Integra Omni-Tract Instrucciones De Uso página 3

Automated Cleaning Procedure:
1. Place instruments in washer/disinfector such as Steris 333 and arrange devices in a way to avoid contact between components.
2. Set Washer parameters on a washer/disinfector and run for full cleaning cycle.
NOTE: Below are the minimal validated parameters. Other automatic washer-sterilizer or washer-disinfector specific parameters
may be available but have not been validated for use with Integra Omni-Tract Table Mounted Retractors.
Phase
Pre-Rinse
Enzyme Wash
Wash
Thermal Rinse
(Disinfection)
Dry
* Time is as needed for drying
3. Place instruments in an instrument tray/container for sterilization.
Post-Cleaning Inspection
1. Carefully inspect each device to ensure that all components are thoroughly dry and visible soil has been removed.
Re-clean if any soil remains.
2. Visually inspect for damage or wear to the components. Do not use the product if it is damaged or defective.
3. Replace any damaged components immediately.
4. Check the action of moving parts by moving them through the full range of motion. (Actuating the cam levers, threads and moving
and rotating all swivel components), check assemblies for proper fit between components according the User's Manual.
5. Lubricate all hinged instruments which may have any "metal to metal" action at the screw or box lock, hinges, threads, bearing
surfaces, cam surfaces, and other moving parts with a surgically acceptable instrument lubricant to reduce friction and wear of
the components. Use a non-silicone, water-soluble surgical lubricant such as Integra Miltex Spray Lubricant. Do not use industrial
oils as lubricants.
Sterilization
Following proper cleaning and prior to sterilization use an appropriate sterilization wrap or sterilization tray to ensure that components
and devices are not damaged in transportation to and from the sterilizer.
Steam Sterilization Method:
Process Validation procedures followed ANSI/AAMI ST79 standards for Pre-vacuum and Gravity sterilizers.
Steam Sterilization is the preferred method for sterilizing Omni-Tract products in wrapped packaging or approved rigid container.
No other methods have been validated and approved for use with Omni-Tract products.
Note: Instruments, regardless of sterilization cycle used, will remain too hot for immediate use. Allow sufficient dry time and cooling
before use.
Prevacuum:
4 Minutes at a minimum temperature of 132°C (270°F) with 30 minute dry time* [1.84 atm above atmospheric pressure]
*30 minutes is from AAMI/AORN standard dry time for Pre-Vacuum cycle
Extended Steam Sterilization Cycles are allowed with either increased temperature or time, where dry time must be at least the
minimum listed.
UK: 3 Minutes at a minimum temperature of 134°C (273°F) with 30 minute dry time [2.11 atm above atmospheric pressure]
France: 18 Minutes at a minimum temperature of 134°C (273°F) with 30 minute dry time [2.11 atm above atmospheric pressure]
Time Water Temp.
2:00 min Cold Tap Water
0:00 min N/A
2:00 min 140°F (60°C)
1:00 min 180°F (82.2°C)
* N/A
Detergent
N/A
N/A
EZ-Zyme
1:256 or 0.5oz/gal (4mL/L)
N/A
N/A