20
2108100003L29 1602V006
Use
9.3 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�
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
880�6850 product code FRG�
i
Shelf life is determined and identified per in-
struction for use of sterilization packaging
used�
9 Disinfection and cleaning
9.1 Clean and disinfect the
handpiece
NOTICE
The wrong cleaning and disinfection
can damage the camera
i
Only clean the surface of the camera�
i
Do not use any aggressive or abrasive
cleaning agents�
i
Only use disinfectant wipes to clean
the camera�
i
Do not clean the camera by submerg-
ing in or spraying with disinfectant�
i
Do not put the camera in an autoclave�
The disposable protective cover must be
used for only one patient and disposed of
properly in accordance with locale code�
Unplug camera components before per-
forming cleaning�
i
Wipe the surface of the camera with an EPA
registered surface dinsinfectant�
9.2 Cleaning the camera lens
NOTICE
Damage to the optical element caused
by incorrect cleaning
Residues of disinfectant will contaminate
the optical element�
i
Only use the supplied microfiber cloth
and alcohol�
i
Clean the window of the optic using the mi-
crofiber cloth with a drop of alcohol�
EN
US
