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Disposal procedure
There are infectious risks related to wrench disposal, according to WHO waste classification. To minimize the risks, the most common
treatments for infectious waste are: steam treatment (autoclaving), integrated steam treatment (hybrid autoclaves or advanced steam
treatment), microwave treatment, dry heat treatment, chemical treatment (internal shredding or chemical disinfectants) and incineration
(combustion, pyrolysis or gasification). One of this method shall be followed to reduce the infectious risk. One of these methods should
be followed to reduce the risk of infection.
5.
Main complications
Any serious incident that as occurred in relation to the device should be reported to the manufacturer and the competent authority of
the member state in which the user and/or patient is established.
However, no specific complications or potential adverse effects are identified for the wrench.
Main complications of interventional technics in stereotactic conditions still apply.
6.
Warranty limit
ALCIS products are submitted to control tests at several stages of manufacturing process to ensure compliance with specifications.
ALCIS can never be held responsible for any expenses or damages directly or indirectly resulting from:
The non-respect of instructions, recommendations and warnings of the instruction for use,
■
The use of accessories or devices unsuited or defective
■
7.
Use procedure
Electrodes removal
Warning: To do without delay at the end of the thermo-coagulation procedure
Use with guidance screws 2023-VG:
•
Check the absence of abnormalities with a suitable technique.
•
Unscrew the cap.
•
Remove the electrode.
•
Use a wrench (2023-CL) on flat parts to unlock the screw.
•
Use a short screwdriver (2023-TO-020) to finish removal of the screw.
•
Close the cutaneous hole after screw removal.
•
Reiterate the above operations for each screw.
•
Check the cerebral structures with a suitable technique.
Use with short guidance screws 2023-VG-C:
•
Check the absence of abnormalities with a suitable technique.
•
Remove the retaining ring and unscrew the cap using a suitable screwdriver (2023-TO-BC).
•
Then pull the electrode to remove it.
•
Unlock the screw with a wrench (2023-CL-C), then unscrew totally with a short screwdriver (2023-TO-C-020).
•
Close the cutaneous hole.
•
Reiterate the same operations for each electrode.
•
Check the cerebral structures with a suitable technique.
References table
Reference
2023-CL
2023-CL-C
Rev. 13 May 2020
Material
Stainless steel
Packaging
Unitary non-sterile
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