Packaging; Sterilization; Storage - KaVo Kerr SonicFill Handpiece Instructions For Use Manual

6.6 Packaging

Note
The sterile goods package must be large enough for the handpiece so that
the packaging is not stretched.
The quality and use of the sterile goods package must meet the applicable
standards and be appropriate for the sterilization process!
▶ Seal each medical device individually in a sterilization item package.

6.7 Sterilization

Sterilization in a steam sterilizer (autoclave) ISO
17665-1
Improper service and care.
Risk of injury.
▶ Perform regular proper care and servicing.
Contact corrosion due to moisture.
Damage to the product.
▶ Remove the product from the steam sterilization immediately after the
sterilization cycle.
Note
Remove the SonicFill Unidose Tip before sterilization. SonicFill
Unidose Tips cannot be sterilized.
The KaVo medical device has a maximum temperature resistance of up to
138 ℃ (280.4 °F).
Sterilization parameters:
Select a suitable procedure (depending on the available autoclave) from the fol-
lowing sterilization processes:
▪ Sterilizer with triple pre-vacuum:
- at least 3 minutes at 135°C (275 °F)
- Drying time: 16 min.
▪ Sterilizer with single pre-vacuum:
- at least 4 minutes at 132°C (270 °F)
- Drying time: 20 min.
▪ Sterilizer using the gravity method:
- at least 30 minutes at 121°C (250 °F)
- Drying time: 15 min.
▶ Use in accordance with the manufacturer's Instructions for Use.

6.8 Storage

Processed products must be stored, protected from bacteria, to the extent pos-
sible, and dust, in a dry, dark, cool room.
6 Processing steps in accordance with ISO 17664 | 6.6 Packaging
CAUTION
NOTICE
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