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Safety and Care
Intended Use
WARNING: The analysis of results from an ultrasound examination requires that you are
trained in the interpretation of diagnostic ultrasound studies and are qualified to make
clinical diagnoses.
Prescription Device Statement: In the United States of America, federal law restricts this device
to sale or use by, or on the order of, a physician.
The
Freestyle ultrasound system supports the applications listed in this
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section .
WARNING: The
studies.
WARNING: No claim is made regarding the safety or efficacy of ultrasound contrast
agents. It is important that you carefully follow the indications, instructions for use,
warning, and cautions that are provided by ultrasound contrast agent manufacturers as
part of the product labeling.
WARNING: Cardiac rhythm disturbances during perfusion studies using gas ultrasound
contrast agents have been observed in the diagnostic range of mechanical index (MI)
values. See the specific package insert for the contrast agent being used for details.
CAUTION: In performing fetal ultrasound studies, it is important to consult consensus
statements and health care organization guidelines for the use of ultrasound imaging in
pregnancy. Reference: Diagnostic Ultrasound Imaging in Pregnancy. NIH Consensus
Statement 1984 Feb 6-8;5(1):1-16
WARNING: Use sterile, endotoxin-free sheaths in intraoperative neurological scanning.
Disinfectant/sterilant residue left on the probe is neurotoxic and endotoxin is pyrogenic.
WARNING: Probe sheaths cannot be relied upon to prevent contamination of the probe
when used intraoperatively on patients with known or suspected Creutzfeld-Jakob disease
(CJD). A probe exposed to central nervous system tissue from know or suspected CJD or
Variant CJD should be destroyed since it may not be possible to sterilize. (See http://www.
cdc.gov/ncidod/qa_cid_infection_control.htm)
2-6
Freestyle ultrasound system is not intended for ophthalmic
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Freestyle User Manual
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