Equi-Flow Valve IFU

English4. Finally, be sure to remove all large bubbles from the shunt system. It is not necessary to remove small bubbles.Note: If Distal Catheter slits are stuck together, fill the shunt system with sterile fluid, then roll slits gently betweenfingers to lubricate and open the slits.Note: To perform an alternative patency test, attach a syringe to the valve’s proximal inlet connector and gentlyflush with sterile fluid.Pre-Implant Valve Pressure TestEvery Integra Equi-Flow Valve is individually tested to ensure it meets rigorous specifications and pressure/flowcharacteristics. If, however, the surgeon wishes to verify the closing pressure of the valve is as stated in thespecifications, the following procedure may be performed in the operating room.CAUTION: Use extreme care to maintain sterility and avoid particulate contamination.Equipment needed (sterile)1. Fluid reservoir or water bath2. 30 cm or larger manometer, graduated in centimeters wih a 3-way stopcock3. 30 cc – 60 cc syringe4. Tubing5. Blunt needle to connect syringe to tubing6. Sterile distilled water or physiological salineTest procedure1. Connect tubing to both sides of the manometer.2. Place one tube into water bath.3. Align the manometer so the zero mark is level with fluid in the water bath.4. Purge all air from system by flushing with syringe.5. Attach the proximal connector of valve to be tested to the tube submerged in water bath.6. Gently flush valve with sterile fluid and submerge completely in the water bath.7. Fill manometer to approximately 30 cm H 2 O.8. While maintaining a gentle flow of fluid through valve using the syringe, isolate syringe from valve with the 3-waystopcock.9. The water column will begin to fall as fluid flows through valve. After 2 – 2.5 minutes, read fluid level inmanometer. The valve must be submerged in the water bath to obtain the correct results.Closing Pressure ResultsPerformance Level (Regular or Small)Acceptable Closing PressureFlow Rate0.5 1.0 – 5.0 cm H 2 O1.0 1.0 – 7.0 cm H 2 O1.5 3.5 – 9.5 cm H 2 O2.0 5.0 – 13.0 cm H 2 OFig. 2Pressure/Flow CharacteristicsPerformance Level0.5 1.0 1.5 2.05 ml/hr, 0 cm H 2 O Hydrostatic Pressure 1-4 cm H 2 O 1-7 cm H 2 O 4.5-9.5 cm H 2 O 6-13 cm H 2 O50 ml/hr, 0 cm H 2 O Hydrostaticpressure5 ml/hr, -50 cm H 2 O HydrostaticPressure50 ml/hr, -50 cm H 2 O HydrostaticPressureValve Marking2-6 cm H 2 O 2-9 cm H 2 O 6.5-11.5 cm H 2 O 8-14 cm H 2 O1-6.5 cm H 2 O 1-9.5 cm H 2 O 4.5-12.5 cm H 2 O 6-15.5 cm H 2 O2-8.5 cm H 2 O 2-11.5 cm H 2 O 6.5-14.5 cm H 2 O 8-17 cm H 2 OFig. 38