ASP Sterrad 100NX, User Manual

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1
Introduction
6 STERRAD ® 100NX ® User’s Guide
The STERRAD
®
Sterilization Process
The STERRAD
®
100NX
®
Sterilizer sterilizes medical devices by diffusing
hydrogen peroxide vapor into the chamber and then electromagnetiy exciting
the hydrogen peroxide molecules into a low-temperature plasma state. The
combined use of hydrogen peroxide vapor and plasma safely and rapidly
sterilizes medical instruments and materials without leaving toxic residue. All
stages of the sterilization cycle operate within a dry environment at a low
temperature, and thus the cycle is not damaging to compatible instruments
that are sensitive to heat and moisture.
The STERRAD
®
100NX
®
Sterilizer can be used for both metal and nonmetal
devices, and can also sterilize instruments that have difficult-to-reach
(diffusion-restricted) spaces, such as hinges on forceps. Refer to the
“Safety Information” chapter for more information on device safety.
The sterilizer consistently provides a Sterility Assurance Level (SAL) of 10
-6
,
as defined by U.S. Food and Drug Administration (FDA) and international
standards, for clinical use on all allowed substrates within the limits of the
claims for materials and geometries when used in accordance with the
directions in this user’s guide.
If You Have Questions
If you have questions about the STERRAD
®
100NX
®
Sterilizer or questions
about which items may be safely sterilized by the STERRAD
®
Process,
please call your local Advanced Sterilization Products (ASP) Representative
or visit our website at www.aspjj.com.
DRAFT