User guide

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Immunity testing requirements
The Edge 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 Edge 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 1: Labeling Symbols
Symbol Definition
Alternating Current (AC)

Class 1 device indicating manufacturer’s declaration of conformance with
Annex VII of 93/42/EEC

0086
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
Follow instructions for use.
Device complies with relevant Australian regulations for electronic devices.
Batch code, date code, or lot code type of control number
LOT