Rev. 03 / Jan. 2019
Plasmapp Co., Ltd.
STERLINK
®
FPS-15s Plus User Manual
13
Chapter 3. Sterilizer overview
3.1. Intended use
The STERLINK
®
FPS-15s Plus sterilization system is a low temperature plasma sterilizer to
inactivate microorganisms for a broad range of metal and nonmetal medical devices and surgical
instruments at low temperature. This sterilizer offers an effective, safe, fast, economical, easy–to-
use, reliable, and flexible sterilization method.
When used as directed by the instruction in this User manual, please review the Chapter 4 "Load
preparation" chapter in which recommended materials and lumen sizes are described. When
selecting reusable medical devices to be processed in this sterilizer system, reprocessing
information should be obtained from the manufacturer of the medical device in accordance with
international norms (such as ISO 17664 or AAMI TIR 12).
3.2. Sterilization procedure
As a medical professional, you may already be familiar with general sterilization principles.
However, the STERLINK
®
FPS-15s Plus sterilizer utilize its own method, and it requires special
attention to the ways in which it differs from other conventional sterilizers.
The STERLINK
®
FPS-15s Plus sterilizer can sterilize medical devices by diffusing hydrogen
peroxide vapor into the chamber or pouch. It rapidly sterilizes medical instruments and materials
without leaving toxic residues. All stages of the sterilization cycle are not damaged to compatible
instruments which are sensitive to heat and moisture.
The STERLINK
®
FPS-15s Plus sterilizer can be used for metal and non-metal medical devices
and can sterilize instruments that have difficult-to-reach (diffusion-restricted) spaces, such as
hinges on forceps. Please refer to "Load preparation" chapter for more information.
The sterilizer consistently provides the 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 manual.
The devices have been pre-validated to the SAL of 10
-6
based upon worst-case conditions,
including lumens within the claim lengths and mated surfaces. If additional technical information
concerning validation is needed, please contact Plasmapp or your local Plasmapp customer
support representative.
