Preimplantation Performance Testing - Codman HAKIM Manual Del Usuario

The following components have been tested and were determined to
be nonpyrogenic:
Valve, In-line with SIPHONGUARD Device
Valve, In-line with SIPHONGUARD Device and Platform with Proximal Tube
Valve, In-line
Valve, Right Angle with SIPHONGUARD Device
Valve, Right Angle
Valve, Cylindrical with Prechamber
Valve, Cylindrical with RICKHAM Reservoir
Valve, Cylindrical
Valve, Micro with RICKHAM Reservoir
Valve, Micro
Peritoneal Catheter
Ventricular Catheter
Priming Adapter
Right Angle Adapter
Straight Connector

Preimplantation Performance Testing

Each CODMAN HAKIM Programmable Valve is individually tested on
a component level to ensure conformance to the advertised performance
characteristics. Each valve is dynamically tested at six different settings
for proper dynamic opening pressure over the entire performance range.
Performing a manometer test is not recommended, as it is susceptible
to environmental factors. Manometer testing yields a result that is not
physiologic in nature and for which manufacturers do not specify performance
ranges. If the surgeon insists upon performing manometer testing for
confirmation of CODMAN HAKIM Valve closing pressures, it is possible,
but is not recommended. When performed correctly, manometer testing
generates valve closing pressures similar to the CODMAN HAKIM Valve
opening pressure setting. However, closing pressure results will typically
vary noticeably from the opening pressure setting.
For those surgeons who wish to perform functional testing, please see
Preimplantation Performance Testing in the Appendix.
Programming the Programmable Valve
Programmer Information
WARNING: The CODMAN HAKIM Programmable Valves are supplied
without a specific programmed pressure and must be programmed
prior to implantation.
Programming must be performed prior to implantation through the
nonsterile outer package. Perform programming postoperatively as needed.
The programmer consists of two parts, the programming unit and the
transmitter unit. The programming unit control panel (Figure 5) features
a power switch, programming instructions, and a representation of the
programmable portion of the valve system as it appears when x-rayed. This
representation also incorporates the 18 pressure selection buttons. Eighteen
LEDs, corresponding to the position of the valve pressure indicator when
viewed on x-ray, confirm the pressure setting chosen.
After depressing the desired pressure selector button, an LED lights in the
programming unit. The lighted LED corresponds exactly with the position of
the pressure indicator on the valve. When programming begins, the transmitter
unit emits a sequentially coded electromagnetic signal. The stepper motor
of the valve detects the signal and rotates the cam assembly, which, in turn
adjusts the tension of the spring to the selected pressure setting.
Transmitter Information
Note: This Transmitter Information is for the CODMAN HAKIM Programmers
ONLY. When using another Integra programmer, please refer to the
instructions for use packaged with your programmer.
The transmitter unit (Figure 6) incorporates an illuminated center hole and
directional arrows to aid in proper positioning over the valve. It connects
to the programming unit via a pronged plug and is activated by the
START button.
Preimplantation Programming Familiarization Procedure
To become familiar with valve programming, perform the following
preimplantation programming procedure while the valve remains in
the blister package.
1.
Insert the pronged plug from the transmitter unit into the receptacle at
the back of the programming unit.
2. Plug the power cord from the programming unit into an appropriate
power source.
Note: The instructions contained in steps 3 through 6 are for the
CODMAN HAKIM Programmers ONLY. When using another Integra
programmer, please refer to the instructions for use packaged with
your programmer.
3. Press the programming unit's power button to the ON position. Both
the ON button and Instruction 1 on the panel will illuminate. Press the
desired pressure selection button; Instruction 2 illuminates.
4. Place the transmitter unit's four prongs in the four depressions in the
blister around the inlet valve. Point the arrow on the transmitter unit in
the same direction as the arrow on the blister (the direction of flow).
Look through the illuminated center hole of the transmitter unit.
CAUTION: Do not move the transmitter unit during programming.
5