Like all medical electrical equipment, the R2i3 scanner requires both correct operation and regular inspections to ensure accuracy, safety, and efficiency.
The operator must inspect the handpiece body and cables for physical damage before every session.
If the system performs differently than usual or shows signs of wear, contact MegaGen immediately to report the issue.
Scanner Tip: Cleaning and Sterilization
1. Manual Cleaning
Before sterilization, the scanner tip must be thoroughly cleaned:
Remove the scanner tip from the handpiece.
Clean the tip and the optical lens using running water followed by 75% medical-grade alcohol. Ensure all dirt, oil, and spots are removed from the lens.
Dry the tip and lens thoroughly using a soft, non-woven cloth and a clean cotton swab.
2. High-Temperature & High-Pressure Sterilization (Autoclave)
Place the cleaned scanner tip into a dedicated sterilization pouch and seal it. Use one of the following validated cycles:
Option A: 134°C for at least 3.5 minutes.
Option B: 121°C for at least 15 minutes.
Post-Sterilization: Store according to your local infection control protocols. If using a tip immediately after autoclaving, allow it to cool to room temperature for at least 30 minutes before installation.
Note: The scanner tip is a consumable item. It is rated for approximately 100 sterilization cycles.
3. Immersion Disinfection (High-Level Disinfection)
If autoclaving is not used, the tip may be disinfected via immersion:
Submerge the scanner tip in a CIDEX OPA solution (0.55% o-phthalaldehyde) for a minimum of 5 minutes.
Dry the tip and lens with a non-woven cloth and dust-free cotton swab. Use the tip immediately after drying to avoid secondary contamination.
Criteria for Disposal
Replace the scanner tip immediately if any of the following are observed:
The outer shell of the tip is cracked or broken.
The contact reeds (metal connectors) have fallen off or are loose.
The optical lens is cracked.
The lens has permanent spots or debris that cannot be removed through cleaning.
Important Maintenance Notes
During immersion disinfection, the scanner tip must be placed vertically in the disinfectant solution. Ensure the tip is completely dried immediately after removal.
The scanner tip must be sterilized or disinfected prior to its first use and between every patient to prevent cross-contamination.
Scanner Handpiece Maintenance
Cleaning and Disinfection
To maintain the integrity of the handpiece, follow this daily cleaning routine:
Wipe the handpiece cover with a clean cotton cloth lightly dampened with mild soapy water.
Immediately remove any soap residue with a damp cloth (do not allow soap to sit on the surface) and dry thoroughly with a clean, dry cloth.
Use a soft, non-woven cloth dampened with 75% medical-grade alcohol to wipe the surface of the handpiece.
Allow the handpiece to air dry naturally or use a fresh, dry non-woven cloth to remove any residual alcohol.
CAUTION: Damage Prevention
Do not use harsh cleaning materials or abrasive scrubs that could scratch or damage the surface covers.
Do not allow liquids to enter the internal housing of the device, as this will cause permanent mechanical and electronic damage.
Pay close attention to the connection ports and the optical window shown in the figure below.
Cleaning and Disinfection of the Scanner Protection Window
The protection window is a critical optical component. Maintain its clarity by following these steps:
Use a lint-free cotton swab lightly dampened with 75% medical-grade alcohol. Gently wipe the surface of the protective window to remove any fingerprints, dust, oil, or debris.
Immediately follow with a fresh, dry lint-free swab to dry the surface and prevent streaks or water spots.
CAUTION
The protective window is a high-precision optical element. Handle it with extreme care to avoid scratches or misalignment.
Do not oversaturate the swab. Ensure no excess liquid flows into the seams of the handpiece housing, as this can damage the internal imaging sensors.
