Equi-Flow Valve IFU

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EnglishOccluderSiliconeDomeReservoirTantalumPressureDotsTantalumDirectionalArrowOccluderSiphonLimitingDeviceInletConnectorReinforcedSheetingPolypropyleneNeedle GuardSiliconeMembraneOutletConnectorDESCRIPTIONThe Integra Equi-Flow Valve is a multi-function membrane valve incorporating a normally open Siphon LimitingDevice, occluders, and integral tubing connectors. It is used in treatment of patients with hydrocephalus when shuntingcerebrospinal fluid (CSF) from ventricles of the brain. It incorporates a central reservoir for pumping and injection,proximal and distal occluders, a Siphon Limiting Device and a fully flexible profile. The Siphon Limiting Device limitsthe reduction of intraventricular pressure and volume caused by the siphoning effect of hydrostatic pressure in the DistalCatheter.The Equi-Flow Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The flat siliconemembrane seats on a conical polypropylene base which is integral to the Siphon Limiting Device. The Siphon LimitingDevice contains a rigid outlet port. This design allows for accurate and precise regulation of CSF flow due to itsstructural integrity. The flat silicone membrane also prevents retrograde flow of CSF.The Equi-Flow Valve is available in two sizes: Regular and Small. Both sizes are available in 4 pressure/flowcharacteristics ranges: Performance levels 0.5, 1.0, 1.5 and 2. The pressure/flow characteristics of both sizes of theIntegra Equi-Flow Valve are shown in the graph (Figure 1) and chart (Figure 3). These pressure values are derived as thevalve is tested at flow rates varying from 5 to 50 ml/hr. Each valve is individually tested to obtain its pressure/flowcharacteristics, closing pressure (Figure 2), and its ability to prevent retrograde fluid flow. The tantalum impregnatedsilicone arrow and pressure dot code on the valve housing allow identification of the pressure/flow rating. Each valve isdot-coded based on its horizontal and vertical operating pressures measured at the time of manufacture. The pressure ofeach valve has been verified to be within the pressure range limits indicated on the package label.The Equi-Flow Valve is designed with a fully flexible profile to conform to the curvature of the skull.The Valve’s integral tubing connectors present an outer diameter of 1.8 mm for connection to standard catheters.The Equi-Flow Valve may be flushed in either the proximal or distal direction by pressing one of the occluders on thevalve and pressing the reservoir. The reservoir is designed to allow penetration with a 25-gauge or smaller beveledneedle. The reservoir contains a polypropylene needle guard to prevent overpenetration of the needle. The valvemembrane is further protected from needle punctures by a rigid polypropylene cartridge.Magnetic Resonance Imaging (MRI)/CT CompatibilityThe Equi-Flow Valve is made of materials that are known not to interfere with CT scans or MRI imaging. Caution shouldbe exercised to ensure that the device is not connected to components that may contain interfering or non-compatiblematerials.MaterialsThe entire bottom surface of the Equi-Flow Valve is constructed of barium-sulfate impregnated silicone elastomer. It alsocontains polyester reinforced sheeting, which is fully encapsulated by silicone elastomer to prevent contact with tissuesor fluids. The Equi-Flow Valve is latex free.Materials in contact with body tissues or body fluids are silicone elastomer with or without barium sulfate,polypropylene with or without barium sulfate, silicone ink and stainless steel.ConfigurationsThe System is available in different configurations; a system generally consists of a ventricular (proximal) catheter, avalve unit, and a drainage (distal) catheter. The drainage catheter may be integral (attached to the valve) or separate.Some configurations contain a burr hole cap and a burr hole reservoir. Included with the Equi-Flow shunt systems thathave a ventricular catheter are one introducing rod (stylet) and one Right-Angle Guide (RAG).4
EnglishVentricular Catheters feature numbered length markers located 5 and 10 cm from the proximal end. Length marker dotsare located at 1 cm increments 3 to 14 cm from the proximal end. The proximal end contains fourty (40) flow holes.Distal Catheter are 91 cm silicone elastomer barium sulfate striped tubings. Numbered length markers are located 5, 10,15, 20, 25 and 30 cm from the distal end to assist catheter placement. The distal end of the catheter has four staggeredrows of 5.5-mm slits, which are not easily visible.Burr Hole Reservoirs are made of radiopaque polypropylene and measure 6.4 mm in diameter and 0.8 mm in depth.INDICATIONSThe Integra Equi-Flow Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device isdesigned to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium ofthe heart or to the peritoneal cavity. The Equi-Flow Valve is indicated in patients where excessive reduction ofintraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the distal catheter ofthe shunt system.CONTRAINDICATIONSHydrocephalus shunt systems should not be implanted when the patient has known or suspected infections in the vicinityof any of the implanted components (meningitis, ventriculitis, skin infections, bacteremia, septicemia, peritonitis, etc.).Avoid implanting hydrocephalus shunt systems if infection is present anywhere in the body. Shunting into the atrium ofpatients with congenital heart disease or other cardiopulmonary anomalies is contraindicated.WARNINGS:• Patients with hydrocephalus shunt systems should be closely observed postoperative for signs and symptomsof shunt obstruction or overdrainage of CSF.• Obstruction of the shunt system may lead to signs and symptoms of increased intracranial pressure. For aninfant, the signs may be increased tension on the fontanelle, congestion of scalp veins, listlessness,drowsiness, nuchal rigidity, irritability, and vomiting. For older patients, the signs may be headaches,vomiting, diminished consciousness, nuchal rigidity, and blurred vision.• Overdrainage by the shunt system may lead to signs and symptoms of reduced intracranial pressure and thedevelopment of a subdural hematoma, subdural hygroma, or collapse of the lateral ventricular walls leadingto obstruction of the Ventricular Catheter.• Shunt obstruction or overdrainage requires immediate surgical intervention. The surgeon is advised to usetechniques to which he/she is accustomed.• The Ventricular Catheter may become bound to the choroid plexus or by fibrous tissue. Use gentle rotationto free it. Forcible removal of the catheter may result in an intraventricular hemorrhage.• Placement of the distal catheter into the right atrium of the heart may lead to embolization of thepulmonary arterial tree with resulting corpulmonale and pulmonary hypertension.PRECAUTIONS• Patients or their representatives should be informed of the warnings and potential complications associated with useof this device prior to implantation.• Avoid cutting or occluding catheter tubing when securing tubing to valve connector with ligatures. Do not kinkcatheters at any point. Other than trimming catheters or valve tubing, modifications are not recommended.• Avoid use of sharp metal instruments when handling silicone components to avoid any damage.• If a hypodermic injection into the reservoir is required, use a 25-gauge or smaller beveled needle and only inject intothe reservoir dome.• Have duplicates of each component available during implantation.• Do not lubricate valves. They will be lubricated adequately by the CSF.• Avoid contaminants such as glove talc and contact with skin oils when handling tubing.• Do not puncture the Siphon Limiting Device with a needle.• Do not place the Equi-Flow Valve under the skin of the neck, chest or abdomen.COMPLICATIONSComplications associated with use of this device may be similar to those associated with medication and anestheticmethods used in other surgical procedures, as well as the patient’s degree of reaction or sensitivity to any foreign objectimplanted in the body.Common complications associated with the shunt system itself may include shunt obstruction, infection, mechanicalfailure of system components, and excessive lowering of intracranial pressure.5
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Equi-Flow Valve IFU

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