Integra LifeSciences Bipolar Forceps - Manual

ENGLISH
Integra ™ Bipolar Forceps
Important Information - Please Read Before Use!
CAUTION
Please read all information contained in this insert. The use of an
instrument for a task other than that for which it is intended, as well as
improper, ineffective and insufficient maintenance can greatly reduce
the life of an instrument and will invalidate the instrument’s warranty.
Incorrect handling and care as well as misuse can lead to premature
wear or can cause hazards to patients and users.
HOW SUPPLIED
Integra Bipolar Forceps are supplied non-sterile and must be cleaned
and sterilized prior to use according to hospital protocol and the
procedures outlined in this document. Failure to follow these procedures
will invalidate the instrument’s warranty and can cause the instrument
to fail.
DESCRIPTION
Bipolar Forceps are intended for use in general surgical procedures. The
device is connected through a suitable bipolar cable with the bipolar
output of an electrosurgical generator. Coagulation is achieved using
electrosurgical energy generated by the electrosurgical generator unit
and activated by a footswitch. The use of an instrument for a task
other than for which it is intended, as well as improper, ineffective, and
insufficient maintenance can greatly reduce the life of an instrument
and will invalidate the instrument’s warranty.
INDICATIONS FOR USE
Bipolar Forceps are designed to grasp, manipulate and coagulate
selected tissue. It is to be connected through a suitable bipolar cable
with the bipolar output of an electrosurgical generator. Bipolar Forceps
must only be used with bipolar coagulation current. The Bipolar Forceps
has not been shown to be effective for tubal sterilization or tubal
coagulation for sterilization procedures and should not be used for
these procedures.
The maximum output of the generator shall not exceed 750 V
p
.
Note: Electrosurgical instruments should be used only by individuals
who are trained and licensed to use such devices. Examples of such
training and experience include: Training through qualified residency
program, surgical skills workshops, training programs offered by
equipment manufacturers or preceptorship/surgical assistant training.
ADVERSE EVENTS
Adverse events reported while using bipolar electrosurgical devices
include: Inadvertent activation with resultant tissue damage at the
wrong site and/or equipment damage. Fires involving surgical drapes
and other combustible materials have been reported. Alternate current
pathways resulting in burns where the patient or physician or assistant
is in contact with exposed metal. Explosions caused by electrosurgical
sparking in a flammable gas environment (i.e., explosive anesthetic
gases). Organ perforation. Sudden massive hemorrhage.
CAUTIONS & WARNINGS
Special safety precautions should be observed when using
electrosurgical instruments. Electrosurgical instruments can pose
a significant shock, burn or explosion hazard if used improperly,
incorrectly or carelessly. Avoid touching or grounding electrosurgical
instruments to non-insulated instruments, scopes, trocar sleeves, etc.
All persons using such devices should be knowledgeable in the use
and handling of laparoscopic instruments, coagulation equipment, their
accessories and other related equipment.
Test all instruments, accessories and equipment prior to each use.
Written Standard Operating Procedures for the cleaning, sterilization,
storage, inspection and maintenance of the instruments, accessories
and equipment are recommended. Do not use in presence of flammable
liquids or anesthetics. Electrosurgical generators used with these
devices are designed to cause destruction of tissue and are inherently
dangerous if operated improperly. Follow all safety precautions and
instructions supplied by the manufacturer of the electrosurgical
generator. The electrode tip must always be in full view before
activating power. Apply power only when electrode tip is in full contact
with the tissue selected for coagulation. Electrode tip must not come
in contact with other metal instruments during use. Failure to observe
these cautions and contraindications may result in injury, malfunction or
other unanticipated occurrences or events for the operator, staff and/or
the patient.
INITIAL USE OF NEW INSTRUMENTS
Every instrument must be cleaned and sterilized before it is used for the
first time. The instrument was developed for sterilization by autoclave
and has shown good results using this method.
INSPECTION AND FUNCTIONAL CHECk
It is very important to examine carefully each surgical instrument for
breaks, cracks or malfunctions before use. It is especially essential to
check areas such as blades, points, ends, stops and snaps as well as
all movable parts.
Do not use damaged instruments. Never attempt
to make repairs yourself. Any repairs made by the customer may void
the warranty. Service and repairs should be referred to trained qualified
persons only. Refer questions about repair to the manufacturer or the
biomedical engineering department or return to Integra LifeSciences for
repair.
CLEANING AND MAINTENANCE
Every surgical instrument should be disinfected and thoroughly cleaned
after each use. Proper cleaning, inspection and maintenance will help
ensure correct function of the surgical instrument. Clean, inspect and
test each instrument carefully. Sterilize all instruments before surgery.
A good cleaning and maintenance procedure will extend the useful life
of the instrument. Special attention must be paid to slots, stops, ends,
hollow tubes and other highly inaccessible areas. Check insulation,
cables and connectors for cuts, voids, cracks, tears, abrasions, etc.
Do
not use damaged instruments. Cleaning and rinsing must take place
immediately after each use for best effect. Failure to clean promptly
may result in adherent particles or dried secretions that may resist
cleaning and complicate or resist future sterilization. Instruments must
be completely cleaned and rinsed off of all foreign matter. Use warm
water and a commercially available instrument pre-soak or cleaning
agent. Enzymatic cleaners must be used to remove protein deposits.
Follow the enzymatic cleaner’s instructions; rinse thoroughly.
• Do not use corrosive cleaning agents (i.e., bleach). Cleaning
solutions and rinses at or near a neutral pH (7.0) are best.
• Do not use abrasive cleaners.
• Only a soft bristle brush should be used.
• Can be disinfected in the washing machine up to 203°F (95°C).
• Rinse thoroughly with distilled water.
• Prepare for storage and/or sterilization.
After cleaning and rinsing, dry instruments completely and carefully
with compressed air (including inside channels and highly inaccessible
areas).
Note: After cleaning and before sterilization, treat all
instruments with a water soluble lubricant which is considered as being
physiologically safe, especially their blades, ends, stops, snaps and all
movable parts.
REPAIRS AND MAINTENANCE
Should your instruments require repair or maintenance, contact Integra
LifeSciences for return authorization and address. Instruments returned
to Integra LifeSciences for repair must have a statement testifying
that each instrument has been thoroughly cleaned and sterilized.
Failure to supply evidence of cleaning and disinfection will result in
a cleaning charge and delayed processing of your instrument repair.
Products repaired by Integra LifeSciences are guaranteed for 90 days
to be free of defects in workmanship and parts when used normally
for their intended surgical purpose. Any workmanship or parts proving
to be defective will be replaced or repaired, at Integra LifeSciences’
discretion, at no charge to the customer.
STORAGE AND STERILIZATION
Instruments must be stored in a clean, dry, moisture free area.
The instruments should be stored individually in their shipping carton
or in a protective tray with partitions. Protect tips with cloth, gauze or
tubing if stored in drawers. Instruments and cables are reusable and
meet AAMI standards for sterilization. Use steam autoclave sterilization.
Thoroughly clean instruments of all debris, tissue and foreign matter
prior to sterilization. Follow the sterilizer manufacturer’s instructions for
operation and loading of steam autoclaves. There must be direct steam
exposure to all surfaces of the instruments being sterilized including
the internal surface and tubes channels. Allow instrument to air cool to
room temperature before use.