Item Brochure

INDICATIONS
FOR USE
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en
LigaSure Impact™
The LF4418 is designed for use with Covidien
electrosurgical generators that include vessel
sealing capability. Please refer to the cover
page for details on compatible generator
models and software versions. If the software
version on your generator is lower than
required, contact Covidien about software
updates.
These instructions assume that the operator is
knowledgeable about correct setup and
operation of the associated Covidien
generator. Refer to the generator user’s guide
for setup information and for additional
warnings and cautions.
The instrument creates a seal by application of
radiofrequency (RF) electrosurgical energy to
vascular structures (vessels and lymphatics) or
tissue bundles interposed between the jaws of
the instrument. A blade within the instrument
is surgeon actuated to divide tissue.
Maximum rated voltage: 288 V
peak
Indications for Use
The LigaSure Sealer/Divider is a bipolar
electrosurgical instrument intended for use in
open surgical procedures where ligation and
division of vessels, tissue bundles, and
lymphatics is desired. The LigaSure Sealer/
Divider can be used on vessels (arteries, veins,
pulmonary arteries, pulmonary veins) up to
and including 7 mm. It is indicated for use in
general surgery and such surgical specialties as
urologic, vascular, thoracic, and gynecologic.
Procedures may include, but are not limited to,
Nissen fundoplication, colectomy,
cholecystectomy, adhesiolysis, hysterectomy,
oophorectomy, etc.
The LigaSure system has not been shown to be
effective for tubal sterilization or tubal
coagulation for sterilization procedures. Do not
use the LigaSure system for these procedures.
General Warnings

LF4418 Curved, Large Jaw,
Open Sealer/Divider,
Nano-coated
36 mm jaw length,
18 cm shaft length
Not made with natural rubber latex
Do not use if package is opened or
damaged
Type CF applied part.
Warning
This product cannot be adequately cleaned
and/or sterilized by the user in order to
facilitate safe reuse, and is therefore
intended for single use. Attempts to clean or
sterilize these devices without appropriate
regulatory authorization may result in bio-
incompatibility, infection, or product failure
risks to the patient.
This instrument is intended for use ONLY
with the Covidien equipment listed on the
cover of this document. Use of this
instrument with other generators may not
result in the desired tissue effect, may result
in injury to the patient or surgical team, or
may cause damage to the instrument.
Do not use the LigaSure system unless
properly trained to use it in the specific
procedure being undertaken. Use of this
equipment without such training may result
in serious unintended patient injury.
Use the system with caution in the presence
of internal or external pacemakers, or other
implanted devices. Interference produced
by electrosurgical equipment can cause a
pacemaker or other device to enter an
unsafe mode or permanently damage the
device. Consult the device manufacturer or
responsible hospital department for further
information when use is planned in patients
with implanted medical devices.
The safe and effective use of RF energy
depends on many factors solely under the
control of the operator. There is no substitute
for properly trained and vigilant personnel. It
is important that the operating instructions
supplied with this or any other medical
equipment be read, understood, and
followed.
Contact between an active instrument
electrode and any metal object (hemostats,
staples, clips, retractors, etc.) may increase
current flow and may result in unintended
surgical effects, such as an effect at an
unintended site or insufficient energy
deposition.
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