Indications For Use; Contraindications - Codman Hakim Bedienungsanleitung

Note that testing of the device may give different results depending on the
test conditions
Devices performed within a tolerance range of the average operating
pressure (mm H 2 O) for each preset operating pressure at flow rates of
5 ml/hr, 20 ml/hr and 50 ml/hr as shown here:
All Devices
When tested with a unitized 120 cm long, 1 0 mm inner diameter
peritoneal catheter, the average pressure increase is dependent on the
flow rate as shown here:
5 ml/hr 7 mm H 2 O
20 ml/hr 21 mm H 2 O
50 ml/hr 50 mm H 2 O
Graph 2. Additional Pressure Needed to maintain Flow for Integrated
SiphonGuard Devices
60
50
40
30
20
10
0
0
Addi onal Pressure Needed To Maintain Flow [mmH
Additional Pressure Needed to Maintain Flow [mm H 2 O]
The SiphonGuard® Device, included in some models of the valve, is
designed with a dual pathway to prevent excessive drainage of CSF by
the shunt system Excessive draining can be induced by a rapid increase
in hydrostatic pressure created by the elevation of the shunt ventricular
catheter with respect to the shunt distal catheter (i e when a patient
moves from a supine to an upright position) A sudden increase in CSF
flow will close the ball and cone valve and the entire volume of CSF will
be forced through the longer secondary spiral passage, effectively slowing
the rate at which CSF is shunted from the brain Graph 2 describes the
incremental pressure required for CSF to flow through the SiphonGuard
secondary pathway

Indications for Use

The Codman Hakim Precision Fixed Pressure Valve Systems are implantable
devices that provide constant intraventricular pressure and drainage of CSF
for the management of hydrocephalus

Contraindications

The Codman Hakim Unitized Valve Systems are not recommended for
atrial placement Use the nonunitized versions for this procedure
These devices are contraindicated in patients receiving anticoagulants or
known to have a bleeding diathesis
Avoid shunt implantation if infection is present within the body Delay
the shunt procedure when infections such as meningitis, ventriculitis,
peritonitis, bacteremia, and septicemia are present
WARNINGS
The valve unit contains components made from titanium and 316L
stainless steel When tested with MRI magnets of up to 3 0 Tesla, the valve
produced an insignificant amount of force and torque This shunt system,
as with other implants containing metallic components, may produce an
artifact during MRI The requesting physician must determine whether the
location of the artifact will affect the area of interest
The SiphonGuard device is intended to reduce the rapid flow of CSF It also
reduces the ability to prime the shunt system during implantation to a rate
of approximately 0 5 cc/minute
± 15 mm H 2 O
20
5
100 200 300 400
2
50
500 600
O]
2