
Instructions for Use 2012-08-23
54
(3) Warnings and Notes
Never use this instrument for patients who have a pacemaker or an implantable cardioverter defibrillator (ICD); it
could cause these devices to operate erratically.
Tip Air
Take great care when using the tip air inside a body cavity or tubular lumen. Raising the air pressure inside a
cavity or lumen could force air into a blood vessel through an open wound and result in a gas embolism. Also take
great care when using the tip air in areas of the oral cavity where it could increase the pressure; this could result in
a severe gas embolism or subcutaneous emphysema.
Combustion Danger due to Elevated Level of Oxygen
Do not use this instrument in the presence of a combustible anesthetic or an elevated concentration of oxygen;
this could result in ignition or explosion. A laser beam will readily ignite a tracheal tube such as those made of
silicon rubber in the presence of a high concentration of oxygen or an anesthetic gas mixed with oxygen. For
example, a laser beam will instantly ignite the tube if the oxygen concentration is 48%.
If use of oxygen is absolutely essential, the oxygen delivery tube must be protected with a non-combustible cuff
and steps must be taken to insure that there is no leakage of oxygen
.
A direct, reflected or scattered laser beam can cause permanent blindness. All individuals in the laser use area
must wear laser safety glasses. Other parts of the body should also be protected. The laser beam can cause serious
injury to the skin and eyes.
Even if you are wearing safety glasses, never look directly into the aperture where the laser comes out; you could
be blinded by the laser. Both the main laser and the guide light are dangerous. The safety glasses provided
only temporary protection.
Read and understand all safety Warnings and Precautions described in the each section.
(4) Adverse Effects
There are no known adverse effects in treating soft or hard tissue applications.
(5) AdvErL EVO INDICATIONS FOR USE
This device is intended for the incision, excision, vaporization, ablation and coagulation of soft tissue in oral and
dentistry and for the ablation and vaporization of hard tissue in dentistry.
Use of AdvErL EVO is indicated for:
Hard Tissue
•
Caries removal
•
Surface ablation of wedge shaped defect
Perio
•
Irradiation to the periodontal pocket
•
Scaling
•
Periodontal curettage
•
Gingivoplasty
•
Gingival flap operation
Soft Tissue
•
Frenectomy
•
Gingival incision and excision
•
Coagulation of stomatitis
•
Removal of pigmentation
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