3.5 NOTES FOR THE OPERATOR
• Use the Medical Device only for the intended purpose, as
described.
• Comply with the legal regulations regarding market
surveillance and obligatory reporting applicable in the
respective country, as well as any further regulations
and standards.
User qualification
• Please familiarize yourself with the contents of the user
manual before starting the device. Please note the
instructions for use of the other equipment as well.
• Before using the device, all medical staff must have
read and understood all the instructions in this user
manual.
• Keep the user manual in a place that is easy to access
at any time by the staff using the Medical Device.
• The Medical Device must be used only by qualified
medical personnel, aware of the possible risks due
to the use of this device and who have received
complete and adequate training for the prevention
and management of any clinical complications.
• The Medical Device should only be used by a staff
who has received adequate training and
instructions. It is the duty of the customer or
institution to instruct and train all personnel who
will use it.
• It is essential to have adequate training to install and use
R-Evo Smart devices correctly, this training is offered by
OPTIKON 2000 S.p.A. Contact the OPTIKON 2000 S.p.A.
local service centre for more information.
Transport
CAUTION Risk of injury to the patient's eye!
The Medical Device has been packaged in such a way as to
minimize the risk of damage during transport.
• In case you should observe any damage due to
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