Newdeal Instrument Systems Instructions for Sterilization

311 Enterprise Dr., Plainsboro, NJ 08536

Tel (609) 275-0500 (800) 997-4868

Instructions for Sterilization Newdeal® Instrument Systems Each Newdeal® Sterilization Tray is intended to organize and store specific Newdeal implants and instruments. The implants and instruments within the organizing trays may be steam sterilized. The organizing tray is not intended to provide a sterile barrier. The trays must be enclosed in a wrapper validated as appropriate for this method of sterilization. Steam sterilization parameters are given for the following stainless steel trays (consisting of all implants and instruments): HintermannTM Distractors Compressor Forceps

Sterilization Parameters The following sterilization parameters are recommended for the aforementioned trays: Method Steam

Cycle Pre-vacuum (wrapped)

Temperature 132°C 270°F

Duration 4 minutes

Drying 20 minutes Minimum

These sterilization parameters assume that all instruments have been properly decontaminated prior to sterilization. The parameters are validated to sterilize specific configurations as noted in the tray markings. If other products are added to the tray or to the sterilizer, the recommended parameters may not be valid and new cycle parameters may need to be validated by the user. The autoclave must be properly installed, maintained and calibrated. Validation Testing Sterilization validation testing was performed according to AAMI TIR12: 2004: Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities and AAMI ST 81: 2004: Sterilization of Medical Devices – Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices.

©2009 Integra LifeSciences Corporation. All Rights Reserved. Newdeal is a registered trademark of Integra Life Sciences Corporation or its subsidiaries. Hintermann and the Integra wave logo are trademarks of Integra Life Sciences Corporation or its subsidiaries. NS1180-06/09