APPENDIX
Preimplantation Performance Testing
Although Integra does not recommend functional testing, some surgeons
may choose to do so. Before testing, it is extremely important that a
CODMAN HAKIM Valve with or without SIPHONGUARD Device be
flushed of all air bubbles. Air bubbles within the CODMAN HAKIM Valve
or SIPHONGUARD Device produce inaccurate manometer test results.
The presence of air bubbles can reduce the cross-sectional area of the flow
path, increase system resistance, and impede the flow of fluid through the
system during testing.
SIPHONGUARD Device Functional Testing
Equipment required (use all sterile equipment, perform testing under
sterile conditions)
One manometer, wide-bore (e.g. 3.5 mm), graduated in mm (available in
lengths from 38 to 60 cm)
One 4-way stopcock
One syringe, 5 cc
One syringe filter, 5 µm
Tubing adapters
Silicone tubing
One male luer connector with 1/16 in. barb
Saline solution
Flushing Procedure
Note: At a rate of 0.5 ml/minute, unitized versions require 2–3 minutes to
complete flushing. This is the time required for fluid to fill the valve and exit the
distal catheter. Allot additional time to ensure the system is free of air bubbles.
1.
Assemble the manometer, stopcock, syringe, and tubing (Figure A-1).
Figure A-1
2.
Detach the syringe from the assembly and fill the syringe with sterile
saline solution using the 5 µm filter in-line. Detach the filter after filling
the syringe.
3.
Remove the valve from the sterile package, and connect the valve
to the manometer/syringe assembly. Note: Do not attach the distal
catheter at this time.
4.
Adjust the stopcock to connect the syringe to the valve assembly
(Figure A-2).
Figure A-2
5.
Position the valve vertically to direct the flow of saline upward through
the assembly. This orientation aids in flushing air from the system.
6.
Using the syringe, gently flush saline through the system while
gently depressing the prechamber to purge air bubbles from the
valve assembly.
7.
Attach the distal catheter and continue to flush the system using the
syringe until saline solution exits the end of the distal catheter.
Manometer
To Valve
8
Valve