Codman HAKIM Manual Del Usuario página 10

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
CODMAN
Description
The CODMAN ® HAKIM
(Figures 1 & 2) that incorporates a flat 316L stainless steel spring in
which the calibration is accomplished by a combination between a pillar
and a micro-adjustable telescoping fulcrum. The valve chassis is made
of titanium. The ball and cone are manufactured from synthetic ruby.
Intraventricular pressure is maintained at a constant level by the ball
and cone valve seat design.
The pressure setting of the spring in the inlet valve unit is noninvasively
adjusted by the use of an external programmer, which activates the
stepper motor within the valve housing. The programmer transmits a
codified magnetic signal to the motor allowing eighteen pressure settings,
ranging from 30 mm to 200 mm H
increments. These are operating pressures of the valve unit and have been
determined with a flow rate of 15–25 mL H
The valve is classified by its working pressure with a specified flow rate
and not by the opening and closing pressures. The pressure that a valve
sustains with a given flow is the parameter that reflects the working
pressure of the valve once it is implanted. Before shipment, each valve
is calibrated with special equipment. Duplication of these test procedures
cannot be accomplished in the operating room.
The valve is marked with an x-ray detectable direction-of-flow indicator.
Indications
The CODMAN HAKIM Programmable Valves are implantable devices that
provide constant intraventricular pressure and drainage of CSF for the
management of hydrocephalus.
Contraindications
The CODMAN HAKIM Programmable 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
Subjecting the valve to strong magnetic fields may change the setting
of the valve.
• The use of Magnetic Resonance (MR) systems up to 3 T will not
damage the valve mechanism, but may change the setting of the valve.
Confirm the valve setting after an MRI procedure. See Programming the
Programmable Valve.
• Common magnets greater than 80 gauss, such as household magnets,
loudspeaker magnets, and language lab headphone magnets, may affect
the valve setting when placed close to the valve.
• Magnetic fields generated from microwaves, high-tension wires, electric
motors, transformers, etc., do not affect the valve setting.
Read MRI Information before performing an MRI procedure on a patient
implanted with the programmable valve.
Any magnet may experience a degradation of magnetic field strength as a
consequence of exposure to the significantly stronger magnet field induced
in an MRI procedure.
• Based on the coercivity of the CHPV magnet material, the valve is
resistant to magnetic degradation in a 1.5T MRI.
• Testing of the CHPV valve following exposure to 10 simulated MRI
procedures at 3T indicates there may be demagnetization that,
subsequently, could lead to a reduction in the ability to program the
valve. Please refer to Troubleshooting section should any difficulty in
programming occur.
The SIPHONGUARD
It also reduces the ability to prime the shunt system during implantation to
a rate of approximately 0.5 mL/minute.
MRI Information
Do not use the programmer in the MR suite.
HAKIM
® ®
® Programmable Valve includes a valve mechanism
® device is intended to reduce the rapid flow of CSF.
Programmable Valves
O (294 to 1960 Pa) in 10 mm (98 Pa)
2
O per hour.
2
1