20
7-4 Packaging, Sterilizing, and Drying
1) Insert the handpiece into an FDA-approved sterilization pouch that conforms to ISO 11607-1, and seal the pouch.
2) Perform steam sterilization with the following conditions.
Type
Gravity Displacement
Pre-Vacuum (Dynamic Air Removal)
Temperature
132
°
C
132
°
C
Full Cycle Time
15 min.
4 min.
Drying Time
30 min.
30 min.
CAUTION
• Use an FDA-approved steam sterilizer to perform sterilization.
• Follow local rules, regulations, and guidelines regarding the reprocessing of devices.
• Immediately after sterilization is complete (within 1 hour), remove the handpiece from the sterilizer. Failure to do so may
cause corrosion.
• Do not perform steam sterilization on the product with other instruments even when it is in a pouch. This is to prevent
possible discoloration and damage to the product from chemical residue on other instruments.
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