Chapter 2: Safety
9
2.3
Biological Safety
Observe the following precautions related to biological safety.
WARNINGS:
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To prevent misdiagnosis, do not use the ECG trace to diagnosis cardiac rhythms.
The SonoSite ECG option is a non-diagnostic feature.
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To prevent injury, only use market cleared ECG electrodes and cables.
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Non-medical (commercial) grade peripheral monitors have not been verified or
validated by SonoSite as being suitable for diagnosis.
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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.
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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 covers contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to the FDA Medical Alert, March 29,
1991.
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Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably
achievable) principle.
`
SonoSite does not currently recommend a specific brand of acoustic standoff.
2.4
Labeling Symbols
Labeling symbols for SonoSite products can be found in the user guide for each
product.
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