Side Effects - Integra Auragen Mode D'emploi

DESCRIPTION
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the
location of epileptogenic foci. Depth electrodes are inserted stereotaxically into the brain.
Depth electrodes are available with varying numbers of contacts. The length of depth electrodes is standard. The type of depth
electrode used is dependent on the procedure and the size of area being tested.
Depth electrodes are available with platinum/iridium contacts and 4 to 12 contacts. The electrode connectors are designed and
fabricated as subminiature cylindrical connectors.
Depth electrodes have standard 2.5 and 5 mm contacts with 2.5, 5 or 7.5 mm gap between contacts. Depth electrodes are pac-
kaged with a stylet. The stylet is used to provide rigidity for placement of the depth electrodes. The stylet must be removed be-
fore recordings are initiated. After removal of the stylet, the depth electrode is flexible to reduce potential trauma to brain tissue.
Materials with patient contact are platinum/iridium, polyurethane and cyanoacrylate glue.
Electrode Connecting Cables
The depth electrodes are designed to be used with the Integra connecting cables. The cables are made with varying numbers of
female pins to fit with the existing electrodes.
Connecting cables are designed to create an easy-to-use, reliable interface between Integra epilepsy monitoring electrodes and
most EEG monitoring systems. These cables feature gold-plated contact pins and connector contacts, with insulated 28 gauge
copper ribbon cable for maximum sensitivity and low impedance.
Note: Cables are sold non sterile.
Should sterilization be desired, the cables may be sterilized at low temperature gas plasma. Sterilization was validated with
Sterrad 100S Sterilization System (Advanced Sterilization Products) up to 10 sterilization cycles. The cycle comprised two iden-
tical exposure phases: 6 min injection, 2 min diffusion and 2 min plasma preceeded by a 10 min pre-exposure plasma phase.
Please refer to the Integra Electrode Connecting Cables Instructions for Use.
INDICATIONS
Auragen depth electrodes are intended for the intraoperative recording of EEG signals at subsurface levels of the brain.

SIDE EFFECTS

Possible complications include: infection, CSF leak, neurological complications, hemorrhage, pain, mechanical or electrical fai-
lure.
WARNINGS:
• These electrodes should not be inserted into any patient who has an active infection (meningitis, ventriculitis, skin infec-
tions, etc.), or who has recently had a scalp laceration
• Electrodes are for single use only and should not be re-sterilized or re-used after removal to avoid the transmission of
Creutzfeldt-Jakob disease by intracranial electrodes.
• Placement in patients with an active CSF leak or CSF Drainage System is not recommended.
• Reminder: Use great caution in the operating room. Ensure adequate support of equipment and staff.
• The tubing segment located next to the stylet point of entry on Depth Electrodes is a handle for stylet insertion and remo-
val. It should not be used as a depth marker.
• Reminder: Remove electrodes in the operating room, as removal remains a critical part of the procedure.
• Not intended as an implant but for intraoperative use only.
PRECAUTIONS
• The electrode leads are fragile and must be handled with extreme care.
• Storage and Transport: The Electrodes may be stored at room temperature. They will withstand the conditions of normal
transport.
• This product is for single use only. Do not reuse.
• This product is sterilized with ethylene oxide. Do not use if the package is open or damaged. Use the device prior to the
«Use by» date on the package label .
Caution - Do not resterilize. Integra will not be liable for any or all damages including, but not limited to, direct, indirect,
incidental, consequential or punitive damages resulting from or related to resterilization.
2
English