Codman Hakim Bedienungsanleitung Seite 11

Precautions
Inspect the sterile package carefully Do not use if:
• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed
Use only with components compatible with the dimensions shown in the
Device Description section
This is a fixed pressure valve It functions on a fixed pressure system within
the indicated range
Aseptic technique is necessary in all phases of the use of this product
Silicone has a low cut and tear resistance; therefore, exercise care when
placing ligatures so as not to tie them too tightly The use of stainless steel
ligatures on silicone rubber is not recommended
Do not use sharp instruments when handling the silicone valve or catheter;
use shod forceps Cuts or abrasions from sharp instruments may rupture or
tear the silicone components
Do not fold or bend the valve during insertion Incorrect insertion may
rupture the silicone housing
To better stabilize the position of the valve underneath the scalp, proper
valve placement is required Place the flat underside of the valve against
the bone, with the round top surface facing upward
Cylindrical Valves only: Before closing the scalp incision (or mastoidal
incision, if a two-step passage technique is employed), confirm that the
black dot on the outlet valve faces up and that the reservoir is placed just
distal to the ventricular catheter
Verify proper placement and integrity of ligatures at all tubing junctions
to prevent obstruction of the catheter lumen and tears or abrasions of the
silicone tubing
Do not fill, flush, or pump the valve with fluid in which cotton, gauze, or
other lint-releasing material has been soaked
Exercise extreme care to prevent the silicone components of the system
from coming in contact with towels, drapes, talc, or any linty or granular
surfaces Silicone rubber is highly electrostatic and, as a result, attracts
airborne particles and surface contaminants that could produce tissue
reaction
After implantation, avoid unnecessary pumping of the prechamber and
pumping chamber to prevent rapid alteration of the intraventricular
pressure
Magnetic Resonance Imaging (MRI) Safety Information
Non-clinical testing has demonstrated that the Codman Hakim Precision
Fixed Pressure Valves are MR Conditional A patient with this device can be
safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 3-Tesla and 1 5-Tesla
• Maximum spatial field gradient of 3,000 G/cm (30 T/m) or less
• The highest SG magnetic field is commonly located off-axis, at a side
wall, and near the opening of the bore of the scanner Please refer to
MRI manufacturer's published value and location of the peak SG that
is accessible to the patient
• Maximum MR system reported, whole body averaged specific
absorption rate (SAR) of 4-W/kg (First Level Controlled Operating
Mode)
MRI-Related Heating
Under the scan conditions defined above, the Codman Hakim Precision
Fixed Pressure Valves are expected to produce a maximum temperature rise
of less than 4°C after 15 minutes of continuous scanning
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