Page 1 M-Turbo Ultrasound System User Guide...
Page 3 M-Turbo Ultrasound System User Guide...
Page 4 Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. M-Turbo, SiteLink, SonoCalc, SonoHD, SonoMB, SonoSite, and the SonoSite logo are trademarks or registered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions.
Page 5: Table Of Contents
Contents Introduction Conventions, symbols, and terms ..............7 Customer comments ..................7 Chapter 1: Getting Started About the system ..................1 Preparing the system ..................1 Installing or removing the battery ............1 Using AC power and charging the battery ...........2 Turning the system on or off ..............3 Connecting transducers ................4 Inserting and removing USB storage devices ........4 System controls ....................5...
Page 6 OB Calculations setup ................20 OB Custom Measurements setup .............. 21 OB Custom Tables setup ................21 Presets setup ....................22 System Information setup ................23 USB Devices setup ..................23 Limitations of JPEG format ............... 23 eFilm Lite image-viewer ..............24 Chapter 3: Imaging Imaging modes ..................
Page 7 IMT calculations .................67 OB calculations ..................69 Small Parts calculations ..............72 Transcranial Doppler and Orbital calculations ........73 Vascular calculations ................75 Patient report ....................77 Vascular and cardiac patient reports ...........77 TCD patient report ................78 OB patient report ................78 EMED worksheets ................78 MSK worksheets ................79 Chapter 5: Troubleshooting and Maintenance Troubleshooting ..................81 Maintenance ....................82...
Page 8 Related guidance documents ............120 Transducer surface temperature rise ............120 Acoustic output measurement ..............121 In Situ, derated, and water value intensities ........121 Tissue models and equipment survey ..........122 Acoustic output tables ................123 Terms used in the acoustic output tables ......... 164 Acoustic measurement precision and uncertainty ......
Page 9 Index...
Page 11: Introduction
Introduction This M‐Turbo Ultrasound System User Guide Customer comments provides information on preparing and using the Questions and comments are encouraged. M‐Turbo ultrasound system and on cleaning and SonoSite is interested in your feedback regarding disinfecting the system and transducers. It also the system and the user guide. Please call provides references for calculations, system SonoSite at 888‐482‐9449 in the US. Outside the specifications, and safety and acoustic output US, call the nearest SonoSite representative. You information. can also e‐mail SonoSite The user guide is for a reader familiar with at comments@sonosite.com. ultrasound techniques. It does not provide For technical support, please contact SonoSite as training in sonography or clinical practices. follows: Before using the system, you must have ultrasound training. SonoSite Technical Support See the applicable SonoSite accessory user guide for information on using accessories and Phone (US or 877-657-8118 peripherals. See the manufacturer’s instructions Canada): for specific information about peripherals. Phone (Outside 425-951-1330 US and Canada): Or call your local Conventions, symbols, and...
Page 12: Customer Comments
Customer comments...
Page 13: Chapter 1: Getting Started
Chapter 1: Getting Started About the system The M‐Turbo ultrasound system is a portable, software‐controlled device using all‐digital architecture. The system has multiple configurations and feature sets used to acquire and display high‐resolution, real‐time ultrasound images. Features available on your system depend on system configuration, transducer, and exam type. Figure 2 System Back Connectors: A license key is required to activate the software. (1) DC input connector, (2) I/O connector, (3) Battery, See “A maintenance icon appears on the system and (4) ECG connector screen. Restart the system. If the issue recurs, system maintenance may be required. Note the To use the ultrasound system number that appears in parentheses on the C: line ...
Page 14: Using Ac Power And Charging The Battery
To install the battery 1 Disconnect the power supply from the ultrasound system. 2 Remove the system from the mini‐dock (if present) and turn it upside down. 3 Place the battery into the battery compartment, at a slight angle. See Figure 4 Slide the battery forward until it locks into place. 5 Push down on the two locking levers to secure the battery. Locking To remove the battery 1 Disconnect the power supply from the ultrasound system. 2 Remove the system from the mini‐dock (if present) and turn it upside down. 3 Pull up the two locking levers. 4 Slide the battery back. 5 Lift the battery from the compartment. Using AC power and charging the battery The battery charges when the system is ...
Page 15: Turning The System On Or Off
The system can run on AC power and charge the To wake up the system battery if AC power is connected to the system To conserve battery life while the system is on, directly, to a mini‐dock, or to a docking system. the system goes into sleep mode if the lid is closed or if the system is untouched for a preset time. To The system can run on battery power for up to adjust the time for sleep delay, see “Audio, two hours, depending on the imaging mode and Battery setup” on page 19. the display brightness. When running on battery power, the system may not restart if the battery is  Press a key, touch the touchpad, or open the low. To continue, connect the system to AC lid. power. WARNING: The equipment shall be connected to a center-tapped single phase supply circuit when users in the United States connect the equipment to a 240V supply system.
Page 16: Connecting Transducers
Connecting transducers To connect a transducer 1 Remove the system from the mini‐dock (if WARNING: To avoid injury to the patient, do present), and turn it upside down. not place the connector on the 2 Pull the transducer latch up, and rotate it patient. Operate the ultrasound clockwise. system in a docking system or on a flat hard surface to allow air flow 3 Align the transducer connector with the ...
Page 17: System Controls
System controls 12 13 Power switch Turns system on and off. Alphanumeric keys Use to enter text and numbers. Annotation keys “Alphanumeric keyboard” on page 9. ZOOM Magnifies the image 100%. Decreases and increases imaging depth. DEPTH UP, DEPTH DOWN AUTO GAIN Adjusts gain automatically.
Page 18 AC power indicator A steady light indicates that AC power is connected. A flashing light indicates that the system is asleep. CALIPER Displays calipers on-screen for measuring. CALCS Turns the calculations menu on and off. Touchpad Selects, adjusts, and moves items on-screen. FREEZE Stops live imaging and displays a frozen image.
Page 19: Screen Layout
Screen layout Figure 1 Screen Layout Mode Data Area Current imaging mode information (for example, Gen, Res, THI, and PW). Orientation Marker Provides indication for image orientation. In dual and duplex images, the orientation marker is green on the active screen. Text Text entered using keyboard.
Page 20 To insert a USB storage device  Insert the USB storage device into any USB WARNING: To avoid damaging the USB storage port on the system or mini‐dock. See Figure 1 device and losing patient data from on page 1. it, observe the following: The USB storage device is ready when the • Do not remove the USB storage USB icon appears. device or turn off the ultrasound system while the system is To view information about the device, see ...
Page 21: General Interaction
Annotation and text Alphanumeric keyboard General interaction Each option is controlled by the pair of keys below it. Depending on the option, the control keys function in one of four ways: Touchpad and cursor Cycle Moves through a list of settings Use the touchpad to adjust and move objects continuously. The upper control key cycles on‐screen. The touchpad controls caliper upward. The lower control key cycles downward. position, CPD or Color box position and size, the Up-Down Moves through a list of settings, cursor, and more. The arrow keys control much stopping at the top or bottom. The upper control of the same functionality as the touchpad. key moves upward. The lower control key moves Make sure to keep the touchpad dry while in use. downward. By default, a beep sounds when you Moisture on the touchpad can cause the cursor to reach either end of the range. (See “Audio, Battery respond erratically. setup” on page 19.) The cursor appears in the setup pages, the patient On-Off Turns a feature on or off. You can press information form, and patient report. You control either control key. In forms, you can instead select the cursor through the touchpad. For example, in the option by using the touchpad and the the patient information form, place the cursor ...
Page 22 Moves cursor among fields DELETE Removes all text from the in the forms, and tabs screen during text entry between text position in and when not measuring. dual screens. Arrow Keys Move highlighted selection CAPS LOCK Sets the keyboard to in calculations menu, move capital letters.
Page 23: Preparing Transducers
Preparing transducers Symbols You can enter symbols and special characters in WARNING: Some transducer sheaths contain select fields and forms. The symbols and special natural rubber latex and talc, which characters available depend on context. can cause allergic reactions in some Patient information form: Last, First, Middle, individuals. Refer to 21 CFR 801.437, Patient ID, Accession, Indications, Procedure ID, User labeling for devices that User, Reading Dr., Referring Dr., and Institution contain natural rubber.
Page 24: Training Videos
3 If there is an active exam, select List on‐screen. WARNING: To prevent contamination, the use 4 Select the Videos tab. of sterile transducer sheaths and 5 If the list does not appear, select the correct sterile coupling gel is USB device: recommended for clinical applications of an invasive or a Select Select USB. surgical nature. Do not apply the b In the Select USB device for media transducer sheath and gel until you playback dialog box, select the Education ...
Page 25: Intended Uses
Intended uses taps, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance This system transmits ultrasound energy into during abdominal, breast, and neurological various parts of the patient’s body to obtain surgery. ultrasound images, as follows. Obstetrical Imaging Applications You can assess For the intended transducer and imaging modes the fetal anatomy, viability, estimated fetal for each exam type, see “Imaging modes and weight, gestational age, amniotic fluid, and exams available by transducer” on page 34. surrounding anatomical structures for the presence or absence of pathology Abdominal Imaging Applications You can assess transabdominally or transvaginally. CPD and the liver, kidneys, pancreas, spleen, gallbladder, Color imaging are intended for high‐risk bile ducts, transplanted organs, abdominal pregnant women. High‐risk pregnancy vessels, and surrounding anatomical structures indications include, but are not limited to, for the presence or absence of pathology multiple pregnancy, fetal hydrops, placental transabdominally. abnormalities, as well as maternal hypertension, Cardiac Imaging Applications You can assess the diabetes, and lupus.
Page 26 presence or absence of pathology. You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps. 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 ophthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected.
Page 27: Chapter 2: System Setup
Chapter 2: System Setup The system setup pages let you customize the Footswitch (L), Footswitch (R) The function of the system and set preferences. left and right footswitches: Save Clip, Record, Freeze, Save Image, or Print. See also “To connect the footswitch.” Displaying the setup pages To connect the footswitch To display a setup page The SonoSite footswitch allows hands‐free operation with a customizable two‐pedal 1 Press the key. SETUP footswitch. The footswitch is an optional feature. 2 Select the setup page under Setup Pages. WARNING: To avoid contamination, do not use To return to imaging from a setup page, select ...
Page 28: Security Settings
Security settings 2 In the User Login list, select On. • On requires a user name and password at WARNING: Health care providers who maintain startup. or transmit health information are required by the Health Insurance • Off allows access to the system without a user name and password. Portability and Accountability Act (HIPAA) of 1996 and the European To change the administrator password or let Union Data Protection Directive users change passwords (95/46/EC) to implement...
Page 29: Exporting Or Importing User Accounts
2 Under User List, select the user. 2 Log in as Administrator. 3 Under User Information, make changes as 3 Select Import on‐screen. desired. 4 Select the USB storage device, and select 4 Select Save. Import. Any change to the user name replaces the 5 Restart the system. previous name. All user names and passwords on the system are replaced with the imported data. To delete a user 1 Log in as Administrator. Exporting and clearing the Event log 2 Under User List, select the user. The Event log collects errors and events and can 3 Select Delete. be exported to a USB storage device and read on ...
Page 30: Logging In As User
Logging in as user 1 In the Exam list on the Annotations setup page, select the exam type whose labels you If user login is required, the User Login screen want to specify. appears when you turn on the system. (See “To require user login” on page 16.) 2 For Group, select A, B, or C for the label group you want associated with that exam. To log in as user The preset labels appear for the selected group. 1 Turn on the system. 3 Do any of the following: 2 In the User Login screen, type your name and password, and select OK. • Add a custom label to the group: Type the label in the Text box, and select Add. To log in as guest •...
Page 31: Audio, Battery Setup
Connectivity setup To import predefined label groups 1 Insert the USB storage device that contains the On the Connectivity setup page, you specify label groups. options for using non‐USB devices and for alerts 2 On the Annotations setup page, select Import when internal storage is full. You also import on‐screen. wireless certificates and specify settings (including Transfer Mode and Location) for 3 Select the USB storage device, and then select SiteLink™ Image Manager and DICOM ® , which Import. are optional features. For SiteLink issues, refer to 4 Select Done in the dialog box that appears. the SiteLink Image Manager user guide. For DICOM issues, such as storage commitment, All predefined label groups for all exams are archivers, and MPPS, refer to Sending and replaced with those from the USB storage Receiving DICOM Data on SonoSite Systems. device. Audio, Battery setup To configure the system for a printer 1 Set up the printer hardware. (See instructions ...
Page 32: Date And Time Setup
IMT Calculations setup 3 Attach a serial cable (RS‐232) from the serial port on the mini‐dock or docking system to On the IMT Calculations setup page, you can the peripheral. customize the IMT calculations menu. You can To receive storage alerts specify up to eight measurement names for both right side and left side calculations. The  On the Connectivity setup page, select measurement names also appear in the patient Internal Storage Capacity Alert. report. The system displays a message if internal storage is near capacity when you end an See also “IMT calculations” on page 67. exam. The system then deletes archived To customize the IMT calculations menu patient exams if specified in DICOM.  On the IMT Calculations setup page, do the following: Date and Time setup •...
Page 33: Ob Custom Measurements Setup
OB Custom Measurements measurement lists under Gestational Age and Growth Analysis. setup Selecting an author places the associated measurement on the calculations menu. On the OB Custom Measurements setup page, you can define measurements that appear in the 2 (Optional) Select More to display the list of OB calculations menu and OB report. OB Custom user‐defined custom measurements and to Measurements is an optional feature. associate a custom table for the custom measurement. See also “OB calculations” on page 69. This option is available only when a To set up OB custom measurements user‐defined custom table has been created You can save up to five custom measurements for the custom measurement. that appear in the OB calculations menu and OB report. To export OB calculation tables 1 Insert a USB storage device. 1 On the OB Custom Measurements setup page, ...
Page 34: Presets Setup
Gestational Age Table Measurements The system To edit or delete an OB custom table provides gestational age measurements by 1 On the OB Calculations or OB Custom selected authors for GS, CRL, BPD, OFD, HC, Measurements setup page, select Tables TTD, APTD, AC, FTA, FL, EFW, Tibia, HL, and on‐screen. 5 additional custom measurement labels. 2 Select the OB custom table. Growth Analysis Table Measurements The 3 Select one of the following on‐screen: system provides growth graphs or curves for BPD, HC, AC, FL, EFW, and HC/AC. • Edit Enter data, and then select Save on‐screen. WARNING: Prior to use, verify that custom table data entries are correct.
Page 35: System Information Setup
Auto save Pat. Form Automatically saves the compression. (See also “Limitations of JPEG patient information form as an image in the format.”) patient’s file. A high compression has a smaller file size but less detail. System Information setup For SiteLink export type, the image format affects only still images. For DICOM export The System Information setup page displays type, the image format affects both still system hardware and software versions, patents, images and clips. and license information. 4 For SiteLink export type, select a sort order See also “To enter a license key” on page 82. under Sort By. To display patents To return to the previous screen, select Devices.  On the System Information setup page, select To include private tags Patents. If you use DICOM export type and a SonoSite software product, include private tags on the USB Devices setup images.
Page 36: Efilm Lite Image-Viewer
DICOM-formatted images on a computer running Windows. eFilm Lite is a licensed feature. WARNING: Russian characters may appear incorrectly in eFilm Lite. FUJIFILM SonoSite recommends that you do not use the eFilm Lite image-viewer to view exams exported in Russian. USB Devices setup...
Page 37: Chapter 3: Imaging
Chapter 3: Imaging Imaging modes brightness, gain, depth settings, viewing angle, and exam type. Also, select an optimization The system has a high‐performance display and setting that best matches your needs. advanced image‐optimization technology that To display the 2D image significantly simplifies user controls. Imaging modes available depend on the transducer and 1 Do any of the following: exam type. See “Imaging modes and exams • Turn on the system. available by transducer” on page 34. • Press the 2 key. 2D imaging Set options as desired. See “2D options.” WARNING: To avoid incorrect needle 2D options placement when MBe is on: In 2D imaging, you can select the following ...
Page 38 Dual Displays side-by-side 2D images. Guide Turns guidelines on and off. Guidelines are for needle guidance, Select Dual, and then press the are an optional feature, and depend key to display the second UPDATE on transducer type. screen and to toggle between the screens.
Page 39 Turns Tissue Harmonic Imaging on and off. When on, THI appears in the upper left-hand screen. This feature depends on transducer and exam type. Page x/x Indicates which page of options is displayed. Select to display the next page. 2D controls Turns on SonoMBe imaging, which enhances linear structures within a selected angle range and can facilitate needle guidance during catheter placement and nerve-block procedures.
Page 40 • Shallow, Medium, or Steep sets the outline’s sloped edge, which is indicated by a dotted line. • Linear transducer: Use whichever setting provides best perpendicularity to the dotted line. Within the affected area, the more perpendicular that a linear structure is to the dotted line, the more it is enhanced.
Page 41 Figure 2: Image with MBe on (linear transducer) 1 Needle 3 Dotted line 2 Outlined area affected by MBe 4 Unenhanced area Figure 3: Curved array transducer Tip: With a curved array transducer, only segments of the needle shaft might show. 1 Upper needle shaft 2 Unshown segment of needle shaft (unshown segment or segments depend on specific image) Chapter 3: Imaging...
Page 42: M Mode Imaging
M Mode imaging CPD and color Doppler imaging Motion mode (M Mode) is an extension of 2D. It Color power Doppler (CPD) and color Doppler provides a trace of the 2D image displayed over (Color) are optional features. time. A single beam of ultrasound is transmitted, CPD is used to visualize the presence of and reflected signals are displayed as dots of detectable blood flow. Color is used to visualize varying intensities, which create lines across the the presence, velocity, and direction of blood flow screen. in a wide range of flow states. To display the M-line To display the CPD or Color image 1 Press the key. M MODE 1 Press the key. COLOR Note: If the M‐line does not appear, make sure ...
Page 43: Pw And Cw Doppler Imaging
PW and CW Doppler imaging Flow The current setting appears Pulsed wave (PW) Doppler and continuous wave Sensitivity on-screen. (CW) Doppler imaging modes are optional • Low optimizes the system for low features. flow states. • Med optimizes the system for PW Doppler is a Doppler recording of blood flow medium flow states. velocities in a range specific area along the length of the beam. CW Doppler is a Doppler recording • High optimizes the system for of blood flow velocities along the length of the ...
Page 44 You can adjust the angle in 2° increments Gate Size Settings depend on transducer and from ‐74° to +74°. exam type. In TCD or Orb exams, use the Cardiac imaging applications touchpad to specify the Doppler You can identify the presence and location of gate depth (the depth of the center fluid around the heart and lungs, use to assist in of the gate in the Doppler image). pericardiocentesis and thoracentesis procedures, ...
Page 45: Adjusting Depth And Gain
To adjust gain automatically Line Sets the baseline position.  Press the key. The gain adjusts AUTO GAIN (On a frozen trace, the baseline can each time you press this key. be adjusted if Live Trace is off.) To adjust gain manually Invert Vertically flips the spectral trace.  Turn a gain knob: (On a frozen trace, Invert is available if Live Trace is off.)
Page 46: Imaging Modes And Exams Available By Transducer
Imaging modes and exams frames in the buffer appears on‐screen in the system status area. available by transducer To zoom in on an image WARNING: To prevent misdiagnosis or harm to You can zoom in 2D and Color imaging. You can the patient, understand your freeze or unfreeze the image or change the system’s capabilities prior to use. imaging mode at any time while zooming. The diagnostic capability differs for 1 Press the key. A ROI box appears. ...
Page 47 Imaging modes and exams available by transducer Imaging Mode     Pros — —     C11x — —     — —     — —     — —...
Page 48 Imaging Mode      — Imaging modes and exams available by transducer...
Page 49 Imaging Mode     ICTx — —     — —      L25x —      —     — —     — — ...
Page 50 Imaging Mode     — —     P21x — —     — —     — —     — —     — — Imaging modes and exams available by transducer...
Page 51: Annotating Images
Imaging Mode     SLAx — —     — —     — —     — —     — —     TEEx — — 1.
Page 52: Patient Information Form
4 (Optional) To add a predefined label, select 2 Select x/x to display the desired Label, and then select the desired label group: pictograph, and then press the key. SELECT , or . Select the group again for The first number shows which pictograph in the desired label. the set is selected. The second number is the number of pictographs available. The first number shows which label in the group is selected. The second number is the 3 Using the touchpad, position the pictograph number of labels available. marker. See “Annotations setup” on page 18. 4 (Optional) To rotate the pictograph marker, press the key and then use the SELECT To turn off text entry, press the key. TEXT touchpad. To reset the home position 5 Select a screen location for the pictograph: U/L 1 Press the ...
Page 53 To edit a patient information form • Procedure (button) Available if the DICOM Worklist feature is licensed and configured. You can edit patient information if the exam has See the DICOM user guide. not been archived or exported and if the information is not from a worklist. Select Back to save entries and return to the previous screen. See also “To edit patient information from the patient list” on page 43. Exam • Type Exam types available depend on 1 Press the key. PATIENT transducer. See “Imaging modes and exams 2 Make changes as desired. available by transducer” on page 34. 3 Select one of the following: • LMP Estab. DD (OB or Gyn exam) In an OB exam, select LMP or Estab. DD and then enter •...
Page 54: Images And Clips
• Weight (Cardiac exam) The patient weight in To capture and save a clip pounds or kilos. (To change the units, see Clips, an optional feature, lets you capture, “Presets setup” on page 22.) preview, and save clips. • BSA (Cardiac exam) Body Surface Area. 1 Set Clips options. (See “To set Clips options” Automatically calculated after you enter on page 42.) height and weight. 2 Press the key. CLIP • Ethnicity (IMT exam) Ethnic origin One of the following occurs: • Reading Dr. • If Prev/Off is selected, the clip saves • Referring Dr. directly to internal storage. • Institution •...
Page 55: Reviewing Patient Exams
Clips options Time, ECG Time and ECG share the same location on-screen. • With Time, capturing is based on number of seconds. Select the time duration. • With ECG, capturing is based on the number of heart beats. Select the number of beats. Preview On, PrevOn and PrevOff turn the Preview Off...
Page 56: Printing, Exporting, And Deleting Images And Clips
2 Select Edit. Printing, exporting, and deleting images and clips 3 Fill in the form fields, and select OK. WARNING: To avoid damaging the USB storage To append images and clips to a patient device and losing patient data from exam it, observe the following: Although you cannot add images and clips to a • Do not remove the USB storage patient exam that is ended, you can automatically ...
Page 57: Ecg Monitoring
Each image appears briefly on‐screen 1 Select one or more patients in the patient list. while printing. 2 Select Archive. To export patient exams to a USB storage To display information about a patient exam device 1 On the patient list, select the exam. You can export patient exams if they are ended. 2 Select Info. (See “To end the exam” on page 41.) A USB storage device is for temporary storage of images and clips. Patient exams should be ECG Monitoring archived regularly. To specify file format, see ECG Monitoring is an optional feature and “USB Devices setup” on page 23. requires a SonoSite ECG cable. 1 Insert the USB storage device. WARNING: To prevent misdiagnosis, do not use 2 In the patient list, select the patient exams you ...
Page 58 2 Select ECG on‐screen. (ECG may be on another page. It appears only if the ECG cable is connected.) 3 Select options as desired. ECG Monitoring options Show/Hide Turns on and off ECG trace. Gain Increases or decreases ECG gain. Settings are 0-20. Position Sets the position of the ECG trace. Sweep Speed Settings are Slow, Med, and Fast. Delay Displays Line and Save for clip acquisition delay.
Page 59: Chapter 4: Measurements And Calculations
Chapter 4: Measurements and Calculations You can measure for quick reference, or you can Working with calipers measure within a calculation. You can perform When measuring, you work with calipers, often general calculations as well as calculations in pairs. Results based on the calipers’ position specific to an exam type. appear at the bottom of the screen. The results update as you reposition the calipers by using the Measurements are performed on frozen images. touchpad. In trace measurements, the results For references used, see Chapter 7, “References.” appear after you complete the trace. Outside a calculation, you can add calipers by Measurements pressing the key. You can have multiple CALIPER sets of calipers and can switch from one set to You can perform basic measurements in any another, repositioning them as needed. Each set imaging mode and can save the image with the shows the measurement result. The active measurements displayed. (See “To save an calipers and measurement result are highlighted image” on page 42.) Except for the M Mode HR green. A measurement is complete when you measurement, the results do not automatically finish moving its calipers. save to a calculation and the patient report. If you prefer, you can first begin a calculation and then Within a calculation, calipers appear when you ...
Page 60: 2D Measurements
To improve precision of caliper placement You can perform a combination of distance, area, circumference, and manual trace measurements  Do any of the following: at one time. The total number possible depends • Adjust the display for maximum on their order and type. sharpness. To measure distance (2D) • Use leading edges (closest to the transducer) or borders for starting and You can perform up to eight distance stopping points. measurements on a 2D image. • Maintain a consistent transducer 1 On a frozen 2D image, press the key. CALIPER orientation for each type of measurement. A pair of calipers appears, connected by a • Make sure that the area of interest fills as dotted line. much of the screen as possible. 2 Using the touchpad, position the first caliper, • (2D) Minimize the depth, or zoom. and then press the ...
Page 61: M Mode Measurements
4 Press the key. 4 Press the key. SELECT SELECT 5 Using the touchpad, complete the trace, and A second vertical caliper appears. press the key. 5 Using the touchpad, position the second See “To save a measurement to a calculation and vertical caliper at the peak of the next patient report” on page 47. heartbeat. See “To save a measurement to a calculation and M Mode measurements patient report” on page 47. Saving the heart rate measurement to the patient report overwrites The basic measurements that you can perform in any heart rate entered on the patient information M Mode imaging are as follows: form. • Distance in cm/Time in seconds See also “To measure fetal heart rate (M Mode)” • Heart Rate (HR) in beats per minute (bpm) on page 71. The time scale above the trace has small marks at 200 ms intervals and large marks at one‐second ...
Page 62 To measure Velocities, Elapsed Time, +/x 4 Using the touchpad, trace the waveform. Ratio, Resistive Index (RI), and Acceleration To make a correction, select Undo on‐screen, (Doppler) backtrack with the touchpad, or press the 1 On a frozen Doppler spectral trace, press the key. BACKSPACE key. CALIPER 5 Press the key. A single caliper appears. The measurement results appear. 2 Using the touchpad, position the caliper to a See “To save a measurement to a calculation and peak systolic waveform. patient report” on page 47. 3 Press the key. SELECT To trace automatically (Doppler) A second caliper appears.
Page 63: General Calculations
• Mean Pressure Gradient (PGmean) Menu items followed by ellipses (. . .) have sub‐entries. • Mean Velocity on Peak Trace (Vmean) To select from the calculations menu • Pressure Gradient (PGmax) 1 On a frozen image, press the key. CALCS • Cardiac Output (CO) The calculations menu appears. • Peak Systolic Velocity (PSV) 2 Using the touchpad or arrow keys, highlight • Time Average Mean (TAM)* the desired measurement name. • +/× or Systolic/Diastolic (S/D) To display additional measurement names, • Pulsatility Index (PI) highlight Next, Prev, or a measurement name that has ellipses (. . .). Then press the SELECT • End Diastolic Velocity (EDV) key. •...
Page 64: Displaying, Repeating, And Deleting Saved Measurements In Calculations
is set to Image/Calcs. (See “Presets setup” Some measurements can be deleted directly from on page 22.) the patient report pages. See “Patient report” on page 77. The calculation saves to the patient report, and the image saves to internal storage EMED calculations with the measurements displayed. The results from EMED calculations automatically appear in the EMED worksheets. Displaying, repeating, and deleting All EMED calculations are available for each saved measurements in calculations exam type. To display a saved measurement To perform an EMED calculation:  Do one of the following: 1 Press the key. CALCS •...
Page 65 a From the calculations menu, select the measurement name under Area Red. Transducer Exam Types b Using the touchpad, move the caliper to the trace starting point, and press the C11x Abdomen, Vascular key. SELECT C60x Abdomen, Msk c Using the touchpad, trace the desired area. HFL38x IMT, Small Parts, Vascular To make a correction, select Undo on‐screen or press the key. BACKSPACE HFL50x Msk, Small Parts d Complete the trace, and press the key. L25x Msk, Vascular Save the calculation. See “To save a L38x IMT, Small Parts, Vascular calculation” on page 51.
Page 66: Volume Calculations
Volume calculations Transducer Exam Types WARNING: To avoid incorrect calculations, SLAx Msk, Nerve, Superficial, verify that the patient information, Vascular date, and time settings are accurate. To calculate volume To avoid misdiagnosis or harming the patient outcome, start a new The volume calculation involves three 2D ...
Page 67 automatically uses the gate size and “(gate)” appears in the calculation results. Transducer Exam Types The Doppler sample volume should completely insonate the vessel. You can measure either the C11x Abdomen, Vascular time average mean or time average peak. To C60x Abdomen specify the live trace setting, see “Presets setup” on page 22. HFL38x Vascular Consider the following factors when performing L25x Vascular volume flow measurements: L38x Vascular • Users should follow current medical practice for volume flow calculation applications. L38xi Vascular • The accuracy of the volume flow calculation P10x Abdomen largely depends on the user. P21x Abdomen • The factors identified in the literature that affect the accuracy are as follows: SLAx Vascular •...
Page 68: Exam-Based Calculations
Exam-based calculations To calculate volume flow 1 If measuring the diameter instead of using the In addition to the general calculations, there are gate size, perform the 2D measurement: calculations specific to the Cardiac, Gynecology a On a frozen full‐screen 2D image or duplex (Gyn), IMT, OB, Orbital, Small Parts, Transcranial image, press the key. Doppler (TCD), and Vascular exam types. CALCS b From the calculations menu, select D Cardiac calculations (distance) under Vol Flow. Position the calipers. (See “Working with WARNING: To avoid incorrect calculations, calipers” on page 47.) verify that the patient information, date, and time settings are accurate. Save the calculation. See “To save a ...
Page 69 Cardiac Calculations Cardiac Menu Calculation Measurements Cardiac Heading Results Menu Calculation (Imaging Mode) Measurements Heading Results (Imaging Mode) LV…LVd RVW (M Mode) RVD (M Mode) LV…LVd RVW (2D) IVS (M Mode) RVD (2D) LVD (M Mode) LVESV IVS (2D) LVPW (M Mode) LVEDV LVD (2D) LVESV...
Page 70 Cardiac Cardiac Menu Calculation Menu Calculation Measurements Measurements Heading Results Heading Results (Imaging Mode) (Imaging Mode) PISA Ann D (2D) PISA Area P. Vein A (Doppler) VMax Radius (Color) Adur (Doppler) time MR/VTI (Doppler) MV Rate S (Doppler) VMax MV/VTI (Doppler) Regurgitant Volume S/D ratio...
Page 71 Cardiac Cardiac Menu Calculation Menu Calculation Measurements Measurements Heading Results Heading Results (Imaging Mode) (Imaging Mode) Vmax (Doppler) Vmax TRmax (Doppler) Vmax PGmax PGmax VTI (Doppler) E (Doppler) Vmax A (Doppler) E PG PGmax Vmean A PG PGmean VTI or Vmax from PHT (Doppler) LVOT (Doppler) VTI or Vmax from...
Page 72 To measure LVd and LVs c Using the touchpad, trace the left ventricular (LV) cavity. 1 On a frozen 2D image or M Mode trace, press the key. CALCS To make a correction, select Undo on‐screen or press the key. BACKSPACE 2 From the calculations menu, select the measurement name. d Complete the trace, and press the key. 3 Position the active (green) caliper at the Save the calculation. (See “To save a starting point. (See “Working with calipers” calculation” on page 51.) on page 47.) To calculate MV or AV area 4 Press the key, and position the second ...
Page 73 5 Positioning the calipers, measure the 4 Using the touchpad, trace the waveform. ventricular length. (See “Working with To make a correction, select Undo on‐screen, calipers” on page 47.) backtrack with the touchpad, or press the 6 Save the calculation. key. BACKSPACE 5 Press the key to complete the trace. To measure peak velocity Save the calculation. (See “To save a For each cardiac measurement, the system saves calculation” on page 51.) up to five individual measurements and calculates their average. If you take more than For information on the automatic trace tool, see five measurements, the most recent measurement “To trace automatically (Doppler)” on page 50. replaces the fifth one. If you delete a saved measurement from the patient report, the next To calculate Right Ventricular Systolic measurement taken replaces the deleted one in Pressure (RVSP) the patient report. The most recently saved ...
Page 74 • In AV, position the caliper at the end To make a correction, select Undo diastole. on‐screen, backtrack with the touchpad, or press the key. BACKSPACE Save the calculation. (See “To save a calculation” on page 51.) d Press the key to complete the trace. e Save the calculation. To calculate Proximal Isovelocity Surface Area (PISA) For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 50. The PISA calculation requires a measurement in 2D, a measurement in Color, and two To calculate Isovolumic Relaxation Time measurements in Doppler spectral trace. After all (IVRT) measurements are saved, the result appears in the patient report. 1 On a frozen Doppler spectral trace, press the key. CALCS 1 Measure from Ann D (2D): 2 From the calculations menu, select MV and ...
Page 75 4 Press the key. a From the calculations menu, locate Qp/Qs SELECT and then select LVOT D or RVOT D. A second horizontal dotted line with an active caliper appears at 300 cm/s. Position the calipers. (See “Working with calipers” on page 47.) 5 Position the second caliper along the waveform at 300 cm/s. Save the calculation. (See “To save a calculation” on page 51.) Save the calculation. (See “To save a calculation” on page 51.) 3 On a frozen Doppler spectral trace, press the key. CALCS To calculate Aortic Valve Area (AVA) 4 Do the following to measure from LVOT VTI The AVA calculation requires a measurement in and again to measure from RVOT VTI: 2D and two measurements in Doppler. After the a From the calculations menu, select Qp/Qs ...
Page 76 Position the calipers. (See “Working with 1 (CI Only) Fill in the Height and Weight fields calipers” on page 47.) on the patient information form. The BSA is calculated automatically. (See “To create a Save the calculation. (See “To save a new patient information form” on page 40.) calculation” on page 51.) Calculate SV. See “To calculate Stroke Volume Measure from aorta (Doppler). See “To (SV) or Stroke Index (SI)” on page 63. calculate Velocity Time Integral (VTI)” on page 61. From the calculations menu, select Calculate HR. See “To calculate Heart Rate (HR)” on page 64. AV and then select VTI. For information on the automatic trace tool, see To calculate Cardiac Output automatically “To trace automatically (Doppler)” on page 50. WARNING: To avoid incorrect calculation To calculate Heart Rate (HR) results, make sure that the Doppler Heart Rate is available in all cardiac packages. ...
Page 77: Measurement Publications And Terminology (Cardiac)
2 Trace automatically (Doppler): Measurement publications and terminology (Cardiac) The automatic trace tool always measures the peak regardless of the Live Trace setting in The following are additional references for the Presets setup. Cardiac exam type. a Display the Doppler spectral trace Left Ventricular Mass in gm for 2D (waveform). , N.B., P.M. Shah, M. Crawford, et.al. b Select Trace on‐screen, and then select “Recommendations for Quantification of the Left Above or Below for the position of the ...
Page 78: Gynecology (Gyn) Calculations
Gynecology (Gyn) calculations Gynecology (Gyn) calculations include Uterus, Ovary, Follicle, and Volume. For instructions to calculate volume, see “Volume calculations” on page 54. To avoid incorrect calculations, WARNING: verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations.
Page 79: Imt Calculations
To measure follicles WARNING: To avoid incorrect calculations, On each side, you can save up to three distance verify that the patient information, measurements on a follicle, for up to 10 follicles. date, and time settings are accurate. If you measure a follicle twice, the average appears in the report. If you measure a follicle To avoid misdiagnosis or harming three times, the average and a volume calculation the patient outcome, start a new appear in the report. patient information form before starting a new patient exam and 1 On a frozen 2D image, press the ...
Page 80 IMT tool options IMT Calculations (2D) When using the IMT tool, you can select the following options on‐screen. Menu Heading Available Measurements Option Description Right-IMT Ant N (Anterior Near Wall) Left-IMT Ant F (Anterior Far Wall) Hide Use to check results. Hides the Lat N (Lateral Near Wall) measurement results and trace line.
Page 81: Ob Calculations
To trace IMT manually a Position the caliper at the beginning of the boundary and press the key. SELECT In manually tracing IMT, the user defines the location. b Using the touchpad, mark points by moving the caliper to the next desired 1 On a frozen 2D image, press the key CALCS point and pressing the key. SELECT 2 From the calculations menu, select a To make a correction, select Undo measurement name. on‐screen or press the key to BACKSPACE 3 Select Edit on‐screen, and then select Manual, delete the last segment. and then select Sketch. c Press the key to complete the trace line. A single caliper appears, and Trace appears d If necessary, adjust or edit the next to the measurement. measurement. See “IMT tool options” on 4 Do the following for the desired ...
Page 82 Results from System-Defined OB Measurements WARNING: To avoid misdiagnosis or harming and Table Authors the patient outcome, start a new patient information form before Calculation Gestational OB Table starting a new patient exam and Result Measurements Authors performing calculations. Starting a new patient information form clears Gestational —...
Page 83 author for the OB tables, which you choose on a system setup Calculation Gestational OB Table page, determines the measurements you must perform to Result Measurements Authors obtain an EFW calculation. (See “OB Calculations setup” page 20.) Individual selections for Hadlock’s EFW equations 1, 2, and 3 Estimated Fetal HC, AC, FL Hadlock 1...
Page 84: Small Parts Calculations
3 Using the touchpad, position the vertical Cerebral Artery) or UmbA (Umbilical caliper at the peak of the heartbeat. Artery). 4 Press the key. b Position the calipers: SELECT A second vertical caliper appears. • For S/D, RI, position the first caliper at the peak systolic waveform. Press the 5 Using the touchpad, position the second key, and position the second SELECT vertical caliper at the peak of the next caliper at the end diastole on the heartbeat. waveform. Save the calculation. (See “To save a • For S/D, RI, PI, position the caliper at calculation” on page 51.) the beginning of the desired waveform, OB Doppler Calculations and press the key. Use the SELECT touchpad to manually trace the desired Menu area. Press the ...
Page 85: Transcranial Doppler And Orbital Calculations
4 Position the baseline, and press the key. Transcranial Doppler and Orbital (See “Working with calipers” on page 47.) calculations Line A (alpha line) appears on‐screen, and WARNING: To avoid injury to the patient, use Line A is selected in the calculations menu. only an Orbital (Orb) exam type 5 Position Line A, and save the measurement. when performing imaging through (See “To save a calculation” on page 51.) the eye. Line B (beta line) appears on‐screen, and Line Verify that the patient information, B is selected in the calculations menu.
Page 86 Transcranial and Orbital Calculations ECVA Menu Heading TCD and Orb Results Measurements Dist Gate Size Prox *Available but not required Bifur* Gate Size WARNING: To avoid injury to the patient, use ACoA* only an Orbital (Orb) or TICA Ophthalmic (Oph) when performing imaging through the PCAp1 eye.
Page 87: Vascular Calculations
• For a manual trace measurement, use the Vascular calculations touchpad to position the caliper. Press the key. Use the touchpad to trace the WARNING: To avoid misdiagnosis or harming SELECT waveform. the patient outcome, start a new patient information form before If you need to make a correction, select starting a new patient exam and Undo on‐screen or press the BACKSPACE performing calculations. Starting a key. new patient information form •...
Page 88 3 Do the following for each measurement you want to take: Vascular Calculations a From the calculations menu, select the Menu Vascular Calculation measurement name. Heading Measurement Results b Using the touchpad, position the caliper at Prox s (systolic), the peak systolic waveform. d (diastolic) c Press the key. SELECT s (systolic), A second caliper appears. d (diastolic) d Using the touchpad, position the second Dist s (systolic), caliper at the end diastole on the d (diastolic) waveform. Bulb s (systolic), Save the calculation. (See “To save a ...
Page 89: Patient Report
• To display additional pages, select 1/x Calculations for L38xi transducer on‐screen. • (Cardiac, Vascular, or TCD) Select Details Exam Type Calculations or Summary on‐screen. The mean of the detail entries is used in the summary. Volume 3 (Optional) Press the key to save the SAVE current page of the patient report. Percent Reduction To exit the patient report and return to imaging, Percent Reduction select Done. Volume To send a patient report to a PC Volume You can send a patient report to a PC as a text file. Percent Reduction Ensure correct configuration. See “To ...
Page 90: Tcd Patient Report
(Cardiac) To adjust the RA pressure To fill out the OB anatomy checklist  On the Summary page of the cardiac patient You can document reviewed anatomy. report, select from the RA list.  On the Anatomy Checklist page in the OB Changing the RA pressure from the default 5 patient report, select the check boxes. affects the RVSP calculation result. Press the key to move between fields and the to select and deselect items in SPACEBAR TCD patient report the checklist. The maximum values for the TAP calculation To complete the OB biophysical profile appear on the summary page. ...
Page 91: Msk Worksheets
To display an EMED worksheet This feature is optional. 1 After or during the exam, press the REPORT key. 2 Select EMED on‐screen. 3 Select the worksheet from the Worksheet list or by selecting x/x on‐screen. MSK worksheets MSK worksheets have lists from which you can select and a field for entering comments. To display an MSK worksheet This feature is optional. 1 After or during the exam, press the REPORT key. 2 Select MSK on‐screen. 3 Select the worksheet from the Worksheet list. To display additional pages in the worksheet, select x/x on‐screen. Each worksheet has its own Comments field, which remains on‐screen even if you display another page in ...
Page 92 Patient report...
Page 93: Chapter 5: Troubleshooting And Maintenance
Chapter 5: Troubleshooting and Maintenance This chapter contains information to help correct System displays the alert “Unable to save image problems with system operation, to enter a or clip. You have reached the maximum number software license, and to take proper care of the of images/clips allowed for a single patient.” system, transducer, and accessories. Delete any unwanted images or clips from the patient exam.
Page 94: Maintenance
Reexport the original data onto the USB storage System Software Transducer Software device. Contact your system administrator. ARM version Transducer part number (REF) A maintenance icon appears on the system or model number (for example, C60x) screen. Restart the system. If the issue recurs, system maintenance may be required. Note the PCBA serial Transducer bundle version number that appears in parentheses on the C: line ...
Page 95: Cleaning And Disinfecting The Ultrasound System
Performing maintenance procedures not WARNING: To prevent contamination, the use described in the user guide or service manual of sterile transducer sheaths and may void the product warranty. sterile coupling gel is recommended for clinical WARNING: Do not modify the M-Turbo applications of an invasive or ultrasound system. surgical nature. Do not apply the transducer sheath and gel until you Contact SonoSite Technical Support for any ...
Page 96: Cleaning And Disinfecting Transducers
instructions for solution strengths and Caution: Do not spray cleaners or disinfectant contact duration. disinfectant directly on the system surfaces. Doing so may cause 5 Wipe surfaces with the disinfectant solution. solution to leak into the system, 6 Air dry or towel dry with a clean cloth. damaging the system and voiding the warranty. Cleaning and disinfecting transducers Do not use strong solvents such as To disinfect the transducer, use the immersion ...
Page 97 To clean and disinfect a transducer Do not allow cleaning solution or (immersion method) disinfectant into the transducer connector. 1 Disconnect the transducer from the system. Do not allow disinfectant to contact 2 Remove any transducer sheath. metal surfaces. Use a soft cloth 3 Clean the surface using a soft cloth lightly lightly dampened in a mild soap or dampened in a mild soap or compatible ...
Page 98: Cleaning And Disinfecting The Battery
Cleaning and disinfecting the battery Cleaning and disinfecting ECG cables Caution: To avoid damaging the battery, do Caution: To avoid damaging the ECG cable, not allow cleaning solution or do not sterilize. disinfectant to come in contact with the battery terminals. To clean and disinfect the ECG cable (wipe method) To clean and disinfect a battery (wipe...
Page 99: Recommended Disinfectants
Recommended disinfectants Table 1 does not have the following regulatory information for disinfectants: • EPA Registration • FDA 510(k) clearance (liquid sterilant, high level disinfectant) • CE approval Before using a disinfectant, confirm that its regulatory status is appropriate for your jurisdiction and use. Verify expiration dates on chemicals.
Page 100 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x/ System Type Active Ingredient HFL38x HFL50x Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx    Asepti-Steryl Spray Ethanol — — — ...
Page 101 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x/ System Type Active Ingredient HFL38x HFL50x Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx    Control III Liquid Quat. Ammonia — —...
Page 102 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x/ System Type Active Ingredient HFL38x HFL50x Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx    Hibiclens Clean Chlorhexidine — — — ...
Page 103 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x/ System Type Active Ingredient HFL38x HFL50x Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx  Reagent alcohol Liquid Denatured Ethyl — — — —...
Page 104 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x/ System Type Active Ingredient HFL38x HFL50x Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx    Liquid Alkyl — — —  ...
Page 105 Table 1: Disinfectant Compatibility with System and Transducers (continued) C60x ICTx Disinfection and Country L38x C11x/ System Type Active Ingredient HFL38x HFL50x Cleaning Solutions of Origin P10x L25x Surfaces P21x SLAx  = Acceptable  = Unacceptable. Do not use —...
Page 107: 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 (MSDs) a,b,c Use of an ultrasound system is defined as the physical interaction between the operator, the ultrasound system, and the transducer.
Page 108: 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 quick height adjustments. • Always sit or stand upright. Avoid bending or stooping. Minimize reaching and twisting •...
Page 109: Take Breaks, Exercise, And Vary Activities
Promote comfortable hand, wrist, and finger postures • Hold the transducer lightly in your fingers. • Minimize the pressure applied on the patient. • Keep your wrist in a straight position. Take breaks, exercise, and vary activities • Minimizing scanning time and taking breaks can effectively allow your body to recover from physical activity and help you avoid MSDs. Some ultrasound tasks may require longer 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. • 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 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 110: Electrical Safety
Electrical safety This system meets EN60601‐1, Class I/internally‐powered equipment requirements and Type BF and Type CF 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 111 To avoid the risk of electrical shock: • This equipment must be connected only to a supply mains with protective earth. • Do not let the bar code scanner or external mouse touch the patient. • Do not let the power supply or connector touch the patient. •...
Page 112: Equipment Safety
To avoid the risk of electrical shock and fire hazard: • Inspect the power supply, AC power cords, cables, and plugs on a regular basis. Ensure that they are not damaged. • The power cord set that connects the power supply of the ultrasound system or MDS to mains power must only be used with the power supply or docking system, and cannot be used to connect other devices to mains power.
Page 113: Battery Safety
Remove the battery from the system if the system is not likely to be used for some time. Do not spill liquid on the system. Battery safety To prevent the battery from bursting, igniting, or emitting fumes and causing personal injury or equipment damage, observe the following precautions. WARNING: Periodically, check to make sure that the battery charges fully. If the battery fails to charge fully, replace it.
Page 114: 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 115: Hazardous Materials
To avoid injury or reduce the risk of infection to the patient, observe the following: • • Follow Universal Precautions when inserting and maintaining a medical device for interventional and intraoperative procedures. • Appropriate training in Interventional and Intraoperative procedures as dictated by current relevant medical practices as well as in proper operation of the ultrasound system and transducer is required.
Page 116: Electromagnetic Compatibility
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. WARNING: The M-Turbo ultrasound system should not be used adjacent to or stacked with other equipment. If such use occurs, verify that the M-Turbo ultrasound system operates normally in that configuration. Caution: Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions.
Page 117 FUJIFILM SonoSite to the ultrasound system may result in malfunction of the ultrasound system or other medical electrical devices in the area. Contact FUJIFILM SonoSite or your local representative for a list of accessories and peripherals available from or recommended by FUJIFILM SonoSite.
Page 118: Separation Distance
Compatible accessories and peripherals FUJIFILM SonoSite has tested the M-Turbo ultrasound system with the following accessories and peripherals and has demonstrated compliance to the requirements of IEC60601-1-2:2007. You may use these FUJIFILM SonoSite accessories and third-party peripherals with the M-Turbo...
Page 119 WARNING: Use of the accessories with medical systems other than the M-Turbo ultrasound system may result in increased emissions or decreased immunity of the medical system. Use of accessories other than those specified may result in increased emissions WARNING: or decreased immunity of the ultrasound system. Accessories and peripherals compatible with M-Turbo ultrasound system Description Maximum Cable Length...
Page 120: Guidance And Manufacturer's Declaration
Accessories and peripherals compatible with M-Turbo ultrasound system (Continued) Black & white printer USB 10.8 ft/3.3 m cable Color printer — Color printer power cable 3.3 ft/1 m Color printer video cable 6.0 ft/ 1.8 m ECG lead wires 24 in/ 0.6 m ECG module 5.8 ft/1.8 m Footswitch...
Page 121 • IEEE 802.11g with Orthogonal Frequency Division Multiplexing (OFDM) at 14 dBm • IEEE 802.11n with OFDM at 14 dBm Chapter 6: Safety...
Page 122 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The M-Turbo ultrasound system is intended for use in the electromagnetic environment specified below. The customer or the user of the M-Turbo ultrasound system should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 Test Level...
Page 123 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued) The M-Turbo ultrasound system is intended for use in the electromagnetic environment specified below. The customer or the user of the M-Turbo ultrasound system should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 Test Level...
Page 124 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued) The M-Turbo ultrasound system is intended for use in the electromagnetic environment specified below. The customer or the user of the M-Turbo ultrasound system should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 Test Level...
Page 125 FCC Caution: Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: •...
Page 126: Applying Alara
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 120. 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 supply current and voltage to the transducer. 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 either the Ophthalmic or Orbital exam, the acoustic output is limited to the following values: ISPTA does not exceed 50 mW/cm ; 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 115. 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 ...
Page 127: Receiver Controls
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 • Comet tails For more information on detecting and interpreting acoustic artifacts, see the following reference: Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B. Saunders Company, (Oct. 17, 2005). 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 1: MI Transducer Depth ...
Page 128 Table 1: MI (Continued) Transducer Depth  ICTx  L25x  L38x  L38xi  P10x  P21x  SLAx  TEEx  Decrease or lower setting of parameter to reduce MI.  Increase or raise setting of parameter to reduce MI.
Page 129 Table 2: TI (TIS, TIC, TIB) Color Power Doppler Settings Transducer PW Settings Depth Optimize Width Height Depth    (Depth) — — — —     (Depth) C11x — — —     (PRF) C60x —...
Page 130: 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 3 indicates for each transducer and operating mode when either the TI or MI is greater than or equal to a value of 1.0, thus requiring display. Note: The D2x transducer has a static continuous wave (CW) output. This output is fixed. Therefore, TI and MI values cannot be changed by any system controls available to the user. Table 3: Modes in which a TI or MI  1.0 CPD/ Transducer Model Index M Mode Color Doppler Doppler — TIC,TIB, or TIS — C11x/8-5 — TIC,TIB, or TIS — C60x/5-2 —...
Page 131: Mi And Ti Output Display Accuracy
Table 3: Modes in which a TI or MI  1.0 (Continued) CPD/ Transducer Model Index M Mode Color Doppler Doppler P10x/8-4 TIC, TIB, or TIS P21x/5-1 TIC, TIB, or TIS SLAx/13-6 — TIC, TIB, or TIS — 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 ...
Page 132: Related Guidance Documents
Measurement errors of the acoustic parameters when taking the reference data are the major source of error that contributes to the display uncertainty. The measurement error is described in “Acoustic measurement precision and uncertainty” on page 165. The displayed MI and TI values are based on calculations that use a set of acoustic output measurements that were made using a single reference ultrasound system with a single reference transducer that is representative of the population of transducers of that type. The reference system and transducer are chosen from a sample population of systems and transducers taken from early production units, and they are selected based on having an acoustic output that is representative of the nominal expected acoustic output for all transducer/system combinations that might occur. Of course every transducer/system 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 ±...
Page 133: Acoustic Output Measurement
Table 4: Transducer Surface Temperature Rise, External Use (°C) Test C11x C60x L25x L38x L38xi P10x P21x Still air 11.3 17.6 16.2 15.5 10.7 16.1 16.3 12.5 15.6 16.8 Simulated Table 5: Transducer Surface Temperature Rise, Internal Use (°C ) Test ICTx SLAx...
Page 134: Tissue Models And Equipment Survey
In Situ= Water [e ‐(0.23alf) 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 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 135: Acoustic Output Tables
A homogeneous tissue model with attenuation coefficient of 0.3 dB/cm MHz throughout the beam path is commonly used when estimating exposure levels. The model is conservative in that it overestimates the In Situ acoustic exposure when the path between the transducer and site of interest is composed entirely of soft tissue. When the path contains significant amounts 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 ...
Page 136 Table 6: Transducer Model: C8x Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.48 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 137 Table 7: Transducer Model: C8x Operating Mode: M Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 3.16 (mW) — min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) (MHz) 5.07 —...
Page 138 Table 8: Transducer Model: C8x Operating Mode: Color Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.18 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 139 Table 9: Transducer Model: C8x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.59 (mW) — 36.0 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 1.10 (cm)
Page 140 — Data is not applicable for this transducer/mode. Table 10: Transducer Model: C11x Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) (mW) — — 38.8 min of [W (mW) —...
Page 141 — Data are not applicable for this transducer/mode. Table 11: Transducer Model: C11x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 46.0 24.9 25.4 min of [W (mW) —...
Page 142 — Data are not applicable for this transducer/mode. Table 12: Transducer Model: C60x Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 1.69 (mW) — — min of [W (mW) —...
Page 143 Table 13: Transducer Model: C60x Operating Mode: M Mode Non-scan Index Label M.I. 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 144 Table 14: Transducer Model: C60x Operating Mode: PW Doppler Non-scan Index Label M.I. 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...
Page 145 Table 15: Transducer Model: D2x Operating Mode: CW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 90.52 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.66 (MHz)
Page 146 Table 16: Transducer Model: HFL38x/13-6 Operating Mode: 2D Non-scan Index Label Scan Non-scan 1 >1 aprt aprt (MPa) 2.56 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) — z@PII .3max (cm) — (MHz) 5.33 —...
Page 147 Table 17: Transducer Model: HFL38x Operating Mode: CPD/Color Non-scan Index Label M.I. Non- Scan 1 scan >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.556 (mW) 37.69 — — min of [W (mW) — TA.3 (cm) — (cm) —...
Page 148 — Data are not applicable for this transducer/mode. Table 18: Transducer Model: HFL38x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.37 (mW) — 43.01 43.01 min of [W (mW) —...
Page 149 Table 19: Transducer Model: HFL50x Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.051 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 150 Table 20: Transducer Model: HFL50x Operating Mode: M Mode Non-scan Index Label M.I. 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 151 Chapter 6: Safety...
Page 152 Table 21: Transducer Model: HFL50x Operating Mode: CPD/Color Non-scan Index Label M.I. 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 153 Table 22: Transducer Model: HFL50x Operating Mode: PW Doppler Non-scan Index Label M.I. 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) —...
Page 154 Table 23: Transducer Model: ICTx Operating Mode: PW Doppler Non-scan Index Label M.I. 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 155 Table 24: Transducer Model: L25x Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.87 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 156 Table 25: Transducer Model L25x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 32.1 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 0.75 (cm) 0.30...
Page 157 # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.)—Data are not applicable for this transducer/mode. Table 26: Transducer Model: L38x Operating Mode: CPD/Color Non-scan Index Label M.I.
Page 158 Table 27: Transducer Model: L38x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 1.04 — — (MPa) 2.345 (mW) — 84.94 84.94 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 159 Table 28: Transducer Model: L38xi/10-5 Operating Mode: 2D Non-scan Index Label M.I. 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 160 Table 29: Transducer Model: L38xi/10-5 Operating Mode: M Mode Non-scan Index Label M.I. 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...
Page 161 Table 30: Transducer Model: L38xi/10-5 Operating Mode: CPD/Color Non-scan Index Label M.I. 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) —...
Page 162 Table 31: Transducer Model: L38xi/10-5 Operating Mode: PW Doppler Non-scan Index Label M.I. 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) —...
Page 163 Table 32: Transducer Model: P10x Operating Mode: 2D Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) (mW) — — 35.24 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 164 Table 33: Transducer Model: P10x Operating Mode: Color Non-scan Index Label M.I. 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) —...
Page 165 Table 34: Transducer Model: P10x Operating Mode: PW Doppler Non-scan Index Label M.I. 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 166 Table 35: Transducer Model: P10x Operating Mode: CW Doppler Non-scan Index Label M.I. 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...
Page 167 Table 36: Transducer Model: P21x Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.03 (mW) — — 171.53 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 168 Table 37: Transducer Model: P21x Operating Mode: M Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.10 (mW) — 40.08 29.71 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 169 Table 38: Transducer Model: P21x Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 A >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.03 (mW) 136.91 — — 116.5 min of (mW) — TA.3 (cm) — (cm) —...
Page 170 Table 39: Transducer Model: P21x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 1.73 (mW) — — 95.55 200.7 min of [W (mW) 124.4 TA.3 (cm) (cm) (cm) (cm) 0.49...
Page 171 Table 40: Transducer Model: P21x Operating Mode: CW Doppler Non-scan Index Label M.I. 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...
Page 173 Table 41: Transducer Model: SLAx Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 11.3 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 0.72 (cm) 0.15...
Page 174 Table 42: Transducer Model: TEEx Operating Mode: PW Doppler Non-scan Index Label M.I. 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 175 Table 43: Transducer Model: TEEx Operating Mode: CW Doppler Non-scan Index Label M.I. 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 176: Terms Used In The Acoustic Output Tables
Terms used in the acoustic output tables Table 44: 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 177: Acoustic Measurement Precision And Uncertainty
Table 44: Acoustic Output Terms and Definitions (Continued) Term Definition Equivalent beam diameter as a function of axial distance z, and is equal to       Wo      z    ...
Page 178: Labeling Symbols
Table 45: 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% Labeling symbols The following symbols are used on the products, packaging, and containers. Table 46: Labeling Symbols Symbol Definition Alternating Current (AC) Class 1 device indicating manufacturer’s declaration of conformance with...
Page 179 Table 46: Labeling Symbols (Continued) Symbol Definition Device complies with relevant Brazilian regulations for electro-medical devices. Canadian Standards Association. The “C” and “US” indicators 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 US, respectively.
Page 180 Table 46: Labeling Symbols (Continued) Symbol Definition Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices. Fragile Sterilized using irradiation STERILE R Sterilized using ethylene oxide STERILE EO Device emits a static (DC) magnetic field. Non-ionizing radiation Paper recycle Serial number type of control number Temperature limitation...
Page 181 Table 46: Labeling Symbols (Continued) Symbol Definition Humidity limitation Submersible. Protected against the effects of temporary immersion. 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) Defibrillator proof type CF patient applied part Underwriter’s Laboratories labeling...
Page 182 Table 46: Labeling Symbols (Continued) Symbol Definition Humidity limitation. Attention, see the user guide. Follow instructions for use. Manufacturer, or Manufacturer and date of manufacture Authorized representative in the European Community WARNING: WARNING: Connect Only Connect Only Accessories and Peripherals Accessories and Recommended by SonoSite Peripherals...
Page 183: 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 Axial < ±2% plus Acquisition Phantom 0-26 cm Distance 1% of full values do not include acoustic anomalies of the scale body. Lateral < ±2% plus Acquisition Phantom 0-35 cm The 2D linear distance measurement results are ...
Page 184: Sources Of Measurement Errors
Table 2: M Mode Measurement and Table 3: PW Doppler Mode Measurement and Calculation Accuracy and Range Calculation Accuracy and Range Velocity < +/- 2% Acquisition Phantom 0.01 cursor plus 1% of cm/sec- Distance < +/- Acquisition Phantom 0-26 cm 550 cm/s full scale plus...
Page 185: Measurement Publications And Terminology
floating‐point versus integer‐type math, which is Body Surface Area (BSA) in m subject to errors introduced by rounding versus Grossman, W. Cardiac Catheterization and truncating results for display of a given level of Angiography. Philadelphia: Lea and Febiger, significant digit in the calculation. (1980), 90. BSA = 0.007184 * Weight 0.425 * Height 0.725 Measurement publications Weight = kilograms and terminology Height = centimeters The following sections list the publications and Cardiac Index (CI) in l/min/m terminology used for each calculation result. Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. Terminology and measurements comply with 2nd Edition, Boston: Little, Brown and Company, AIUM published standards. (1999), 59. Cardiac references CI = CO/BSA where: CO = Cardiac Output Acceleration (ACC) in cm/s BSA = Body Surface Area Zwiebel, W.J. Introduction to Vascular ...
Page 186 Delta Pressure: Delta Time (dP:dT) in Elapsed Time (ET) in msec mmHg/s ET = time between velocity cursors in milliseconds Otto, C.M. Textbook of Clinical Echocardiography. 2nd ed., W.B. Saunders Company, (2000), 117, Heart Rate (HR) in bpm 118. HR = 3 digit value input by user or measured on 32 mmHg/time interval in seconds M Mode and Doppler image in one heart cycle E:A Ratio in cm/sec Interventricular Septum (IVS) Fractional E:A = velocity E/velocity A Thickening, percent Laurenceau, J. L., M.C. Malergue. The Essentials of E/Ea Ratio Echocardiography. Le Hague: Martinus Nijhoff, ...
Page 187 LVDS = Left Ventricular Dimension Left Ventricular Volume: Single Plane at Systole Method in ml LVEDV = (7.0 * LVDD )/(2.4 + LVDD) N.B., P.M. Shah, M. Crawford, et.al. “Recommendations for Quantitation of the Left where: LVEDV = Left Ventricular End Ventricle by Two‐Dimensional Diastolic Volume Echocardiography.” Journal of American Society of LVDD = Left Ventricular Dimension Echocardiography. September‐October 1989, 2:362. at Diastole      Left Ventricular Mass in gm  -- - -- -     Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. ...
Page 188 Mitral Valve Area (MVA) in cm Pressure Half Time (PHT) in msec Reynolds, Terry. The Echocardiographer’s Pocket Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 391. Arizona Heart Institute, (2000), 391, 452. PHT = DT * 0.29 MVA = 220/PHT where: DT = deceleration time where: PHT = pressure half time Note: 220 is an empirical derived constant and may Proximal Isovelocity Surface Area (PISA) in not accurately predict mitral valve area in mitral prosthetic heart valves. The mitral valve area continuity equation may be utilized in mitral Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. prosthetic heart valves to predict effective orifice area. 2nd ed., Boston: Little, Brown and Company, (1999), 125. MV Flow Rate in cc/sec ...
Page 189: Obstetrical References
Right Ventricular Systolic Pressure (RVSP) in Stroke Volume (SV) 2D and M Mode in ml 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 (1994), 44. Reference. School of Cardiac Ultrasound, Arizona Heart Institute, (1993), 152. SV = (LVEDV – LVESV) RVSP = 4 * (Vmax TR) + RAP where: SV = Stroke Volume where: RAP = Right Atrial Pressure LVEDV = End Diastolic Volume LVEDSV = End Systolic Volume Velocity Time Integral (VTI) in cm Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Reynolds, Terry. The Echocardiographer’s Pocket Arizona Heart Institute, (2000), 217.
Page 190: Gestational Age Tables
EDD = LMP date + 280 days Last Menstrual Period Derived (LMPd) by Established Due Date (Estab. DD) Estimated Fetal Weight (EFW) Results are displayed as month/day/year. Hadlock, F., et al. “Estimation of Fetal Weight LMPd(Estab. DD) = Estab. DD – 280 days with the Use of Head, Body, and Femur Measurements, A Prospective Study.” American Gestational age tables Journal of Obstetrics and Gynecology, 151:3 (February 1, 1985), 333‐337. Abdominal Circumference (AC) Hansmann, M., et al. Ultrasound Diagnosis in Hadlock, F., et al. “Estimating Fetal Age: Obstetrics and Gynecology. New York: Computer‐Assisted Analysis of Multiple Fetal Springer‐Verlag, (1986), 154. Growth Parameters.” Radiology, 152: (1984), Osaka University. Ultrasound in Obstetrics and 497‐501. Gynecology. (July 20, 1990), 103‐105. Hansmann, M., et al. Ultrasound Diagnosis in ...
Page 191 Hadlock, F., et al. “Estimating Fetal Age: Hadlock, F., et al. “Estimating Fetal Age: Computer‐Assisted Analysis of Multiple Fetal Computer‐Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), Growth Parameters.” Radiology, 152: (1984), 497‐501. 497‐501. Hansmann, M., et al. Ultrasound Diagnosis in Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Obstetrics and Gynecology. New York: Springer‐Verlag, (1986), 440. Springer‐Verlag, (1986), 431. Osaka University. Ultrasound in Obstetrics and Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 98. Gynecology. (July 20, 1990), 101‐102. University of Tokyo, Shinozuka, N. FJSUM, et al. University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal “Standard Values of Ultrasonographic Fetal Biometry.” Japanese Journal of Medical Ultrasonics, Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885. 23:12 (1996), 886. Cisterna Magna (CM) Fetal Trunk Cross-Sectional Area (FTA) Mahony, B.; P. Callen, R. Filly, and W. Hoddick. Osaka University. Ultrasound in Obstetrics and “The fetal cisterna magna.” Radiology, 153: Gynecology. (July 20, 1990), 99‐100. (December 1984), 773‐776.
Page 192: Growth Analysis Tables
Hadlock, F., et al. “Estimating Fetal Age: Jeanty P., E. Cousaert, and F. Cantraine. “Normal Computer‐Assisted Analysis of Multiple Fetal Growth of the Abdominal Perimeter.” American Growth Parameters.” Radiology, 152: (1984), Journal of Perinatology, 1: (January 1984), 129‐135. 497‐501. (Also published in Hansmann, Hackeloer, Hansmann, M., et al. Ultrasound Diagnosis in Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Obstetrics and Gynecology. Springer‐Verlag, Springer‐Verlag, (1986), 431. New York, (1986), 179, Table 7.13.) Humerus (HL) Biparietal Diameter (BPD) Jeanty, P.; F. Rodesch; D. Delbeke; J. E. Dumont. Chitty, Lyn S. et al. “Charts of Fetal Size: 2. Head “Estimate of Gestational Age from Measurements.” British Journal of Obstetrics and Measurements of Fetal Long Bones.” Journal of Gynaecology 101: (January 1994), 43, Appendix: Ultrasound in Medicine. 3: (February 1984), 75‐79 BPD‐Outer‐Inner. Hadlock, F., et al. “Estimating Fetal Age: Occipito-Frontal Diameter (OFD) Computer‐Assisted Analysis of Multiple Fetal Hansmann, M., et al. Ultrasound Diagnosis in Growth Parameters.” Radiology, 152: (1984), Obstetrics and Gynecology. New York: 497‐501. Springer‐Verlag, (1986), 431. Jeanty P., E. Cousaert, and F. Cantraine. “A Longitudinal Study of Fetal Limb Growth.” Tibia American Journal of Perinatology, 1: (January 1984), ...
Page 193: Ratio Calculations
in Obstetrics and Gynecology. Springer‐Verlag, Head Circumference (HC)/Abdominal New York, (1986), 186, Table 7.20.) Circumference (AC) Campbell S., Thoms Alison. “Ultrasound Femur Length (FL) Measurements of the Fetal Head to Abdomen Chitty, Lyn S. et al. “Charts of Fetal Size: 4. Femur Circumference Ratio in the Assessment of Length.” British Journal of Obstetrics and Growth Retardation,” British Journal of Obstetrics Gynaecology 101: (February 1994), 135. and Gynaecology, 84: (March 1977), 165‐174. Hadlock, F., et al. “Estimating Fetal Age: Ratio calculations Computer‐Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), FL/AC Ratio 497‐501. Hadlock F.P., R. L. Deter, R. B. Harrist, E. Roecker, Jeanty P, E. Cousaert, and F. Cantraine. “A and S.K. Park. “A Date Independent Predictor of Longitudinal Study of Fetal Limb Growth.” Intrauterine Growth Retardation: Femur American Journal of Perinatology, 1: (January 1984), Length/Abdominal Circumference Ratio,” 136‐144, Table 5. American Journal of Roentgenology, 141: (November (Also published in Hansmann, Hackeloer, 1983), 979‐984. Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer‐Verlag, FL/BPD Ratio New York, (1986), 182, Table 7.17.) Hohler, C.W., and T.A. Quetel. “Comparison of ...
Page 194: General References
General references Noninvasive Measurement of Atherosclerosis?” Journal of the American College of Cardiology. (June +/x or S/D Ratio 4, 2003), 41:11, 1886‐1898. +/x = abs (Velocity A/Velocity B) Percent Area Reduction where A = velocity cursor + Taylor K.J.W., P.N. Burns, P. Breslau. Clinical B = velocity cursor x Applications of Doppler Ultrasound, Raven Press, N.Y., (1988), 130‐136. Acceleration Index (ACC) Zwiebel W.J., J.A. Zagzebski, A.B. Crummy, et al. Zwiebel, W.J. Introduction to Vascular “Correlation of peak Doppler frequency with Ultrasonography, 4th ed., W.B. Saunders lumen narrowing in carotid stenosis.” Stroke, 3: Company, (2000), 52. (1982), 386‐391. ACC = abs (delta velocity/delta time) % Area Reduction = (1 ‐ A2(cm )/A1(cm )) * 100 Elapsed Time (ET) where: A1 = original area of the vessel in square cm ET = time between velocity cursors in A2 = reduced area of the vessel in ...
Page 195 PGmax = 4 * PV2 One of the following, depending on the Live Trace setting: Mean Pressure Gradient (PGmean) VF = CSA * TAM * .06 PGmean = 4 * Vmax VF = CSA * TAP * .06 Pulsatility Index (PI) Kurtz, A.B., W.D. Middleton. Ultrasound‐the Requisites. Mosby Year Book, Inc., (1996), 469. PI = (PSV – EDV)/V where PSV = peak systolic velocity EDV = end diastolic velocity V = mean flow velocity throughout the entire cardiac cycle Resistive Index (RI) Kurtz, A.B., W.D. Middleton. Ultrasound‐the Requisites. Mosby Year Book, Inc., (1996), 467. RI = abs ((Velocity A – Velocity B)/Velocity A) in measurements 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 = peak (peak Trace) Volume (Vol) Beyer, W.H. Standard Mathematical Tables, 28th ed., ...
Page 196 Measurement publications and terminology...
Page 197: Chapter 8: Specifications
Chapter 8: Specifications This chapter contains system and accessory • SLAx/13‐6 MHz (7.5 ft/2.3 m) specifications and standards. The specifications • TEEx/8‐3 MHz (11.8 ft./3.6 m) for recommended peripherals are in the manufacturers’ instructions. Imaging modes Dimensions • 2D (256 gray shades) • Color power Doppler (CPD) (256 colors) System • Color Doppler (Color) (256 colors) Length: 11.8 in. (29.97 cm) • M Mode Width: 10.8 in. (27.43 cm) • Pulsed wave (PW) Doppler Height: 3.1 in. (7.87 cm) • Continuous wave (CW) Doppler Weight: 8.5 lbs. (3.9 kg) with the C60x transducer • Tissue Doppler Imaging (TDI) and battery installed • Tissue Harmonic Imaging (THI) Display Length: 8.4 in. (21.34 cm) Image and clip storage Height: 6.3 in. (16 cm) Internal storage: The number of images and clips ...
Page 198: Peripherals
• Mobile docking system Shipping and storage • Needle Guide System and transducer • Power supply ‐35–65°C (‐31–149°F), 15–95% R.H. • SiteLink Image Manager 500 to 1060hPa (0.5 to 1.05 ATM) • SonoCalc IMT Battery • System AC power cord (10 ft/3.1 m) ‐20–60°C (‐4–140°F), 15–95% R.H. ( For storage • Triple Transducer Connect longer than 30 days, store at or below room temperature.) Peripherals 500 to 1060hPa (0.5 to 1.05 ATM) See the manufacturer’s specifications for the following peripherals. Electrical Medical grade Power Supply Input: 100‐240 VAC, 50/60 Hz, 2.0 • Bar code scanner, serial A Max @ 100 VAC • Bar code scanner, USB Power Supply Output #1: 15 VDC, 5.0 A Max •...
Page 199: Acoustic Standards
IEC 60601‐1:2012, Medical electrical equipment ‐ Biocompatibility standards Part 1: General requirements for basic safety and AAMI/ANSI/ISO 10993‐1, Biological evaluation essential performance [Edition 3.1]. of medical devices ‐ Part 1: Evaluation and testing (2009). IEC 60601‐2‐37:2001, International Electrotechnical Commission, Particular Requirements for the Safety of Ultrasonic Airborne equipment standards Medical Diagnostic and Monitoring Equipment. RTCA/DO‐160E, Radio Technical Commission IEC 60601‐2‐37:2007, Medical electrical for Aeronautics, Environmental Conditions and equipment ‐ Part 2‐37: Particular requirements Test Procedures for Airborne Equipment, for the basic safety and essential performance of Section 21.0 Emission of Radio Frequency ultrasonic medical diagnostic and monitoring Energy, Category B.118. equipment. DICOM standard IEC 61157, International Electrotechnical Commission, Standard Means for the Reporting NEMA PS 3.15, Digital Imaging and of the Acoustic Output of Medical Diagnostic Communications in Medicine (DICOM)‐Part 15: Ultrasonic Equipment.EMC standards Security and System Management Profiles. classification HIPAA standard45 CFR 160, General IEC 60601‐1‐2:2007, Medical electrical equipment ...
Page 200 Standards...
Page 201: 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 202 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 203: Abbreviations
Abbreviations Abbreviations in User Interface Abbreviation Definition +/× “+” Caliper/”×” Caliper Ratio “A” Wave Peak Velocity A PG “A” Wave Peak Pressure Gradient 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 204 Abbreviations in User Interface (Continued) Abbreviation Definition Aorta Aortic Root Diameter Apical Apical View APTD Anteroposterior Trunk Diameter Acceleration (Deceleration) Time 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.
Page 205 Abbreviations in User Interface (Continued) Abbreviation Definition Continuous Wave Doppler CxLen Cervix Length Diameter D Apical Distance Apical DCCA Distal Common Carotid Artery DECA Distal External Carotid Artery DICA Distal Internal Carotid Artery Dist Distal dP:dT Delta Pressure: Delta Time “E”...
Page 206 Abbreviations in User Interface (Continued) Abbreviation Definition 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 Epicardial EPSS “E” Point Septal Separation Estab.
Page 207 Abbreviations in User Interface (Continued) Abbreviation Definition Heart Rate Internal Carotid Artery Intima Media Thickness IVRT Iso Volumic Relaxation Time Interventricular Septum IVSd Interventricular Septum Diastolic IVSFT Interventricular Septum Fractional Thickening IVSs Interventricular Septum Systolic Left Atrium LA/Ao Left Atrium/Aorta Ratio LAT F Lateral Far LAT N...
Page 208 Abbreviations in User Interface (Continued) Abbreviation Definition LVDFS Left Ventricular Dimension Fractional Shortening LVDs Left Ventricular Dimension Systolic LVEDV Left Ventricular End Diastolic Volume LVESV Left Ventricular End Systolic Volume LVET Left Ventricular Ejection Time Left Ventricular Opacification LVOT Left Ventricular Outflow Tract LVOT Area Left Ventricular Outflow Tract Area LVOT D...
Page 209 Abbreviations in User Interface (Continued) Abbreviation Definition 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 MV ERO Mitral Valve Effective Regurgitant Orifice MV PISA Area Mitral Valve Proximal Iso Velocity Surface Area MV Rate...
Page 210 Abbreviations in User Interface (Continued) Abbreviation Definition PGmean Mean Pressure Gradient Pressure Gradient Pressure Half Time Pulsatility Index PICA Proximal Internal Carotid Artery PISA Proximal Isovelocity Surface Area Plaq Plaque POST F Posterior Far POST N Posterior Near Pulse Repetition Frequency Prox Proximal Peak Systolic Velocity...
Page 211 Abbreviations in User Interface (Continued) Abbreviation Definition RVWd Right Ventricular Free Wall Diastolic RVWs Right Ventricular Free Wall Systolic SonoHD technology Systolic/Diastolic Ratio Stroke Index Siphon Siphon (internal carotid artery) Submandibular Small Parts Suboccipital Superficial Stroke Volume Time Average Mean Time Average Peak Trans-cerebellum Diameter (OB measurement) Transcranial Doppler (exam type)
Page 212 Abbreviations in User Interface (Continued) Abbreviation Definition Ultrasound Age Calculated on the mean measurements taken for a particular fetal biometry. Umb A Umbilical Artery Vertebral Artery VArty Vertebral Artery Vascular Venous Volume Flow Vmax Peak Velocity Vmean Mean Velocity Volume Velocity Time Integral Yolk Sac...
Page 213 Index Symbols audio 19 +/x measurement 50 Numerics bar code scanner 19 2D imaging 25 baseline 33 2D options 25 battery clean 86 A & B shortcut keys 15 safety 101 abbreviations 191 setup 19 abdominal, intended uses 13 specifications 186 AC power indicator 6 beeps 19 acceleration (ACC) index 50...
Page 214 volume 54 clip acquisition delay 46 volume flow 54, 55 clips calipers 47 See also images and clips cardiac calculations options 26, 42 AAo 60 color Doppler (Color) imaging 30 Ao 60 color power Doppler (CPD) imaging 30 AVA 63 color scheme, background 22 CI 64 color suppress 30...
Page 215 transducers 84 export and import disinfectants, compatibility 87 OB calculation tables 21 display setup 20 predefined label groups 18 distance measurements user accounts 17 2D 48 M mode 49 far 5 D-line 31 fetal heart rate (FHR) 71 Doppler flow sensitivity 31 Doppler gate depth 32 focal zones, optimize 25 measurements 49...
Page 216 images and clips left ventricular outflow tract diameter (LVOT archive 45 D) 60 delete 45 left ventricular systolic (LVs) 60 export to USB 45 left ventricular volume (LV volume) 60 review 44 license key 82 imaging modes live trace 22, 33 list of 185 login transducer 35...
Page 217 Velocities, Doppler 50 general 77 mechanical index (MI) 119, 189 OB 78 mitral valve/aortic valve (MV/AV) 60 save measurement to 47 M-line 30 vascular 77 mode data 7, 20 PC 19 modes, keys 6 pediatric, intended uses 13 MPPS 19 percent reduction calculations 52 peripherals 186 near 5...
Page 218 right ventricular systolic pressure (RVSP) 61 Doppler 32 storage commitment 19 safety storage specifications battery 101 equipment 186 biological 102 images 185 electrical 98 stroke volume (SV) 63 electromagnetic compatibility 104 superficial, intended uses 13 equipment 100 sweep speed save Doppler 33 calculations 51 ECG 46...
Page 219 invasive or surgical use 11 linear array 189 preparation 11 problems 81 specifications 185 troubleshoot 81 ultrasound terminology 189 unfreeze text 18 USB storage device, export to 45 user account 17 user guide, conventions used 7 user setup 16 uses, intended 13–14 variance 31 vascular calculations 75...
Page 222 P07662-04 *P07662-04*...

FujiFilm SonoSite M-Turbo User Manual

Introduction

Chapter 1: Getting Started

Chapter 2: System Setup

Chapter 3: Imaging

Chapter 4: Measurements and Calculations

Chapter 5: Troubleshooting and Maintenance

Chapter 6: Safety

Chapter 7: References

Chapter 8: Specifications

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