Biolase EPIC X - Contraindications, Warnings, and Precautions; Contraindications for Epic X Use; Warnings and Precautions for Safe Operation

Epic X User Manual 7
3 Contraindications, Warnings, and Precautions
3.1 CONTRAINDICATIONS
All clinical procedures performed with Epic X must be subjected to the same clinical judgment and
care used 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 and exercise caution for general medical conditions that might contraindicate a local
procedure; such conditions may include, but are not limited to, allergy to local or topical anesthetics,
heart disease (including pacemakers and implantable defibrillators), lung disease, bleeding
disorders, sleep apnea, an immune system deficiency, or any medical conditions or medications that
may contraindicate the use of certain light/laser-type sources associated with this device, including
general neurovascular conditions which can reduce a patient's pain sensitivity while undergoing pain
therapy procedures (e.g., patients with neurodegeneration associated with Type II diabetes). Medical
clearance from the patient’s physician is advisable when doubt exists regarding treatment.
3.2 WARNINGS AND PRECAUTIONS
PRESCRIPTION STATEMENT
U.S. Federal Law restricts this device to sale by or on the order of a dentist or other licensed dental
practitioner.
TRAINING
Only licensed professionals who have reviewed and understood this user manual should use this
device. BIOLASE assumes no responsibility for parameters, techniques, methods, or results.
Physicians must use their own clinical judgment and professional knowledge to determine all aspects
of treatment, including technique, power settings, pulse interval, duration, etc.
EYEWEAR
Doctor, patient, assistant, and all others inside or entering the operatory must wear appropriate laser
protective eyewear suitable for the 940 nm ± 10 nm wavelength, OD4 (DIR LB4) or greater,
whenever the laser is in use. Prior to use, inspect the eyewear for pitting and/or cracking. Replace if
damaged; do not use.
CAUTION: The specifications for the protective eyewear provided with the Epic X laser
system are marked on the side of the glasses. Always check the eyewear
specifications marked on the glasses to ensure they offer the required
protection for the specific laser wavelength.
For additional information, refer to the instructions for use provided with the glasses.