Labeling Symbols - FujiFilm SonoSite X-Porte User Manual

Immunity testing requirements
TheSonoSite X-Porte 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 X-Porte 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 intracorporeal use

Labeling Symbols

The following symbols are used on the products, packaging, and containers.
Table 9-5: Labeling Symbols
Symbol
Safety
Definition
Alternating Current (AC)
Class 1 device indicating manufacturer's declaration of conformance with Annex
VII of 93/42/EEC
Class 1 device requiring verification by the Notified Body of sterilization or
measurement features, or to a Class IIa, IIb, or III device requiring verification or
auditing by the Notified Body to applicable Annex(es) of 93/42/EEC
Attention, see the user guide
Reading the accompanying documentation is necessary for safe operation of the
medical device.
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