Synthes Sterilization Guide for Small Battery Drive Sets April 2010

Sterilization Guide for Small Battery Drive Sets

To sterilize the Small Battery Drive and attachments: – Disassemble all parts, including attachments, adaptors, instruments and battery packs – Remove battery pack from Drive Unit – Remove battery from casing. Battery casing must be open for sterilization Note: Do not sterilize batteries! Batteries will no longer function.

Synthes Small Battery Drive Sets should be steam sterilized in the graphic case in accordance with the following guidelines: Method Steam

Cycle Prevacuum (Wrapped)

Minimum Temperature 132°C (270°F)

Minimum Exposure Time 4 minutes

Mimimum Dry Time 20 minutes*

These parameters are validated to sterilize only these devices. The autoclave manufacturer’s operating instructions and recommended guidelines for maximum sterilization load should be followed. The autoclave must be properly installed, maintained, and calibrated. Only legally marketed, FDA cleared sterilization wrap/pouches should be used by the end-user for packaging terminally sterilized devices. * Synthes recommends a minimum dry time of 20 minutes for this device when sterilized using the recommended parameters. However, because dry time can be influenced by various factors such as autoclave performance, sterilization load, sterilization wrap/package materials, steam quality, varying cool-down time, and environmental conditions, adequate drying of this device should be verified by visual inspection. Important: Times represent exposure times only, and not total cycle times. Do not accelerate the cooling process. A thermal overload circuit prevents operation of the Drive Unit when hot. This safety feature requires the unit to have cooled sufficiently following sterilization before use. This also switches the unit off if it begins to overheat during operation. The unit becomes operational when it has cooled sufficiently. Hot air, ethylene oxide, plasma and formaldehyde sterilization are not recommended.

Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 © 2000 Synthes, Inc. or its affiliates. All rights reserved.

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

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

www.synthes.com Printed in U.S.A.

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