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4. Attach the tubing connector to a suction source.
DURING SURGERY
1. Prior inserting the electrode, close electrode suction outflow by moving the Flow Control Valve as far
proximal as possible.
2. Insert the electrode into a fluid-filled joint space through a prepared entry point. Ensure that the
electrode is immersed in conductive irrigant solution when in use.
3. Ensure that the flow control valve is open (fully distal).
USE OF HAND CONTROLS AND FLOW CONTROL VALVE
4. To activate the ABLATE mode using the hand controls on the electrode handle (ensure suction is
turned on), press and hold any of the YELLOW buttons. The ABLATE power setting on the generator
will flash and emit a tone. Always keep the electrode in motion and in contact with tissue. Refer to
the VAPR VUE User Manual on how to activate using the footswitch (wired or wireless). The hand
controls are de-activated when using the footswitch.
5. Refer to the VAPR VUE User Manual for instructions on how to adjust the ABLATE and COAG power
settings on the generator panel. Use the lowest power possible to achieve the desired tissue effect.
NOTE: ABLATE power settings can also be adjusted using the footswitch (wired or wireless). Please
refer to the VAPR VUE User Manual.
6. To activate the COAG mode using the hand controls on the electrode handle, press and hold any of
the BLUE buttons. The COAG power setting on the generator will flash and emit a tone (at a different
frequency than during ABLATE). Always keep the electrode in contact with tissue. Refer to the
VAPR VUE User Manual for instructions on how to activate using the footswitch (wired or wireless).
Use the lowest power possible to achieve the desired tissue effect.
NOTE: COAG power settings are adjusted using only the buttons on the generator. Please refer to the
VAPR VUE User Manual.
CAUTION: Based on the multiple button design, there is an increased risk of inadvertent activation.
7. Adjust the flow rate, using the Flow Control Valve, to optimize the fluid removal rate and bubble
extraction, and to assist with bleeding blood vessels. Sliding the Flow Control Valve distally will
increase flow (up to ~500ml/min); moving the Valve proximally will decrease flow.
8. Reduce suction when device is not in use.
CAUTION: Inspect the active tip of the electrode for any damage after all faults. If the active tip is
loose or dislodged, insert a new electrode. If electrode becomes covered in tissue debris, use a new
electrode.
Audible Alarm
As a safety feature, and to notify the user of the presence of a short circuit within the VAPR VUE
system, a dual frequency audible alarm indicates either contact between the activating electrode tip
and a metal object in the joint space, or an electrical fault in the electrode or handpiece.
If the audio signal continues when the electrode is moved away from a metal object, inspect the
electrode and/or handpiece. Discard damaged accessories immediately. Remove excessive debris
build-up across the distal tip area with an appropriate wipe.
If the alarm sounds continuously, and there is no contact with a metal object, discard the electrode.
AFTER SURGERY
1. Discontinue suction and remove the electrode from the joint space.
2. Disconnect from suction source. Disconnect the electrode cable from the generator by steadying the
generator and pulling on the plug body. DO NOT pull on the cable; this can cause damage to the
generator.
3. The generator can be left in idle mode between surgical procedures. Turn off the generator at the
conclusion of a surgical day.
4. Dispose of the single use components according to hospital procedure.
HOW SUPPLIED
The VAPR COOLPULSE Curve and COOLPULSE Curve XL Suction Electrodes are provided sterile
unless the package is opened or damaged. The electrodes are intended to be disposed of after a single
use and are not intended to be re-sterilized (see warning section).
STORAGE
Store at controlled temperature up to 25° (77°F). Avoid excessive heat > 40°C (104°F). Bring to ambient
temperature before unpacking /use. Do not use after USE BY date.
ESPAÑOL
ELECTRODOS DE SUCCIÓN VAPR
CURVO Y VAPR
Lea atentamente toda la información, especialmente el manual del usuario que se incluye con
el sistema de radiofrecuencia (RF) VAPR VUE
componentes del sistema VAPR VUE están diseñados para ser utilizados conjuntamente como un
solo sistema. Si no se siguen las instrucciones se pueden producir lesiones eléctricas o térmicas y es
posible que el dispositivo no funcione correctamente.
DESCRIPCIÓN DEL SISTEMA
El sistema de radiofrecuencia (RF) VAPR VUE ha sido diseñado para ser utilizado en procedimientos
quirúrgicos artroscópicos. El sistema se compone de un generador electroquirúrgico de alta frecuencia
y puede incluir una pieza de mano reutilizable con cable conector, electrodos desechables y electrodos
desechables alternativos con cable conector integrado. Otros componentes disponibles son controles
manuales, un pedal y una alternativa con pedal inalámbrico. Los componentes están diseñados para
ser utilizados como una sola unidad. Utilice únicamente accesorios y electrodos VAPR
de RF VAPR VUE.
DESCRIPCIÓN DEL DISPOSITIVO
Los electrodos VAPR son dispositivos de ablación y coagulación/hemostasia de tejidos blandos
diseñados para su uso con el sistema de RF VAPR VUE. El electrodo VAPR
COOLPULSE
curvo XL tiene funciones de succión que mejoran la eficiencia del electrodo y amplían
®
la utilidad del sistema al facilitar la eliminación de las burbujas y los residuos creados durante la
activación en el lugar de la intervención. Los electrodos VAPR están diseñados para que los usen
cirujanos ortopédicos en un entorno quirúrgico.
INDICACIONES
Los electrodos VAPR diseñados para su uso con el sistema de radiofrecuencia VAPR VUE están
concebidos para la resección, la ablación y la extirpación de tejidos blandos, la hemostasia de vasos
sanguíneos y la coagulación de tejidos blandos en pacientes que necesitan cirugía artroscópica.
COOLPULSE
®
, antes de utilizar el dispositivo. Los diversos
®
®
CURVO XL
®
4
COOLPULSE
con el sistema
®
COOLPULSE
®
®
curvo y
®
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