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Operation Manual
Biological Safety
For safety information on the probe and biopsy, refer to ‘Chapter 9. Probes’.
WARNING:
X
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
X
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 Samsung Medison customer support department.
X
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.
X
The system limits the maximum contact temperature to 43 degree Celsius, and the ultrasonic
waves output observes American FDA regulations.
ALARA Principle
Performing diagnoses using an ultrasound device is dened by the “As Low As Reasonably Achievable”
(ALARA) principle. The decision as to what is reasonable has been considered and dened by many
people. However, no set of rules can be formulated that would be suciently 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 bioeects.
Since the threshold for diagnostic ultrasound bioeects 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 role in putting the ALARA
principle into eect.
Numerous variables aect the output data that forms the basis of the provided information. These
variables include mass, body size, location of the bone relative to the focal point, attenuation in the
body, and ultrasound exposure time. Among these, exposure time is the variable that one must pay the
most attention to. For, unlike other variables, exposure time is entirely controlled by the operator of the
ultrasound system.
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