Johnson & Johnson DePuy Mitek VAPR Manual Del Usuario página 3

ENGLISH
DePuy Mitek 3.5 mm VAPR
Electrode, Electrode with Integrated
Handpiece
DePuy Mitek 2.3 mm VAPR Electrode,
Electrode with Integrated Handpiece
DePuy Mitek 3.5 mm VAPR T Thermal
Electrode, Electrode with Integrated
Handpiece
DePuy Mitek 3.5 mm VAPR FLEX
Electrode, Electrode with Integrated
Handpiece
Rx Only
Instructions for Use
Please read all information carefully, in particular the
User Manual, which is provided with the DePuy Mitek
VAPR Generator prior to using the device. The various
components of the DePuy Mitek VAPR System are
designed to be used together as a single unit. Failure
to properly follow instructions may lead to electrical
or thermal injury and result in improper functioning of
the device.
Device Description
The DePuy Mitek VAPR System is designed for
arthroscopic surgical procedures. The System
consists of a high frequency electrosurgical
Generator, a reusable Handpiece with Connector
Cable, disposable Electrodes, Electrode with
integrated handpiece, and a Footswitch. The
components are designed and intended to be
operated as a single unit. Use only DePuy Mitek
VAPR Electrodes and accessories with the DePuy
Mitek VAPR System.
WARNINGS
• Do not touch the electrode tip when power is
being applied.
• Do not insert or withdraw the Electrode while
power is being applied.
• Inadvertent activation or movement of the
Electrode outside the field of vision may result in
patient injury.
• Avoid unnecessary and prolonged activation
between tissue applications as unintended injury
may result.
• Avoid bubble accumulation in the joint space
during use. The accumulation of bubbles around
the working tip of the Electrode will diminish
performance and may produce overheating
sufficient to damage adjacent structures.
• Do not reuse any accessories labeled as
SINGLE USE.
• Using arthroscopic guidance, ensure that the
Electrode tip is completely surrounded by
conductive irrigant solution during use.
• When bending the FLEX Electrode, do not exceed
a 45° angle with the plane of the shaft.
• Do not change the FLEX Electrode shape more
than three times at the same point on the shaft.
More than three angle modifications can result in
electrode fracture.
• Use of instruments to bend the electrodes can
cause damage to the FLEX Electrode. Electrodes
should only be bent using fingers.
• Avoid touching the ceramic and active tip of the
electrode with your fingers or instruments.
• Attempts to bend non-FLEX 3.5 mm Electrodes
can result in electrode fracture.
• Due to low joint-space volume in smaller joints,
such as the wrist, it may be necessary to manually
lower the power settings or increase the flow
through the joint in order to maintain adequate
inter-joint cooling.
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