User's Manual Part 5

8065751025 4.5
Constellation
®
Vision System
3 Automated Washer Cleaning Procedure
In the event use of an automated process is required, perform all of the
following steps to process the handpiece.
NOTES:
a) Due to the potential for the accumulation of particulate and bioburden
residues in the washer 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 solutions into the handpieces.
b) This automated washing procedure provides a method per ISO 176641 for
effectively processing up to three (3) handpieces at a time.
c) The temperatures and cycle parameters below will not cause damage to the
product.
d) Do not wash the handpieces with non-ophthalmic instruments.
3.1 Manually clean the handpiece immediately after each surgical procedure per the
manual cleaning procedure above before using an automated washer.
3.2 Prepare the washer with multi-purpose injector per the washer operator’s
manual. The circulation rate of the automated washer should be at least 106
gallons (401 liters) of water per minute. The use of a typical automated washer
and wire basket is depicted below. Note: Use de-ionized water only.
Required materials:
• Detergent with pH range of 8.5 up to 9.5
• Organic acid neutralizer with pH range of 2.6 to 3.0.
• Adaptors and silicone tubing, e.g. Customized Auto Wash Kit: Alcon REF
8065750456.
3.3 Set detergent and neutralizer dispensers as recommended by detergent and
washer manufacturer.
3.4 Program washer to have the following automated cycle:
• Main wash at 55° C for 10 minutes (dispense detergent as recommended by
detergent and washer manufacturer)
• Neutralize for a minimum of 1.5 minutes (dispense neutralizer as
recommended by detergent and washer manufacturer)
• Rinse for 5 minutes at 22 - 27° C then drain
• Repeat rinse for 5 minutes at 22 - 27° C then drain
• Final Rinse at 70° C for 1.5 minutes then drain
• Dry at 100° C for 5 minutes
NOTE: Additional rinsing steps will not alter the effectiveness of the
validated cycle.