Figure A: Connection
to Smoke Evacuator
Remove Bovie® Orca™ pencil
from packaging. When
removing the device from the
packaging, ensure that the
device does not come into
contact with any part of the
non-sterile packaging. Connect
the provided tubing to a
surgical smoke evacuator or
other compatible vacuum
source. Be sure to avoid
placing the tubing in areas
through which personnel will
travel.
Figure B: Connection
to Electrosurgical
Generator
Plug the 3-prong power
cord into the monopolar
port on an electrosurgical
generator. Prior to
beginning a procedure,
ensure that all power
settings on the generator
are at the appropriate
levels. The intensity
setting on the
electrosurgical generator
should be set to the
lowest value that can
achieve the desired result.
Figure C: Removal of
Blade Cover
The Orca pencil has a translucent
blade cover that provides
additional protection to both the
patient and user during use. This
cover can be removed by firmly
grasping the shaft of the pencil
and pulling the cover off. Avoid
contact with the electrode and
buttons when maneuvering the
electrode blade cover. Build-up
of eschar may hinder the device’s
ability to perform. To avoid
injury, do not activate the device
while cleaning the electrode.
Figure D: Removal of
Electrode Blade
1. Unplug the pencil from the
electrosurgical generator.
2. Use a surgical clamp to
pull electrode from the
socket.
3. Insert replacement
electrode into socket.
4. Ensure electrode is
entirely seated into
socket prior to activating
pencil.
Figure E: Modes of Operation
The Orca pencil has 2 modes of
operation. The modes of operation
are CUT and COAGULATION. The
YELLOW button on top of the pencil
shaft activates the CUT mode and
the BLUE button on top of the pencil
shaft activates the COAGULATION
mode. When finished with the
device, turn off the smoke
evacuation unit as well as the
electrosurgical generator. Discard
the pencil assembly (pencil, blade,
tubing and power cord) per protocol
for contaminated items, as it should
now be considered a biological
hazard.
Figure F: Smart Shark
Remote Activator
Device
Bovie® Smart Shark Remote
Activator Device can be used
with the Orca pencil in order
to maximize the smoke
evacuator’s filter life. The
Remote Activator Device
ensures that the smoke
evacuation unit is activated
only when the cut and
coagulation buttons on the
Orca pencil have been
pressed and for a few
seconds after their release.
IMPORTANT INFORMATION, Please Read Before Use:
CONTRAINDICATIONS
DO NOT USE
device in patients with electronic implants without first consulting a
with a qualified professional in advance
CAUTIONS
CAUTION:
Intended for use with a maximum voltage of 5kVp
CAUTION
: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Inspect every device before use. Damaged device may cause electrical burns to the patient or physician.
Active electrosurgical devices must be placed away from the patient when not in use. A holster is
recommended.
Use a wet sponge to remove eschar build up from active electrode tips.
Do not perform electrosurgery in the presence of flammable anesthetics or other flammable gases, fluids
or objects, or in the presence of oxidizing agents, as fire could result.
Avoid unnecessary or prolonged activation. Activate only when touching or immediately next to intended
point of contact.
Electrodes must be compatible with the pencil and ensured that the insulated sleeve fits securely inside
the handle. Improperly seated electrodes may cause burn or injury.
Indications for Use:
This product is a disposable electrosurgical pencil which is adaptable to common brands of electrosurgical
generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. This model can be
utilized to remove smoke from the surgical field.
Do not bend, cut, or modify electrode before or during surgery.
Keep the voltage/power settings at the lowest possible level to achieve the desired effect.
After use, safely discard in accordance with established procedures for biological hazards
WARNINGS
Improper use of any element in electrosurgical systems may cause serious burn, shock, and fire or explosion
hazard. The use of the device with safely functioning and compatible handles, cords, electrosurgical generators
and accessories is the user’s responsibility. Read and understand all precautions and instructions before
attempting to use any electrosurgical devices. This product is not intended to be used for fluid removal. This
product is for SINGLE USE ONLY; DO NOT RESTERILIZE. Use aseptic technique in all phases of handling. Symmetry
Surgical single use devices have not been designed to undergo or withstand any form of alteration, such as
disassembly, cleaning or resterilization after a single patient use. Reuse can potentially compromise device
performance and any usage beyond the design intent of this single use device may result in unpredictable loss of
functionality.
This product is sterilized utilizing Ethylene Oxide. These products can expose you to chemicals including Ethylene
Oxide (EtO), which is known to the state of California to cause cancer and/or birth defects or other reproductive
harm. For more information go to www.P65Warnings.ca.gov.
MC- 23437
Rev.1
ISEP1000
