Johnson & Johnson DePuy Synthes VAPR 90 225028 Manual Del Usuario página 2

ENGLISH
VAPR TRIPOLAR 90 SUCTION Electrode
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INSTRUCTIONS FOR USE
Please read all information carefully prior to use, with particular attention to The User Manual
provided with the VAPR VUE
System are designed for use as a single system. Failure to follow instructions may lead to improper
functioning of the device and cause electrical or thermal injury.
SYSTEM DESCRIPTION
The VAPR VUE Radiofrequency (RF) System is designed for arthroscopic surgical procedures.
The system consists of a high frequency electrosurgical generator and may include a reusable
handpiece with connector cable and disposable electrodes, alternative disposable electrodes
with integrated connector cable, also available with hand controls, a footswitch, and a wireless
footswitch alternative. The components are designed and intended to be operated as a single unit.
Use only VAPR electrodes and accessories with the VAPR VUE RF system.
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DEVICE DESCRIPTION
The VAPR Electrodes are soft tissue ablation and hemostasis / coagulation devices intended for
use with the VAPR VUE RF System. The VAPR
capabilities which enhance the efficiency of the electrode and extend the utility of the system by
assisting in the removal of bubbles and debris created during activation within the operating site.
INDICATIONS
The VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for
resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft
tissue in patients requiring arthroscopic surgery.
VAPR electrodes are intended to be used by an orthopedic surgeon in a surgical setting.
CONTRAINDICATIONS
The VAPR Electrosurgical System is contraindicated in:
• any non-arthroscopic surgical procedure,
• patients with heart pacemakers or other electronic device implants,
• patients for whom arthroscopic procedures are contraindicated for any reason.
WARNINGS
• The operator should be experienced in arthroscopic surgical techniques.
• Please refer to the user manual for step-by-step instructions regarding the assembly and initial
system check of the VAPR VUE system.
• As with all electrosurgical devices, do not use in the presence of flammable anesthetics,
oxidizing gases or other flammable substances, as an electrosurgical device has the potential for
providing a source of ignition.
• 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 activate the probe for unnecessary and prolonged periods as irrigant overheating
and tissue damage may result. Prolonged probe activation at maximum power while
adjusting irrigant flow via the flow control valve to a low flow rate may cause the shaft and
suction tubing to reach temperatures of up to 58°C. 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. 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.
• Operating the electrode at minimal suction rate or failure to attach the suction tubing to an
adequate suction source may cause thermal injury to the physician or patient.
• 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 assess electrode tip for wear and
proper operation. Replace the electrode if excessive wear is noted.
• Attach the suction adapter to standard hospital suction equipment. Ensure that the vacuum is in
the range of 300 mmHg to 700 mmHg.
• Damage to surrounding tissue through iatrogenic injury could occur, as an effect of
electrosurgery.
• Attempts to bend electrodes can result in electrode fracture or degradation of electrode
performance.
Radiofrequency (RF) System. The components of the VAPR VUE
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TRIPOLAR 90 SUCTION Electrode has suction
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