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cavities of instruments by using sterile compressed air.
6.8 Functional Testing, Maintenance:
Visual inspection for cleanliness of the instruments and reassembling. Functional
testing according to instructions of use. If necessary, perform reprocessing process
again until instruments is visibly clean. Before packaging and autoclaving, make
sure that the file clip, touch probe and lip hook has been maintained acc. to
manufacturer's instruction.
6.9 Packaging:
Pack the instruments in an appropriate packaging material for sterilization. The
packaging material and system refer to EN ISO 1167.
6.10 Sterilization:
Sterilization of instruments by applying a fractionated pre-vacuum steam
sterilization process (according to EN 285/EN 13060/EN ISO17665) under
consideration of the respective country requirements. Minimum requirements: 3 min
at 134°C (in EU: 5 min at 134°C) Maximum sterilization temperature: 137°C.
Note: Flash sterilization is not allowed on lumen instruments!
6.11 Storage:
Storage of sterilized instruments in a dry, clean and dust free environment at
modest temperatures, refer to label and instructions for use.
7 Storage, maintenance and transportation
7.1 Storage
7.1.1 This equipment should be stored in a room where the relative humidity is
10% ~ 93%, atmospheric pressure is 70kPa to106kPa, and the temperature is -20°C
~ +55°C.
7.1.2 Avoid the storage in a too hot condition. High temperature will shorten the
Summary of Contents for Ai-Pex
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