DePuy Synthes
Synthes Pen Drive Sets Sterilization Guide April 2012
Sterilization Guide
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Electric Pen Drive Sets Sterilization Guide.
The Electric Pen Drive Set should be steam sterilized in the Graphic Case (690.580, 690.586, 690.596, or 690.597) in accordance with the following guidelines: – Ensure all accessories, attachments and cables are disassembled from the Drive Unit. – Position the components in the correct orientation in the Graphic Case. – Ensure the Graphic Case is used to sterilize the set at these parameters.
Cycle
Minimum Temperature
Minimum Exposure Time
Prevacuum (Wrapped)
132°C (270°F)
4 minutes
Minimum Dry Time (wrapped only) 20 minutes*
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 recommends a minimum dry time of 20 minutes for this device when sterilized using the parameters recommended above. 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. 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 USA 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 327-6887 Fax: (800) 327-6661 E-mail: [email protected] © 2012 Synthes, Inc. or its affiliates. All rights reserved.
Graphic Cases, for Electric Pen Drive 690.580 Graphic Case 690.586 Three Level Modular Graphic Case 690.596 Single Level Modular Graphic Case 690.597 Two Level Modular Graphic Case Caution: Do not sterilize the consoles! Consoles will no longer function! Do not sterilize the Foot Switch! Foot Switch will no longer function! Disassemble the Hand Switch and Drive Unit before sterilization! Disassemble the Seal Nipple for Cable from the ends of the cable before sterilization!
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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