Buffalo Filter PlumePen Elite - Manual

If you have any questions or need any assistance with the set-up
or use of the PlumePen ® Elite Surgical Plume Evacuation Pencil
please contact Buffalo Filter ® at:
U.S. toll-free: 800.343.2324
International: 1.716.835.7000
Email: [email protected]
5900 Genesee Street, Lancaster, NY 14086
U.S. toll-free 800.343.2324 . International: 1.716.835.7000
Fax: 716.835.3414 . Email: [email protected]
www.buffalofilter.com
PlumePen
®
Elite
Surgical Plume Evacuation Pencil
CAUTION:
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 (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.
Indications For 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.
Indications for Use for the PlumePen
® Elite Integrated Smoke Evacuation Pencil
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 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.
Figure 5.
The PlumePen ® Elite has CUT and
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 ® Elite assembly (Pencil, Blade,
Tubing, and Power Cord) per facility protocol
for contaminated items.
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 Plume Evacuator on or turn it off
when either the CUT or COAG function is activated/
de-activated on the PlumePen ® Elite . Contact Buffalo
Filter ® for more details on the EZLink™ .
904162 RevB.pdf
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 2.
Prior to connecting the PlumePen ® Elite 3-prong
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 3.
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 isnecessary to achieve the desired effect. The PlumePen ®
Elite is a 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.
ONLY
CAUTION:
Intended for use with a
maximum voltage of 10kV P-P.
Do Not Use
Damaged
Single Use Only
Do Not Reuse
PLP1001
PLP2001
PLP1501
PLP2501
Do Not
Resterilize STERILE R
Does Not
Contain Natural
Rubber Latex