How to Use the STERRAD 100NX System DUO Test Pack

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