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4.2 Instructions for Disinfecting/Sterilizing the CliXdish

Warnings

• Do not allow the device to exceed 134° C.

• The Prime&Bond elect Adhesive Unit Dose container and flocked applicator tip are intended for single use only. Do not attempt to reprocess and/or re-

use.

Limitations on Reprocessing

• The CliXdish mixing well can be subjected to the cleaning, disinfection, and sterilization process up to 20 times.

• Cold liquid disinfection/sterilization, chemical vapor sterilization, and dry heat sterilization methods have not been tested or validated for efficacy and are

not recommended for use.

Point of Use

• Remove excess soil with disposable cloth / paper wipe.It is recommended that the CliXdish mixing well is reprocessed as soon as is reasonably practical

following use.

Containment & Transportation

• No particular requirements.

Cleaning & Disinfection:

• Use only a properly maintained, inspected, calibrated, and approved washer/disinfector (according to ISO 15883). Perform a cleaning program cycle

Automated

(the following cycle is recommended):

• 1 minute pre-wash / rinse in cold tap water.

• 5 minutes wash with enzymatic detergent at 55° C.

• 1 minute enzymatic neutralization in cold tap water.

• 1 minute rinse in cold tap water.

• Thermal disinfection with minimum A0 of 3000 (e.g. 5 minutes at 90°C).

• 20 minutes drying at 100°C.

• Follow manufacturer's recommendation for use of detergent and neutralizer, observing concentrations and contact times.

Cleaning & Disinfection:

• As an alternative to automated cleaning and disinfection, the CliXdish mixing well has to be cleaned by scrubbing with hot water and soap or detergent.

Manual

• After cleaning thoroughly wipe all device surfaces with a single-use cloth in combination with an alcohol-based, bactericidal, virucidal and fungicidal

disinfection solution approved according to local regulations and use according to disinfectant solution manufacturer's Instructions for Use. Make sure

disinfectant solution is compatible with cleaning solution. Pay special attention to device seams and insertions.

• Remove disinfectant solution residue with a cloth soaked with water.

• Dry device with a lint-free single-use cloth

Packaging

• Paper/plastic steam sterilization pouches may be used, but are not required.

Sterilization

• Use a steam autoclave. Do not exceed 134°C.

• Steam autoclaving – Full cycle: wrapped or unwrapped at 134°C, 2 bar/273°F, 29 psi for 3 minutes.

Drying

• Use the drying cycle of the autoclave. Do not exceed 134°C.

• Allow the CliXdish mixing well to fully dry before storage.

Maintenance

• If the CliXdish mixing well is damaged, worn, or distorted it should be discarded.

Storage

• Store the CliXdish mixing well at room temperature, away from moisture or excessive humidity. CliXdish mixing well should be disinfected/sterilized and

dried prior to storage.

Manufacturer Contact

• Within the United States, call DENTSPLY at 1-302-422-4511. For areas outside the United States, contact your local DENTSPLY representative.

5. LOT NUMBER

ND EXPIR TION D TE

1. Do not use after expiration date. ISO standard uses: "YYYY/MM"

2. The following numbers should be quoted in all correspondence:

• Reorder Number

• Lot number

• Expiration date

Manufactured by:

DENTSPLY