Codman HAKIM Manual Del Usuario página 11

The CODMAN HAKIM Programmable Valve is considered "MR Conditional"
according to ASTM F 2503. The valve demonstrates no known hazards
when an MRI is performed under the following conditions:
• MRI can be performed at any time after implantation
• Use an MR system with a static magnetic field of 3 T or less
• Use an MR system with a spatial gradient of 720 gauss/cm or less
• Limit the exposure to RF energy to a whole-body-averaged specific
absorption rate (SAR) of 3 W/kg for 15 minutes
• Verify the valve setting after the MRI procedure (see Programming the
Programmable Valve)
In non-clinical testing, the valve produced a temperature rise of 0.4°C at a
maximum whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg
for 15 minutes of MR scanning in a 3 T EXCITE
MR scanner.
MR image quality may be compromised if the area of interest is relatively
close to the device. Distortion may be seen at the boundaries of the artifact.
Therefore, optimization of the MR imaging parameters may be necessary.
The following chart provides a comparison between the signal void and
imaging pulse sequence at 3 T:
Signal Void
1590 mm
2
1022 mm
2
2439 mm
2
2404 mm
2
Precautions
The programmable valves are supplied without a specific programmed
pressure and must be programmed prior to use.
Inspect the sterile package carefully. Do not use if:
• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed.
This is an adjustable valve and the surgeon must take that into account
when evaluating patients. It is important to verify the current pressure
setting as part of any treatment plan.
Do not allow the programming unit or transmitter unit to remain in
environmental extremes.
After exposure of the programming unit or the transmitter unit to
environmental extremes, such as those found in transport or storage,
allow the unit to come within operating range before operating.
Do not program the valve on a metal surface, such as a Mayo stand.
While becoming familiar with valve programming, it is recommended that
the pressure setting of the implanted valve be changed in increments of
no more than ±40 mm H
pressure setting has been changed should be carefully monitored during the
first 24 hours post programming. It is recommended that x-rays be taken to
confirm the changes made to valve pressure setting.
Before use, check the programming unit and transmitter unit
connections, settings, and function (see Preimplantation Programming
Familiarization Procedure).
Use only Integra branded programmers to program the pressure of the
CODMAN HAKIM Programmable Valve.
Unauthorized modifications to the programming unit or transmitter unit may
cause a malfunction that could result in serious patient injury or death.
Electrical shock hazard: Do not open the programming unit or transmitter
unit. Refer servicing to qualified service personnel.
Explosion hazard: Do not use the programming unit in the presence of
flammable materials; i.e., anesthetics, solvents, cleaning agents, and
endogenous gases.
Before turning on the 100/120, 220/240 VAC programming unit (catalog
no. 82-3121 or 82-3190), verify that the supply voltage selector on the rear
of the unit is set to the correct voltage for the electrical outlet.
Do not move the transmitter unit during programming.
Never immerse the programming unit or the transmitter unit in any liquid.
Do not sterilize the programming unit or the transmitter.
Use only with components compatible with the dimensions shown in the
Device Description section.
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 cause
rupture of the silicone housing.
Pulse Sequence
T1-SE
T1-SE
GRE
GRE
O (392 Pa) in a 24-hour period. Patients whose
2
2
General Electric
™