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PlumePen

Ultra

BUFFALO FILTER

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: [email protected] . www.buffalofilter.com

905230 RevD 12/11/2018

STERILE EO

Emergo Europe

Prinsessegracht 20

2514 AP The Hague

The Netherlands

0120

PLPUL2000

PLPUL2500

Consult Symbol Glossary at www.buffalofilter.com

Federal USA law restricts this device to sale

by or on the order of a physician.

Not made with natural rubber latex.

AU SPONSOR:

Getz Healthcare Pty Ltd

5 Orion Road

Lane Cove, NSW 2060

Australia

Figure 1

Open product packaging

and remove

PlumePen

Ultra

assembly. Connect

the tubing provided with

PlumePen

Ultra

to a

surgical smoke evacuator

or other appropriate

vacuum source; example

shown, (Figure 1). For

connection and operation

to a specific surgical smoke

evacuator, please refer to

the specific instructions for

use that accompany that

system for appropriate set-

up and use.

Figure 2

Plug the 3-prong power

cord into the electrosurgical

generator of your choice,

(Figure 2). 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.

PlumePen

Ultra

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.

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.

Figure 5

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 5).
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

Ultra

Contact Buffalo Filter

for more details on the

EZLink

Figure 6

If neccessary to

remove blade,

Unplug the pencil

. Ensure that CAM

is in the lock position

. Use a surgical

clamp and pull blade

forward

. Replace with

blade of choice

. Confirm that

blade is completely

inserted and secure

before activating

pencil. Never force

the blade into the

pencil.

CAUTION:

We do not

recommend re-using

the original blade after

it has been removed.

Figure 3

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.

Rotate the CAM locking mechanism to the unlock position.

Extend Capture Port / Blade to desired length. Please note Capture Port and Blade move together.

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.

Intended Use:

PlumePen

Ultra

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:

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.

Surgical Smoke Evacuation Pencil

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

Ultra 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.
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 [email protected] or to your local distributor. In

addition, European customers should also report to [email protected] and the competent authority in your member state.