Buffalo Filter PlumePen Elite Handbuch

BUFFALO FILTER
PlumePen
Surgical Smoke Evacuation Pencil
Figure 1.
Open product packaging and remove the
PlumePen Elite Surgical Plume Evacuation
®
Pencil assembly. Connect the tubing provided
with the PlumePen Elite to a smoke evacuation
®
system or other appropriate vacuum source;
example shown, (Figure 1). For connection and
operation to a specific smoke evacuation system,
please refer to the specific instructions for use for
appropriate setup and use.
Figure 4.
The PlumePen Elite is equipped with several key features for the
®
surgeon's convenience. Above the electrode blade is a translucent
plastic tube that can be positioned at varying lengths, (Figure 4) to
most effectively capture surgical smoke plume as it is created.
With the electrosurgical generator off and the electrode blade
cool, position this tube as near the point of the tissue interaction
as possible without obstructing the view of the target tissue.
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.
CAUTION:
Intended for use with a maximum voltage of 10kV P-P.
DO NOT USE in patients who have electronic implants such as cardiac
pacemakers without first consulting a qualified professional (e.g.,
cardiologist). A possible hazard exists because interference with the action
of the electronic implant may occur, or the implant may be damaged.
INSPECT instruments and cables for damage prior to each use, especially
the insulation of laparoscopic/endoscopic instruments. This 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.
Sterility unless packaging is damaged or any seal is broken. Do not use electrosurgery
in the presence of flammable anesthetics or other flammable gases, fluids, or objects,
or in the presence of oxidizing agents, as fire may result. Place active accessories in a
holster or in a clean, dry, non-conductive and highly visible area away from the patient
when not in use. Inadvertent contact with the patient may result in burns. Contact with
drapes or linens may cause a fire.
DO NOT activate the instrument when not in contact with target tissue, as this may cause
injuries due to capacitive coupling.
PlumePen Elite is designed and intended only to be used with an electrosurgical
®
generator that has been tested to the IEC 60601 standard. Please refer to generator to
ensure compatibility. PlumePen Elite is not a fluid removal device, therefore, it should
®
not be used for such application.
ASPIRATE fluid from the area before activating the instrument. Conductive fluids
Buffalo Filter LLC
5900 Genesee Street, Lancaster, NY 14086
U.S. toll-free 800.343.2324 . International: +1 716.835.7000 . Fax: +1 716.835.3414
Email: bf.smoke.info@filtrationgroup.com . www.buffalofilter.com
904162 RevE - 08/16/2017
Elite
®
Figure 2.
Prior to connecting the PlumePen
power cord to the electro-surgical generator,
ensure that the electrode blade (provided) is fully
inserted into the pencil by gently pressing it in
front of the PlumePen Elite. Remove the plastic
®
shield from the blade and discard.
Figure 5.
The PlumePen
COAG buttons located on the top of the
electrosurgical pencil body. The YELLOW
button is for cutting and the BLUE button is
for coagulation, (Figure 5).
After use, turn off smoke evacuation unit and
electrosurgical generator. Discard the entire
PlumePen
Tubing, and Power Cord) per facility protocol
for contaminated items.
Intended Use: The PlumePen Elite is designed for general
®
electrosurgical applications, including cutting and coagulation, and for removing
smoke generated by electrosurgery when used in conjunction with an effective
smoke evacuation system. The pencil enables the operator to remotely conduct
an electrosurgical current from the output connector of an electrosurgical unit to the
operative site for the desired surgical effect to remove tissues and control bleeding by
means of high-frequency electrical current.
Indications for Use for the PlumePen
include:
a. To remove smoke plume from the surgical site.
b. To remotely conduct an electrosurgical current from the output connector of an
electrosurgical unit to the target tissue for the desired surgical effect.
Figure 3.
Elite 3-prong Plug the 3-prong power cord into the electrosurgical generator
®
of your choice, (Figure 3). Confirm that all power settings on the
generator are appropriate for the procedure being performed. The
electrosurgical generator's intensity should be set as low as is
necessary to achieve the desired effect. The PlumePen
monopolar electrode, the use of a dispersive electrode is required
to prevent burns/injury to patient. Please refer to electrosurgical
generator user manual and dispersive electrode instructions for
use for additional instructions.
Elite has CUT and
®
Elite assembly (Pencil, Blade,
®
(e.g., blood or saline) in direct contact with or in close proximity to an active electrode
may carry electrical current or heat away from target tissues, which may cause
unintended burns to the patient.
Buffalo Filter recommends that the original blade be utilized with the PlumePen Elite.
If original blade is removed, visually confirm new blade is completely inserted and
secured before activating the pencil. Never force the blade into the pencil. Rotate the
pencil if the smoke tube is obstructing view of the insertion point.
For procedures where visualization may be impaired, be alert of these potential hazards:
• The electrode tip may remain hot enough to cause burns after the current has been
de-activated.
• Inadvertent activation or movement of the activated electrode outside of the field of
vision may result in injury to the patient.
• Localized burns to the patient or physician may result from electrical currents carried
through conductive objects. Current may be generated in conductive objects by direct
contact with the active electrode, or by the active accessory being in close proximity
to the conductive object.
For single use only. Do not reuse, reprocess, or re-sterilize. Reuse, reprocessing, or
re-sterilization may compromise the structural integrity of the device and/or lead to device
failure which in turn may result in patient injury, illness, or death.
This single-use product is not designed or validated to be reused. Reuse may cause a risk
of cross-contamination or cause a malfunction as a result of the product being physically
damaged due to cleaning, disinfection, re-sterilization, or reuse.
Not Made with
Natural Rubber Latex
Consult Regulatory Symbol Glossary at www.buffalofilter.com
Elite Integrated Smoke Evacuation Pencil
®
Figure 6.
To optimize the life of your smoke evacuation filter, it
is recommended that a Buffalo Filter Surgical Smoke
Plume Evacuator be used in conjunction with an
EZLink Automatic Activation Device
®
(Model EZLink01), (Figure 6).
The EZLink will automatically turn the Buffalo Filter
®
Surgical Smoke Evacuator on or turn it off when either
the CUT or COAG function is activated/de-activated on
the PlumePen Elite. Contact Buffalo Filter
®
details on the EZLink .
®
STERILE EO
0120
ONLY
Elite is a
®
for more
®
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2514 AP The Hague
The Netherlands
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