8 Chapter 2: Safety
Biological Safety
Observe the following precautions related to biological safety.
Labeling Symbols
Labeling symbols for SonoSite products can be found in the user guide for each product.
WARNING:
Non-medical (commercial) grade peripheral monitors have not been verified or validated by
SonoSite as being suitable for diagnosis.
Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in the
scanning sequence are indicative of a hardware failure that must be corrected before use.
Do not use the system if it exhibits artifacts on the LCD screen, either within the clinical image or
in the area outside of the clinical image. Artifacts are indicative of hardware and/or software
errors that must be corrected before use.
Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions
in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber.
Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable)
principle and follow the prudent use information concerning MI and TI.
SonoSite does not currently recommend a specific brand of acoustic standoff. If an acoustic
standoff is used, it must have a minimum attentuation of .3dB/cm/MHz.
Some SonoSite transducers are approved for intraoperative applications if a market-cleared
sheath is used.
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