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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.
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
10 mm H
O (98 Pa) – Very Low Range
2
40 mm H
O (392 Pa) – Low Range
2
70 mm H
O (686 Pa) – Medium Low Range
2
100 mm H
O (980 Pa) – Medium High Range
2
130 mm H
O (1274 Pa) – High Range
2
3
Dot Code
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