CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS

Contraindications

• All clinical procedures performed with Diolase Plus™ must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.
• Patients with snoring difficulties, possibly due to alcohol consumption or being overweight, are not candidates for Laser Assisted Uvulopaletoplasty (LAUP) unless other treatments have been attempted. NOTE: LAUP procedures should be performed by ENT trained professionals only.

Warnings

Eyewear

Doctor, patient, assistant and all others inside the operatory must wear appropriate laser eyewear protection for the diode laser wavelength of 815±15 nm.

Anesthesia

In soft tissue cases anesthesia may not be required, patients should be closely monitored for signs of pain or discomfort. If such signs are present, adjust settings, apply anesthesia or cease treatment if required.

Adjacent Structures

Diolase Plus™ is designed to remove soft tissues. Therefore, always be aware of adjacent structures and substructures during treatments. Be extremely careful not to inadvertently penetrate or ablate underlying or adjacent tissues. Do not direct energy towards hard tissues such as tooth or bone. Do not direct energy towards amalgam, gold or other metallic surfaces. Do not direct energy towards cements or other filling materials.

Suction

Use high-speed suction as required to maintain a clear field of vision during treatment. Do not use the Diolase Plus™ if you cannot clearly see the treatment site.

Training

Only licensed professionals who have successfully completed a Diolase Plus™ training seminar and have read and understood this User Manual should use this device. BIOLASE assumes no responsibility for parameters, techniques, methods or results. Physicians must us their own clinical judgment and professionalism in determining all aspects of treatment, technique, proper power settings, interval, duration, etc.

LAUP

Candidates considering LAUP treatment should be advised that this treatment could affect vocalization.

Introduction

To efficiently remove tissues it is imperative to understand the nature of the Diolase Plus™ device. Diolase Plus™ operates unlike traditional devices and the technique must be practiced and perfected to ensure efficient operation. Please study this section carefully, practice on model tissues and attend a quality diode laser training seminar before using this device in a clinical situation.

ENT Laser assisted Uvulopaletoplasty (LAUP) (For LAUP, this laser is effective for cutting, ablation, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring.) This procedure is for ENT professionals only.