Sterilization; Storage - KaVo SURGmatic S11 L Instructions For Use Manual

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.6 Sterilization

7.6 Sterilization

Sterilization in a steam sterilizer (autoclave) in
accordance with ISO 17665-1
Sterilization has to be performed using a steam sterilizer (autoclave) approved
by the U.S. Food and Drug Administration (FDA).
Improper service and care.
Risk of injury.
4 Perform regular proper care and servicing.
Contact corrosion due to moisture.
Damage to the product.
4 Remove the product from the steam sterilizer immediately after the steril-
ization cycle.
The medical device has a maximum temperature resistance up to 138
o
(280.4 F).
Sterilization parameters:
Sterilization of the product is approved for the following "wrapped" steam steril-
ization cycles:
▪ Sterilizer with Dynamic-Air-Removal (pre-vacuum) method:
– 3 minutes at 135 °C (275 °F)
Drying time: 16 min.
▪ Sterilizer with gravity displacement method:
– 10 minutes at 135 °C (275 °F)
Drying time: 30 min.
– 30 minutes at 121 °C (250 °F)
Drying time: 15-30 min.
4 Remove the medical device from the sterilizer immediately after completion
of the sterilization cycle.
4 Use in accordance with the manufacturer's Instructions for Use.

7.7 Storage

Processed products must be stored, protected from bacteria, to the extent pos-
sible, and dust, in a dry, dark, cool room.
NOTE
Comply with the expiration date of the sterilized items.
CAUTION
NOTICE
24 / 28
o
C