User's Manual Part 5

8065751025 4.3

Constellation

Vision System

STERILIZATION INSTRUCTIONS

Please consult the accompanying Directions For Use (DFU) for cleaning and sterilization

instructions for Alcon approved reusable accessories. The DFU will provide the recommended

time and temperature guidelines for steam autoclave cycles performed by Alcon, Inc. The sterility

assurance level achieved with these parameters must be validated by each surgical facility.

Please refer to Association for the Advancement of Medical Instrumentation (AAMI) Standards or

your facility’s standard procedures for the most current speciﬁcations.

Additionally, per the Sterilizer Equipment Manual, the sterilizer reservoir is to be ﬁlled with distilled

or deionized water.

NOTE: The reusable items will withstand steam autoclave cycles at 134° C (273°F). Due to

the variations found in steam autoclaves and the variable bioburden on devices

in clinical use, it is not possible for Alcon to provide speciﬁc parameters to ensure

an adequate sterility assurance level. Validation of the individual autoclave, and

veriﬁcation of the sterility assurance level achieved with a given steam sterilization

cycle, must be performed by each surgical facility. Please refer to below AAMI

Standards or your facility’s standard procedures for the most current speciﬁcations.

Please refer to appropriate accessory DFU for proper cleaning instructions.

AAMI TIR No. 12-1994, Designing, Testing, and Labeling Reusable Medical Devices

for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.

ANSI/AAMI Standards and Recommended Practices Volume 1.1: Sterilization

• Designation ST37-1996 (Good Hospital Practice: Flash sterilization – steam

sterilization of patient care items for immediate use)

• Designation ST46-1993 (Good Hospital Practice: Steam sterilization and sterility

assurance)