2109100018L29 1608V002
27
Use
i
Steam sterilize the spacer in a gravity steam
sterilizer at 250 °F for 30 minutes and dry time
of 20 minutes before use
Use a new replacement spacer as needed
Storage
i
Store the product protected against contami-
nation
i
After sterilization, store the parts in a steriliza-
tion packaging cleared by FDA under 21 CFR
8806850 product code FRG
i
Shelf life is determined and identified per in-
struction for use of sterilization packaging
used
12 Maintenance
12.1 Replacing the o-ring
If the interchangeable head does not engage
properly when being placed on, the O-ring on
the handpiece can be replaced
i
Replacing the O-ring
i
Dry clean the lens in the handpiece with com-
pressed air or with a cotton bud
11.3 Preparing the spacer
The following instructions are verified as suit-
able for preparing the product for further use
Preparation process:
– Sterilization in steam sterilizer
The person responsible for preparation must en-
sure that the process and the equipment, mate-
rials, and personnel used achieve the required
results If there is any deviation from the validat-
ed preparation process, the person responsible
for the preparation is responsible for the effec-
tiveness of the process and for any adverse
consequences
i
Carry out validations and routine monitoring of
the preparation process
i
Observe any national and local regulations
that apply to the cleaning, disinfection, steril-
ization and storage
Steam sterilization
WARNING
Incorrect sterilization inhibits the ef-
fectiveness, and can damage the
product
i
Only use steam sterilization
i
Observe the process parameters
i
Do not use any other process
250 °F
Process parameters
Sterilizer type: Gravity
Minimum temperature: 250 °F
Exposure time: 30 min
Dry time: 20 min
Wear protective gloves
EN
US
