DePuy Synthes VAPR COOLPULSE Curve Manual De Instrucciones página 3

• Electrodes will wear with 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.
• When not using instruments, place them in a clean, dry, highly visible area not in contact with the
patient. Inadvertent contact with the patient may result in burns.
• Inspect instruments and cables for damage prior to each use, especially the insulation of electrode.
Inspection may be done visually under magnification or with a high voltage insulation testing device.
Insulation failures may result in burns or other injuries to the patient or operator.
• The surface of the active electrode may remain hot enough to cause burns after the RF current is
deactivated.
PRECAUTIONS
• Prior to initial use, read and understand all package inserts including warnings, cautions, and
Instructions for Use. 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.
• The intensity should be set as low as is necessary to achieve the desired effect.
• Keep the active electrodes clean. Build-up of eschar may reduce the instrument's effectiveness. Do
not activate the instrument while cleaning. Injury to operating room personnel may result.
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 set the
VAPR VUE generator to the 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
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 overriding power settings
to non-default values, the adjusted values are 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 COOLPULSE Curve and COOLPULSE Curve XL Suction
Electrodes:
VAPR COOLPULSE Curve and COOLPULSE Curve XL
Suction Electrodes
ABLATE
Basic Advanced
1
2
3
4
5
NOTE: ADVANCED mode provides smaller increments in output power than 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.
COOLPULSE Curve and
COOLPULSE Curve XL
VAPR VUE only
Basic
4
3
5
4
COAGULATE
Basic
(W)
10 1
100 2
150 3
200 4
260
COOLPULSE
Advanced
(W)
200
80
260
100
6.5 mm
Advanced
(W)
10
40
80
100
3