Preat Corporation Dental Instruments may only be used for its intended purpose according to the general rules for dental/surgical treatment, occupational safety and accident prevention. The instruments must only be used by dentists and surgeons with training and experience in oral surgery, prosthetics as well as diagnosis and pre-operative planning. Preat Corporation or its partners, collectively as the manufacture, the importer, and the distributor are not liable for damages resulting from treatment outside of our control. The responsibility rests with the provider.
Preat Corporation Dental Instruments are manufactured from surgical steel. The Instruments are delivered non-sterile and must be cleaned, disinfected and sterilized according to standard sterilization procedures.
INDICATIONS FOR USE
Preat Corporation Dental Instruments are hand-held dental instruments intended to perform various tasks in general dentistry and oral surgery procedures.
Federal (U.S.A.) law restricts this device to sale on or by the order of a physician.
Re-use of this device without proper cleaning and sterilization may result in serious cross infection or be harmful to the patient. All components that are used intra-orally must be secured to prevent aspiration or swallowing. After use, this product may be a potential biohazard. Handle in accordance with accepted medical practice and applicable laws and regulations.
Preat Corporation Dental Instruments must only be used if they are in good condition. Surgical instruments are susceptible to damage and wear and should be inspected before use. If inspection reveals signs of wear, damage, or unrecognizable color or label identification, replace the instrument(s) accordingly.
Disinfection and sterilization procedures should conform to OSHA or local guidelines for blood borne pathogens.
Use the following guidelines for cleaning instruments:
- Instruments that have a closing mechanism (such as scissors and clamps) must be in the open configuration during cleaning and sterilization to ensure all surfaces are disinfected.
- Rise with cool-to-lukewarm tap water for 2.5 minutes. Use a soft bristle brush to clean the instruments until all visible soil is removed. Place in an ultrasonic cleaner with an enzymatic detergent diluted with tap water per the manufacture’s guidelines.
- Sonicate for 10 minutes. Rinse with tap water for 3 minutes. Dry the instruments with a clean cloth.
These tools are provided non-sterile. Sterilize non-sterile product and components prior to use in patients. Individual parts should be placed in appropriate autoclave pouches prior to sterilization. The following sterilization parameters (method, time and temperature) are required to achieve a 10-6 sterility assurance level (SAL). Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table. Verify the calibration of your unit to ensure recommended temperatures are not being exceeded. To ensure autoclave is performing effectively, periodic use of biological indicators should be considered. Chemclave sterilization is NOT recommended. Excessive and long term exposure to water or moisture in the atmosphere could result in discoloration of metals and in some instances rust.
Sterilization Parameters For Individual Instruments
1. Minimum validated sterilization time and temperature required to achieve a 10-6 sterility assurance level (SAL)
After use, this product may be a potential biohazard. Handle in accordance with accepted medical practice and applicable laws and regulations.