Chapter 2. Safety 2 - 23
Biological Safety
For safety information on the probe and biopsy, refer to 'Chapter 5. Probes'.
WARNING
■ Ultrasound waves may have damaging effects on cells, and
therefore may be harmful to the patient. If there is no medical
benefit, minimize the exposure time and maintain a low
ultrasound wave output level. Please refer to the ALARA
principle.
■ Do not use the product if an error message or a warning
message about a dangerous situation is displayed on the
screen. Write down the message displayed on the screen, turn
the power off, and contact the service department of Samsung
Medison.
■ Do not use a system that exhibits erratic or inconsistent
behavior. Discontinuities in the scanning sequence are an
indication of a hardware failure that must be repaired before
use.
■ The system limits the maximum contact temperature to 43℃,
and the ultrasonic waves output observes American FDA
regulations.
ALARA Principle
Performing diagnoses using an ultrasound device is defined by the “As Low As Reasonably
Achievable” (ALARA) principle. The decision as to what is reasonable has been considered and
defined by many people. However, no set of rules can be formulated that would be sufficiently
complete to dictate the correct response for every circumstance. By keeping ultrasound
exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic
bioeffects.
Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s
responsibility to control the total energy transmitted into the patient. The sonographer must
reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and
limit exposure time, the ultrasound system provides controls that can be manipulated during the
exam to optimize the results of the exam.
The user's knowledge of, and the ability to abide by, the ALARA principle is very important.
Advances in diagnostic ultrasound, not only in the technology, but also in the applications of the
technology, have resulted in the need for more and better information to guide the user. This
important information is based on a variety of ultrasound output data, and plays an important
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