How to Use the STERRAD 100NX System DUO Test Pack ® DUO Cycle Test Pack* *For the frequent monitoring of the STERRAD® 100NX® System DUO Cycle 1.Set Up • Prior to using CYCLESURE® 24 BI, check the expiration date on the box and vial. • Label an unprocessed CYCLESURE® 24 BI vial with a marker and write the load number and date. If a sticker is used, do not block the two holes on the cap. • Check vial for color and consistency For STERRAD® 100NX® System DUO Cycle, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration. For more information on the STERRAD® 100NX® System DUO Cycle Test Pack, contact ASP Customer Support at 1-888-STERRAD or visit www.sterrad.com. After completing the performance testing, the Test Vials should be cleaned using a mild detergent, rinsed thoroughly with water, and dried prior to reuse. Check the vial for signs of wear and visible cracks prior to use, and replace with a new vial if necessary. © Ethicon, Inc. 2013 AD-130009-01-US_A 2.Getting Started 5. Incubation • Place the processed CYCLESURE® 24 BI vial in the incubator rack. The incubator temperature should be between 55˚C and 60˚C. • Remove an unprocessed CYCLESURE® 24 BI vial from box to serve as the positive control. • Label it with the date and the letter “C” for control. • While holding the control vial upright, press down on the cap and gently crush the media ampoule. • Place the control vial in the incubator rack.Incubate both vials for at least 24 hours but no more than 72 hours. 3.After Processing • Place one (1) CYCLESURE® 24 BI inside a Test Vial. Make sure that the CYCLESURE® 24 BI Chemical Indicator disc is positioned in the open end of the Test Vial. Tighten the test vial cap firmly. • Place the DUO Cycle Test Pack in the most challenging area for the sterilant to reach in a fully-loaded chamber. This is typically on the shelf close to the rear of the sterilizer on top of the load (if two shelves are used in your sterilizer, placement should be on the bottom shelf). Secure the Test Pack to the load with a small piece of the STERRAD® SEALSURE® Chemical Indicator Tape. Yellow Cap and Purple Media: (Negative BI) ® • ASP recommends gloves to be worn when handling CYCLESURE® 24 BI as peroxide burns can result if the media ampoule is broken. • Immediately after the cycle is completed, remove the CYCLESURE® 24 BIs from each Test Vial. Check the CYCLESURE® 24 BI Chemical Indicator disc for a color change from red to golden yellow or bronze. • Press down on the cap until the cap is firmly seated and the black line is no longer visible. 4.Crushing the Vial • Keeping the CYCLESURE® 24 BI vial in an upright position, place the vial in the tube crusher so the white label is showing. Squeeze gently until the media ampoule has been crushed. You will hear a “pop” sound. Red Cap and Yellow Media: Positive Control (Positive BI) 6.After Incubation 7.Reading Results • After 24 hours, check both CYCLESURE® 24 BI vials and record the results in the STERRAD® System Sterilization Log. • The processed CYCLESURE® 24 BI vial should have a golden yellow or bronze top and contain purple solution. This means conditions for sterilization have been met. Skip step 7 and proceed to step 8. • If the processed CYCLESURE® 24 BI solution changes color from purple to yellow (as in the positive control vial), and/ or exhibit sturbidity, this indicates that conditions for sterilization have not been met. Proceed to step 7. • If the CYCLESURE® 24 BI vial reads positive, follow your facility’s policy for retrieval of instruments. Repeat the test with another CYCLESURE® 24 BI vial. If the result is negative, run a third test to ensure sterilization performance. • If two consecutive positive results are observed in the processed STERRAD® CYCLESURE® 24 BI vials, follow your facility’s policy for retrieval of instruments, report the positive BI to Advanced Sterilization Products (ASP), division of Ethicon, Inc., including lot number, and have the sterilizer checked by ASP. Do not use the sterilizer until it has been checked. 8.Disposal • Discard all CYCLESURE® 24 BI vials immediately after reading (after 24 hours but before 72 hours) according to your facility’s procedures. • The positive control CYCLESURE® 24 BI and any positive-result CYCLESURE® 24 BI vials can be autoclaved at 121°C for 30 minutes prior to disposal, or follow your facility’s procedure. Please read and follow the User's Guide and Instruction for Use for more detailed on processing information