Small Battery Drive II Sterilization Guide

Sterilization Guide Small Battery Drive II Sterilization The DePuy Synthes Power Tools Small Battery Drive II system may be resterilized using validated steam sterilization methods (ISO 17665 or national standards). DePuy Synthes Power Tools recommendations for packed devices and cases are as follows. Drying times generally range from 20 to 60 minutes due to differences in packaging materials (Sterile Barrier System, e.g., wraps or reusable rigid container systems), steam quality, device materials, total mass, sterilizer performance, and varying cool down time.

Precautions • The following maximum values may not be exceeded: 138°C over a maximum of 18 minutes. Higher values can damage the sterilized products. • Do not accelerate the cooling process. • Hot air, ethylene oxide, plasma, and formaldehyde sterilization are not recommended.

Cycle type

Sterilization exposure time (Wrapped or unwrapped)

Sterilization exposure temperature

Drying time*

Saturated steam-forced air removal (pre-vacuum)

Minimum 4 minutes

Minimum 132 °C Minimum 138 °C

20–60 minutes

Minimum 3 minutes

Minimum 134 °C Minimum 138 °C

20–60 minutes

Washing basket/Containers

DePuy Synthes Power Tools recommends a minimum dry time of 20 minutes for this device when sterilized using the parameters recommended above. However, because dry time can be infl uenced 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 enduser for packaging terminally sterilized devices.

Manufactured or distributed by: Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132 USA To order (USA): 800-327-6887 To order (Canada): 855-946-8999 © DePuy Synthes 2020. All rights reserved. DSUS/PWT/0714/0048 Rev 3

www.jnjmedicaldevices.com