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ROCAMED SIRIUS - 2.13 Labelling Plan

ROCAMED SIRIUS
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15
DGM001519.01 UM Sirius CE/ROTW
Emission of toxic gas or vapor
The radiation of this LASER device is able to melt, burn or vaporize almost all materials. Vapors or emitted gases
resulting from laser operation may be dangerous to both patient and medical personnel in the surgical area.
The use of this LASER device is limited to the applications specified in this manual.
Safety features for the electromagnetic compatibility (EMC)
The Sirius device does not include any type of direct connection with other external devices.
The Sirius device can be disturbed by the interference with external electromagnetic fields generated by other
electrical devices installed near it.
Warning: Turn off mobile phones and similar devices while operating the device.
This Sirius device must be installed and used according to EMC information described in the tables reported in
Appendix B.
Warning and instructions for the device disposal
At the end of its lifetime, the device has to be handled according to the National or Local regulations for the
disposal of waste electrical and electronic equipment.
The device is subject to national standards which regulates the disposal of waste such as electrical equipment.
It is forbidden to dispose of the device as municipal waste, instead it has to be collected separately according to
the WEEE Directive (Waste Electrical and Electronic Equipment).
The penalties for violating law requirements are severe.
Labelling plan
Label 1
Laser characteristics
Label 2
Footswitch connector label
Label 3
Emergency laser off label according to
IEC 60601-2-22
Label 4
ON and OFF label

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