EDAN Acclarix AX15 User Manual Download Page 4

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III

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.................................................................................................................... 48

6.3 Transducer Cleaning and Disinfecting ...................................................................................... 51

6.3.1. Cleaning ........................................................................................................................... 51

6.3.2. Disinfecting ....................................................................................................................... 51

6.4 Needle Biopsy Guide ................................................................................................................ 54

6.4.1. Installing Needle Guide Bracket ....................................................................................... 54

6.4.2. Activating Needle Guide Function .................................................................................... 58

6.4.3. Calibrating the Needle Guide Line .................................................................................... 59

6.5 Needle Visualization ................................................................................................................. 60

6.6 Center Line ............................................................................................................................... 61

6.7 Needle Guide Bracket Cleaning and Sterilization ..................................................................... 61

Features ...................................................................................................................................... 62

7.1 Comment .................................................................................................................................. 62

7.2 Body Mark ................................................................................................................................ 64

7.3 Dual Image Display .................................................................................................................. 65

7.4 Zoom ........................................................................................................................................ 65

7.5 Cine Review ............................................................................................................................. 66

Measurements and Reports ...................................................................................................... 67

8.1 Generic Measurements ............................................................................................................ 68

8.1.1. B-mode Generic Measurements ....................................................................................... 68

8.1.2. Strip Doppler Generic Measurements .............................................................................. 71

8.1.3. M-mode Generic Measurements ...................................................................................... 75

8.2 Application Measurements ....................................................................................................... 76

8.2.1. Abdomen Measurements.................................................................................................. 77

8.2.2. Gynecology Measurements .............................................................................................. 78

8.2.3. Obstetrics Measurements................................................................................................. 79

8.2.4. Cardiac Measurements .................................................................................................... 81

8.2.5. Small Parts Measurements .............................................................................................. 84

8.2.6. Urology Measurements .................................................................................................... 84

8.2.7. Vascular Measurements ................................................................................................... 85

8.3 Worksheet and Report .............................................................................................................. 88

8.3.1. Worksheet ........................................................................................................................ 88

Summary of Contents for Acclarix AX15

Page 1: ...1 ...

Page 2: ...n this manual prior to using the system Disregarding instructions particularly warnings and cautions is considered abnormal use 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 yo...

Page 3: ... 3 System Preparation 23 3 3 1 Battery Use 23 3 3 2 AC Power Use 24 3 3 3 Transducer Connection 25 3 3 4 Powering on off 27 4 Exam Operation 28 4 1 How to Start an Exam 28 4 2 How to End an Exam 29 4 3 How to Restart an Exam 29 4 4 The Patient Information Page 29 4 5 Modality Worklist 32 5 Imaging 33 5 1 B mode 33 5 1 1 Using B mode 33 5 1 2 B mode Image Optimization 33 5 2 Color Mode 36 5 2 1 Col...

Page 4: ...sualization 60 6 6 Center Line 61 6 7 Needle Guide Bracket Cleaning and Sterilization 61 7 Features 62 7 1 Comment 62 7 2 Body Mark 64 7 3 Dual Image Display 65 7 4 Zoom 65 7 5 Cine Review 66 8 Measurements and Reports 67 8 1 Generic Measurements 68 8 1 1 B mode Generic Measurements 68 8 1 2 Strip Doppler Generic Measurements 71 8 1 3 M mode Generic Measurements 75 8 2 Application Measurements 76 ...

Page 5: ...4 10 3 3 Comment Preset 105 10 3 4 Body Mark Preset 106 10 3 5 Measure Preset 107 11 Utilities 109 11 1 System Set up 109 11 1 1 General Set up 109 11 1 2 Patient Set up 111 11 1 3 Store Print Set up 112 11 1 4 Report Set up 113 11 1 5 Image Set up 114 11 2 Connectivity 115 11 2 1 TCP IP 115 11 2 2 DICOM 116 11 3 Maintenance 118 11 3 1 License 118 11 3 2 Version 119 11 3 3 Demo 119 11 3 4 Tool 120...

Page 6: ...rence 130 Appendix B Ultrasound Intensity and Safety 131 B 1 Ultrasound in Medicine 131 B 2 Ultrasound Safety and the ALARA Principle 131 B 3 Explanation of MI TI 132 B 3 1 MI Mechanical Index 132 B 3 2 TI Thermal Index 132 B 3 3 Display of MI TI 133 B 4 Acoustic Output 133 B 4 1 Factors that Contribute to Uncertainty in the Output Display 133 B 4 2 Differences between Actual and Displayed MI TI 1...

Page 7: ...consists of a main system and associated ultrasound transducers The system circuitry generates an electronic voltage pulse which is transmitted to the transducer In the transducer a piezoelectric array converts the electronic pulse into an ultrasonic pressure wave When coupled to the body the pressure wave transmits through body tissues The waves are then reflected within the body and detected by ...

Page 8: ...s Please keep connectors dry Do not use in a wet environment or when the relative humidity exceeds 95 Do not reverse the positive and negative poles when installing the battery Do not use the battery near heat sources or when the ambient temperature is over 40o C Do not heat or dispose of in fire Do not destroy the battery do not pierce or cause a strong impact to the battery Do not touch the conn...

Page 9: ...a qualified technician who has adequate training knowledge and experience That person should be familiar with the Service Manual available from your Edan representative Keep non medical equipment out of the vicinity of the patient 1 5m 6ft Use of an extension cord or multi socket outlet setup to provide power to the ultrasound system or to the system s peripheral devices may compromise the system ...

Page 10: ...not dispose of them together with household garbage At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries Inappropriate disposal of waste may contaminate the environment Inspect the system regularly at least weekly Before use ensure there is no visible evidence of damage to the equipment cables and transducers If a component is da...

Page 11: ...he 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 The packaging is to be disposed of according to local or hospital s regulations otherwise it may cause environmental contamination Place the packaging at a location that is inaccessible to child...

Page 12: ...articular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an out...

Page 13: ...ine Black 7 Refer to User Manual Background Blue Symbol White 8 Caution 9 Biological Risks 10 CE Marking 11 Authorized Representative in the European Community 12 Disposal method Indicates that the equipment should be sent to special agencies according to local regulations for separate collection after its useful life 13 General Symbol for Recovery Recyclable 14 Caution Federal U S law restricts t...

Page 14: ...served 19 Transducer lock 20 Transducer unlock 21 Network port 22 Trademark 23 Direct current 24 S Video Output port 25 USB 2 0 port 26 USB 3 0 port 27 HDMI HDMI port 28 AC Power Indicator 29 System Working Indicator 30 Battery Indicator 31 Non ionizing electromagnetic radiation 32 FCC ID SMQAX3EDAN Federal Communications Commission FCC ID SMQAX3EDAN ...

Page 15: ...9 The following labels are used on the packaging No Symbol Definition 1 This way up 2 Fragile 3 Keep away from rain 4 General Symbol for Recovery Recyclable 5 Stacking limit by number 6 Do not step on 7 Handle with care NOTE The user manual is printed in black and white ...

Page 16: ...llowing options are also available Transducers C5 2Q L12 5Q E8 4Q P5 1Q L17 7Q Needle Guide Bracket Kit Model Angle Depth Description BGK C5 2 20 28 40 For use with the C5 2Q Supports 14G 23G BGK L40UB 34 43 53 66 For use with the L17 7Q Supports 14G 23G BGK 001 1 0cm 1 5cm 2 0cm For use with the L17 7Q Supports 21G BGK 002 38 46 58 For use with the L12 5Q Supports 14G 23G BGK 003 1 0cm 1 5cm 2 0c...

Page 17: ...or USB HP Deskjet Ink Advantage 2010 USB HP Deskjet 1010 USB HP Deskjet 1510 USB HP LaserJet 400 M401d USB HP DeskJet Ink Advantage Ultra 2029 USB HP DeskJet 1112 USB Canon E518 USB Canon iP2780 USB HP LaserJet Pro MFP M126nw USB EPSON L310 USB HP DeskJet 1050 USB HP DeskJet 2050 USB HP LaserJet M252n USB EPSON L130 USB Table 3 2 Printer List WARNING Only the recommended printers listed above are ...

Page 18: ...Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started 12 3 2 System Overview 3 2 1 Main Unit Figure 3 1 Main Unit 1 2 3 4 5 6 7 6 7 8 11 9 10 ...

Page 19: ... illuminates in green when the system operates on battery power or the battery is charging 6 Transducer Locking Lever Use to lock or unlock the transducer 7 Transducer Port Used for connecting a transducer to the system 8 Handle Used for carrying the system 9 Safety Lock Connector Used for connecting a safety lock to the system 10 Vents Used for heat dissipation and ventilation 11 I O Ports Use to...

Page 20: ...Network port 3 S Video output port 4 HDMI port 5 USB 3 0 port 6 USB 2 0 port 7 USB 2 0 port Table 3 4 I O Ports Caution 1 The HDMI port does not support hot plug feature Please connect the external display to the HDMI port before starting the ultrasound system Otherwise the external display may be unrecognized or display abnormally 1 2 3 4 5 6 7 ...

Page 21: ...power on off the system 2 Patient Invokes the Patient Information Screen typically used to start end exams or to modify patient information during an exam See section 4 1 3 Transducer Press to switch transducers or exam presets 4 Review Press to enter exam database or image review mode See section 9 for details 5 Print Press to print images via the connected video printer ...

Page 22: ...ection 5 2 for details 14 M Press to enter or exit M Mode See section 5 5 for details Use the trackball to adjust the M sample line 15 PW Press to get the sample line Use the trackball to adjust the position of the sample line Press it again to display the Doppler strip See section 5 3 for details 16 CW Press to get the sample line Use the trackball to adjust the position of the sample line Press ...

Page 23: ...ckball keys provide a wide variety of functions depending on the system state e g selects a start or end point of a measurement selects menu items on the screen etc For the convenience of introduction we call them Set throughout this user manual 27 Zoom Angle The functions of this knob vary with system functions When one function is activated its indicator illuminates Then rotate to zoom an image ...

Page 24: ...s your hospital institution name Please see Section 11 1 1 General Set up for information on customization The second line of this field contains the patient name gender age and ID as entered through the Patient Information screen This field also contains data fields for The currently active transducer The currently active preset System date and time Image Field The ultrasound image appears in the...

Page 25: ... removable storage devices 4 Page Up Turns the page up when more than one page of images are displayed 5 Page Down Turns the page down when more than one page of images are displayed Soft Keys Field The soft keys filed is displayed below image field and above status bar This field displays The illustration of trackball and trackball keys Cine bar when the system is frozen An Exit icon Only display...

Page 26: ...ing on this button shows a list of available Wi Fi networks Selecting an available network displays a dialog box for entering password 6 Network Transfer Status icon The network transfer status icon shows the transfer statuses of the DICOM network Outline in grey color At least one DICOM network is configured for file transfer Outline in green color Data exchange with a DICOM Server Outline in red...

Page 27: ...re 3 5 Touch screen of the System A Tabs Each imaging mode that is active has a tab at the top of the touch screen Usually the imaging mode that was most recently activated is the top tab and has priority Pressing on any other tab will bring it to the top and provide access to the controls available for that imaging mode B Paddle Pressing on the top or bottom of a paddle changes the control settin...

Page 28: ... your finger horizontally across the dots These dots do not appear when there is only one page in the current tab 3 2 5 Trackball The trackball operation is easy and convenient It can achieve the following functions Move the measurement cursor during measurement Move the comment cursor in the comment status Move the M Mark in the B M mode Move the scan area of Color mode increase or decrease the s...

Page 29: ...mpartment A is displayed with letter A on it and the battery icon of the battery which is installed in battery compartment B is displayed with letter B on it CAUTION 1 If the system will remain unused for more than one week charge the battery to at least 75 capacity take the battery out and store the system and battery separately 2 During long term storage the battery should be charged at least on...

Page 30: ...three screws WARNING 1 When the battery capacity is 20 the battery status icon turns red 2 When the battery capacity is 10 the system displays a prompt Low Battery The system will shutdown in 3 mins Please plug in the power supply immediately 3 3 2 AC Power Use When using AC power position the system so that it is easy to disconnect it from AC power supply To connect AC power 1 Connect the AC powe...

Page 31: ...0Hz 2 Only use a hospital grade grounded power outlet and plug Do not use with an ungrounded outlet 3 Only use Edan supplied power adapter and power cord 3 3 3 Transducer Connection To connect a transducer Figure 3 8 Tansducer Locking Handle 1 Align the connector with the transducer port and carefully push into place 2 Toggle the locking handle to the top position 3 Do not allow the transducer hea...

Page 32: ...e transducer connector 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 CAUTION 1 Do not touch the pins of the transducer connector 2 Broken or bent connector pins can cause image artifacts Do not use a transducer with broken or bent pins 3 Only disconnect a transducer when the system is shutd...

Page 33: ...will shut down the system directly NOTE 1 Turn off and unplug the device after use 2 Please unplug the AC adapter from the power socket and disconnect the battery prior to storage Sleep mode The system will enter a sleep mode that maintains exam information while using minimal power There are three events that can invoke sleep mode Close the cover of the system without powering off the system No u...

Page 34: ...lect this to start a new exam If Same Patient is checked selecting New Exam will end the previous exam and create a new exam for the same patient The main screen will display the Patient Information Page with the previously entered patient information except for the exam accession number Changing the patient information for one exam will not impact the others If Same Patient is unchecked selecting...

Page 35: ...ialog to confirm you want to end the exam but does not invoke the Patient Information Page for the next exam 4 3 How to Restart an Exam 1 Select an exam from the Exam Database within the time limit selected in Patient Set up menu For the setting of time limit refer to section 11 1 2 Patient Set up 2 Press Restart on the touch screen to continue edit the exam that was performed on the selected pati...

Page 36: ...l the possible patient information fields you may need to fill in are listed below Gender Select the patient s gender M Male F Female O Other or blank LMP Last Menstrual Period yyyy mm dd or mm dd yyyy 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 autocalculated when LMP or EDD is...

Page 37: ...Ref Physician Dx Physician Enter the name of the Dx Physician Operator Enter the name of the person performing the exam CPT code Current Procedural Terminology code Comment Enter any additional comments While the Patient Information Page is displayed the following buttons are displayed on the touch screen and Patient Information Page Figure 4 4 Patient Information Touch Screen Press OK to exit the...

Page 38: ...ed patient name and patient ID Clicking on the header of each column will sort the list for the corresponding column The worklist shows all scheduled ultrasound exams within the date range specified in the DICOM connectivity setup screen See 11 2 2 Typing any text in the Filter field will filter the list to exams that contain the entered text Update Press to query the patient data and update the l...

Page 39: ...amic Range or log compression adjusts how echo intensities are converted to brightness A high dynamic range will display more shades of gray while a low dynamic range will display fewer shades of gray and a more contrasty image 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...

Page 40: ...ocus shallower regardless of the U D invert status of the image Gray Map Gray Map adjusts the postprocessing map used on the B mode image In general higher map numbers correspond to more contrast in the image Colorize The Colorize control adds a color tint to the B mode image Tint The Tint control changes the color tint being used There are 20 tint maps available If Colorize had been off changing ...

Page 41: ... a part of the B mode function and available in live imaging Image Type B mode supports presets for Detail General and Penetration See section 10 3 2 for more information Line Density Adjusts the line density to optimize the lateral resolution for the best possible image The higher the line density the higher the lateral resolution but the lower the frame rate Needle Press to invoke the touch scre...

Page 42: ...gative flow 5 2 2 Using Color Mode 1 Perform the image scanning to get a good image in B mode 2 Press Color to enter B Color mode and display ROI box 3 Adjust the size and position of ROI box Presses on Set switch between the status of adjusting the size and position of ROI box Use trackball to adjust 4 Press PDI DPDI or Color mode key on the touch screen to switch Color Doppler modes when necessa...

Page 43: ...ill suppress more strong single of the vessel walls but low flow signal will be missing 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 Higher filter...

Page 44: ...he live B image without color and the same live B image with color are simultaneously displayed on each side of the image field Freezing the image will freeze both sides simultaneously Cine review will review both sides simultaneously Dynamic Range The Dynamic Range or log compression adjusts how echo intensities are converted to brightness A high dynamic range presents a flatter less contrasty co...

Page 45: ...arameters to optimize the Doppler strip 6 When spectrum is displayed pressing Update toggles between acquiring the Doppler strip and acquiring the reference image 5 3 2 PW Image Optimization The following touch controls can be used to optimize the PW image Name Control Description Scale Scale adjusts the range of velocities that are displayed Upward presses increase scale and downward presses decr...

Page 46: ...ic Range or log compression adjusts how signal intensities are converted to brightness A high dynamic range will display more shades of gray while a low dynamic range will display fewer shades of gray and a more contrasty Doppler display 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 ...

Page 47: ...orts image presets for Low Flow Medium Flow and High Flow Steer This control is only available for linear transducers and steers the Doppler cursor angle left or right Frequency This determines the Doppler transmit frequency used for imaging Auto Trace Press to activate the Auto Trace function on a real time or frozen PW Doppler strip The Auto Trace function automatically traces the spectral Doppl...

Page 48: ... decrease the scale or move the primary PW gate to a shallower location until only one gate is displayed 5 4 CW Mode 5 4 1 Using CW Mode CW mode is only available on phased array transducer 1 Perform the image scanning to get a good image in B mode or B Color DPI DPDI mode 2 Press CW on the console to display sample line 3 Use the trackball and touch controls to adjust the position of the sample l...

Page 49: ...ype Strip Doppler supports image presets for Low Flow Medium Flow and High Flow Invert Normally signals above the baseline are positive velocities moving toward the transducer However when Invert is pressed then negative velocities are above the baseline Invert does not affect the baseline position Quick Angle Adjusts the angle correct quickly to one of 60 0 60 Filter The Filter control removes ex...

Page 50: ...are available Upward presses increase sweep speed Downward presses decrease sweep speed Strip Size 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 This can be adjusted in pre Doppler to set the initial volume upon invoking Doppler acquisition Acoustic Power Adjusts the ...

Page 51: ...ap Tint Adjusts the current postprocessing either grayscale or tinted Dynamic Range The Dynamic Range or log compression adjusts how echo intensities are converted to brightness A high dynamic range will display more shades of gray while a low dynamic range will display fewer shades of gray and a more contrasty M mode display Focus Pos The focus position set in B mode applies to M mode as well Upw...

Page 52: ...etermines how many M mode lines are averaged together for the display similar to persistence in B Mode Off Low Med and High settings are available Frequency Frequency determines the transmit frequency used by M Mode Upward presses increase the frequency Downward presses decrease the frequency Acoustic power Adjusts the acoustic output power of the activated transducer It is only available in live ...

Page 53: ...cs Urology Gynecology Musculoskeletal Surface 2 E8 4Q Micro Convex Fetal Obstetrics Gyncecology Trans vaginal Trans rectal Urology Endocavity 3 L12 5Q Linear Small parts Peripheral Vascular Musculoskeletal Surface 4 P5 1Q Phased Array Adult Cardiac Abdomen Pediatric Cardiac Adult Cephalic Surface 5 L17 7Q Linear Small Parts Peripheral Vascular Musculoskeletal Surface Table 6 1 Transducer Model App...

Page 54: ...ns 2 Center line mark Indicates the center line position of the transducer which are usually used for out of plane needle guide 3 Transducer model Displays the transducer model 4 Needle guided bracket fixing tabs and groves Provides mounting support for the needle guided bracket 5 Transducer orientation mark The side of orientation mark on the transducer corresponds to the side of orientation mark...

Page 55: ...g or disconnecting the transducer Do not drop the transducer onto the floor or collide with hard objects Otherwise it will be damaged easily Do not heat the transducer Do not pull or bend the transducer cable Coupling gel can only be used on the head of the transducer and it should be wiped off after use Clean and disinfect the transducer after every use The acoustical window and the shell of the ...

Page 56: ...h before using the transducer 6 Use of protective sheath with natural rubber latex may lead to a severe anaphylactic reaction in persons sensitive to the natural latex protein 7 Transducer sheath should be used with all clinical situations where infection is a concern To install transducer sheath 1 Place an adequate amount of sterile coupling gel in the protective sheath and or on the acoustic win...

Page 57: ...th a soft cloth dampened with the cleaning solution until no visible contaminants remain 4 After cleaning wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains 5 Wipe off with a dry cloth to remove residual moisture 6 Leave the transducer to air dry WARNING 1 Unplug the transducer from the system prior to cleaning or disinfecting...

Page 58: ...lution to the transducer interface or wipe it with a soft cloth dampened with the disinfectant solution Follow the disinfectant manufacturer s recommended contact time and mode 5 Rinse the transducer according to the disinfectant instructions Wipe the transducer with a dry cloth or leave the transducer to air dry 6 Inspect the transducer to ensure that there is no damage Note If Ethanol or Isoprop...

Page 59: ...he strain relief of the transducer array Do not immerse or soak any part of a transducer in any cleaning material not listed in the recommended list of disinfectant 4 Use the immersion method to disinfect the intra cavitary transducer 5 Only non immersion method can be used with solution of ethanol or isopropanol The solution concentration should not exceed the value provided above 6 The immersion...

Page 60: ...er etc may cause deflection of a needle outside of the displayed video pathway even when the transducer needle guide and the system software are all performing as intended and within manufacturing specification The specialist performing a biopsy procedure must be aware of potential external factors when performing an invasive procedure 4 Do not freeze the system when performing a biopsy 5 EDAN nee...

Page 61: ...ch the bracket to the transducer by aligning the locating markers on the bracket and the transducer Properly secure the clamp of bracket with the locking knob Ensure the backet is firmly attached 3 Loosen the angle knob to select a needle guide angle and secure the angle knob 4 Press the tab release and place the biopsy needle into the needle guide path Use the adjusting knob to properly secure th...

Page 62: ...emove the bracket from the transducer BGK CR10UA Structures Installation and Use Steps 1 Place an appropriate amount of gel on transducer surface and insert transducer into the sheath 2 Loosen the locking knob to open the clamp of bracket Attach the bracket to the transducer by aligning the locating markers on the bracket and the transducer Clamp Needle Guide Path Locking Knob ...

Page 63: ...teps for BGK 001 and BGK 003 brackets are the same Here we take one bracket for illustration Structures Installation and Use Steps 1 Place an appropriate amount of gel on transducer surface and insert transducer into the sheath 2 Loosen the locking knob to open the clamp bracket Attach the bracket to the transducer by aligning the locating markers on the bracket and the transducer Properly secure ...

Page 64: ... Activating Needle Guide Function To enable the needle guide function 1 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 2 Press Double Line button to switch double line and single line as the Needle guide Line graphics 3 Some needle guide brackets support multiple angles If the current transduce...

Page 65: ...sed with a given transducer b Any time the needle guide or transducer has been dropped or struck against a hard surface c After repeated use 3 Do not use the needle guide bracket if the needle does not track with the guide during calibration Figure 6 5 Needle Guide Calibration Touch Screen To calibrate the guide line 1 Assemble the needle guide bracket on the transducer and use the transducer to i...

Page 66: ...de for all linear transducers Figure 6 6 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 ...

Page 67: ... technique at all times when performing a biopsy 2 Ensure that protective gloves are worn WARNING The needle guide bracket kits are not disinfected or sterilized before delivery The operators must clean and sterilize the needle guide bracket kits before and after each use To clean a needle guide bracket 1 Disconnect the needle guide bracket from the transducer after each use and remove all visible...

Page 68: ...ls on how to configure these The bottom portion of the screen shows controls available while the Comment function is active Table 7 1 gives an overview of these controls Figure 7 1 Comment Touch Screen Button Description Home Set the cursor in a pre defined location Set Home Set the current cursor location as the new Home location Delete Delete a whole text or text group or an arrow Delete All Cle...

Page 69: ...on 2 Press Arrow button on the touch screen to display an arrow at the current cursor location 3 Move the arrow to the desired location Note that while the arrow is being moved the orientation of the arrow is fixed 4 Rotate the Angle knob on the console to adjust the orientation of the arrow 5 Press Set key to confirm the arrow and you can now enter text at the end of the arrow If the Continuous A...

Page 70: ...e area Exit Press to exit the body mark function Table 7 2 Body Mark Touch Screen Description Adding a body mark 1 Invoke the Body Mark function The default body mark graphic appears on the main screen with the transducer icon shown in the default position 2 Select a desired body mark graphic on the touch screen that graphic replaces the default 3 Move the position of transducer icon as needed The...

Page 71: ...e Single hard key on the console to return to single image real time scanning Dual Exit Exit Dual using any of the following Pressing the B M PW CW hard key Transducer change preset recall or new exam Dual image display is available in B and Color Doppler mode 7 4 Zoom Zoom mode is available on the live or frozen image in B mode and Color mode When the indicator of zoom function illuminates rotate...

Page 72: ...frame until the frame that you want to set as the start point press Set Start button on the touch screen to select a frame as the start frame 2 Set the end frame in manual review status move the trackball to review frame by frame until the frame that you want to set as the end point press Set End button on the touch screen to select a frame as the end frame 3 Adjust the review speed by the Speed p...

Page 73: ...lication Measurements These are measurements for specific anatomy or clinical conditions The results can be entered into a report that can be printed later On the Measure touch screen the lower part of the touch screen shows Generic Measurements These are different for each imaging mode The upper part of the touch screen shows Application Measurements These are different for each imaging mode and ...

Page 74: ...ix the result window on the new position 8 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 used to perform the me...

Page 75: ... start point 5 Move the caliper and press the Set key to fix the end point An ellipse appears and can be adjusted with the trackball Presses of the Update key will toggle between active calipers allowing you to adjust the ellipse diameter 6 Press the Set key to complete the measurement To measure Area or Circumference with a Trace 1 Invoke the measure function on a B mode image 2 Select Circ Area ...

Page 76: ... Measure Function on a B mode image 2 Select Stenosis from the touch screen If Caliper is not the default tool press Tool Options to switch to Caliper 3 Move the caliper to the start point 4 Press the Set key to fix the start pint 5 Move the caliper to the end point Presses of the Update key will toggle between active calipers allowing you to adjust the position of start point and end point 6 Pres...

Page 77: ...n Stenosis measurement result displays 8 1 2 Strip Doppler Generic Measurements The system supports the following types of generic strip Doppler measurements Caliper Trace Auto Trace HR Heart Rate RI Resistive Index TEI dp dt Caliper The Caliper measurement can provide a wide range of results as shown below The actual results displayed will depend on the results you selected in Tool Options V1 V2 ...

Page 78: ...ure Function on a Doppler strip 2 Select Trace from the touch screen Trace can be done with a Draw Draw will follow your movements 3 Move the caliper to the start point 4 Press the Set key to fix the start point and start drawing the trace 5 Moving the caliper to mark the trace outline Presses of the Update key will toggle between active calipers allowing you to adjust the positions of the PS or E...

Page 79: ...bled then the mean value waveform is displayed HR The HR measurement tool can provide the heart rate calculation To use the HR measurement tool 1 Invoke the Measure Function on a Doppler strip 2 Select HR from the touch screen 3 Move the caliper to the first heartbeat 4 Press the Set key to fix the start point 5 Move the caliper to the next beat Presses of the Update key will toggle between active...

Page 80: ...reen 3 Measure Time A Mitral Valve Close Open Duration by caliper pairs 4 Measure Time B Ventricular Ejection Time by caliper pairs 5 The system calculates the TEI index automatically The illustration is shown below dp dt The left ventricular dp dt measurement is a useful index for evaluating myocardial contractility To use the dp dt measurement 1 Invoke the Measure Function on a Doppler strip 2 S...

Page 81: ...Move caliper to the end point Presses of the Update key will toggle between active calipers allowing you to adjust the position of start point and end point 6 Press the Set key to fix the end point and complete the measurement HR The HR measurement tool can provide the heart rate calculation To use the HR measurement tool 1 Invoke the Measure Function on an M mode strip 2 Select HR from the touch ...

Page 82: ...needs For example if you select BPD from the OB application it will automatically invoke a distance measurement These measurements generally behave as described above for generic measurements The results are entered into the report when the measurement is done Some application measurements can have multiple variations For example in a twin OB exam the OB measurements can be done on either fetus As...

Page 83: ...reas Panc duct Pancreatic duct Panc head Pancreatic head Panc body Pancreatic body Panc tail Pancreatic tail 1 4 Spleen Spleen L Spleen Length Spleen H Spleen Height 1 5 Renal Renal L Renal Length Renal W Renal Width Renal H Renal Height Cortex Renal Cortex thickness 1 6 Aorta Diam Aorta Diameter Section 2 Doppler Measurements 2 1 AA Abdominal Aorta Caliper Trace Auto Trace 2 2 SMA Superior Mesent...

Page 84: ...vity Uterine Cavity Depth 1 2 Cervix Cervix L Cervix Length Cervix W Cervix Width Cervix H Cervix Height 1 3 Ovary Ovary L Ovary Length Ovary W Ovary Width Ovary H Ovary Height 1 4 Cyst Cyst D1 Cyst Distance 1 Cyst D2 Cyst Distance 2 Cyst D3 Cyst Distance 3 1 5 Follicle Fol D1 Follicle Distance 1 Fol D2 Follicle Distance 2 Fol D3 Follicle Distance 3 1 6 Fluid POD Fluid Pouch of Douglas Section 2 D...

Page 85: ...ted below every measurement and calculation supports multiple fetuses The system supports the B D M obstetric measurements No OB Measurement Description Tool Section 1 B mode Measurements 1 1 GS Gestational Sac Caliper 1 2 YS Yolk Sac 1 3 CRL Crown Rump Length 1 4 NT Nuchal Translucency 1 5 NF Nuchal Fold 1 6 BPD Biparietal Diameter 1 7 OFD Occipital Frontal Diameter 1 8 HC Head Circumference Elli...

Page 86: ... Diam Aorta Arch Diameter 1 34 Ao Isthmus Aorta Isthmus Diameter 1 35 Desc Aorta Descending Aorta Diameter 1 36 MPA Diam Main Pulmonary Artery 1 37 Ductus A Duct Arteriosus Diameter 1 38 CTAR A1 Cardio Thorax area ratio Cardio Area Trace A2 Thorax Area Ellipse Section 2 Doppler Measurements 2 1 MCA Middle Cerebral Artery Caliper Trace Auto Trace 2 2 Umb A Umbilical Artery 2 3 Planenta A Placenta A...

Page 87: ... A2C Dias Left Ventricular apical two chamber views at End diastole A2C Sys Left Ventricular apical two chamber views at End systole 1 2 Vent Dim Ventricular Diameter RVAWd Right Ventricular Anterior Wall Thickness at End diastole Caliper RVIDd Right Ventricular Internal Diameter at end diastole IVSTd Interventricular Septal Thickness at End diastole IVSTs Interventricular Septal Thickness at End ...

Page 88: ...pid Valve Maximum Velocity Caliper 2 3 AoV Aortic Valve LVOT Trace Left ventricular outflow tract Trace Trace LVOT Vmax Left ventricular outflow tract maximum Velocity Caliper AoV Trace Aortic Valve Trace Trace AoV Vmax Aortic Valve maximum Velocity Caliper 2 4 PV Pulmonic Valve PV Trace Pulmonic Valve Trace Trace PV Vmax Pulmonic Valve maximum Velocity Caliper 2 5 P Vein Pulmonic Vein PVein S Vel...

Page 89: ... s Method of Disks MOD Simpson s MOD is a method used to calculate LV diastolic and systolic volumes and ejection fraction Simpson s MOD is available in the Cardiac presets To use the Simpson s MOD 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 and A2C Sys A single caliper wil...

Page 90: ...5 Breast Lesion 5 1 3 Testis Testis L Testis Length Testis W Testis Width Testis H Testis Height Section 2 Doppler Measurements 2 1 STA Superior Thyroid Artery Caliper Trace Auto Trace 2 2 ITA Inferior Thyroid Artery Table 8 5 Small Parts Measurement The tools can be switched by Tool Options in the touch screen after the Measurement is selected 8 2 6 Urology Measurements Urology measurements inclu...

Page 91: ...al A Renal Artery Caliper Trace Auto Trace 2 2 Arcuate A Arcuate Artery 2 3 Seg A Segmental Artery 2 4 Int A Interlobar Artery Table 8 6 Urology Measurements The tools can be switched by Tool Options in the touch screen after the Measurement is selected 8 2 7 Vascular Measurements Vascular measurements include IMT in B Mode Carotid and Artery in Doppler Mode No Vascular Measurement Description Too...

Page 92: ... 16 Pop A Popliteal Artery 2 17 Peron A Peroneal Artery 2 18 PTA Posterior Tibial Artery 2 19 ATA Anterior Tibial Artery 2 20 DPA Dorsalis Pedis Artery 2 21 SUBC V Subclavian Vein Caliper 2 22 Axill V Axillary Vein 2 23 Brach V Brachial Vein 2 24 Cepha V Cephalic Vein 2 25 Basilic V Basilic Vein 2 26 Ulnar V Ulnar Vein 2 27 Radial V Radial Vein 2 28 M Cubital V Median Cubital Vein 2 29 CFV Common ...

Page 93: ... 43 ACA Anterior Cerebral Artery Auto Trace 2 44 MCA Middle Cerebral Artery 2 45 PCA Posterior Cerebral Artery 2 46 ACoA Anterior Communicating Artery 2 47 PCoA Posterior Communicating Artery 2 48 BA Basilar Artery 2 49 VA Vertebral Artery 2 50 ICA Internal Carotid Artery Table 8 7 Vascular Measurements The tools can be switched by Tool Options in the touch screen after the Measurement is selected...

Page 94: ...m 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 8 3 1 Worksheet To view a worksheet Press Report key on the console to open worksheet screen A worksheet includes Patient Information Measure Calculation data and Comments Figure 8 3 2D Worksheet Main Screen Display ...

Page 95: ...hether it is measured or not when it is on and contracts unmeasured items when it is off All those measured items are always displayed regardless it is in current measure preset or not Comment Press to display or hide comment section This is an editable field for user to type any diagnosis or treatment comments Fetus Compare Click it to get the pages to compare multiple fetus data in one page It o...

Page 96: ...dited 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 Figure 8 6 OB Worksheet With Expand on ...

Page 97: ... BPD HC AC and or FL measurement result AUA is the averaged value of the selected GAs calculated from single parameter including BPD HC AC FL etc Whether CUA or AUA is displayed depends on the Default GA display configured in Measure Preset see section 10 3 5 for details F EFW reference Change the equation used to calculate the estimated fetal weight 8 3 3 Growth Curve OB Growth Curve indicates pr...

Page 98: ...press the Growth Curve button on the touch screen to display the Growth Curve Graph Figure 8 8 Growth Curve Touch Screen Following controls are invoked by Growth Curve button Single Quad press to select the number of the growth curve graph for display Figure 8 9 Quad Growth Curve Graph Fetus Compare Press to display multiple fetus data in the same graphic for comparing their ...

Page 99: ...button to switch fetus and the growth curve graph shows data of selected fetus It is only available in multiple fetus situations and the number of enabled button equals current fetus number which is determined in patient information page It is disabled when Fetus Compare is on 8 3 4 Report Press the Report hard key to enter the Worksheet and then press the Report button on the touch screen to disp...

Page 100: ...the report Image Column Selects the column number and the images will be displayed accordingly On the right side of the main screen you can select images to add into the report Maximum 21 images can be added to the report Figure 8 12 Report Touch Screen Save As Press it to store the report as PDF file to external storage Preview Press it to invoke print preview before print Then switching report p...

Page 101: ... Full Screen 5 Circumference Trace Full Screen 5 Area Ellipse Full Screen 10 Area Trace Full Screen 10 Angle Full Screen 3 2 M Mode Measurement Distance Full Screen 5 Time Timeline display 5 HR Timeline display 5 3 Doppler Mode Measurement Velocity PW mode 10 200cm s When angle 60 10 Velocity CW mode 10 200cm s When angle 60 10 Time Timeline display 5 HR Timeline display 5 Table 8 9 Measurement ac...

Page 102: ...ore Live store is to capture the moving images in image scanning status The system continues scanning while storing The store starts with the press of the hard key and continues for the configured length of the clip or until the clip store is interrupted The length of the clip can be configured by setting the Duration for prospective on the Store Print page See section 11 1 3 for details Frozen St...

Page 103: ...w touch screen is shown as the figure below NOTE If nothing has been stored in the current exam then the Review hard key will invoke the Exam Database function see the next section Figure 9 1 Review Touch Screen Button Description Change the displayed layout 4 4 2 2 1 1 2 3 Turn pages to move forward or backward through the available images one page at a time Select all the images in the current e...

Page 104: ...ist menu select the export format and click OK to export If there is no USB plugged in the Export button is unavailable Note Cine clips are not supported to export in AVI and DICOM format for this release Load the raw data of the selected image or clip for post processing On the touch screen press the mode tabs for example B Mode to adjust the imaging parameters for post processing images Note The...

Page 105: ...hat is typed in this field The filter applies to all fields By default the filter is set to blank so the default list shows all exams Storage Size There is a box displaying current disk usage It contains text with the current usage and is filled with a solid color to the extent that the current capacity is used The text shows current usage of total capacity The units are Mb for values less than 1 ...

Page 106: ...ent information Confirm successful archiving before deleting a study from the hard drive Working with multiple studies Multiple studies can be selected by clicking the small box at the left of each listed study Multiple studies can be stored to a DICOM server saved to a USB device or deleted Only one study can be reviewed at a time 9 4 Archiving Studies All Clips and Static images stored on the sy...

Page 107: ...f how Transducers Exam Presets and Application Presets are related For simplicity this shows just a few of the items that are on the real system In this example the C5 2Q and the E8 4Q both have an OB Exam Preset The C5 2Q OB Exam Preset optimizes the C5 2Q imaging for OB while the E8 4Q OB Exam Preset optimizes the E8 4Q for the same use The parameters used for each transducer can be different an...

Page 108: ... store or modify an exam preset Snapshot and Editing Snapshot Select the exam preset you want to modify or use as the basis for a new preset Make any changes you want to system settings using the standard imaging UI Press the Transducer key on the console Press the Save button on the touchscreen to update the current exam preset with the new setting Press the Save As button to create a new preset ...

Page 109: ...e Body Mark or Patient info presets are associated with each exam preset Figure 10 4 Exam Preset Page Transducer Select one transducer from the list to configure its exam presets Exam List Select one exam preset to configure its associated Comment Measure Body Mark or Patient info settings Measure Select one of the pre defined application measurement packages to be the default measure preset for t...

Page 110: ... set up screen for Image Preset where you can configure the imaging parameters for an exam preset This example shows the screen for editing the B mode settings for the C5 2Q OB exam preset Figure 10 5 Example Set up Screen for Image Preset Transducer and Exam There are drop downs at the top of the screen for selecting the Transducer and Exam Preset you want to edit Each transducer has its own set ...

Page 111: ...n do the followings to edit the comment texts for the selected preset Adding a new Comment 1 Move the cursor to a blank block and press Set 2 Enter a new comment through keyboard Editing an Exist Comment in Comment Preset 1 Move the cursor to a comment and press Set 2 Edit the selected comment through keyboard Deleting an Exist Comment in Comment Preset 1 Move the cursor to a comment and press Set...

Page 112: ...phics for the select preset it is marked with a green check mark in the Body Mark Library box When more than one page of Body Mark graphics are added to the middle box the system will create another new page indicating by dots at the top of the box Clicking the dots switches the page Deleting a Body Mark from a Preset Move the cursor to a Body Mark graphic in the middle box and press Set Press the...

Page 113: ... the default unit of volume measurement mm3 and cm3 are available Cardiac Settings The system supports following Cardiac measurement settings EDV ESV set the author of the formula that is used in EDV ESV calculation There are three options Teichholz Gibson and Cube HR Cycle set the number of heartbeats that are assumed in the HR or FHR measurement calculation Range 1 8 GYN Settings The system supp...

Page 114: ...g fetal age Fetal Growth set equation for measurements which are used for calculating fetal growth Estimated Fetus Weight select an equation for the Estimated Fetus Weight calculation Growth Curves Display set single or quad curves as the default display format for the Growth Curves Default GA display set the CUA Composite Ultrasound Age or AUA Average Ultrasound Age as a default result displayed ...

Page 115: ...Set up System setup is used to configure parameters that are unrelated to presets Generally there is one value of each system setup parameter that is shared across all presets Entering System Set up Open Utility screen Press Set up touch screen button and then the System touch screen button to access system setup Reloading Factory Default Settings 1 Press Restore Factory Settings on the System Set...

Page 116: ...uto freeze function by default or not and set the waiting time to perform auto freeze Sleep Waiting time 1 999 min Set whether to turn on system sleep function by default or not and set the system waiting time to enter sleep mode Button F1 F2 PDI DPDI Needle Center Line Define the F1 F2 keys select one of the pull down options The options that are available will depend on what functions are enable...

Page 117: ...ion screen The Patient Information screen only displays the data entry when you define the title of the custom field Time limit for exam restart 0 12h 24h 48h 72h Unlimited You can define the time limit for restarting exam Only exams within the time limit can be restart If 0 is selected no exam can be restart Patient name display option One field Two fields You can define the patient name display ...

Page 118: ...he cine length for prospective cine storing in live scanning status Duration for retrospective Set the default cine length for retrospective cine storing in the frozen status Video Printer SONY UP D25MD SONY UP_X898MD Select one video printer as the default printer from the list when more than one video printer are connected with the system via USB cable Table 11 3 Store Print Set up Description ...

Page 119: ...from USB disk 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 Delete Delete the imported logo Report Printer Default Printer Select one report printer as the default printer from the list when more than one report printer are connected with the system via USB cable Table 11 4 Report Set up Description ...

Page 120: ... up Figure 11 5 Image Set up Screen Item Options Description Scale unit cm s kHz Set the velocity units of spectrum scale Auto zoom image on linear probe at the shallow depth Set whether to auto zoom image at the shallow depth when using linear transducers Table 11 5 Image Set up Description ...

Page 121: ...1 6 TCP IP settings Wired Settings The following settings apply when connecting a system to a wired network via the network port on the side of the system Get Local IP Either Manually entered Static or DHCP The correct setting will depend on how your DICOM network is administrated If you are unsure try DHCP first Generally a Static IP is only needed if the target PACS system requires it If it is n...

Page 122: ...ork list Click on the name of a network to select it Join This joins the selected network If a password is needed a dialog box will be displayed to enter it Forget Network This forgets any password of the selected network that had been entered but the network is still shown in the list Advanced Settings This brings up a dialog box with additional settings for the selected wireless network The dial...

Page 123: ...h your server may be different Testing the server There are two tests to ensure that the server information is entered correctly Click on any field for a given server to make that server selected then Ping A successful Ping means that the system can communicate with the server at a low level basically that the two computers see each other As a security measure some servers on the Internet may be c...

Page 124: ...ion of the system 11 3 1 License The License page displays which features are currently licensed for use on the system At the top of the screen is displayed the current license key as well as a license QR code Below that is a list of all licensable features along with its current status The system supports temporary trial licenses Click the Trail button can try the function for one time in the val...

Page 125: ...e with unknown provenance to the ultrasound system 3 To avoid loss of patient data please backup the patient data prior to software upgrade 11 3 3 Demo The Demo screen provides access for you to show a set of images you collected for demonstration purpose Import Imports a collection of images to the ultrasound system 1 Before import you need create any a folder in USB disk and put the images insid...

Page 126: ...ility page Press Set up touch screen button and then the Screen Adjust touch screen button to access Screen Setup touch screen The brightness and contrast of the monitor and touch screen in the system can be customized Main Screen Brightness adjusts the brightness value of the monitor Main Screen Contrast adjusts the contrast value of the monitor Touch Screen Brightness adjusts the brightness valu...

Page 127: ...Acclarix AX3 Series Diagnostic Ultrasound System User Manual Utilities 121 Figure 11 10 Screen Adjust Screen ...

Page 128: ...CAUTION 1 Switch off the ultrasound system Unplug the AC adapter from the power source and secure the power cable 2 Remove the transducer and place them in a safe place 3 Disconnect and secure the connecting cable 4 Connect optional system accessories 5 Secure the system and complete the system setup and then perform all the daily checking before using it To prepare the system for shipment over lo...

Page 129: ...fter the system is switched on Visually check the on screen display and lighting Verify that the monitor displays the current date and time and there isn t any error message Verify that the transducer identification and indicated frequency on the screen are correct for the activated transducer Ensure that there isn t obvious abnormal noise discontinuous image or dark area Ensure that it isn t smel...

Page 130: ...e cleaning and disinfection General Points Keep your monitor cables and accessories free of dust and dirt To prevent the device from damage please follow the procedure Use only recommended cleaning substances and disinfectants listed in this manual Others may cause damage not covered by warranty reduce product lifetime or cause safety hazards Always dilute according to the manufacturer s instructi...

Page 131: ...quipment thoroughly until no visible contaminants remain 3 Wipe off the disinfecting agent with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains 4 Dry the system in a ventilated and cool place NOTE 1 Make sure the system is free of gel and any other visible residue 2 Use a soft dry cloth without chemicals for cleaning The monitor surface is easi...

Page 132: ...l operation and damage the system NOTE Be sure to clean the X and Y idler wheels and the auxiliary idler wheel 13 4 Maintenance The system should be maintained regularly at least annually by a qualified technician who has adequate training knowledge and experience That person should be familiar with the Service Manual available from your Edan representative Rotate clockwise to remove the fixing ri...

Page 133: ...lammable gas Equipment not suitable for use in the presence of a flammable gas According to the mode of operation Continuous operation According to the grade of EMC CISPR 11 Group 1 Class A Standards Compliance EN 60601 1 2006 A1 2013 idt IEC 60601 1 2005 A1 2012 EN 60601 1 2 2015 idt IEC 60601 1 2 2014 EN 60601 2 37 2008 A1 2015 idt IEC 60601 2 37 2007 A1 2015 A 2Power Supply Operating Voltage 10...

Page 134: ...nal Size 15 6 inches Open Angle 0 180 Pixel Number 1920x1080 White Luminance 300 cd m2 typ Contrast Ratio 700 typ A 5General Specifications Display Modes B Mode B 2B Color Mode B C Single Dual B B C Dual Live B C PW triplex mode PDI DPDI Mode B PDI DPDI Single Dual B B PDI DPDI Dual Live B PDI DPDI PW triplex mode PW Mode B PW Update B PW duplex simultaneous B C PW Update B C PW B PDI DPDI PW trip...

Page 135: ...bpsCCK 17 3dBm 6MbpsOFDM 17 1dBm 9MbpsOFDM 17 1dBm 12MbpsOFDM 17 1dBm 18MbpsOFDM 17 1dBm 24MbpsOFDM 16 2dBm 36MbpsOFDM 15 3dBm 48MbpsOFDM 14 6dBm 54MbpsOFDM 13 8dBm A 7Operating Storage and Transportation Environment A 7 1 Operating Environment Temperature 0 C 40 C 32 F 104 F Relative humidity range 15 RH 95 RH non condensing Atmospheric pressure range 86kPa 106kPa A 7 2 Storage and Transportation...

Page 136: ...A 9Configuration Difference Models Configuration Difference Feature 1 Feature 2 Feature 3 Feature 4 Seminal Vesicle Meas Testis Meas Single Button Footswitch Socket Number Acclarix AX3 Double Acclarix AX3 Exp X Double Acclarix AX3 Super X X Double Acclarix AX25 X Double Acclarix AX28 X X Double Acclarix AX2 Single Acclarix AX2 Exp X Single Acclarix AX2 Super X X Single Acclarix AX15 X Single Accla...

Page 137: ...t there are no known adverse effects from the use of diagnostic ultrasound however exposure levels should always be limited to As Low As Reasonably Achievable the ALARA principle Imaging Functions Affecting Acoustic Output In addition to the level of voltage transmitted adjustment of the following imaging functions and or controls may affect the acoustic output Item Affection Probe Acoustic output...

Page 138: ...tation is still undetermined Generally speaking the higher the acoustic pressure the greater the potential for mechanical bioeffects the lower the acoustic frequency the greater the potential for mechanical bioeffects The AIUM and NEMA formulate mechanical index MI in order to indicate the potential for mechanical effects The MI is defined as the ratio of the peak rarefactional acoustic pressure s...

Page 139: ...f system mode transducer assembly and transmit patterns or all allowed combinations of them Accuracy of system software MI and TI calculation algorithms Engineering approximations for real time calculations B 4 2 Differences between Actual and Displayed MI TI Actually many assumptions adopted in the process of measurement and calculations are relatively conservative Over estimation of actual in si...

Page 140: ...ency and MI measurement uncertainties table Power Center frequency MI Uncertainty 23 68 0 2 11 84 Notes Uncertainties based on the intensity uncertainties Uncertainties based on the oscilloscope Uncertainties based on the pressure and center frequency B 4 4 Acoustic Power Default Settings The ultrasound system allows direct control of acoustic power by the Power paddle key on the touch screen The ...

Page 141: ...ipment have ever been reported the potential exists that such bioeffects may be identified in the future Therefore the ultrasound should be used prudently High levels of acoustic output and long exposure time should be avoided while acquiring necessary clinical information B 7References for Acoustic Output and Safety 1 Bioeffects and Safety of Diagnostic Ultrasound issued by AIUM in 1993 2 Medical...

Page 142: ...lowing accessories are recommended for use on the ultrasound system Part Name Part Number Transducer E8 4Q 02 01 214513 Transducer P5 1Q 02 01 213916 Transducer L17 7Q 02 01 214800 Transducer C5 2Q 02 01 212622 Transducer L12 5Q 02 01 212623 BGK C5 2 Needle Guide Bracket Kit 02 01 211006 BGK L40UB Needle Guide Bracket Kit 02 01 210407 BGK CR10UA Needle Guide Bracket Kit 02 01 102963 BGK 001 Needle...

Page 143: ...x AX3 Series Diagnostic Ultrasound System User Manual Order List 137 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 ...

Page 144: ...ause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The system is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC61000 3 3 Complies NOTE The EMISSI...

Page 145: ... 4 5 1 kV for line to line 2 kV for line to ground 1 kV for line to line 2 kV for line to ground Mains power quality should be that of a typical commercial or hospital environment Power frequency 50 60Hz magnetic field IEC EN 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Voltage dips ...

Page 146: ...uld be used no closer to any part of the system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P d 2 1 150KHz to 80MHz P d 2 1 80 MHz to 800 MHz P d 3 2 800 MHz to 2 7 GHz at RF wireless communications equipment bands Portable RF communications equipment including peripherals such...

Page 147: ...r the frequency range 150kHz to 80MHz field strengths should be less than 3V m c The ISM industrial scientific and medical bands between 0 15 MHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz to 2 0 MHz 3 5 MHz to 4 0 MHz 5 3 MHz to 5 4 MHz 7 MHz to 7 3 MHz 10 1 MHz ...

Page 148: ... radiated RF disturbances are controlled The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the system as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance a...

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