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This Instructions for Use (IFU) is related to ALCIS wrench from range 2023-CL. It is an additional part of the IFU associated to ALCIS
depth electrodes from the range 2069-EPC and associated accessories (ranges 2023 and 2036).
1.
Products description
Performances:
•
Wrench REF 2023-CL and 2023-CL-C
o
Ability to be assembled with guidance screws to allow them to be unlocked on the patient's skull.
Technical characteristics of the wrench:
Range
2023-CL
Wrench
Year of CE
marking:
2002
2.
Intended use
Wrench is intended to unlock the guidance screw before unscrewing by the screwdriver. As the wrench is an accessory of Depth
Coagulation Electrode, (2069-EPC) It is used in the context of pre-surgical diagnosis of drug-resistant epilepsies.
3.
Contraindications
No specific contraindications.
4.
Recommendations / Warnings
The use of 2023-CL Wrench must be carried out by an experienced neurosurgeon and according to a controlled stereotactic
procedure. The choice of the model is responsibility of the neurosurgeon. The patient must be placed under a continuous surveillance
and in an adapted environment to avoid every risk of incidents.
Do not "force" for accessories assembly or disassembly (assemblies must be performed without excessive stress)
■
Check the products integrity and condition before each use.
■
Storage and maintenance
•
Store in a cold dry place and away from sunshine at room temperature.
•
Inspect packaging before use to detect any damage.
•
Do not use in case of wear and/or damage of any kind. (risk of fall which can cause a deterioration or a breakage of the
device)
Cleaning, disinfection and sterilization
Reusable accessories
Reusable devices are provided unsterile
-
-
Before use, clean and sterilize according to a controlled and
validated process (alkaline detergent and sterilization in an
autoclave at 134°C for 18 minutes – prion cycle).
During the cleaning, take care to biological residues absence.
-
After use, clean the reusable ancillaries (alkaline detergent).
-
Other important user information
Check if the device is sold with this Instructions for uses to use it in recommended conditions.
-
Rev. 13 May 2020
REF 2023-CL-C
Technical form 2023-AVG-C-FT
REF 2023-CL
Technical form 2023-APR-FT
any devices identified with any of the
symbols shown here
Useful opening 3.5mm; to be used exclusively
with ALCIS short guidance screws range 2023-
VG-C.
Useful opening 1.9mm to be used exclusively
with standard guidance screws range 2023-VG.
any devices identified
with symbol shown here (refer
to table 1 or product label)
(Refer to product
label).
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