Safety and Regulatory Information
2-6
NeoGraft 2.0® User Manual
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A patient history should be completed prior to treatment to
ensure that no complications could arise. It is important to
verify that the patient does not fall under the exclusion criteria.
•
The product should not be in contact with other equipment.
•
For patients with cardiac pacemakers or other active implants, a
possible hazard exists because interference with the action of
the pacemakers may occur, or the pacemaker may be damaged.
In case of doubt, approved qualification advice should be
obtained.
•
The patient should be fully informed of the treatment protocol
and the expected results, and should sign the informed consent
form prior to beginning of the treatments.
•
Grafts donor and receiver site belongs to the SAME patient.
•
Only authorized persons are allowed to stand near the system
during the treatment.
•
Stop the treatment in case of unexpected changes in the patient's
condition.
•
Do not drop the handpieces. If a handpiece is dropped, turn off
the system immediately. Do not use a broken handpiece and call
the local service representative.
•
There are no user-serviceable parts inside the system. ONLY
VENUS CONCEPT PERSONNEL MAY SERVICE THE
SYSTEM, ESPECIALLY INSIDE ITS CABINET.