Labeling Symbols - FujiFilm SonoSite Edge II User Manual

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FCC Caution: Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause undesired
operation.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause undesired
operation.
Immunity testing requirements
The SonoSite Edge II ultrasound system complies with the essential performance requirements specified in
IEC 60601-1-2 and IEC 60601-2-37. Results of immunity testing show that the SonoSite Edge II ultrasound
system meets these requirements and is free from the following:
Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value that
cannot be attributed to a physiological effect and that may alter the diagnosis
Display of incorrect numerical values associated with the diagnosis to be performed
Display of incorrect safety related indications
Production of unintended or excessive ultrasound output
Production of unintended or excessive transducer assembly surface temperature
Production of unintended or uncontrolled motion of transducer assemblies intended for intra-corporeal
use

Labeling symbols

The following symbols are used on the products, packaging, and containers.
Table 9-5: Labeling symbols
Symbol
Definition
Follow instructions for use.
Safety
9-21

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