Medical Ultrasound Imaging
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Class I, II, III Devices
Classification by the Food and Drug Administration of medical devices according to potential risks like e.g. ultrasonic heating. The US FDA 510k document provides guidance in the preparation of a regulatory submission to prevent hazards.
Handheld Ultrasound
Handheld ultrasound systems are portable devices for smartphone or tablet and are increasingly common in emergency, intensive care and veterinary medicine, but also in the pocket of the stationary doctor. This type of ultrasound machine enables immediate diagnoses directly on site (handheld point-of-care-ultrasound / HPOCUS) and quickly provide information regarding the patient's further care. Handheld ultrasound machines fit into a single-use plastic cover and can be easily disinfected, making them particularly useful in infectious environments.
The most striking advantage of handheld POCUS devices is the small footprint. The design is very compact, lightweight (approx. 200 g/0,44 lbs. - 500 g/1,1 lbs) and flexible. Due to this compactness and the necessary technical compression, the quality of the imaging is still limited compared to 'high-end devices', but sufficient to the extent that handheld ultrasound devices are already successfully used in many medical disciplines.
Depending on the model, handheld ultrasound systems run on Android, iOS, Windows or proprietary operating systems. They are connected to the end device via USB cable or wirelessly via Bluetooth or WiFi. The respective end device is used as an ultrasound monitor to display the ultrasound images. The associated app is operated via touchscreen, although some devices have a few buttons, e.g. for recording ultrasound images or freeze images. The images can be stored and managed on the end device itself, the inserted memory card or in the cloud. Theoretically, also a private smartphone can be connected, but this can lead to complications with reimbursement.
See also Portable Ultrasound Machine, Ultrasound Technology, Environmental Protection, Ultrasound Accessories and Supplies and Sonographer.
Portable Ultrasound Machine
Ultrasound technology has evolved significantly, providing sonographers with a wide range of ultrasound machines. As technology has advanced, portable ultrasound equipment, including handheld ultrasound systems, have emerged in the field of medical imaging. However, these devices may have limited imaging capabilities and reduced image quality compared to larger systems.
Types of ultrasound systems compiled according to their portability:
Handheld Ultrasound Devices:
Handheld ultrasound devices are compact, lightweight, and easily maneuverable. They offer convenience and point-of-care imaging capabilities, making them ideal for emergency medicine, primary care, and remote settings. Pros include portability, rapid assessments, and ease of use. However, these devices may have limited imaging capabilities and reduced image quality compared to larger systems.
Laptop-Based Ultrasound Scanner:
Laptop-based ultrasound machines combine portability with a larger display and enhanced imaging capabilities. They are versatile and suitable for various applications, including primary care, obstetrics, and musculoskeletal imaging. These machines provide good image quality, a user-friendly interface, and improved storage capacity. However, they may still be bulkier and less portable than handheld devices.
Console-Based Ultrasound Systems: Console-based ultrasound machines are larger, stationary systems commonly found in hospitals and specialized imaging centers. They offer comprehensive imaging capabilities, advanced features, and excellent image quality. These machines are suitable for a wide range of specialties and can perform complex examinations. Pros include high image resolution, advanced imaging modes, and comprehensive data management. However, they lack the portability and immediate accessibility of handheld or laptop-based devices.
Cart-Based Ultrasound Machines:
Cart-based ultrasound machines strike a balance between portability and advanced imaging capabilities. They consist of a console unit mounted on a mobile cart. These machines are commonly used in hospitals, clinics, and larger healthcare facilities. They provide excellent image quality, a wide range of imaging options, and ergonomic considerations. While less portable than handheld or laptop-based devices, cart-based machines offer enhanced functionality and versatility.


In summary, pros and cons of portable ultrasound machines:
Pros:
Compact portable ultrasound machines eliminate transfers and reduce wait times, improving patient comfort. Scans at the bedside minimize discomfort and anxiety while optimizing workflow efficiency. Sonographers can quickly assess patients and detect abnormalities. Real-time examinations provide immediate visualization, procedural guidance, and support for critical decision-making especially in emergency, critical care, and resource-limited settings.
Cons:
Portable ultrasound machines may have restricted features and imaging modes compared to larger systems, potentially affecting diagnostic quality and detail. The compact size can lead to compromises in image resolution and overall quality due to factors like lower power output and smaller transducers.The small displays and simplified controls of portable systems may pose challenges for sonographers, potentially impacting workflow efficiency and user fatigue. Portable ultrasound machines often come with a higher price tag, requiring careful evaluation of cost versus expected benefits and specific practice needs.

See also Ultrasound Accessories and Supplies, Environmental Protection, Sonographer, Ultrasound Technology and Equipment Preparation.
Ultrasound Machine
Ultrasound machines, widely used in medical imaging, are essential tools in the field of diagnostic ultrasound. These devices utilize high-frequency sound waves to create real-time images of internal body structures. Ultrasound machines consist of several key components that work together to generate diagnostic images. These include:
The transducer is a handheld device that emits and receives sound waves. It converts electrical energy into sound waves and captures the returning echoes to create images.
The control panel houses the interface where the sonographer adjusts imaging parameters such as depth, frequency, and gain. It allows for customization of imaging settings based on the clinical requirements. The transducer pulse controls change the amplitude, frequency and duration of the pulses emitted from the transducer probe.
The central processing unit (CPU) serves as the brain of the ultrasound machine, processing the acquired data and transforming it into images. It handles complex calculations, image optimization, data storage and contains the electrical power supplies for itself and the transducer probe.
The display monitor (oscilloscope, tablet, computer monitor, etc.) showcases the real-time ultrasound images produced by the machine. It provides visual feedback to the sonographer, aiding in the interpretation and analysis of anatomical structures. Handheld ultrasound devices and mobile ultrasound probes can be connected wirelessly to a smartphone or tablet via Bluetooth or WiFi. These end device serves then as the ultrasound monitor.
Data input and measurements are done with the keyboard cursor (trackball). Ultrasound devices used for handheld point of care ultrasound (HPOCUS) are operated via the touch screen of the control panel.
Images are captured, reviewed, stored and transmitted digitally, using a standard format for digital imaging and communications in medicine (DICOM). Disk storage devices (FDD, HDD, CD, DVD) are outdated, but may be used in older machines to store the acquired images if no picture archiving and communication system (PACS) connection is possible.
The displayed ultrasound pictures are usually digitally stored in a PACS. The images from portable ultrasound machines can be stored and conveniently managed on the end device itself, the inserted memory card or in the cloud. With a QR scanner, the images can be accessed via the Internet in the cloud. Often there is also the possibility to get a picture of a baby sonography as a printout.

B-mode machines represent the vast majority of machines used in echocardiology, obstetrical scans, abdominal scans, gynecological scans, etc. B-mode ultrasound machines usually produce the sector (or pie segment-shaped) scans. These ultrasound scans require either a mechanical scanner transducer (the transducer moves to produce the sector scan), or a linear array transducer operated as a phased array.


Ultrasound machines come in different types, each catering to specific clinical needs. The two primary types are stationary and portable ultrasound machines:

Stationary units are typically larger in size and are installed in dedicated imaging rooms. These machines offer advanced imaging capabilities and a wide range of specialized features. They are commonly found in hospitals, clinics, and university medical centers where comprehensive imaging services are provided.
Portable units (see Portable Ultrasound Machine), as the name suggests, are compact and lightweight, designed for on-the-go imaging. These machines are highly versatile and offer excellent mobility, allowing healthcare professionals to bring the ultrasound system directly to the patient's bedside. Portable ultrasound machines are particularly useful in emergency settings, rural healthcare facilities, and point-of-care applications.

See also Handheld Ultrasound, Ultrasound System Performance, Equipment Preparation, Coaxial Cable, and Microbubble Scanner Modification, Environmental Protection and Ultrasound Accessories and Supplies.
Filter
A filter in electronics is a circuit that only passes certain signals. In ultrasound is a filter a device to suppress acoustic or electromagnetic waves of certain frequencies, letting other frequencies pass, e.g. high pass filter, low pass filter. The high pass filter is the wall filter (also called thump filter) used in Doppler devices to eliminate low frequency Doppler shifts caused by clutter. For blood flow measurement, a low pass filter is often used to strip out high frequency noise, leaving only the biological components of interest. Frame averaging is a form of a low pass filter.
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