Domain Surgical FMX Instrucciones De Uso página 7

NOTE: The validation of this cleaning process was completed with Steris® Prolystica
2X Concentrate Enzymatic Detergent and a HAMO LS-1000 Washer-Disinfector.
NOTE: Dilute detergent according
to manufacturer's instructions.
After the drying cycle is complete, the product
is ready for steam (autoclave) sterilization.
Steam Sterilization (Moist Heat) is Recommended
NOTE: An autoclave cycle has been validated as
being capable of sterilizing this medical device;
however autoclave design and performance can
affect the efficacy of the process. Healthcare
facilities should validate the process that they
use, employing the actual equipment and
operators that routinely process the devices.
NOTE: Autoclaves should comply with the
requirements of, and be validated, maintained
and checked in accordance with EN285/EN
13060, ISO 17665 and ANSI/AAMI ST79.
Preparing the RPM for Moist-Heat
(Autoclave)Sterilization Process
Wrap the RPM with CSR wrap (or equivalent). Use only
wrappers validated for use in double simultaneous
wrapping. Two single-layer wrappers or one bonded
double-layer wrapper can be used. Simultaneous
double wrapping refers to when two layers of wrap
material are wrapped together simultaneously
using the fold technique described below.
• Place the wrap sheets on the table to form
a diamond shape. Place the RPM to be
wrapped in the center of the wrap, parallel
with the edge of the table (figure 4).
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