Codman Hakim Bedienungsanleitung Seite 12

Artifact Information
In non-clinical testing, the image artifact caused by the device extends
approximately 47 mm from the Codman Hakim Precision Fixed Pressure
Valve when imaged with a gradient echo pulse sequence and a 3-Tesla MRI
system
Adverse Events
Devices for shunting CSF may have to be replaced at any time due to
medical reasons or failure of the device
Keep patients with implanted shunt systems under close observation for
symptoms of shunt failure
Complications of implanted shunt systems include mechanical failure,
shunt pathway obstruction, infection, foreign body (allergic) reaction to
implants, and CSF leakage along the implanted shunt pathway
Clinical signs such as headache, irritability, vomiting, drowsiness, or
mental deterioration may be signs of a nonfunctioning shunt Low-grade
colonization, usually with Staph. epidermidis, can cause, after an interval
from a few days to several years, recurrent fevers, anemia, splenomegaly,
and eventually, shunt nephritis or pulmonary hypertension An infected
shunt system may show redness, tenderness, or erosion along the shunt
pathway
Accumulated biological matter (i e blood, protein accumulations, tissue
fragments, etc ) in the ball/seat interface can interfere with the pressure
regulation of the device
Biological matter can obstruct the ventricular catheter Also, the
ventricular catheter can become obstructed by excessive reduction of
ventricle size
Do not use excessive force if attempting to remove the catheter(s)
Excessive force can cause the catheter to break, leaving part of the
catheter within the body
Excessive CSF drainage can cause subdural hematomas, slit-like ventricles,
and in infants, sunken fontanelles
If not properly located in the lateral ventricle, the catheter can become
embedded in the ventricular wall or choroid plexus
Fibrous adhesions may bind the catheter to the adjacent choroid plexus
or to the ventricular wall Gentle rotation may free the catheter DO NOT
REMOVE THE CATHETER FORCEFULLY If the catheter cannot be removed
without force, it is recommended that it remain in place, rather than risk
intraventricular hemorrhage
The ventricular catheter can be withdrawn from, or lost in, the lateral
ventricles of the brain if it becomes detached from the shunt system
Blunt or sharp trauma to the head in the region of implant or repetitive
manipulation of the valve during implant may compromise the shunt
Check valve position and integrity after occurrence
Device Description
Precision Fixed Pressure Valve
Precision Fixed Pressure Valves have a preset pressure, available in five
ranges The valve pressure range is identified by an x-ray detectable dot
code applied to the valve These codes are as follows:
Precision Fixed Pressure Valve Operating Pressures Dot Code
10 mm H 2 O (98 Pa) – Very Low Range
40 mm H 2 O (392 Pa) – Low Range
70 mm H 2 O (686 Pa) – Medium Low Range ...
100 mm H 2 O (980 Pa) – Medium High Range ...
130 mm H 2 O (1274 Pa) – High Range ...
Precision Fixed Pressure Valve Configurations
In-line with SiphonGuard Device
In-line
Right Angle with SiphonGuard Device
Right Angle
Cylindrical with Prechamber
Cylindrical
Micro with Rickham Reservoir
®
Micro
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