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• Carefully insert and withdraw electrodes to avoid
possible damage to the device and/or injury to the
patient or surgical personnel.
• Ensure that fluid inflow and outflow is adequate and
that the electrode is activated only when surrounded
by conductive irrigant solution (e.g., saline or
Ringer's Lactate). The use of RF energy with
inadequate irrigation may overheat the fluid enough
to cause skin burns at or near the access site and
may result in damage to the electrode tip assembly.
• Do not touch the electrode tip when power is being
applied.
• During an electrosurgical procedure, the patient
should not be allowed to come into direct contact
with grounded metal objects. Inadvertent contact
with the patient when the VAPR system is activated
may result in burns.
• Observe extreme caution when using electrosurgery
in close proximity to, or in direct contact with, any
metal objects. The majority of arthroscopes and
arthroscopic instruments are metal. Do not activate
the electrode while any portion of the electrode tip is
in contact with metal objects or instruments; avoid
ablating tissue that is trapped between the
arthroscope and the electrode. Doing so may result
in unintended injury to the patient or surgical
personnel and/or damage to the electrode and/or
other equipment.
• Avoid unnecessary and prolonged activation of the
electrode during and between tissue applications.
Failure to do so may result in unintended injury.
• Do not reuse any accessories labeled as SINGLE
USE. These products are for single-use only and
have not been designed to be re-used/re-sterilized.
Reprocessing may lead to changes in material
characteristics such as metallic corrosion and dulled
edges, ceramic and plastic deformation or splitting
which may impact the strength of the device and
compromise device performance. Reprocessing of
single use devices can also cause cross-
contamination leading to patient infection. These
risks may potentially affect patient safety.
• Re-sterilization by autoclave may cause hand
control shorts resulting in inadvertent activation
when the electrode is connected to the generator.
• Avoid touching the distal tip of the instrument
(ceramic insulator or metal active component) with
fingers or instruments.
• Inadvertent activation or movement of an active
VAPR electrode outside the field of vision may
result in patient injury and damage to the electrode
tip assembly.
• Using arthroscopic guidance, ensure that the
electrode is completely surrounded by conductive
irrigant solution during use. Failure to do so may
result in electrode tip damage.
• Avoid bubble accumulation in the joint space during
use. The accumulation of bubbles around the
electrode diminishes performance and may produce
overheating sufficient to damage adjacent structures
or the electrode tip assembly.
• Do not wrap handpiece, footswitch or generator
power cables around metal objects. Wrapping
cables around metal objects may induce currents
that could lead to electric shock, fire or injury to
patient and/or surgical personnel.
• Failure to attach the suction tubing to an adequate
suction source may cause thermal injury to the
physician or patient.
• DO NOT activate the probe for unnecessary and
prolonged periods as irrigant overheating and
unintended tissue damage may result. Prolonged
probe activation while using the suction feature may
result in elevated shaft or suction tubing
temperatures.
• Electrodes will wear from normal use, dependent on
factors such as length of use, high tissue removal
rate, prolonged use against bony surfaces, prolonged
use in saline, high power settings, and use with
minimal suction or fluid management. Periodically
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