Buffalo filter PlumePen Ultra Quick Start Manual

BUFFALO FILTER
PlumePen Ultra
®
Surgical Smoke Evacuation Pencil
Figure 1. Figure 2.
Open product packaging Plug the 3-prong power
and remove PlumePen cord into the electrosurgical
®
Ultra assembly. Connect generator of your choice,
the tubing provided with (Figure 2). Confirm that
PlumePen ® Ultra to a all power settings on the
surgical smoke evacuator generator are appropriate
or other appropriate for the procedure being
vacuum source; example performed.
shown, (Figure 1). For
The electrosurgical
connection and operation
generator's intensity should
to a specific surgical smoke
be set as low as
evacuator, please refer to
is necessary to achieve the
the specific instructions for
desired effect. PlumePen
use that accompany that
Ultra is a monopolar
system for appropriate set-
electrode, the use of a
up and use.
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.
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.
Sterile 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.
When not in use, the active electrode should be placed in a clean, dry, non-conductive safety holster. 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 Ultra 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
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
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
905230 RevD 12/11/2018
Intended Use: PlumePen
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:
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.
3a. The PlumePen
Ultra is equipped with several key features for the surgeon's convenience. Surrounding the
®
electrode blade is a translucent plastic tube that allows the blade and tube to be positioned at varying lengths
to most effectively capture surgical smoke plume as it is created.
3b. Rotate the CAM locking mechanism to the unlock position.
3c. Extend Capture Port / Blade to desired length. Please note Capture Port and Blade move together.
3d. Turn the CAM locking mechanism back to the lock position and ensure that the tube is securely locked in place.
Avoid contact with blade and buttons when adjusting the capture port. 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.
Ultra is not a fluid removal device,
®
Not made with natural rubber latex.
Federal USA law restricts this device to sale
by or on the order of a physician.
Consult Symbol Glossary at www.buffalofilter.com
Ultra is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by
®
3a.
3b.
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.
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.
Report serious incidents involving this device to Buffalo Filter at bf.customerfeedback@filtrationgroup.com or to your local distributor. In
addition, European customers should also report to EmergoVigilance@ul.com and the competent authority in your member state.
3c.
3d.
Figure 4.
The PlumePen Ultra 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 4).
After use, turn off smoke
evacuation unit and
electrosurgical generator.
Discard the entire
PlumePen Ultra assembly
®
(Pencil, Blade, Tubing, and
Power Cord) per facility
protocol for contaminated
items.
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Australia
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Figure 5. Figure 6.
To optimize the life of If neccessary to
your smoke evacuation
remove blade,
6a. Unplug the pencil
filter, it is recommended
that a Buffalo Filter 6b. Ensure that CAM
Surgical Smoke Plume
is in the lock position
6c. Use a surgical
Evacuator be used in
conjunction with an clamp and pull blade
EZLink Automatic
® forward
6d. Replace with
Activation Device
(Model EZLink01), blade of choice
6e. Confirm that
(Figure 5).
blade is completely
The EZLink will
®
inserted and secure
automatically turn the
before activating
Buffalo Filter Surgical
pencil. Never force
Smoke Evacuator on or
the blade into the
turn it off when either
pencil.
the CUT or COAG
function is activated/
CAUTION: We do not
de-activated on the
recommend re-using
PlumePen Ultra.
®
the original blade after
Contact Buffalo Filter
®
it has been removed.
for more details on the
EZLink .
®
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