23
EN
FR
8-4
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.
• Do not touch the product immediately after steam
sterilization as it will be very hot and must remain in a
sterile condition.
• 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.
• Clean and lubricate the handpiece prior to sterilization. If
blood remains on the internal surface it can become clotted
and cause product failure.
• Do not heat or cool the product too quickly. Rapid change
in temperature could cause damage to the product.
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