Siemens ACUSON Freestyle, User Manual, Page: 30 / 138

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ACUSON
Freestyle User Manual
Safety and Care
Biohazard Considerations
WARNING: Siemens makes every effort to manufacture safe and effective probes. You
must take all necessary precautions to eliminate the possibility of exposing patients,
operators, or third parties to hazardous or infectious materials. These precautions should
be considered in the use of any application that may indicate the need for such care, for
example, when scanning patients with open wounds.
WARNING: To eliminate the possibility of exposing patients, operators, or third parties
to hazardous or infectious materials, always dispose hazardous or infectious materials
according to local, state, and regional regulations.
WARNING: Probe Sheaths: There have been reports of severe allergic reactions to
medical devices containing latex (natural rubber). Health care professionals are advised
to identify latex sensitive patients and to be prepared to treat allergic reactions promptly.
For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1.
WARNING: Ultrasound energy is transmitted more effectively through water than through
tissue. When using a standoff device of any kind, for example, a waterpath or gel pad, the
actual mechanical and thermal indices, MI and/or TI, may be higher than indicated in the
output display on the ultrasound system.
The assessment of the biological effects of diagnostic ultrasound on humans is a subject of
ongoing scientific research. This ultrasound system, and all diagnostic ultrasound procedures,
should be used for valid reasons, for the shortest possible period of time, and at the lowest
mechanical and thermal indices necessary to produce clinically acceptable images.
According to the principles of ALARA (As Low As Reasonably Achievable), the acoustic output
should be the lowest level required to satisfactorily perform the examination .
The ultrasound imaging system complies with the standards of the American Institute of
Ultrasound in Medicine (AIUM) and the National Electrical Manufacturers Association (NEMA),
the guidelines of the United States Food and Drug Administration (FDA) and the standards
of the International Electrotechnical Commission (IEC) in terms of safety and acoustic output
levels. The ultrasound output levels are stated to permit the user to critically evaluate the
ultrasound system settings in the event of new research findings being announced.