Johnson & Johnson DePuy Mitek 2.3 mm VAPR, Instructions For Use Manual

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CAUTIONS
• Use only conductive irrigant solution (e.g., saline
or Ringer’s lactate). Do not use non-conductive
irrigants (e.g., sterile water, air, gas, glycine, etc.)
• Ensure that the Electrode is fully seated in the
Handpiece prior to use. (Note: Not applicable on
Electrodes with integrated cable.)
• Avoid fluid contact with the proximal end of
the Electrode/Handpiece interface. (Note: Not
applicable on Electrodes with integrated cable.)
• Place accessories in a clean, dry, nonconductive
and highly visible area away from the patient when
not in use. Inadvertent contact with the patient
may result in burns. Contact with drapes or other
flammable materials may cause fire.
• Do not wrap the Handpiece/Electrode cable
around metal objects. Wrapping the cable around
metal objects may induce currents that could
lead to shock, fires, or injury to the patient or
surgical personnel.
• During arthroscopic procedures be alert to these
potential hazards:
• As with all electrosurgical devices, do not use
in the presence of flammable anesthetics or
oxidizing gases, such as nitrous oxide or oxygen.
An electrosurgical device has the potential for
providing a source for ignition. Endogenous gases
which accumulate in body cavities can also be a
source of ignition.
• The Electrode tip may remain hot enough to
cause burns after the electrosurgical current
is deactivated.
• Do not activate the Electrode while in contact
with metal objects and instruments as unintended
tissue injury may occur.
• Carefully insert and withdraw Electrodes to avoid
possible damage to the devices and/or injury to
the patient or surgical personnel.
• The patient should not be allowed to come in
contact with grounded metal objects.
• Prior to initial use, ensure that all package inserts
including warnings, cautions, and Instructions
for Use are read and understood. Safe and
effective electrosurgery is dependent not only on
equipment design, but also on factors under the
control of the user. (Refer to User Manual.)
• Excessive force may damage the electrode
tip assembly.
IMPORTANT:
This package insert is designed to
provide instructions for use of the DePuy Mitek VAPR
System for Arthroscopic Use. It is not a reference to
electrosurgical technique.
Indications
The DePuy Mitek VAPR Electrosurgical System, when
used with a VAPR Electrode or VAPR FLEX Electrode,
is intended for resection, ablation, excision of soft
tissue, hemostasis of blood vessels and coagulation
of soft tissues in patients requiring arthroscopic
surgery of the knee, shoulder, ankle, elbow and wrist.
The DePuy Mitek VAPR Electrosurgical System, when
used with a VAPR T Thermal Electrode, is intended
for coagulation of soft tissues in patients requiring
arthroscopic surgery of the knee, shoulder, ankle,
elbow and wrist.
Contraindications
The DePuy Mitek VAPR System is contraindicated
in any non-arthroscopic surgical procedure and
in procedures where saline or Ringer’s lactate is
not used as an irrigant. The System is also not
appropriate for patients for whom an arthroscopic
procedure is contraindicated for any reason. Use of
the System is also contraindicated in patients with
heart pacemakers or other electronic device implants.
Instructions for Use
• Read all instructions carefully. Failure to properly
follow instructions may lead to electrical or
thermal injury and cause improper functioning
of the device.
• The operator should be experienced in
arthroscopic surgical techniques.