Biohazard Considerations - Siemens ACUSON Antares Instructions For Use Manual

Biohazard Considerations

WARNING: This equipment is not suitable for intracardiac use or direct cardiac
contact.
WARNING: For neonatal head imaging, Siemens recommends that you
exercise special care during neonatal cephalic scanning to avoid possible
damage to the posterior region of the eye. The ultrasound energy emitted by the
transducer easily penetrates the fontanels of the infant.
WARNING: Siemens makes every effort to manufacture safe and effective
transducers. 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, and during endocavity or intraoperative
scanning; during biopsy or puncture procedures; or when scanning patients with
open wounds.
WARNING: Transducer Covers: 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
perform the examination
The ultrasound imaging system complies with the standards of the
American Institute of Ultrasound in Medicine (AIUM) and the National
Electrical Manufacturer's 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.
[ 1 ] I N S T R U C T I O N S F O R
lowest level required to satisfactorily
.
U S E
2 S a f e t y a n d C a r e
System Reference
Acoustic Output Ch 1
2 - 1 1