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Philips iU22 - FDA Medical Alert on Latex

Philips iU22
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Wilde, A.A. "Premature ventricular contractions during triggered imaging
with ultrasound contrast." Journal of the American Society of Echocardiography,
2000;13(4):288-94.
Preventricular contractions can be caused by the oscillations of microbubbles
when a high-MI acoustic field is triggered in the heart at the end of systole.
In a very sick patient with certain risk factors, theoretically, this could lead
to ventricular fibrillation. Reference: van Der Wouw, P.A., Brauns, A.C.,
Bailey, S.E., Powers, J.E., Wilde, A.A. "Premature ventricular contractions
during triggered imaging with ultrasound contrast." Journal of the American
Society of Echocardiography, 2000;13(4):288-94.
If a sterile transducer cover becomes compromised during an intraoperative
application involving a patient with transmissible spongiform encephalopathy,
such as Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Centers
for Disease Control and this document from the World Health Organization:
WHO/CDS/ APH/2000/3, WHO Infection Control Guidelines for
Transmissible Spongiform Encephalopathies. The transducers for your
system cannot be decontaminated using a heat process.
If the system becomes contaminated internally with bodily fluids carrying
pathogens, you must immediately notify your Philips service representative.
Components inside the system cannot be disinfected. In that case, the
system must be disposed of as biohazardous material in accordance with
local or federal laws.
The backlight lamps in the system displays contain mercury and must be
recycled or disposed of according to local, state, or federal laws.
Select the correct application when starting an exam, and remain in that
application throughout the exam. Some applications are for parts of the
body that require lower limits for acoustic output. One example is the
ophthalmic application, which is activated by selecting a Tissue Specific
preset such as Orbital TCD. When performing an ophthalmic exam, use
only an ophthalmic preset.
FDA Medical Alert on Latex
March 29, 1991, Allergic Reactions to Latex-Containing Medical Devices
45
iU22 User Manual
4535 614 45861
2
Safety

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