LEAP Instructions for Use

Intended Use
The LEAP device is for use by trained clinicians to provide intraoral lighting and retraction for illumination and observation during oral procedures.

Product Features

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.

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.