cleaning, decontamination and sterilization protocols for all

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

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CLEANING, DECONTAMINATION AND STERILIZATION PROTOCOLS FOR ALL SATELEC ACCESSORIES




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CONTENTS:

PIEZOTOME HANDPIECE: ............................................................................................................. 3

Manual Cleaning, Decontamination and Sterilization Instructions for SATELEC Piezotome Handpiece-Cord assembly and Nosepiece ............................................................................................................ 3

Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC Piezotome Handpiece-Cord assembly and Nosepiece ..................................................................................................... 7

PIEZOTOME II HANDPIECE: ......................................................................................................... 11

Manual Cleaning, Decontamination and Sterilization Instructions for SATELEC Piezotome II Handpiece-cord assembly, Nosepiece, Optical guide and LED ring .......................................................................... 11

Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC Piezotome II Handpiece-cord assembly, Nosepiece, Optical guide and LED ring .................................................................... 15

SUPRASSON OR NEWTRON HANDPIECE: ........................................................................................ 19

Manual Cleaning, Decontamination and Sterilization Instructions for SATELEC Suprasson or Newtron Handpiece and Nosepiece ......................................................................................................... 19

Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC Suprasson or Newtron Handpiece and Nosepiece ......................................................................................................... 23

NEWTRON LED HANDPIECE: ....................................................................................................... 27

Manual Cleaning, Decontamination and Sterilization Instructions for SATELEC Handpiece LED Nosepiece, Optical guide and LED ring ....................................................................................................... 27

Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC LED Handpiece, Nosepiece, Optical guide and LED ring ........................................................................................ 31

ULTRASONIC TIPS: .................................................................................................................. 35

Manual Cleaning, Decontamination and Sterilization Instructions for Satelec Ultrasonic Tips ................. 35

Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC Ultrasonic Tips ........... 38

WRENCHES: ........................................................................................................................... 42

Manual Cleaning, Decontamination and Sterilization Instructions for all Satelec Wrenches .................... 42

Automated Cleaning, Decontamination and Sterilization Instructions for all SATELEC Wrenches .............. 45

TUBING AND CLIPS: ................................................................................................................. 49

Manual Cleaning/Decontamination and Sterilization Protocol for Satelec Autoclavable Irrigation Tubing and Clips .................................................................................................................................... 49

I-SURGE: ............................................................................................................................... 51

I-Surge: Cleaning protocols (manual and automated), decontamination and sterilization ....................... 51

I-SURGE LED: ......................................................................................................................... 56

I-Surge: Cleaning protocols (manual and automated), decontamination and sterilization ....................... 56




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PIEZOTOME HANDPIECE: Manual Cleaning, Decontamination and Sterilization Instructions for SATELEC Piezotome Handpiece-Cord assembly and Nosepiece

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Piezotome Handpiece-cord assembly is manual and mechanical. The Handpiece-cord assembly and its nosepiece require particular attention during cleaning. Do not place Satelec Piezotome Handpiece-cord assembly in an ultrasonic cleaner. Note: Ultrasonic cleaning may cause further damage to devices that have prior surface damage. Note: The Ultrasonic process is for Nosepiece only. The Handpiece-cord assembly should not be exposed to ultrasonic cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Handpiece and its nosepiece. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include manual washing and sterilization have minimal effects on the Piezotome Handpiece-cord assembly. Repeated processing cycles that include ultrasonic, manual washing and sterilization have minimal effects on the Piezotome Nosepiece. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.

Points of use of care

Pull the perforator out of the irrigant solution. Plunge the perforator into an enzymatic or alkaline cleaner solution. With the flush button of the Piezotome device, flush the irrigation tubing, the handpiece and

the tip for 1 min after each use to prevent the drying of soil and/or debris inside the unit. Plunge the perforator into a deionized (DI) or purified (PURW) water solution and with the flush

button, rinse for 1 min in order to eliminate the enzymatic or alkaline cleaner. Purge the irrigation tubing to eliminate the liquid inside. Soiled devices should be separated from non-contaminated devices to avoid contamination of

personnel or surroundings. Wipe blood and/or debris from the Handpiece to prevent it from drying onto the surface. Handpiece should be covered with a towel dampened with purified water to prevent blood

and/or debris from drying.




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Containment and Transportation Soiled devices should be transported separate from non-contaminated devices to avoid contamination Preparation for cleaning/decontamination Clean and sterilize instruments as soon as possible after use (Satelec devices should be reprocessed no more than two hours after use).

After each use and prior to cleaning: o Unscrew the tip at the front of the Piezotome Handpiece-cord assembly and place it in

the appropriate container. The cleaning of the tip is subject to a separate protocol. o Remove the irrigation single-use or autoclavable tubing and the autoclavable clips from

the handpiece cord assembly. The autoclavable irrigation tubing and autoclavable clips are subject to a separate protocol. In any case, discard the single-use perforator and/or single-use irrigation tubing.

o Unscrew the nosepiece.

Manual Cleaning Method

Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, Ultrasonic cleaner, enzymatic or alkaline cleaner

Step Duration (minimum)

Cleaning instructions

1.

1 minute

Rinse soiled device under running cold tap water for a minimum of two minutes. Use a soft-bristled brush and/or lint-free swab to assist in the removal of gross soil and debris. Use a syringe or pipette or water jet to flush the cannulation with an Enzymatic or Alkaline cleaner solution

2.

10 minutes

Soak device in an enzymatic or alkaline cleaner for a minimum of ten minutes. Follow the cleaner manufacturer's instructions for use for correct exposure time, temperature, water quality (i.e. pH, hardness) and concentration.

3.

2 minutes

Rinse device with cool to lukewarm water for a minimum of two minutes. Use a syringe or pipette or water jet to flush the cannulation with tap water

4.

5 minutes

Manually clean device for a minimum of five minutes in a freshly prepared enzymatic or alkaline cleaner solution. Use a soft-bristled brush to remove soil and debris on the Nosepiece and the threaded fitting.

Gently use a lint-free swab to remove soil and




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debris on the inside of the Nosepiece. Clean device under water to prevent aerosolization of contaminants.

2 minutes

Rinse device thoroughly with deionized (DI) or purified (PURW) water for two minutes.

2 minutes

Manually clean device for a minimum of two minutes in a neutral pH detergent solution Use a soft-bristled brush for the Nosepiece and the threaded fitting. Gently use a lint-free swab to remove soil and debris on the inside of the Nosepiece. Clean device under water to prevent aerosolization of contaminants.

2 minutes

Use a syringe or pipette or water jet to flush the cannulation with deionized or purified water and rinse device thoroughly with deionized or purified water for two minutes.

Visually inspect device.

Visually inspect device. Repeat the manual cleaning procedure until no visible soil remains on devices.

Final Rinse Perform a final rinse on device using DI or PURW.

Drying Dry device using a soft, lint free cloth or clean compressed air.

Inspection

Processed Handpiece and Nosepiece must be inspected for corrosion, damage such as scratches and notches, discoloration, or residue. Damaged devices should be discarded. Devices should not be lubricated.

Before the cleaned products are packaged and sterilized, carefully examine them to see if they are clean, undamaged and function properly. Repeat cleaning steps until no visible soil remains on device.

Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.

Packaging Use an appropriate sterilization wrap or re-usable rigid container system for sterilization, such as a Sterile Barrier System according to ISO 11607. Care should be taken to protect tips from contact with other objects that may damage the surface or the Sterile Barrier System.




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Sterilization If not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed Handpieces and Nosepiece are as follows.

Cycle type Sterilization exposure

time Sterilization

exposure temperature Dry 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 differences in packaging materials (Sterile Barrier System, e.q., wraps or re-usable rigid container systems), 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 labeled "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 note of any expiration date on the label.

Olivier Petit Quality System Manager




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Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC Piezotome Handpiece-Cord assembly and Nosepiece

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Piezotome Handpiece-cord assembly is manual and mechanical. The Handpiece-cord assembly and its nosepiece require particular attention during cleaning. Do not place Satelec Piezotome Handpiece-cord assembly in an ultrasonic cleaner. Note: Ultrasonic cleaning may cause further damage to devices that have prior surface damage. Note: The Ultrasonic process is for Nosepiece only. The Handpiece-cord assembly should not be exposed to ultrasonic cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Handpiece and its nosepiece. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include mechanical washing and sterilization have minimal effects on the Piezotome Handpiece-cord assembly. Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effects on the Piezotome Nosepiece. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.


Pull the perforator out of the irrigant solution. Plunge the perforator into an enzymatic or alkaline cleaner solution. With the flush button of the Piezotome device, flush the irrigation tubing, the handpiece and

the tip for 1 min after each use to prevent the drying of soil and/or debris inside the unit. Plunge the perforator into a deionized (DI) or purified (PURW) water solution and with the flush

button, rinse for 1 min in order to eliminate the enzymatic or alkaline cleaner. Purge the irrigation tubing to eliminate the liquid inside. Soiled devices should be separated from non-contaminated devices to avoid contamination of



Containment and Transportation Soiled devices should be transported separate from non-contaminated devices to avoid contamination




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Preparation for cleaning/decontamination Clean and sterilize instruments as soon as possible after use (Satelec devices should be reprocessed no more than two hours after use).

After each use and prior to cleaning: o Unscrew the tip at the front of the Piezotome Handpiece-cord assembly and place it in


the handpiece cord assembly. The autoclavable irrigation tubing and autoclavable clips are subject to a separate protocol.

o In any case, discard the single-use perforator and/or single-use irrigation tubing. o Unscrew the nosepiece.

Automatical Cleaning Method

Pre-cleaning method Note: The manual pre-cleaning method has to be performed for handpiece and nosepiece prior to automated cleaning Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, Ultrasonic cleaner, Washer/disinfector, enzymatic or alkaline cleaner

Note: Ultrasonic process: for nosepiece only.



1.

1 minute

1. Rinse soiled device under running cold tap water for a minimum of one minute. Remove gross soil using a soft- bristled brush, a lint-free swab or soft, lint-free cloth.

Use a syringe or pipette or water jet to flush the cannulation with an Enzymatic or Alkaline cleaner solution

2.

2 minutes

Manually clean device for a minimum of two minutes in a freshly prepared enzymatic or alkaline cleaner solution. Follow the cleaner manufacturer's instructions for the correct dilution, temperature, water quality (i.e. pH, hardness) and exposure time. Use a soft-bristled brush to remove soil and debris on the Nosepiece, handpiece-cord assembly and the threaded fitting. Gently use a lint-free swab to remove soil and debris on the inside of the Nosepiece. Clean device under water to prevent aerosolization of contaminants.




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3.

1 minutes

Rinse device using cool to lukewarm running tap water for a minimum of one minute. Use a syringe, pipette or water jet to flush cannulation with tap water.

4.

15 minutes

Ultrasonic process: for nosepiece only. Clean device ultrasonically for 15 minutes in an enzymatic or alkaline cleaner solution.

2 minutes

Rinse device cool to lukewarm running tap water for a minimum of two minutes. Use a syringe, pipette or water jet to flush Handpiece cannulation.

Visually inspect device. Visually inspect device. Repeat steps until no visible soil remains on device.

Automated cleaning method

Step Step duration (minimum) cleaning/decontamination instructions

Pre-cleaning 2 minutes Cold tap water

Cleaning 2 minutes Warm tap water (> 40°C); use alkaline or

enzymatic cleaner solution Neutralization 5 minutes Warm tap water with neutralizer, if necessary

Rinsing 2 minutes Rinse with warm DI or PURW (>40°C) Drying 40 minutes 90°C

Thermal Disinfection For automated cleaning, thermal disinfect at 90°C for a minimum of 5 minutes. Inspection







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Sterilization If not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed Handpieces and Nosepiece are as follows.


time Sterilization



(pre-vacuum)








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PIEZOTOME II HANDPIECE: Manual Cleaning, Decontamination and Sterilization Instructions for SATELEC Piezotome II Handpiece-cord assembly, Nosepiece, Optical guide and LED ring

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Piezotome handpiece-cord assembly is manual and mechanical. The components of the Handpiece (nosepiece, LED ring and plastic optical guide) require particular attention during cleaning. Do not place Satelec Piezotome handpiece-cord assembly in an ultrasonic cleaner. Note: Ultrasonic cleaning may cause further damage to devices that have prior surface damage. Note: The Ultrasonic process is for Nosepiece only. The Handpiece-cord assembly, LED ring and Optical Guide should not be exposed to ultrasonic cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Handpiece and accessories. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include manual washing and sterilization have minimal effects on the Piezotome II Handpiece-cord assembly, optical guide and LED ring. Repeated processing cycles that include ultrasonic, manual washing and sterilization have minimal effects on the Piezotome Nosepiece. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.


Pull the perforator out of the irrigant solution. Plunge the perforator into an enzymatic or alkaline cleaner solution. With the flush button of the Piezotome II device, flush the irrigation tubing, the handpiece and

the tip for 1 min after each use to prevent the drying of soil and/or debris inside the unit. - Plunge the perforator into a deionized (DI) or purified (PURW) water solution and with the flush

button, rinse for 1 min in order to eliminate the enzymatic or alkaline cleaner. - Purge the irrigation tubing to eliminate the liquid inside. Soiled devices should be separated from non-contaminated devices to avoid contamination of

personnel or surroundings. Wipe blood and/or debris from the Handpiece to prevent it from drying onto the surface.




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Handpiece should be covered with a towel dampened with purified water to prevent blood and/or debris from drying.


After each use and prior to cleaning: o Unscrew the tip at the front of the Piezotome II Handpiece-cord assembly and place it

in the appropriate container. The cleaning of the tip is subject to a separate protocol. o Remove the irrigation single-use or autoclavable tubing and the autoclavable clips from


o Unscrew the nosepiece. o Remove the Optical guide. o Disconnect the LED ring from the Piezoelectric Handpiece, pulling it gently.


Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, Ultrasonic cleaner, enzymatic or alkaline cleaner



1.

1 minute

Rinse soiled device under running cold tap water for a minimum of two minutes. Use a soft-bristled brush and/or lint-free swab to assist in the removal of gross soil and debris. Use a syringe or pipette or water jet to flush the cannulation with an Enzymatic or Alkaline cleaner solution

2.

10 minutes

Soak device in an enzymatic or alkaline cleaner for a minimum of ten minutes. Follow the cleaner manufacturer's instructions for use for correct exposure time, temperature, water quality (i.e. pH, hardness) and concentration.

3.

2 minutes

Rinse device with cool water for a minimum of two minutes. Use a syringe or pipette or water jet to flush the cannulation with tap




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water

4.

6 minutes

Manually clean device for a minimum of five minutes in a freshly prepared enzymatic or alkaline cleaner solution. Use a soft-bristled brush to remove soil and debris on the Nosepiece, Optical guide, LED ring, handpiece-cord assembly and the threaded fitting.

Gently use a lint-free swab to remove soil and debris on the inside of the Nosepiece, Optical guide and LED ring. Clean device under water to prevent aerosolization of contaminants.

2 minutes

Rinse device thoroughly with deionized (DI) or purified (PURW) water for two minutes.

2 minutes

Manually clean device for a minimum of two minutes in a neutral pH detergent solution Use a soft-bristled brush for the Nosepiece, Optical guide, LED ring, handpiece-cord assembly and the threaded fitting. Gently use a lint-free swab to remove soil and debris on the inside of the Nosepiece, Optical guide and LED ring. Clean device under water to prevent aerosolization of contaminants.

2 minutes

Use a syringe or pipette or water jet to flush the cannulation with deionized or purified water and rinse device thoroughly with deionized or purified water for two minutes.



Final Rinse Perform a final rinse on device using DI or PURW.


Inspection




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Processed Handpiece and accessories must be inspected for corrosion, damage such as scratches and notches, discoloration, or residue. Damaged devices should be discarded. Devices should not be lubricated.




Sterilization If not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed Handpieces and accessories are as follows.


time Sterilization



(pre-vacuum)








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Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC Piezotome II Handpiece-cord assembly, Nosepiece, Optical guide and LED ring

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Piezotome handpiece-cord assembly is manual and mechanical. The components of the Handpiece (nosepiece, LED ring and plastic optical guide) require particular attention during cleaning. Do not place Satelec Piezotome handpiece-cord assembly in an ultrasonic cleaner. Note: Ultrasonic cleaning may cause further damage to devices that have prior surface damage. Note: The Ultrasonic process is for Nosepiece only. The Handpiece-cord assembly, LED ring and Optical Guide should not be exposed to ultrasonic cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Handpiece and accessories. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include mechanical washing and sterilization have minimal effects on the Piezotome II Handpiece-cord assembly, optical guide and LED ring. Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effects on the Piezotome II nosepiece. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.


Pull the perforator out of the irrigant solution. Plunge the perforator into an enzymatic or alkaline cleaner solution. With the flush button of the Piezotome II device, flush the irrigation tubing, the handpiece and

the tip for 1 min after each use to prevent the drying of soil and/or debris inside the unit. - Plunge the perforator into a deionized (DI) or purified (PURW) water solution and with the flush

button, rinse for 1 min in order to eliminate the enzymatic or alkaline cleaner. - Purge the irrigation tubing to eliminate the liquid inside. Soiled devices should be separated from non-contaminated devices to avoid contamination of







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After each use and prior to cleaning : o Unscrew the tip at the front of the Piezotome II Handpiece-cord assembly and place it

in the appropriate container. The cleaning of the tip is subject to a separate protocol. o Remove the irrigation single-use or autoclavable tubing and the autoclavable clips from


o Unscrew the nosepiece. o Remove the Optical guide. o Disconnect the LED ring from the Piezoelectric Handpiece, pulling it gently.


Pre-cleaning method Note: The manual pre-cleaning method has to be performed for handpiece and accessories prior to automated cleaning Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, Ultrasonic cleaner, Washer/disinfector, enzymatic or alkaline cleaner Note: Ultrasonic process: for nosepiece only.



1.

1 minute

Rinse soiled device under running cold tap water for a minimum of one minute. Remove gross soil using a soft- bristled brush, a lint-free swab or soft, lint-free cloth. Use a syringe or pipette or water jet to flush the cannulation with an Enzymatic or Alkaline cleaner solution

2.

2 minutes

Manually clean device for a minimum of two minutes in a freshly prepared enzymatic or alkaline cleaner solution. Follow the cleaner manufacturer's instructions for the correct dilution, temperature, water quality (i.e. pH, hardness) and exposure time. Use a soft-bristled brush to remove soil and debris on the Nosepiece, Optical guide, LED ring, handpiece-cord assembly and the threaded fitting.




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Gently use a lint-free swab to remove soil and debris on the inside of the Nosepiece, Optical guide and LED ring. Clean device under water to prevent aerosolization of contaminants.

3.

1 minute

Rinse device using cool to lukewarm running tap water for a minimum of one minute. Use a syringe, pipette or water jet to flush cannulation with tap water.

4.

15 minutes

Ultrasonic process: for nosepiece only. Clean device ultrasonically for 15 minutes in an enzymatic or alkaline cleaner solution.

2 minutes

Rinse device cool to lukewarm running tap water for a minimum of two minutes. Use a syringe, pipette or water jet to flush Handpiece cannulation.


Visually inspect device. Repeat steps until no visible soil remains on device.












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time Sterilization



(pre-vacuum)








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SUPRASSON OR NEWTRON HANDPIECE: Manual Cleaning, Decontamination and Sterilization Instructions for SATELEC Suprasson or Newtron Handpiece and Nosepiece

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Suprasson or Newtron Handpiece is manual and mechanical. The Suprasson or Newtron Handpiece and its nosepiece require particular attention during cleaning. Do not immerse the Suprasson or Newtron Handpiece and its components. Do not place Satelec Suprasson or Newtron Handpiece in an ultrasonic cleaner. Ultrasonic cleaning may cause further damage to devices that have prior surface damage. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Handpiece and accessories. Prevent overloading of wash baskets for washer/disinfector. Limits on reprocessing Repeated processing cycles that include manual washing and sterilization have minimal effects on the Newtron Handpiece and Nosepiece. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.


In case of external irrigation tubing or tank configuration, activate after each use the flush button of the electronic device and

o Flush the irrigation tubing, handpiece and tip for 1 minute with an enzymatic or alkaline cleaner solution, to prevent the drying of soil and/or debris inside the unit.

o Rinse with deionized (DI) or purified (PURW) water for 1 minute in order to eliminate the enzymatic or alkaline cleaner. Purge the irrigation tubing to eliminate the liquid inside.

If case of irrigation coming from the dental office water network, flush and rinse the cord, handpiece and tip for 1 minute after each use.

Soiled devices should be separated from non-contaminated devices to avoid contamination of personnel or surroundings.

Wipe blood and/or debris from the Handpiece to prevent it from drying onto the surface. Handpiece should be covered with a towel dampened with purified water to prevent blood






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After each use and prior to cleaning disassemble device, if applicable: o Unscrew the tip at the front of the Suprasson or Newtron Handpiece- and place it in the

appropriate container. The cleaning of the tip is subject to a separate protocol. o Remove the irrigation single-use or autoclavable tubing. o Disconnect the handpiece from the cord. o Unscrew the nosepiece.


Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, enzymatic or alkaline cleaner

Step Duration

(minimum) Cleaning instructions

2 minutes

Rinse soiled device under running cold tap water for a minimum of two minutes. Use a soft-bristled brush and/or lint-free swab to assist in the removal of gross soil and debris.

10 minutes

Use a syringe or pipette or water jet to flush the cannulation and hard to reach areas of the handpiece with an alkaline or enzymatic cleaner solution Soak the nosepiece ultrasonically in a fresh alkaline or enzymatic cleaner solution during 10 minutes

1 minute Rinse the handpiece body and the nosepiece under running cold tap water for a minimum of one minute.

4 minutes

Clean and disinfect the handpiece body and nosepiece in a freshly prepared Alkaline or enzymatic cleaner solution with the aid of soft-bristled brush and/or lint-free swab, paying particular attention to the screw thread cavity and the nosepiece, for at least four minutes.

1 minute

Rinse the handpiece body and nosepiece with distilled or purified water, to eliminate any detergent residues, for a minimum of one minute. Use a syringe or pipette or water jet to flush the cannulation and hard to reach areas with distilled or purified




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water




Inspection





Sterilization If not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed Handpiece and Nosepiece are as follows.


time Sterilization



(pre-vacuum)



Dry times generally range from 20 to 60 minutes due to differences in packaging materials (Sterile Barrier System, e.q., wraps or re-usable rigid container systems), steam quality, device materials, total mass, sterilizer performance, and varying cool-down time.




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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 labeled "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 note of any expiration date on the label.





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Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC Suprasson or Newtron Handpiece and Nosepiece

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Suprasson or Newtron Handpiece is manual and mechanical. The component of the Handpiece (nosepiece), require particular attention during cleaning. Do not immerse Suprasson or Newtron Handpiece. Do not place Satelec Suprasson or Newtron Handpiece in an ultrasonic cleaner. Ultrasonic cleaning may cause further damage to devices that have prior surface damage. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Handpiece and accessories. Prevent overloading of wash baskets for washer/disinfector. Limits on reprocessing Repeated processing cycles that include mechanical washing and sterilization have minimal effects on the Suprasson or Newtron Handpiece and Nosepiece. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.



- Flush the irrigation tubing, Handpiece and tip for 1 minute with an enzymatic or alkaline cleaner solution to prevent the drying of soil and/or debris inside the unit.

- Rinse with deionized (DI) or purified (PURW) water for 1 minute in order to eliminate the enzymatic or alkaline cleaner. Purge the irrigation tubing to eliminate the liquid inside.









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After each use and prior to cleaning disassemble device, if applicable: o Remove the tip at the front of the Suprasson or Newtron Handpiece and place it in the

appropriate container. The cleaning of the tip is subject to a separate protocol. o Remove the irrigation single-use or autoclavable tubing and the autoclavable clips from

the handpiece cord assembly, if applicable. The autoclavable irrigation tubing and autoclavable clips are subject to a separate protocol. In any case, discard the single-use perforator and/or single-use irrigation tubing.

o Disconnect the handpiece from the cord. o Unscrew the nosepiece, if applicable.


Pre-cleaning method Note: The manual pre-cleaning method has to be performed for handpiece and accessories prior to automated cleaning Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, Washer/disinfector, enzymatic or alkaline cleaner



1 minute

Rinse soiled device under running cold tap water for a minimum of one minute. Remove gross soil using a soft- bristled brush, a lint-free swab or soft, lint-free cloth.

2 minutes

Soak the nosepiece ultrasonically in a fresh alkaline or enzymatic cleaner solution during 2 minutes Use a syringe or pipette or water jet to flush the cannulations and hard to reach areas with an Enzymatic or Alkaline cleaner solution

1 minute Rinse all the components under running cold tap water for a minimum of one minute.

2 minutes

Clean and disinfect the handpiece body and nosepiece, in a freshly prepared Alkaline or enzymatic cleaner solution with the aid of soft-bristled brush and/or lint-free swab, paying particular attention to the screw thread cavity and the nosepiece, for at least two minutes.




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1 minutes

Rinse each components under cool to lukewarm running tap water for a minimum of one minute. Use a syringe, pipette or water jet to flush Handpiece cannulation.














Sterilization




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If not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed Handpieces and accessories are as follows.


time Sterilization



(pre-vacuum)








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NEWTRON LED HANDPIECE: Manual Cleaning, Decontamination and Sterilization Instructions for SATELEC Handpiece LED Nosepiece, Optical guide and LED ring

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Handpiece LED is manual and mechanical. The components of the Handpiece (nosepiece, LED ring and plastic optical guide) require particular attention during cleaning. Do not immerse Satelec Handpiece LED and its accessories. Do not place Satelec Handpiece LED in an ultrasonic cleaner. Ultrasonic cleaning may cause further damage to devices that have prior surface damage. The Ultrasonic process is for Nosepiece only. The Handpiece LED, LED ring and Optical Guide should not be exposed to ultrasonic cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Handpiece LED and accessories. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include manual washing and sterilization have minimal effects on the LED Handpiece, Nosepiece, Opical guide and LED ring. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.



o Flush the irrigation tubing, LED handpiece and tip for 1 minute with an enzymatic or alkaline cleaner solution to prevent the drying of soil and/or debris inside the unit. Purge the irrigation tubing to eliminate the liquid inside.

o Rinse with deionized (DI) or purified (PURW) water for 1 minute in order to eliminate the enzymatic or alkaline cleaner.

If case of irrigation coming from the dental office water network, flush and rinse the cord, LED handpiece and tip for 1 minute after each use.







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After each use and prior to cleaning disassemble device, if applicable: o Unscrew the tip at the front of the Piezotome Handpiece-cord assembly and place it in



o Disconnect the handpiece from the cord. o Unscrew the nosepiece. o Remove the Optical guide. o Disconnect the LED ring from the Piezoelectric Handpiece, pulling it gently.


Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, enzymatic or alkaline cleaner



2 minutes

Rinse soiled device under running cold tap water for a minimum of two minutes. Use a soft-bristled brush and/or lint-free swab to assist in the removal of gross soil and debris.

10 minutes

Use a syringe or pipette or water jet to flush the cannulation and hard to reach areas with an alkaline or enzymatic cleaner solution Soak the nosepiece ultrasonically in a fresh alkaline or enzymatic cleaner solution during 10 minutes

1 minute Rinse each individual component under running cold tap water for a minimum of one minute.




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4 minutes

Clean and disinfect the handpiece and nosepiece, in a freshly prepared alkaline or enzymatic cleaner solution with the aid of soft-bristled brush and/or lint-free swab, paying particular attention to the screw thread cavity and the nosepiece, for at least four minutes.

1 minute

Rinse each individual component with distilled or purified water, to eliminate any detergent residues, for a minimum of one minute. Use a syringe or pipette or water jet to flush the handpiece cannulation.




Inspection







time Sterilization







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(pre-vacuum) 18 minutes 134°C Minimum 20 minutes






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Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC LED Handpiece, Nosepiece, Optical guide and LED ring

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Handpiece LED is manual and mechanical. The components of the Handpiece (nosepiece, LED ring and plastic optical guide) require particular attention during cleaning. Do not immerge SATELEC Handpiece Led and accessories. Do not place Satelec Handpiece LED in an ultrasonic cleaner. Ultrasonic cleaning may cause further damage to devices that have prior surface damage. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Handpiece LED and accessories. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include mechanical washing and sterilization have minimal effects on the LED Handpiece, Nosepiece, Opical guide and LED ring. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.



o Flush the irrigation tubing, LED handpiece and tip for 1 minute with an enzymatic or alkaline cleaner solution to prevent the drying of soil and/or debris inside the unit.


If case of irrigation coming from the dental office water network, flush and rinse the cord, LED handpiece and tip for 1 minute after each use.


Wipe blood and/or debris from the Handpiece to prevent it from drying onto the surface. LED Handpiece should be covered with a towel dampened with purified water to prevent blood






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After each use and prior to cleaning disassemble device, if applicable: o Unscrew the tip at the front of the Piezotome Handpiece-cord assembly and place it in



o Disconnect the handpiece from the cord. o Unscrew the nosepiece. o Remove the Optical guide. o Disconnect the LED ring from the Piezoelectric Handpiece, pulling it gently.

Disassemble device, if applicable, prior to cleaning The front part of the Handpiece LED, the Nosepiece, must be unscrewed. Remove the Optical guide. Disconnect the LED ring from the Handpiece, pulling it gently.


Pre-cleaning method Note: The manual pre-cleaning method has to be performed for handpiece and accessories prior to automated cleaning Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, Washer/disinfector, enzymatic or alkaline cleaner



1 minute

Rinse soiled device under running cold tap water for a minimum of one minute. Remove gross soil using a soft- bristled brush, a lint-free swab or soft, lint-free cloth.

2 minutes

Soak the nosepiece ultrasonically in a fresh alkaline or enzymatic cleaner solution during 2 minutes Use a syringe or pipette or water jet to flush the cannulation and hard to reach areas with an Enzymatic or Alkaline cleaner solution

1 minute Rinse all the components under running cold tap water for a




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minimum of one minute.

2 minutes

Clean and disinfect, in a freshly prepared alkaline or enzymatic cleaner solution, each individual element : the handpiece body, paying particular attention to the screw thread cavity, the nosepiece, the optical guide and LED ring, for at least two minutes.

1 minute

Rinse each components under cool to lukewarm running tap water for a minimum of one minute. Use a syringe, pipette or water jet to flush Handpiece cannulation.

















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Sterilization If not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed Handpieces LED and accessories are as follows.


time Sterilization



(pre-vacuum)








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ULTRASONIC TIPS: Manual Cleaning, Decontamination and Sterilization Instructions for Satelec Ultrasonic Tips

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Tips is manual and mechanical. The Tips require particular attention during cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. These instructions are the same for all SATELEC Ultrasonic surgical and non-surgical tips. Whenever possible, a washer/disinfector should be used for tips. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effects on the Tips. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.



o Flush the irrigation tubing, handpiece and tip for 1 minute with an enzymatic or alkaline cleaner solution to prevent the drying of soil and/or debris inside the unit.




Wipe blood and/or debris from the Tips to prevent it from drying onto the surface. Tips should be covered with a towel dampened with purified water to prevent blood and/or

debris from drying.





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Preparation for cleaning/decontamination Clean and sterilize instruments as soon as possible after use (Satelec devices should be reprocessed no more than two hours after use). Prior to cleaning, unscrew the tip after each use at the front of the Ultrasonic Handpiece.

Manual cleaning method

Step Duration


1.

2 minutes

Rinse soiled device under running cold tap water. Remove gross soil using a soft-bristled brush or clean, soft, lint-free cloth. Use a syringe or pipette or water jet to flush tip’s cannulation with an Alkaline or Enzymatic cleaner solution

2.

10 minutes

Soak device ultrasonically in a fresh, newly-made alkaline or enzymatic cleaner solution.

3.

2 minutes

Rinse device with cool water. Use a syringe, pipette or water jet to flush tip’s cannulation

4.

4 minutes

Manually clean device in a freshly prepared alkaline or enzymatic cleaner solution. Use a softbristled brush to remove soil and debris. Clean device under water to prevent aerosolization of contaminants.

5.

2 minutes

Rinse device thoroughly with DI or PURW Use a syringe, pipette or water jet to flush tip’s cannulation. Repeat rinse.

6. Visually inspect

device. Repeat the manual deaning procedure until no visible soil remains on device.

7. Perform final rinse using DI or PURW.

8. Dry device using a clean, soft, lint-free cloth or clean compressed air.

Inspection

Processed tips must be inspected for corrosion, damage such as scratches and notches, discoloration, or residue. Damaged tips should be discarded. Tips should not be lubricated.




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Sterilization If not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed tips are as follows.


time Sterilization



(pre-vacuum)




Olivier Petit

Quality System Manager




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Automated Cleaning, Decontamination and Sterilization Instructions for SATELEC Ultrasonic Tips Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Tips is manual and mechanical. The Tips require particular attention during cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. These instructions are the same for all SATELEC Ultrasonic surgical and non-surgical tips. Whenever possible, a washer/disinfector should be used for tips. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effects on the Tips. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.




o Rinse with deionized (DI) or purified (PURW) water for 1 minute in order to eliminate the enzymatic or alkaline cleaner.


Purge the irrigation tubing to eliminate the liquid inside. Soiled devices should be separated from non-contaminated devices to avoid contamination of

personnel or surroundings. Wipe blood and/or debris from the Tips to prevent it from drying onto the surface. Tips should be covered with a towel dampened with purified water to prevent blood and/or

debris from drying. Containment and Transportation Soiled devices should be transported separate from non-contaminated devices to avoid contamination Preparation for cleaning/decontamination Clean and sterilize instruments as soon as possible after use (Satelec devices should be reprocessed no more than two hours after use).




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Prior to cleaning, unscrew the tip after each use at the front of the Ultrasonic Handpiece.


Pre-cleaning method Note: The manual pre-cleaning method has to be performed for tips prior to automated cleaning Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, Ultrasonic cleaner, Washer/disinfector, enzymatic or alkaline cleaner

Step Duration


1.

1 minute

Rinse soiled device under running cold tap water. Remove gross soil using a soft-bristled brush or clean, soft, lint-free cloth. Use a syringe or pipette or water jet to flush tip’s cannulation with an Alkaline or Enzymatic cleaner solution

2.

2 minutes

Soak device ultrasonically in a fresh, newly-made alkaline Alkaline or Enzymatic cleaner solution.

3.

1 minutes

Rinse device with cool water. Use a syringe, pipette or water jet to flush tip’s cannulation

4.

10 minutes


5.

2 minutes

Rinse device thoroughly with DI or PURW Use a syringe, pipette or water jet to flush tip’s cannulation. Repeat rinse.

6. Visually inspect

device. Repeat the pre-deaning procedure until no visible soil remains on device.

Automated cleaning method for Tips



Cleaning 10 minutes Warm tap water (> 40°C); use Alkaline or

Enzymatic cleaner solution Neutralization 2 minutes Warm tap water with neutralizer, if necessary





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Processed tips must be inspected for corrosion, damage such as scratches and notches, discoloration, or residue. Damaged tips should be discarded. Tips should not be lubricated.






time Sterilization



(pre-vacuum)



Dry times generally range from 20 to 60 minutes due to differences in packaging materials (Sterile Barrier System, e.q., wraps or re-usable rigid container systems), 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 labeled "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




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temperature and humidity. Use products in the order in which they are received ("first-in, first-out principle "), taking note of any expiration date on the label.





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WRENCHES: Manual Cleaning, Decontamination and Sterilization Instructions for all Satelec Wrenches

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Wrenches is manual and mechanical. The Wrenches require particular attention during cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Wrenches. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include ultrasonic, manual washing and sterilization have minimal effects on the Wrenches. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.







Wipe blood and/or debris from the Wrench to prevent it from drying onto the surface. should be covered with a towel dampened with purified water to prevent blood and/or debris

from drying.

Containment and Transportation Soiled devices should be transported separate from non-contaminated devices to avoid contamination Preparation for cleaning/decontamination




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Clean and sterilize instruments as soon as possible after use (Satelec devices should be reprocessed no more than two hours after use). Manual cleaning method

Step Duration


1.

2 minutes

Rinse soiled device under running cold tap water. Remove gross soil using a soft-bristled brush or clean, soft, lint-free cloth. Use a syringe or pipette or water jet to flush wrenche’s hard to reach areas with an alkaline or enzymatic cleaner solution

2.

10 minutes

Soak device ultrasonically in a fresh, newly-made alkaline or enzymatic cleaner solution.

3.

2 minutes

Rinse device with cool water. Use a syringe, pipette or water jet to flush wrenche’s hard to reach areas

4.

4 minutes


5.

2 minutes

Rinse device thoroughly with DI or PURW Use a syringe, pipette or water jet to flush Wrenche’s hard to reach areas. Repeat rinse.

6. Visually inspect

device. Repeat the manual cleaning procedure until no visible soil remains on device.

7. Perform final rinse using DI or PURW.

8. Dry device using a clean, soft, lint-free cloth or clean compressed air.

Inspection

Processed Wrenches must be inspected for corrosion, damage such as scratches and notches, discoloration, or residue. Damaged wrenches should be discarded. Wrenches should not be lubricated.





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Packaging Use an appropriate sterilization wrap or re-usable rigid container system for sterilization, such as a Sterile Barrier System according to ISO 11607. Care should be taken to protect wrenches from contact with other objects that may damage the surface or the Sterile Barrier System.



time Sterilization



(pre-vacuum)




Olivier Petit

Quality System Manager




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Automated Cleaning, Decontamination and Sterilization Instructions for all SATELEC Wrenches

Cautions: Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. The recommended cleaning method for Wrenches is manual and mechanical. The Wrenches require particular attention during cleaning. It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Whenever possible, a washer/disinfector should be used for Wrenches. Prevent overloading of wash baskets for ultrasonic cleaning and washer/disinfector. Limits on reprocessing Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effects on the Wrenches. End of life is normally determined by wear and damage due to use. pH of detergents/disinfectants should be between 7 and 11.







Wipe blood and/or debris from the Wrench to prevent it from drying onto the surface. should be covered with a towel dampened with purified water to prevent blood and/or debris

from drying.





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Pre-cleaning method Note: The manual pre-cleaning method has to be performed for Wrench prior to automated cleaning Equipment: soft-bristled brush, lint-free swab and/or soft, lint-free cloth, syringe, pipette and/or water jet, Ultrasonic cleaner, Washer/disinfector, enzymatic or alkaline cleaner



1.

1 minute

Rinse soiled device under running cold tap water. Remove gross soil using a soft-bristled brush or clean, soft, lint-free cloth. Use a syringe or pipette or water jet to flush Wrenche’s hard to reach areas with an Alkaline or Enzymaticcleaner solution

2.

2 minutes

Soak device ultrasonically in a fresh, newly-made alkaline Alkaline cleaner solution.

3.

1 minutes

Rinse device with cool water. Use a syringe, pipette or water jet to flush Wrenche’s hard to reach areas

4.

10 minutes


5.

2 minutes

Rinse device thoroughly with DI or PURW Use a syringe, pipette or water jet to flush wrenche’s hard to reach areas. Repeat rinse.

6. Visually inspect

device. Repeat the pre-deaning procedure until no visible soil remains on device.




Cleaning 10 minutes Warm tap water (> 40°C); use Alkaline or

Enzymatic cleaner solution Neutralization 2 minutes Warm tap water with neutralizer, if necessary





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Thermal Disinfection For automated cleaning, thermal disinfect at 90°C for a minimum of 5 minutes.

Inspection

Processed Wrenches must be inspected for corrosion, damage such as scratches and notches, discoloration, or residue. Damaged wrenches should be discarded. Wrenches should not be lubricated.






time Sterilization



(pre-vacuum)



Dry times generally range from 20 to 60 minutes due to differences in packaging materials (Sterile Barrier System, e.q., wraps or re-usable rigid container systems), 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 labeled "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




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temperature and humidity. Use products in the order in which they are received ("first-in, first-out principle "), taking note of any expiration date on the label.





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TUBING AND CLIPS: Manual Cleaning/Decontamination and Sterilization Protocol for Satelec Autoclavable Irrigation Tubing and Clips These recommendations concern the Manual Cleaning/Decontamination and Sterilization Protocol for Satelec Autoclavable Irrigation Tubing and Clips. Satelec doesn’t recommend an Automated Cleaning/Decontamination method with a Washer/disinfector for the Autoclavable Irrigation Tubing and clips. Points of use of care Pull the perforator out of the irrigant solution. Plunge the perforator into an enzymatic or alkaline cleaner solution. With the flush button of the electronic device, flush after each use the irrigation tubing, the handpiece and the tip for 1 min to prevent the drying of soil and/or debris inside the unit. Follow the cleaner manufacturer's instructions for use for correct concentration. Plunge the perforator into a deionized (DI) or purified (PURW) water solution and with the flush button, rinse for 1 min in order to eliminate the enzymatic or alkaline cleaner. Purge the irrigation tubing to eliminate the liquid inside. Remove the irrigation single-use or autoclavable tubing and the autoclavable clips from the handpiece cord assembly. Soiled devices should be separated from non-contaminated devices to avoid contamination of personnel or surroundings. Devices should be covered with a towel dampened with purified water to prevent blood and/or debris from drying. It is recommended that devices should be reprocessed as soon as is reasonably practical following use. Satelec devices should be reprocessed no more than two hours after use.

It is the responsibility of the end user to ensure that all equipment used to reprocess Satelec devices is properly installed, validated, maintained and calibrated. Manual Protocol for Cleaning/Decontamination Rinse soiled device under running cold tap water for a minimum of two minutes. Use a soft-bristled brush and/or lint-free swab to assist in the removal of gross soil and debris. Clean carefully the external part of the tubing and clips with disinfecting wipes alcohol based until no visible soil remains on device.




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Rinse tubing and clips with deionized (DI) or purified (PURW) water. Visually inspect device. Repeat protocol until no visible soil remains on device. Dry tubing and clips using a soft, lint free cloth or clean compressed air. Packaging Use an appropriate sterilization wrap or re-usable rigid container system for sterilization, such as a Sterile Barrier System according to ISO 11607. Care should be taken to protect tubings and clips from contact with other objects that may damage the surface or the Sterile Barrier System. Tubings and clips should be packed separately. Sterilization If not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Satelec recommendations for packed tubings and clips are as follows.


time Sterilization



(pre-vacuum) Saturated steam-forced air removal

(pre-vacuum)







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I-SURGE:

I-Surge: Cleaning protocols (manual and automated), decontamination and sterilization

Maintenance

Important • The device is delivered “non sterile”. • Before the first use and 30 minutes maximum after each treatment, the device should be cleaned, disinfected, lubricated and sterilized. Observing this procedure eliminates any blood, saliva or saline solution residues and prevents the transmission system from being blocked. • Only devices bearing a pictogram can be placed in a washer/disinfector. • Do not immerse in an ultrasonic bath. • Use only SATELEC or recommended by SATELEC maintenance products and components. Using other products or components can lead to working defaults and/or an annulment of the warranty. Precautions of use Universal precautions, including individual protection equipment (gloves, glasses…), must be observed by medical personnel who maintain contaminated or potentially contaminated medical devices. Sharp instruments have to be handled with caution. Check that the sterilizer and the water that is used are clean. After each sterilization cycle, immediately get the device out of the sterilizer to reduce corrosion risk. Suitable detergent For the automated cleaning-disinfection: • A lightly alkaline enzymatic detergent is recommended for cleaning in washer/disinfector of surgical or dental instruments.




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For the manual cleaning-disinfection: • Detergent or disinfecting-detergent (pH 6- 9.5) recommended for cleaning-disinfection of surgical or dental instruments. Enzymatic/ ammonium quaternary type tensioactive detergent. • Do not use detergents which are corrosive or which contain chlorine, acetone, aldehyde, bleach. • Do not immerse in physiological liquid (NaCl). Important In the event of prolonged disuse, the instrument must be stored in a dry environment. Clean, lubricate and sterilize the device before reuse. Following to the cleaning, disinfection and sterilization of the device and before its use, make it turn at moderate speed from 10 to 15 seconds to spread and remove the excess of lubricant.

1. Pre-disinfection

Preparation • Disconnect the micro-motor from the cable. • Perform manual pre-cleaning or pre-cleaning in a bath. Manual pre-cleaning Use the Spraynet cleaning product or an equivalent dental ethanol spray. • Spray the interior and the exterior of the instrument for 2 seconds to remove residue. • Clean carefully the surfaces. • Let drain and wipe down the external surfaces with an absorbent paper towel or go immediately to stage n°2.




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2. Cleaning- disinfection

Manual cleaning-disinfection Cleaning If necessary repeat stage n°1. Disinfection Disinfect with suitable product by soaking a clean cloth. Inadvisable products: disinfectants which contain chlorine, acetone, bleach. Before sterilization Remove the residue and clean carefully the instrument (possible witrh running water). Lubricate the instrument.

OR

Automated cleaning-disinfection Warning: only for engraved instruments Washer/disinfector Use a valid washer/disinfector with suitable detergent. Washing cycle Select the specified washing cycle for these instruments which should be compatible with the detergent’s manufacturer instructions. Temperatures recommended for these instruments : Pre-washing Water: cold to max 35°C – Length: 2 min. Washing Water: 50 to 65 °C – Length: 5 min. Rinsing Water: cold to max 35°C – Length: 2 min. Thermic disinfection Water: 80 to 97°C – Length: 5 min. Drying Air: 65 to 75°C – Length: 25 min.




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Warning: Never rinse the instruments to cool them down.

3. Lubrication, checks and conditioning

Check for cleanliness Visually inspect the cleanliness of the instrument. If necessary, clean again with a soft brush. Lubrication Use Lubrifluid lubricant spray or an equivalent spray based on low boiling point hydrogen treated Naphta. • Place the motor in a cloth to collect all surplus lubricant. • Insert the plastic nozzle of the spray fully into the nose of the motor. • Operate the spray for 1 sec. • Maintain the motor vertically (nose up) to spread the lubricant and to remove the excess of lubricant by the back of the device. Conditioning process Wrap the instrument in an approved packaging for steam sterilization.

4. Sterilization

Important The quality of the sterilization highly depends on the cleanliness of the instrument. Sterilize only perfectly clean instruments. Do not sterilize with another process than the one below. Process: With steam after fractionned initial vacuum phase according to EN285 or with Class B cycle according to EN13060. Nominal temperature: 134°C. Length: From 3 to 18 minutes depending on local directives in force. Overhaul Never disassemble the device. For all modifications and repairs, we recommended that you contact your regular supplier or SATELEC directly. SATELEC asks the user to have its dynamic instruments checked or inspected at least once a year.




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Environment Temperature between -40°C and 70°C, relative humidity between 10% and 100%, atmospheric pressure 50 kPa and 106 kPa. Information The technical specifications, illustrations and dimensions contained in these instructions are given only as a guide. They may not be the subject of any claim. The manufacturer reserves the right to make technical improvements to its equipment, without amending these instructions. For all additional information, please contact SATELEC Acteon Group at the address indicated on the back cover.





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I-SURGE LED:

I-Surge: Cleaning protocols (manual and automated), decontamination and sterilization

Maintenance

Important • The device is delivered “non sterile”. • Before the first use and 30 minutes maximum after each treatment, the device should be cleaned, disinfected, lubricated and sterilized. Observing this procedure eliminates any blood, saliva or saline solution residues and prevents the transmission system from being blocked. • Only devices bearing a pictogram can be placed in a washer/disinfector. • Do not immerse in an ultrasonic bath. • Use only SATELEC or recommended by SATELEC maintenance products and components. Using other products or components can lead to working defaults and/or an annulment of the warranty. Precautions of use Universal precautions, including individual protection equipment (gloves, glasses…), must be observed by medical personnel who maintain contaminated or potentially contaminated medical devices. Sharp instruments have to be handled with caution. Check that the sterilizer and the water that is used are clean. After each sterilization cycle, immediately get the device out of the sterilizer to reduce corrosion risk. Suitable detergent For the automated cleaning-disinfection: • A lightly alkaline enzymatic detergent is recommended for cleaning in washer/disinfector of surgical or dental instruments.




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For the manual cleaning-disinfection: • Detergent or disinfecting-detergent (pH 6- 9.5) recommended for cleaning-disinfection of surgical or dental instruments. Enzymatic/ ammonium quaternary type tensioactive detergent. • Do not use detergents which are corrosive or which contain chlorine, acetone, aldehyde, bleach. • Do not immerse in physiological liquid (NaCl). Important In the event of prolonged disuse, the instrument must be stored in a dry environment. Clean, lubricate and sterilize the device before reuse. Following to the cleaning, disinfection and sterilization of the device and before its use, make it turn at moderate speed from 10 to 15 seconds to spread and remove the excess of lubricant.

1. Pre-disinfection

Preparation • Disconnect the micro-motor from the cable. • Perform manual pre-cleaning or pre-cleaning in a bath. Manual pre-cleaning Use the Spraynet cleaning product or an equivalent dental ethanol spray. • Spray the interior and the exterior of the instrument for 2 seconds to remove residue. • Clean carefully the surfaces. • Let drain and wipe down the external surfaces with an absorbent paper towel or go immediately to stage n°2.




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2. Cleaning- disinfection

Manual cleaning-disinfection Cleaning If necessary repeat stage n°1. Disinfection Disinfect with suitable product by soaking a clean cloth. Inadvisable products: disinfectants which contain chlorine, acetone, bleach. Before sterilization Remove the residue and clean carefully the instrument (possible witrh running water). Lubricate the instrument.

OR

Automated cleaning-disinfection Warning: only for engraved instruments Washer/disinfector Use a valid washer/disinfector with suitable detergent. Washing cycle Select the specified washing cycle for these instruments which should be compatible with the detergent’s manufacturer instructions. Temperatures recommended for these instruments : Pre-washing Water: cold to max 35°C – Length: 2 min. Washing Water: 50 to 65 °C – Length: 5 min. Rinsing Water: cold to max 35°C – Length: 2 min. Thermic disinfection Water: 80 to 97°C – Length: 5 min. Drying Air: 65 to 75°C – Length: 25 min.




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Warning: Never rinse the instruments to cool them down.

3. Lubrication, checks and conditioning

Check for cleanliness Visually inspect the cleanliness of the instrument. If necessary, clean again with a soft brush. Lubrication Use Lubrifluid lubricant spray or an equivalent spray based on low boiling point hydrogen treated Naphta. • Place the motor in a cloth to collect all surplus lubricant. • Insert the plastic nozzle of the spray fully into the nose of the motor. • Operate the spray for 1 sec. • Maintain the motor vertically (nose up) to spread the lubricant and to remove the excess of lubricant by the back of the device. Conditioning process Wrap the instrument in an approved packaging for steam sterilization.

4. Sterilization

Important The quality of the sterilization highly depends on the cleanliness of the instrument. Sterilize only perfectly clean instruments. Do not sterilize with another process than the one below. Process: With steam after fractionned initial vacuum phase according to EN285 or with Class B cycle according to EN13060. Nominal temperature: 134°C. Length: From 3 to 18 minutes depending on local directives in force. Overhaul Never disassemble the device. For all modifications and repairs, we recommended that you contact your regular supplier or SATELEC directly. SATELEC asks the user to have its dynamic instruments checked or inspected at least once a year. Environment




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Temperature between -40°C and 70°C, relative humidity between 10% and 100%, atmospheric pressure between 50 kPa and 106 kPa. Information The technical specifications, illustrations and dimensions contained in these instructions are given only as a guide. They may not be the subject of any claim. The manufacturer reserves the right to make technical improvements to its equipment, without amending these instructions. For all additional information, please contact SATELEC Acteon Group at the address indicated on the back cover.


cleaning, decontamination and sterilization protocols for all

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