5
Instructions for Use
Copyright © 2020
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Version
Date
5 / 33
Fiagon GmbH
DOC-19-00169 2
08-2020
EN / US
Explanation of Symbols
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To ensure safety, follow the instructions for use
Marking of conformity to the European Medical Device Directive 93/42/EEC (MDD).
MR UNSAFE. The system must not be used in a Magnetic Resonance Environment. It contains
ferromagnetic parts and poses a clear threat to persons and equipment in the magnetic room.
Caution: Consult instructions for use. Follow the supporting documentation
Recommended storage tempe15°C to +35°C
Applied part type BF
This is the general warning sign. It is used to alert the user to potential hazards. All safety
messages that follow this sign shall be obeyed to avoid possible harm
The device is delivered non-sterile
Devices that include RF transmitters or that apply RF electromagnetic energy for diagnosis or
treatment. Portable and mobile RF communications equipment can affect the performance of
the device. Interference may occur in the vicinity of equipment marked with this symbol.
The device must not be opened and repairing must only be done by qualified personal.
Alternating current (AC)
Protective earth (PE)
Federal law (USA) restricts this device to sale by or on the order of a physician.
Consult instructions for use