Battery Power Line II (BPL II) Manual and Mechanical Cleaning Guide

8. Automated cleaning cycle parameters. Note: The washer/disinfector should fulfill the requirements as specified in ISO 15883.

Step

Duration (minimum)

Cleaning instructions

Rinse

2 minutes

Cold tap water

Pre-wash

1 minute

Warm water (≥ 40 °C); use detergent

Cleaning

2 minutes

Warm water (≥ 45 °C); use detergent

Rinse

5 minutes

Rinse with de-ionized (DI) or purified water (PURW)

Thermal processing

5 minutes

Hot DI water, ≥ 93 °C

Dry

40 minutes

≥ 90 °C

MANUAL AND MECHANICAL CLEANING For Battery Power Line II (BPL II)

9. Inspect the device. Remove all the devices from the washing basket. Inspect the cannulations, sliding sleeves, etc. for visible soil. If necessary, repeat the manual pre-clean/automated cleaning cycle. Confirm that all parts are completely dry. Precaution: Mechanical cleaning/disinfection is an additional stress for power equipment, especially for seals and bearings. Therefore, systems must be properly lubricated and regularly sent to be serviced (at least once per year).

Limited Warranty and Disclaimer: DePuy Synthes Power Tools products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. Not all products are currently available in all markets.

Synthes USA Synthes (Canada) Ltd. 1302 Wrights Lane East 2566 Meadowpine Boulevard West Chester, PA 19380 Mississauga, Ontario L5N 6P9 USA Telephone: (905) 567-0440 Tel: (610) 719-5000 To order: (800) 668-1119 To Order: (800) 327-6887 Fax: (905) 567-3185 Fax: (800) 327-6661 Email: [email protected] www.depuysynthes.com © DePuy Synthes Power Tools, a division of DOI 2013. All rights reserved. J12506-A 7/13 DS Studio

MANUAL AND MECHANICAL CLEANING For Battery Power Line II (BPL II)

Manual Cleaning Instructions

1. Remove debris.

3. Spray and wipe.

4. Clean with detergent.

Rinse the device under running cold tap water for a minimum of 2 minutes. Use a sponge, soft lint-free cloth or soft-bristled brush to assist in removing gross soil. For cannulations of the handpiece and attachments, the cleaning brush (516.101) should be used.

Spray and wipe the device using a neutral pH enzymatic solution for a minimum of 2 minutes.

Clean the device manually under running warm water using an enzymatic cleaner or detergent for a minimum of 5 minutes. Manipulate all moving parts under running water. Use a soft-bristled brush and/or soft lint-free cloth to remove all visible soil and debris.

Follow the enzymatic detergent manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and concentration/dilution.

Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct temperature, water quality and concentration/dilution.

Note: Do not use pointed objects for cleaning.

2. Manipulate moving parts. Manipulate all moving parts such as triggers, sliding sleeves, attachment release rings, saw blade coupling and switches under running tap water to loosen and remove gross debris.

5. Rinse with tap water. Rinse the device thoroughly using cool to lukewarm running water for a minimum of 2 minutes. Use a syringe, pipette or water jet to flush lumens and channels. Actuate joints, handles and other movable device features in order to rinse thoroughly under running water.

Note: For the Quick Coupling for Pins Ø3.2 mm (530.796) the brush should only be inserted from the front.

7. Final rinse with de-ionized/ purified water. Final rinse with de-ionized or purified water for a minimum of 2 minutes.

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

6. Visually inspect device. Inspect the cannulations, coupling sleeves, etc. for visible soil. Repeat steps 1 – 6 until no visible soil remains.

Mechanical /Automated Cleaning Instruction with Manual Pre-cleaning Important: – Manual pre-cleaning prior to mechanical/automated cleaning/disinfection is important to ensure that cannulations and other difficult to access areas are clean. – Alternative cleaning/disinfection procedures other than in the procedure described below (including manual precleaning) have not been validated by DePuy Synthes.

1. Remove debris.

3. Spray and wipe.

Rinse the device under running cold tap water for a minimum of 2 minutes. Use a sponge, soft lint-free cloth or soft-bristled brush to assist in removing gross soil. For cannulations of the handpiece and attachments, the cleaning brush (516.101) should be used.

Spray and wipe the device using a neutral pH enzymatic solution for a minimum of 2 minutes. Follow the enzymatic detergent manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and concentration/dilution.

Note: Do not use pointed objects for cleaning.

2. Manipulate moving parts. Manipulate all moving parts such as triggers, sliding sleeves, attachment release rings, saw blade coupling and switches under running tap water to loosen and remove gross debris.

4. Clean with detergent.

5. Rinse with tap water.

7. Load washing basket.

Clean the device manually under running warm water using an enzymatic cleaner or detergent for a minimum of 5 minutes. Manipulate all moving parts under running water. Use a soft-bristled brush and/or soft lint-free cloth to remove all visible soil and debris.

Rinse the device thoroughly using cool to lukewarm running water for a minimum of 2 minutes. Use a syringe, pipette or water jet to flush lumens and channels. Actuate joints, handles and other movable device features in order to rinse thoroughly under running water.

Place devices in the specially designed tray for machine washing supplied by DePuy Synthes (68.001.620). Ensure that all cannulations (handpiece and attachments), if applicable, are positioned vertically, i.e. in an upright position as shown.

Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct temperature, water quality and concentration/dilution.

6. Visually inspect device. Inspect the cannulations, coupling sleeves, etc. for visible soil. Repeat steps 1 – 6 until no visible soil remains.

Note: Specific lid (68.001.602) is available for the washing basket. This can be used for sterilization, but is not required for machine washing. Do not wash the system in the Synthes VARIO CASETM (689.202).

8. Automated cleaning cycle parameters. Note: The washer/disinfector should fulfill the requirements as specified in ISO 15883.

Step

Duration (minimum)

Cleaning instructions

Rinse

2 minutes

Cold tap water

Pre-wash

1 minute

Warm water (≥ 40 °C); use detergent

Cleaning

2 minutes

Warm water (≥ 45 °C); use detergent

Rinse

5 minutes

Rinse with de-ionized (DI) or purified water (PURW)

Thermal processing

5 minutes

Hot DI water, ≥ 93 °C

Dry

40 minutes

≥ 90 °C

MANUAL AND MECHANICAL CLEANING For Battery Power Line II (BPL II)

9. Inspect the device. Remove all the devices from the washing basket. Inspect the cannulations, sliding sleeves, etc. for visible soil. If necessary, repeat the manual pre-clean/automated cleaning cycle. Confirm that all parts are completely dry. Precaution: Mechanical cleaning/disinfection is an additional stress for power equipment, especially for seals and bearings. Therefore, systems must be properly lubricated and regularly sent to be serviced (at least once per year).

Limited Warranty and Disclaimer: DePuy Synthes Power Tools products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. Not all products are currently available in all markets.

Synthes USA Synthes (Canada) Ltd. 1302 Wrights Lane East 2566 Meadowpine Boulevard West Chester, PA 19380 Mississauga, Ontario L5N 6P9 USA Telephone: (905) 567-0440 Tel: (610) 719-5000 To order: (800) 668-1119 To Order: (800) 327-6887 Fax: (905) 567-3185 Fax: (800) 327-6661 Email: [email protected] www.depuysynthes.com © DePuy Synthes Power Tools, a division of DOI 2013. All rights reserved. J12506-A 7/13 DS Studio