Remanufactured LigaSure Exact Dissector, Without Nano-coating
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Remanufactured LigaSure Exact Dissector, without Nano-coating Description
The LF2019 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 set-up and operation of the associated Covidien
generator. Refer to the generator user’s guide for set up information and for additional warnings and cautions.
The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and
lymph) or tissue bundles interposed between the jaws of the instrument. A cutting blade within the instrument is surgeon-
activated to divide tissue.
Maximum rated voltage: 288 V
peak
Not made with natural rubber latex
Do not use if package is opened or damaged
Type CF applied part
Indications for Use
The Remanufactured 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 and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical
specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections,
gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy,
and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended
thermally-sensitive structures such as nerves and parathyroid glands.
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.
Contraindications for Use
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.
Warnings
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.
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.
