S Series Ultrasound System User Guide
S Series Ultrasound System User Guide
SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 USA T: 1‐888‐482‐9449 or 1‐425‐951‐1200 F: 1‐425‐951‐1201 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 0AP UK T: +44‐1462‐444800 F: +44‐1462‐444801 Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. S-Cath, S-FAST, S-ICU, S-Nerve, SiteLink, SonoHD, SonoMB, and SonoSite are registered trademarks or trademarks of SonoSite, Inc.
Contents Introduction Conventions .................................................................................................................. vii Customer comments .................................................................................................. vii Chapter 1: Getting Started About the system .......................................................................................................... 1 Preparing the system ...............................................................
Chapter 3: Imaging Imaging modes ............................................................................................................ 21 2D imaging ........................................................................................................... 21 CPD and color Doppler imaging ................................................................... 22 Adjusting depth and gain ........................................................................................
Direct controls .....................................................................................................63 Indirect controls ..................................................................................................64 Receiver controls ................................................................................................64 Acoustic artifacts .........................................................................................................
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Introduction The user guide is for a reader familiar with ultrasound techniques. It does not provide training in sonography or clinical practices. Before using the system, you must have ultrasound training. See the applicable SonoSite accessory user guide for information on using accessories and peripherals. See the manufacturer’s instructions for specific information about peripherals.
For technical support, please contact SonoSite as follows: SonoSite Technical Support Phone (US or Canada): 877-657-8118 Phone (Outside US and Canada): 425-951-1330 Or call your local representative. Fax: 425-951-6700 E-mail: service@sonosite.com Web site: www.sonosite.com. Click Support & Service. Europe Service Center: +44-(0)1462-444-800 e-mail: uk.service@sonosite.
Chapter 1: Getting Started About the system 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. A license key is required to activate the software. See “Software licensing” on page 38. On occasion, a software upgrade may be required. SonoSite provides a USB device containing the software. One USB device can upgrade multiple systems.
1 3 3 2 4 Figure 1.
Each connector on the back and side of the system has a symbol that describes its use.
The system can run on battery power for up to two hours, depending on the imaging mode and the display brightness. 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. Caution: Verify that the hospital supply voltage corresponds to the power supply voltage range. See “Electrical” on page 87.
Connecting transducers WARNING: To avoid injury to the patient, do not place the connector on the patient. Operate the ultrasound system in the S Stand or on a convenient surface to allow air flow past the connector. Caution: To avoid damaging the transducer connector, do not allow foreign material in the connector. Getting Started Figure 1.2 Connect the Transducer To connect a transducer 1 Pull the transducer latch up, and rotate it clockwise.
Inserting and removing USB storage devices Images and clips are saved to internal storage and are organized in a sortable patient list. You can archive the images and clips from the ultrasound system to a PC using a USB storage device. Although the images and clips cannot be viewed from a USB storage device on the ultrasound system, you can remove the device and view them on your PC. You can also import and export user accounts and the event log using a USB storage device.
System controls 1 Getting Started 2 2 3 4 5 Figure 1.3 System Controls: 1 Power switch Turns the system on and off. 2 Control keys Perform an action or make a selection based on context. Current names appear on-screen adjacent to the keys. 3 Control knobs Adjust gain, depth, cine buffer, ROI box, and brightness. Sometimes perform an action. Are turned or pressed. 4 Touchpad Moves the pointer and other items. Touchpad key Works in conjunction with the touchpad.
Screen layout 5 1 2 6 3 7 8 4 9 Figure 1.4 Screen Layout 8 1 Mode Data Area Current imaging mode information (for example, Gen, S, THI). S and THI are on when available on the transducer and are not user-controlled. For definitions, see “Glossary.” 2 Orientation Marker Provides indication for image orientation. 3 Image Ultrasound image. 4 Measurement Data Area Current data on measurements.
General interaction Touchpad In forms and the setup pages, the touchpad is similar to a mouse on portable PCs. Using the touchpad, you move the pointer to an item and then click (press the key below the touchpad) to activate that item. Control keys The control keys display forms, adjust settings, and perform actions such as freezing and zooming.The functionality depends on context. The current name appears on‐screen next to the key. Control keys are usually pressed, but in forms you can also click them.
• The DELETE key deletes the character right of the pointer. 3 (Optional) Navigate among text fields: • Click Next to advance to the next field. • Click Prev to return to the previous field. 4 To exit the keyboard, click one of the following: • OK to save changes. • 2D to save changes and display 2D imaging. Preparing transducers WARNING: Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.
To install a transducer sheath SonoSite recommends the use of market‐cleared, transducer sheaths for intracavitary or surgical applications.To lessen the risk of contamination, install the sheath only when you are ready to perform the procedure. 1 Place gel inside the sheath. 2 Insert the transducer into the sheath. 3 Pull the sheath over the transducer and cable until the sheath is fully extended. 5 Check for and eliminate bubbles between the face of the transducer and the sheath.
Obstetrical Imaging Applications This system transmits ultrasound energy into the pelvis of pregnant women using 2D, SonoMB technology, color Doppler (Color), and color power Doppler (CPD) to obtain ultrasound images. The fetal anatomy, amniotic fluid, and surrounding anatomical structures can be assessed for the presence or absence of pathology transvaginally. CPD and color Doppler (Color) imaging is intended for high‐risk pregnant women.
Chapter 2: System Setup The setup pages let you customize the system and set preferences. Displaying the setup pages To display a setup page 1 In 2D imaging mode, do one of the following: • Press Patient, and then press Setup on the horizontal row of control keys. • Press Setup on the vertical row of control keys. 2 Click the setup page under Setup Pages. System Setup To return to imaging from a setup page, press Done.
Administration setup On the Administration setup page, you can configure the system to require users to log in and enter passwords. Required login helps protect patient data. You can also add and delete users, change passwords, import and export user accounts, and view the event log.
To change the administrator password or let users change passwords 1 Log in as Administrator. 2 Under User List, click Administrator. 3 Do any of the following: • Change the administrator password: Under User Information, type the new password in the Password box and Confirm box. (See “Choosing a secure password” on page 17.) • Let users change their passwords: Select the Password changes check box. 4 Click Save. User setup To add a new user 2 Click New.
To change a user password 1 Log in as Administrator. 2 In the User List, click the user. 3 Type the new password in the Password box and Confirm box. 4 Click Save. Exporting or importing user accounts The export and import commands let you configure multiple systems and back up user account information. To export user accounts 1 Insert a USB storage device. 2 Log in as Administrator. 3 Press Export. A list of USB devices appears. 4 Click the USB storage device, and click Export.
To export the Event log The Event log has the file name (log.txt). Exporting the Event log to a USB storage device overwrites any existing log.txt file. 1 Insert a USB storage device. 2 Press Log and then press Export. A list of USB devices appears. 3 Click the USB storage device, and click Export. The Event log is a text file that you can open in a text‐editing application (for example, Microsoft Word or Notepad). To clear the Event log 1 View the Event log. 2 Press Clear.
Audio, Battery setup On the Audio, Battery setup page, you can select options from the following lists: Key click: Click On or Off for keys to make a clicking sound when pressed. Beep alert: Click On or Off for the system to beep when saving, warning, starting, or shutting down. Sleep delay: Click Off, or 5 or 10 minutes to specify the period of inactivity before the system goes into sleep mode.
Date and Time setup To set the date and time On the Date and Time setup page, do the following: • In the Date box, type the current date. (See “Entering text” on page 9.) • In the Time box, type the current time in 24 hour format (hours and minutes). Display Information setup On the Display Information setup page, you can specify which details appear on‐screen during imaging. You can select check boxes in the following sections: Patient Header: Information from the patient information form.
System Information setup The System Information setup page displays system hardware and software versions, and license information. See also “To enter a license key” on page 38. USB Devices setup On the USB Devices setup page, you can view information about connected USB devices, including space availability. You can also specify a file format for images you export to a USB storage device. To specify a file format for exported images The image format you specify affects only still images.
Chapter 3: Imaging Imaging modes The system has a high‐performance LCD and advanced image‐optimization technology that greatly simplifies user controls. Imaging modes available depend on the transducer and exam type. See “Imaging modes and exams available by transducer” on page 24. 2D imaging 2D is the systemʹs default imaging mode. The system displays echoes in two dimensions by assigning a brightness level based on the echo signal amplitude.
2D settings (Continued) Control key Optimize Icon Description Settings are as follows: • Res provides the best possible resolution. • Gen provides a balance between resolution and penetration. • Pen provides the best possible penetration. Some of the parameters optimized to provide the best image include focal zones, aperture size, frequency (center and bandwidth), and waveform. They cannot be adjusted by the user.
Adjusting depth and gain To adjust depth You can adjust the depth in all imaging modes. The vertical depth scale is marked in 0.5 cm, 1 cm, and 5 cm increments, depending on the depth. To change the style of depth markers, see “Presets setup” on page 19. Turn the Depth knob: • Right increases the displayed depth. • Left decreases the displayed depth. To adjust gain manually To adjust gain automatically in 2D, see “2D settings” on page 21.
To zoom in on an image You can freeze or unfreeze the image or change the imaging mode at any time while zooming. 1 Press Zoom. A ROI box appears. 2 Using the touchpad, position the ROI box as desired. 3 Press Zoom again. The image in the ROI box is magnified by 100%. 4 (Optional) If the image is frozen, use the touchpad to pan the image up, down, left, and right. To exit zoom, press Zoom again. Turning guidelines on and off Guidelines are for needle guidance and are an optional feature.
Imaging modes and exams available by transducer Imaging Mode Exam Type1 S Series System 2D2 CPD Color C11x Nrv S-Nerve X X X Vas S-Nerve X X X Abd S-Cath S-FAST S-ICU X X X Nrv S-Nerve X X X Bre S-Cath X X X Nrv S-Nerve X X X SmP S-Cath S-FAST S-ICU X X X Vas S-Cath S-FAST S-ICU S-Nerve X X X Ven S-Cath S-FAST S-ICU X X X Gyn S-FAST X X X OB S-FAST X X X C60x HFL38x ICTx Imaging Transducer Chapter 3: Imaging 25
Imaging modes and exams available by transducer (Continued) Imaging Mode Transducer Exam Type1 S Series System 2D2 CPD Color L25x Nrv S-Nerve X X X Sup S-Cath X X X Vas S-Cath S-ICU S-Nerve X X X Ven S-Cath S-ICU X X X Bre S-Cath X X X Nrv S-Nerve X X X SmP S-Cath S-FAST S-ICU X X X Vas S-Cath S-FAST S-ICU S-Nerve X X X Ven S-Cath S-FAST S-ICU X X X Abd S-Cath S-FAST S-ICU X X X Crd S-FAST S-ICU X — X L38x P21x 1.
Patient information form The patient information form lets you enter patient identification, exam, and clinical information for the patient exam. When you create a new patient information form, all images and other data you save during the exam are linked to that patient. (See “Saving images and clips” on page 28.) To create a new patient information form 1 In 2D, press Patient. 2 Press New. 3 Fill in the form fields. See “Patient information form fields” on page 28 and “Entering text” on page 9.
Patient information form fields Field Description Last First Patient name ID Patient identification number Exam Exam type Exam label Exam-specific label that appears in the lower-right screen User User initials, up to 3 characters. Appears in the patient list and image header. Institution Institution name. Appears in the image header. Images and clips Saving images and clips When you save an image or clip, it saves to internal storage.
Figure 3.1 Patient List To open the patient list 1 In 2D, press Patient. Imaging 2 Press Review 3 If there is a current patient, press List. To sort the patient list After the system starts, the patient list is arranged by date and time, with the most recent patient file first. You can re‐sort the patient list as needed. Click the column heading that you want to sort by. Click it again if sorting in reverse order. Note: The selection column is sortable.
To review images and clips You can review only one patient’s images and clips at a time. 1 In the patient list, click the patient whose images and clips you want to review. The patient row is highlighted. 2 Press the Review knob. The icon on the knob changes to two numbers: the file displayed and the total files saved. 3 Turn the knob to cycle to the image or clip you want to review 4 (Clip Only) Press the Play key. The clip plays automatically after loading. The load time depends on clip length.
To export images and clips to a USB storage device A USB storage device is for temporary storage of images and clips. Patient exams should be archived regularly. To specify file format, see “USB Devices setup” on page 20. A patient exam must be ended before you can export its images and clips. See “To end the exam.” 1 Insert the USB storage device. (See “Inserting and removing USB storage devices” on page 6.) 2 In the patient list, select the patients whose images and clips you want to export. 3 Select Exp.
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Chapter 4: Measurements You can perform distance, area, and circumference measurements in any imaging mode. Measurements are performed on frozen images. You can perform multiple measurements at one time: up to eight distance measurements or four area/circumference measurements or a combination; for example, six distance measurements and one area/circumference measurement. Measurements Figure 4.
To switch the active calipers Do one of the following: • To switch the active caliper within a set, click. • To switch the active set, press Switch. To delete or edit a measurement With the measurement active (highlighted), do one of the following: • To delete, press the Delete knob. • To edit, use the touchpad to move the calipers. To improve precision of caliper placement Do any of the following: • Adjust the display for maximum sharpness.
Area and circumference measurements Area and circumference measurements use an ellipse with calipers. You can measure the following: • Area in cm2 • Circumference in cm To measure area or circumference 1 On a frozen image, press Calipers. 2 Press Ellipse. Note: If you exceed the allowed number of measurements, Ellipse is not available. 3 Use the touchpad to adjust the size and position of the ellipse. Clicking toggles between position and size.
Table 1: 2D Measurement Accuracy and Range 2D Measure Accuracy and Range System Tolerancea Accuracy By Test Methodb Range (cm) Axial Distance < ±2% plus 1% of full scale Acquisition Phantom 0-26 cm Lateral Distance < ±2% plus 1% of full scale Acquisition Phantom 0-35 cm Diagonal Distance < ±2% plus 1% of full scale Acquisition Phantom 0-44 cm Areac < ±4% plus (2% of Acquisition full scale/smallest dimension) * 100 plus 0.5% Phantom 0.01-720 cm2 Circumferenced < ±3% plus (1.
Chapter 5: Troubleshooting and Maintenance This chapter contains information to help correct problems with system operation, to enter a software license, and to take proper care of the system, transducer, and accessories. Troubleshooting If you encounter difficulty with the system, use the following table to help troubleshoot the problem. If the problem persists, contact SonoSite Technical Support. (See “SonoSite Technical Support” on page viii.) Troubleshooting Symptom Solution System does not turn on.
Software licensing SonoSite software is controlled by a license key. After you install new software, the system prompts you for a license key. You must obtain one key for each system or transducer that uses the software. The software will operate for a short time (the “grace period”) without a license key. During the grace period, all system functions are available. After the grace period, the system is not usable until you enter a valid license key.
Maintenance Use the recommendations in this section when cleaning or disinfecting your ultrasound system, transducer, and accessories. Use the cleaning recommendations in the peripheral manufacturer’s instructions when cleaning or disinfecting your peripherals. No periodic or preventive maintenance is required for the system, transducer, or accessories other than cleaning and disinfecting the transducer after every use. (See “Cleaning and disinfecting transducers” on page 41.
Cleaning and disinfecting the ultrasound system The exterior surface of the ultrasound system and the accessories can be cleaned and disinfected using a recommended cleaner or disinfectant. See Table 1, “Disinfectants Compatible with System and Transducers” on page 44. WARNING: To avoid electrical shock, before cleaning, disconnect the system from the power supply or remove it from the stand. To avoid infection always use protective eyewear and gloves when performing cleaning and disinfecting procedures.
4 Mix the disinfectant solution compatible with the system, following disinfectant label instructions for solution strengths and disinfectant contact duration. 5 Wipe surfaces with the disinfectant solution. 6 Air dry or towel dry with a clean cloth. Cleaning and disinfecting transducers To disinfect the transducer and its cable, use the immersion method or the wipe method. Immersible transducers can be disinfected only if the product labeling indicates they can be used with an immersion method.
To clean and disinfect a transducer (wipe method) 1 Disconnect the transducer from the system. 2 Remove any transducer sheath. 3 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids. Apply the solution to the cloth rather than the surface. 4 Rinse with water or wipe with water‐dampened cloth, then wipe with a dry cloth.
Cleaning and disinfecting the battery Caution: To avoid damaging the battery, do not allow cleaning solution or disinfectant to come in contact with the battery terminals. To clean and disinfect a battery (wipe method) 1 Remove the battery from the system. 2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution. Apply the solution to the cloth rather than the surface. 3 Wipe the surfaces with the disinfection solution. Theracide disinfectant is recommended.
44 Table 1 does not have the following regulatory information for disinfectants: • EPA Registration • FDA 510(k) clearance (liquid sterilant, high level disinfectant) • CE approval Prior to use, confirm that the regulatory status of the disinfectant is appropriate for your jurisdiction and use. See www.sonosite.com for updated cleaning and disinfectant information. Click Quick Link, and then click Documentation.
Table 1: Disinfectants Compatible with System and Transducers (Continued) Chapter 5: Troubleshooting and Maintenance C60x/ICTx/ L38x/P21x HFL38x C11x/ L25x System Surfaces Sodium Dichloroisocyanurate N N N U Liquid Peracetic Acid N N N U USA Liquid Quat Ammonia A A A U Asepti-HB USA Liquid Quat Ammonia A A A U Asepti-Steryl USA Spray Ethanol A A A N Asepti-Wipes USA Wipe Propanol (Isopropyl Alcohol A A A A Bacillocid rasant DEU Liquid Glut./Quat.
46 Table 1: Disinfectants Compatible with System and Transducers (Continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient C60x/ICTx/ L38x/P21x HFL38x C11x/ L25x System Surfaces Control III USA Liquid Quat. Ammonia A A N U Coverage Spray USA Spray Quat. Ammonia A A N N DentaSept FRA Liquid Quat.
Table 1: Disinfectants Compatible with System and Transducers (Continued) C60x/ICTx/ L38x/P21x HFL38x C11x/ L25x System Surfaces Hydrogen Peroxide A A A U Liquid Alcohol N N N U DEU Liquid Propanol A A A U Kohrsolin ff DEU Liquid Gluteraldehyde A U A U Korsolex basic DEU Liquid Gluteraldehyde N N N U Korsolex extra DEU Liquid Ethanol/Propanol A A A U Lem-O-Quat USA Liquid Alkyl/Chloride N N N U LpHse USA Liquid O-phenylphenol A A A U Lysol USA
48 Table 1: Disinfectants Compatible with System and Transducers (Continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient C60x/ICTx/ L38x/P21x HFL38x C11x/ L25x System Surfaces Ruthless USA Spray Quat. Ammonia A A N U Sagrosept Wipe DEU Wipe Propanol A A A U Salvanios pH 7 FRA Liquid Quat. Ammonia A A A U Sani-Cloth HB USA Wipe Quat. Ammonia A A N A Sani-Cloth Plus USA Wipe Quat.
Table 1: Disinfectants Compatible with System and Transducers (Continued) Chapter 5: Troubleshooting and Maintenance C60x/ICTx/ L38x/P21x HFL38x C11x/ L25x System Surfaces Alcohol N N N U Liquid Chlorine Dioxide A A A U GBR Wipe Chlorine Dioxide N N N N Vesphene II USA Liquid Sodium/ o-Phenylphenate A A A U Virex II 256 USA Liquid Ammonium Chloride A A A U Virex TB USA Liquid Quat.
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Chapter 6: Safety 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 disordersa,b,c. Use of an ultrasound system is defined as the physical interaction among the operator, the ultrasound system, and the transducer.
e.Habes, D.J. and S. Baron. “Health Hazard Report 99-0093-2749.” University of Medicine and Dentistry of New Jersey. (1999). f.Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. “Prevalence of Carpal Tunnel Syndrome and Other Work-related Musculoskeletal Problems in Cardiac Sonographers.” Journal of Medicine. 35:6 (1993), 605-610. Position the system Promote comfortable shoulder, arm, and hand postures Use a stand to support the weight of the ultrasound system.
Promote comfortable hand, wrist, and finger postures • Hold the transducer lightly in your fingers. Safety • 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. One way of taking a break is to stop and relax.
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. This does not include the transducer face.
WARNING: To avoid the risk of electrical shock, inspect cables and power cords used within the system on a regular basis for damage. To avoid the risk of electrical shock to the patient/subject, do not touch the system battery contacts while simultaneously touching a patient/subject. To prevent injury to the operator/bystander, the transducer must be removed from patient contact before the application of a high-voltage defibrillation pulse.
Equipment safety To protect your ultrasound system, transducer, and accessories, follow these precautions. Caution: Excessive bending or twisting of cables can cause a failure or intermittent operation. Improper cleaning or disinfecting of any part of the system can cause permanent damage. For cleaning and disinfecting instructions, see Chapter 5, “Troubleshooting and Maintenance.” Do not submerge the transducer connector in solution.
WARNING: Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles. Caution: To avoid the battery bursting, igniting, or emitting fumes from the battery and causing equipment damage, observe the following precautions: Do not immerse the battery in water or allow it to get wet. Do not put the battery into a microwave oven or pressurized container.
WARNING: SonoSite does not currently recommend a specific brand of acoustic standoff. If an acoustic standoff is used, it must have a minimum attentuation of .3dB/cm/MHz. Some SonoSite transducers are approved for intraoperative applications if a market-cleared sheath is used. 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.
Caution: Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. Static shock is a discharge of the electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system.
The system is intended for use in the electromagnetic environment specified below. Table 2: Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electrostatic Discharge (ESD) 2.0KV, 4.0KV, 6.0KV contact 2.0KV, 4.0KV, 6.0KV contact IEC 61000-4-2 2.0KV, 4.0KV, 8.0KV air 2.0KV, 4.0KV, 8.0KV air Electrical fast 2KV on the mains 2KV on the mains Transient burst 1KV on signal lines 1KV on signal lines 0.5KV, 1.0KV, 2.
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued) IEC 60601 Test Level Compliance Level Power Frequency Magnetic Field 3 A/m 3 A/m If image distortion occurs, it may be necessary to position the SonoSite ultrasound system further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the Intended installation location to assure that it is sufficiently low.
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued) Immunity Test Radiated RF IEC 61000-4-3 (continued) IEC 60601 Test Level Compliance Level Electromagnetic Environment Field strengths from fixed RF transmitters, as determined by an electromagnetic Site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: (IEC 60417 No.
The variables which affect the way the qualified ultrasound user implements the ALARA principle include: patient body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because the qualified ultrasound user can control it. The ability to limit the exposure over time supports the ALARA principle.
Indirect controls The controls that indirectly affect output are controls affecting imaging mode, freeze, and depth. The imaging mode determines the nature of the ultrasound beam. Tissue attenuation is directly related to transducer frequency. The higher the PRF (pulse repetition frequency), the more output pulses occur over a period of time. Receiver controls The receiver controls are the gain controls. Receiver controls do not affect output.
“↓” means to decrease or lower setting of parameter to reduce MI or TI.
Output display The system meets the AIUM output display standard for MI and TI (see last reference listed in “Related guidance documents” below). Table 5 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. Table 5: Cases Where Either a Thermal or Mechanical Index is ≥ 1.
Mechanical and thermal indices output display accuracy The accuracy result for the thermal index (TI) is stated statistically. With 90% confidence, 90% of the measured TI values will be within +26% to –50% of the displayed TI value, or +0.2 of the displayed value, whichever value is larger. The values equate to +1dB to –3dB. A displayed value of 0.0 for MI or TI means that the calculated estimate for the index is less than 0.05.
• 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.
Acoustic output measurement The acoustic output for this ultrasound system has been measured and calculated in accordance with the “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD2‐2004), and the “Standard for Real‐Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment” (NEMA UDe3‐2004). In Situ, derated, and water value intensities All intensity parameters are measured in water.
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.
Acoustic output tables Table 8 through Table 13 indicate the acoustic output for the system and transducer combinations with a thermal index or mechanical index equal to or greater than one. These tables are organized by transducer model and imaging mode. For a definition of terms used in the tables, see “Terms used in the acoustic output tables” on page 78.
Table 8: Transducer Model: C11x/8-5 Operating Mode: CPD/Color TIS Index Label M.I. Associated Acoustic Parameter Global Maximum Index Value pr.3 Other Information Non-scan Scan Aaprt≤1 Aaprt>1 (a) — — # — W0 (mW) min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) deq(zsp) (cm) fc (MHz) Dim of Aaprt PD PRF pr@PIImax X (cm) Y (cm) (μsec) (Hz) (MPa) deq@Pllmax Focal Length IPA.3@MImax Operating Control Conditions (MPa) (a) # TIB Non-scan TIC — 1.2 — 40.
Table 9: Transducer Model: C60x/5-2 Operating Mode: 2D Index Label Associated Acoustic Parameter Global Maximum Index Value pr.3 Other Information (MPa) 1.0 1.59 Non-scan Scan Aaprt≤1 Aaprt>1 (a) — — # — W0 (mW) min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) deq(zsp) (cm) fc Non-scan TIC — (b) — # — 5.3 — (MHz) # # # deq@Pllmax 2.86 X (cm) Y (cm) (μsec) 0.579 (Hz) 7923 (MPa) 2.
Table 10: Transducer Model: HFL38x/13-6 Operating Mode: CPD/Color TIS Index Label Associated Acoustic Parameter Global Maximum Index Value pr.3 Other Information (MPa) 1.1 2.556 Non-scan Aaprt≤1 Aaprt>1 1.0 — — — (b) 53.49 — — # (mW) min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) deq(zsp) (cm) fc (MHz) PD PRF pr@PIImax deq@Pllmax Focal Length IPA.
Table 11: Transducer Model: L38x/10-5 Operating Mode: CPD/Color Index Label Associated Acoustic Parameter Global Maximum Index Value pr.3 Other Information (MPa) 1.3 2.89 TIB Non-scan Scan Aaprt≤1 Aaprt>1 1.0 — 64.88 — — W0 (mW) min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) deq(zsp) (cm) fc (MHz) Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Operating Control Conditions M.I.
Table 12: Transducer Model: P21x/5-1 Operating Mode: 2D TIS Index Label Associated Acoustic Parameter Global Maximum Index Value pr.3 Other Information (MPa) 1.3 1.83 Non-scan Scan Aaprt≤1 Aaprt>1 1.1 — — 122.87 — W0 (mW) min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) deq(zsp) (cm) fc (MHz) Non-scan TIC — (b) — # — 5.1 — 1.84 1.88 0.590 1.3 — — — — — — — — — # # # deq@Pllmax X (cm) Y (cm) (μsec) 0.963 (Hz) 4421 (MPa) 2.
Table 13: Transducer Model: P21x/5-1 Operating Mode: CPD/Color Index Label M.I. Associated Acoustic Parameter Global Maximum Index Value pr.3 Other Information Non-scan Scan Aaprt≤1 Aaprt>1 1.3 — — 136.91 — W0 (mW) min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) deq(zsp) (cm) fc Non-scan TIC — (b) — # — 4.5 — (MHz) 2.16 0.918 1.3 deq@Pllmax 2.15 X (cm) Y (cm) (μsec) 1.20 (Hz) 1063 (MPa) 2.574 (cm) Focal Length FLx (cm) 3.68 — — # FLy (cm) 5.
Terms used in the acoustic output tables Table 14: Acoustic Output Terms and Definitions 78 Term Definition ISPTA.3 Derated spatial peak, temporal average intensity in units of milliwatts/cm2. 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. MI Mechanical index. Ipa.3@MImax Derated pulse average intensity at the maximum MI in units of W/cm2.
Table 14: Acoustic Output Terms and Definitions (Continued) Definition deq(z) Equivalent beam diameter as a function of axial distance z, and is equal to Safety Term ( 4 ⁄ ( π ) ) ( ( Wo ) ⁄ ( I TA ( z ) ) ) , where ITA(z) is the temporal-average intensity as a function of z in centimeters. fc Center frequency in MHz. Dim. of Aaprt Active aperture dimensions for the azimuthal (x) and elevational (y) planes in centimeters.
Table 15: Acoustic Measurement Precision and Uncertainty (Continued) Precision (% of standard deviation) Uncertainty (95% confidence) PII 3.2% +12.5 to -16.8% PII.3 3.2% +13.47 to -17.5% Quantity Labeling symbols The following symbols are used on the products, packaging, and containers.
Table 16: Labeling Symbols (Continued) Definition REF Catalog number Safety Symbol Collect separately from other household waste (see European Commission Directive 93/86/EEC). Refer to local regulations for disposal. STERILE EO Contents sterilized using ethylene oxide process. Corrugated recycle Dangerous voltage Date of manufacture Direct Current (DC) Do not get wet. Do not stack over 2 high. Do not stack over 5 high. Do not stack over 10 high.
Table 16: Labeling Symbols (Continued) Symbol Definition Fragile GEL STERILE R Gel sterilized by radiation. Hot Indoor use only Device emits a static (DC) magnetic field. Non-ionizing radiation Paper recycle SN Serial number type of control number Storage temperature conditions Submersible. Protected against the effects of temporary immersion. Water-Tight Equipment. Protected against the effects of extended immersion. Handle transducer with care.
Table 16: Labeling Symbols (Continued) Symbol Definition Safety Pollution Control Logo. (Applies to all parts/products listed in the China RoHS disclosure table. May not appear on the exterior of some parts/products because of space limitations.) China Compulsory Certificate mark (“CCC Mark”). A compulsory safety mark for compliance to Chinese national standards for many products sold in the People’s Republic of China. Contains mercury.
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Chapter 7: Specifications This chapter contains system and accessory specifications and standards. The specifications for recommended peripherals are in the manufacturers’ instructions. Supported transducers • L25x/13‐6 MHz (7.5 ft/2.3 m) • C60x/5‐2 MHz (5.5 ft/1.7 m) • L38x/10‐5 MHz (5.5 ft/1.7 m) • HFL38x/13‐6 MHz (5.6 ft/1.7 m) • P21x/5‐1 MHz(6 ft/1.8 m) Specifications • C11x/8‐5 MHz (6 ft/1.8 m) • ICTx/8‐5 MHz (5.5 ft/1.
Peripherals Peripherals include medical grade (conforming to EN60601‐1 requirements) and non‐medical grade (commercial) products. Manufacturer’s instructions accompany each peripheral. Medical grade • Black-and-white printer Recommended sources for printer paper: Contact Sony at 800-686-7669 or www.sony.com/professional to order supplies or to find the local distributor.
Electrical Power Supply Input 100‐240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC Power Supply Output #1 15 VDC, 5.0 A Max Power Supply Output #2 12 VDC, 2.3 A Max Specifications Battery The battery comprises six lithium‐ion cells plus electronics, a temperature sensor, and battery contacts. Run time is up to two hours, depending on imaging mode and display brightness. Electromechanical safety standards EN 60601‐1:1997, European Norm, Medical Electrical Equipment–Part 1. General Requirements for Safety.
The Classification for the ultrasound system, stand, accessories, and peripherals when configured together is: Group 1, Class A. Airborne equipment standards RTCA/DO‐160E:2004, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. HIPAA standard The Health Insurance and Portability and Accountability Act, Pub.L. No. 104‐191 (1996). 45 CFR 160, General Administrative Requirements.
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). The guiding principle of ultrasound use, which states that you should keep patient exposure to ultrasound energy as low as reasonably achievable for diagnostic results. curved array transducer Identified by the letter C (curved or curvilinear) and a number (60).
90 skinline A depth on the display that corresponds to the skin/transducer interface. SonoHD™ imaging technology A subset of the 2D imaging mode in which the 2D image is enhanced by reducing speckle noise artifact at tissue margins and improving contrast resolution by reducing artifacts and improving visualization of texture patterns within the image.
Abbreviations Abbreviations in User Interface Definition Abd Abdomen Bre Breast CPD Color Power Doppler Crd Cardiac MB SonoMB MI Mechanical Index Msk Musculoskeletal Nrv Nerve NTSC National Television Standards Committee OB Obstetrical S SonoHD imaging technology SmP Small Parts THI Tissue Harmonic Imaging TI Thermal Index Vas Vascular Ven Venous Glossary Abbreviation Glossary 91
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Index Numerics 2D imaging 21 A abbreviations 91 abdominal, intended uses 11 accessories list 85 acoustic measurement precision 79 acoustic output measurement 69 tables 71 terms in tables 78 acquisition error 36 add new user 15 Administrator 14 airborne equipment standards 88 ALARA principle 62, 63, 89 alphanumeric keys 7 audio 3, 18 click 9 clips length 19 See also images and clips color Doppler (Color) imaging 22 color power Doppler (CPD) imaging 22 Color.
errors acquisition 36 algorithmic 36 measurement 36 Event log 16 exam end 27 type and transducer 25 type, change 24 export Event log 16 images and clips 31 USB Devices setup 20 user accounts 16 intended uses 11 intensity derated 69 in situ 69 water-value 69 interventional, intended uses 11 F labeling symbols 80 language 19 LCD screen clean 40 output 67 license key 38 login Administrator 14 user 14 focal zones, optimize 22 freeze 23 G gain adjust 23 Auto Gain 21 grace period 38 guidance documents, relat
orientation marker 8 option 22 output display 67 P PAL definition 89 option 18 password 15, 16, 17 patient header 8, 19 patient information form 27 patient list 28 PC 18 pediatric, intended uses 12 peripherals 86 power delay 18 power key 7 precision, acoustic measurement 79 preferences 19 presets 19 pressure limits 86 print 30 print control 3 printer problem 37 setup 18 probe.
U ultrasound terminology 89 USB export 20, 31 insert or remove device 6 port 3 user accounts 16 user guide, conventions used vii user setup 15 uses, intended 11 V vascular, intended uses 12 video 3 W warnings, definition vii Z zoom 24 96 Index
P07525-01 *P07525-01*
