KaVo SONICflex, Instructions For Use Manual, Page: 17 / 20

Instructions for use SONICflex seal tips
6 Reprocessing steps in accordance with ISO 17664 | 6.4 Packaging
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NOTE
Please comply with the instructions for use of the washer disinfector.
6.4 Packaging
NOTE
The sterile goods package must be large enough to accommodate the product
without stretching the packaging. The quality and use of the packaging of the
items to be sterilised must meet the applicable standards and be appropriate
for the sterilisation process!
4
Seal the medical device separately in a sterile pack.
6.5 Sterilisation
Sterilisation in a steam steriliser (autoclave) in
accordance with EN 13060 / EN ISO 17665-1
CAUTION
Contact corrosion due to moisture.
Damage to product.
4 Immediately remove the product from the steam steriliser after the steril-
isation cycle.
The medical device has a max. temperature resistance of up to 138
o
C (280.4
o
F).
Sterilisation parameters:
Select a suitable process from the following sterilisation processes (depending
on the available steriliser):
▪ Steriliser with triple pre-vacuum:
– at least 3 minutes at 134
o
C -1
o
C / +4
o
C (273
o
F -1.6
o
F / +7.4
o
F)
▪ Steriliser using the gravity method:
– at least 10 minutes at 134
o
C -1
o
C / +4
o
C (273
o
F -1.6
o
F / +7.4
o
F)
– at least 60 minutes at 121
o
C -1
o
C / +4
o
C (250
o
F -1.6
o
F / +7.4
o
F)
Use according to the manufacturer's Instructions for Use.
6.6 Storage
Reprocessed products must be stored appropriately protected from light in a
dry, dark, cool low-germ room.
NOTE
Comply with the expiry date of the sterilised items.