Evaluation: Esaote MyLab Twice Premium General-Purpose Ultrasound Scanner

November 16, 2016 | Evaluations & Guidance

Preview

  • Diagnostic ultrasound scanners are used to obtain images and other data that are used to assess patient anatomy and physiology. These devices are also used to provide guidance for interventional procedures.
  • Premium general-purpose ultrasound scanners are used to obtain high-quality ultrasound data and allow users to perform advanced imaging assessments.
  • There are no supplementary uses of these devices.
  • The major components of the MyLab Twice and their functions are:
    • A console on wheels
      • The console contains a computer that controls the ultrasound signal generator, receiver, and processor using Esaote's eHD technology.
      • Imaging modes and features that are included as standard: Conventional and harmonic B-mode imaging, M-mode, pulsed-wave (PW) Doppler, continuous-wave (CW) Doppler, color Doppler imaging (CDI), power Doppler imaging (PDI), tissue velocity mapping.
      • The console top is designed to accommodate peripheral devices such as a printer or digital video recorder.
    • A control panel user interface
      • Used to select transducers, presets, and imaging modes; adjust image quality; obtain measurements; annotate images; and perform calculations.
      • The user interface is position-adjustable and has various hard controls, including buttons, slide pods, knobs, a trackball, and an alphanumeric keyboard. The controls available and their locations are customizable. There is also a customizable 30.5 cm (12 in) touchscreen that can be tipped down during transport. Handles are used to position the control panel during exams and for transport. Transducers and gel-bottle holders can be connected to the main panel.
    • A 48.3 cm (19 in) flat-panel video display
      • Used to view ultrasound images and other data
      • Attached to the scanner on an articulated arm to allow users to position it for optimal viewing during exams
    • Five transducer ports located on the lower front of the console
      • Used to connect transducers.
      • One port is only for CW Doppler transducers.
    • A recess with a spring-loaded plastic door for accessories
      • Used to store accessories
      • Located on the left side of the console
    • Internal digital storage
      • Used to archive acquired data and support software applications.
      • A 500 GB hard drive is located in the console.
    • Access ports
      • Allow data to be exported for archiving or review and imported for fusion imaging and review
      • Has four USB ports, one composite video connector, one S-video connector, one serial RS-232 port, one XVGA port, one LAN RJ45 port, and audio jacks.
  • Facilities and clinical departments that would use this device:
    • Radiology department
    • Freestanding imaging facility
  • Optional components and software features:
    • Application-specific transducers (see the Transducers Supported by the MyLab Twice table below)
      • Transmit the ultrasound beam into the patient's body and receive the returning echoes for data acquisition, processing, and display.
      • Transducers consist of a handheld probe on a cable with a connector to attach it to the scanner.
    • MyLabSat portable ultrasound scanner
      • The MyLabSat offers most of the functionality of the MyLab Twice, but it can be hand-carried for easy transport and use at the point of care.
      • The MyLab Twice is equipped with a docking station on its side to store the MyLabSat and recharge its battery. Data from the MyLabSat can be transferred to the MyLab Twice for archiving, analysis, and transfer to a PACS. The MyLabSat scanner was not provided to ECRI Institute for our Evaluation.
    • Optional components and software features, including Digital Imaging and Communications in Medicine (DICOM) capability, automatic gain, extended field of view, panoramic imaging, trapezoidal view, panoramic 3-D, radio-frequency (RF) Data Management, PPSF (postprocessing of archived images and clips), and MyLabRemote
      • Specialized software allows additional imaging capabilities, plus workflow and security enhancements.
      • Software is required for each capability or feature.
    • Optional application-specific calculation, analysis, and reporting packages, including elastography, cardiac, obstetric, gynecology/fertility, vascular, adult cephalic, pediatric, and urology
      • Provide the ability to perform measurements and calculations to enhance diagnosis and improve workflow.
      • Software is required for each application.
    • ElaXto elastography
      • Used to assess tissue stiffness, enhance tumor characterization, and improve diagnosis.
      • Strain imaging is available on select transducers (see the table below). ElaXto software is required.
    • Virtual Navigator fusion imaging
      • Combines previously acquired computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT data with real-time ultrasound imaging to enhance diagnosis, monitoring, and therapy.
      • Hardware includes an electromagnetic field generator and sensors that attach to transducers to allow tracking of the transducer's spatial position during the exam. Fiducials that are placed on the patient during the CT, MRI, or PET/CT exam enhance the data registration process. Virtual Navigator software is available in three configurations: Basic, Advanced, or Extended.
    • Needle navigation (Needle Tracking; requires Extended Virtual Navigation option)
      • Uses fusion imaging technology, which is described above, to guide placement of needles and other interventional devices for diagnostic biopsies and therapeutic procedures such as RF ablation, fluid drainage, and injections.
      • Hardware includes reusable clips that attach to conventional (third-party) needles. Consumables include specialized needles that have sensors at the tip. Extended Virtual Navigation software is required.
    • Contrast Tuned Imaging (CnTI) contrast-enhanced ultrasound (CEUS)
      • Improves the use of ultrasound contrast agents to enhance diagnosis.
      • Contrast-enhanced imaging is supported on select transducers (see the table below). CnTI software is required.
    • 3-D/4-D imaging
      • Allows acquisition of static (3-D) or live (4-D) volume data to enhance the display of anatomical and physiologic information and aid diagnosis
      • Supported on volume transducers (see the table) and requires 3-D/4-D software
    • CD/DVD drive
      • Allows data to be copied to removable media and allows data to be imported into the scanner for fusion imaging applications.
      • The slot drive is located on the control panel behind the touchscreen.
    • Two-pedal footswitch
      • Can be used to activate commonly used controls, such as freeze/unfreeze, and to store a digital image to facilitate the exam process. A footswitch is also useful when the user is not within reach of the scanner and for interventional procedures.
      • The footswitch is connected to the scanner via a cable and placed in proximity to the user.

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