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X-CUBE 70 Quick Guide

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EN 61000-4-5:2014 (IEC 61000-4-5:2014)

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EN 61000-4-6:2014 (IEC 61000-4-6:2013)

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EN 61000-4-8:2010 (IEC 61000-4-8:2009)

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EN 62304:2006+A1:2015 (IEC 62304:2006/AMD1:2015)

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EN 62366-1:2015 (IEC 62366-1:2015)

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MEDDEV 2.12/2 Rev.2

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MEDDEV 2.7.1 Rev.4

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NEMA UD2:2004 (R2009)

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Medical Devices Regulations (SOR/98-282)

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의료기기법, 의료기기법 시행령, 의료기기법 시행규칙

Содержание X-CUBE 70

Страница 1: ...DIAGNOSTIC ULTRASOUND SYSTEM X CUBE 70 Quick Guide Rev 0 ENG D N 70003656 ...

Страница 2: ...t by unauthorized persons is strictly prohibited Alpinion provides this document without warranty of any kind implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose Alpinion has taken care to ensure the accuracy of this document However Alpinion assumes no liability for errors or omissions and reserves the right to make chan...

Страница 3: ...t the majority of people who are familiar with English can read and correctly understand the instructions The user documentation is translated into other languages so that most people who are familiar with languages other than English can read the instructions and understand them correctly The translated user documentation is intended for users who speak the language of the country where they sell...

Страница 4: ...statement WARNING WARNING indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause severe or fetal personal injury or substantial property damage CAUTION CAUTION indicates that a potential hazard may exist which through inappropriate conditions or actions will or can cause minor poersonal injury or property damage such as loss of patient or sys...

Страница 5: ...nical safety standards met MDD 93 42 EEC EN ISO 10993 1 2009 ISO 10993 1 2009 EN ISO 10993 10 2013 ISO 10993 10 2010 EN ISO 10993 5 2009 ISO 10993 5 2009 EN ISO 13485 2016 ISO 13485 2016 EN ISO 14155 2011 AC 2011 ISO 14155 2011 EN ISO 14971 2012 ISO 14971 2007 EN ISO 15223 1 2016 ISO 15223 1 2016 EN 1041 2008 A1 2013 EN 55011 2016 A1 2017 CISPR 11 2015 AMD1 2016 EN 55032 2015 CISPR 32 2015 EN 6060...

Страница 6: ...0 4 6 2014 IEC 61000 4 6 2013 EN 61000 4 8 2010 IEC 61000 4 8 2009 EN 62304 2006 A1 2015 IEC 62304 2006 AMD1 2015 EN 62366 1 2015 IEC 62366 1 2015 MEDDEV 2 12 2 Rev 2 MEDDEV 2 7 1 Rev 4 NEMA UD2 2004 R2009 Medical Devices Regulations SOR 98 282 의료기기법 의료기기법 시행령 의료기기법 시행규칙 ...

Страница 7: ...17a 85399 Hallbergmoos Germany 49 0 811 99 82 86 0 North or South America countries Authorized US Reperesentative ALPINION USA Kevin Chun 21222 30th Dr SE Ste C 122 Bothell WA 98021 United States 1 425 949 1059 Asia countries ALPINION MEDICAL SYSTEMS Co Ltd ALPINION MEDICAL SYSTEMS Co Ltd 5FL I Dong 77 Heungan daero 81beon gil Dongan gu Anyang si Gyeonggi do Republic of Korea 82 2 3282 0903 ALPINI...

Страница 8: ...pinion com en contact contact do Manufacturer ALPINION MEDICAL SYSTEMS Co Ltd 5FL I Dong 77 Heungan daero 81beon gil Dongan gu Anyang si Gyeonggi do Republic of Korea Telephone 82 2 3282 0903 Fax 82 2 851 5593 www alpinion com Copyright ALPINION MEDICAL SYSTEMS Co LTD All rights reserved This product complies with regulatory requirements of the following European Directive 93 42 EEC concerning med...

Страница 9: ...this manual is as follows Rev Date YYYY MM DD Description Rev 0 2021 04 26 Initial Release Please verify that you are using the latest revision of this document If you need to know the latest revision contact your local agent or local Alpinion sales representative ...

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Страница 11: ... 17 System Start Up 1 18 Power On 1 18 Power Off 1 18 Transducer 1 19 Connecting the Transducer 1 19 Disconnecting the Transducer 1 19 Activating the Transducer 1 20 Deactivating the Transducer 1 20 System Preset 1 21 System Preset Display 1 21 System Preset Menus 1 22 General Workflow 1 23 Configuring Connectivity 1 24 Connectivity 1 24 2 Performing an Exam 2 1 Beginning an Exam 2 2 Patient Scree...

Страница 12: ... and Patient Data 2 31 Clipboard 2 31 E View 2 32 Measurement and Report 2 36 Basic Measurement Operations 2 36 Measurement Result Window 2 36 Basic Measurements 2 37 Viewing and Editing a Worksheet 2 53 3 After the Exam is Over 3 1 Data Backup 3 2 Backup Restore 3 2 System Care and Maintenance 3 4 Daily Maintenance 3 4 Weekly Maintenance 3 4 Monthly Maintenance 3 5 Transducer Care and Maintenance...

Страница 13: ... 5 Patient Safety 4 6 Patient Identification 4 6 Patient Data 4 6 Diagnostic Information 4 6 Mechanical Hazards 4 7 ALARA As Low As Reasonably Achievable 4 7 Training 4 7 Anti Virus Program 4 8 Anti Virus Program 4 8 Transducer Safety 4 9 Handling and Care Precautions 4 9 Special Handling Instructions 4 10 System Symbols and Labels 4 11 System Symbols and Labels 4 11 ...

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Страница 15: ...1 Introduction 1 2 Console Overview 1 5 System Start Up 1 18 Transducer 1 19 System Preset 1 21 Configuring Connectivity 1 24 This chapter introduces the followings Getting Started ...

Страница 16: ...eight 1440 1605 mm Width 580 mm Depth 835 mm Weight 85 kg not including options Clinical Applications Abdomen OB GYN Cardiology Small Parts MSK Vascular Urology EM TCD Breast Appendix Available Imaging Modes 2D mode Harmonic mode HAR M mode Color M mode Anatomical M mode AMM Color Flow Doppler CF mode Power Doppler PD mode Directional PD mode Pulsed Wave Doppler PWD mode Continuous Wave Doppler CW...

Страница 17: ...hear Wave X MicroView Filter Method Tissue Harmonic Image FTHI Pulse Inversion Tissue Harmonic Image PTHI Raw Data Processing Post Processing Operable Transducers Pencil Doppler Linear Array Sector Phased Array Convex Array Endocavity Volume Convex Volume Endocavity Measurement Package Including reports for Abdomen OB GYN Cardiology Vascular Urology Pediatrics Small Parts Breast MSK EM ...

Страница 18: ...S DICOM Q R DICOM Structured Report OB GYN DICOM Structured Report Echocardiography DICOM Structured Report Vascular CUBE View Cube Note Network Storage Wireless LAN Option User Interface English German French Spanish Italian Russian Portuguese Chinese NOTE Not all features transducers optional supplies or peripherals described in this document may be available or cleared for sale in all markets P...

Страница 19: ... 4 8 12 13 5 9 Figure 1 1 X CUBE 70 System Front view No Component No Component 1 Monitor 8 Control panel swivel button 2 LED lamp 9 Transducer cable holder 3 Touch screen 10 Control panel up down button 4 Gel warmer 11 Speaker 5 Transducer holder 12 CW port 6 Control panel 13 ECG port 7 Front handle 14 Transducer port ...

Страница 20: ... USB 3 0 USB 2 0 1 Figure 1 2 X CUBE 70 System Rear view No Component No Component 1 Transducer holder 4 I O panel 2 Endocavity transducer holder 5 System On Off switch 3 AC outlet 6 AC inlet NOTE When connecting an external monitor to your system use the monitor with 1366 x 768 or higher resolution ...

Страница 21: ...rview 1 7 System_Side View 1 2 4 5 6 7 8 3 Figure 1 3 X CUBE 70 System Side view No Component No Component 1 Monitor arm 5 Side tray Option 2 Rear handle 6 Body base 3 Speakers 7 Caster lock 4 Body cover 8 Caster ...

Страница 22: ... 2 3 4 5 Figure 1 4 Monitor buttons No Component No Component 1 LED lamp button 4 Down button 2 Up button 5 Touch screen Brightness buttons 3 Mode Select button CAUTION The LED lamp may overheat Be careful not to directly touch it to avoid injury ...

Страница 23: ...on Press the Down button to decrease the contrast Repeat step 2 until the desired value is reached Adjusting the touch screen s contrast and brightness To adjust the brightness of the touch screen 1 1 Press the Mode Select button on the touch screen once 2 2 To increase the brightness press the Up button Press the Down button to decrease the brightness Repeat step 2 until desired value reached To ...

Страница 24: ...ting Start Control Panel The control panel can be used for controlling the system 1 2 3 4 5 6 Figure 1 5 Control panel layout 1 Power on off key 4 TGC slides 2 USB port 5 QWERTY keyboard 3 Soft keys 6 Trackball ...

Страница 25: ...the desired function from the context menu on the screen Angle Adjust the angle In 2D or Color mode rotate to adjust the angle steer In CW or PW mode rotate to adjust the Doppler angle correct In Body Pattern mode rotate to adjust the transducer angle In Arrow mode rotate to adjust the arrow angle In CW or PW mode press to adjust the auto angle Clear Delete the arrow annotation body patterns and m...

Страница 26: ...ty Adjust the priority of Trackball In 2D mode press to select the priority between the width and tilt functions In Duplex or Triplex mode press to select the priority between ROIs of the activated imaging modes Single Dual Quad View an image in dual or quad screen P1 P2 P3 P4 Control the designated recording device or perform alternative storage To configure these keys go to Utility Setup SystemP...

Страница 27: ...l Name Description Quick ID Access the Quick ID screen Patient Browser Access the E View screen Image Preset Access the Image Preset screen System Preset Access the System Preset screen DICOM Spooler Display the DICOM Spooler on the screen Symbol Lock Lock all keyboard symbol keys New Preset Create your own user preset DVR Access the DVR menu Eject Eject a media Initial Restore the default setting...

Страница 28: ...ideline Speaker Volume Turn up down the speaker volume Reverse Flip the image 180 degrees left right Clear All Clear your input or cancel your selection Hide Hide the current menu screen Xpeed Activate Xpeed to automatically optimize image parameters on the live screen Arrow Show the arrow pointer on the screen ...

Страница 29: ... that enable the major workflow activities for starting performing and completing an exam 1 Shortcut Bar Quick access to different functions on the system B Tabs Contain mode specific or application specific controls in different tabs 2 Scanning Modes Tab Select the tab to activate scanning mode C Controls The main area of the touch screen which shows the controls for the currently selected tab in...

Страница 30: ...lications have two rows of labels while some have no soft keys You can select the functions assigned to the soft keys by touching the labels or by pressing or rotating the knob below the label 6 Soft Menus Rotary Push buttons with mode function specific controls Press the button to switch between controls Rotate the dial to adjust the value ...

Страница 31: ...ransducer name 15 Image clipboard 4 Mechanical index Thermal index 16 Status bar Symbol lock Caps lock USB connection Network connection Wireless network connection User defined key Data backup status Cube View connection Windows Defender Battery status 5 Zoom reference window 6 Labeled measurement menu 7 Report 8 Gray Color scale bar 17 Clipboard icons Touch Clip Thumbnail Preview Trash can Singl...

Страница 32: ...Users and select the System Auto Login check box 7 7 Enter the operator s ID and password and then click OK Power Off CAUTION Do not unplug the power cord during the system operation Do not push the System On Off switch before pressing the Power On Off key This may lead to data loss or system software damage NOTE Depending on the power off setting you can activate Sleep mode or turn the system off...

Страница 33: ...he transducer connector NOTE After connecting the transducer to the system you need to activate the desired transducer by selecting it from the screen 4 4 Place the transducer in its holder CAUTION Do not allow the transducer head to hang free Impact to the transducer head could result in irreparable damage Disconnecting the Transducer You can disconnect the transducer from the transducer port whe...

Страница 34: ...tomatically 3 3 Click Exit to complete the transducer selection NOTE Selecting the Automatic Preset selection when changes the Transducer check box shows the default application and preset for the selected transducer Deactivating the Transducer NOTE Before deactivating the transducer press the Freeze key on the control panel An error may occur when you deactivate the transducer while the system is...

Страница 35: ... 1 21 System Preset In each preset menu you can configure different default settings for its submenus System Preset Display 1 2 3 4 Figure 1 8 System preset display 1 System presets 3 Exit 2 Preset menus 4 Save Exit ...

Страница 36: ...body pattern settings Measurement Customize the labeled measurement for each study and create a new measurement and OB table Report Customize the report and report print settings User Setting Customize the user defined settings Connectivity Customize the DICOM device and service Administration Create a user ID activate the service browser and view the option information Backup Restore Back up and ...

Страница 37: ...s you want to change To change a parameter do one of the following Enter the desired value using the keyboard in the text box Select the value from a drop down list Select or clear a check box Click one value from a choice of two or more radio buttons 7 7 When you have finished click Save Exit to save the changes and return to scanning In some cases you may need to reboot the system for the change...

Страница 38: ...uch Setup on the touch screen 3 3 Touch the SystemPreset tab on the touch screen The System Preset screen appears 4 4 Select Connectivity on the touch screen General The General menu allows you to configure the general network connection settings such as computer name AE title and port number NOTE To set up Internet Protocol contact your hospital s network administrator To configure the general ne...

Страница 39: ... mask Default Gateway Enter the default gateway address Preferred DNS Server Enter the preferred DNS server Alternate DNS Server Enter the alternate DNS server Network Speed Select the network speed Wireless To connect to the wireless network 1 1 Specify the following IP address settings 2 2 Select the desired SSID from the Wireless search list 3 3 Click Connect 4 4 Enter a password and click OK 5...

Страница 40: ... field 3 3 Enter a shared directory path for the device in the Shared Dir field 4 4 Enter an ID of the device in the ID field 5 5 Enter a password of the device in the Password field 6 6 Select a device that is connected to the intra network driver 7 7 Click Verify to verify the network connection To delete a network storage device 1 1 Select the destination name that you want to delete 2 2 Click ...

Страница 41: ... to General menu and click CubeNote on the bottom right of the display To add a Control Server device 1 1 Enter a hospital code in the Hospital Code field 2 2 Enter a name of the CubeNote Control Server device in the Destination Name field 3 3 Enter an access ID of CubeNote Client in the ID filed 4 4 Enter a password of CubeNote Client in the Password field 5 5 Click Verify to verify the CubeNote ...

Страница 42: ...ach service AE Title Enter the Application Entity AE title of this service Port No Enter a port number of the service Retry Enter a maximum number of times to try when the system fails to connect to a destination device Retry Interval s Set the time interval of retry Timeout s Set the period of timeout when the retry connection is over Move AE Title Enter the Application Entity AE title of this se...

Страница 43: ...h DICOM standard format to view or interpret in PACS In this menu you can add edit and remove a DICOM storage service and configure the service properties To add a DICOM storage device 1 1 Click New 2 2 Enter a name of the DICOM storage device in the Destination Name field 3 3 Enter a device s IP address in the IP Address field 4 4 Enter the Application Entity AE title for a device in the AE Title...

Страница 44: ...ou can specify the following information Properties Select an associated storage Accepter Specify the accepter s settings such as AE title port number and timeout Worklist The Worklist menu provides a list of patients sorted by query parameters The Search Criteria menu allows you to define specific search parameters for the system to use when querying the patient archive To add a worklist 1 1 Clic...

Страница 45: ... item Add to list Add tag and value to the list of search criteria Remove Remove tag and value to the list of search criteria Clear Clear all tags from the list MPPS The MPPS menu provides a notifying function that the procedure information of the current study is transferred to PACS while performing a study DICOM Q R DICOM Query Retrieve The DICOM Q R menu provides a list of patients sorted by qu...

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Страница 47: ...2 Beginning an Exam 2 2 Optimizing the Image 2 7 Managing Image and Patient Data 2 31 Measurement and Report 2 36 This chapter introduces the followings Performing an Exam ...

Страница 48: ...tient Screen The following components are shown on the screen 6 7 2 5 3 4 1 Figure 2 1 Patient screen 1 X Assistant 5 Exam information 2 Function selection 6 Patient list Study list 3 Patient information 7 Save Exit Exit 4 Application selection ...

Страница 49: ...Register on the touch screen 3 3 Select the desired application from exam application categories When a category is selected the measurement and category presets are displayed 4 4 Enter the required application information for the selected application NOTE Using the TAB or Enter key on the QWERTY keyboard allows you to navigate through each field on the Patient screen You can use Trackball and the...

Страница 50: ... the application information go to the Patient screen by touching Patient on the touch screen 3 3 Click OK to save the patient information Searching for an Existing Patient 1 1 Touch Patient on the touch screen The Patient screen appears 2 2 Select a search criteria Patient ID Patient Name Birth Date Sex Exam Date and Locked from the Search drop down list and enter a search keyword If you select E...

Страница 51: ...t Start Exam on the touch screen to return to the scan screen 8 8 Perform an exam 9 9 Store the raw data to the clipboard Retrieving Patient Information via Worklist 1 1 Touch Patient on the touch screen The Patient screen appears 2 2 Select Worklist on the function selection to view patient data from the default worklist server 3 3 To change the worklist server select a source from the Source dro...

Страница 52: ...ed in the local hard disk Touch End Exam on the touch screen to save the current study You can also end a study by selecting New Patient on the Patient screen NOTE You can return to the Patient screen after ending the current study To configure go to Utility Setup SystemPreset System General After End Exam ...

Страница 53: ...n see the display and image parameters are automatically changed Xpeed Xpeed is an auto optimizing technology that enables you to easily adjust an image s the contrast resolution and brightness uniformity To activate or deactivate Xpeed press the Xpeed key on the QWERTY keyboard Time Gain Compensation TGC To compensate for weak signals or over bright signals at various depths you can adjust Time G...

Страница 54: ...ntrol panel The image is shown on the left of the display 2 2 Press the Dual or Quad key again to activate the second image 3 3 To switch between the two or four images press the Dual or Quad key 4 4 Press the 2D key to exit the dual or quad imaging Priority The priority function has the following two options Width Tilt Width Control the size or angle width of the 2D image sector A smaller angle g...

Страница 55: ...ed THI FTHI can be used to optimize temporal resolution To adjust FTHI 1 1 Select Harmonic on the touch screen 2D HAR appears next to 2D image parameters 2 2 To change the frequency of FTHI rotate the Frequency soft key clockwise or counter clockwise 3 3 To exit FTHI select Harmonic on the touch screen Live Dual Live Dual is a feature that enables you to view the 2D image and activate other functi...

Страница 56: ... extended 2D image You can perform the Panoramic feature on 2D images with linear and convex transducers For more information please refer to Panoramic Imaging in User Manual To perform the panoramic imaging 1 1 Select Panoramic on the touch screen You can access the Panoramic setup mode and the blue colored ROI appears 2 2 Press the Set key to start the image acquisition 3 3 Move the transducer l...

Страница 57: ...control panel 7 7 Estimate the size and hardness of lesions 8 8 To exit the Strain Elastography mode select Exit on the touch screen Point Shear Wave Elastography Option Point Shear Wave Elastography detects the velocity of the shear wave propagated through the targeted lesion and displays the numerical measurement of tissue stiffness in kPa or m s For more information please refer to Point Shear ...

Страница 58: ...Contrast on the touch screen The contrast image and 2D image are displayed side by side 2 2 Adjust the acoustic power experientially to obtain a good image 3 3 Observe the tissue image to find the target view 4 4 Inject the contrast agent and select Timer on the touch screen to start the timing When the timer begins to work the time will be displayed on the screen 5 5 Observe the image 6 6 To save...

Страница 59: ... on the touch screen VelocityUs VelocityUS allows you to change the transmitted speed of sound for various tissue types To adjust the transmitted speed of sound select or of VelocityUS on the touch screen Frequency You can adjust the operating frequency of the transducer The selected frequency is displayed in the Image Parameter To adjust the frequency rotate the Frequency soft key clockwise or co...

Страница 60: ...des To adjust the power rotate the Power soft key clockwise or counter clockwise Edge Enhance Edge Enhance demonstrates subtle tissue differences and boundaries by enhancing the gray scale differences corresponding to the edges of structures This function allows your system to display the outline of tissues or an organ more clearly To adjust the edge enhance rotate the Edge Enhance soft key clockw...

Страница 61: ... time line and anatomy displayed To adjust the display format select or of Display Format on the touch screen Sweep Speed During M mode imaging you can adjust the sweep speed of the display To increase or decrease the sweep speed rotate the Sweep soft key clockwise or counter clockwise Anatomical M mode Option Anatomical M mode allows you to move or rotate an M line and review an image on the desi...

Страница 62: ... adjust the size of the zoom box and press the Set key 4 4 To zoom out press the Exit key on user defined key M color mode M color mode is a combination mode of M mode and Color Flow mode which color flow information overlays the M mode image by using the velocity and color map The color flow wedge is shown on the M mode timeline The color map in this mode is the same as in Color Flow mode but the...

Страница 63: ...Color Flow mode press the CF or 2D key Micro Vascular Imaging Option MVI aims to visualize low velocity and small diameter blood vessel To activate or deactivate MVI mode select X MicroView on the touch screen Invert Color Invert Invert allows you to view blood flow from a different perspective e g red away negative velocities and blue toward positive velocities You can invert a real time or froze...

Страница 64: ...en the 2D image and the color image To adjust this function select or of Blend Level on the touch screen Line Density Line density optimizes the Color Flow mode frame rate or spatial resolution for the best possible color image A lower line density is useful in fetal heart beat adult cardiac applications and in clinical Radiology applications requiring significantly higher frame rates A higher lin...

Страница 65: ...the axial direction To adjust the smooth rotate the Smooth soft key to clockwise or counter clockwise Color Map Color Map allows you to change the color map used for Color Flow mode Power Doppler mode and Tissue Doppler Imaging mode To adjust the color map rotate the Color Map soft key clockwise or counter clockwise Baseline Baseline adjusts the Color Flow or Doppler spectrum baseline to accommoda...

Страница 66: ...reen To activate or deactivate the hide color select Hide Color on the touch screen Adaptive Blend Adaptive Blend superimposes a translucent color image over a 2D image in the color image area You can adjust the transparency of the color image easily to demonstrate the tissues behind the color To activate or deactivate this function select Adaptive Blend on the touch screen Adaptive Blend Level Ad...

Страница 67: ... or of Flow State on the touch screen Angle Steer In Power Doppler mode you can tilt an image left or right by using a linear transducer To adjust the angle steer select or of Angle Steer on the touch screen The each level of the angle increment decrement is 3 or 5 degrees depending on the linear transducer type ...

Страница 68: ...n the control panel The velocity scale changes when you adjust angle correct Invert Invert vertically inverts the spectral trace without affecting the baseline position To invert the spectral trace select Invert on the touch screen The plus and minus signs on the velocity scale are reversed when the spectrum is inverted Positive velocities display below the baseline Auto Angle Auto angle allows yo...

Страница 69: ...r select or of WF on the touch screen Angle Steer Angle steer tilts the sample volume for the Doppler spectrum This function is only for linear transducers To adjust the angle steer select or of Angle Steer on the touch screen The each level of the angle increment decrement is 5 degrees Direction Direction is used to specify the part of the spectrum to calculate when using AutoCalc To adjust the d...

Страница 70: ...e of sound in smaller increments to avoid startling the patient Sound adjusts the Doppler sound volume Audio sounds of the blood flow in a vessel can be used to check the proper position of the transducer To adjust the sound rotate the Sound soft key clockwise or counter clockwise Sweep Speed Sweep speed allows you to adjust the sweep speed of the Doppler spectrum To increase or decrease the sweep...

Страница 71: ...low velocity in a direction at an angle to the Doppler vector by computing the angle between the Doppler vector and the flow to be measured Flow toward the transducer is mapped above the baseline and vice versa To adjust the angle relative to the transducer face rotate the Angle key on the control panel The velocity scale changes when you adjust angle correct Full Timeline Full timeline allows you...

Страница 72: ...ge Quad Show three reference images and one 3D image Priority While or after acquiring the volume data press to change the function The activated function is shown on the bottom right of the display Priority Cine Cine Calc Move ROI Curved ROI Line1 2 3 Light Direction Set Run and Stop Cine or Cine Calc Image and Axis Move Pos and Size ROI Pos and Rot Line1 2 3 Cursor Cursor Display remains blank T...

Страница 73: ...tion soft key 7 7 When you have finished press the Freeze key on the control panel to acquire the image data Performing 4D image scanning In 4D mode you can acquire real time 4D images through an acquisition interface 1 1 Obtain a 2D image and optimize the image for the best quality 2 2 On the control panel press the 3D 4D key 3 3 Touch the 4D tab on the touch screen The yellow colored ROI and sof...

Страница 74: ...ect Full Screen in the 2D tab The magnified image is displayed in full screen 2 2 To exit the Full Screen mode select Full Screen again Freezing an image 1 1 While scanning an image press the Freeze key on the control panel to freeze the image You can also freeze an image with the right pedal of the footswitch if supported 2 2 To reactivate the image press the Freeze again Activating Cine mode 1 1...

Страница 75: ...lable on the system 5 5 When a specific comment or comment group is selected the color turns to green Once the comment is set or fixed the color returns to yellow or to the user selected color 6 6 Delete characters or all comments if necessary To delete comments by character select Backspace on the touch screen To delete comments by word rotate and press the Grab Delete soft key To delete the comm...

Страница 76: ... will vary depending on the selected application 3 3 Select the desired body pattern on the touch screen The body pattern with a transducer marker is shown on the screen 4 4 To reposition the body pattern press the Move Pattern soft key 5 5 Use Trackball to adjust the position of the body pattern and press the Set key 6 6 Rotate the Probe Size soft key to select the desired size of transducer mark...

Страница 77: ...ad the selected image on the full screen image You can also double click a thumbnail image to reload an image To scroll the page click the arrow mark of the scroll bar to move up and down Deleting images from the clipboard 1 1 Press the Cursor key to obtain the cursor 2 2 Move the cursor over the image you want to delete by using Trackball and press the Set key 3 3 Click the trash can icon on the ...

Страница 78: ...p on the function selection The dialog box appears 5 5 Select a media from the Device drop down list 6 6 If you select USB or USB HDD from the Device drop down list you can enter the description such as information or comment 7 7 If you select CD DVD from the Device drop down list you can use the following options Finalization of CD DVD Finalize the CD or DVD to prevent from further writing Verifi...

Страница 79: ...ou can use the following options Generate DICOMDIR file Save the patient data as DICOMDIR file Finalization of CD DVD Finalize the CD or DVD to prevent from further writing Verification after CD burning Verify your patient data in a CD or DVD after burning the CD or DVD 8 8 The system automatically creates a file name To change the file name select the Edit File Name check box and enter a file nam...

Страница 80: ...list 2 2 Select the patient s from the patient list 3 3 Select Send To on the touch screen or select Send To on the function selection The dialog box appears 4 4 Select Printer on the left of the dialog box 5 5 Select a standard default printer and set up the printing options 6 6 When you have finished click Print The selected printer prints out the selected image s Patient Browser Report Report a...

Страница 81: ...age and Patient Dat 2 35 Reviewing an image Select an image and select Review on the touch screen The image is shown on the scan screen Ending a study To end a study immediately Touch End Exam on the touch screen ...

Страница 82: ... current value press the Caliper key when the caliper is active To activate the caliper of another value press the Priority key repeatedly until the desired value is highlighted To delete a measurement 1 1 Click the result value you want to delete from the Result window The caliper is activated 2 2 Press the Clear key on the control panel To exit press the Exit key on user defined key or 2D key on...

Страница 83: ... Lengths 1 1 Select Distance on the touch screen The start point appears 2 2 Draw three straight lines using Trackball and press the Set key 3 3 Move the fourth point and then press the Set key 4 4 The measured value is fixed and three distances D1 D2 D3 are shown on the Result window Trace Length 1 1 Select Distance on the touch screen The start point appears 2 2 Use Trackball to move the marker ...

Страница 84: ...ce 1 1 Select Trace on the touch screen The start point appears 2 2 Use Trackball to move the marker to the start point and press the Set key The end point appears 3 3 Use Trackball to move the end point gradually along the circumference of the target object 4 4 When the start point and the end point are connected with a line press the Set key to complete the measurement 5 5 The measured value is ...

Страница 85: ... appears 7 7 The angle Angle is shown on the Result window Angle 3 Lines 1 1 Select Angle on the touch screen The start point appears 2 2 Use Trackball to move the marker to the start point and press the Set key The first point is fixed and the second arrow shaped point appears 3 3 Use Trackball to move the marker to the second point 4 4 Draw the baseline and press the Set key to fix the baseline ...

Страница 86: ...d press the Set key 4 4 The two diameters D1 D2 and the diameter percent stenosis Steno Diam are shown on the Result window Two ellipses percent stenosis calculation 1 1 Select Stenosis on the touch screen The start point appears 2 2 Measure the outer area A1 of the stenosis using Trackball and press the Set key 3 3 Measure the inner area A2 of the stenosis using Trackball and press the Set key 4 ...

Страница 87: ...e measured value is fixed The three distances D1 D2 D3 and the volume Vol are shown on the Result window Ellipse 1 1 Select Volume on the touch screen The start point appears 2 2 Use Trackball to move the marker to the start point and press the Set key The first point is fixed and the second point appears 3 3 Use Trackball to move the marker to the second point and press the Set key The ellipse ap...

Страница 88: ... Set key again 6 6 The volume is calculated The area A the circumference C the diameter D and the volume V are shown on the Result window Spline 1 1 Select DiskVolume on the touch screen The start point appears 2 2 Use Trackball to move the marker to the start point and press the Set key The second point appears 3 3 Set the third and subsequent points in the same manner 4 4 Press the Set key twice...

Страница 89: ...art point appears 2 2 Measure the first area A1 of the ratio using Trackball and press the Set key 3 3 Measure the second area A2 of the ratio using Trackball and press the Set key 4 4 The ratio is calculated The two ellipses A1 A2 and A B ratio A B Ratio are shown on the Result window Histogram 1 1 Select Histogram on the touch screen 2 2 Use Trackball to move the caliper to the corner of the are...

Страница 90: ...er to the start point on the 2D image and press the Set key The start point is fixed and the end point appears 7 7 Use Trackball to move the marker to the end point and press the Set key 8 8 The copied caliper appears on the Elastography image area 9 9 Use Trackball to move the marker of the copied start point to the desired position on the Elastography image and press the Set key The copied start...

Страница 91: ...kball to move the marker to the end point and press the Set key The target strain is shown on the Result window 8 8 The copied caliper appears on the Elastography image area 9 9 Use Trackball to move the marker of the copied caliper to the reference strain point on the Elastography image and press the Set key The reference strain is shown on the Result window 10 10 The measured value is fixed The ...

Страница 92: ...marker to the start point and press the Set key 3 3 Draw the first straight line using Trackball and press the Set key 4 4 Draw the second straight line using Trackball and press the Set key 5 5 Draw the third straight line using Trackball and press the Set key to complete the measurement 6 6 The measured value is fixed and three distances D1 D2 D3 are shown on the Result window Time 1 1 Select Ti...

Страница 93: ...played and the slope is calculated The distance D time T and slope Slope are shown on the Result window Stenosis Two diameters percent stenosis calculation 1 1 Select Stenosis on the touch screen The vertical line and the horizontal line are perpendicular to each other 2 2 Measure the larger vertical diameter D1 of the stenosis using Trackball and press the Set key 3 3 Measure the smaller vertical...

Страница 94: ...the touch screen The vertical line and the horizontal line are perpendicular to each other 2 2 Measure the first vertical diameter T1 of the ratio using Trackball and press the Set key 3 3 Measure the second vertical diameter T2 of the ratio using Trackball and press the Set key 4 4 The ratio is calculated The two distances T1 T2 and A B ratio Time Ratio are shown on the Result window Heart Rate H...

Страница 95: ...the Set key The start point is fixed and the end point appears 3 3 Use Trackball to move the point and press the Set key again 4 4 The time interval between the two points appears The velocity Vel and time T are shown on the Result window Acceleration 1 1 Select Acceleration on the touch screen The vertical line and the horizontal line are perpendicular to each other 2 2 Use Trackball to move to t...

Страница 96: ...rackball and press the Set key The end point appears 3 3 Use Trackball to manually trace the waveform and press the Set key 4 4 The pulsatility index is calculated The peak systolic velocity PS end diastolic velocity ED minimum diastolic velocity MD the maximum time average velocity TAmax the resistivity index RI the pulsatility index PI and systole diastole ratio S D Ratio are shown on the Result...

Страница 97: ... vertical line and the horizontal line are perpendicular to each other 2 2 Measure the first time interval T1 of the ratio using Trackball and press the Set key 3 3 Measure the second time interval T2 of the ratio using Trackball and press the Set key 4 4 The ratio is calculated The two time values T1 T2 and A B ratio Time Ratio are shown on the Result window AC DC 1 1 Select AC DC on the touch sc...

Страница 98: ...e key on the control panel to freeze the image The caliper and waveform trace automatically appear 5 5 The calculated value is shown on the Result window Auto Trace 1 1 In PW mode select the desired measurement item and then select Auto Trace on the touch screen The Doppler spectrum is traced automatically and the results are displayed 2 2 If necessary adjust the calculation cycle using Trackball ...

Страница 99: ...form and press the Set key The end point appears 3 3 Use Trackball to trace one cycle of the waveform and press the Set key 4 4 The calculated value is shown on the Result window Viewing and Editing a Worksheet Viewing a worksheet To view a worksheet do one of the following Touch Report on the touch screen Select Report on the context menu The system displays the worksheet for the current exam To ...

Страница 100: ...sk mark is appended to the updated value and resultant value to indicate that it was manually entered To delete measurement values 1 1 Use Trackball to move the cursor to the field that you want to erase The field is highlighted 2 2 Do one of the following Select Delete Value to delete the current value Press the Delete All soft key to delete all values for all measurement modes from the report Pr...

Страница 101: ... Patient screen you can edit text in the Exam Comments field Previewing the report To preview the report in print layout Select Preview on the touch screen or select Preview on the context menu You can preview a report to be printed To add an image to the report 1 1 Move the cursor to the desired image on the clipboard and press the Set key 2 2 Move the cursor where the selected image is to be ins...

Страница 102: ...r Select Print on the touch screen To capture the report screen Press the P1 P2 P3 or P4 key on the control panel NOTE A default standard printer can be configured in Utility Setup SystemPreset System Peripheral Standard Printer The supported paper size for report is A4 Letter only ...

Страница 103: ...3 Data Backup 3 2 System Care and Maintenance 3 4 Transducer Care and Maintenance 3 6 This chapter introduces the followings After the Exam is Over ...

Страница 104: ...DICAL SYSTEMS does not have the responsibility for data loss caused by the user s carelessness To access the Backup Restore preset 1 1 Touch Utility on the touch screen 2 2 Touch Setup on the touch screen 3 3 Touch the SystemPreset tab on the touch screen The System Preset screen appears 4 4 Select Backup Restore on the touch screen User Backup The User Backup menu allows you to back up the each p...

Страница 105: ...ns Image Backup The Image Backup menu allows you to perform image backup using a storage media Select your memory storage such as CD DVD USB flash drive USB hard disk and network storage To back up Image Archive 1 1 Configure Media 2 2 Configure Image Archive Option 3 3 Prepare unformatted CD s 4 4 Click Backup to start backup Image archive The media formatting starts and the instructional message...

Страница 106: ...r frayed cable Visually inspect all power cords Do not turn on the power if a cord is frayed or split or shows signs of wear If your system s power cord is frayed or split or shows signs of wear contact your ALPINION service representative for power cord replacement Visually inspect that the trackball and other controls on the control panel to make sure that they are clean and free from gel or oth...

Страница 107: ... NOTE To maintain the safety and functionality of the ultrasound system maintenance must be performed every 12 months Electrical safety tests must also be performed at regular intervals as specified by local safety regulations Refer to the service manual for the electrical leakage test To inspect the system examine the following on a monthly basis Connectors on cables for any mechanical defects En...

Страница 108: ...s or strain reliefs as it can damage those parts of the transducer This damage is not covered by the transducer warranty Cleaning the transducer 1 1 Disconnect the transducer from the system 2 2 Moisten a clean gauze pad with purified water and wipe the transducer to remove any gel or particles remaining on the transducer If purified water is not effective then you can use an approved pre cleaner ...

Страница 109: ...ed by the disinfection solution manufacturer 5 5 After disinfecting examine the housing strain relief lens and seal for damage and check for any functional problem If any damage is found do not use a transducer and contact your ALPINION MEDICAL service engineer or an authorized agent To high level disinfect a transducer 1 1 Disconnect the transducer from the system 2 2 Thoroughly clean rinse and d...

Страница 110: ...disinfectant products please refer to the relevant chapters in the User Manual Cable Handling Take the following precautions with transducer cables Keep free from wheels Do not bend the cable acutely Avoid crossing cables between transducers Planned Maintenance The following maintenance schedule is suggested for the transducer to ensure the optimum operation and safety Daily inspect transducers Af...

Страница 111: ...4 Safety Precautions 4 2 Equipment and Personnel Safety 4 3 Patient Safety 4 6 Anti Virus Program 4 8 Transducer Safety 4 9 System Symbols and Labels 4 11 This chapter introduces the followings Safety ...

Страница 112: ...s levels of safety precautions on your equipment and each level of caution can be identified by one of the following flag words and icons which precede the precautionary statement WARNING WARNING indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause severe or fetal personal injury or substantial property damage CAUTION CAUTION indicates that...

Страница 113: ...ower and unplug the power cord from the power outlet before cleaning up and disinfecting the system WARNING To avoid injury Do not remove the covers of a system yourself to avoid damage to the system and unexpected electrical shock Only qualified ALPINION service engineer must repair or replace components You must make sure grounded integrity of the power outlet and system regularly To avoid risk ...

Страница 114: ...mended to perform a regular backup CAUTION Do not use this system if a safety problem is known to exist Have the unit repaired and performance verified by qualified service personnel before returning to use CAUTION Your ultrasound system is not intended for diagnosing and monitoring ECG Do not use the system for cardiac operation CAUTION Always use approved ECG cables and recommended electrodes by...

Страница 115: ...nd accessories for transport Be sure the pathway is clear Move the system slowly and carefully Avoid collisions with walls or door frames Always place the system on horizontal ground and engage the caster brakes Do not move the system when the brakes are engaged Caution for Using Monitor When adjusting the height or position of the monitor do not place a finger hand or object on the joint of the m...

Страница 116: ...rs and should not be considered as the sole and incontrovertible basis for clinical diagnosis Users are encouraged to study the literatures and make their own professional conclusions regarding the clinical utility of the system The user should be familiar with product specifications system accuracy and stability limitations and consider these limitations before making decisions based on quantitiv...

Страница 117: ...e care when handling or storing transducers A damaged housing lens or cable can result in patient injury or transducer malfunctions CAUTION Do not use the system with defibrillator The system does not include a defibrillation proof applied part for ECG ALARA As Low As Reasonably Achievable Ultrasound can have harmful effects on tissues potentially causing patient injuries Always minimize exposure ...

Страница 118: ...lly a few points as to why ALPINION MEDICAL SYSTEMS Co LTD do not use the anti virus software Commercial anti virus software is commonly used on general purpose computers to detect the presence of malicious software e g virus Trojan horse worm Anti virus software is useful on general purpose computers as they typically cannot be sufficiently hardened against the attack vectors used by malicious so...

Страница 119: ...ly disconnect the ultrasound transducer and notify the ALPINION Service Representative Failure to follow these precautions can result in serious injury CAUTION After each use inspect the transducer s lens cable and casing Look for any damage that would allow liquid to enter the transducer If any damage is found do not use the transducer until it has been inspected and repaired replaced by ALPINION...

Страница 120: ...o not use an expired transducer sheath Before using transducer sheaths verify whether the term of validity has expired Failure to follow these instructions could lead to exposure to infectious agents WARNING Devices containing latex may cause severe allergic reactions in latex sensitive individuals CAUTION Do not use pre lubricated condoms as a sheath In some cases they may damage the transducer C...

Страница 121: ...ents Depending on the transducer model the immersion label may differ On the multi caution label rating label for overseas transducer label and gel warmer label This symbol indicates that when the end user wishes to discard this product it must be sent to separate collection facilities Please contact an authorized representative of the manufacturer for information concerning the decommissioning of...

Страница 122: ...ate format On the system rating label for overseas and transducer label Symbol for manufacturer This symbol shall be accompanied by the name and the address of the manufacturer On the system rating label for overseas and transducer label Serial Number On the multi caution label To ensure safety of user moving and delivering system shall be performed by at least 2 persons On the LCD caution label a...

Страница 123: ...ting the monitor arm Rear of the LCD monitor Caution label Top of the monitor arm Care against pinch shall be taken In accordance with IEC 60878 Rear of the system body Multi caution label Right cover of the system body No gender detection label Top or side panel of the system body Safety working load label Bottom of the control panel System rating label for overseas ...

Страница 124: ... rating label for domestics On the cable port of the gel warmer Gel warmer voltage label Rear of the gel warmer Gel warmer label Transducer Name of transducer manufacturer WEEE symbol indicating separate collection Certification mark Transducer Transducer name Serial IPX Rating Caution mark ...

Страница 125: ... Anyang si Gyeonggi do Republic of Korea T 82 2 3282 0903 F 82 2 851 5593 www alpinion com Copyright ALPINION MEDICAL SYSTEMS Co Ltd All rights reserved Reproduction adaptation or translation without prior written permission is prohibited except as allowed under the copyright laws ...

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