OmniGuide BEAMPATH OTO-S Manual Del Usuario página 2

ENGLISH
Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.
SECTION I: DEVICE DESCRIPTION D IK1AL B
(Humidity limitation: The range of humidity to which the fiber can be safely exposed)
The OmniGuide CO Laser Fibers enable the delivery of CO
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from a laser source to the target tissue. The fiber attaches to an OmniGuide
Fiber Enabled Laser System. Along with the CO
BeamPath-S series fiber may transmit up to 1 liter/min of gas flow, cooling
the fiber as well as clearing the surgical field of smoke or blood.
The system consists of following components:
• OmniGuide fiber-enabled laser system
• Medical Grade Helium gas connected to the laser system
• OmniGuide CO Laser Fiber, sterile, single use
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• OmniGuide handpiece or other rigid delivery device
• Gas Filter Unit (GFU) system for use of sterile gas in sterile field
SECTION II: INDICATIONS FOR USE
The OmniGuide BeamPath OTO-S Fiber is indicated for the incision,
excision, ablation, vaporization and coagulation of body soft tissues.
SECTION III: Y WARNINGS
• Pressurized gas exiting the fiber tip during the laser procedure may cause gas
embolism if fiber comes in contact with blood vessels or vascular tissue, leading to
serious injury or death.
◦ Do not bring the fiber tip into direct contact with blood vessels or vascular tissues
◦ Monitor vital signs of the patient and blood oxygen level for symptoms of gas
embolism
◦ Stop using the laser if you see sudden or unexplained changes of the levels of
end tidal carbon dioxide, subcutaneous emphysema, sudden change in oxygen
tension via oximetry or sudden changes in hemodynamics
• Pressurized gas exiting the fiber's tip during the laser procedure may cause
temporary inflation and separation of sub-mucosal flaps or emphysema under
superficial layers of tissue.
◦ To reduce this risk, use a longer working distance between the fiber tip and tissue.
◦ Any signs of subcutaneous emphysema or hemodynamic instability during use,
immediately stop using laser and proceed to standard treatment protocol.
• Inspect fiber packaging. Do not use if package is damaged or opened.
• Fiber is intended for single use only. Do not re-sterilize or reuse.
• Fiber reuse may pose the risk of infection.
• Re-sterilization/reprocessing of the fiber could lead to fiber damage, resulting in
fiber failure leading to potential:
◦ Laser radiation exposure
◦ Fiber overheating
◦ Fiber foreign material being left in the patient
• Handle the fiber with care. Do not bend it excessively (radius < 2 cm) to avoid
damage and increased possibility of failure during use.
• Medical Grade Helium gas must be flowing through the fiber at specified settings
throughout the procedure to avoid increased possibility of failure during use.
• The laser should be activated only when the laser treatment site is clearly visible
and the fiber tip is directed at it.
90%
m
20%
laser energy
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laser energy, the
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OMNIGUIDE ADVANCED ENERGY FIBERS
BEAMPATH OTO-S INSTRUCTIONS FOR USE
• Laser energy can cause eye damage, burns, and ignite flammable materials.
◦ User should wear appropriate laser eyewear and skin protection in accordance
with the facility's laser safety policies
◦ Avoid reflective materials and combustive materials near the surgical site
◦ Flammable prep solutions must not be used during laser procedures
◦ Fire extinguisher must be available for the operating room when the laser is
being utilized
◦ Refer to ANSI Z136.3 Use of Lasers in Health Care
SECTION IV: PRECAUTIONS
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Observe all laser and compressed gas safety precautions as specified in
laser system User Manual.
• Do not use the fiber outside its recommended parameters in Section VI.
SPECIFICATIONS below. Always use the minimum appropriate laser power and gas
settings required for a given procedure.
• See the Fiber Procedural Setting Guide (DOC-GEN-3) or the OR Staff Training
Binder (DOC-FELS-27) for recommended power and gas ranges.
• Laser surgical procedures should be performed only by a licensed physician or
dentist adequately trained and familiar with such surgical techniques and clinical
use of CO lasers.
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• A smoke evacuation system or suction should be utilized to remove surgical
plume.
• Do not touch the fiber tip to tissue or fluids as it will increase the risk of tip
clogging and/or product failure. If tissue or debris buildup occurs, set gas pressure
to at least 10psi and clean the fiber tip by dipping it in saline solution.
• There is a possibility that an OmniGuide BeamPath OTO-S Fiber will fail during the
course of a surgical procedure. Therefore, do not start a surgical procedure unless
you have at least two fibers or another surgical tool available.
SECTION V: ADVERSE REACTIONS
• Inflammatory reaction at the sites where energy is applied.
• As with any surgical tool, iatrogenic injury may occur.
• Pressurized gas may cause mechanical damage to the middle ear, inner ear
anatomy and perilymph at pressures greater than 10psi.
◦ Warning: reduce pressure to 10psi when working in the middle ear
• Continuous lasing without adequate cooling flow may cause the fiber tip to heat to
temperatures > 60° C.
◦ Warning: use fiber in single pulse mode in middle ear and near critical structures
◦ Warning: do not use fiber in contact mode on critical structures and locations
DANGER
VISIBLE AND INVISIBLE LASER RADIATION
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AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
CO LASER 10,6μM. CW. 30WMAX.
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CLASS IV LASER PRODUCT
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