SATELEC Tips and Files Manual Pre-Disinfection and Cleaning and Sterilization Instructions

− Soiled devices should be separated from non-contaminated devices to avoid contamination of personnel or surroundings. − Wipe blood and/or debris from the tips or files to prevent it from drying onto the surfaces. Cover the tip or the file with a soft lint-free wipe dampened with purified water to prevent blood and/or debris from drying.

Containment and transportation Soiled devices must be transported separately from non-contaminated devices to avoid contamination.

Preparation for pre-disinfection/cleaning It is advisable to treat devices immediately or as soon as possible after use. Satelec devices must be treated within two hours of use. Before cleaning, unscrew the tip or the file at the front of the ultrasonic handpiece after each use.

Pre-disinfection/Cleaning – Manual method Equipment: soft-bristled brush, soft and lint-free swab, lint-free cloth, syringe, pipette and/or water jet, enzymatic or alkaline cleaning solution, ultrasonic cleaner. Step duration (minimum)

Cleaning instructions

1 minute

Rinse soiled device under cold running water. Use a soft-bristled brush or a soft and lint-free clean cloth to remove most of the contamination and debris. Use a syringe, a pipette or a water jet with an enzymatic or alkaline cleaning solution to rinse the tip cannulation.

10 minutes

In an ultrasonic cleaner, immerse the device in a freshly prepared enzymatic or alkaline cleaning solution.

1 minute

Rinse device under cold running water. Use a syringe, a pipette or a water jet to rinse the tip cannulation.

4 minutes

Manually wash device in a freshly prepared enzymatic or alkaline cleaning solution. Use a soft-bristled brush to remove soil and debris. Wash device under water to prevent aerosolization of contaminants.

1 minute

Thoroughly rinse device with distilled or purified water. Use a syringe, a pipette or a water jet to rinse the tip cannulation. Repeat rinsing. Repeat the pre-cleaning procedure until no visible contamination remains on device.

Cleaning instructions for SATELEC tips and files ● J02009 ● V1 ● (13) ● 11/2013 ● RB01US010A - Page 2/7 SATELEC • A company of ACTEON Group 17 av. Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • FRANCE Tel + 33 (0) 556 34 06 07 • Fax + 33 (0) 556 34 92 92 E-mail: [email protected] • www.acteongroup.com

Perform a final rinse of device using distilled or purified water. Dry the device with a soft, lint-free cloth or with clean compressed air.

Inspection − Devices must be inspected to check that no contamination remains, that they are not corroded, dulled, discoloured or damaged. − Before packaging and sterilizing the cleaned devices, check they are clean, undamaged and function properly. − Damaged devices must be discarded. Tips must not be lubricated.

Packaging Use suitable packaging for sterilization, such as a Sterile Barrier System in compliance with ISO 11607. Care should be taken to protect tips (or files) from contact with other objects that may damage their surface or the Sterile Barrier System.

Sterilization Unless otherwise specified, non-sterile products can be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed tips are as follows:

Cycle type

Sterilization exposure time

Sterilization exposure temperature

Drying time

Saturated steam forced air removal (pre-vacuum)

4 minutes

132°C

Minimum 20 minutes

Dry times generally range from 20 to 60 minutes due to the difference in packaging materials, steam quality, device materials, total mass, sterilizer performance, and varying cool-down time. The distributor and manufacturer accept no responsibility for sterilization procedures performed by the customer that are not performed according to these Satelec recommendations.

Storage Storage conditions for products labelled “STERILE” are printed on the packaging label. Packaged products should be stored in a dry, clean environment, protected from direct sunlight, pests, and extremes of temperature and humidity. Use products in the order in which they are received (“first in, first out” principle), taking into account the expiry date indicated on the label.

Page 3/7 - Cleaning instructions for SATELEC tips and files ● J02009 ● V1 ● (13) ● 11/2013 ● RB01US010A SATELEC • A company of ACTEON Group 17 av. Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • FRANCE Tel + 33 (0) 556 34 06 07 • Fax + 33 (0) 556 34 92 92 E-mail: [email protected] • www.acteongroup.com

Automated Pre-disinfection/Cleaning and Sterilization Instructions for SATELEC Tips and Files Cautions Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or with a high chlorine content. The pH of detergents/disinfectants must be between 7 and 11. The cleaning method for tips and files recommended by Satelec is manual or automated. All devices must be carefully cleaned and must be sterilized after cleaning prior to use. The sterilization parameters are only valid for correctly cleaned devices. Tips and files must be cleaned with extreme care. During automated cleaning, tips or files must be placed on suitable instrument holders or in small baskets to prevent them from damage during washing. It is the responsibility of the end user to ensure that all equipment used to treat Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for tips. Prevent the overloading of wash baskets for ultrasonic cleaning or cleaning in a washer/disinfector.

Cleaning/sterilization cycle limits Repeated treatment cycles that include ultrasonic cleaning, manual washing and sterilization have minimal effects on tips and files. End of service life is normally determined by wear and damage due to use.

Important − If the irrigation tubing is external or if configuring the device with tank, press the cleaning button on the device after each use and o Remove the perforator from the irrigation solution, and then immerse it in an enzymatic or alkaline cleaning solution. By pressing the flush button on the device, rinse the irrigation tubing, the handpiece and the tip (or the file) for 1 minute to prevent the drying of soil and debris inside the device. o Immerse the perforator in a distilled or purified water solution, rinse for 1 minute in order to eliminate the enzymatic or alkaline cleaning solution. o Remove the perforator from the distilled or purified water solution and purge the irrigation tubing to remove the liquid from the inside. − If the case of irrigation coming from the dental practice water network, clean and rinse the cord, the handpiece and the tip (or file) for 1 minute after each use. Cleaning instructions for SATELEC tips and files ● J02009 ● V1 ● (13) ● 11/2013 ● RB01US010A - Page 4/7 SATELEC • A company of ACTEON Group 17 av. Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • FRANCE Tel + 33 (0) 556 34 06 07 • Fax + 33 (0) 556 34 92 92 E-mail: [email protected] • www.acteongroup.com

− Soiled devices should be separated from non-contaminated devices to avoid contamination of personnel or surroundings. − Wipe blood and/or debris from the tips or files to prevent it from drying onto the surfaces. − Cover the tip or the file with a soft lint-free wipe dampened with purified water to prevent blood and/or debris from drying.

Containment and transportation Soiled devices must be transported separately from non-contaminated devices to avoid contamination.

Preparation for pre-disinfection/cleaning It is advisable to treat devices immediately or as soon as possible after use. Satelec devices must be treated within two hours of use. Before cleaning, unscrew the tip or the file at the front of the ultrasonic handpiece after each use.

Pre-disinfection/Cleaning – Automated method Pre-disinfection/pre-cleaning method Note: The manual pre-disinfection/pre-cleaning method has to be performed for the tips prior to automated cleaning. Equipment: soft-bristled brush, soft and lint-free swab, lint-free cloth, syringe, pipette and/or water jet, ultrasonic cleaner, washer/disinfector, enzymatic or alkaline cleaning solution. Step duration (minimum)

Cleaning instructions

1 minute

Rinse soiled device under cold running water. Use a soft-bristled brush or a soft and lint-free clean cloth to remove most of the contamination and debris. Use a syringe, a pipette or a water jet with an enzymatic or alkaline cleaning solution to rinse the tip cannulation.

Manually wash device in a freshly prepared enzymatic or alkaline cleaning 1 minute 30 seconds solution. Use a soft-bristled brush to remove soil and debris. Wash device under water to prevent aerosolization of contaminants. 1 minute

Rinse device under cold running water. Use a syringe, a pipette or a water jet to rinse the tip cannulation.

10 minutes

In an ultrasonic cleaner, immerse the device in a freshly prepared enzymatic or alkaline cleaning solution.

1 minute

Thoroughly rinse device with distilled or purified water. Use a syringe, a pipette or a water jet to rinse the tip cannulation. Repeat rinsing. Repeat the pre-cleaning procedure until no visible contamination remains on device.

Page 5/7 - Cleaning instructions for SATELEC tips and files ● J02009 ● V1 ● (13) ● 11/2013 ● RB01US010A SATELEC • A company of ACTEON Group 17 av. Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • FRANCE Tel + 33 (0) 556 34 06 07 • Fax + 33 (0) 556 34 92 92 E-mail: [email protected] • www.acteongroup.com

Automated cleaning method Step Pre-washing

Duration 2 minutes

Washing

10 minutes

Neutralization

2 minutes

Rinsing

2 minutes

Drying

40 minutes

Cleaning instructions Cold tap water Warm tap water (> 40°C); use alkaline or enzymatic cleaning solution Warm tap water with neutralizer, if necessary Rinse with warm distilled or purified water (>40°C) 90°C

Thermal disinfection For automated cleaning: thermal disinfection at 90°C for a minimum of 5 minutes.

Inspection −

Tips must be inspected to check that no contamination remains, that they are not corroded, dulled, discoloured or damaged. − Before packaging and sterilizing the cleaned products, check they are clean, undamaged and function properly. − Damaged tips must be discarded. Tips must not be lubricated.

Packaging Use suitable packaging for sterilization, such as a Sterile Barrier System in compliance with ISO 11607. Care should be taken to protect tips (or files) from contact with other objects that may damage their surface or the Sterile Barrier System.

Sterilization Unless otherwise specified, non-sterile products can be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed tips are as follows: Cycle type

Sterilization exposure time

Sterilization exposure temperature

Drying time

Saturated steam forced air removal (pre-vacuum)

4 minutes

132°C

Minimum 20 minutes

Dry times generally range from 20 to 60 minutes due to the difference in packaging materials, steam quality, device materials, total mass, sterilizer performance, and varying cool-down time. The distributor and manufacturer accept no responsibility for sterilization procedures performed by the customer that are not performed according to these Satelec recommendations.

Cleaning instructions for SATELEC tips and files ● J02009 ● V1 ● (13) ● 11/2013 ● RB01US010A - Page 6/7 SATELEC • A company of ACTEON Group 17 av. Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • FRANCE Tel + 33 (0) 556 34 06 07 • Fax + 33 (0) 556 34 92 92 E-mail: [email protected] • www.acteongroup.com

Storage Storage conditions for products labelled “STERILE” are printed on the packaging label. Packaged products should be stored in a dry, clean environment, protected from direct sunlight, pests, and extremes of temperature and humidity. Use products in the order in which they are received (“first in, first out” principle), taking into account the expiry date indicated on the label.

Page 7/7 - Cleaning instructions for SATELEC tips and files ● J02009 ● V1 ● (13) ● 11/2013 ● RB01US010A SATELEC • A company of ACTEON Group 17 av. Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • FRANCE Tel + 33 (0) 556 34 06 07 • Fax + 33 (0) 556 34 92 92 E-mail: [email protected] • www.acteongroup.com