LEAP Instructions for Use
The LEAP device is for use by trained clinicians to provide intraoral lighting and retraction for illumination and observation during oral procedures.
Handling and Operation
- LEAP should be handled and operated by trained clinicians familiar with mouth retraction devices and props.
- Prior to each procedure, the LEAP device must be sterilized in an autoclave per the recommendations in the sterilization section of this IFU.
- If desired, lightly insert aspiration tubes into the aspiration attachment feature.
- Gently place the bite block into the patient’s mouth, in between the patient’s teeth with the LEDs facing into the mouth.
- The LEAP device should not be used after the light has been exhausted. This is the limit of the battery life of the device.
Cleaning and Sterilization
- DO NOT CLEAN IN AN ULTRASONIC CLEANER. This may result in a non-functional device.
- Rinse thoroughly after use to remove any blood, debris, or tissue. Failure to thoroughly rinse may affect sterilization. Device has not been tested in chemical sanitizing solutions.
- After rinsing, dry using a clean lint free cloth until visibly free of water droplets.
- Inspect LEAP after the cleaning and rinsing step for corrosion, and damaged surfaces. Do not use if instrument is damaged. If instruments are still dirty, rinse again.
- We recommend placement of the LEAP device into an FDA cleared Autoclave sterilization pouch of 3.5 inches x 5.25 inches or larger following the instructions by the pouch manufacturer.
Recommended Autoclave Sterilization Cycle:
- Dynamic-Air Removal : Minimum Temp: 270°F (134°C) Minimum Exposure: 15 minutes Minimum Dry Cycle: 20 minutes*
- Gravity: Minimum Temp: 250°F (121°C) Minimum Exposure: 30 minutes Minimum Dry Cycle: 25 minutes*
*Ensure device is dry before placing into storage.
Please store the device after sterilization at room temperature in a dry and dust free place in the clean section of the instrument processing area.