Trauma Recon System TRS Manual and Mechanical Cleaning Chart

Manual and Mechanical Cleaning Mechanical/Automated Cleaning Instruction with Pre-cleaning for Trauma Recon System (TRS) This information is provided in accordance with ISO 17664: 2004 and ANSI/AAMI ST81:2004. Important: x Manual pre-cleaning prior to mechanical/automated cleaning/disinfection is important to ensure cannulations and other difficult to access sites are clean.



1 Disassemble Disassemble device if applicable, and remove the battery or power module from casing or handpiece. Batteries/power modules and charger may be wiped with a cloth. DO NOT disinfect, immerse, or sterilize batteries/power modules.

x Alternative cleaning/disinfection procedures other than the procedure described below (including manual pre-cleaning) have not been validated by DePuy Synthes Power Tools.

Important: Do not sterilize batteries or power modules! Batteries/power modules will no longer function.

2 Return batteries to charger Return batteries/power modules to charger after each use.

Note: The screw coupling of the Sagittal Saw Attachment, long, 05.001.224, and the TRS Recon Saw, 05.001.240, completely disassemble from saw for cleaning.

3 Remove debris Rinse device under running cold tap water for a minimum of two minutes. Use a sponge, soft lint-free cloth, and/ or soft-bristled brush to assist in the removal of gross soil and debris. Clean all cannulations, handpiece, and attachments, with the Cleaning Brush (516.101). Manipulate all moving parts such as the triggers, release sleeves for attachments, mode switch, etc. under running cold tap water to loosen and remove gross debris.

Note: Do not use pointed objects for cleaning.

4 Spray with solution

5 Clean with detergent

6 Rinse with tap water

Spray and wipe device using a neutral pH enzymatic solution or foam spray for a minimum of two minutes. Follow the enzymatic detergent manufacturer’s instructions for use for correct temperature, water quality, and concentration/dilution.

Clean device manually under running warm water using a neutral pH enzymatic detergent for a minimum of five 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 instructions for use for correct temperature, water quality and concentration/dilution.

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

Note: For Sagittal Saw Attachment, long, 05.001.224, and the TRS Recon Saw, 05.001.240, process the Screw Coupling in an ultrasonic cleaner using a neutral pH enzymatic cleaner for a minimum of 15 minutes.

Visually inspect device. Repeat Steps 3–6 until no visible soil remains. Note: Manual pre-cleaning as described above must be followed by the mechanical/automated cleaning procedure.

7 Load washing machine basket Place articles in the specially designed trays for machine washing supplied by DePuy Synthes Power Tools. Ensure that all cannulations (handpiece and attachments), if applicable, are positioned vertically, i.e., in an upright position as shown.

Note: Never immerse the handpiece, lid or attachments in an ultrasonic bath or any other liquid as this could decrease the service life of the system.

8 Automated cleaning cycle parameters Step

Minimum time (minutes)

Rinse

2 Cold tap water N/A

Pre-wash

1

Warm water (40°C) Neutral pH enzymatic cleaner

Cleaning

2

Warm water (45°C) Neutral pH enzymatic cleaner

Rinse

5 De-ionized (DI) N/A

Thermal disinfection

5 Hot DI water (93°C) N/A

Dry

40

9 Inspect devices Remove all devices from washing basket. Inspect the cannulations, coupling sleeves, etc. for visible soil. If necessary, repeat the manual pre-clean/automated cleaning cycle. Please refer to DePuy Synthes Power Tools Battery Powered Equipment Lubrication Chart after cleaning and prior to sterilization. Precaution: Mechanical cleaning/disinfection is an additional stress for power equipment, especially for seals and bearings. Therefore, systems must be properly lubricated and serviced regularly.

Temperature/water

Type of detergent

90°C N/A

Manual and Mechanical Cleaning For Trauma Recon System (TRS)

Limited Warranty and Disclaimer: DePuy Synthes USA 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. To order in the US, call DePuy Synthes Power Tools Customer Service: (800) 327-6887. Not all products are currently available in all markets. Some devices listed in this Cleaning Chart may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.

US Legal Manufacturer: DePuy Synthes Products LLC. 1302 Wrights Lane East West Chester, PA 19380 USA Tel: (610) 719-5000 To Order: (800) 327-6887 Fax: (800) 327-6661 Email: [email protected]

Canadian Legal Manufacturer: Synthes Canada Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185

www.depuysynthes.com

cleaning chart

© DePuy Synthes Power Tools, a division of DOI 2014. All rights reserved. DSUS/PWT/0814/0061 12/14 DV