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  • DEUTSCH, seite 21
• Drying time depends on several variables, including altitude, humidity, type
of wrap, preconditioning, size of chamber, mass of load, material of load, and
placement in chamber. Users must verify that drying time set in their autoclave
yields dry surgical equipment.
• The adequacy of any sterilization procedure must be tested. To substantiate the
process and its reliability and reproducibility, it is critical that appropriate process
parameters be validated for each facility's sterilization equipment and product/load
configuration by persons who have training and expertise in sterilization processes.
• The following autoclave processes have been validated by the manufacturer;
however, the sterility assurance level for any given sterilization cycle is dependent
on the actual conditions selected by the user and the correct calibration of the
user's sterilization equipment and instrumentation. Because these factors are
not within the control of T.A.G. Medical Products Corporation Ltd., the user is
responsible for the sterility assurance level.
Gravity - Displacement Steam Sterilization:
™ Sterilizer Type:
™ Minimum Temperature:
™ Minimum Exposure Time:
™ Minimum Dry Time:
Pre-vacuum Steam Sterilization:
™ Sterilizer Type:
™ Minimum Temperature:
™ Minimum Exposure Time:
™ Minimum Dry Time:
Pre-vacuum Steam Sterilization (alternate cycle):
™ Sterilizer Type:
™ Minimum Temperature:
™ Minimum Exposure Time:
™ Minimum Dry Time:
(6) Exposure time of 18 minutes is permitted (as mandatory in some European countries).
Do not exceed 140°C (284°F) during sterilization.

Storage:

• Between uses, store instruments in a clean, dry environment.
• To prevent damage, minimize contact between instruments and with other
equipment.
• Warning: These storage parameters are not intended to preserve instrument
sterility. If necessary, reprocess the instruments again prior to use.

Service Life:

The reusable instruments should be replaced after one year.
Gravity
132°C (270°F)
10 minutes
40 minutes
Pre-vacuum
132°C (270°F)
4 minutes
15 minutes
Pre-vacuum
134°C (273°F)
3 minutes
(6)
15 minutes
9

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