User's Manual Part 5

8065751025 4.7
Constellation
®
Vision System
3.8 Start the wash program. When the wash program is completed, replace the
processed handpiece and cable in the sterilization tray to prevent damage to
connector and handpiece during storage and autoclaving.
4 Sterilize the handpiece using a steam sterilization cycle.
The sterilization temperatures and settings provided in Table 1 below have been
validated by Alcon Laboratories, Inc. as being capable of sterilizing the reusable
U/S and Frag handpieces and non-electrical accessories for re-use. It remains
the responsibility of the processor to ensure that the processing as actually
performed using equipment, materials and personnel in the facility achieve the
desired result. This requires verification and routine monitoring of the process.
Likewise any deviation by the processor from the instructions provided should
be properly evaluated for effectiveness and potential adverse consequences.
Please refer to nationally recognized standards, such as AAMI Standards
2,3,4
or
to your facility’s standard procedures.
NOTE: Due to the potential for the accumulation of particulate and
bioburden residues in the sterilizer water reservoirs, it is the surgical
facility’s responsibility to properly maintain the equipment and their
associated filters to ensure the introduction of contaminant-free steam into
the handpieces.
Table 4-1. Recommended Sterilization Temperatures and Time Settings
Sterilizer Type Pulses
Sample
Configuration
Temperature
Min. Exposure Time
for U/S and Frag
Handpiece (Minutes)
Min. Exposure Time
for non-electrical
accessories (Minutes)
Gravity
Displacement
N/A Wrapped
132°C
(270°F)
18 15
Gravity
Displacement
N/A Unwrapped
132°C
(270°F)
8 10
Pulsing
Prevacuum
4 Unwrapped
132°C
(270°F)
4 4
Pulsing
Prevacuum
4 Wrapped
134°C
(273°F)
5 5
Pulsing
Prevacuum
(four negative
and four positive
pulses)
4 Wrapped
134-137°C
(273-279°F)
3 3
References:
1. ISO 17664: Sterilization of medical devices - Information to be provided by the
manufacturer for the processing of resterilizable medical devices
2. AAMI TIR12:2004, Designing, testing, and labeling reusable medical devices for
reprocessing in health care facilities: A guide for device manufacturers, 2ed.
3. AAMI TIR30:2003, A compendium of processes, materials, test methods, and
acceptance criteria for cleaning reusable medical devices, 1ed.
4. ANSI/AAMI ST79:2006, Comprehensive guide to steam sterilization and sterility
assurance in health care facilities.
* Registered trademark of Miele & Cie. KG