7.6
Packaging
Note
The sterilisation bag must be large enough for the handpiece so that the bag is
not stretched.
The quality and use of the sterilisation packaging must satisfy applicable stand‐
ards and be suitable for the sterilisation procedure!
▶ Weld each medical device individually in a sterilised item package!
7.7
Sterilisation
Sterilisation in a steam steriliser (Autoclave) EN 13060/ISO 17665-1
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶ Before each sterilisation cycle, service the medical device with KaVo care
products.
CAUTION
Contact corrosion due to moisture.
Damage to product.
▶ Immediately remove the product from the steam steriliser after the sterilisa‐
tion cycle!
The medical device has a maximum temperature resistance up to 138℃
(280.4°F).
KaVo recommends for example
▪ STERIclave B 2200/ 2200P by KaVo
▪ Citomat/ K-series by Getinge
Autoclave with a pre-vacuum for least four minutes at 134°C ± 1°C
(273°F ± 1.8°F)
Drying time: 20 min.
Autoclave with the gravitation method for at least 10 minutes at 134℃ ±1°C ± 1°C
(273°F ± 1.8°F)
Drying time: 30 min.
Autoclave with the gravitation method for at least 60 minutes at 121° ±1°C
(250°F ± 1.8°F)
Drying time: 30 min.
Follow the manufacturer's instructions for use.
Instructions for use GENTLEsilence 8000BS - 1.000.5600
7 Preparation methods according to ISO 17664 | 7.6 Packaging
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