Cleaning, Disinfection & Sterilization Instructions

Procedure “A”

Basic Principles:

• All products are supplied non-sterile and may be appropriately cleaned, disinfected, and sterilized before use.
• Ensure equipment used is serviced and checked regularly, and manufacturer’s use instructions are followed.
• Please heed regulations applicable to your country.
• Repeated reprocessing may affect the product. Decommissioning of the device is normally determined by wear and damage prior to use.
• Avoid contact of dissimilar metals at any point during the cleaning & sterilization process. 

Cleaning:

• Products should be cleaned as soon as possible after use to prevent soils from hardening.
• Remove all visible debris after use and prior to sterilization.
• Product can be manually cleaned with IMS® Daily Clean*, following manufacturer’s instructions.
• Use a nylon brush or similar soft brush. For FX400, FX500, FX600, 3D500, 3D600, & 3DXR: Take care not to damage the Soft-Face™ during cleaning.
• You may optionally pre-soak the contaminated rings with IMS® Daily Clean*, following the manufacturer’s instructions, for up to 6 minutes to aid in manual cleaning.
• DO NOT expose product to solutions containing chemicals such as alcohol, acetone, ketone, or other harsh chemical disinfectants.
• Visually inspect product for damage (eg. rust and cracking). Remove from service if damage is present.
• If any visible debris remains, repeat process above as needed.

Sterilization:

• Process product through steam autoclave and store only in CE/FDA approved sterilization pouch.
• Steam autoclave sterilization only. Perform one cycle at 270°F (132°C) and 30.46 psi (210kPa) for 6 minutes, following the autoclave manufacturer’s instructions, with a 20–30 minute drying time. Never exceed temperatures of 278.6°F (137°C).
• DO NOT use chemical sterilization techniques.

Storage:

• Store sterilized product in a dry and dust free location.
• Keep product sealed in the sterilization pouch until ready to use. 

Procedure “B”

Basic Principles:

• All products are supplied non-sterile and may be appropriately sterilized before use.
• Ensure equipment used is serviced and checked regularly, and manufacturer’s use instructions are followed.
• Please heed regulations applicable to your country.
• Products are single use only and cannot be reprocessed.
• Avoid contact of dissimilar metals at any point during the sterilization process.

Sterilization:

• Process product through steam autoclave and store only in CE/FDA approved sterilization pouch.
• Steam autoclave sterilization only. Perform one cycle at 270°F (132°C) and 30.46 psi (210kPa) for 6 minutes, following the autoclave manufacturer’s instructions, with a 20–30 minute drying time. Never exceed temperatures of 278.6°F (137°C).
• DO NOT use chemical sterilization techniques.

Storage:

• Store sterilized product in a dry and dust free location.
• Keep product sealed in the sterilization pouch until ready to use.

Procedure “C”

Cleaning:

• Instrument must be in open position. Take care not to damage tips.
• Remove visible debris or organic matter from the instrument and surface with a disposable wipe or surface brush. This is to be done by scrubbing with warm tap water and soap or detergent.
• Inspect instrument for debris. Repeat cleaning if there is debris left.
• All external surfaces must be wiped with a lint-free cloth or sprayed with a suitable disinfectant.
• Rinse external surfaces with warm tap water.
• Dry instrument.
• Do not immerse the instrument in liquid or place it in an ultrasonic cleaning unit.

Sterilization:

• Sterilize in a steam autoclave using distilled water at a temperature of 134°C (273°F) for 3 minutes.
• Sterilization is NOT a substitute for proper cleaning. Clean the instrument first then sterilize it.
• Do not use cold sterilization methods that involve soaking the instrument in a liquid.

Storage:

• Store sterilized product in a dry and dust free location.
• Keep product sealed in the sterilization pouch until ready to use.

Procedure “F”

Basic Principles:

• All products are supplied non-sterile and may be appropriately sterilized before use.
• Ensure equipment used is serviced and checked regularly, and manufacturer’s use instructions are followed.
• Please heed regulations applicable to your country.
• Products are single use only.

Sterilization:

• Moist heat sterilization with fractional prevacuum. Full cycle, 134°C (273°F) / 3.1 bar (45 psi) for at least 5 minutes, drying time 10 minutes. Do not exceed 135°C (275°F). IMPORTANT: Use suitable packaging for sterilization.
• Warning: not suitable for sterilization with hot air or chemiclave. This procedure was validated by an independent and accredited laboratory.

Storage:

• A dry, dust-free storage at 2–28°C (36–82°F) is recommended. Improper storage conditions can shorten the shelf life and cause malfunction of the product. 
   

Procedure “G”

Cleaning During Use:

• The Loop™ handpiece, charging base and light shield are not autoclavable and no portion can be sterilized. Only use approved disinfecting solutions. Refer to Section “Cleaning After Use”.
• To keep the Loop™ handpiece clean and functioning properly, a new barrier sleeve should be used for each patient. Only use Loop™ barrier sleeves that are specifically designed for use with the Loop™ curing light.
• The supplied Loop™ lens cleaning cloth should be used exclusively for drying the lens after cleaning.

Cleaning After Use:

• Only use approved disinfecting solutions. If using a spray, do not spray the disinfecting solution directly on the device. Instead, spray or moisten a gauze or soft cloth with disinfecting solution and use it to wipe down and clean the unit. This ensures that significant amounts of disinfectant solution do not wick into the seams of the unit. When f inished, dry any residual disinfectant solution remaining on the surface of the handpiece with a soft cloth. Do not use the supplied Loop™ lens cleaning cloth for anything other than drying the lens after cleaning
• Approved disinfectant solutions:
  • Lysol® Brand III Disinfectant Spray
  • Lysol® disinfectant or Lysol® concentrate (alcohol-based only)
  • Cavicide™ non-bleach products
  • Isopropyl alcohol
  • FD 366 (Dürr Dental)
• CAUTION: Do not use a metal edged instrument on the OLED display screen.

Cleaning the Lens:

Inspect the lens after each cleaning. If contaminates are found on the lens or the OLED Display Screen shows a failure for a Self-Check Dirty Lens Detection, carefully clean with the following method:

1. Clean the lens with a dry Loop™ lens cleaning cloth. If this does not clean the lens, then proceed to the next step.
2. Buff the lens surface with your regular disinfectant solution or isopropyl alcohol and a soft cloth using light pressure in a circular motion. If this does not remove the dental material or contaminant, then proceed to the next step.
3. Use a metal edged (non-diamond tipped) dental instrument to apply lateral pressure to the side and/or edge of the cured dental material that has bonded to the lens. Take care to not scratch the lens and avoid repeated scraping motions to clear away the cured dental material.
4. Repeat Steps 1-2. Surface is now ready for use.

Cleaning the Charging Base:

Clean every few weeks or as needed. Carefully clean with the following method:

1. Temporarily disconnect the charging base from the power supply cord.
2. For cleaning, refer to Section “Cleaning After Use.”
3. Make sure that the charging pins and surrounding area are completely dry when finished. You may use compressed air or gentle use of a dry soft cloth. Take care to not bend the charging pins when drying.
4. Reconnect the power supply cord to the charging base.

Cleaning the Self-Check & Calibration Surfaces:

On the charging base, there are two calibration surfaces that should be cleaned. Clean once per year or if having problems with Calibration.

Black surface used for Self-Check Dirty Lens Detection: Clean the Self-Check Dirty Lens Detection surface with air blow-off only. Use sufficiently to remove all dust and debris. In most cases, nothing more will be required to keep the black surface functional. In cases of severe contamination, the use of a mild surface cleaner like Sparkle™ or Windex™ may be gently applied via a cotton swab if followed with a gentle rinse of distilled water and dried with clean compressed air.

White surface used for Calibration: Cleaning of the white calibration surface is rarely needed due to its protected location, but the process requires more care:

1. Carefully clean the white surface with the supplied Loop™ lens cleaning cloth. If this does not fully clean the surface, then proceed to the next step.
2. Do not use sprays or cleaners other than what is prescribed. Gently wipe with gauze or a towelette saturated with Sparkle™ or Isopropyl Alcohol. Wipe in a gentle circular motion.
3. Repeat the above step using distilled water.
4. Blow off with compressed air and allow 5 minutes additional dry time. Surface is now ready for use.