Cleaning, Disinfection & Sterilization Instructions

This cleaning, disinfection and sterilization guide has been provided in accordance with ISO 17664, covering the proper techniques necessary to ensure Garrison® Dental Solutions’ product will be suitable for safe and optimal use. 
 

Failure to follow the stated procedure may result in product failure, premature wear and/or non-optimal performance.

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How to use this guide:

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 “D”

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 inspection for wear and damage prior to use.
• Avoid contact of dissimilar metals at any point during the cleaning & sterilization process to prevent corrosion.

Notices:

• Avoid the use of strong acids and bases as they may oxidize the stainless steel shaft.
• Rinse with distilled water after treatment with cleaning and disinfectant solutions.
• Avoid temperatures >150°C (302°F).
• Ultrasonic bath temperatures must not exceed temperatures of 42°C (107°F) to avoid possible coagulation of proteins resulting from blood and tissue.
• The label on the cleaning and/or disinfecting solution MUST specifically say “suitable for rubber polishers or synthetics/silicones.”

Point of Use:

• Products should be cleaned as soon as possible after use to prevent soils from hardening.

  Pre-clean under running water with a plastic bristle brush.

Manual Cleaning:

• Under running water with a plastic bristle brush.
• Optional — Ultrasonic assisted cleaning with a suitable cleaning agent and disinfectant. Rinse afterwards under running water.

Automatic Cleaning:

• Thermal disinfector — Manufacturer’s specification according to EN ISO 15883 using the cleaning program as indicated by the manufacturer’s operating instructions. 

Disinfection:

• Use a solution classified suitable for rubber and silicone polishers/synthetics by the manufacturer. Follow manufacturer’s recommendations for exposure times and concentrations.
• Rinse with distilled water after treatment with cleaning and disinfectant solutions.

Drying:

• Dry with fresh, clean, lint-free cellulose tissues.

Inspection:

• Visually check all instruments for cleanliness and safe suitability of use with 5–10X magnification. Repeat cleaning if necessary. Decommission and dispose of instruments in the event of discernible defects.

Sterilization:

• Steam Autoclave according to manufacturer’s operating instructions using a hold time of 5 minutes full cycle, a sterilization temperature of 134°C (273°F) and a drying time of 10 minutes.

Storage:

• Store instruments packed and protected in suitable sterile packaging, cassettes or retainers in dry, clean conditions at ambient temperature.

Validated Materials:

Manual Cleaning — Durr Dental ID 212, 2% concentration, 5 minute holding time

Ultrasonic — Durr Dental ID 212 ready made solution, 2% concentration, 2 minute holding time

Automatic Cleaning — Miele G 7883, Special Program 93°C (199°F) for 10 minutes, 10 minute holding time, detergent — Dr. Weigert neodisher MediClean Dental, rinsing for 3 minutes at 75°C (167°F) with neodisher Z Dental

Sterilization — Holding time full cycle 5 minutes, sterilization temperature 134°C (273°F), drying time 10 minutes, threshold values of contents for feed-water and steam condensates

Procedure “E”

Basic Principles:

• Products are single use only and cannot be reprocessed.

Sterilization:

• DO NOT clean or sterilize as this will affect the astringent coating.

Storage:

• Store in original packaging in a cool dry location.
• Do not mix in with similar products.

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.