
User Manual
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Biological Safety
Verify the alignment of the biopsy guide before use. See the “Chapter 9. Probes” section of this manual.
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 the ultrasound
wave output level at low. Please refer to the ALARA principle.
X
Do not use the system if an error message appears on the video display indicating that a
hazardous condition exists. Note the error code, turn off the power to the system, and call your
local Samsung Medison Customer Service Department.
X
Do not use a system that exhibits erratic or inconsistent updating. Discontinuities in the scanning
sequence are indicative of a hardware failure that should be corrected 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
Guidance for the use of diagnostic ultrasound is dened by the “as low as reasonably achievable” (ALARA)
principle. The decision as to what is reasonable has been left to the judgment and insight of qualified
personnel. 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 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 ability of the user to abide by the ALARA principle is 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. The output indices are designed to provide that important information
There are a number of variables, which aect the way in which the output display indices can be used to
implement the ALARA principle. These variables include mass, 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 user controls it. The ability to limit the index values over time support the ALARA
principle.
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