Johnson & Johnson DePuy Synthes VAPR 90 225028 Manual Del Usuario página 3

PRECAUTIONS
• 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 the user manual).
• Use caution when overriding the default power settings. Use the lowest power setting and the
minimum tissue contact time necessary to achieve the appropriate surgical effect.
• When not in use, place the active electrode in a clean, dry, nonconductive, and highly visible
area not in contact with the patient. Inadvertent activation while in contact with the patient may
result in burns.
• Excessive force may damage the electrode tip assembly.
• Failure to maintain the recommended suction may result in device failure.
INSTRUCTIONS FOR USE
1. Read all instructions carefully. Failure to properly follow instructions may lead to electrical or
thermal injury and cause improper functioning of the device.
2. The operator should be experienced in arthroscopic surgical techniques.
3. Please refer to the user manual for step-by-step instructions regarding the assembly and initial
system check of the VAPR VUE RF system.
BEFORE SURGERY
1. Switch on the VAPR VUE generator. Follow the instructions in the user manual. The generator
will display: "Attach Instrument" .
2. Connect a new, sterile electrode to the generator. Follow the instructions in the user manual. The
generator will display the Ablate/Coag screen.
3. For optimal performance, safety, and convenience, the VAPR electrodes automatically preset
the VAPR VUE generator to default output settings. The default settings are as follows:
CAUTION: If the VAPR VUE generator display does not match the default settings specified below,
consult the user manual for further instructions.
ELECTRODE GEOMETRY
VAPR SYSTEM
Default mode
Default ABLATE Power (W)
Default COAGULATE Power (W)
Maximum ABLATE Power (W)
Maximum COAGULATE Power (W)
Minimum Cannula Size
Caution should be used when overriding the default power settings. Use the lowest power setting
and the minimum tissue contact time necessary to achieve the appropriate surgical effect. If power
settings have been overridden to non-default values, the adjusted values will be retained when
unplugging and re-plugging the same electrode, when connecting a new electrode of the same
type, or when connecting a different electrode model with the same default values. If the generator
is switched off and then on, a newly attached electrode will always revert to its default values.
Always confirm proper, desired power settings before proceeding with surgery.
The generator display can be set up to display output power in Watts (ADVANCED mode) or in
relative numbers (BASIC mode). The equivalent values for ADVANCED and BASIC mode vary by
electrode type.
BASIC-ADVANCED equivalency table for the VAPR TRIPOLAR 90 SUCTION Electrode:
Basic
1
2
3
4
5
6
7
8
9
10
NOTE: In ADVANCED mode, output power can be adjusted in finer increments than in BASIC
mode.
NOTE: When an instrument is attached, switching between ADVANCED and BASIC User Mode
after adjusting the power output settings will reset the power output values to the default settings
for the specific electrode type. The Mode button on the generator must be pressed to confirm use.
4. Attach the tubing connector to a suction source.
DURING SURGERY
1. Prior to insertion of the electrode, close suction outflow of the electrode 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 surrounded by 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 a tone will be heard. 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 will be de-activated when using the footswitch.
5. Refer to the VAPR VUE User Manual 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 a tone (at a
different frequency than during ABLATE) will be heard. Always keep the electrode in contact with
tissue. Refer to the VAPR VUE User Manual on how to activate using the footswitch (wired or
wireless). Use the lowest power possible to achieve the desired tissue effect.
VAPR TRIPOLAR 90 SUCTION Electrode
ABLATE
Advanced (W)
10
100
190
220
260
280
300
320
340
380
TRIPOLAR 90 SUCTION Electrode
VAPR VUE only
COOLPULSE
Advanced (W)
220
100
380
160
Ø5.5mm
COAGULATE
Basic
1
2
3
4
5
6
3
Basic
4
4
10
6
Advanced (W)
10
40
80
100
130
160