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FujiFilm SONOSITE X-PORTE, User Manual

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FujiFilm SONOSITE X-PORTE User Manual Download Page 23

Getting started

2-13

To connect a transducer to the system (without a TTC)

If the TTC is not installed on your system, you can connect one transducer directly to the system. 

1

Pull the transducer latch up, and rotate it clockwise.

2

Insert the transducer connector into the transducer port underneath the stand platform.

3

Make sure that the connector is firmly seated, and then turn the latch handle counterclockwise.

4

Press the latch up, securing the transducer connector to the system.

Summary of Contents for SONOSITE X-PORTE

Page 1: ...USER GUIDE ...

Page 2: ...A 2 371 711 CN 98108973 9 CN 98106133 8 CN 97113678 5 CN 103237499 CN 102753104 CN 101231457 DE 69831698 3 DE 69830539 6 DE 69730563 5 DE 60034670 6 DE 60029777 2 DE 602004027882 3 DE 602004023816 3 EP 1552792 EP 1589878 EP 1180971 EP 1180970 EP 0881492 EP 0875203 EP 0815793 ES 2229318 ES 159878 ES 1552792 ES 0881492 FR 158978 FR 1552792 FR 1180970 FR 0881492 FR 0875203 FR 0815793 GB 158978 GB 155...

Page 3: ... 6 Clinical monitor 2 6 VGA or digital video output 2 8 Touch panel 2 8 Onscreen keyboard 2 10 Preparing transducers 2 11 Connecting transducers 2 11 Selecting a transducer and exam type 2 14 Gel 2 19 Sheaths 2 20 Ports 2 20 Battery charge indicator 2 22 Transporting the system 2 22 Visual Guide videos 2 23 Intended uses 2 24 3 Setting up the system Administration settings 3 1 About security setti...

Page 4: ...ork Status settings 3 27 Power and Battery settings 3 28 Presets settings 3 28 General preferences 3 29 Brightness 3 29 Labels 3 30 Exam types 3 30 User profile settings 3 32 Importing and exporting 3 33 Routing selections 3 34 Associating routing selections with exams 3 34 Specifying educational DICOM archivers 3 35 System Information settings 3 36 USB settings 3 36 Limitations of JPEG format 3 3...

Page 5: ... the worklist 4 32 Ending the exam 4 35 Patient form fields 4 35 Images and clips 4 38 Reviewing 4 38 Printing images 4 41 Archiving and exporting 4 41 Saving images and video clips 4 44 DVR recording 4 47 Image Gallery 4 48 ECG 4 49 5 Measurements and calculations Measuring 5 1 Calipers 5 1 Viewing and deleting measurement results 5 2 Basic measurements in 2D 5 2 Basic measurements in M Mode 5 3 ...

Page 6: ...tetrical references 6 14 General references 6 20 7 Troubleshooting and maintenance Troubleshooting 7 1 Software licensing 7 2 Maintenance 7 5 System backups 7 5 Servicing 7 6 8 Cleaning and disinfecting Before getting started 8 1 Determining the required cleaning and disinfecting level 8 2 Spaulding classifications 8 2 Clean and disinfect system and transducer to a high level semi critical uses 8 ...

Page 7: ... Electrical 9 25 Imaging modes 9 25 Image and video clip storage capacity 9 25 Standards 9 25 Electromechanical safety standards 9 25 EMC standards classification 9 26 DICOM standard 9 26 HIPAA standard 9 26 10 Acoustic output ALARA principle 10 1 Applying the ALARA principle 10 1 Direct indirect and receiver controls 10 2 Acoustic artifacts 10 3 Guidelines for reducing MI and TI 10 3 Output displ...

Page 8: ... 11 1 Network for connecting the device 11 1 Specifications for the connection 11 1 Hardware specification 11 1 Security 11 1 Data flow 11 2 IT network failure recovery measures 11 3 Glossary Terms A 1 Abbreviations A 2 Index B 1 ...

Page 9: ...ing Refer to the applicable FUJIFILM SonoSite accessory user guide for information on using accessories and peripherals Refer to the manufacturer s instructions for specific information about peripherals Changes in version 1 2 Document conventions A WARNING describes precautions necessary to prevent injury or loss of life A Caution describes precautions necessary to protect the products A Note pro...

Page 10: ...nd then tap Help SonoSite X Porte Getting Started Guide Service manual FUJIFILM SonoSite Technical Support Phone U S or Canada 877 657 8118 Phone Outside U S or Canada 425 951 1330 or call your local representative Fax 425 951 6700 E mail ffss service fujifilm com Web www sonosite com Europe Service Center Main 31 20 751 2020 English support 44 14 6234 1151 French support 33 1 8288 0702 German sup...

Page 11: ...lable depend on your system configuration transducer and exam type Figure 2 1 and Figure 2 2 display the SonoSite X Porte in kiosk mode The ultrasound core can be detached from the kiosk to provide a desktop configuration WARNING Do not use the system if it exhibits erratic or inconsistent behavior Such behavior could indicate a hardware failure Contact FUJIFILM SonoSite Technical Support ...

Page 12: ...lections See Selecting a transducer and exam type on page 2 14 4 Optional Enter patient information See Entering patient information on page 4 31 5 Scan See Imaging modes on page 4 1 Figure 2 1 X Porte front view Figure 2 2 X Porte rear view 1 Clinical monitor 2 Touch panel 3 Platform 4 Hook 4 5 Transducer connector 6 Locking wheel 4 7 Height adjustment pedal 8 Basket 9 USB ports 3 10 Power button...

Page 13: ...inical monitor does not display the battery charge status disconnect and reconnect the system to AC power Connect the system to AC power to maintain battery charge especially if the system will not be used for several days To connect the system to AC power battery charge maintenance 1 Turn off the system 2 Disconnect the system from AC power WARNINGS Verify that the hospital supply voltage corresp...

Page 14: ...the wheel press up on the bottom of the lever To adjust the clinical monitor angle Grasping the clinical monitor on both sides tilt or rotate it Note The system will not charge and maintain the batteries if the battery switches are depressed to the O symbol which is the OFF position Note If the system appears unresponsive wait several minutes before restarting it Restarting the system while it is ...

Page 15: ...ure 2 3 on page 2 5 Figure 2 3 Clinical monitor collapsed for system transport USB devices You can use the USB ports on the system for connecting devices such as a USB printer or a USB memory stick For a list of supported devices see Compatible accessories and peripherals on page 9 12 One of the USB ports at the back of the system is for DVR recording only See Ports on page 2 20 and DVR recording ...

Page 16: ...void damaging the USB memory stick and losing patient data from it observe the following Do not remove the USB memory stick or turn off the ultrasound system while the system is exporting Do not bump or otherwise apply pressure to the USB memory stick while it is in a USB port on the ultrasound system The connector could break If the USB icon does not appear in the system status area on the clinic...

Page 17: ...he exam and system status Figure 2 4 Clinical monitor layout 1 Patient header 5 System status area 2 Measurement and calculation area 6 Imaging mode or modes controls selected 3 Ultrasound image 7 Depth scale 4 Selected transducer exam type and MI and TI values 8 Orientation marker 1 2 8 4 5 6 3 7 ...

Page 18: ...GS To avoid possible electrical shock or electromagnetic interference verify proper operation and compliance with relevant safety standards for all equipment before clinical use Connecting additional equipment to the ultrasound system constitutes configuring a medical system FUJIFILM SonoSite recommends verifying that the system all combinations of equipment and accessories connected to the ultras...

Page 19: ...color or zoom box Move calipers Move D line or M line Move Doppler baseline With two or more fingers drag anywhere on the touch panel to move or resize the active object such as the Color box or the Doppler gate Move depth marker in biopsy guide Change the D line angle selection Move labels pictograms and transducer marker Move through frames in the cine buffer Move controls to the Controls bar Pa...

Page 20: ...s of the characters Tap the shift key to change alphabet keys to uppercase characters Tap Previous to jump to previous text box Tap Freeze Adjust depth Select calipers Select image in dual Select mode in split screen 2D D line or Doppler trace Select control Double tap With two or more fingers double tap to freeze or unfreeze Double tap with one finger in the zoom box to zoom Double tap with one f...

Page 21: ... the transducer latch handle up and rotate it clockwise Note To display international characters on the keyboard tap and then tap the shift key WARNINGS Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals FUJIFILM SonoSite recommends that you identify your latex and talc sensitive patients and be prepared to treat allergic reactions ...

Page 22: ... connector into one of the three TTC connector ports on the bottom of the TTC 3 Make sure that the connector is firmly seated and then turn the latch handle counterclockwise 4 Press the latch handle up securing the transducer connector to the TTC ...

Page 23: ...ansducer directly to the system 1 Pull the transducer latch up and rotate it clockwise 2 Insert the transducer connector into the transducer port underneath the stand platform 3 Make sure that the connector is firmly seated and then turn the latch handle counterclockwise 4 Press the latch up securing the transducer connector to the system ...

Page 24: ...e exam type Tap the exam type and then tap SCAN or tap Cancel to cancel Scrolling the list of exam types displays any hidden items You can also select the exam type on the patient form see Entering patient information on page 4 31 Related topics Intended uses 2 24 Caution To avoid equipment damage that could lead to image quality degradation do not disconnect a transducer while it is in use Either...

Page 25: ...ble in the cardiac exam only Color Power Doppler CPD is available in all exams except the cardiac exam type Color Velocity Doppler CVD is supported on all transducers except for D2xp b For the cardiac exam type PW TDI is also available c Make sure you unscrew the D2xp stabilization handle before moving the transducer from its parked position d Needle guide capable For more information refer to Usi...

Page 26: ... aColor Doppler Variance Var is available in the cardiac exam only Color Power Doppler CPD is available in all exams except the cardiac exam type Color Velocity Doppler CVD is supported on all transducers except for D2xp b For the cardiac exam type PW TDI is also available c Make sure you unscrew the D2xp stabilization handle before moving the transducer from its parked position d Needle guide cap...

Page 27: ...lerb CW Doppler a Color Doppler Variance Var is available in the cardiac exam only Color Power Doppler CPD is available in all exams except the cardiac exam type Color Velocity Doppler CVD is supported on all transducers except for D2xp b For the cardiac exam type PW TDI is also available c Make sure you unscrew the D2xp stabilization handle before moving the transducer from its parked position d ...

Page 28: ...or Doppler Variance Var is available in the cardiac exam only Color Power Doppler CPD is available in all exams except the cardiac exam type Color Velocity Doppler CVD is supported on all transducers except for D2xp b For the cardiac exam type PW TDI is also available c Make sure you unscrew the D2xp stabilization handle before moving the transducer from its parked position d Needle guide capable ...

Page 29: ...exam types on transducers continued Transducer Exam type Imaging mode 2D M Mode Colora PW Dopplerb CW Doppler a Color Doppler Variance Var is available in the cardiac exam only Color Power Doppler CPD is available in all exams except the cardiac exam type Color Velocity Doppler CVD is supported on all transducers except for D2xp bFor the cardiac exam type PW TDI is also available cMake sure you un...

Page 30: ...e no holes or tears Ports Two dock configurations are now available The dock provides ports for various applications see Figure 2 5 on page 2 20 and Figure 2 6 on page 2 21 Figure 2 5 Back of system with first dock configuration 1 USB 2 Digital video in 3 Audio in 4 MicroSD DVR software upgrade 5 USB storage DVR 6 E SATA unsupported 7 USB 8 Ethernet WARNING Use market cleared sterile transducer sh...

Page 31: ...nd dock configuration 1 USB 2 USB 3 MicroSD DVR software upgrade 4 USB storage DVR 5 VGA out 6 Ethernet Each connector has a symbol that describes its use USB Ethernet MicroSD DVR software upgrade USB storage DVR VGA out Digital video in Audio in 1 2 3 4 5 6 ...

Page 32: ...at the battery charges fully If the battery fails to charge fully contact FUJIFILM SonoSite Technical Support see Getting help on page 1 2 Use only FUJIFILM SonoSite batteries with the system The battery is partially charged The length of the blue bar indicates the level of battery charge The example illustrates a battery charge of 25 If Beep Alert is on see Audio settings on page 3 6 the system b...

Page 33: ...f positions Visual Guide videos The Visual Guide library contains animated 3D videos that describe scanning techniques terminology and more Scanning is active while a video plays so you can practice scanning techniques in conjunction with the visual guides ...

Page 34: ...t the bottom of the player Tap the volume control to mute the audio Tap again to unmute Drag the volume slider to adjust the volume Tap Hide to hide the player You can tap LEARN to show the player again Tap another video in the list to play it Tap LEARN to return to the Visual Guide screen Intended uses The system is used with a transducer attached and is powered either by battery or by AC electri...

Page 35: ...nd infertility imaging applications You can assess the uterus ovaries adnexa and surrounding anatomical structures for the presence or absence of pathology transabdominally or transvaginally You can assess blood flow in pelvic organs transabdominally and transvaginally Interventional department imaging applications You can use the system for ultrasound guidance in biopsy and drainage procedures va...

Page 36: ...h nodes hernias musculoskeletal structures soft tissue structures ophthalmic structures and surrounding anatomical structures for the presence or absence of pathology You can detect normal lung motion for the presence or absence of pathology You can demonstrate blood flow in superficial anatomical structures You can use the system for ultrasound guidance in biopsy and drainage procedures vascular ...

Page 37: ...enter passwords Required login helps protect patient information You can also add and delete users and change passwords To display the Administration Login settings page 1 Tap MORE and then tap System Settings 2 Tap Administration in the list on the left Notes Not all system settings are available if you log in to the system as a guest see Logging in on page 3 5 Reset functions are provided on som...

Page 38: ...name in the Password text box 3 Tap Login To log out as Administrator Do one of the following Tap any other settings page Turn off or restart the system To change the administrator password 1 On the Administration Login settings page log in as a user with administrative privileges 2 Under User List tap Administrator 3 Type the new password in the Password text box and in the Confirm text box Cauti...

Page 39: ...play the patient name and ID number on the clinical monitor and to remove it from exported images and video clips 1 On the Administration Login settings page log in as a user with administrative privileges 2 Tap Administrator in the User List 3 Select Disable Patient Header 4 Tap Save To disable export and recording of patient data You can prevent users from exporting patient data to USB memory st...

Page 40: ... administration privileges 7 Tap Save 8 Tap Done To modify a user 1 On the Administration Login settings page log in as a user with administrative privileges 2 Under User List select the user 3 Make changes to the Name User or Administration Access entries 4 Tap Save 5 Tap Done To change a user password 1 On the Administration Login settings page log in as a user with administrative privileges 2 U...

Page 41: ...nd clips view worksheets and access Help and Visual Guide videos Guests cannot access patient information or system settings except Monitor Brightness and Touch Panel Brightness When you log in as a guest the system always displays the 2D imaging screen no matter which startup mode is specified in User Profile settings see User profile settings on page 3 32 1 Turn on the system 2 In the login scre...

Page 42: ...g the Beeps and Clicks Volume slider To mute the volume for Beeps and Clicks tap the volume control to mute the audio Tap again to unmute Calculations settings On the Calculations settings page you can specify measurement names that appear in the Tissue Doppler Imaging TDI calculations list and in the reports for cardiac exams You can select authors for obstetrics calculation tables and import cus...

Page 43: ...culations lists in the list of custom measurements in Calculations settings and in the obstetric report You can create custom measurements on the system or in the SonoSite X Porte OB Custom Table Editor a Microsoft Excel file available at www sonosite com You can associate table data with a custom measurement only if you create the measurement in the OB Custom Table Editor Export custom measuremen...

Page 44: ...Content after the Security Warning at the top of the page Mac OS Click Enable Macros 3 If needed specify the language of the editor by selecting a language from the Please Specify Language list located on the Setup First tab The language selected must match the language of the SonoSite X Porte system on which you import the tables 4 On the Setup First tab click the Growth or Age table that you wan...

Page 45: ...ngs page tap Tables d Tap Import e Select the USB memory stick that contains the CSV file and then tap Import f The system restarts To create custom obstetrics measurements on the system 1 End the current exam 2 On the Calculations settings page tap OB 3 In the OB Custom Measurements area tap Add New 4 In the Name box type a unique name 5 In the Type list select the desired measurement type 6 Tap ...

Page 46: ...m obstetric table 1 On the Calculations settings page tap Tables 2 Select Gestational Age or Growth Analysis and then select the Measurement and Author for the table you want to delete 3 Tap Delete CDA Report settings When you select Include CDA on the DICOM Archivers configuration page the ultrasound system archives the patient report in DICOM Encapsulated CDA Clinical Document Architecture forma...

Page 47: ... fields in the Authenticator section 6 Tap Save To specify a CDA profile On the CDA Report settings page select a profile from the Active Configuration list To delete a CDA profile 1 On the CDA Report settings page tap Config 2 Select the CDA profile you want to delete in the CDA List and tap Delete Related topics DICOM 3 13 Connectivity settings On the Connectivity settings page you specify the s...

Page 48: ...lude DICOM configuration data for locations wireless settings archivers printers storage commit servers worklist servers and MPPS servers The system does not import IP addresses or AE titles when you import configuration data from another system To import connectivity settings 1 Connect the USB memory stick that contains the settings see To connect a USB memory stick for importing or exporting on ...

Page 49: ...OM Using data in the Digital Imaging and Communications in Medicine DICOM standard the ultrasound system can do the following Transfer patient exam data to an archiver DICOM printer or storage commitment server see Archiving and exporting on page 4 41 Import patient data from a worklist see Entering patient information on page 4 31 Export exam data as DICOMDIR files to a USB storage device see USB...

Page 50: ...ation settings to a USB memory stick kept in a secure location You can revert to the default settings if necessary See Importing and exporting connectivity settings on page 3 12 2 Connect to the network See Connecting to the network on page 3 14 3 Complete the configuration pages for locations and devices See DICOM configuration pages on page 3 16 4 Associate devices with locations See Associating...

Page 51: ...upports the following file types CER PFX and PVK 1 Tap MORE and then tap System Settings 2 Tap Connectivity in the list on the left 3 On the Connectivity setup page tap Wireless Certificates A list of certificates on the system appears 4 Do one of the following Import certificates Connect the USB memory stick that contains the certificates see To connect a USB memory stick for importing or exporti...

Page 52: ...n for storage commitment servers devices that take responsibility for and provide receipt of content sent by the ultrasound system Worklist Configuration for worklist servers devices that contain scheduled patient procedure data You can import the data into the patient form see Entering patient information on page 4 31 MPPS Configuration for MPPS servers devices that coordinate detailed informatio...

Page 53: ...ltrasound system location Cannot be between 127 0 0 0 and 127 0 0 8 Subnet Mask Identifies a network subdivision The default value is 255 255 0 0 Default Gateway IP address where network connects to another network Cannot be between 127 0 0 0 and 127 0 0 8 Transfer Images Specify when to transfer images during or at end of exam JPEG Compression Select High Medium or Low A high compression has a sm...

Page 54: ...on of letters and symbols that allows user access Certification Authority Validates the authentication server or certificate authority The list is populated by wireless certificates that you have imported see Optional To import or delete wireless certificates on page 3 15 Select the desired certificate from the list EAP PEAPv0 User Name Name of designated user Password A unique combination of lett...

Page 55: ...e Authentication Protocol The following fields appear User Name Name of designated user Password A unique combination of letters and symbols that allows user access Certification Authority Validates the authentication server or certificate authority The list is populated by wireless certificates that you have imported see Optional To import or delete wireless certificates on page 3 15 Select the d...

Page 56: ...o associate the archiver with the Educational routing select See Routing selections on page 3 34 Printer Required fields are marked with asterisks Name Network host name for a printer Alias Personalized name for a printer IP Address Unique identifier for the printer Port Device port number IP port 104 is typically assigned for DICOM AE Title Printer DICOM Application Entity Title Ping Select to de...

Page 57: ...sity of the black value in hundredths of optical density OD Min Minimum density of the white value in hundredths of optical density OD Border Density of the areas surrounding and between film images in hundredths of optical density OD Empty Empty image density in hundredths of optical density OD Magnification Type of interpolation used during printing Configure Printer specific configuration value...

Page 58: ...are marked with asterisks Name Network host name for a worklist server Alias Personalized name for a worklist server AE Title Application Entity Title Worklist Restricts the query to patient procedures that are scheduled for Today Yesterday today tomorrow All This Device Only Restricts the query to patient procedures that are scheduled for the system based on its AE Title Modality US Ultrasound is...

Page 59: ...S server Port Device port number IP port 104 is typically assigned for DICOM Ping Tap to determine whether the IP address is accessible The system displays OK or Failed Associating devices with locations For each location select which devices archivers and printers you want to receive the data that you transfer which archivers you want to designate as an MPPS or storage commitment server and which...

Page 60: ...n 7 If you want to use the storage commitment service associate the storage commitment server with the archiver a Check the box for the storage commitment server that you want Storage commitment servers appear at the end of the list b Check the box for the archiver c Check the box in the archiver s SC column 8 Complete any additional configuration tasks and then tap Done To disassociate devices wi...

Page 61: ...To set the date and time On the Date and Time settings page do the following In the Date boxes type the current year month and day In the Time boxes type the current time in hours and minutes To obtain the system time from a time server select Use Time on Time Server and enter the Server Address These options are available only if the DICOM licensed feature is enabled on the system To specify that...

Page 62: ...lowing logs User Collects information about user logins and user creation as well as information about when the log was exported or cleared DICOM Collects network errors and events typically to support diagnostics see DICOM on page 3 13 Assert Collects processor exceptions and software generated assertions to support diagnostics The assert log is visible only to users with administrative privilege...

Page 63: ...p Yes to confirm the deletion Related topics DICOM 3 13 Network Status settings The Network Status settings page displays information on system IP address location subnet mask default gateway wireless network SSID connected BSSID wireless MAC address the Ethernet MAC address as well as signal strength and connected status when connected to a wireless network To display the Network Status settings ...

Page 64: ...lowing lists Sleep Delay Select Off or 5 or 10 minutes to specify the period of inactivity before the system goes into sleep mode The system will automatically turn off if it is in sleep mode and the battery charge level drops below 14 Power Delay Select Off or 15 or 30 minutes to specify the period of inactivity before the system automatically turns off Presets settings The Presets settings page ...

Page 65: ...ally generates a unique patient ID upon starting an exam from the patient form unless a patient ID is entered manually or from the worklist This option can be used to accommodate certain workflows Prefix Defines a prefix string attached to the beginning of the automatically generated patient ID This enables you to easily search for the patient ID on the image storage system at a later time This op...

Page 66: ...label tap the X next to the label To reset labels to the factory default tap Reset To select a new exam type tap Exam Type To specify label retention when unfreezing You can specify that all labels be cleared from an image when you unfreeze the image 1 On the Presets settings page tap Labels 2 Select Clear Labels on Unfreeze Exam types The system displays both system defined and user defined exam ...

Page 67: ...type transducer combination For example you can customize five different exam types for Abdomen on the P21xp transducer and five different exam types for Abdomen on the C60xp transducer You can rename delete export show hide reorder and import user defined exam types See Presets settings on page 3 28 To customize an exam type 1 Select a transducer and exam type see Selecting a transducer and exam ...

Page 68: ...ype or viewing visual guides Scanning Displays the 2D imaging screen Transducer Exam Select Displays the options for selecting transducers and exam types Patient Info Displays the patient form To automatically query the worklist from a bar code scanner You can specify that the system query the worklist for patient information when you scan a patient ID bar code 1 On the Presets settings page tap U...

Page 69: ...ow to the factory default If you have moved controls from the More Controls window to the Controls bar resetting the controls removes them from the Controls bar Similarly resetting the controls moves controls you have moved from the Controls bar to the More Controls window 1 On the Presets settings page tap User Profile 2 Tap Reset More Controls To show or hide the Learn button You can specify tha...

Page 70: ... then tap Yes Select the desired USB memory stick and then tap Export A copy of all labels exam types user accounts and system settings saves to the USB memory stick Passwords for user accounts are encrypted Routing selections Routing selections let you control where patient exams are archived You can associate one or more routing selections with an exam The system supports three routing selection...

Page 71: ...s associated with the Educational Accreditation routing selection to that archiver Archivers that are not specified as educational are procedural billing archivers The system archives exams associated with the Diagnostic and Procedural routing selections to these archivers If you do not specify an archiver as an educational archiver exams associated with the Educational Accreditation routing selec...

Page 72: ...ng on page 7 2 To display the System Information settings page 1 Tap MORE and then tap System Settings 2 Tap System Information in the list on the left USB settings On the USB settings page you can view information about connected USB devices including space availability You can also specify a file format and options for images and video clips in patient exams that you export to a USB memory stick...

Page 73: ...at affects both still images and video clips For optimal DICOM image quality select RGB image format and low compression 3 Multimedia Export only Select a sort order from the Sort By list 4 Select Auto Export to enable automatic export of ended exams See also To export patient exams automatically to a USB memory stick on page 4 44 5 DICOM Export only Select any of the following Include eFilm Lite ...

Page 74: ...te image viewer after exporting exams 1 Insert the USB memory stick into your computer 2 Display the USB memory stick s contents 3 Double click eFilmLite bat 4 eFilmLite bat starts the executable file in the eFilmLite folder The eFilmLite folder contains the eFilm Lite software and related files See also the eFilm Lite User s Guide a PDF file in the eFilmLite folder Setting Quality Level Low 100 T...

Page 75: ...Setting up the system 3 39 ...

Page 76: ...3 40 Setting up the system ...

Page 77: ...ion about working with controls see Imaging controls on page 4 6 For a list of imaging modes available by transducer and exam type see Selecting a transducer and exam type on page 2 14 Related topics Doppler 4 4 Color 4 3 M Mode 4 2 2D 4 2 Dual 4 5 Imaging controls 4 6 Controls in 2D 4 8 Controls in Color 4 12 Controls in Doppler 4 16 Controls in M Mode 4 14 Note When you change display formats fo...

Page 78: ...ded See Controls in 2D on page 4 8 Related topics Controls in 2D 4 8 M Mode Motion mode M Mode is an extension of 2D It provides a trace of the 2D image displayed over time A single beam of ultrasound is transmitted and reflected signals are displayed as dots of varying intensities creating lines across the screen When you tap M Mode the M line appears You can drag the M line to the area of intere...

Page 79: ... topics Controls in M Mode 4 14 Color Color imaging shows the presence velocity and direction of blood flow toward and away from the transducer In Color mode the area within the highlighted box displays blood flow in color To scan in Color 1 Tap Color The color box appears 2 Position and resize the color box as needed To position drag the box To resize do either of the following Pinch or spread th...

Page 80: ...ler Imaging PW TDI and continuous wave CW Doppler are available CW Doppler is not range specific When you tap Doppler the D line appears You can position the D line adjust the gate size or correct the angle of the D line before you display the Doppler trace To scan in Doppler 1 Tap Doppler The D line appears 2 Do any of the following as needed Position the D line by dragging the line left or right...

Page 81: ...ctivate them or tap Update to toggle between them Related topics Controls in Doppler 4 16 Dual Dual displays side by side 2D and Color images The system supports independent image information for each dual side for example depth and orientation markers You can switch between the two images and adjust some controls for example depth mode and gain independently You can view frames in the cine buffer...

Page 82: ...is hidden tapping More Controls displays it 3 Tap FREEZE 4 Do any of the following Drag the slider Right moves forward and left moves backward Tap or to move forward or backward through frames one at a time The current frame number appears on the touch panel The frame number changes as you move forward or backward Tap the right hand or left hand image or tap Update to switch between the right hand...

Page 83: ...ntrols window tap More Controls or tap anywhere outside the More Controls window To place controls in the Controls bar 1 Start the imaging mode whose controls you want to place 2 If placing controls for frozen imaging freeze the image see To freeze the image on page 4 22 3 Tap More Controls The More Controls window appears 4 Do the following for each imaging mode available At the top of the window...

Page 84: ...he 2D pane Needle Profiling Tap on highlighted icon to enhance linear structures within a selected angle range and facilitate needle guidance See Visualizing needles on page 4 24 Orientation Tap to select the image orientation and align the image with the transducer Upper Right Upper Left Lower Left Lower Right Res Gen Pen Settings are as follows Res provides the best possible resolution Gen provi...

Page 85: ...ers that are needle guide capable and important safety information see the transducer s user guide and Using CIVCO Products with FUJIFILM SonoSite Systems Only compatible with Full sector ECG Displays ECG trace options ECG is available only on the cardiac exam type See ECG on page 4 49 Procedure Mode Tap this control to turn it on highlighted icon or off dimmed icon Allows you to view the image un...

Page 86: ...Turns the centerline graphic on or off See Related topics on page 4 11 Centerline is available only with certain transducers and is not available in zoom mode or when Needle Guide is on Distance Measures the distance between two points See Measuring on page 5 1 Ellipse Uses an ellipse to measure a region s circumference or area See Measuring on page 5 1 Trace Lets you trace manually to measure an ...

Page 87: ...ationship of the centerline graphic to the transducer and the ultrasound image Small tilts or rotations of the transducer can affect the relationship between any external reference points and the anatomy that appears on the ultrasound image Figure 4 2 Relationship of the ultrasound image to the transducer angle or tilt Related topics Ensure orientation marks on the screen and transducer are on the...

Page 88: ...Variance displays a color map that shows regurgitant jet turbulence The highest velocities appear as green Flow State Lets you adjust the sensitivity of color parameters or settings to enhance the flow state The system initially selects a setting based on the exam type High optimizes for high flow states such as cardiac The High setting minimizes flash artifacts Medium optimizes for medium flow st...

Page 89: ...ilable when Color is set to CPD Hide Color Show Color Shows and hides color Zoom Magnifies the image See Zooming in on the image on page 4 23 Save Exam Type See Customizing exam types on page 3 31 Video Clip Settings See Saving video clips on page 4 45 Target Depth Measures the distance from the skin line to a specified point on the image For instructions see Measuring on page 5 1 Label Provides t...

Page 90: ...censed Acute Care feature See Acute Care calculations on page 5 45 Table 4 3 M Mode controls Button name Description Available in Live Froze n Dyn Range Adjusts the grayscale range Tap the control and then tap Up or Down to select a setting 3 2 1 0 1 2 or 3 The selected setting is applied to both 2D and M Mode The positive range increases the number of grays displayed and the negative range decrea...

Page 91: ...mages independently of each other To make an image active tap it or tap Update Label Provides tools that let you place text pictographs and arrows onto an image See Labeling images on page 4 28 Update Tap to toggle display of 2D and M Mode controls and calculations Distance Time Available when displaying the M Mode sweep Provides calipers to measure distance in centimeters and measure time in seco...

Page 92: ...oppler Imaging CW and TDI are available only in the Cardiac exam type Steering Linear transducers only Determines the angle of the D line Angle Correct Available only in PW Doppler Corrects the angle Tap this control and then drag the slider or select a setting 0 60 or 60 You can also adjust the angle by tapping the double headed arrows on the D line Gate Size Tap Up to increase the gate size Tap ...

Page 93: ...h Measures the distance from the skin line to a specified point on the image For instructions see Measuring on page 5 1 Label Provides tools that let you place text pictographs and arrows onto an image See Labeling images on page 4 28 Distance Measures the distance between two points See Measuring on page 5 1 Ellipse Uses an ellipse to measure a region s circumference or area See Measuring on page...

Page 94: ...ecrease the gate size You may also pinch or expand the gate with your fingers Wall Filter Helps to filter out echoes from low frequency signals Tap to select the strength of the filter Low Med or High Sweep Speed Sets the sweep speed Tap this control and then select the speed Slow Med or Fast Update Updates the image In Dual tapping the control switches the active side from left to right or right ...

Page 95: ...ontrol the display relative to the baseline While Peak and Mean are available both during live imaging and when the image is frozen the settings Above Below and All are available during live imaging only ECG Displays ECG trace options ECG is available only on the cardiac exam type See ECG on page 4 49 Save Exam Type See Customizing exam types on page 3 31 Label Provides tools that let you place te...

Page 96: ... value appears in a rectangle in the lower right corner of the image area or upper right corner if the image orientation is upside down Do either of the following on the touch panel Tap a marker on the depth scale Calcs See About calculations on page 5 8 Heart Rate Provides calipers to measure heart rate Slope Provides calipers to measure slope and slope related measurements Only available in the ...

Page 97: ... the gain sliders Drag a slider left or right to decrease or increase the gain respectively In Color or Doppler drag the C Color or the D Doppler gain slider at the bottom of the touch panel In 2D or M Mode tap the gain slider or the M M Mode gain slider at the bottom of the touch panel Two additional sliders appear The upper slider adjusts the near gain of the 2D image controlling the display int...

Page 98: ...ze the image Do either of the following Drag or swipe the Slide to Unfreeze slider to the right With two or more fingers double tap the touch panel Related topics Measuring 5 1 Viewing the cine buffer While imaging X Porte always retains a certain number of frames in the cine buffer You can move forward and backward in the cine buffer The system clears the cine buffer when you unfreeze the image Y...

Page 99: ...es as you move forward or backward Zooming in on the image You can zoom in on a 2D image in 2D M Mode Doppler and Color imaging You can freeze or unfreeze the image or change the imaging mode while zooming When you zoom in on an image the Zoom icon appears on the image To zoom in live imaging 1 Tap Zoom A zoom box appears If this control is hidden tapping More Controls displays it 2 Size and posit...

Page 100: ...le Profiling is on Using movement and fluid injection verify the needle tip location and trajectory Needle Profiling enhances linear structures within a selected angle range on the ultrasound plane Linear structures outside the selected angle range or the ultrasound plane such as a bent needle may be less apparent Note that linear structures are enhanced only in an outlined portion of the image Th...

Page 101: ... enhanced when perpendicular to the angle guide Figure 4 3 on page 4 25 Figure 4 3 Image with Steep Needle Profiling on The area within the green trapezoidal outline is the enhancement area For curved array transducers Steep Needle Profiling technology can help identify the direction of the needle although only segments of the needle shaft may show in the image See Figure 4 4 on page 4 26 Use move...

Page 102: ...hange the enhancement area from one side of the image to another Tap Shallow Medium or Steep to select a needle angle The needle angle sets the angle guide dashed angled line Linear transducer Use whichever setting best provides a perpendicular intersection with the angle guide Within the enhancement area the more perpendicular that a linear structure is to the angle guide the more it is enhanced ...

Page 103: ...ed procedures You can angle the needle up to 50 from the transducer surface Beyond 50 the needle may be less enhanced Needle Profiling has little or no benefit to out of plane procedures Needle Profiling is intended for in plane procedures only Figure 4 5 Needle size and angle 1 Needle 2 Transducer For best results angle the needle only up to 50 from the transducer surface Additional recommendatio...

Page 104: ...t and then tap Done To add one or more predefined labels tap them and then tap Done To place text manually and add a predefined label type text in the field at the top of the form tap in the field again and then tap one or more predefined labels Collapse the onscreen keyboard by tapping outside the keyboard area or tapping Tap Done To clear text or predefined labels tap Clear To undo changes and r...

Page 105: ...d orient the arrow To position the arrow drag it To orient the arrow drag the circle s edge To remove the arrow select it and then tap Delete in the Arrow list Adding pictographs The pictograph set available depends on transducer and exam type Each pictograph you place includes a transducer orientation icon To place a pictograph on an image 1 Tap Label If this control is hidden tapping More Contro...

Page 106: ...l in review 1 In Review tap the image or video clip you want to label To view the previous or next image or video clip tap Prev or Next 2 Video clips only Tap the pause button and then drag the slider to the frame you want to label 3 Tap Labels 4 Do one of the following Place the label For text see To place text on an image on page 4 28 For an arrow see To place an arrow on an image on page 4 29 F...

Page 107: ...Entering patient information manually on page 4 32 Importing information from a DICOM worklist server see Entering patient information from the worklist on page 4 32 Scanning a patient bar code and obtaining patient information from a worklist server see To enter patient information from the worklist with a bar code scanner on page 4 32 Scanning a patient bar code to obtain the patient ID see Bar ...

Page 108: ...following Connect the system to the network Configure the system for DICOM transfer Select a worklist server for the active location See DICOM on page 3 13 To enter patient information from the worklist with a bar code scanner You can specify that the system query the worklist for patient information when you scan a patient ID bar code 1 On the User Profile setup page select Bar Code Auto Query se...

Page 109: ...res Name Scheduled procedures Protocol Protocol for the selected procedure Meaning Definition of the selected procedure To change the procedure You can select a procedure different from the scheduled procedure 1 Under Performed Procedure on the patient form select the desired procedure from the Code list The definition of the procedure appears in the Meaning field 2 If you want to modify the Code ...

Page 110: ...ithson Smithy Under Additional Worklist Query Parameters specify any of the following Modality Select a procedure type from the list US Ultrasound is the default Requested Procedure ID Type a procedure ID 2 Tap Query The worklist appears with the query results The number of results is in the lower right screen The time of the last query appears below the worklist 3 Highlight the patient procedure ...

Page 111: ...ttings on page 3 32 Patient form fields Field descriptions The patient form fields available depend on exam type In some fields you can enter symbols and special characters see To enter text using the onscreen keyboard on page 2 10 Patient Last First Middle Patient name ID Patient identification number Date of Birth Gender Accession Enter number if applicable Indications Enter desired text Exam No...

Page 112: ...wins Obstetrical exam Select the Twins check box to display Twin A and Twin B measurements on the calculations menu and for access to Twin A and Twin B screens for previous exam data LMP or EDD Obstetrical or Gynecology exam In an Obstetrical exam select LMP or EDD and then enter either the date of the last menstrual period or the established due date In a Gynecology exam enter the date of the las...

Page 113: ...ting Any additional person obtaining or interpreting the images Routing Selection When you associate one or more routing selections with an exam the system reflects the routing selections in the patient report and in the Acute Care worksheet if the Acute Care Worksheets licensed option is installed See Worksheets and reports on page 5 52 If you have specified a DICOM archiver as an Educational arc...

Page 114: ...s To measure during review see Measuring during review on page 5 57 Patient list The patient list organizes saved images and video clips in patient exams You can sort the patient list view and delete exams edit patient information and append images and video clips to an existing exam From the patient list you can also export exams to a USB memory stick select a routing selection to associate with ...

Page 115: ...ient list Tap the column heading that you want to sort by Tap it again to sort in reverse order To select all exams in the patient list Tap Select All To deselect all exams tap Clear All To delete an exam 1 In the patient list select the check box next to one or more exams 2 Tap Delete To view exam information 1 Tap the exam in the patient list 2 Tap Info To edit patient information from the patie...

Page 116: ...ideo clips play automatically after loading The load time depends on video clip length To review images and video clips 1 Tap REVIEW and then do either of the following Review the current exam Review a completed exam Tap Patient List In the patient list tap the exam and then tap Thumbnails 2 Do any of the following To view the previous or next image or video clip tap Prev or Next To view images or...

Page 117: ... saved image from a current or ended exam 1 Make sure that the power button on the printer is in the On position 2 Tap REVIEW 3 Do one of the following Select the check box for an image from a current exam Select an image from an ended exam Tap Patient List tap the exam tap Thumbnails and then select the check box for an image 4 Tap Full Screen 5 Tap Print Archiving and exporting The patient list ...

Page 118: ...tion configuration page Exams are printed only at the end of an exam You can also manually archive exams The Archive in Progress icon is animated when patient exams are archiving Pending exams are archived starting at the top of the patient list To verify that exams transferred 1 Tap REVIEW 2 Tap Patient List The column shows the status of exam transfer Patient exam is archived Patient exam is arc...

Page 119: ...t to one or more exams 5 Tap Archive The system removes any status markers To discontinue MPPS for an exam You can discontinue MPPS for an exam before completing the exam On the patient form tap Discontinue Exporting exams You can export patient exams if they are ended and if the system administrator has not disabled USB export See Ending the exam on page 4 35 and Administration settings on page 3...

Page 120: ...ted the exam To export patient exams automatically to a USB memory stick 1 Make sure that automatic export is enabled See To specify export options on page 3 37 2 Insert a USB memory stick into a USB port on the side of the system 3 End the exam Saving images and video clips You can save images and video clips to internal storage The system plays a sound if Beep Alert is on see Audio settings on p...

Page 121: ...after you tap Save Video Clip The system captures frames for the number of seconds or beats you specify in the Time or ECG list A forward clip symbol displays in the system status area Retrospective captures frames from presaved data available before you tap Save Video Clip The system captures presaved frames for the number of seconds or beats you specify in the Time or ECG list A backward clip sy...

Page 122: ... Video Clip Settings the video clip automatically begins playing on the clinical monitor 3 Optional Preview Video Clip only Trim the video clip a Tap the scissors icon b Drag the trim sliders to remove frames from the left or right sides of the video clip c Tap Save Managing internal storage space The save available icon in the system status area see Figure 2 4 on page 2 7 shows the percentage of ...

Page 123: ... Ports on page 2 20 2 Tap Rec at the upper right of the touch panel The system begins recording to the USB memory stick in the DVR port and displays a flashing recording indicator 3 To stop recording tap Rec or end the exam To copy DVR recordings to another device 1 After you stop recording remove the USB memory stick from the DVR 2 Insert the USB memory stick into another device for example a per...

Page 124: ...y Individually exported images and clips are saved as jpg and avi files and do not contain other study information To export images 1 Insert a USB memory stick into a USB port on the X Porte system 2 On an active exam tap REVIEW Note If video recorded from the DVR is too bright when you view it on a personal computer you can adjust the video color settings on your PC s monitor For example change t...

Page 125: ...tient information can be included during export by selecting the Include patient information on images and video clips check box 9 Tap Export ECG The ECG feature requires an optional FUJIFILM SonoSite ECG module ECG is available only on the cardiac exam type Note All images and clips exported to the USB memory stick are stored on the root level of the drive This is to facilitate viewing in Image G...

Page 126: ... Controls displays it 4 Do any of the following in the ECG Settings window To display the ECG trace select Show Cautions Use only accessories recommended by FUJIFILM SonoSite with the system Connecting an accessory not recommended by FUJIFILM SonoSite can damage the system If you defibrillate a patient while the ECG module is connected to the system the ECG signal may display incorrectly and the E...

Page 127: ... To set the ECG scroll speed select Slow Medium or Fast under Sweep Speed If the Doppler or M Mode trace is active the ECG scroll speed matches the sweep speed for the trace To move the ECG trace up or down vertically on the image tap Up or Down under Position 5 Tap Done ...

Page 128: ...4 52 Imaging ...

Page 129: ...nt to save a measurement you must assign it to a calculation which saves results to the patient report or you can save the image with the calipers displayed If you prefer to start within a calculation see About calculations on page 5 8 Calipers You perform most measurements by using calipers that you drag into position The active caliper has a round highlighted handle To activate calipers Tap the ...

Page 130: ... hidden tapping More Controls displays it 2 Drag the active caliper to the first point 3 Drag the other caliper to the second point 4 As needed tap and drag each caliper until it is precisely positioned To measure circumference or area using an ellipse 1 On a frozen image tap Ellipse If this control is hidden tapping More Controls displays it An ellipse with three calipers appears 2 Position and r...

Page 131: ...More Controls displays it A dotted line appears extending from the skin line to a single caliper at the end 2 Drag the caliper to the desired location Basic measurements in M Mode To measure distance and time You can measure distance in centimeters and measure time in seconds 1 On a frozen M Mode sweep tap Distance Time If this control is hidden tapping More Controls displays it A caliper appears ...

Page 132: ...c measurements in M Mode but start from a frozen Doppler spectral trace To measure Velocity cm s and Pressure Gradient This measurement involves a single caliper from the baseline 1 On a frozen Doppler spectral trace tap Velocity A single caliper appears If this control is hidden tapping More Controls displays it Heart Rate Minimum Diastolic Velocity MDV Velocity cm s Velocity Time Integral VTI Pe...

Page 133: ...astole on the waveform Elapsed time between the times indicated by the two calipers is calculated Measured velocities are given as results and a generic ratio between the velocities indicated by the two calipers are calculated If the absolute value of the earlier velocity is less than that of the later velocity identified by the calipers Acceleration is calculated otherwise RI is calculated To mea...

Page 134: ...splays it A single caliper appears Table 5 1 Doppler trace measurements Tool Exam type Cardiac OB Gyn Venous Arterial TCD Orbital Lung Other Manual Trace VMax VTI PGMax PGMean VMean VMax PI RI SD EDV MDV TAV VMax PI RI SD EDV MDV TAV VTI VMax PI RI SD EDV MDV TAV Gate Depth VMax VMax PI RI SD EDV MDV AT TAV Auto Measure VMax VTI PGMax PGMean VMean VMax PI RI SD EDV MDV TAP VMax PI RI SD EDV MDV TA...

Page 135: ...A vertical caliper appears 2 Drag the caliper to the beginning of the waveform If calipers are not positioned correctly the calculation result is inaccurate 3 Drag the second caliper to the end of the waveform and lift your finger The measurement results appear To measure slope VMax Decel and PHT The Slope control can only be used in the cardiac exam type 1 On a frozen Doppler spectral trace tap S...

Page 136: ...About calculations In X Porte you can perform calculations whose results save to the patient report see Worksheets and reports on page 5 52 There are three kinds of calculations Basic calculations that are available in multiple exam types Note If Calcs is unavailable the measurement is unavailable for saving to a calculation WARNINGS To avoid incorrect calculations verify that the patient informat...

Page 137: ...cialized calculations or the Acute Care control for Acute Care calculations If these controls are hidden tapping More Controls displays them After you tap the control a calculation list appears on the left side of the touch panel Tap Calcs or Acute Care again to exit the list The selected measurement is highlighted with save and delete controls In some measurements and calculations that use a Dopp...

Page 138: ... on page 3 32 To redo or delete a saved measurement 1 On a frozen image tap Calcs or for the Acute Care calculations tap Acute Care If these controls are hidden tapping More Controls displays them 2 In the calculation list that contains the measurement do one of the following To redo perform the measurement again To save the new measurement tap under the measurement name The new measurement saves ...

Page 139: ...e To save the measurement and close the trace tap The percent area reduction result appears on the clinical monitor and saves to the patient report To calculate percent diameter reduction 1 On a frozen 2D image tap Calcs If this control is hidden tapping More Controls displays it 2 On the Diameter Reduction calculation list do the following for D1 and then for D2 a Tap the measurement name b Posit...

Page 140: ...sure 1 On the frozen 2D image tap Calcs If this control is hidden tapping More Controls displays it 2 On the Volume 1 Volume 2 or Volume 3 calculation list do the following for each measurement you need to take a Tap the measurement name b Position the calipers by dragging c Save the measurement Volume flow calculation To calculate volume flow in the abdominal exam type see page 13 To calculate vo...

Page 141: ... 36 38 Exam based calculations Abdominal calculations To calculate volume flow 1 On a frozen 2D or Doppler trace tap Calcs If this control is hidden tapping More Controls displays it WARNINGS To avoid incorrect calculations verify that the patient information date and time settings are accurate To avoid misdiagnosis or harming the patient outcome start a new patient form before starting a new pati...

Page 142: ...he measurement 5 Tap WORKSHEET to view the results Arterial calculations The Arterial calculations that you can perform are listed in Table 5 3 on page 5 15 In the Arterial exam you can also calculate ICA CCA ratio volume volume flow and percent reduction See Volume calculation on page 5 12 Volume flow calculation on page 5 12 and Percent reduction calculations on page 5 11 WARNINGS To avoid incor...

Page 143: ...forming a volume flow calculation bWhen the Doppler trace is measured the result includes velocity time integral and time averaged velocity calculations depending upon the trace type When the waveform is manually traced TAV and VTI are displayed When the waveform is automatically traced using Peak Time Averaged Peak TAP and VTI are displayed When the waveform is automatically traced using Mean Tim...

Page 144: ...rate blood flow volume calculations require both the vessel area and velocity of blood flow In addition accurate blood flow velocity is dependent on a correct Doppler angle of incidence Table 5 3 Arterial calculations Calculation list Measurement name a See Considerations on page on page 5 12 for factors to consider when performing a volume flow calculation b When the Doppler trace is measured the...

Page 145: ...Flow menu tap Diam ii Position the calipers by dragging iii Tap to save the measurement b Calculate the blood velocity i On a frozen Doppler trace on the Volume Flow 1 menu tap TAP peak To use a different velocity measurement tap and then choose either Mean or Manual ii For Manual trace the waveform by dragging the calipers To make a correction trace backward on the dotted line iii For Peak or Mea...

Page 146: ...sing the Mean option will not provide a VTI measurement WARNINGS To avoid incorrect calculations verify that the patient information date and time settings are accurate To avoid misdiagnosis or harming the patient outcome start a new patient form before starting a new patient exam and performing calculations Starting a new patient form clears the previous patient s data The previous patient s data...

Page 147: ...FAC IVC Max D 2D or M Mode Min D 2D or M Mode Collapse aHR needed for CO You can enter the HR measurement on the patient form or by measuring in M Mode or Doppler see page 3 b Performed at 300 cm s on the negative side of the baseline cThe AVA by VMax measurement requires the LVOT D LVOT VMax and AV VMax measurements The AVA by VTI measurement requires the LVOT D LVOT VTI and the AV VTI measuremen...

Page 148: ...sults continued Calculation list Measurement name imaging mode Results aHR needed for CO You can enter the HR measurement on the patient form or by measuring in M Mode or Doppler see page 3 bPerformed at 300 cm s on the negative side of the baseline c The AVA by VMax measurement requires the LVOT D LVOT VMax and AV VMax measurements The AVA by VTI measurement requires the LVOT D LVOT VTI and the A...

Page 149: ... and results continued Calculation list Measurement name imaging mode Results aHR needed for CO You can enter the HR measurement on the patient form or by measuring in M Mode or Doppler see page 3 b Performed at 300 cm s on the negative side of the baseline cThe AVA by VMax measurement requires the LVOT D LVOT VMax and AV VMax measurements The AVA by VTI measurement requires the LVOT D LVOT VTI an...

Page 150: ...tio Table 5 4 Cardiac calculations and results continued Calculation list Measurement name imaging mode Results aHR needed for CO You can enter the HR measurement on the patient form or by measuring in M Mode or Doppler see page 3 bPerformed at 300 cm s on the negative side of the baseline cThe AVA by VMax measurement requires the LVOT D LVOT VMax and AV VMax measurements The AVA by VTI measuremen...

Page 151: ...ode Table 5 4 Cardiac calculations and results continued Calculation list Measurement name imaging mode Results a HR needed for CO You can enter the HR measurement on the patient form or by measuring in M Mode or Doppler see page 3 bPerformed at 300 cm s on the negative side of the baseline cThe AVA by VMax measurement requires the LVOT D LVOT VMax and AV VMax measurements The AVA by VTI measureme...

Page 152: ...culation list tap Radius c Position the calipers by dragging d Save the calculation Tap under the measurement name 3 On a frozen Doppler spectral trace tap Calcs 4 Do the following to measure from MR VTI and again to measure from MV VTI a On the PISA calculation list tap MR VTI or MV VTI b Drag the caliper to the start of the waveform and lift your finger to start the trace A pencil icon appears c...

Page 153: ...late fractional area change FAC 1 On a frozen 2D image tap Calcs If this control is hidden tapping More Controls displays it 2 On the calculation list tap FAC 3 Do the following for each measurement a Drag the caliper to the desired start position After lifting your finger from the screen a pencil icon appears indicating that the start location is set and you can begin your trace b Use your finger...

Page 154: ...he start location is set and you can begin your trace c Using your finger trace the atrial cavity LA or RA To make a correction trace backward on the dotted line d Complete the trace at the other annulus by lifting your finger from the screen The trace closes automatically e You can adjust the atrial length by dragging the cursor f To save the calculation tap under the measurement name Notes Even ...

Page 155: ...ve the calculation Tap under the measurement name 4 To trace each measurement automatically a Under the measurement name tap the gear icon and select Border Assist b Adjust the calipers so that one is at the mitral annulus another is at the other annulus and the third is at the highest point apex of the left ventricular LV cavity c Tap on Trace d Once the trace is completed you may adjust the shap...

Page 156: ...ace the desired area To make a correction trace backward on the dotted line 3 Tap under the measurement name to save the calculation and close the trace 4 On the LV Mass calculation list tap Apical 5 Positioning the calipers measure the ventricular length 6 Save the calculation Tap under the measurement name To measure Inferior Vena Cava IVC Collapse 1 On a frozen 2D or M Mode sweep tap Calcs If t...

Page 157: ...asurements the most recent measurement replaces the oldest measurement If you delete a saved measurement from the patient report the next measurement taken replaces the deleted one in the patient report 1 On a frozen Doppler spectral trace tap Calcs If this control is hidden tapping More Controls displays it 2 For each calculation you want to perform on the calculation list choose MV MR TV TR TDI ...

Page 158: ...veform c Drag the second caliper to the end of the waveform and lift your finger The measurement results appear To calculate Right Ventricular Systolic Pressure RVSP 1 On a frozen Doppler spectral trace tap Calcs If this control is hidden tapping More Controls displays it 2 On the TV TR calculation list tap TR VMax 3 Position the caliper by dragging 4 Save the calculation Tap under the measurement...

Page 159: ...lation list tap IVRT A vertical caliper appears 3 Drag the caliper to the aortic valve closure A second vertical caliper appears 4 Drag the second caliper to onset of mitral inflow 5 Save the calculation Tap under the measurement name To calculate Delta Pressure Delta Time dP dT To perform the dP dT measurements the CW Doppler scale must include velocities of 300 cm s or greater on the negative si...

Page 160: ...ment VTI In the AV LVOT AI calculation list tap LVOT VTI trace the Doppler waveform by dragging and then tap to save the measurement 3 In Doppler measure either AV VMax or AV VTI VMax In the AV LVOT AI calculation list tap AV VMax position the caliper by dragging and then tap to save the measurement VTI In the AV LVOT AI calculation list tap AV VTI trace the Doppler waveform by dragging and then t...

Page 161: ...nder the measurement name For information on the automatic trace tool see To measure automatically on page 5 7 To calculate Stroke Volume SV or Stroke Index SI The SV and SI calculations require a measurement in 2D and a measurement in Doppler SI also requires Body Surface Area BSA After the measurements are saved the result appears in the patient report 1 SI Only Fill in the Height and Weight fie...

Page 162: ...lculate LVOT diameter a On a frozen 2D image tap Calcs If this control is hidden tapping More Controls displays it b From the CO calculation list tap LVOT D c Position the calipers across the LVOT by dragging d To save the measurement tap under the measurement name 3 Measure LVOT VTI a On a frozen Doppler spectral trace tap Calcs If this control is hidden tapping More Controls displays it b From t...

Page 163: ...tapping More Controls displays it 3 Do the following for each measurement you want to take a On the TDI calculation list tap the measurement name b Position the calipers by dragging c Save the calculation Tap under the measurement name Gynecological calculations The Gynecological calculations include measurements for uterus ovaries and follicles In the Gynecological exam you can also calculate vol...

Page 164: ...easure ovaries 1 On the frozen 2D image tap Calcs If this control is hidden tapping More Controls displays it 2 On the Ovary calculation list do the following for each measurement you want to take a Tap the measurement name under Right Ovary or Left Ovary b Position the calipers by dragging c Save the measurement Measuring follicles On each side you can save up to three distance D measurements per...

Page 165: ...the first measurement tap under the follicle number A superscripted measurement number appears after the follicle number to indicate the dimension being measured d Position the calipers by dragging e Tap under the follicle number to save the first two measurements f To measure a third dimension of the same follicle acquire a new image of the follicle and then tap the same follicle number A supersc...

Page 166: ...id incorrect obstetrics calculations verify with a local clock and calendar that the system s date and time settings are correct before each use of the system The system does not automatically adjust for daylight savings time changes Prior to use verify that Obstetrical custom table data entries are correct The system does not confirm the accuracy of the custom table data entered by the user To av...

Page 167: ... same type are averaged bFor Tokyo U APTD and TTD are used only to calculate EFW No age or growth tables are associated with these measurements cThe Estimated Fetal Weight EFW calculation uses an equation that consists of one or more fetal biometry measurements The author for the Obstetrical tables which you choose on a system setup page determines the measurements you must perform to obtain an EF...

Page 168: ...age of the results is the AUA Only measurements of the same type are averaged b For Tokyo U APTD and TTD are used only to calculate EFW No age or growth tables are associated with these measurements cThe Estimated Fetal Weight EFW calculation uses an equation that consists of one or more fetal biometry measurements The author for the Obstetrical tables which you choose on a system setup page deter...

Page 169: ...nt name The caliper tool may change depending on the measurement selected but the position remains constant c Position the calipers by dragging d Tap under the measurement name To measure heart rate M Mode or Doppler 1 Make sure that the Obstetrics exam type is selected 2 On a frozen M Mode sweep or Doppler trace tap Calcs If this control is hidden tapping More Controls displays it 3 Tap HR on the...

Page 170: ...culations list tap the measurement name under MCA or UmbA b Position the calipers For S D RI drag the first caliper to the peak systolic waveform Tap Next and then drag the second caliper to the end diastole on the waveform For S D RI PI drag the caliper to the beginning of the desired waveform and lift your finger to start the trace Trace the desired area Lift your finger again to finish the trac...

Page 171: ...onal Sac measurement on the same frozen image tap Next make an additional measurement and then tap To make a single Gestational Sac measurement tap after the measurement Table 5 6 MCA or UmbA calculations and results Calculation list Section heading Measurement name Results Doppler Measurements MCA S D RI S D S D RI S D RI PI S D MDV TAV or TAP S D RI PI Umb A S D RI S D S D RI S D RI PI S D MDV T...

Page 172: ...ppear d Position Line A by dragging calipers and tap e Tap Line B beta line Calipers for Line B appear f Position Line B by dragging calipers and tap To calculate hip ratio 1 On a frozen 2D image tap Calcs If this control is hidden tapping More Controls displays it 2 Do the following under Right Hip and again under Left Hip a Under d D Ratio tap Fem Hd femoral head WARNINGS To avoid incorrect calc...

Page 173: ... information date and time settings are accurate To avoid misdiagnosis or harming the patient outcome start a new patient form before starting a new patient exam and performing calculations Starting a new patient form clears the previous patient s data The previous patient s data will be combined with the current patient if the form is not first cleared See Editing patient information on page 4 31...

Page 174: ...eight Right Ovarian Cyst Resistive index Doppler Adnexa Left Ovarian Size 2D c Length Width Height Left Ovarian Cyst Resistive index Doppler Table 5 7 Acute Care calculations continued Calculation list Measurement name imaging mode aCalculates a gestational age See Obstetrics calculations on page on page 5 38 for related information bUses the selected gestational age table See Calculations setting...

Page 175: ...D Thoracic Aorta Diameter 2D IVC Maximum Diameter 2D Minimum Diameter 2D Soft Tissue MSK Tissue Thickness 2D Subcutaneous Collection Diameter 2D Table 5 7 Acute Care calculations continued Calculation list Measurement name imaging mode a Calculates a gestational age See Obstetrics calculations on page on page 5 38 for related information bUses the selected gestational age table See Calculations se...

Page 176: ...ond caliper appears Drag the second caliper to the end diastole on the waveform d Save the measurement Tap under the measurement name To measure Inferior Vena Cava IVC Collapse See To measure Inferior Vena Cava IVC Collapse on page 5 28 Ocular Eye Right ONSD 2D Left ONSD 2D Table 5 7 Acute Care calculations continued Calculation list Measurement name imaging mode a Calculates a gestational age See...

Page 177: ...agnosis or harming the patient outcome start a new patient form before starting a new patient exam and performing calculations Starting a new patient form clears the previous patient s data The previous patient s data will be combined with the current patient if the form is not first cleared See Editing patient information on page 4 31 Note The system will display ratios of the following velocity ...

Page 178: ... Dist BA Mid BA Prox ECVA Gate depth Velocity PSV EDV MDV PI RI S D Left Transtemporal MCA Dist MCA Mid MCA Prox Bifur ACA ACoA TICA PCAp1 PCAp2 PCoA Gate depth Velocity PSV EDV MDV PI RI S D Table 5 8 Transcranial Doppler and Orbital calculations and results continued Calculation list Measurements Results The velocity measurement is labeled either TAM for a manual trace or TAP for an automatic tr...

Page 179: ...ECVA Gate depth Velocity PSV EDV MDV PI RI S D WARNING To avoid injury to the patient use only an Orbital Orb or Ophthalmic Oph exam type when performing imaging through the eye The FDA has established lower acoustic energy limits for opthalmic use The system will not exceed these limits only if the Orbital or Ophthalmic exam type is selected Note For information about these exam types see Intende...

Page 180: ...report see Displaying reports after the exam has ended on page 5 56 The value for a calculation appears in the report only if the calculation is saved The pound symbol indicates a value that is out of range for example too large or small Calculation values that are out of range are not included in derived calculations for example mean Calculations appear in the order that they were saved When you ...

Page 181: ...re not included in the summary information To save worksheets as images 1 Tap WORKSHEETS and display the report preview 2 To save the worksheet Tap Save Image to save an image of the information displayed on the screen Tap Save Images to save images of all the worksheet pages Arterial reports To modify the ICA CCA ratio 1 Display the arterial report preview 2 Tap Summary 3 Select measurements for ...

Page 182: ...th Analysis author has been selected for the measurement see Obstetrics calculations settings on page 3 7 To display Obstetrics graphs 1 Tap WORKSHEETS 2 Tap Graphs 3 In the Graphs list select the desired measurement and author The graph for the selected measurement appears For twins both measurement sets are plotted on the same graph 4 Optional Tap Save to save the current graph page as an image ...

Page 183: ...ctions in the Findings section Select Other Findings to enter additional information Acute Care worksheets only Interpretation You can make multiple selections in the Interpretation section Select Other Interpretations to enter additional information MSK worksheets only Procedure Details and Conclusions You can make multiple selections in the Procedure Details and Conclusions section Enter comment...

Page 184: ...he exam including Acute Care or MSK worksheet data if available To display the report after the exam has ended 1 Tap REVIEW 2 Tap Patient List 3 Select an exam 4 Tap Thumbnails 5 Tap View Report The system displays the read only report 6 Tap Next and Prev to view multiple pages 7 Tap Done to return to the patient list Customizing worksheets You can create up to 12 customizable worksheets Each work...

Page 185: ...ll arrows or tap the pause button and then drag the slider to the frame you want to measure 2 Select a measurement from the Calcs or Acute Care menus or select a basic measurement 3 To make a measurement See Measuring on page 5 1 to make a basic measurement See Exam based calculations on page 5 13 to make a measurement from the Calcs menu See Acute Care calculations on page 5 45 to make an acute c...

Page 186: ...5 58 Measurements and calculations ...

Page 187: ...y the clinician The accuracy values require that you can place the calipers over one pixel The values do not include acoustic anomalies of the body The 2D linear distance measurement results are displayed in centimeters with one place past the decimal point if the measurement is ten or greater two places past the decimal point if the measurement is less than ten The linear distance measurement com...

Page 188: ... with 0 7 dB cm MHz attenuation was used cThe area accuracy is defined using the following equation tolerance 1 lateral error 1 axial error 1 100 0 5 d The circumference accuracy is defined as the greater of the lateral or axial accuracy and by the following equation tolerance 2 maximum of 2 errors 100 0 5 Table 6 2 M Mode Measurement and Calculation Accuracy and Range M Mode Measurement Accuracy ...

Page 189: ...3 bpm Table 6 3 PW Doppler Mode Measurement and Calculation Accuracy and Range Doppler Mode Measurement Accuracy and Range System Tolerance Accuracy By Test Methoda Range Velocity cursor 2 plus 1 of full scaleb Acquisition Phantom 0 01 cm sec 550 cm sec Frequency cursor 2 plus 1 of full scaleb Acquisition Phantom 0 01kHz 20 8 kHz Time 2 plus 1 of full scalec Acquisition Phantom 0 01 10 sec aFUJIFI...

Page 190: ...Seward A J Tajik The Echo Manual 3rd ed Lippincott Williams and Wilkins 2007 p 147 148 time a time b where time a early time time b later time only valid when a b Aortic Valve Area AVA by Continuity Equation in cm2 Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Lippincott Williams and Wilkins 2007 p 73 and p 191 195 A2 A1 V1 V2 where A2 Ao valve area A1 LVOT area V1 Peak LVOT velocity VMax or ...

Page 191: ... in cm2 Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Lippincott Williams and Wilkins 2007 p 70 71 CSA 0 785 D2 where D diameter of the anatomy of interest Deceleration Time in msec Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Lippincott Williams and Wilkins 2007 p 73 74 time a time b where time a time associated with VMax time b when the line tangent to the envelope and through VMax cr...

Page 192: ...R Vel 100 Ejection Fraction EF percent Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Lippincott Williams and Wilkins 2007 p 115 116 EF LVEDV LVESV LVEDV 100 where EF Ejection Fraction LVEDV Left Ventricular End Diastolic Volume LVESV Left Ventricular End Systolic Volume Elapsed Time ET in msec ET time between velocity cursors in milliseconds FAC LV Dennis A T et al Haemodynamics in women with...

Page 193: ...ening percent Laurenceau J L M C Malergue The Essentials of Echocardiography Le Hague Martinus Nijhoff 1981 p 71 IVSFT IVSS IVSD IVSD 100 where IVSS Interventricular Septal Thickness at Systole IVSD Interventricular Septal Thickness at Diastole Isovolumic Relaxation Time IVRT in msec Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Philadelphia Lippincott Williams and Wilkins 2007 p 123 124 time...

Page 194: ...aphy and European Association of Cardiovascular Imaging Journal of the American Society of Echocardiography January 2015 28 p 1 39 LA Vol p 4 h D1 D2 where LA Vol Left Atrial Volume in ml h Height of stacked oval disks making up the LA D1 Orthogonal minor axis D2 Orthogonal major axis Left Atrial Volume Index Lang R M Bierig R Devereux et al Recommendations for chamber quantification a report from...

Page 195: ...Seward A J Tajik The Echo Manual 3rd ed Philadelphia Lippincott Williams and Wilkins 2007 p 115 LV Mass 1 04 LVID PWT IVST 3 LVID3 0 8 0 6 where LVID Internal Dimension PWT Posterior Wall Thickness IVST Interventricular Septal Thickness 1 04 Specific gravity of the myocardium 0 8 Correction factor Left Ventricular Volume Biplane Method in ml Schiller N B P M Shah M Crawford et al Recommendations f...

Page 196: ...nal Shortening percent Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Philadelphia Lippincott Williams and Wilkins 2007 p 115 LVDFS LVDD LVDS LVDD 100 where LVDD Left Ventricle Dimension at Diastole LVDS Left Ventricle Dimension at Systole LV Ejection Fraction Schiller N B Shah P M Crawford M et al Recommendations for Quantification of the Left Ventricle by Two Dimensional Echocardiography Jou...

Page 197: ... Flow Rate in cc sec Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Philadelphia Lippincott Williams and Wilkins 2007 p 73 76 p 210 Flow PISA Va where PISA Proximal Isovelocity SurfaceArea Va aliasing Velocity Pressure Gradient PG in mmHG Baumgartner H Hung J Bermejo J et al Echocardiographic Assessment of Valve Stenosis EAE ASE Recommendations for Clinical Practice Journal of American Society...

Page 198: ... 76 PISA 2 π r2 where r aliasing radius Qp Qs Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Philadelphia Lippincott Williams and Wilkins 2007 p 70 72 Qp Qs SV Qp site SV Qs site RVOT SV LVOT SV where RVOT SV RVOT CSA RVOT VTI π 4 RVOT diameter2 RVOT VTI LVOT SV LVOT CSA LVOT VTI π 4 LVOT diameter2 LVOT VTI Regurgitant Fraction RF in percent Oh J K J B Seward A J Tajik The Echo Manual 3rd ed P...

Page 199: ...al minor axis Right Atrial Volume Index Wang Y J Gutman et al Atrial volume in a normal adult population by two dimensional echocardiography Chest 1984 86 p 595 601 RA Vol Index RA Vol BSA ml L2 Right Ventricular Systolic Pressure RVSP in mmHg Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Philadelphia Lippincott Williams and Wilkins 2007 p 66 RVSP 4 VMax TR 2 RAP where RAP Right Atrial Pressu...

Page 200: ...diograph 2010 p 685 713 M Mode distance measurement of systolic excursion of the right ventricle Tricuspid Valve Area TVA Oh J K J B Seward A J Tajik The Echo Manual 3rd ed Philadelphia Lippincott Williams and Wilkins 2007 p 73 74 TVA 220 PHT Velocity Time Integral VTI in cm Reynolds Terry The Echocardiographer s Pocket Reference 2nd ed School of Cardiac Ultrasound Arizona Heart Institute 2000 p 3...

Page 201: ...inger Verlag 1986 p 154 Osaka University Ultrasound in Obstetrics and Gynecology July 20 1990 p 103 105 Shepard M J V A Richards R L Berkowitz et al An Evaluation of Two Equations for Predicting Fetal Weight by Ultrasound American Journal of Obstetrics and Gynecology 142 1 January 1 1982 p 47 54 University of Tokyo Shinozuka N FJSUM et al Standard Values of Ultrasonographic Fetal Biometry Japanese...

Page 202: ... Analysis of Multiple Fetal Growth Parameters Radiology 152 1984 p 497 501 Hansmann M et al Ultrasound Diagnosis in Obstetrics and Gynecology New York Springer Verlag 1986 p 440 Osaka University Ultrasound in Obstetrics and Gynecology July 20 1990 p 98 University of Tokyo Shinozuka N FJSUM et al Standard Values of Ultrasonographic Fetal Biometry Japanese Journal of Medical Ultrasonics 23 12 1996 p...

Page 203: ...20 1990 p 01 102 University of Tokyo Shinozuka N FJSUM et al Standard Values of Ultrasonographic Fetal Biometry Japanese Journal of Medical Ultrasonics 23 12 1996 p 886 Fetal Trunk Cross Sectional Area FTA Osaka University Ultrasound in Obstetrics and Gynecology July 20 1990 p 99 100 Gestational Sac GS Hansmann M et al Ultrasound Diagnosis in Obstetrics and Gynecology New York Springer Verlag 1986...

Page 204: ...ndix AC Derived Hadlock F et al Estimating Fetal Age Computer Assisted Analysis of Multiple Fetal Growth Parameters Radiology 152 1984 p 497 501 Jeanty P E Cousaert and F Cantraine Normal Growth of the Abdominal Perimeter American Journal of Perinatology 1 January 1984 p 129 135 Also published in Hansmann Hackeloer Staudach Wittman Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag ...

Page 205: ...7 501 Jeanty P E Cousaert and F Cantraine A Longitudinal Study of Fetal Limb Growth American Journal of Perinatology 1 January 1984 p 136 144 Table 5 Also published in Hansmann Hackeloer Staudach Wittman Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag New York 1986 p 182 Table 7 17 Head Circumference HC Chitty Lyn S et al Charts of Fetal Size 2 Head Measurements British Journal o...

Page 206: ... 3 October 1984 p 439 442 HC AC Ratio Campbell S Thoms Alison Ultrasound Measurements of the Fetal Head to Abdomen Circumference Ratio in the Assessment of Growth Retardation British Journal of Obstetrics and Gynaecology 84 March 1977 p 165 174 General references x or S D Ratio x Velocity A Velocity B where A velocity cursor B velocity cursor x Acceleration Index ACC Zwiebel W J Introduction to Va...

Page 207: ...atients The Renal Artery Doppler Technique Ultrasound in Medicine and Biology 12 12 1986 p 945 952 Diameter Reduction 1 D2 cm D1 cm 100 where D1 original diameter of the vessel in cm D2 reduced diameter of the vessel in cm Pressure Gradient PG in mmHG Oh J K J B Seward A J Tajik The Echo Manual 2nd ed Lippincott Williams and Wilkins 1999 p 64 PG 4 Velocity 2 velocity units must be meters second Pe...

Page 208: ...s where A velocity cursor B velocity cursor x Time Averaged Mean TAM in cm s TAM mean mean Trace Time Averaged Peak TAP in cm s TAP mean peak Trace Volume Vol Beyer W H Standard Mathematical Tables 28th ed CRC Press Boca Raton FL 1987 p 131 Volume Bladder Dicuio M et al Measurements of urinary bladder volume comparison of five ultrasound calculation methods in volunteers Arch Ital Urol Androl 2005...

Page 209: ...ian Balen A H Laven J S Tan S L Dewailly D Ultrasound assessment of the polycystic ovary international consensus definitions Human Reproduction Update 2003 Vol 9 No 6 p 505 514 Volume Uterine Wiener J J and Newcombe R G Measurements of uterine volume a comparison between measurements by ultrasonography and by water displacement J Clin Ultrasound 1992 20 7 p 457 460 ...

Page 210: ...6 24 Measurement references ...

Page 211: ...charged stand system Plug the system into AC power to reactivate battery operation if the battery switches have been in the OFF position which is indicated by the O symbol stand system System image quality is poor Adjust the clinical monitor to improve viewing angle Adjust the brightness Adjust the gain No CPD image Adjust the gain CPD has a hide control Ensure that this control is not activated N...

Page 212: ...y stick included with the system Make sure that the USB memory stick is not software encrypted and is not defective System prompts you to ensure the USB device contains valid data Make sure that the data are present on the USB memory stick Re export the original data onto the USB memory stick Contact your system administrator USB device does not appear in the list Check that the USB device has bee...

Page 213: ...ate screen To obtain a license key 1 Turn on the system 2 Navigate to System Information to gather version information a Tap MORE and then tap System Settings b Tap System Information in the list on the left and scroll to display System Licensing and Scanhead Licensing 3 Contact FUJIFILM SonoSite Technical Support see Getting help on page 1 2 You will be asked for the following information from Sy...

Page 214: ...nter it either at startup or in System Setup To enter the license key at startup 1 Turn on the system The license update screen appears 2 Enter the license key in the Enter license number box 3 Tap Enter 4 If the license update screen reappears verify that you entered the license key correctly If the license update screen still appears contact FUJIFILM SonoSite Technical Support see Getting help o...

Page 215: ...calibration In addition to cleaning and disinfecting the transducer FUJIFILM SonoSite recommends that you plug the system in when not in use to fully charge the batteries When charging all three battery switches must be in the ON position Performing maintenance procedures not described in this document or the service manual may void the product warranty Contact FUJIFILM SonoSite Technical Support ...

Page 216: ...ore information see Presets settings on page 3 28 Servicing Your ultrasound engine may be repaired or replaced at the manufacturer s discretion If servicing is necessary then you must remove the ultrasound engine Before the engine is removed and shipped to a repair facility you must take precautions to protect patient data and to preserve your customized settings To prepare your system for service...

Page 217: ...nd rotate it clockwise 2 Pull the transducer connector away from the system To remove the engine from the stand 1 Locate the two gray latch levers under the left and right sides of the stand head Cautions Turn off the system before removing the ultrasound engine from the stand Removing the ultrasound system from the stand while the system is powered on may damage the dock Disconnect any devices at...

Page 218: ...ance 2 Simultaneously pull each latch outward away from the engine and towards the outer edges of the stand The engine ejects from the stand 3 Lift the engine from the back edge and lift forward and up away from the top of the stand ...

Page 219: ...e eyewear and gloves Inspect the system and transducer to determine that it is free of any unacceptable deterioration such as corrosion discoloration pitting or cracked seals If damage is evident discontinue use and contact FUJIFILM SonoSite or your local representative Confirm that cleaning and disinfecting materials are appropriate for your facility s use FUJIFILM SonoSite tests cleaners and dis...

Page 220: ...ong solvents such as thinner or benzene or abrasive cleansers since these will damage the exterior surfaces Use only FUJIFILM SonoSite recommended cleaners or disinfectants WARNING The cleaning instructions contained in this chapter are based on requirements mandated by the American Food and Drug Administration FDA Failure to follow these instructions may result in cross contamination and patient ...

Page 221: ...upply Wear the appropriate personal protective equipment PPE recommended by the chemical manufacturer such as eyewear and gloves Cautions Do not skip any steps or abbreviate the cleaning and disinfecting process in any way Do not spray cleaners or disinfectants directly on the system surfaces or on system and transducer connectors Doing so may cause solution to leak into the system damaging it and...

Page 222: ...act time and refer to manufacturer s instructions Monitor the system for wet appearance Re apply with a new wipe if no longer wet e Allow the ultrasound system to air dry in a clean well ventilated space 6 Clean the ultrasound system STAND to remove any debris or bodily fluids 7 Clean the TRANSDUCER CABLE AND BODY to remove any debris or bodily fluids Use the following procedure Approved cleaners ...

Page 223: ...isinfectants for the transducer Product Compatible transducers Minimum wet contact timea SaniCloth AF3b C11xp C35xp C60xp HFL38xp HFL50xp HSL25xp ICTxp L25xp L38xp P10xp P21xp rP19xp 3 minutes SaniCloth Plus C60xp HFL38xp HFL50xp ICTxp 3 minutes PI Spray II C11xp C60xp D2xp HFL38xp HFL50xp HSL25xp ICTxp L25xp L38xp P10xp P21xp rP19xp 10 minutes a For maximum effectiveness the component being clean...

Page 224: ... Immerse the transducer in a high level disinfectant solution WARNING Failure to remove all gel debris and bodily fluid could leave contaminants on the transducer High level disinfectants compatible with SonoSite X Porte transducers Disinfectanta Compatible transducers Temperature Disinfectant soak duration Cidex C11xp C35xp C60xp HFL38xp HFL50xp HSL25xp ICTxp L25xp L38xp P10xp P21xp rP19xp 25o C ...

Page 225: ... the next rinse 12 Dry the transducer with a sterile lint free cloth 13 Dispose of the disinfectant according to the manufacturer s guidelines 14 Examine the transducer and cable for damage such as cracks or splitting where fluid can enter If damage is evident discontinue use of the transducer and contact FUJIFILM SonoSite or your local representative Cautions Do not soak the transducer longer tha...

Page 226: ...l cleaning and disinfection procedure See Clean and disinfect system and transducer to a high level semi critical uses on page 8 3 Blood Broken skin Mucosal membranes Bodily fluids WARNINGS To avoid electrical shock before cleaning turn off the system and disconnect it from the power supply Wear the appropriate personal protective equipment PPE recommended by the chemical manufacturer such as eyew...

Page 227: ...ination d Observe the minimum wet contact time and refer to manufacturer s instructions Monitor the system for wet appearance Re apply with a new wipe if no longer wet 6 Clean the ultrasound system STAND to remove any debris or bodily fluids 7 Clean the TRANSDUCER CABLE AND BODY to remove any debris or bodily fluids Use the following procedure Approved cleaners disinfectants for the ultrasound sys...

Page 228: ...cer If necessary repeat steps 5 6 and 7 with a new wipe Approved cleaners disinfectants for the transducer Product Compatible transducers Minimum wet contact timea SaniCloth AF3b C11xp C35xp C60xp HFL38xp HFL50xp HSL25xp ICTxp L25xp L38xp P10xp P21xp rP19xp 3 minutes SaniCloth Plus C60xp HFL38xp HFL50xp ICTxp 3 minutes PI Spray II C11xp C60xp D2xp HFL38xp HFL50xp HSL25xp ICTxp L25xp L38xp P10xp P2...

Page 229: ...nvironment that is safe and has good airflow Do not store the transducer in closed containers or where condensation may occur Avoid direct sunlight and exposure to x rays Recommended storage temperature range is between 0o C 32o F and 45o C 113o F If using a wall mounted rack for storage ensure that It is securely mounted The storage slots do not mar the transducer or cause damage to the cable The...

Page 230: ... and seal it Do not allow any part of the transducer to protrude from the container 2 Ship the transducer using the following precautions Clearly label the container as fragile WARNING To prevent cross contamination or unprotected exposure of personnel to biological material containers used to transport contaminated transducers should carry an ISO biohazard label similar to the following Caution E...

Page 231: ...eripheral manufacturer s instructions when cleaning or disinfecting peripherals Cleaning and disinfecting accessories Clean accessories prior to disinfecting You can disinfect the exterior surface of accessories using a recommended disinfectant Refer to the cleaners and disinfection document available at www sonosite com To clean and disinfect accessories 1 If necessary unplug the power supply and...

Page 232: ... Clean the surfaces using a soft cloth lightly dampened in a mild soap or detergent cleaning solution Apply the solution to the cloth rather than the surface 3 Wipe the surfaces with the disinfecting solution Follow the manufacturer s instructions for the disinfecting solution including exposure time and temperature for effective disinfection 4 Air dry or towel dry with a clean cloth Cleaning the ...

Page 233: ...litting 3 Clean the surface using a soft cloth lightly dampened in a mild soap cleaning solution or pre moistened wipe Apply the solution to the cloth rather than the surface 4 Wipe the surfaces with a FUJIFILM SonoSite Approved cleaner or disinfectant 5 Air dry or dry with a clean cloth For more information on the ECG slave cable refer to the ECG Slave Cable User Guide Caution To avoid damaging t...

Page 234: ...8 16 Cleaning and disinfecting ...

Page 235: ...es you may experience occasional discomfort in your hands fingers arms shoulders eyes back or other parts of your body However if you experience symptoms such as constant or recurring discomfort pain throbbing aching tingling numbness burning sensation or stiffness do not ignore these warning signs Promptly see a qualified health professional Symptoms such as these can be linked with MSDs MSDs can...

Page 236: ...h Musculoskeletal Pain in Cardiac Ultrasonographers Results of a Random Survey Journal of American Society of Echocardiography May1997 p 357 362 WARNING While researchers are not able to definitively answer many questions about MSDs there is a general agreement that certain factors are associated with their occurrence including preexisting medical and physical conditions overall health equipment a...

Page 237: ...ectly Keep moving Avoid sustaining the same posture by varying your head neck body arm and leg positions Do targeted exercises Targeted exercises can strengthen muscle groups which may help you avoid MSDs Contact a qualified health professional to determine stretches and exercises that are right for you Electrical safety This system meets EN60601 1 Class I internally powered equipment requirements...

Page 238: ...rd Before using the transducer inspect the transducer face housing and cable Do not use the transducer if the transducer or cable is damaged Turn the engine off when cleaning Do not use any transducer that has been immersed beyond the specified cleaning or disinfection level See Troubleshooting and maintenance on page 7 1 Use only accessories and peripherals recommended by FUJIFILM SonoSite includ...

Page 239: ... if an error message appears on the image display note the error code call FUJIFILM SonoSite or your local representative turn off the system by pressing and holding the power key until the system powers down To avoid increasing the system and transducer connector temperature do not block the airflow to the ventilation holes on the front and back of the system Class I equipment The ultrasound syst...

Page 240: ...the AC input power cord from the stand base 4 Depress all three battery switches to the OFF position indicated by the O symbol Equipment safety To protect your ultrasound system transducer and accessories follow these precautions Caution Unplugging the AC power cord before you hear the tone may result in loss of data If you don t hear a tone then your system may be set up to mute all sounds To rei...

Page 241: ...d disinfecting Do not submerge the transducer connector in solution The cable is not liquid tight beyond the transducer connector cable interface Do not use solvents such as thinner or benzene or abrasive cleaners on any part of the system Do not spill liquid on the system Position the system to allow access to the mains power cord connector At high elevations greater than 1948 meters 6391 feet ab...

Page 242: ...cted before use Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals FUJIFILM SonoSite recommends identifying your latex and talc sensitive patients and being prepared to treat allergic reactions promptly Perform ultrasound procedures prudently Use the ALARA as low as reasonably achievable principle and follow the prudent use informat...

Page 243: ...the P10xp and P21xp transducers contain a magnet that is used to ensure the bracket is correctly oriented on the transducer The magnetic field in direct proximity to the pacemaker or medical electronic implant may have an adverse effect To avoid applying unsafe voltage levels to the patient while a device is connected to the external VGA or digital video out port do not touch the ultrasound system...

Page 244: ...determine the source of disruption and take the following actions to eliminate the source s Turn equipment in the vicinity off and on to isolate disruptive equipment Relocate or re orient interfering equipment Increase distance between interfering equipment and your ultrasound system Manage use of frequencies close to ultrasound system frequencies Remove devices that are highly susceptible to EMI ...

Page 245: ...nary procedures an introduction to the physics of electrostatic charge the voltage levels that can occur in normal practice and the damage that can occur to electronic components if equipment is touched by an individual who is electrostatically charged IEC 60601 1 2 section 5 2 1 2 d Caution Electrostatic discharge ESD or static shock is a naturally occurring phenomenon ESD is common in conditions...

Page 246: ...ment transmitters and the SonoSite X Porte ultrasound system as recommended below according to the maximum output power of the communications equipment Compatible accessories and peripherals FUJIFILM SonoSite has tested the SonoSite X Porte ultrasound system with the following accessories and peripherals and has demonstrated compliance to the requirements of IEC 60601 1 2 2007 Table 9 1 Separation...

Page 247: ... 5 7 ft 1 7 m HFL50xp transducera 5 7 ft 1 7 m HSL25xp transducera 7 5 ft 2 3 m ICTxp transducera 5 7 ft 1 7 m L25xp transducera 7 5 ft 2 3 m L38xp transducera 5 5 ft 1 7 m P10xp transducera 6 0 ft 1 8 m P21xp transducera 6 0 ft 1 8 m TEExp transducera 7 1 ft 2 2 m Bar code scanner 4 8 ft 1 5 m a For transducers maximum cable length is measured between the strain reliefs The stated lengths do not ...

Page 248: ...nd engine USB flash memory 16 GB Table 9 2 System components and compatible accessories continued Description Maximum Cable Length aFor transducers maximum cable length is measured between the strain reliefs The stated lengths do not include the lengths of cable in the following locations underneath the strain reliefs inside the transducer enclosure or inside the transducer connector b Before you ...

Page 249: ... 2 m Power cords engine and monitor desktop configuration only 3 3 ft 1 m Mouse desktop configuration only 6 ft 1 8 m Digital video cable desktop configuration only 22 5 in 0 57 m Table 9 2 System components and compatible accessories continued Description Maximum Cable Length aFor transducers maximum cable length is measured between the strain reliefs The stated lengths do not include the lengths...

Page 250: ...s buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flickeremissions IEC 61000 3 3 Complies Table 9 4 Manufacturer s Declaration Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Electrostatic Discharge ESD IEC 61000 4 2 2 0KV 4 0KV 6 0KV contact 2 0KV 4 0KV 8 0KV air 2 0KV 4 0KV 6 0KV contact 2...

Page 251: ...er Frequency Magnetic Field IEC 61000 4 8 3 A m 3 A m If image distortion occurs it may be necessary to position the FUJIFILM SonoSite ultrasound system further from sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the Intended installation location to assure that it is sufficiently low Conducted RF IEC 61000 4 6 3...

Page 252: ...he vicinity of equipment marked with the following symbol IEC 60417 No 417 IEC 5140 Source of non ionizing radiation a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fix...

Page 253: ...tion of unintended or excessive ultrasound output Production of unintended or excessive transducer assembly surface temperature Production of unintended or uncontrolled motion of transducer assemblies intended for intracorporeal use Labeling Symbols The following symbols are used on the products packaging and containers Table 9 5 Labeling Symbols Symbol Definition Alternating Current AC Class 1 de...

Page 254: ...tors next to this mark signify that the product has been evaluated to the applicable CSA and ANSI UL Standards for use in Canada and the U S respectively Canadian Standards Association component certification mark Catalog number Collect separately from other household waste see European Commission Directive 93 86 EEC Refer to local regulations for disposal Corrugated recycle Date of manufacture Ma...

Page 255: ...c sensitive devices Device complies with relevant FCC regulations for electronic devices Fragile GEL Gel Sterilized using irradiation Sterilized using ethylene oxide Hot Device emits a static DC magnetic field Non ionizing radiation Paper recycle Table 9 5 Labeling Symbols continued Symbol Definition STERILE R STERILE EO ...

Page 256: ...on Water Tight Equipment Protected against the effects of extended immersion Handle transducer with care Follow manufacturer s instructions for disinfecting time Disinfect transducer Type BF patient applied part B body F floating applied part Defibrillation proof type CF applied part Underwriter s Laboratories labeling Table 9 5 Labeling Symbols continued Symbol Definition SN IPX7 IPX8 ...

Page 257: ...ry Certificate mark CCC Mark A compulsory safety mark for compliance to Chinese national standards for many products sold in the People s Republic of China Follow instructions for use Authorized representative in the European Community Equipotentiality Pushing Prohibited Do not push on monitor System may tip due to pushing or leaning on the monitor Equipment mass including its safe working load We...

Page 258: ... 8 cm Height max 64 in 162 6 cm Height min 42 2 in 107 2 cm First configuration Second configuration Length exterior dimension 18 8 in 47 8 cm 20 2 in 51 4 cm Height exterior dimension 14 2 in 36 cm 14 33 in 36 4 cm Diagonal viewable area 17 in 43 cm minimum 19 89 in 50 5 cm Length exterior dimension 16 1 in 40 8 cm Height exterior dimension 10 2 in 25 8 cm Diagonal viewable area 12 1 in 30 7 cm N...

Page 259: ...s Table 9 6 Electromechanical safety standards Standard Description ANSI AAMI ES60601 1 2005 R 2012 and A1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Edition 3 1 CAN CSA C22 2 No 60601 1 2014 Medical electrical equipment Part 1 General Requirements for Basic Safety and Essential Performance Edition 3 1 IEC 60601 1 2012 Medical electrica...

Page 260: ...n the system IEC 60601 1 6 2013 Medical Electrical Equipment part 1 6 General requirements for basic safety and essential performance Collateral Standard Usability Edition 3 1b CSA C22 2 60601 2 37 08 Medical Electrical Equipment Part 2 37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment Adopted IEC 60601 2 37 2007 Edi...

Page 261: ...Safety 9 27 The Health Insurance and Portability and Accountability Act Pub L No 104 191 1996 45 CFR 160 General Administrative Requirements 45 CFR 164 Security and Privacy ...

Page 262: ...9 28 Safety ...

Page 263: ...oncentrated exposure than a scanned beam which spreads that exposure over that area The transducer capability depends upon the frequency penetration resolution and field of view The default system presets are reset at the start of each new patient It is the scanning technique of the qualified ultrasound user along with patient variability that determines the system settings throughout the exam The...

Page 264: ...iver controls Direct controls The system does not have a direct user control for output Rather the system has been designed to automatically adjust output to ensure that acoustic and thermal limits are not exceeded for all imaging modes Since there is no direct user control for output the sonographer should rely on controlling exposure time and scanning technique to implement the ALARA principle T...

Page 265: ...5 Guidelines for reducing MI and TI The following are general guidelines for reducing MI or TI If multiple parameters are given the best results may be achieved by minimizing these parameters simultaneously In some modes changing these parameters does not affect MI or TI Changes to other parameters may also result in MI and TI reductions Please note the MI and TI values on the screen For a visual ...

Page 266: ...put HFL50xp HSL25xp ICTxp L25xp L38xp P10xp P21xp Table 10 1 Guidelines for reducing MI continued Transducer Depth Decrease or lower setting of parameter to reduce MI Increase or raise setting of parameter to reduce MI ...

Page 267: ...PD Settings Depth Box Width Box Height Box Depth PRF Depth Optimize C11xp Depth C35xp Depth C60xp Depth HFL38xp Depth HFL50xp Depth HSL25xp Depth ICTxp Depth L25xp Depth Decrease or lower setting of parameter to reduce TI Increase or raise setting of parameter to reduce TI ...

Page 268: ...th P21xp PRF Table 10 2 Guidelines for reducing TI continued Transducer CPD Settings Depth Box Width Box Height Box Depth PRF Depth Optimize Decrease or lower setting of parameter to reduce TI Increase or raise setting of parameter to reduce TI ...

Page 269: ... Yes No TIC TIB or TIS No No Yes HFL50xp MI Yes Yes No TIC TIB or TIS No No Yes HSL25xp MI Yes Yes No TIC TIB or TIS No No Yes Even if MI is less than 1 0 the system provides a continuous real time display of MI in all imaging modes in increments of 0 1 The system meets the output display standard for TI and provides a continuous real time display of TI in all imaging modes in increments of 0 1 Th...

Page 270: ...es Yes Yes P21xp MI Yes Yes Yes No TIC TIB or TIS Yes Yes Yes Yes Note For output display information for the TEExp transducer refer to the TEExp Transducer User Guide included with the TEExp transducer Table 11 TI or MI 1 0 continued Transducer Model Index 2D M Mode CPD Color PW Doppler CW Doppler Even if MI is less than 1 0 the system provides a continuous real time display of MI in all imaging ...

Page 271: ...ut on which the display estimates are based This variability between systems and transducers introduces an error into displayed value By doing acoustic output sampling testing during production the amount of error introduced by the variability is bounded The sampling testing ensures that the acoustic output of transducers and systems being manufactured stays within a specified range of the nominal...

Page 272: ... Bioeffects Considerations for the Safety of Diagnostic Ultrasound J Ultrasound Med Sept 1988 Vol 7 No 9 Supplement The report sometimes referred to as the Stowe Report reviewed available data on possible effects of ultrasound exposure Another report Bioeffects and Safety of Diagnostic Ultrasound dated January 28 1993 provides more current information Table 10 1 Transducer Surface Temperature Rise...

Page 273: ...und passing through the tissue The intensity value in the tissue In Situ has been estimated by using the following formula In Situ Water e 0 23alf where where In Situ In Situ intensity value Water Water intensity value e 2 7183 a attenuation factor dB cm MHz Attenuation factor a for various tissue types are given below brain 0 53 heart 0 66 kidney 0 79 liver 0 43 muscle 0 55 l skinline to measurem...

Page 274: ...ount of underestimation depends upon each specific situation Fixed path tissue models in which soft tissue thickness is held constant sometimes are used to estimate In Situ acoustic exposures when the beam path is longer than 3 cm and consists largely of fluid When this model is used to estimate maximum exposure to the fetus during transabdominal scans a value of 1 dB cm MHz may be used during all...

Page 275: ...50xp Operating Mode Color CPD 10 31 Transducer Model HFL50xp Operating Mode PW Doppler 10 32 Transducer Model HSL25xp Operating Mode 2D 10 33 Transducer Model HSL25xp Operating Mode M Mode 10 34 Transducer Model HSL25xp Operating Mode Color CPD Mode 10 35 Transducer Model HSL25xp Operating Mode PW Doppler 10 36 Transducer Model HSL25xp Ophthalmic use Operating Mode 2D 10 37 Transducer Model HSL25x...

Page 276: ...Model P10xp Operating Mode CW Doppler 10 59 Transducer Model P21xp Orbital use Operating Mode 2D 10 60 Transducer Model P21xp Operating Mode 2D 10 61 Transducer Model P21xp Orbital use Operating Mode M Mode 10 62 Transducer Model P21xp Operating Mode M Mode 10 63 Transducer Model P21xp Orbital use Operating Mode Color CPD Mode 10 64 Transducer Model P21xp Operating Mode Color CPD 10 65 Transducer ...

Page 277: ...rmation PD μsec PRF Hz pr PIImax MPa deq Pllmax cm 0 46 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type CRD Control 2 Sample Volume Position Fixed Control 3 Control 4 a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condit...

Page 278: ... 205 PRF Hz 800 pr PIImax MPa 1 06 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 46 Operating Control Conditions Control 1 Exam Type Ven Control 2 Optimization Gen Control 3 Depth 4 0 cm Control 4 PRF a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condi...

Page 279: ...PIImax MPa 2 49 deq Pllmax cm 0 20 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 184 Operating Control Conditions Control 1 Exam Type Abd Abd Control 2 Sample Volume Size 1 mm 12 mm Control 3 Sample Volume Position Zone 3 22 mm Zone 2 15 mm Control 4 PRF 1563 Hz 10417 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal ce...

Page 280: ...Imax MPa 3 23 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 296 Operating Control Conditions Control 1 Exam Type Msk Control 2 Optimization Res Control 3 Depth 6 0 cm Control 4 MB THI On On Control 5 Needle Vision On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this...

Page 281: ...686 PRF Hz 800 pr PIImax MPa 3 43 deq Pllmax cm 0 28 Focal Length FLx cm 4 25 FLy cm 5 00 IPA 3 MImax W cm2 317 Operating Control Conditions Control 1 Exam Type Abd Abd Abd Control 2 Optimization Res Gen Res Control 3 Depth 3 0 cm 7 0 cm 3 0 cm Control 4 THI On Off On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal ceph...

Page 282: ... PIImax MPa 2 01 deq Pllmax cm 0 27 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 141 Operating Control Conditions Control 1 Exam Type Abd Abd Control 2 Sample Volume Size 1 mm 10 mm Control 3 Sample Volume Position Zone 0 5 mm Zone 3 23 mm Control 4 PRF 1562 Hz 1562 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cep...

Page 283: ...max MPa 3 09 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 516 Operating Control Conditions Control 1 Exam Type Msk Control 2 Optimization Gen Control 3 Depth 9 9 cm Control 4 MB THI On Off Control 5 Needle Vision On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this...

Page 284: ...c 0 534 PRF Hz 800 pr PIImax MPa 3 70 deq Pllmax cm 0 33 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 392 Operating Control Conditions Control 1 Exam Type Abd Abd Control 2 Optimization Pen Gen Control 3 Depth 7 7 cm 11 cm Control 4 THI Off On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are rep...

Page 285: ...m 2 71 FLy cm 6 5 IPA 3 MImax W cm2 346 Operating Control Conditions Control 1 Exam Type ABD OB Control 2 Optimization Color Color Control 3 2D Optimization THI Depth Gen On 11 cm Gen Off 6 0 cm Control 4 Color Optimization PRF High 3049 Hz Low 414 Hz Control 5 Color Box Position Size Def Wide Tall Def Narrow a This index is not required for this operating mode value is 1 b This transducer is not ...

Page 286: ...2 pr PIImax MPa 2 89 deq Pllmax cm 0 45 Focal Length FLx cm 15 90 FLy cm 6 50 IPA 3 MImax W cm2 239 Operating Control Conditions Control 1 Exam Type OB OB OB Control 2 Sample Volume Size 1 mm 12 mm 12 mm Control 3 Sample Volume Position Zone 2 Zone 10 Zone 0 Control 4 PRF 1302 Hz 1302 Hz 2604 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for t...

Page 287: ...z 7977 pr PIImax MPa 2 16 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 62 Operating Control Conditions Control 1 Exam Type Ven Control 2 Optimization Res Control 3 Depth 3 5 cm Control 4 Needle Profiling On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operatin...

Page 288: ... μsec 0 200 PRF Hz 800 pr PIImax MPa 2 82 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 121 Operating Control Conditions Control 1 Exam Type Breast Control 2 Optimization Gen Control 3 Depth 1 9 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating conditio...

Page 289: ...ax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 51 Operating Control Conditions Control 1 Exam Type Nerve Control 2 Mode Color Control 3 2D Optimization Depth Res 4 0 cm Control 4 Color Optimization PRF High 7812 Hz Control 5 Color Box Position Size Def Wide a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic us...

Page 290: ... PIImax MPa deq Pllmax cm 0 20 Focal Length FLx cm 4 68 FLy cm 2 50 IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Non Art Non Art Control 2 Sample Volume Size 5 mm 1 mm Control 3 Sample Volume Position Zone 11 Zone 8 Control 4 PRF 1562 Hz 2604 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cepha...

Page 291: ...PIImax MPa 3 31 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 427 Operating Control Conditions Control 1 Exam Type SmP Control 2 Optimization Res Control 3 Depth 4 8 cm Control 4 MB On Off Control 5 Needle Profiling On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for th...

Page 292: ...D μsec 0 230 PRF Hz 800 pr PIImax MPa 4 51 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 401 Operating Control Conditions Control 1 Exam Type Bre Control 2 Optimization Gen Control 3 Depth 1 9 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition ...

Page 293: ...cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 398 Operating Control Conditions Control 1 Exam Type SmP Control 2 Mode CVD Control 3 2D Optimization Depth Res 4 0 cm Control 4 Color Optimization PRF High 7812 Hz Control 5 Color Box Position Size Def Wide and Tall a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic...

Page 294: ...z pr PIImax MPa deq Pllmax cm 0 20 Focal Length FLx cm 4 68 FLy cm 2 50 IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Any Any Control 2 Sample Volume Size 6 mm 1 mm Control 3 Sample Volume Position Zone 11 Zone 8 Control 4 PRF 1562 Hz 2604 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic ...

Page 295: ... PIImax MPa 2 92 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 328 Operating Control Conditions Control 1 Exam Type Ven Control 2 Optimization Res Control 3 Depth 2 4 cm Control 4 MB On Control 5 Needle Profiling On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this ...

Page 296: ...D μsec 0 192 PRF Hz 800 pr PIImax MPa 3 98 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 408 Operating Control Conditions Control 1 Exam Type Ven Control 2 Optimization Gen Control 3 Depth 3 1 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition ...

Page 297: ...q Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 321 Operating Control Conditions Control 1 Exam Type Msk Control 2 Mode CPD Control 3 Optimization Depth Res 2 0 cm Control 4 Color Optimization PRF Low 312 Hz Control 5 Color Box Position Size Def Narrow a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic us...

Page 298: ...c PRF Hz pr PIImax MPa deq Pllmax cm 0 16 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Ven Control 2 Sample Volume Size 7mm Control 3 Sample Volume Position Zone 6 Control 4 PRF 2604 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for...

Page 299: ...0 183 PRF Hz 10710 pr PIImax MPa 0 78 deq Pllmax cm Focal Length FLx cm 3 80 FLy cm 2 70 IPA 3 MImax W cm2 11 Operating Control Conditions Control 1 Exam Type Oph Oph Control 2 Optimization Gen Gen Control 3 Depth 4 9 cm 6 0 cm Control 4 MB On On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are ...

Page 300: ... Information PD μsec 0 181 PRF Hz 800 pr PIImax MPa 0 75 deq Pllmax cm 0 12 Focal Length FLx cm 1 95 FLy cm 2 70 IPA 3 MImax W cm2 12 Operating Control Conditions Control 1 Exam Type Oph Oph Oph Control 2 Optimization Gen Gen Gen Control 3 Depth 2 7 cm 4 5cm 3 5cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic...

Page 301: ...m Focal Length FLx cm 4 34 FLy cm 2 70 IPA 3 MImax W cm2 18 Operating Control Conditions Control 1 Exam Type Oph Oph Control 2 Mode CPD CPD Control 3 2D Optimization Depth Res 4 2 cm Res 4 9cm Control 4 Color Optimization PRF Low 1250 Hz Low 781 Hz Control 5 Color Box Position Size Top Wide Short Bottom Def a This index is not required for this operating mode value is 1 b This transducer is not in...

Page 302: ... Hz 1562 pr PIImax MPa 0 50 deq Pllmax cm 0 34 Focal Length FLx cm 4 68 FLy cm 2 70 IPA 3 MImax W cm2 6 Operating Control Conditions Control 1 Exam Type Oph Oph Oph Control 2 Sample Volume Size 2 mm 3mm 3mm Control 3 Sample Volume Position Zone 2 Zone 11 Zone 11 Control 4 PRF 1562 Hz 5208Hz 5208Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for...

Page 303: ...22 PRF Hz 1600 pr PIImax MPa 3 07 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 347 Operating Control Conditions Control 1 Exam Type Gyn Control 2 Optimization Gen Control 3 Depth 4 1 cm Control 4 THI Off a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating c...

Page 304: ...1302 pr PIImax MPa 2 49 deq Pllmax cm 0 19 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 263 Operating Control Conditions Control 1 Exam Type OB OB Control 2 Sample Volume Size 1 mm 12 mm Control 3 Sample Volume Position Zone 2 Zone 3 Control 4 PRF 1302 Hz 1562 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic ...

Page 305: ...PIImax MPa 2 92 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 328 Operating Control Conditions Control 1 Exam Type Ven Control 2 Optimization Res Control 3 Depth 2 4 cm Control 4 MB On Control 5 Needle Profiling On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this o...

Page 306: ... μsec 0 192 PRF Hz 800 pr PIImax MPa 3 98 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 408 Operating Control Conditions Control 1 Exam Type Ven Control 2 Optimization Gen Control 3 Depth 3 1 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition s...

Page 307: ...max cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 321 Operating Control Conditions Control 1 Exam Type Msk Control 2 Mode CPD Control 3 2D Optimization Depth Res 2 0 cm Control 4 Color Optimization PRF Low 312 Hz Control 5 Color Box Position Size Def Narrow a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses...

Page 308: ... PRF Hz pr PIImax MPa deq Pllmax cm 0 16 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Ven Control 2 Sample Volume Size 7mm Control 3 Sample Volume Position Zone 6 Control 4 PRF 2604 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for ...

Page 309: ...0 183 PRF Hz 10710 pr PIImax MPa 0 78 deq Pllmax cm Focal Length FLx cm 3 80 FLy cm 2 70 IPA 3 MImax W cm2 11 Operating Control Conditions Control 1 Exam Type Oph Oph Control 2 Optimization Gen Gen Control 3 Depth 4 9 cm 6 0 cm Control 4 MB On On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are ...

Page 310: ...nformation PD μsec 0 181 PRF Hz 800 pr PIImax MPa 0 75 deq Pllmax cm 0 12 Focal Length FLx cm 1 95 FLy cm 2 70 IPA 3 MImax W cm2 12 Operating Control Conditions Control 1 Exam Type Oph Oph Oph Control 2 Optimization Gen Gen Gen Control 3 Depth 2 7 cm 4 5 cm 3 5 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic...

Page 311: ... Focal Length FLx cm 4 34 FLy cm 2 70 IPA 3 MImax W cm2 18 Operating Control Conditions Control 1 Exam Type Oph Oph Control 2 Mode CPD CPD Control 3 2D Optimization Depth Res 4 2 cm Res 4 9 cm Control 4 Color Optimization PRF Low 1250 Hz Low 781 Hz Control 5 Color Box Position Size Top Wide Short Bottom Def a This index is not required for this operating mode value is 1 b This transducer is not in...

Page 312: ... 1562 pr PIImax MPa 0 50 deq Pllmax cm 0 34 Focal Length FLx cm 4 68 FLy cm 2 70 IPA 3 MImax W cm2 6 Operating Control Conditions Control 1 Exam Type Oph Oph Oph Control 2 Sample Volume Size 2 mm 3 mm 3 mm Control 3 Sample Volume Position Zone 2 Zone 11 Zone 11 Control 4 PRF 1562 Hz 5208 Hz 5208 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended fo...

Page 313: ...Imax MPa 4 02 deq Pllmax cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 622 Operating Control Conditions Control 1 Exam Type Ven Control 2 Optimization Gen Control 3 Depth 3 5 cm Control 4 MB On Off Control 5 Needle Profiling On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this...

Page 314: ...n PD μsec 0 277 PRF Hz 800 pr PIImax MPa 4 18 deq Pllmax cm 0 62 Focal Length FLx cm 7 02 FLy cm 1 50 IPA 3 MImax W cm2 538 Operating Control Conditions Control 1 Exam Type Ven Ven Ven Control 2 Optimization Pen Pen Pen Control 3 Depth 4 0 cm 9 0 cm 9 0 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No...

Page 315: ...cm Focal Length FLx cm FLy cm IPA 3 MImax W cm2 678 Operating Control Conditions Control 1 Exam Type Ven Control 2 Mode Color Control 3 2D Optimization Depth Gen 3 5 cm Control 4 Color Optimization PRF High 6250 Hz Control 5 Color Box Position Size Def Wide Tall a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic u...

Page 316: ... PIImax MPa 2 33 deq Pllmax cm 0 40 Focal Length FLx cm 7 02 FLy cm 1 5 IPA 3 MImax W cm2 210 Operating Control Conditions Control 1 Exam Type Nrv Nrv Nrv Control 2 Sample Volume Size 1 mm 3 mm 3 mm Control 3 Sample Volume Position Zone 0 Zone 11 Zone 11 Control 4 PRF 1562 Hz 1562 Hz 1562 Hz a This index is not required for this operating mode value is 1 b This transducer is not intended for trans...

Page 317: ...00 pr PIImax MPa 3 67 deq Pllmax cm Focal Length FLx cm 2 19 FLy cm 5 00 IPA 3 MImax W cm2 420 Operating Control Conditions Control 1 Exam Type Abd Crd Control 2 Optimization Gen Gen Control 3 Depth 3 0 cm 4 0 cm Control 4 Sector Size N A Narrow a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are r...

Page 318: ...ion PD μsec 0 317 PRF Hz 800 pr PIImax MPa 4 40 deq Pllmax cm 0 27 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 593 Operating Control Conditions Control 1 Exam Type Abd Abd Control 2 Optimization Gen Res Control 3 Depth 4 0 cm 4 0 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for ...

Page 319: ...Focal Length FLx cm 0 94 FLy cm 5 00 IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Abd Control 2 Mode Color Control 3 2D Optimization Depth Gen 2 0 cm Control 4 Color Optimization PRF Low 521 Hz Control 5 Color Box Position Size Def Narrow a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic use...

Page 320: ... 26 Focal Length FLx cm 3 97 0 52 FLy cm 5 00 5 00 IPA 3 MImax W cm2 209 Operating Control Conditions Control 1 Exam Type Crd Crd Crd Crd Control 2 Sample Volume Size 1 mm 5 mm 7 mm 6 mm Control 3 Sample Volume Position Zone 2 15 mm Zone 5 40 mm Zone 2 15 mm Zone 0 5 mm Control 4 PRF 1563 Hz 1008 Hz 1563 Hz 1953 Hz Control 5 TDI Off On Off Off a This index is not required for this operating mode v...

Page 321: ...er Information PD μsec PRF Hz pr PIImax MPa deq Pllmax cm 0 28 Focal Length FLx cm 1 54 FLy cm 5 00 IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Crd Crd Control 2 Sample Volume Position Zone 1 9 mm Zone 2 15 mm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for t...

Page 322: ...sec 0 555 PRF Hz 5000 pr PIImax MPa 0 37 deq Pllmax cm Focal Length FLx cm 16 8 FLy cm 9 00 IPA 3 MImax W cm2 4 67 Operating Control Conditions Control 1 Exam Type Orbital Orbital Control 2 Optimization Gen Gen Control 3 Depth 5 0 cm 27 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reporte...

Page 323: ... 2 63 deq Pllmax cm Focal Length FLx cm 18 94 FLy cm 9 00 IPA 3 MImax W cm2 240 Operating Control Conditions Control 1 Exam Type Crd Crd Control 2 Optimization Gen Pen Control 3 Depth 9 0 cm 35 cm Control 4 MB THI Off On Off On Control 5 Sector Size Full Narrow a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic us...

Page 324: ...mation PD μsec 0 555 PRF Hz 800 pr PIImax MPa 0 37 deq Pllmax cm 0 597 Focal Length FLx cm 16 77 FLy cm 9 00 IPA 3 MImax W cm2 4 67 Operating Control Conditions Control 1 Exam Type Orbital Orbital Orbital Control 2 Optimization Gen Gen Gen Control 3 Depth 5 0 cm 27 cm 27 cm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonata...

Page 325: ...pr PIImax MPa 2 63 deq Pllmax cm 0 35 Focal Length FLx cm 2 25 FLy cm 9 00 IPA 3 MImax W cm2 240 Operating Control Conditions Control 1 Exam Type Crd Abd OB Control 2 Optimization Gen Gen Pen Control 3 Depth 9 0 cm 11 cm 5 0 cm Control 4 THI On On Off Control 5 Simultaneous Off Off On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial...

Page 326: ...al Length FLx cm 11 51 FLy cm 9 00 IPA 3 MImax W cm2 2 40 Operating Control Conditions Control 1 Exam Type Orbital Orbital Control 2 Mode Color Color Control 3 2D Optimization Depth Gen 5 cm Gen 15 cm Control 4 Color Optimization PRF Low 1096 Hz Low 1453 Hz Control 5 Color Box Position Size Def Def Bottom Def a This index is not required for this operating mode value is 1 b This transducer is not ...

Page 327: ...y cm 9 0 9 0 IPA 3 MImax W cm2 240 Operating Control Conditions Control 1 Exam Type Crd Abd Abd Control 2 Mode Color Color Color Control 3 2D Optimization THI Depth Gen On 9 0 cm Gen Off 5 0 cm Gen Off 5 0 cm Control 4 Color Optimization PRF Low 880 Hz High 2500 Hz High 2500 Hz Control 5 Color Box Position Size Top Short Wide Top Def Top Def a This index is not required for this operating mode val...

Page 328: ...a 2 37 deq Pllmax cm 0 49 Focal Length FLx cm 14 01 1 30 FLy cm 9 0 9 0 IPA 3 MImax W cm2 184 Operating Control Conditions Control 1 Exam Type Abd Crd Abd Abd Control 2 Sample Volume Size 0 mm 14 mm 14 mm 7 mm Control 3 Sample Volume Position Zone 1 Zone 8 Zone 8 Zone 0 Control 4 PRF 1562 Hz 1562 Hz 1562 Hz 1953 Hz Control 5 TDI Off a This index is not required for this operating mode value is 1 b...

Page 329: ...Pa 0 383 deq Pllmax cm 0 78 Focal Length FLx cm 27 30 FLy cm 9 00 IPA 3 MImax W cm2 3 25 Operating Control Conditions Control 1 Exam Type Orbital Orbital Orbital Control 2 Sample Volume Size 5 mm 9 mm 9 mm Control 3 Sample Volume Position Zone 9 16 8 cm Zone 13 27 3 cm Zone 13 27 3 cm Control 4 PRF 1562 Hz 1562 Hz 1562 Hz a This index is not required for this operating mode value is 1 b This trans...

Page 330: ...1 30 1 30 Other Information PD μsec PRF Hz pr PIImax MPa deq Pllmax cm 0 47 Focal Length FLx cm 1 30 1 30 FLy cm 9 0 9 0 IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Crd Crd Crd Control 2 Sample Volume Zone 0 Zone 1 Zone 0 a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are re...

Page 331: ...d to derive the values in the acoustic output table are shown in the table below In accordance with Section 6 4 of the Output Display Standard the following measurement precision and uncertainty values are determined by making repeat measurements and stating the standard deviation as a percentage Table 10 57 Acoustic Measurement Precision and Uncertainty Quantity Precision of standard deviation Un...

Page 332: ...are centimeter MI Mechanical index PD Pulse duration microseconds associated with the transmit pattern giving rise to the reported value of MI Pr 3 Derated peak rarefactional pressure associated with the transmit pattern giving rise to the value reported under MI Megapascals pr PIImax Peak rarefactional pressure at the point where the free field spatial peak pulse intensity integral is a maximum i...

Page 333: ...al distance z1 in units of milliwatts Wo Ultrasonic power except for TISscan in which case it is the ultrasonic power passing through a one centimeter window in units of milliwatts z1 Axial distance corresponding to the location of maximum min W3 z1 ITA 3 z x 1 cm2 where z zbp in centimeters zbp 1 69 Aapr t in centimeters zsp For MI the axial distance at which pr 3 is measured For TIB the axial di...

Page 334: ...10 72 Acoustic output ...

Page 335: ...ork time service Communicating procedure status via the Modality Performed Procedure Step MPPS service Requesting transfer of responsibility for image ownership to another system via the Storage Commitment service Network for connecting the device To ensure safety use an IT network that is isolated from the external environment by a firewall Specifications for the connection Hardware specification...

Page 336: ...ecting the equipment to an uncontrolled IT Network make sure that all potential risks resulting from such connections were identified and evaluated and suitable countermeasures were put in place IEC 80001 1 2010 provides guidance for addressing these risks 2 When a setting of the IT network to which this device is connected has been changed check that the change does not affect this device and tak...

Page 337: ... to stable the user can re initiate the transfer of data Delay of transmission to a PACS Incorrect data transmitted to a PACS Misdiagnosis Integrity of the data is ensured by the TCP IP and DICOM Protocols used by SonoSite X Porte Unable to get order data from an MWL server Delay of exam On SonoSite X Porte the user can initiate create a new study Delay of getting order from an MWL server Incorrec...

Page 338: ...noSite X Porte closes unnecessary network ports Infection by computer virus Leak of exam data SonoSite X Porte prevents a user from loading software and executing it Table 11 1 IT network failure recovery continued Network failure Impact on equipment Hazard SonoSite X Porte countermeasures ...

Page 339: ...Identified by the letter L linear and a number 38 The number corresponds to the length of the array expressed in millimeters The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam For example L38xip mechanical index MI An indication of the likelihood of mechanical bioeffects occurring the higher the MI the greater the likelihood of mec...

Page 340: ...e resolution transducer A device that transforms one form of energy into another form of energy Ultrasound transducers contain piezoelectric elements which when excited electrically emit acoustic energy When the acoustic energy is transmitted into the body it travels until it encounters an interface or change in tissue properties At the interface an echo is formed that returns to the transducer wh...

Page 341: ...nnulus Diameter ANT F Anterior Far ANT N Anterior Near Ao Aorta AoD Aortic Root Diameter Apical Apical View APTD Anteroposterior Trunk Diameter AT Acceleration Deceleration Time AUA Average Ultrasound Age Calculated by averaging the individual ultrasound ages for the fetal biometry measurements performed during the exam The measurements used to determine the AUA are based on the selected OB calcul...

Page 342: ...sterna Magna CO Cardiac Output CPD Color Power Doppler Crd Cardiac CRL Crown Rump Length CVD Color Velocity Doppler CW Continuous Wave Doppler CxLen Cervix Length D Diameter D Apical Distance Apical DCCA Distal Common Carotid Artery DECA Distal External Carotid Artery Decel Deceleration time DICA Distal Internal Carotid Artery Dist Distal Table A 1 Abbreviations in user interface continued Abbrevi...

Page 343: ... by LMP Estimated Date of Delivery by Last Menstrual Period The due date calculated from the user entered LMP EDV End Diastolic Velocity EF Ejection Fraction EF SLOPE E F Slope EFW Estimated Fetal Weight Calculated from the measurements performed during the exam The measurements used to determine EFW are defined by the currently selected EFW calculation author Endo Endocardial Epi Epicardial EPSS ...

Page 344: ...d LMP GA by LMPd Gestational Age by derived Last Menstrual Period The fetal age calculated using the Last Menstrual Period LMPd derived from the Estab DD Gate Depth of Doppler Gate GS Gestational Sac Gyn Gynecology HC Head Circumference HL Humerus Length HR Heart Rate ICA Internal Carotid Artery IMT Intima Media Thickness IVC Inferior Vena Cava IVRT Iso Volumic Relaxation Time IVS Interventricular...

Page 345: ...ser entered Estab DD LV Left Ventricular LV Area Left Ventricular Area LV mass Left Ventricular mass LV Volume Left Ventricular Volume LVd Left Ventricular diastolic LVD Left Ventricular Dimension LVDd Left Ventricular Dimension Diastolic LVDFS Left Ventricular Dimension Fractional Shortening LVDs Left Ventricular Dimension Systolic LVEDV Left Ventricular End Diastolic Volume LVESV Left Ventricula...

Page 346: ...echnology MCA Middle Cerebral Artery MCCA Mid Common Carotid Artery MECA Mid External Carotid Artery MI Mechanical Index MICA Mid Internal Carotid Artery Mid Middle MM M Mode MR PISA Mitral Regurgitation Proximal Iso Velocity Surface Area MR VTI Mitral Regurgitation Velocity Time Integral Msk Musculoskeletal MV Mitral Valve MV Area Mitral Valve Area MV Regurgitant Fraction Mitral Valve Regurgitant...

Page 347: ...ameter Oph Ophthalmic Orb Orbital PAL Phase Alternating Line PCAp Posterior Cerebral Artery Peak PCCA Proximal Common Carotid Artery PCoA Posterior Communicating Artery PECA Proximal External Carotid Artery PGMax Maximum Pressure Gradient PGMean Mean Pressure Gradient PGr Pressure Gradient PHT Pressure Half Time PI Pulsatility Index PICA Proximal Internal Carotid Artery PISA Proximal Isovelocity S...

Page 348: ... Diastolic RVDs Right Ventricular Dimension Systolic RVOT D Right Ventricular Outflow Tract Diameter RVOT VTI Right Ventricular Outflow Tract Velocity Time Integral RVSP Right Ventricular Systolic Pressure RVW Right Ventricular Free Wall RVWd Right Ventricular Free Wall Diastolic RVWs Right Ventricular Free Wall Systolic S Tricuspid Lateral Annular Systolic Velocity TDI measurement S D Systolic Di...

Page 349: ...meter OB measurement Transcranial Doppler exam type TDI Tissue Doppler Imaging THI Tissue Harmonic Imaging TI Thermal Index TICA Terminal Internal Carotid Artery TO Transorbital TRMax Tricuspid Regurgitation peak velocity TT Transtemporal TTD Transverse Trunk Diameter TV Tricuspid Valve TVA Tricuspid Valve Area UA Ultrasound Age Calculated on the mean measurements taken for a particular fetal biom...

Page 350: ... Vertebral Artery Vas Vascular Ven Venous VF Volume Flow VMax Peak Velocity VMean Mean Velocity Vol Volume VTI Velocity Time Integral YS Yolk Sac Table A 1 Abbreviations in user interface continued Abbreviation Definition ...

Page 351: ...orksheet 5 55 worksheets 5 54 adjust height 2 2 2 4 settings 2 8 administrator 3 2 ALARA principle 10 1 A 1 amniotic fluid index AFI 5 40 6 14 angle 4 16 annotate See labels aorta Ao 5 25 6 7 aortic valve area AVA 5 27 5 32 6 4 archive exam 4 42 archivers DICOM 3 19 archiving educational 3 35 exam 4 43 images and clips 4 42 procedural 3 35 area ellipse 5 2 trace 5 2 arrows 4 29 arterial calculatio...

Page 352: ... orbital 5 49 percent area reduction 5 11 redo 5 10 save 5 10 settings 3 6 small parts 5 44 TCD 5 49 volume 5 12 volume flow 5 12 calipers about 5 1 activate 5 1 switch 5 1 cardiac calculations 5 18 exam 2 15 intended uses 2 25 references 6 4 settings 3 7 cardiac calculations aorta Ao 5 25 aortic valve area AVA 5 27 5 32 ascending aorta AAo 5 25 atrial volume 5 26 cardiac index CI 5 34 cardiac out...

Page 353: ...nd 8 14 system and transducer 8 3 8 8 transducer connect 8 14 clinical monitor See monitor clips play 4 40 record 4 47 save 4 45 See also images and clips Color controls 4 12 imaging or scanning 4 3 steering 4 13 Color Doppler Variance Var 2 15 4 12 Color Power Doppler CPD 2 15 4 12 Color Velocity Doppler CVD 2 15 connectivity setup 3 11 continuous wave CW Doppler 2 15 4 4 4 16 contraindications 2...

Page 354: ...8 2 system and transducer 8 3 8 8 display format 4 15 distance 2D 5 2 M Mode 5 3 D line 4 4 angle 4 16 controls 4 16 gate size 4 16 steering 4 16 4 18 Doppler controls 4 16 D line 4 4 4 16 gate size 4 16 imaging or scanning 4 4 measurements 5 4 scale setup 3 29 steering 4 16 4 18 sweep speed 4 18 trace 5 6 types 4 4 Dual cine viewing 4 6 imaging or scanning 4 5 update 4 17 DVR port 2 5 2 20 record...

Page 355: ...ges and clips 4 40 information 4 43 routing 3 34 Steep Needle Profiling SNP 4 24 transfer 4 42 type and transducer 2 15 3 30 type change 2 14 types manage 3 30 verify transfer 4 42 export connectivity settings 3 12 exams 4 44 images and clips 4 48 logs 3 27 settings 3 33 USB 4 44 femur length FL 6 17 fetal trunk cross sectional area FTA 6 17 FL AC ratio 6 20 FL BPD ratio 6 20 FL HC ratio 6 20 flow...

Page 356: ...ps archive 4 42 delete 4 41 exam 4 40 export 4 48 export to USB 3 37 file formats 3 37 image gallery 4 48 review 4 30 4 38 save 4 44 view 4 48 imaging 2D 4 2 Color 4 3 controls 4 6 data 3 26 Doppler 4 4 Dual 4 5 M Mode 4 2 modes list of 9 25 optimize 4 8 orientation 4 8 procedure mode 4 9 transducers 2 15 import connectivity settings 3 12 settings 3 33 in situ definition A 1 inferior vena cava IVC...

Page 357: ...ional shortening 6 10 dimension systolic LVDs 5 24 ejection fraction 6 10 end volumes 6 8 FAC 6 6 mass 5 28 6 9 outflow tract diameter LVOT D 5 25 posterior wall fractional thickening 6 10 volume 5 27 volume biplane 6 9 volume single plane 6 10 license key 2 2 7 3 limits humidity 9 24 operating 9 24 pressure 9 24 LMPd 6 16 locations DICOM 3 17 3 23 system 3 11 lock wheel 2 2 2 4 login 3 5 administ...

Page 358: ... 5 36 pressure gradient PG 5 4 pressure half time PHT 5 7 publications 6 4 ratio 5 5 resistive index RI 5 5 slope 4 20 5 7 target depth 5 3 TCD 5 49 terminology 6 4 time 5 3 5 5 tracing 5 2 uterus 5 35 velocity 5 4 5 5 VMax 5 7 mechanical index MI 10 8 A 1 middle cerebral artery MCA 5 41 mitral valve MV area 5 27 6 11 flow rate 6 11 M line 4 2 mode data 3 26 monitor 2 2 2 6 adjust 2 4 collapse 2 5...

Page 359: ...utput display 10 8 ovary 5 36 6 23 password administrator 3 2 change 3 5 user 3 4 patient header 3 26 information 4 31 4 35 4 39 list 4 38 4 39 pedal 2 2 2 4 pediatric neonatal percent area reduction 5 11 6 21 percent diameter reduction 5 11 6 21 peripherals 2 3 9 13 pictographs 4 29 PISA 5 24 6 12 A 9 platform 2 2 adjust 2 4 ports audio 2 20 digital video 2 8 2 20 dock 2 2 2 20 DVR 2 5 2 20 ether...

Page 360: ...53 printing 5 56 resistive index RI 5 5 5 41 6 22 review images and clips 4 30 4 38 labels 4 30 measure 5 57 right atrial RA pressure 5 30 volume 6 13 volume index 6 13 right ventricular RV FAC 6 7 right ventricular systolic pressure RVSP 5 30 6 13 routing selections 3 34 S D 5 41 6 13 A 10 safety electrical 9 3 electromagnetic compatibility 9 9 equipment 9 6 save exam type 3 31 images and clips 4...

Page 361: ...9 24 shipping 9 24 storage 9 24 stand clean and disinfect 8 14 standards DICOM 9 26 electromechanical 9 25 EMC classification 9 26 HIPAA 9 26 Steep Needle Profiling SNP A 1 exam types and transducers 4 24 4 26 needle size and angle 4 27 recommendations 4 27 steering Color 4 13 D line 4 16 4 18 Doppler 4 16 4 18 storage alerts 3 12 commit servers 3 21 images 9 25 internal 4 46 store images and clip...

Page 362: ...8 adjust 2 5 trace area or circumference 5 2 auto 4 19 5 7 Doppler 5 6 manual 5 6 Transcranial Doppler TCD calculations 5 49 measurements 5 49 transcranial intended uses 2 26 transducer connect 2 2 2 11 8 14 9 11 curved array A 1 definition A 2 exam type 2 15 general use 2 20 imaging modes 2 15 linear array A 1 preparation 2 19 problems 7 2 remove 2 14 7 7 select 2 14 sheath 2 20 ship 8 12 9 24 St...

Page 363: ... calculation reference 6 14 venous exam 2 15 intended uses 2 25 video instructional 2 23 output 2 8 visual guide videos 2 23 visualize needles 4 24 volume 3 6 atrial 5 26 bladder 6 22 calculations 5 12 follicle 6 23 LV 5 27 ovarian 6 23 reference 6 22 uterine 6 23 volume flow 5 12 abdominal 5 13 arterial 5 17 reference 6 22 wall filter 4 12 warnings definition 1 1 wheel locking 2 4 wheel lock 2 2 ...

Page 364: ...B 14 Index printing 5 56 zoom 4 23 ...

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Page 366: ...P14645 05 P14645 05 ...

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