SATELEC Wrenches Manual Pre-Disinfection, Cleaning and Sterilization Instructions

Step duration (minimum)

I

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.

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.

2 minutes seconds

1 minute

30

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

Thoroughly rinse device with distilled or purified water. Repeat the manual cleaning procedure until no visible contamination remains on device.

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

Inspection  Wrenches 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 wrenches must be discarded. Wrenches 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 wrenches 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 wrenches are as follows:

Page 2/6 – Cleaning instructions of SATELEC wrenches ● J81009 ● V1 ● (13) ● 11/2013 ● RA14US010A 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

Cycle type

Sterilization exposure time

Saturated steam forced air removal 4 minutes (pre-vacuum)

Sterilization exposure temperature 132℃

Dry time

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.

Cleaning instructions of SATELEC wrenches ● J81009 ● V1 ● (13) ● 11/2013 ● RA14US010A - Page 3/6 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 all SATELEC Wrenches 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 wrenches 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. Wrenches must be cleaned with extreme care. 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 wrenches. 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 wrenches. End of service life is normally determined by wear and damage due to use.

Important  Soiled devices should be separated from non-contaminated devices to avoid contamination of personnel or surroundings.  Wipe blood and/or debris from the wrenches to prevent it from drying onto the surfaces.  Cover the wrench with a soft lint-free cloth 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.

Pre-disinfection/pre-cleaning method Note: The pre-disinfection/pre-cleaning method has to be performed for the wrench prior to automated cleaning. Equipment: soft-bristled brush, soft lint-free swab, lint-free cloth, ultrasonic cleaner, washer/disinfector, enzymatic or alkaline cleaner. Page 4/6 – Cleaning instructions of SATELEC wrenches ● J81009 ● V1 ● (13) ● 11/2013 ● RA14US010A 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

Step duration (minimum)

Cleaning instructions

30 seconds

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.

1 minute

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

30 seconds

Rinse device under cold running water.

8 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. Repeat the pre-cleaning procedure until no visible contamination remains on device.

Automated cleaning method Step Pre-washing

Duration (minimum) 2 minutes

Washing

2 minutes

Neutralization

5 minutes

Rinsing

2 minutes

Drying

40 minutes

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

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

Inspection  Wrenches 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 wrenches must be discarded. Wrenches must not be lubricated. Cleaning instructions of SATELEC wrenches ● J81009 ● V1 ● (13) ● 11/2013 ● RA14US010A - Page 5/6 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

Packaging Use suitable packaging for sterilization, such as a Sterile Barrier System in compliance with ISO 11607. Care should be taken to protect wrenches 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 wrenches are as follows: Cycle type

Sterilization exposure time

Saturated steam forced air removal 4 minutes (pre-vacuum)

Sterilization exposure temperature 132°C

Drying time

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 6/6 – Cleaning instructions of SATELEC wrenches ● J81009 ● V1 ● (13) ● 11/2013 ● RA14US010A 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