SonoSite S-Cath User Manual
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SonoSite S-Cath User Manual

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  • Page 1 S Series Ultrasound System User Guide...
  • Page 3 S Series Ultrasound System User Guide...
  • Page 4 DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. The SonoSite ultrasound system(s) referenced in this document may be covered by one or more of the following U.S. patents: 5722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630,...

  • Page 5: Table Of Contents

    Contents Introduction Conventions ........................vii Customer comments ....................vii Chapter 1: Getting Started About the system ......................1 Preparing the system ....................1 Compartments and connectors ..............1 Installing or removing the battery ..............2 Using AC power and charging the battery ..........3 Turning the system on or off ................
  • Page 6 Presets setup .........................16 System Information setup ..................16 USB Devices setup .......................16 Limitations of JPEG format ................17 Chapter 3: Imaging Imaging modes ......................19 2D imaging ......................19 M Mode imaging ....................20 CPD and Color imaging ..................20 PW and CW Doppler imaging ................21 Adjusting depth and gain ..................23 Freezing, viewing frames, and zooming .............24 Imaging modes and exams available by transducer ........24...
  • Page 7 Chapter 5: Troubleshooting and Maintenance Troubleshooting ......................55 Software licensing .......................55 Maintenance ........................56 Cleaning and disinfecting the ultrasound system ........57 Cleaning and disinfecting transducers ............58 Cleaning and disinfecting the battery or USB keyboard ......59 Recommended disinfectants ..................60 Chapter 6: Safety Ergonomic safety ......................67 Position the system ....................68 Position yourself ....................68 Take breaks, exercise, and vary activities ...........68...
  • Page 8 Measurement publications and terminology ..........128 Cardiac references ................... 128 Obstetrical references ..................132 Gestational age tables ................... 133 Ratio calculations .................... 135 General references ..................136 Chapter 8: Specifications Supported transducers ................... 137 Imaging modes ......................137 Images and clips storage ..................137 Accessories ........................

  • Page 9: Conventions

    SonoSite at 888‐482‐9449 in the US. Outside the  and acoustic output information.  US, call the nearest SonoSite representative. The user guide is for a reader familiar with  You can also e‐mail SonoSite at  ultrasound techniques. It does not provide  comments@sonosite.com. training in sonography or clinical practices.  For technical support, please contact SonoSite as  Before using the system, you must have  follows: ultrasound training. See the applicable SonoSite accessory user guide  SonoSite Technical Support for information on using accessories and  peripherals. See the manufacturer’s instructions  Phone (US or 877-657-8118 for specific information about peripherals. Canada): Phone 425-951-1330 Conventions (Outside US Or call your local and Canada): representative. The user guide follows these conventions: Fax: 425-951-6700 •...

  • Page 10: Customer Comments

    viii Customer comments...

  • Page 11: Chapter 1: Getting Started

    Chapter 1: Getting Started About the system Basic steps 1 Turn the system on. (For power switch  The SonoSite S Series ultrasound system is a  location, see “System controls” on page 5.) portable, software‐controlled device using  2 Attach a transducer. all‐digital architecture. The S Series includes the  following: 3 Press  Patient, and complete the patient  • S‐Cath™ ultrasound system information form. • S‐FAST™ ultrasound system 4 If all imaging modes are licensed, press Mode,  • S‐GYN™ ultrasound system and select an imaging mode. • S‐ICU™ ultrasound system By default, the system is in 2D imaging. • S‐MSK™ ultrasound system Preparing the system •...

  • Page 12: Installing Or Removing The Battery

    Each connector on the back and side of the system  has a symbol that describes its use. Connectivity Symbols on System Symbol Definition DC input RS-232 (DVD recorder or bar code scanner) Composite video out Print control S-video out S-video in DVI video out Ethernet Audio out Installing or removing the battery WARNING: To avoid injury to the operator and to prevent damage to the ultrasound system, inspect the battery for leaks prior to installing.

  • Page 13: Using Ac Power And Charging The Battery

    Caution: Do not use the system if an error message appears on the display. Note the error code and turn off the Using AC power and charging the system. Call SonoSite or your local battery representative. The battery charges when the system is  connected to the AC power supply. A fully  To turn the system on or off discharged battery recharges in less than five ...

  • Page 14: Connecting Transducers

    Connecting transducers To connect a transducer 1 Pull the transducer latch up, and rotate it  WARNING: To avoid injury to the patient, do clockwise. not place the connector on the 2 Align the transducer connector with the  patient. Operate the ultrasound connector on the back of the system. system in the S Series stand, the V-Universal™ stand, or on a 3 Insert the transducer connector into the ...

  • Page 15: System Controls

    System controls WARNING: To avoid damaging the USB storage device and losing patient data from it, observe the following: • Do not remove the USB storage device or turn off the ultrasound system while the system is exporting. • Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system.

  • Page 16: Screen Layout

    Screen layout Figure 4 Screen Layout Mode data area Current imaging mode information and settings (for example, Gen, THI, MB). For definitions, see “Glossary. ” Orientation marker Provides indication for image orientation. Text Text entered using keyboard. Picto Pictograph to indicate anatomy and transducer position. You can select anatomy and screen location.

  • Page 17: General Interaction

    WARNING: To avoid contamination, do not use next to the key or knob. the USB keyboard supplied by To select a control key, press it. To select a control  SonoSite in a sterile environment. knob, press it, turn it, or both, depending on  The USB keyboard is not sterilized context. and cannot withstand sterilization. Functionality To enter text in text fields using the In general, a control functions in one of the ...

  • Page 18: Preparing Transducers

    Caution: To avoid damage to the transducer, install the sheath only when you are ready to  use only gels recommended by perform the procedure. SonoSite. Using gels other than the one recommended by SonoSite can 1 Place gel inside the sheath. damage the transducer and void 2 Insert the transducer into the sheath. the warranty. If you have questions about gel compatibility, contact 3 Pull the sheath over the transducer and cable ...

  • Page 19: Training Videos

    6 Inspect the sheath to ensure that there are no  • Play Resumes playing of a paused video. holes or tears. • Forward Advances the video 10 seconds. To exit a video Training videos Press one of the following: The SonoSite ®  Education Key™ training videos  • List to return to the video list. are an optional feature. • Done to return to 2D imaging. Note: Training videos are unavailable while the  system is archiving or exporting data. Intended uses To display the list of videos The system transmits ultrasound energy into  1 Insert the Education Key USB device into a  various parts of the patient’s body using 2D, color  USB port. (See “To insert a USB storage  Doppler (Color), and color power Doppler (CPD)  device.”) to obtain ultrasound images as follows.
  • Page 20 obstetrical procedures and to provide assistance  surrounding anatomical structures for the  during abdominal, breast, and neurological  presence or absence of pathology. You can use the  surgery. system to provide ultrasound guidance for  biopsy and drainage procedures, vascular line  Obstetrical Imaging Applications You can assess  placement, peripheral nerve blocks, and spinal  the fetal anatomy, viability, estimated fetal  nerve blocks and taps. weight, gestational age, amniotic fluid, and  surrounding anatomical structures for the  WARNING: To avoid injury to the patient, use presence or absence of pathology  only an Ophthalmic (Oph) exam transabdominally or transvaginally. CPD and  type when performing imaging Color imaging are intended for high‐risk  through the eye. The FDA has pregnant women. High‐risk pregnancy ...

  • Page 21: Chapter 2: System Setup

    To log in as Administrator control key below it (the upper‐left control  1 On the Administration setup page, type  key).  in the Name box. (See  Administrator The system beeps several times. “Entering text” on page 7.) 2 Type the administrator password in the  Administration setup Password box. If you don’t have the administrator password,  On the Administration setup page, you can  contact SonoSite. (See “SonoSite Technical  configure the system to require users to log in  Support” on page vii.) and enter passwords. Required login helps  protect patient data. You can also add and delete  3 Click Login. users, change passwords, import and export user  accounts, and display the Event log. To log out as Administrator Turn off or restart the system. Chapter 2: System Setup...

  • Page 22: User Setup

    To require user login 6 Click Save. You can set the system to display the User Login  To modify user information screen at startup. 1 Log in as Administrator. 1 Log in as Administrator. 2 Under User List, click the user. 2 In the User Login list, click On. 3 Under User Information, make changes as  • On requires a user name and password at  desired. startup. 4 Click Save. • Off allows access to the system without a  Any change to the user name replaces the  user name and password. previous name. To change the administrator password or let To delete a user users change passwords 1 Log in as Administrator.

  • Page 23: Exporting And Clearing The Event Log

    To import user accounts 2 Press Clear. 1 Insert the USB storage device that contains the  3 Click Yes. accounts. Logging in as user 2 Log in as Administrator. If user login is required, the User Login screen  3 Press Import. appears when you turn on the system. (See “To  4 Click the USB storage device, and click  require user login” on page 12.) Import. To log in as user 5 Click Restart in the dialog box that appears. 1 Turn on the system. The system restarts. All user names and  2 In the User Login screen, type your name and  passwords on the system are replaced with ...

  • Page 24: Audio, Battery Setup

    To predefine a label group 3 Select the USB storage device, and click  Export. You can specify which labels are available for an  exam type when annotating an image. (See “To  A copy of all predefined label groups for all  place text on an image” on page 26.) exams saves to the USB storage device. 1 In the Exam list on the Annotations setup  To import predefined label groups page, select the exam type whose labels you  1 Insert the USB storage device that contains the  want to specify. label groups. 2 For Group, select A, B, or C for the label group  2 On the Annotations setup page, press Import. you want associated with that exam.  3 Select the USB storage device, and then click  The preset labels for the selected group appear  Import. in the scroll list. 4 Click OK in the dialog box that appears.

  • Page 25: Connectivity Setup

    To specify cardiac measurement names To receive storage alerts Under TDI Walls on the Cardiac Calculations  On the Connectivity setup page, select  setup page, select a name for each wall.  Internal Storage Capacity Alert. The system displays a message if internal  storage is near capacity when you end an  Connectivity setup exam. On the Connectivity setup page, you select  options for using devices and for alerts when  Date and Time setup internal storage is full. You also import wireless  certificates and specify settings (including  To set the date and time ™ Transfer Mode and Location) for SiteLink   On the Date and Time setup page, do the  ®...

  • Page 26: Ob Calculations Setup

    Clip Length: Clip length in seconds.  including space availability. You can also specify  a file format for images in patient exams that you  Units: Units for patient height and weight in  export to a USB storage device. cardiac exams: in/ft/lbs or cm/m/kg. Language: The system language. Changing the  To specify a file format for exported images language requires restarting the system. The image format you specify affects only still  images. Clips export in H.264 video saved as MP4  Display Brightness: Scheme 1 displays brighter  files. To view them, SonoSite recommends  key names and icons and is suitable for a bright  QuickTime 7.0 or later.  environment, such as daylight. Scheme 2 displays dimmer key names and icons and is  1 On the USB Devices setup page, click Export. suitable for a dark environment. 2 Under SiteLink, select an image format. For  Auto save Pat. Form: Automatically saves the  JPEG image format, also select a JPEG  patient information form as an image in the  compression.

  • Page 27: Limitations Of Jpeg Format

    3 Select a sort order under Sort By. Digital Diagnostic Imaging within  Radiology,” Approved: June 2008.  The sort order specifies how exported files are  www.car.ca/Files/%5CLossy_Compression. organized. To return to the previous screen, click Devices. To include private tags If you use DICOM export type and a SonoSite  software product, include private tags on the  images. On the USB Devices setup page, select Include private tags. Note: Because the tags may be incompatible with  some earlier archivers, keep this check box  unselected unless you use SonoSite software  products. For more information, see the ultrasound  system’s DICOM conformance statement. Limitations of JPEG format When transferring or exporting images in JPEG  format, the system uses lossy compression. Lossy  compression may create images that have less  absolute detail than BMP format and that don’t  render identically to the original images. In some circumstances, lossy‐compressed images  may be inappropriate for clinical use. For  ® example, if you use images in SonoCalc  IMT  software, you should transfer or export them ...
  • Page 28 USB Devices setup...

  • Page 29: Chapter 3: Imaging

    Chapter 3: Imaging Imaging modes See also “Adjusting depth and gain” on page 23. Auto Gain The gain adjusts automatically each The system has a high‐performance LCD and  time you press the key. advanced image‐optimization technology that  simplifies user controls. Imaging modes available  To adjust gain manually, see depend on the transducer and exam type. See  “Adjusting depth and gain” “Imaging modes and exams available by  page 23. transducer” on page 24. Optimize Settings are as follows: Res provides the best possible 2D imaging resolution.

  • Page 30: M Mode Imaging

    3 Adjust controls as desired. Guide Turns guidelines on and off. Many optimization and depth settings  If using a variable angle needle guide, available in 2D imaging are also available in  press Guide and then press again to M Mode imaging. See “2D controls” on  select the angle: A, B, or C. The page 19. touchpad moves the depth cursor. See also Bracket and Needle Guide User To display the M Mode trace Guide or Bracket and Needle Guide for...

  • Page 31: Pw And Cw Doppler Imaging

    • Press Mode and select Color. For CPD,  Color Shows or hides color information. press CPD on the left. Suppress You can select Show or Hide while A ROI box appears in the center of the 2D  in live or frozen imaging. image. The current selection (Color or CPD) appears  Invert Switches the displayed direction of in the mode data area. flow. In Color imaging, the Color indicator bar on  Available in Color imaging. the upper left‐hand screen displays velocity in  cm/s. Steering Select the steering angle setting of the color ROI box (-15, 0, or +15).
  • Page 32 To display the D-line • If using a duplex layout, press Mode and  select Doppler to toggle between the  The default Doppler imaging mode is PW  full‐screen D‐line and the duplex layout. Doppler. In the cardiac exam, you can select CW  Doppler. To set a duplex layout, see “Presets setup”  on page 16. 1 Press Mode and select Doppler. 2 Do any of the following as needed: PW Doppler controls • Adjust controls. See “PW Doppler  CW, PW (Cardiac exam only) Toggles controls” on page 22. between PW Doppler and CW Doppler. • Using the touchpad, position the D‐line  The current selection appears in the and gate where desired. Horizontal ...

  • Page 33: Adjusting Depth And Gain

    Steering Press to select the desired steering Live Trace Displays a live trace of the peak or angle setting. Settings available mean. (See “Presets setup” depend on the transducer. The PW page 16 to specify peak or mean.) Doppler angle automatically corrects to the optimum setting.

  • Page 34: Freezing, Viewing Frames, And Zooming

    Freezing, viewing frames, and Imaging modes and exams zooming available by transducer To freeze or unfreeze an image WARNING: To prevent misdiagnosis or harm to the patient, understand your Press  Freeze. system’s capabilities prior to use. On a frozen image, the cine icon and frame  The diagnostic capability differs for number appear in the lower left‐hand corner.
  • Page 35 Imaging modes and exams available — L25x — Imaging — Mode — L38x — — — L38xi — — S-Cath C60x — — HFL38x — P21x — — — — — — S-GYN C60x — L25x — — — —...

  • Page 36: Annotating Images

    3. This transducer includes Tissue Harmonic Imaging. L25x — For more information, see “Glossary” on page 141. 4. The TEEx transducer is available for certain product L38xi — configurations. Contact SonoSite or your SonoSite SLAx — representative. — S-Nerve C11x — Annotating images —...

  • Page 37: Patient Information Form

    • Click, and then type text. See “Entering  To place a pictograph on an image text” on page 7. The pictograph set available depends on  transducer and exam type. • Press Label, and then press the desired  1 Press Options and select Annotate. label group:  ,  , or  . Press the  group again to select the desired label.  2 Press Picto. The first number shows which label in the  3 Press  x/x to display the desired  group is selected. The second number is  pictograph, and then click. the number of labels available. The first number shows which pictograph in  See “Annotations setup” on page 13.  the set is selected. The second number is the  To return to the previous screen, press the  number of pictographs available. Back knob.

  • Page 38: Patient Information Form Fields

    calculations and report page. To save this information,  Patient information form fields save the screen for each item. Patient 1 In 2D, press  Patient. • Last, First, Middle Patient name 2 Press  New/End. • ID Patient identification number Fill in the form fields. See “Patient  • Accession Enter number, if applicable information form fields” on page 28 and  “Entering text” on page 7. • Date of birth 4 Press Done. • Gender  See also “To append images and clips to a patient  • Indications Enter desired text exam” on page 30. •...

  • Page 39: Images And Clips

    If the internal storage icon does not appear in the system status area, • Reading Dr. internal storage may be defective. • Referring Dr. Contact SonoSite Technical Support. (See “SonoSite Technical • Institution Support” on page vii.) Images and clips The patient list lets you organize saved images ...
  • Page 40 To select patient exams in the patient list To review images and clips Do one of the following: You can review only one patient exam’s images  and clips at a time. • Select the check box for one or more  patient exams. 1 In the patient list, click the patient exam  whose images and clips you want to review. Clicking Select All selects all patient  exams. The patient row is highlighted. • If using a USB keyboard, press the    2 Press the Review knob.  or     key to highlight  ARROW DOWN ARROW The icon on the knob changes to two numbers:  the patient exam, and then press the  the file displayed and the total files saved.

  • Page 41: Printing, Exporting, And Deleting Images And Clips

    Printing, exporting, and deleting images To export patient exams to a USB storage device and clips You can export patient exams if they are ended.  WARNING: To avoid damaging the USB storage (See “To end the exam” on page 28.) device and losing patient data from A USB storage device is for temporary storage of  it, observe the following: images and clips. Patient exams should be  • Do not remove the USB storage archived regularly. To specify file format, see ...
  • Page 42 To manually archive images and clips You can send patient exams to a DICOM printer  or archiver, or to a PC using SiteLink. DICOM  and SiteLink are optional features. For more  information about archiving, see the SiteLink and  DICOM documentation. 1 Select one or more patient exams in the patient  list. 2 Press Archive. To display information about a patient exam 1 In the patient list, select the patient exam. 2 Click Info. Images and clips...

  • Page 43: Chapter 4: Measurements And Calculations

    Chapter 4: Measurements and Calculations You can measure for quick reference, or you can  measure within a calculation.  Measurements are performed on frozen images.  For references used, see Chapter 7, “References.” Measurements You can perform basic measurements in any  imaging mode. Options available depend on  your configuration, transducer, and exam type. About saving measurements After performing a measurement, you can save  Figure 1 2D image with one distance and one the image with the measurements displayed. (See  circumference measurement “To save an image” on page 29.) Some  measurements can be saved to a calculation and  the patient report.  Working with calipers When measuring, you work with calipers.  If you prefer to select a measurement name  Results based on the calipers’ position appear at  before performing a measurement, start a ...

  • Page 44: 2D Measurements

    See also “To add calipers (2D)” on page 34 and  • To switch the active set, press  Switch. “To save a measurement to a calculation and  patient report” on page 33. To delete or edit a measurement To measure area and circumference With the measurement active (highlighted),  do one of the following: Area and circumference measurements use an  ellipse with calipers. Area is in cm , and  • To delete, press the Delete knob. Circumference is in cm. • To edit, use the touchpad to move the  calipers. You can edit only distance and  1 On a frozen 2D image, press  Calipers. area/circumference measurements. To place calipers more precisely 2 Press  Ellipse.

  • Page 45: M-Mode Measurements

    3 Using the touchpad, position the vertical  • Ellipse to measure area and  caliper at the peak of the heartbeat, and then  circumference click. A second vertical caliper appears.  • Manual to trace manually 4 Using the touchpad, position the second  The second measurement is labeled B. The  vertical caliper at the peak of the next  third is labeled C, and so on. heartbeat. 5 (Cardiac exam) If you want to save the  M-Mode measurements measurement to the patient report, press  The basic measurements that you can perform in  Save HR. M Mode imaging are as follows: • Distance in cm/Time in seconds Saving the heart rate measurement to the  patient report overwrites any heart rate  • Heart Rate (HR) in beats per minute (bpm) entered on the patient information form. The time scale above the trace has small marks at  See also “To measure fetal heart rate (M Mode)”  200 ms intervals and large marks at one‐second  on page 51. intervals.
  • Page 46 To measure Velocity (cm/s) and Pressure 3 Using the touchpad, position the caliper  where desired, and then click.  Gradient (Doppler) This measurement involves a single caliper from  A second caliper appears. the baseline. 4 Using the touchpad, position the second  1 On a frozen Doppler spectral trace, press  caliper where desired.  Calipers. See also “To add calipers (Doppler)” on page A single caliper appears. To measure Pressure Half Time (Doppler) 2 Using the touchpad, position the caliper to a  1 On a frozen Doppler spectral trace in the  peak velocity waveform. Cardiac exam, press  Calipers. See “To save a measurement to a calculation and  patient report” on page 33. 2 Press  PHT.

  • Page 47: Calculations

    See also“To save a measurement to a calculation  • Acceleration Time (AT) and patient report” on page 33 and “To add  • Resistive Index (RI) calipers (Doppler)” on page • Maximum Pressure Gradient (PGmax) To trace automatically (Doppler) To add calipers (Doppler) After tracing automatically, confirm that the  system‐generated boundary is correct. If you are  With a measurement active, you can add calipers  not satisfied with the trace, obtain a high‐quality  to perform additional measurements. Doppler spectral trace image, or trace manually.  Press one of the following: (See “To trace manually (Doppler)” on page 36.) • Add Caliper to measure velocity and  1 On a frozen Doppler spectral trace, press  pressure gradient Calipers.  • Time to measure time duration 2 Press  Auto.  • Manual to trace manually A vertical caliper appears.

  • Page 48: Performing And Saving Measurements In Calculations

    Menu items followed by ellipses (. . .) have  The calculation saves to the patient report,  subentries.  and the image saves to internal storage  with the measurements displayed. To select from the calculations menu Displaying and deleting saved 1 On a frozen image, press  Calcs. measurements in calculations The calculations menu appears. To display a saved measurement 2 Using the touchpad, highlight the desired  Do one of the following: measurement name. • Highlight the measurement name in the  To display additional measurement names,  calculations menu. The result appears  highlight and click Next, Prev, or a  below the menu. measurement name that has ellipses (. . .).  • Open the patient report. See “Patient  Only measurement names available for the ...

  • Page 49: Cardiac Calculations

    Systems and Exam Types for Cardiac Ao/LA Ao (2D or Calculations M Mode) LA/Ao Exam Type S Series System AAo (2D) Cardiac S-Cath LA (2D or S-FAST M Mode) LA/Ao S-ICU LVOT D (2D) LVOT D The following table shows the measurements  LVOT area required to complete different cardiac ...
  • Page 50 Cardiac Cardiac Menu Calculation Menu Calculation Measurements Measurements Heading Results Heading Results (Imaging Mode) (Imaging Mode) LV…LVd RVW (M Mode) PISA Ann D (2D) PISA Area RVD (M Mode) Radius (Color) IVS (M Mode) MR/VTI (Doppler) MV Rate LVD (M Mode) LVESV MV/VTI (Doppler) Regurgitant...
  • Page 51 Cardiac Cardiac Menu Calculation Menu Calculation Measurements Measurements Heading Results Heading Results (Imaging Mode) (Imaging Mode) P. Vein A (Doppler) VMax Vmax (Doppler) Vmax PGmax Adur (Doppler) time VTI (Doppler) S (Doppler) VMax Vmax S/D ratio D (Doppler) PGmax Vmean E (Doppler) PGmean A (Doppler)
  • Page 52 To measure LVd and LVs Cardiac Menu Calculation 1 On a frozen 2D image or M Mode trace, press  Measurements Heading Results (Imaging Mode) Calcs.  2 From the calculations menu, select the  TRmax (Doppler) Vmax measurement name. PGmax 3 Position the active (green) caliper at the  E (Doppler) starting point, and then click. (See “Working  A (Doppler) E PG with calipers” on page 33.) 4 Position the second caliper, and then click. A PG Another caliper appears, and the calculations  menu highlights the next measurement name.
  • Page 53 c Using the touchpad, trace the left  5 Positioning the calipers, measure the  ventricular (LV) cavity. ventricular length. (See “Working with  calipers” on page 33.) To make a correction, press  Undo. 6 Save the calculation. d Complete the trace, and then click.  To measure peak velocity Save the calculation. (See “To save a  For each cardiac measurement, the system saves  calculation” on page 38.) up to five individual measurements and  calculates their average. If you take more than  To calculate MV or AV area five measurements, the most recent measurement  replaces the fifth one. If you delete a saved  1 On a frozen 2D image, press  Calcs. measurement from the patient report, the next  2 In the calculations menu, locate Area, and  measurement taken replaces the deleted one in  then select MV or AV. the patient report. The most recently saved ...
  • Page 54 4 Using the touchpad, trace the waveform. • In AV, position the caliper at the end  diastole. To make a correction, press  Undo or  Save the calculation. (See “To save a  backtrack with the touchpad. calculation” on page 38.) 5 Press Set to complete the trace. To calculate Proximal Isovelocity Surface Save the calculation. (See “To save a  Area (PISA) calculation” on page 38.) The PISA calculation requires a measurement in  For information on the automatic trace tool, see  2D, a measurement in Color, and two  “To trace automatically (Doppler)” on page 37. measurements in Doppler spectral trace. After all  measurements are saved, the result appears in  To calculate Right Ventricular Systolic the patient report. Pressure (RVSP) 1 Measure from Ann D (2D): 1 On a frozen Doppler spectral trace, press ...
  • Page 55 3 Using the touchpad, position the first caliper  To make a correction, press  Undo or  along the waveform at 100 cm/s, and then  backtrack with the touchpad. click. d Press Set to complete the trace. A second horizontal dotted line with an active  caliper appears at 300 cm/s. e Save the calculation. 4 Using the touchpad, position the second  For information on the automatic trace tool, see  caliper along the waveform at 300 cm/s. “To trace automatically (Doppler)” on page 37.  Save the calculation. (See “To save a  To calculate Isovolumic Relaxation Time calculation” on page 38.) (IVRT) To calculate Aortic Valve Area (AVA) 1 On a frozen Doppler spectral trace, press  The AVA calculation requires a measurement in  Calcs. 2D and two measurements in Doppler. After the  2 From the calculations menu, select MV and  measurements are saved, the result appears in ...
  • Page 56 To calculate Qp/Qs To calculate Stroke Volume (SV) or Stroke Index (SI) The Qp/Qs calculation requires two  measurements in 2D and two measurements in  The SV and SI calculations require a  Doppler. After the measurements are saved, the  measurement in 2D and a measurement in  result appears in the patient report. Doppler. SI also requires Body Surface Area  (BSA). After the measurements are saved, the  1 On a frozen 2D image, press  Calcs. result appears in the patient report. 1 (SI Only) Fill in the Height and Weight fields  2 Do the following to measure from LVOT D  on the patient information form. The BSA is  and again to measure from RVOT D: calculated automatically. (See “To create a  a From the calculations menu, locate Qp/Qs  new patient information form” on page 27.) and then select LVOT D or RVOT D. 2 Measure from LVOT (2D): Position the calipers. (See “Working with ...
  • Page 57 4 Using the touchpad, position the second  The system can maintain the accuracy of  vertical caliper at the peak of the next  automatic Cardiac Output measurements only if  heartbeat. the flow rate is 1 L/min or greater. Save the calculation. (See “To save a  1 Measure from LVOT (2D): calculation” on page 38.) a On a frozen 2D image, press  Calcs. To calculate Cardiac Output (CO) or Cardiac b From the calculations menu, select CO, and  Index (CI) then select LVOT D. The CO and CI calculations require Stroke  Position the calipers. (See “Working with  Volume and Heart Rate calculations. CI also  requires Body Surface Area (BSA). After the  calipers” on page 33.) measurements are saved, the result appears in  Save the calculation. (See “To save a  the patient report. calculation” on page 38.) 1 (CI Only) Fill in the Height and Weight fields ...

  • Page 58: Emed Calculations (S-Fast)

    To measure a Tissue Doppler Imaging (TDI) Gynecology (Gyn) calculations waveform Gynecology (Gyn) calculations include Uterus,  Ensure that TDI is on. (See “PW Doppler  Ovary, Follicle, and Volume. For instructions to  controls” on page 22.) calculate volume, see “Volume calculations” on  page 51. 2 On a frozen Doppler spectral trace, press  WARNING: To avoid incorrect calculations, Calcs. verify that the patient information, 3 From the calculations menu, select TDI, and  date, and time settings are accurate. then do the following for each measurement ...

  • Page 59: Ob Calculations

    To measure follicles To avoid incorrect obstetrics On each side, you can save up to three distance  calculations, verify with a local measurements on a follicle, for up to 10 follicles.  clock and calendar that the system’s If you measure a follicle twice, the average  date and time settings are correct appears in the report. If you measure a follicle  before each use of the system. The three times, the average and a volume calculation  system does not automatically appear in the report.
  • Page 60 Calculation Gestational OB Table Result Measurements Authors Calculation Gestational OB Table Result Measurements Authors BPD, TTD Hansmann Gestational — BPD, FTA, FL Osaka U. BPD, AC Shepard Hansmann, Nyberg, Tokyo U. BPD, TTD, APTD, FL Tokyo U. Hadlock, Ratios HC/AC Campbell Hansmann, FL/AC...

  • Page 61: Volume Calculations

    27. 3 Using the touchpad, position the vertical  caliper at the peak of the heartbeat, and then  click. Systems and Exam Types for Volume Calculations A second vertical caliper appears. 4 Using the touchpad, position the second  Exam Types S Series System vertical caliper at the peak of the next  heartbeat. S-Cath S-GYN Save the calculation. (See “To save a  S-Women’s Health calculation” on page 38.) S-FAST S-GYN S-Women’s Health To calculate volume The volume calculation involves three 2D  distance measurements: D , D , and D...

  • Page 62: Patient Report

    From the calculations menu, select the  OB patient report measurement name under Volume. (If  To delete an OB measurement Volume is not available in a Gyn exam,  select Gyn and then select Volume.) 1 Display the OB patient report. Position the calipers. (See “Working  2 Select the measurements to delete: with calipers” on page 33.) • Select one measurement by clicking it. Save the measurement. (See “To save a  • Select all measurements by clicking the  calculation” on page 38.) measurement name. The selected measurements are highlighted  Patient report green. The patient report contains calculation results  3 Press Delete. and patient information for the exam. For OB and  Cardiac exams, the patient report has additional  Cardiac patient report details and features. To delete a cardiac measurement The S‐FAST system has EMED worksheets ...

  • Page 63: Emed Worksheets (S-Fast)

    EMED worksheets (S-FAST) EMED worksheets contain results from EMED  calculations and checklists that you can  complete. To display an EMED worksheet 1 After or during the exam, press Options and  select Report. 2 Select the worksheet from the Worksheet list  or by pressing  x/x. MSK worksheets (S-MSK) The MSK worksheets have lists from which you  can select and a field for entering comments.  Saved MSK worksheets become part of the  patient report. To display an MSK worksheet 1 After or during the exam, press Options and  select Report. 2 Select the worksheet from the Worksheet list. To display additional pages in the worksheet,  press x/x. Each worksheet has its own  Comments field, which remains on‐screen  even if you display another page in the  worksheet.
  • Page 64 MSK worksheets (S-MSK)

  • Page 65: Chapter 5: Troubleshooting And Maintenance

    This chapter contains information to help correct  Ensure that the printer is turned on and set up  problems with system operation, to enter a  properly. See the printer manufacturer’s  software license, and to take proper care of the  instructions, if necessary. system, transducer, and accessories. DVD recorder does not record Check the DVD  recorder connections. Troubleshooting Ensure that the DVD recorder is turned on and  set up properly. See the applicable SonoSite  If you encounter difficulty with the system, use  accessory user guide and the manufacturers’  the following list to help troubleshoot the  instructions. problem. If the problem persists, contact SonoSite  Technical Support. (See “SonoSite Technical  System does not recognize the transducer Support” on page vii.) Disconnect and reconnect the transducer. System does not turn on Check all power  A maintenance icon appears on the system connections.

  • Page 66: Maintenance

    PCBA serial number Transducer bundle version WARNING: Disinfectants and cleaning methods listed are recommended by After you obtain a license key, you must enter it  SonoSite for compatibility with into the system. product materials, not for biological To enter a license key effectiveness. Refer to the disinfectant label instructions for 1 Turn on the system.

  • Page 67: Cleaning And Disinfecting The Ultrasound System

    WARNING: To prevent contamination, the use of sterile transducer sheaths and Caution: Do not spray cleaners or sterile coupling gel is disinfectant directly on the system recommended for clinical surfaces. Doing so may cause applications of an invasive or solution to leak into the system, surgical nature.

  • Page 68: Cleaning And Disinfecting Transducers

    8 Examine the transducer and cable for damage  using incorrect solution strength, or immersing a transducer deeper or such as cracks, splitting, or fluid leaks.  for a longer period of time than If damage is evident, discontinue use of the  recommended can damage or transducer, and contact SonoSite or your local  discolor the transducer and void representative. the transducer warranty. Maintenance...

  • Page 69: Cleaning And Disinfecting The Battery Or Usb Keyboard

    (31‐46 cm) from the point where the cable  enters the connector. To clean and disinfect the USB keyboard Follow the instructions on the disinfectant  1 Disconnect the USB keyboard from the  label for the duration of the transducer  system. immersion. 2 Wipe the surface with any of the following  7 Using the instructions on the disinfectant  products: label, rinse to the point of the previous  • Sani‐Cloth Wipes. immersion, and then air dry or towel dry with  a clean cloth. • Isopropyl alcohol 8 Examine the transducer and cable for damage  • Hydrogen peroxide such as cracks, splitting, or fluid leaks. If damage is evident, discontinue use of the  transducer, and contact SonoSite or your local  representative. Chapter 5: Troubleshooting and Maintenance...

  • Page 70: Recommended Disinfectants

    • Before using a disinfectant, confirm that its regulatory status is appropriate for your jurisdiction and use. Verify expiration dates on chemicals. When disposing of chemicals, follow manufacturer recommendations and EPA regulations. See www.sonosite.com for updated cleaning and disinfectant information. For cleaning and disinfecting the TEEx transducer, see the TEEx Transducer User Guide. Table 1: Disinfectant Compatibility with System and Transducers...
  • Page 71 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x System Type Active Ingredient HFL38x HFL50x L38xi Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx Alkacide Liquid Glutaraldehyde — — — Alkazyme Liquid Quat.
  • Page 72 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x System Type Active Ingredient HFL38x HFL50x L38xi Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx Cavicide Liquid Isopropyl — — — Caviwipes Wipes Isopropanol —...
  • Page 73 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x System Type Active Ingredient HFL38x HFL50x L38xi Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx Dynacide PA Liquid Peracetic Acid — — — Echo Clean Lingettes Wipe Alkylamine, Isopropyl...
  • Page 74 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x System Type Active Ingredient HFL38x HFL50x L38xi Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx Korsolex basic Liquid Glutaraldehyde — — — Korsolex extra Liquid Ethanol/Propanol —...
  • Page 75 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x System Type Active Ingredient HFL38x HFL50x L38xi Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx Rely+On™ PeraSafe™ Liquid Paracetic Acid — — — —...
  • Page 76 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x System Type Active Ingredient HFL38x HFL50x L38xi Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx Liquid Quat. Ammonia — — — Transeptic Cleaner Alcohol —...

  • Page 77: Chapter 6: Safety

    Chapter 6: Safety This chapter contains information required by regulatory agencies, including information  about the ALARA (as low as reasonably achievable) principle, the output display standard,  acoustic power and intensity tables, and other safety information. The information applies to  the ultrasound system, transducer, accessories, and peripherals.  Ergonomic safety These healthy scanning guidelines are intended to assist you in the comfort and effective use  of your ultrasound system. WARNING: To prevent musculoskeletal disorders, follow the guidelines in this section. Use of an ultrasound system may be linked to musculoskeletal disorders a,b,c Use of an ultrasound system is defined as the physical interaction among the operator, the ultrasound system, and the transducer.

  • Page 78: Position The System

    Position the system Promote comfortable shoulder, arm, and hand postures Use a stand to support the weight of the ultrasound system. Minimize eye and neck strain • If possible, position the system within reach. • Adjust the angle of the system and display to minimize glare. • If using a stand, adjust its height so that the display is at or slightly below eye level. Position yourself Support your back during an exam • Use a chair that supports your lower back, that adjusts to your work surface height, that  promotes a natural body posture, and that allows for quick height adjustments. • Sit or stand upright. Avoid bending or stooping. Minimize reaching and twisting • Use a bed that is height adjustable. •...

  • Page 79: Electrical Safety Classification

    or more frequent breaks. However, simply changing tasks can help some muscle groups  relax while others remain or become active. • Work efficiently by using the software and hardware features correctly. • Keep moving. Avoid sustaining the same posture by varying your head, neck, body, arm,  and leg positions. • 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 classification Class I equipment The ultrasound system is classified as Class I equipment when powered from the external power supply or mounted on the stand because the external power supply is a Class 1 protectively earthed power supply.

  • Page 80: Electrical Safety

    Electrical safety This system meets EN60601‐1, Class I/internally‐powered equipment requirements and Type  BF isolated patient‐applied parts safety requirements. This system complies with the applicable medical equipment requirements published in the  Canadian Standards Association (CSA), European Norm Harmonized Standards, and  Underwriters Laboratories (UL) safety standards. See Chapter 8, “Specifications.” For maximum safety observe the following warnings and cautions. WARNING: To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the patient. Under certain circumstances, the transducer connector and back of the display enclosure can reach temperatures that exceed EN60601-1 limits for patient contact, therefore only the operator shall handle the system.
  • Page 81 Do not use the system if an error message appears on the image display: note the error code; call SonoSite or your local representative; turn off the system by pressing and holding the power key until the system powers down.

  • Page 82: Equipment Safety

    Equipment safety To protect your ultrasound system, transducer, and accessories, follow these precautions. Caution: Excessive bending or twisting of cables can cause a failure or intermittent operation. Improper cleaning or disinfecting of any part of the system can cause permanent damage. For cleaning and disinfecting instructions, see Chapter 5, “Troubleshooting and Maintenance.

  • Page 83: Clinical Safety

    If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult SonoSite or your local representative.

  • Page 84: Hazardous Materials

    Hazardous materials WARNING: The liquid crystal display (LCD) contains mercury. Dispose of the LCD properly in accordance with local regulations. Electromagnetic compatibility The ultrasound system has been tested and found to comply with the electromagnetic  compatibility (EMC) limits for medical devices to IEC 60601‐1‐2:2001. These limits are designed  to provide reasonable protection against harmful interference in a typical medical installation. Caution: Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions. It is possible that high levels of radiated or conducted radio-frequency electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or nearby radio-frequency sources, could result in performance disruption of the ultrasound...

  • Page 85: Manufacturer's Declaration

    SonoSite could result in malfunctioning of your ultrasound system or other medical electrical devices in the area. Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite. See the SonoSite accessories user guide.
  • Page 86 0.5 cycle for 0.5 cycle and voltage environment. If the user of the 40% U 40% U variations on SonoSite ultrasound system (60% dip in U ) for 5 (60% dip in U ) for power supply requires continued operation...
  • Page 87 Portable and mobile RF communications equipment IEC 61000-4-6 150 kHz to 80 MHz should be used no closer to any part of the SonoSite ultrasound system including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 88 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the SonoSite ultrasound system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SonoSite ultrasound system.

  • Page 89: Alara Principle

    ALARA principle ALARA is the guiding principle for the use of diagnostic ultrasound. Sonographers and other  qualified ultrasound users, using good judgment and insight, determine the exposure that is  “as low as reasonably achievable.” There are no set rules to determine the correct exposure for  every situation. The qualified ultrasound user determines the most appropriate way to keep  exposure low and bioeffects to a minimum, while obtaining a diagnostic examination. A thorough knowledge of the imaging modes, transducer capability, system setup and  scanning technique is necessary. The imaging mode determines the nature of the ultrasound  beam. A stationary beam results in a more concentrated 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 variables which affect the way the qualified ultrasound user implements the ALARA  principle include: patient body size, location of the bone relative to the focal point, attenuation  in the body, and ultrasound exposure time. Exposure time is an especially useful variable,  because the qualified ultrasound user can control it. The ability to limit the exposure over time  supports the ALARA principle. Applying ALARA The system imaging mode selected by the qualified ultrasound user is determined by the  diagnostic information required. 2D imaging provides anatomical information; CPD imaging  provides information about the energy or amplitude strength of the Doppler signal over time  at a given anatomical location and is used for detecting the presence of blood flow; Color  imaging provides information about the energy or amplitude strength of the Doppler signal  over time at a given anatomical location and is used for detecting the presence, velocity, and  direction of blood flow; Tissue Harmonic Imaging uses higher received frequencies to reduce  clutter, artifact, and improve resolution on the 2D image. Understanding the nature of the  imaging mode used allows the qualified ultrasound user to apply the ALARA principle. Prudent use of ultrasound requires that patient exposure to ultrasound be limited to the lowest  ultrasound output for the shortest time necessary to achieve acceptable diagnostic results.  Decisions that support prudent use are based on the type of patient, exam type, patient history,  ease or difficulty of obtaining diagnostically useful information, and potential localized  heating of the patient due to transducer surface temperature. The system has been designed to ensure that temperature at the face of the transducer will not  exceed the limits established in Section 42 of EN 60601‐2‐37: Particular requirement for the  safety of ultrasound medical diagnostic and monitoring equipment. See “Transducer surface  temperature rise” on page 85. In the event of a device malfunction, there are redundant controls  that limit transducer power. This is accomplished by an electrical design that limits both power ...

  • Page 90: Direct Controls

    The sonographer uses the system controls to adjust image quality and limit ultrasound output.  The system controls are divided into three categories relative to output: controls that directly  affect output, controls that indirectly affect output, and receiver controls. Direct controls The system does not exceed a spatial peak temporal average intensity (ISPTA) of 720 mW/cm   for all imaging modes. (For the Ophthalmic exam, the acoustic output is limited to the  following values: ISPTA does not exceed 50 mW/cm2; TI does not exceed 1.0, and MI does not  exceed 0.23.) The mechanical index (MI) and thermal index (TI) may exceed values greater than  1.0 on some transducers in some imaging modes. One may monitor the MI and TI values and  adjust the controls to reduce these values. See “Guidelines for reducing MI and TI” on page 81.  Additionally, one means for meeting the ALARA principle is to set the MI or TI values to a low  index value and then modifying this level until a satisfactory image or Doppler mode is  obtained. For more information on MI and TI, see BS EN 60601‐2‐37:2001: Annex HH. Indirect controls The controls that indirectly affect output are controls affecting imaging mode, freeze, and  depth. The imaging mode determines the nature of the ultrasound beam. Tissue attenuation is  directly related to transducer frequency. The higher the PRF (pulse repetition frequency), the  more output pulses occur over a period of time. Receiver controls The receiver controls are the gain controls. Receiver controls do not affect output. They should  be used, if possible, to improve image quality before using controls that directly or indirectly  affect output. Acoustic artifacts An acoustic artifact is information, present or absent in an image, that does not properly  indicate the structure or flow being imaged. There are helpful artifacts that aid in diagnosis and  those that hinder proper interpretation. Examples of artifacts include: • Shadowing • Through transmission • Aliasing • Reverberations •...

  • Page 91: Guidelines For Reducing Mi And Ti

    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 right side of the  screen. Table 3: MI Transducer Depth ↑ C11x ↑ C60x ↑ HFL38x ↑ HFL50x ↑ ICTx ↑ L25x ↑ L38x ↑ L38xi ↑ P10x ↑ P21x ↑ SLAx ↑ TEEx ↓...
  • Page 92 Table 4: TI (TIS, TIC, TIB) CPD Settings Transducer PW Settings Depth Optimize Width Height Depth ↑ ↓ ↑ ↓ (Depth) C11x ↓ ↑ ↓ ↑ ↓ (PRF) C60x ↑ ↑ ↑ ↓ (Depth) HFL38x ↑ ↑ ↑ ↓ (Depth) HFL50x ↑...

  • Page 93: Output Display

    Output display The system meets the AIUM output display standard for MI and TI (see last reference in  “Related guidance documents” below). Table 5 indicates for each transducer and operating  mode if either the TI or MI is greater than or equal to a value of 1.0, thus requiring display. Table 5: TI or MI is ≥ 1.0 CPD/ Transducer Model Index M Mode Color Doppler Doppler C11x/8-5 — TIC,TIB, or TIS — C60x/5-2 — TIC, TIB, or TIS — HFL38x/13-6 — TIC, TIB, or TIS —...

  • Page 94: Mi And Ti Output Display Accuracy

    M Mode Color Doppler Doppler TEEx/8-3 TIC, TIB, or TIS Even when 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. The TI consists of three user‐selectable indices, and only one of these is displayed at any one  time. In order to display TI properly and meet the ALARA principle, the user selects an  appropriate TI based on the specific exam being performed. SonoSite provides a copy of AIUM  Medical Ultrasound Safety, which contains guidance on determining which TI is appropriate (See  “Related guidance documents” on page 85). MI and TI output display accuracy The accuracy result for the MI is stated statistically. With 95% confidence, 95% of the measured  MI values will be within +18% to –25% of the displayed MI value, or +0.2 of the displayed value,  whichever value is larger. The accuracy result for the TI is stated statistically. With 95% confidence, 95% of the measured  TI values will be within +21% to –40% of the displayed TI value, or +0.2 of the displayed value,  whichever value is larger. The values equate to +1dB to –3dB. A displayed value of 0.0 for MI or TI means that the calculated estimate for the index is less than  0.05. Factors that contribute to display uncertainty The net uncertainty of the displayed indices is derived by combining the quantified uncertainty ...

  • Page 95: Related Guidance Documents

    combination has its own unique characteristic acoustic output, and will not match the nominal  output 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 acoustic output. Another source of error arises from the assumptions and approximations that are made when  deriving the estimates for the display indices. Chief among these assumptions is that the  acoustic output, and thus the derived display indices, are linearly correlated with the transmit  drive voltage of the transducer. Generally, this assumption is very good, but it is not exact, and  thus some error in the display can be attributed to the assumption of voltage linearity. Related guidance documents • Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound  Systems and Transducers, FDA, 1997. • Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994. (A  copy is included with each system.) • Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA  UD2‐2004. • Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound  Equipment, American Institute of Ultrasound in Medicine, 1993. • Standard for Real‐Time Display of Thermal and Mechanical Acoustic Output Indices on  Diagnostic Ultrasound Equipment, NEMA UD3‐2004. • Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH,  BS EN 60601‐2‐37 reprinted at P05699. Transducer surface temperature rise Table 6 lists the measured surface temperature rise from ambient (23°C ± 3°C) of transducers  used on the ultrasound system. The temperatures were measured in accordance with EN  60601‐2‐37 section 42 with controls and settings positioned to give maximum temperatures. Chapter 6: Safety...

  • Page 96: Acoustic Output Measurement

    Table 6: Transducer Surface Temperature Rise Internal Use External Use (°C) (°C) Test 17.6 16.2 15.5 10.7 16.1 16.3 12.5 15.6 16.8 Still air Simulated Acoustic output measurement Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects)  from ultrasound exposure have been studied by various scientific and medical institutions. In  October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report from  its Bioeffects Committee (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. The acoustic output for this ultrasound system has been measured and calculated in  accordance with “Acoustic Output Measurement Standard for Diagnostic Ultrasound  Equipment” (NEMA UD2‐2004), and “Standard for Real‐Time Display of Thermal and  Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment” (NEMA  UDe3‐2004).

  • Page 97: Tissue Models And Equipment Survey

    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: brain = 0.53 heart = 0.66 kidney = 0.79 liver = 0.43 muscle = 0.55 l = skinline to measurement depth in cm f = center frequency of the transducer/system/mode combination in MHz Since the ultrasonic path during the exam is likely to pass through varying lengths and types  of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used  for general reporting purposes; therefore, the In Situ value commonly reported uses the  formula:  In Situ (derated) = Water [e  ‐(0.069lf) Since this value is not the true In Situ intensity, the term “derated” is used to qualify it. The maximum derated and the maximum water values do not always occur at the same  operating conditions; therefore, the reported maximum water and derated values may not be  related by the In Situ (derated) formula. For example: a multi‐zone array transducer that has  maximum water value intensities in its deepest zone, but also has the smallest derating factor  in that zone. The same transducer may have its largest derated intensity in one of its shallowest  focal zones. Tissue models and equipment survey Tissue models are necessary to estimate attenuation and acoustic exposure levels In Situ from ...

  • Page 98: Acoustic Output Tables

    of fluid, as in many first and second‐trimester pregnancies scanned transabdominally, this  model may underestimate the In Situ acoustic exposure. The amount 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 trimesters. Existing tissue models that are based on linear propagation may underestimate acoustic  exposures when significant saturation due to non‐linear distortion of beams in water is present  during the output measurement. The maximum acoustic output levels of diagnostic ultrasound devices extend over a broad  range of values: • A survey of 1990‐equipment models yielded MI values between 0.1 and 1.0 at their highest  output settings. Maximum MI values of approximately 2.0 are known to occur for currently  available equipment. Maximum MI values are similar for real‐time 2D and M Mode  imaging. • Computed estimates of upper limits to temperature elevations during transabdominal  scans were obtained in a survey of 1988 and 1990 pulsed Doppler equipment. The vast  majority of models yielded upper limits less than 1° and 4°C (1.8° and 7.2°F) for exposures  of first‐trimester fetal tissue and second‐trimester fetal bone, respectively. The largest values  obtained were approximately 1.5°C (2.7°F) for first‐trimester fetal tissue and 7°C (12.6°F) for  second‐trimester fetal bone. Estimated maximum temperature elevations given here are for  a “fixed path” tissue model and are for devices having I  values greater than 500 mW/ SPTA . The temperature elevations for fetal bone and tissue were computed based on  calculation procedures given in Sections 4.3.2.1‐4.3.2.6 in “Bioeffects and Safety of  Diagnostic Ultrasound” (AIUM, 1993). Acoustic output tables Table 7 through Table 31 indicate the acoustic output for the system and transducer ...
  • Page 99 Table 7: Transducer Model: C11x Operating Mode: CPD/Color Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — — (MPa) (mW) — — 38.8 min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
  • Page 100 Table 8: Transducer Model: C11x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 46.0 24.9 25.4 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 1.06 (cm)
  • Page 101 Table 9: Transducer Model: C60x Operating Mode: 2D Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 1.69 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
  • Page 102 Table 10: Transducer Model: C60x Operating Mode: M Mode Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 1.62 (mW) — min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) (MHz) 2.85 —...
  • Page 103 Table 11: Transducer Model: C60x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 85.64 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 1.255 (cm) 0.51 (MHz)
  • Page 104 Table 12: Transducer Model: HFL38x Operating Mode: CPD/Color Non-scan Index Label Non- Scan ≤1 scan >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.556 (mW) — — — min of [W (mW) — TA.3 (cm) — (cm) —...
  • Page 105 Table 13: Transducer Model: HFL38x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.37 (mW) — 46.55 46.55 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.33...
  • Page 106 Table 14: Transducer Model: HFL50x Operating Mode: 2D Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.14 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
  • Page 107 Table 15: Transducer Model: HFL50x Operating Mode: M Mode Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 3.14 (mW) — min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) (MHz) 6.75 —...
  • Page 108 Table 16: Transducer Model: HFL50x Operating Mode: CPD/Color Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.05 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
  • Page 109 Table 17: Transducer Model: HFL50x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.69 (mW) — 42.6 42.6 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.33...
  • Page 110 Table 18: Transducer Model: ICTx Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 16.348 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.192 (MHz) —...
  • Page 111 Table 19: Transducer Model L25x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 28.3 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.31 (MHz) —...
  • Page 112 Table 20: Transducer Model: L38x Operating Mode: CPD/Color Non-scan Index Label Scan Non-scan ≤1 A >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.89 (mW) 66.6 — — min of [W (mW) — TA.3 (cm) — (cm) —...
  • Page 113 Table 21: Transducer Model: L38x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.345 (mW) — 84.94 84.94 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.4685...
  • Page 114 Table 22: Transducer Model: L38xi/10-5 Operating Mode: 2D Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.54 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
  • Page 115 Table 23: Transducer Model: L38xi/10-5 Operating Mode: M Mode Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 3.54 (mW) — 37.1 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.49 (MHz)
  • Page 116 Table 24: Transducer Model: L38xi/10-5 Operating Mode: CPD/Color Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.30 (mW) 47.5 — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) (MHz)
  • Page 117 Table 25: Transducer Model: L38xi/10-5 Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.56 (mW) — 114.5 114.5 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 1.19 (cm)
  • Page 118 Table 26: Transducer Model: P10x Operating Mode: Color Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.02 (mW) — — 41.38 min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
  • Page 119 Table 27: Transducer Model: P10x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.03 (mW) — 36.25 34.4 31.5 min of [W (mW) — TA.3 (cm) — (cm) —...
  • Page 120 Table 28: Transducer Model: P10x Operating Mode: CW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 40.72 30.00 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.36 (MHz)
  • Page 121 Table 29: Transducer Model: P21x Operating Mode: 2D Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.03 (mW) — — 155.2 min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
  • Page 122 Table 30: Transducer Model: P21x Operating Mode: M Mode Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.10 (mW) — 40.08 79.71 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 3.645 (cm)
  • Page 123 Table 31: Transducer Model: P21x Operating Mode: CPD/Color Non-scan Index Label Scan Non-scan ≤1 A >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.03 (mW) 135.05 — — 126.57 min of [W (mW) — TA.3 (cm) — (cm) —...
  • Page 124 Table 32: Transducer Model: P21x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) 1.73 (mW) — — 93.28 200.7 min of [W (mW) 124.4 TA.3 (cm) (cm) (cm) (cm) 0.49 (MHz)
  • Page 125 Table 33: Transducer Model: P21x Operating Mode: CW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — — 90.1 104.9 min of [W (mW) 104.9 TA.3 (cm) 1.20 (cm) 1.31 (cm) 1.255 (cm)
  • Page 126 Table 34: Transducer Model: SLAx Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 12.45 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.15 (MHz) —...
  • Page 127 Table 35: Transducer Model: TEEx Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 29.29 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.34 (MHz) —...
  • Page 128 Table 36: Transducer Model: TEEx Operating Mode: CW Doppler Non-scan Index Label Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 27.23 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.39 (MHz) —...

  • Page 129: Terms Used In The Acoustic Output Tables

    Terms used in the acoustic output tables Table 37: Acoustic Output Terms and Definitions Term Definition Derated spatial peak, temporal average intensity in units of milliwatts/cm SPTA TI type Applicable thermal index for the transducer, imaging mode, and exam type. TI value Thermal index value for the transducer, imaging mode, and exam type.
  • Page 130 Table 37: Acoustic Output Terms and Definitions (Continued) Term Definition Equivalent beam diameter as a function of axial distance z, and is equal to ⁄ π ( ) ) Wo ⁄ z ( ) , where I (z) is the temporal-average intensity as a function of z in centimeters.

  • Page 131: Acoustic Measurement Precision And Uncertainty

    Acoustic measurement precision and uncertainty All table entries have been obtained at the same operating conditions that give rise to the  maximum index value in the first column of the table. Measurement precision and uncertainty  for power, pressure, intensity, and other quantities that are used 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 38: Acoustic Measurement Precision and Uncertainty Precision Uncertainty Quantity (% of standard deviation) (95% confidence) 1.9% +11.2% 1.9% +12.2% 3.4% +10% 0.1% +4.7% 3.2% +12.5 to -16.8% 3.2% +13.47 to -17.5% Chapter 6: Safety...

  • Page 132: Labeling Symbols

    Labeling symbols The following symbols are used on the products, packaging, and containers. Table 39: Labeling Symbols Symbol Definition Alternating Current (AC) Class 1 device indicating manufacturer’s declaration of conformance with Annex VII of 93/42/EEC Class 1 device requiring verification by the Notified Body of sterilization or measurement features, or to a Class IIa, IIb, or III device requiring verification or auditing by the Notified Body to applicable Annex(es) of 93/42/EEC Attention, see the user guide Device complies with relevant Australian regulations for electronic devices.
  • Page 133 Table 39: Labeling Symbols (Continued) Symbol Definition Corrugated recycle Dangerous voltage Date of manufacture Direct Current (DC) Do not get wet. Do not stack over 2 high. Do not stack over 5 high. Do not stack over 10 high. Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices.
  • Page 134 Table 39: Labeling Symbols (Continued) Symbol Definition Indoor use only Device emits a static (DC) magnetic field. Non-ionizing radiation Paper recycle Serial number type of control number Temperature limitation Atmospheric pressure limitation Humidity limitations Submersible. Protected against the effects of temporary immersion. Water-Tight Equipment.
  • Page 135 People’s Republic of China. Contains mercury. (Applies to the LCD and may apply to other components in the ultrasound system.) WARNING: WARNING: Connect Only Connect Only Accessories and Peripherals Accessories and Recommended by SonoSite Peripherals Recommended by SonoSite Chapter 6: Safety...

  • Page 137: Chapter 7: References

    Chapter 7: References Measurement accuracy Table 1: 2D Measurement Accuracy and Range The measurements provided by the system do  not define a specific physiological or anatomical  parameter. Rather, the measurements are of a  physical property such as distance for evaluation  by 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. Axial Distance < ±2% plus Acquisition Phantom 0-26 cm The 2D linear distance measurement results are  1% of full scale displayed in centimeters with one place past the  decimal point, if the measurement is ten or  Lateral < ±2% plus Acquisition Phantom 0-35 cm greater; two places past the decimal point, if the ...

  • Page 138: Sources Of Measurement Errors

    Sources of measurement Aortic Valve Area (AVA) by Continuity Equation in cm errors Reynolds, Terry. The Echocardiographer’s Pocket  In general, two types of errors can be introduced  Reference. 2nd ed., School of Cardiac Ultrasound,  into the measurement: Arizona Heart Institute, (2000), 393, 442. Acquisition Error Includes errors introduced by   = A  * V the ultrasound system electronics relating to  where:  = Ao valve area signal acquisition, signal conversion, and signal  processing for display. Additionally,   = LVOT area; V  = LVOT velocity;  computational and display errors are introduced   = Ao valve velocity by the generation of the pixel scale factor,  LVOT = Left Ventricular Outflow  application of that factor to the caliper positions  Tract on the screen, and the measurement display. AVA (PV ) * CSA LVOT LVOT Algorithmic Error The error introduced by ...
  • Page 139 Ejection Fraction (EF), percent Cross Sectional Area (CSA) in cm Reynolds, Terry. The Echocardiographer’s Pocket  Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual.  Reference. 2nd ed., School of Cardiac Ultrasound,  2nd ed., Lippincott, Williams, and Wilkins,  Arizona Heart Institute, (2000), 383. (1999), 40. EF = ((LVEDV – LVESV)/LVEDV) * 100% CSA = 0.785 * D where: EF = Ejection Fraction where: D = diameter of the anatomy of  interest LVEDV = Left Ventricular End  Diastolic Volume Deceleration Time in msec LVESV = Left Ventricular End  Reynolds, Terry. The Echocardiographer’s Pocket  Systolic Volume Reference. 2nd ed., School of Cardiac Ultrasound,  Elapsed Time (ET) in msec Arizona Heart Institute, (2000), 453. ET = time between velocity cursors in  |time a ‐ time b| milliseconds Delta Pressure: Delta Time (dP:dT) in...
  • Page 140 Left Ventricular End Volumes (Teichholz) in π ⎛ ⎞ ⎛ ⎞ ∑ -- - -- - ⎝ ⎠ ⎝ ⎠ Teichholz, L.E., T. Kreulen, M.V. Herman, et. al.  “Problems in echocardiographic volume  where: V = Volume in ml determinations: echocardiographic‐angiographic  a = Diameter correlations in the presence or absence of  b = Diameter asynergy.” American Journal of Cardiology, (1976),  n = Number of segments (n=20) 37:7. L = Length LVESV = (7.0 * LVDS )/(2.4 + LVDS) i = Segment where: LVESV = Left Ventricular End  Left Ventricular Volume: Single Plane Systolic Volume Method in ml LVDS = Left Ventricular Dimension ...
  • Page 141 Left Ventricular Posterior Wall Fractional E PG = 4 * PE Thickening (LVPWFT), percent Peak A Pressure Gradient (A PG) Laurenceau, J. L., M.C. Malergue. The Essentials of  A PG = 4 * PA Echocardiography. Le Hague: Martinus Nijhoff,  (1981), 71. Peak Pressure Gradient (PGmax) LVPWFT = ((LVPWS – LVPWD)/LVPWD) * 100% PGmax = 4 * PV where: LVPWS = Left Ventricular Posterior  Mean Pressure Gradient (PGmean) Wall Thickness at Systole PGmean = Average of pressure  LVPWD = Left Ventricular Posterior  gradients/Duration of flow Wall Thickness at Diastole Pressure Half Time (PHT) in msec Mean Velocity (Vmean) in cm/s Reynolds, Terry. The Echocardiographer’s Pocket  Vmean = mean velocity Reference. 2nd ed., School of Cardiac Ultrasound, ...

  • Page 142: Obstetrical References

    where: RV = Regurgitant Volume VTI = Velocity Time Integral of the  aortic valve MV SV = Mitral Stroke Volume Tricuspid Valve Area (TVA) Regurgitant Volume (RV) in cc Reynolds, Terry. The Echocardiographer’s Pocket  Reynolds, Terry. The Echocardiographer’s Pocket  Reference. 2nd ed., School of Cardiac Ultrasound,  Reference. School of Cardiac Ultrasound, Arizona  Arizona Heart Institute, (2000), 55, 391, 452. Heart Institute, (2000), 396, 455. TVA = 220 / PHT RV = ERO * MR VTI Stroke Volume (SV) 2D and M Mode in ml Right Ventricular Systolic Pressure (RVSP) in mmHg Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual.  2nd ed., Boston: Little, Brown and Company,  Reynolds, Terry. The Echocardiographer’s Pocket ...

  • Page 143: Gestational Age Tables

    Estimated Date of Delivery (EDD) by Average Gestational Age (GA) by Last Menstrual Ultrasound Age (AUA) Period (LMPd) Derived from Established Due Date (Estab. DD) Results are displayed as month/day/year. Same as GA by Estab. DD. EDD = system date + (280 days – AUA in days) The gestational age derived from the system  Estimated Date of Delivery (EDD) by Last derived LMP using the Established Due Date  Menstrual Period (LMP) entered on the patient information form.
  • Page 144 Crown Rump Length (CRL) Hadlock, F., et al. “Fetal Crown‐Rump Length:  WARNING: The gestational age calculated by Re‐evaluation of Relation to Menstrual Age (5‐18  your SonoSite system does not weeks) with High‐Resolution, Real‐Time  match the age in the Ultrasound.” Radiology, 182: (February 1992),  aforementioned reference at the 501‐505. 20.0 cm and 30.0 cm abdominal circumference (AC) measurements. Hansmann, M., et al. Ultrasound Diagnosis in  The implemented algorithm Obstetrics and Gynecology. New York: ...

  • Page 145: Ratio Calculations

    Nyberg, D.A., et al. “Transvaginal Ultrasound.”  Transverse Trunk Diameter (TTD) Mosby Yearbook, (1992), 76. Hansmann, M., et al. Ultrasound Diagnosis in  Obstetrics and Gynecology. New York:  Gestational sac measurements provide a fetal  Springer‐Verlag, (1985), 431. age based on the mean of one, two, or three  distance measurements; however, Nyberg’s  University of Tokyo, Shinozuka, N. FJSUM, et al.  gestational age equation requires all three  “Standard Values of Ultrasonographic Fetal  distance measurements for an accurate  Biometry.” Japanese Journal of Medical Ultrasonics,  estimate. 23:12 (1996), 885. Tokyo University. “Gestational Weeks and  Computation Methods.” Ultrasound Imaging  Ratio calculations Diagnostics, 12:1 (1982‐1). FL/AC Ratio Head Circumference (HC) Hadlock F.P., R. L. Deter, R. B. Harrist, E. Roecker,  Chitty, L. S. and D.G. Altman. “New charts for  and S.K. Park. “A Date Independent Predictor of  ultrasound dating of pregnancy.” Ultrasound in  Intrauterine Growth Retardation: Femur  Obstetrics and Gynecology 10: (1997), 174‐191,  Length/Abdominal Circumference Ratio,”  Table 5, 182. American Journal of Roentgenology, 141: (November  1983), 979‐984. Hadlock, F., et al. “Estimating Fetal Age:  Computer‐Assisted Analysis of Multiple Fetal ...

  • Page 146: General References

    General references Volume (Vol) Beyer, W.H. Standard Mathematical Tables, 28th ed.,  CRC Press, Boca Raton, FL, (1987), 131. Measurement publications and terminology...

  • Page 147: Chapter 8: Specifications

    Chapter 8: Specifications This chapter contains system and accessory  Images and clips storage specifications and standards. The specifications  Internal storage: The number of images and clips  for recommended peripherals are in the  you can save depends on imaging mode and file  manufacturers’ instructions. format. Supported transducers Accessories • C11x/8‐5 MHz (6 ft/1.8 m) The following items are either included with or  • C60x/5‐2 MHz (5.5 ft/1.7 m) available for use on the ultrasound system. • HFL38x/13‐6 MHz (5.6 ft/1.7 m) • Battery • HFL50x/15‐6 MHz (5.5 ft/1.7 m) • Biopsy Guide • ICTx/8‐5 MHz (5.5 ft/1.7 m) • Education keys • L25x/13‐6 MHz (7.5 ft/2.3 m)  • Mobile docking system • L38x/10‐5 MHz (5.5 ft/1.7 m) •...

  • Page 148: Non-Medical Grade

    Battery • DVD recorder Non-medical grade The battery comprises six lithium‐ion cells plus  electronics, a temperature sensor, and battery  • Kensington Security Cable contacts. • USB keyboard Run time is up to two hours, depending on  imaging mode and display brightness. Temperature and humidity limits Electromechanical safety standards Operating EN 60601‐1:1997, European Norm, Medical  System, battery, and transducer Electrical Equipment–Part 1. General  Requirements for Safety. 10–40°C (50–104°F), 15–95% R.H. EN 60601‐1‐1:2001, European Norm, Medical  700 to 1060hPa(0.7 to 1.05 ATM) Electrical Equipment–Part 1. General  Requirements for Safety–Section 1‐1. Collateral  Shipping and storage Standard. Safety Requirements for Medical  Electrical Systems.

  • Page 149: Emc Standards Classification

    EMC standards classification EN 60601‐1‐2:2001, European Norm, Medical  Electrical Equipment. General Requirements for  Safety‐Collateral Standard. Electromagnetic  Compatibility. Requirements and Tests. CISPR11:2004, International Electrotechnical  Commission, International Special Committee on  Radio Interference. Industrial, Scientific, and  Medical (ISM) Radio‐Frequency Equipment  Electromagnetic Disturbance  Characteristics‐Limits and Methods of  Measurement. The Classification for the ultrasound system,  stand, accessories, and peripherals when  configured together is: Group 1, Class A. Airborne equipment standards RTCA/DO‐160E:2004, Radio Technical  Commission for Aeronautics, Environmental  Conditions and Test Procedures for Airborne  Equipment, Section 21.0 Emission of Radio  Frequency Energy, Category B. HIPAA standard 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. Chapter 8: Specifications...
  • Page 150 HIPAA standard...

  • Page 151: Terms

    Glossary Terms For ultrasound terms not included in this glossary, refer to Recommended Ultrasound  Terminology, Second Edition, published in 1997 by the American Institute of Ultrasound in  Medicine (AIUM). as low as reasonably The guiding principle of ultrasound use, which states that you should achievable (ALARA) keep patient exposure to ultrasound energy as low as reasonably achievable for diagnostic results. curved array Identified by the letter C (curved or curvilinear) and a number (60). The transducer number corresponds to the radius of curvature of the array expressed in millimeters.
  • Page 152 skinline A depth on the display that corresponds to the skin/transducer interface. SonoHD™ imaging A subset of the 2D imaging mode in which the 2D image is enhanced technology by reducing speckle noise artifact at tissue margins and improving contrast resolution by reducing artifacts and improving visualization of texture patterns within the image.

  • Page 153: Abbreviations

    Abbreviations Abbreviations in User Interface Abbreviation Definition “A” Wave Peak Velocity A PG “A” Wave Peak Pressure Gradient A Caliper/B Caliper: Ratio A2Cd Apical 2 Chamber diastolic A2Cs Apical 2 Chamber systolic A4Cd Apical 4 Chamber diastolic A4Cs Apical 4 Chamber systolic Abdominal Aortic Aneurysm Ascending Aorta Abdomen...
  • Page 154 Abbreviations in User Interface (Continued) Abbreviation Definition 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 calculation authors. Aortic Valve AV Area Aortic Valve Area...
  • Page 155 Abbreviations in User Interface (Continued) Abbreviation Definition DICA Distal Internal Carotid Artery Dist Distal dP:dT Delta Pressure: Delta Time “E” Wave Peak Velocity E PG “E” Wave Peak Pressure Gradient E:A Ratio E/e’ E velocity = Mitral Valve E velocity divided by the annular e’ velocity External Carotid Artery ECICA Extracranial Internal Carotid Artery...
  • Page 156 Abbreviations in User Interface (Continued) Abbreviation Definition Estab. DD Established Due Date A user-entered due date based on previous exam data or other available information. The LMP is derived from the Established Due Date and is listed in the patient report as LMPd. Elapsed Time FM (Right and Left) Foramen Magnum (same as SO)
  • Page 157 Abbreviations in User Interface (Continued) Abbreviation Definition Left Ventricular LV Area Left Ventricular Area LV mass Left Ventricular mass LV Volume Left Ventricular Volume Left Ventricular diastolic Left Ventricular Dimension LVDd Left Ventricular Dimension Diastolic LVDFS Left Ventricular Dimension Fractional Shortening LVDs Left Ventricular Dimension Systolic LVEDV...
  • Page 158 Abbreviations in User Interface (Continued) Abbreviation Definition MR PISA Mitral Regurgitation Proximal Iso Velocity Surface Area MR/VTI Mitral Regurgitation/Velocity Time Integral Musculoskeletal Mitral Valve MV Area Mitral Valve Area MV Regurgitant Mitral Valve Regurgitant Fraction Fraction MV Regurgitant Volume Mitral Valve Regurgitant Volume MV/VTI Mitral Valve/Velocity Time Integral Mitral Valve Area...
  • Page 159 Abbreviations in User Interface (Continued) Abbreviation Definition Pulse Repetition Frequency Peak Systolic Velocity Pulmonic Valve Pulsed Wave Doppler Qp/Qs Pulmonary blood flow divided by systemic blood flow Right Atrial (pressure) Resistive Index Right Ventricular Dimension RVDd Right Ventricular Dimension Diastolic RVDs Right Ventricular Dimension Systolic RVOT D...
  • Page 160 Abbreviations in User Interface (Continued) Abbreviation Definition Tissue Harmonic Imaging Thermal Index TRmax Tricuspid Regurgitation (peak velocity) Tricuspid Valve Tricuspid Valve Area Ultrasound Age Calculated on the mean measurements taken for a particular fetal biometry. Vertebral Artery VArty Vertebral Artery Vascular Venous Vmax...

  • Page 161: Index

    Index Numerics 2D imaging 19 cables, connect power 3 calculations about 37 cardiac. See cardiac calculations delete measurement 38 A/B measurement 36 display measurement 38 abbreviations 143 EMED 48 abdominal, intended uses 9 gynecology (Gyn) 48 acceleration (ACC) index 36 menu 37 accessories list 137 OB 49...
  • Page 162 cardiac output (CO) 47 duplex 16 cardiac references 128 DVD recorder 2, 15, 55 cardiac, intended uses 9 cautions, definition vii cine buffer 24 clean elapsed time (ET) measurement 36 battery 59 electrical safety 70 LCD screen 57 electromagnetic compatibility 74 system 57 electromechanical safety standards 138 transducers 58...
  • Page 163 guidance documents, related 85 layout 16 gynecology, intended uses 9 LCD screen clean 57 output 84 left atrium (LA) 42 left ventricular diastolic (LVd) 42 heart rate (HR) 28, 35, 46, 51 left ventricular outflow tract diameter (LVOT D) 42 HIPAA standard 139 left ventricular systolic (LVs) 42 home position 27...
  • Page 164 NTSC recording problem 55 definition 141 references setting 15 cardiac 128 general 136 gestational age tables 133 obstetrical 132 ratio calculations 135 report, patient 52 calculations 16, 49 resistive index (RI) measurement 36 intended uses 10 right ventricular systolic pressure (RVSP) 44 references 132 optimize 19 orientation...
  • Page 165 stroke volume (SV) 46 user guide, conventions used vii superficial, intended uses 10 user setup 12 sweep speed uses, intended 9 Doppler 23 M Mode 20 symbols, labeling 122 system variance 21 clean and disinfect 57 vascular, intended uses 10 controls 5 velocity measurement 36 software 1...
  • Page 166 Index...
  • Page 168 P07525-04 *P07525-04*...

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