Integra JARIT DETACH Manual Del Usuario página 10

Immediate Use, ANSI/AAMI ST37:3ed. AAMI standards recommend that the
sterilizer manufacturer's written instructions for cycle parameters should
also be followed. Steam sterilization of lumened instruments requires that
they be flushed with sterile water just prior to wrapping and sterilization.
The water generates steam within the lumen to move air out. Air is the
greatest enemy to steam sterilization, preventing steam contact if not
eliminated. Medical device manufacturer's exposure times to sterilization
temperature may need to be longer than the minimum indicated by the
sterilizer manufacturer but must never be shorter.
Below are the recommended steam sterilization parameters:
Independent laboratory testing conducted according to ISO 17664, has validated the
following sterilization parameters
Surgical
Instruments
Independent laboratory testing, referencing FDA (21CFR Part 58) Good Laboratory
Practice Regulations has validated the following sterilization parameters
Jarit Endoscopic
Instruments
Jarit Endoscopic
Instruments
Jarit Endoscopic
Instruments
McCulloch
Retractor System
Fukushima-Day
Retractor System
Fukushima-Day
Retractor System
Flexi-Spine™
Retractor System
LumbarTrak™
Retractor System
LumbarTrak™
Retractor System
Sterilizer Exposure
Temperature
Pre-vacuum 132 °C
(wrapped)
Pre-vacuum 121 °C
(wrapped) 132 °C
134 °C
Pre-vacuum 132 °C
(unwrapped)
Gravity Steam 132 °C
(wrapped)
Pre-vacuum 132 °C
(wrapped)
Pre-vacuum 132 °C
(wrapped)
Gravity Steam 132 °C
(wrapped)
Pre-vacuum 132 °C
(wrapped)
Pre-vacuum 132 °C
(wrapped)
Gravity Steam 132 °C
(wrapped)
Exposure
Time
3 min
20 min
4 min
3 min
4 min
18 min
5 min
10 min
24 min
18 min
10 min
20 min
10
Minimum
Dry Time
10 min
20 min
20 min
15 min
20 min
20 min
20 min
20 min
20 min
30 min