DePuy Synthes VAPR COOLPULSE Curve Manual De Instrucciones página 2

ENGLISH
VAPR COOLPULSE
®
COOLPULSE
Please read all information carefully prior to use, giving special attention to the User Manual provided
with the VAPR VUE
use as a single system. Failure to follow instructions may lead to improper functioning of the device
causing 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, disposable electrodes, and alternative disposable electrodes with integrated
connector cable. Also available are 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.
DEVICE DESCRIPTION
The VAPR Electrodes are soft tissue ablation and hemostasis/coagulation devices intended for use with
the VAPR VUE RF System. The VAPR
suction capabilities 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. VAPR
electrodes are intended to be used by an orthopedic surgeon in a surgical setting.
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.
CONTRAINDICATIONS
The VAPR VUE RF 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; an electrosurgical device has the potential for providing a
source of ignition.
• Do not use in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N
and oxygen), or close to volatile solvents (such as ether or alcohol), as explosion may occur.
• Do not place instruments near, or in contact with flammable materials (such as gauze or surgical
drapes). Instruments that are activated or hot from use may cause a fire.
• 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 instrument when not in contact with target tissue, as this may cause injuries due
to capacitive coupling with other surgical equipment.
• 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 49°C. Do not touch the electrode tip when power is
being applied.
• During an electrosurgical procedure, do not allow the patient 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 devices in close proximity to, or in direct contact
with, any metal objects. Most 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.
• Unnecessary and prolonged activation of the electrode during and between tissue applications may
result in unintended injury.
• Do not reuse any accessories labeled as SINGLE USE. These products are for single-use only
and are not 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 a hand control short-circuit 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 immersed in conductive irrigant
solution during use. Failure to completely immerse in irrigant solution 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.
CURVE XL SUCTION ELECTRODES
®
Radiofrequency (RF) System. VAPR VUE System components are designed for
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CURVE AND VAPR
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COOLPULSE Curve and COOLPULSE
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Curve XL Electrodes
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