Piezoelectric System Maintenance and Cleaning Instructions

Synthes Piezoelectric System Cleaning Instructions Cleaning the Console and Foot Pedal NOTE: Do not sterilize the Console or Foot Pedal.

Disconnect all cables and turn the Console OFF. Wipe the Console with a soft cloth moistened with a disinfectant. The Console must not be immersed or cleaned under running water.

Wipe the Foot Pedal with a soft cloth moistened with a disinfectant. Do not immerse. Allow to dry after cleaning.

Disassembly Instructions Preparation for decontamination

Nose cone LED ring Light diffuser

The handpiece, cable and handpiece components (nose cone, LED ring and light diffuser) should be manually precleaned prior to processing in an automated washer. Soak and /or rinse heavily soiled devices prior to cleaning, to loosen any dried soil or debris. Use a neutral pH enzymatic cleaner solution to soak devices. Follow the enzymatic cleaner manufacturer's instructions for use, for correct exposure time, temperature, water quality and concentration. Use cool tap water to rinse devices.

Piezoelectric handpiece-cable assembly

It is recommended that devices should be reprocessed as soon as possible following use. Synthes devices should be reprocessed no more than two hours after use. Disassemble the handpiece prior to cleaning – The front part of the Piezoelectric handpiece assembly, the nose cone, must be unscrewed. – Remove the light diffuser. – Disconnect the LED ring from the Piezoelectric handpiece, pulling it gently.

Synthes Piezoelectric devices must be first cleaned separately from their graphic cases. Lids should be removed from graphic cases for the cleaning process, if applicable. It is the responsibility of the end user to ensure that all equipment used to reprocess Synthes devices is properly installed, validated, maintained and calibrated.

Cleaning – Manual Method (Handpiece must be disassembled as shown above) This information is provided in accordance with ISO 17664 and ANSI/AAMI ST81.

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

2

5

6

1

Manually clean device for a minimum of five minutes in a freshly prepared neutral pH enzymatic cleaner solution. Use a soft-bristled brush to remove soil and debris on the nose cone, light diffuser, LED ring, handpiece-cable assembly and the threaded fitting. Gently use a lint-free swab to remove soil and debris on the inside of the nose cone and LED ring. Clean device under water to prevent aerosolization of contaminants.

Use a syringe, pipette, or water jet to flush the cannulation with a neutral pH enzymatic cleaner solution.

Soak device in a neutral pH enzymatic cleaner solution for a minimum of 10 minutes. Follow the enzymatic cleaner manufacturer’s instructions for use for correct exposure time, temperature, water quality and concentration.

4

Rinse device with cool water for a minimum of two minutes.

Rinse device thoroughly with deionized or purified water for two minutes.

7

NOTE: Fresh solution is a newly-made, clean solution.

Manually clean device for a minimum of two minutes in a neutral pH detergent solution. Use a soft-bristled brush for the nose cone, light diffuser, LED ring, handpiece-cable assembly and the threaded fitting. Gently use a lint-free swab for the inside of the nose cone, optical guide and LED ring. Clean device under water to prevent aerosolization of contaminants.

9

10 Perform a final rinse on device using deionized or

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

3

purified water.

8

Use a syringe, pipette, or water jet to flush the cannulation with deionized or purified water and rinse device thoroughly with deionized or purified water for 2 minutes.

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

Synthes Piezoelectric System Cleaning Instructions Cleaning the Console and Foot Pedal NOTE: Do not sterilize the Console or Foot Pedal.

Disconnect all cables and turn the Console OFF. Wipe the Console with a soft cloth moistened with a disinfectant. The Console must not be immersed or cleaned under running water.

Wipe the Foot Pedal with a soft cloth moistened with a disinfectant. Do not immerse. Allow to dry after cleaning.

Disassembly Instructions Preparation for decontamination

Nose cone LED ring Light diffuser

The handpiece, cable and handpiece components (nose cone, LED ring and light diffuser) should be manually precleaned prior to processing in an automated washer. Soak and /or rinse heavily soiled devices prior to cleaning, to loosen any dried soil or debris. Use a neutral pH enzymatic cleaner solution to soak devices. Follow the enzymatic cleaner manufacturer's instructions for use, for correct exposure time, temperature, water quality and concentration. Use cool tap water to rinse devices.

Piezoelectric handpiece-cable assembly

It is recommended that devices should be reprocessed as soon as possible following use. Synthes devices should be reprocessed no more than two hours after use. Disassemble the handpiece prior to cleaning – The front part of the Piezoelectric handpiece assembly, the nose cone, must be unscrewed. – Remove the light diffuser. – Disconnect the LED ring from the Piezoelectric handpiece, pulling it gently.

Synthes Piezoelectric devices must be first cleaned separately from their graphic cases. Lids should be removed from graphic cases for the cleaning process, if applicable. It is the responsibility of the end user to ensure that all equipment used to reprocess Synthes devices is properly installed, validated, maintained and calibrated.

Cleaning – Manual Method (Handpiece must be disassembled as shown above) This information is provided in accordance with ISO 17664 and ANSI/AAMI ST81.

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

2

5

6

1

Manually clean device for a minimum of five minutes in a freshly prepared neutral pH enzymatic cleaner solution. Use a soft-bristled brush to remove soil and debris on the nose cone, light diffuser, LED ring, handpiece-cable assembly and the threaded fitting. Gently use a lint-free swab to remove soil and debris on the inside of the nose cone and LED ring. Clean device under water to prevent aerosolization of contaminants.

Use a syringe, pipette, or water jet to flush the cannulation with a neutral pH enzymatic cleaner solution.

Soak device in a neutral pH enzymatic cleaner solution for a minimum of 10 minutes. Follow the enzymatic cleaner manufacturer’s instructions for use for correct exposure time, temperature, water quality and concentration.

4

Rinse device with cool water for a minimum of two minutes.

Rinse device thoroughly with deionized or purified water for two minutes.

7

NOTE: Fresh solution is a newly-made, clean solution.

Manually clean device for a minimum of two minutes in a neutral pH detergent solution. Use a soft-bristled brush for the nose cone, light diffuser, LED ring, handpiece-cable assembly and the threaded fitting. Gently use a lint-free swab for the inside of the nose cone, optical guide and LED ring. Clean device under water to prevent aerosolization of contaminants.

9

10 Perform a final rinse on device using deionized or

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

3

purified water.

8

Use a syringe, pipette, or water jet to flush the cannulation with deionized or purified water and rinse device thoroughly with deionized or purified water for 2 minutes.

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

Synthes Piezoelectric System Cleaning Instructions Cleaning the Console and Foot Pedal NOTE: Do not sterilize the Console or Foot Pedal.

Disconnect all cables and turn the Console OFF. Wipe the Console with a soft cloth moistened with a disinfectant. The Console must not be immersed or cleaned under running water.

Wipe the Foot Pedal with a soft cloth moistened with a disinfectant. Do not immerse. Allow to dry after cleaning.

Disassembly Instructions Preparation for decontamination

Nose cone LED ring Light diffuser

The handpiece, cable and handpiece components (nose cone, LED ring and light diffuser) should be manually precleaned prior to processing in an automated washer. Soak and /or rinse heavily soiled devices prior to cleaning, to loosen any dried soil or debris. Use a neutral pH enzymatic cleaner solution to soak devices. Follow the enzymatic cleaner manufacturer's instructions for use, for correct exposure time, temperature, water quality and concentration. Use cool tap water to rinse devices.

Piezoelectric handpiece-cable assembly

It is recommended that devices should be reprocessed as soon as possible following use. Synthes devices should be reprocessed no more than two hours after use. Disassemble the handpiece prior to cleaning – The front part of the Piezoelectric handpiece assembly, the nose cone, must be unscrewed. – Remove the light diffuser. – Disconnect the LED ring from the Piezoelectric handpiece, pulling it gently.

Synthes Piezoelectric devices must be first cleaned separately from their graphic cases. Lids should be removed from graphic cases for the cleaning process, if applicable. It is the responsibility of the end user to ensure that all equipment used to reprocess Synthes devices is properly installed, validated, maintained and calibrated.

Cleaning – Manual Method (Handpiece must be disassembled as shown above) This information is provided in accordance with ISO 17664 and ANSI/AAMI ST81.

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

2

5

6

1

Manually clean device for a minimum of five minutes in a freshly prepared neutral pH enzymatic cleaner solution. Use a soft-bristled brush to remove soil and debris on the nose cone, light diffuser, LED ring, handpiece-cable assembly and the threaded fitting. Gently use a lint-free swab to remove soil and debris on the inside of the nose cone and LED ring. Clean device under water to prevent aerosolization of contaminants.

Use a syringe, pipette, or water jet to flush the cannulation with a neutral pH enzymatic cleaner solution.

Soak device in a neutral pH enzymatic cleaner solution for a minimum of 10 minutes. Follow the enzymatic cleaner manufacturer’s instructions for use for correct exposure time, temperature, water quality and concentration.

4

Rinse device with cool water for a minimum of two minutes.

Rinse device thoroughly with deionized or purified water for two minutes.

7

NOTE: Fresh solution is a newly-made, clean solution.

Manually clean device for a minimum of two minutes in a neutral pH detergent solution. Use a soft-bristled brush for the nose cone, light diffuser, LED ring, handpiece-cable assembly and the threaded fitting. Gently use a lint-free swab for the inside of the nose cone, optical guide and LED ring. Clean device under water to prevent aerosolization of contaminants.

9

10 Perform a final rinse on device using deionized or

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

3

purified water.

8

Use a syringe, pipette, or water jet to flush the cannulation with deionized or purified water and rinse device thoroughly with deionized or purified water for 2 minutes.

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

Maintenance and Cleaning. Instructions for the Synthes Piezoelectric System.

Cleaning

These recommendations are for reprocessing, specifically cleaning, Synthes Piezoelectric System reusable medical devices, including the Piezoelectric System handpiece-cable assembly and the flat wrench.

Cautions – Do not use steel wool or abrasive cleaners. – Avoid solutions containing iodine or high chlorine content. – Contaminated or used Synthes accessories should not be loaded in a graphic case and cleaned in a mechanical washer. – Metallic handpiece nosepiece, LED ring, light diffuser and handpiece-cable assembly cannulation require particular attention during cleaning. – All devices must be thoroughly cleaned. – Synthes doesn’t recommend or support the flash sterilization of Synthes instruments. – Synthes instruments are critical devices and must be terminally sterilized prior to use. – The sterilization parameters are only valid for devices that are adequately cleaned. – The following parameters are only valid for properly installed, maintained, calibrated and compliant reprocessing equipment. – The recommended cleaning method for Piezoelectric handpiece and accessories is manual and mechanical. Do not place Synthes Piezoelectric handpiece-cable assembly in an ultrasonic cleaner. – Use a soft, lint-free cloth moistened with a neutral pH cleaner to wipe the console and foot pedal. Do not immerse.

Processing instructions Point of use care – Wipe blood and / or debris from the devices throughout surgical procedure to prevent it from drying onto the surface. – After the operation, remove the single-use tip at the front of the Piezoelectric handpiece assembly and dispose of it in the appropriate container. Important: In the operating room, rinse the irrigation line of the Piezoelectric System handpiece-cable assembly using distilled or sterile water. Operate the irrigation pump for 20 seconds after each use to prevent the drying of debris inside the handpiece. Disconnect and dispose of irrigation tubing and clips in a proper container.

Soiled devices should be separated from noncontaminated 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. Containment and transportation Soiled devices should be transported separately from noncontaminated devices to avoid contamination.

Cleaning Chart

Cleaning

Cleaning – Mechanical method Note: Ultrasonic cleaning may cause further damage to devices that have prior surface damage.

9) Mechanical washer – (after manual preclean) Use the following cycle parameters:

Equipment: Soft-bristled brushes, lint-free swab and / or soft, lint-free cloth, syringe, pipettes, and /or water jet, ultrasonic cleaner, washer / disinfector, neutral enzymatic cleaner and /or neutral detergent with a pH ≤ 8.5. Note: Ultrasonic process – flat wrench and nose cone only. 1) Disassemble device if applicable. (Refer to chart.) 2) 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. 3) Manually clean device for a minimum of two minutes in a freshly prepared neutral pH enzymatic cleaner solution. Follow the enzymatic cleaner manufacturer's instructions for the correct dilution, temperature, water quality (i.e. pH, hardness) and exposure time. Use a soft-bristled brush and/or lint-free swab to remove soil and debris. Clean device under water to prevent aerosolization of contaminants. Note: Fresh solution is a newly-made, clean solution. 4) 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. 5) Prepare a fresh detergent solution using a neutral pH enzymatic cleaner. Follow the enzymatic cleaner manufacturer’s instructions for the correct dilution, temperature, water quality (i.e. pH, hardness) and exposure time. Ultrasonic process - flat wrench and nose cone only. Note: Fresh solution is a newly-made, clean solution. 6) Clean only flat wrench and nose cone ultrasonically for 15 minutes. 7) Rinse device in cool to lukewarm running tap water for a minimum of two minutes. Use a syringe, pipette or water jet to flush the cannulation. 8) Visually inspect device. Repeat Steps 2 – 7 until no visible soil remains on device.

Distributed by Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 © 2011 Synthes, Inc. or its affiliates. All rights reserved.

Cycle

Time (minutes)

Temperature / Water

Type of Detergent

Prewash

2

Cold tap water

N /A

Wash I

2

Cool to warm tap water

Neutral enzymatic pH ≤ 8.5

Wash II

5

Warm tap water (> 40°C)

Detergent pH ≤ 8.5

Rinse

2

Warm DI or PURW (>40°C)

N /A

Dry

40

90°C

N/A

Thermal Disinfection For automated cleaning, thermal disinfect at 93°C for a minimum of 5 minutes. Drying If a dry cycle is not included in a mechanical washer or if the device is not processed in a mechanical washer: – Dry each device thoroughly inside and out to prevent rusting and malfunction. – Use a soft, lint free cloth to avoid damage to the surface. – Pay special attention to threads or areas where fluid can accumulate. – Open and close devices so that all areas are reached. – Dry hollow parts using clean compressed air.

Manufactured by Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.synthes.com

Synthes is a trademark of Synthes, Inc. or its affiliates.

SATELEC A Company of ACTEON Group 17 av. Gustave Eiffel BP 30216 33708 MERIGNAC cedex France Printed in U.S.A. 3/11 J10416-A

Maintenance and Cleaning. Instructions for the Synthes Piezoelectric System.

Cleaning

These recommendations are for reprocessing, specifically cleaning, Synthes Piezoelectric System reusable medical devices, including the Piezoelectric System handpiece-cable assembly and the flat wrench.

Cautions – Do not use steel wool or abrasive cleaners. – Avoid solutions containing iodine or high chlorine content. – Contaminated or used Synthes accessories should not be loaded in a graphic case and cleaned in a mechanical washer. – Metallic handpiece nosepiece, LED ring, light diffuser and handpiece-cable assembly cannulation require particular attention during cleaning. – All devices must be thoroughly cleaned. – Synthes doesn’t recommend or support the flash sterilization of Synthes instruments. – Synthes instruments are critical devices and must be terminally sterilized prior to use. – The sterilization parameters are only valid for devices that are adequately cleaned. – The following parameters are only valid for properly installed, maintained, calibrated and compliant reprocessing equipment. – The recommended cleaning method for Piezoelectric handpiece and accessories is manual and mechanical. Do not place Synthes Piezoelectric handpiece-cable assembly in an ultrasonic cleaner. – Use a soft, lint-free cloth moistened with a neutral pH cleaner to wipe the console and foot pedal. Do not immerse.

Processing instructions Point of use care – Wipe blood and / or debris from the devices throughout surgical procedure to prevent it from drying onto the surface. – After the operation, remove the single-use tip at the front of the Piezoelectric handpiece assembly and dispose of it in the appropriate container. Important: In the operating room, rinse the irrigation line of the Piezoelectric System handpiece-cable assembly using distilled or sterile water. Operate the irrigation pump for 20 seconds after each use to prevent the drying of debris inside the handpiece. Disconnect and dispose of irrigation tubing and clips in a proper container.

Soiled devices should be separated from noncontaminated 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. Containment and transportation Soiled devices should be transported separately from noncontaminated devices to avoid contamination.

Cleaning Chart

Cleaning

Cleaning – Mechanical method Note: Ultrasonic cleaning may cause further damage to devices that have prior surface damage.

9) Mechanical washer – (after manual preclean) Use the following cycle parameters:

Equipment: Soft-bristled brushes, lint-free swab and / or soft, lint-free cloth, syringe, pipettes, and /or water jet, ultrasonic cleaner, washer / disinfector, neutral enzymatic cleaner and /or neutral detergent with a pH ≤ 8.5. Note: Ultrasonic process – flat wrench and nose cone only. 1) Disassemble device if applicable. (Refer to chart.) 2) 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. 3) Manually clean device for a minimum of two minutes in a freshly prepared neutral pH enzymatic cleaner solution. Follow the enzymatic cleaner manufacturer's instructions for the correct dilution, temperature, water quality (i.e. pH, hardness) and exposure time. Use a soft-bristled brush and/or lint-free swab to remove soil and debris. Clean device under water to prevent aerosolization of contaminants. Note: Fresh solution is a newly-made, clean solution. 4) 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. 5) Prepare a fresh detergent solution using a neutral pH enzymatic cleaner. Follow the enzymatic cleaner manufacturer’s instructions for the correct dilution, temperature, water quality (i.e. pH, hardness) and exposure time. Ultrasonic process - flat wrench and nose cone only. Note: Fresh solution is a newly-made, clean solution. 6) Clean only flat wrench and nose cone ultrasonically for 15 minutes. 7) Rinse device in cool to lukewarm running tap water for a minimum of two minutes. Use a syringe, pipette or water jet to flush the cannulation. 8) Visually inspect device. Repeat Steps 2 – 7 until no visible soil remains on device.

Distributed by Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 © 2011 Synthes, Inc. or its affiliates. All rights reserved.

Cycle

Time (minutes)

Temperature / Water

Type of Detergent

Prewash

2

Cold tap water

N /A

Wash I

2

Cool to warm tap water

Neutral enzymatic pH ≤ 8.5

Wash II

5

Warm tap water (> 40°C)

Detergent pH ≤ 8.5

Rinse

2

Warm DI or PURW (>40°C)

N /A

Dry

40

90°C

N/A

Thermal Disinfection For automated cleaning, thermal disinfect at 93°C for a minimum of 5 minutes. Drying If a dry cycle is not included in a mechanical washer or if the device is not processed in a mechanical washer: – Dry each device thoroughly inside and out to prevent rusting and malfunction. – Use a soft, lint free cloth to avoid damage to the surface. – Pay special attention to threads or areas where fluid can accumulate. – Open and close devices so that all areas are reached. – Dry hollow parts using clean compressed air.

Manufactured by Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.synthes.com

Synthes is a trademark of Synthes, Inc. or its affiliates.

SATELEC A Company of ACTEON Group 17 av. Gustave Eiffel BP 30216 33708 MERIGNAC cedex France Printed in U.S.A. 3/11 J10416-A