangular hole, as shown in Figure 7-17. Rectangular Hole 矩形孔 Figure 7-17 Inserting Needle into Rectangular Hole Installing needle guide bracket of endocavity probe: Step 1: Take the needle guide bracket kit out of the package.
Acclarix AX8 Diagnostic Ultrasound System User Manual Knob 1 Features Lock Fixing claws Figure 7-18 Structure of Needle Guide Bracket Kit Step 2: Attach the needle guide bracket kit to the transducer by placing the bracket over the head of the probe, ensure that the three fixing claws of the bracket catch in the notches at the probe tip, turn the lock clockwise as the arrow direction shown in Figure 7-21, and then turn knob 1 clockwise until it locks in place, as shown in Figure 7-22.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Figure 7-21 Turning the Knob 1 Clockwise Step 3: Insert the needle into the round hole, as shown in Figure 7-22. Round hole Figure 7-22 Insert the Needle into the Round Hole 7.5.2. Activating Needle Guide Function To enable the needle guide function: 1. 2. 3. 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.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features 7.5.3. To Adjust the Needle Guide Line The needle guide bracket was calibrated during manufacture. However, certain events may cause the bracket alignment to shift, and new calibration required. WARNING 1. Calibrate the needle guide under any of the following conditions: a) The first time a needle guide is used with a given transducer. b) Any time the needle guide or transducer has been dropped or struck against a hard surface.
Acclarix AX8 Diagnostic Ultrasound System User Manual Features Angle Line Figure 7-25 Needle Enhancement Visualization Needle Visualization is invoked by pressing the Needle button on B-mode touch screen, and then the Enable button in the Needle Visualization section of the Needle touch screen. The following parameters can be adjusted when it is active. Enable: Enables or disables Needle Visualization. L/R: press to display the angle line on left side or right side of the image field.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 8 Presets 8.1 Preset Organization The Acclarix AX8 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: The image parameters that optimize its transducer for an intended use. The list of data fields displayed on the patient demographic page.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 8.2 Selecting a Preset There are two ways to select a preset The Preset Function: The preset function is invoked by pressing the Preset button in the upper left corner of the console. See figure 8-2 for an example preset touch screen. The currently active transducer is shown at the top of the touch screen. Below it are all the presets associated with that transducer.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Press System to edit overall system settings unrelated to presets. See section 9 for details. Press Presets to do any of the following: o Edit the imaging parameters of an exam preset. o Configure the demographic fields that appear for that preset o Configure which Comment, Measure, or Bodymarker presets are associated with each exam preset. Press Comments to configure the pre-defined text of each comment preset.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 8.3.1.1. Editing Image Settings Figure 8-5 shows an example imaging set-up screen for imaging parameters. This example shows the screen for editing the B-mode settings for the C5-2XQ Abdomen exam preset. Figure 8-5: Example Set-up Screen for Imaging Parameters Transducer and Exam Preset: There are drop-downs at the top of the screen for selecting the transducer and Exam Preset you want to edit.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Figure 8-6 Example Patient Information Configuration Page To change the demographic fields shown with any preset: Select the preset you want to configure. This can either be done at the Preset Definition level before invoking the Patient Information Configuration page, or it can be done directly on this page. Click the check box on any field you want to display. 8.3.1.3.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 8.3.2. Comments Presets Figure 8-7 Comments Preset Adding a new Comment： 1. Move the cursor to a blank field in the comments area and press Set. 2. Enter a new comment through keyboard and press Enter to finish editing. Editing an Exist Comment in Comment Preset: 1. Move the cursor to a comment in the comments area and press Set. 2. Edit the selected comment through keyboard and press Enter to finish editing.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Suppress Comment on Unfreeze: If this option is enabled the Comment function goes away when the system is unfrozen, and comes back again with the next freeze. Manually exiting the function causes it to remain inactive until manually activated. Figure 8-8 Comment Setting 8.3.3.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Pre-defined graphics area Figure 8-10 Bodymarker Preset Deleting a Bodymarker from a Preset: If the selected bodymarker is from a user-defined which does not point to any exam preset, you can delete it with the Delete button. If the selected bodymarker is from a user-defined which points to an exam preset, or the selected bodymarker is from a default preset, the Delete button will be unavailable. 1.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Figure 8-11 Bodymaker Preset 8.3.4. Measure Presets The Preset UI of the Measure Presets set-up page is divided into the main screen display and the touchscreen display. The main screen display shows the current measure presets. The list of presets is shown along the left side, and the grid of buttons to the right show the current content of the selected preset.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Adding a new Measure Preset： A new measure preset can be added by copying an existing preset. The new measure preset contains the same measurements as the copied preset. Select a preset from the list along the left, and then press the Copy As button. Enabling/Disabling a measurement in a Preset Select the preset you want to configure from the list along the left side of the main screen.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Figure 8-14 Measurement Option 8.3.4.1. General Settings Figure 8-15 Measurement General Settings Report Logo The system supports a user-defined report header by importing a logo and setting the logo‟s position and size. Report logo settings are as follows: Import: import a bmp format logo from USB disk. Delete: delete the imported logo.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Logo Position: set the logo position to locating at the left or right side of report header. Logo Size: set the logo size to Small or Large. OB Settings The system supports the following OB measurement settings: Fetal Age: select the author / measurement options for Fetal age calculation. Fetal Growth: select the author / measurement options for Fetal Growth calculation.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 9 Utilities The Utilities hard key provides access to setup, screen adjust, connectivity and maintenance software. Each of these is described in separate sections below. 9.1 Set-up The Set-up function is divided into several sections, accessed by separate touch screen buttons System Set-up: Described in the remainder of this section. Presets: Supports edits of preset organization and image preset. See section 8.3.
Acclarix AX8 Diagnostic Ultrasound System User Manual Item Hospital System Setup Options Description Input freely Set hospital name displayed on the top left of the screen and diagnosis report Language Chinese, English, German, French, Italian, Spanish, Russian, Turkish Set the system language（new language is effective after reboot the system） Keyboard U.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 9.1.2. Patient Set-up Figure 9-2 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 Title of custom field 1/2 / You can define two additional fields for data entry on the Patient Information screen 0/12h/24h/48h/72h You can define the time limit for restarting exam. Only exams within the time limit can be restart.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 9.1.3. Store/Print Set-up Figure 9-3 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 SONY-UP-D25MD, SONY-UP-D898MD_X898MD Connect the corresponding printer to print the current image.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 9.1.4. Miscellaneous Set-up Figure 9-4 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 Gain √/× Optimize Gain or not when press auto button in PW mode. DR √/× Optimize Dynamic Range or not when press auto button in PW mode.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 9.1.5. User Set-up Figure 9-5 User Set-up Screen Item Enable Password Protection User List Options Description Show or hide the login dialog when booting up the system. √/× √/× Show all users displaying user name and user type. Click the dialog before the user to select this user for edit operation. Table 9-5 User Set-up Information User type includes Administrator and Operator.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 9.2 Connectivity The Connectivity screens support configuration of network access and services. into 3 tabs: TCP/IP: Configures access to the network from the AX8. DICOM: Configures network DICOM services. Network Store: Configures non-DICOM storage to a network via FTP. It is divided 9.2.1. TCP/IP This screen configures access to a network. Access can be either wired or wireless*.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 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. Networks that have been previously accessed will show up with a checkmark (“√”). If there is currently an active network it will show up with an asterisk („*‟). If the network requires a password it shows up with a lock icon.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Figure 9-7 DICOM Settings 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, Transfer Syntax: These determine how the DICOM messages are configured. The AX8 default settings are common, and you will typically not have to change them.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Default: A check mark on the left side indicates which server is the default for Auto-Transfer. Name: The name of the server that appears in the drop-down list of the patient database AE Title, IP Address, Port, Max PDU: These are the settings of the destination DICOM server; it‟s how the AX8 finds the DICOM server on your network.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 9.2.3. Network Store This screen configures the system to connect to an FTP server on the local network. This allows the system to store .avi and .bmp files to a local server without using DICOM. To use this, a PC or server needs to be configured as an FTP server on the local network. The mechanism to do this depends on the operating system used. Please contact your local IT support for assistance.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup Edit: Available when an FTP Server has been selected. This invokes a dialog that edits the IP address, name, directory, and password. Delete: Available when an FTP Server has been selected. This deletes the selected server. 9.3 Maintenance The Maintenance screens provide access to controls that are not typically needed during normal operation of the system. 9.3.1.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup upgrade will include instructions regarding use of these buttons. 9.3.3. Demo A Demo exam is a special exam with a patient name of “Demo”. of images from multiple exams. To create a Demo exam: It allows you to collect any set 1. Export the images you want as DICOM format from the system to a USB external storage device. (See section 7.4.3) 2.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 1. Press Utilities hard key, select Maintenance Export/ImportExport. 2. Select an external USB storage device. 3. Check the items to be exported: Image Presets, Comment Presets, Body Mark Presets, User Settings, System Log, Findings. The Preset items can be expanded to select a specific preset. Each type of preset can be expanded using the arrow graphics on the left side.
Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup 3. Check the items to be imported: Image Presets, Comment Presets, Body Mark Presets, User Settings, Findings. The Preset items can be expanded to select a specific preset. 4. Press Import button to begin the import process. Note: Import of System Logs is not supported. Figure 9-12 System Import Screen 9.4 Screen Adjust The brightness and contrast of the monitor and touch screen in the system can be customized.
Acclarix AX8 Diagnostic Ultrasound System User Manual Figure 9-13 Screen Adjust Screen - 112 - System Setup
Acclarix AX8 Diagnostic Ultrasound System User Manual In Between Exams 10 In Between Exams 10.1 Unpacking Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage. 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. Then, install the device according to the installation requirements and methods. WARNING 1.
Acclarix AX8 Diagnostic Ultrasound System User Manual Order List 11 Order List The following accessories are recommended for use on the Acclarix AX8. 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.
Acclarix AX8 Diagnostic Ultrasound System User Manual Order List USB Disk 11.18.052245 Trolley MT-807 83.63.560199 Footswitch(single button) 01.10.000910 Fottswitch(doule button) 01.10.027323 Suitcase 01.56.466102 Multi-Transducer Connector(MTC) 83.63.560232 NOTE: The part name may vary depending on context, but the part number is constant.
Acclarix AX8 Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance 12 Troubleshooting and Maintenance In order to ensure proper system operation and function, a maintenance and inspection plan should be established to periodically check the safety of the system. If any system malfunction is experienced, contact EDAN or authorized representatives. 12.
Acclarix AX8 Diagnostic Ultrasound System User Manual 2 Strip-shape or snowflake-shape disturbance occurs on the display screen. 3 Image is not displayed clearly on the screen. 4 Image window is dark. 5 The button is no response Troubleshooting and Maintenance 1. Inspect the power supply. 2. Check whether it is disturbed by the ignition action of any other device. 3. Check the disturbance of electric or magnetic field in the surrounding environment. 4.
Acclarix AX8 Diagnostic Ultrasound System User Manual Troubleshooting and Maintenance WARNING The console (including touch screen, track pad and hard keys) of system is splash resistant (IPX 1) but not waterproof. Do not immerse or expose to extended moisture. Splash resistance does not extend to transducer connectors. Keep connectors dry. For cleaning agents and disinfectants, refer to section 6.3 Transducer Cleaning and Disinfection 12.4.1.Cleaning the System Surface To clean the system surface: 1.
Acclarix AX8 Diagnostic Ultrasound System User Manual Specifications 13 Specifications 13.
Acclarix AX8 Diagnostic Ultrasound System User Manual Specifications 13.3 Machine Specifications Main unit dimensions 38.8cm(W)x 40.7cm（D）x 7.7cm（H） Net weight 9.25kg including transducer) battery (not including power adaptor or 13.4 Display Specifications Display TFT-LCD Diagonal Size 15.6 inches View Angle Right 80, Left 80, Up 80, Down 80 (min) Pixel Number 1920x1080 White Luminance 300 cd/m2(typ) Contrast Ratio 700 (typ) 13.
Acclarix AX8 Diagnostic Ultrasound System User Manual Specifications Image Conversion Up/Down flip, Left/Right flip Language Display Chinese, English, German, French, Italian, Spanish, Russian, Turkish Focus Number Max.
Acclarix AX8 Diagnostic Ultrasound System User Manual EMC Information 14 EMC Information Electromagnetic emissions Electromagnetic emission The Acclarix AX8 is intended for use in the electromagnetic environment specified below; The customer or the user of the Acclarix AX8 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment-guidance RF emissions Group 1 The Acclarix AX8 uses RF energy only for its internal function.
Acclarix AX8 Diagnostic Ultrasound System User Manual EMC Information Electromagnetic immunity Electromagnetic immunity The Acclarix AX8 is intended for use in the electromagnetic environment specified below. The customer or the user of Acclarix AX8 should assure that it is used in such an environment.
Acclarix AX8 Diagnostic Ultrasound System User Manual EMC Information Electromagnetic immunity Electromagnetic immunity The Acclarix AX8 is intended for use in the electromagnetic environment specified below. The customer or the user of the Acclarix AX8 should assure that it is used in such an environment.
Acclarix AX8 Diagnostic Ultrasound System User Manual EMC Information Recommended separation distances between portable and mobile RF communication equipment and the EQUIPMENT or SYSTEM Recommended separation distances between portable and mobile RF communications equipment and the Acclarix AX8 The Acclarix AX8 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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