Sterilization Instructions - Stryker SPY-PHI Manual Del Usuario

Recommended minimal washer /disinfector parameters:
Heated Wash
Heated Tap Water Rinse
Heated Deionized Water Rinse
Forced Air Drying

10.3 Sterilization Instructions

NOTE:
1. For components with moving parts, lubricate joints with a
steam-permeable, water soluble component lubricant prior
to sterilization.
2. Components should be sterilized in the opened or unlocked
position. Central knob of the articulating arms must be
opened for sterilization.
3. Components should be sterilized by standard cycles using
steam with the procedures listed below.
Preparation for Sterilization:
Note: Use only FDA Cleared CSR Sterilization Wrap for
component packaging.
• Each component should be wrapped in two layers of FDA
Cleared CSR Wrap using the simultaneous double-
wrapping equal fold technique.
• Chemical Indicator Tape should be used to secure
packaging and for labeling the contents. Note: Chemical
Indicator Tape will change color or display diagonal stripes
when exposed to temperatures of 121°C (250°F).
Note: Only use wrappers validated for use in double simultaneous
wrapping.
Two single-layer wrappers or one bonded double 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:
1. Place the edge of the wrapper parallel with the edge of
the table. Place the device in the center of the wrapper
parallel with the edge of the wrapper.
2. Fold the edge of the wrapper over the top of the contents,
covering the entire item. Fold the edge back over itself
(toward the technician) to form a cuff. This will facilitate
aseptic opening of the pack when used.
©2020 IFU-0100 / rev3
Temperature
60°C (140°F)
60°C (140°F)
82°C (180°F)
116°C (240°F)
Time
2 Min.
20 Sec.
1 Min.
9 Min.
12