Integra CONTOUR-FLEX Instrucciones De Uso página 2

Occluder
Inlet Connector
DESCRIPTION
The Integra NeuroSciences Contour-Flex™ Valve is a multi-function membrane valve with occluders and integral
connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from
ventricles of the brain. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a
fully flexible profile. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to
CSF flow. The flat silicone membrane seats on a conical polypropylene base. This base is integral to a rigid outlet port.
The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone
membrane also prevents retrograde flow of CSF.
The Contour-Flex valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow
characteristics ranges: low, medium, and high. The pressure/flow characteristics of both sizes of the Integra
NeuroSciences Contour-Flex Valve are shown in the graph (Figure 1) and chart (Figure 3). These pressure values are
derived as the valve is tested at flow rates varying from 5 to 50 ml/hr. Each valve is individually tested to obtain its
pressure/flow characteristics, closing pressure (Figure 2), and ability to prevent retrograde fluid flow. The tantalum
impregnated silicone arrow and pressure dot code on the valve housing allow identification of the pressure/flow rating.
The Contour-Flex Valve is designed with a fully flexible profile to conform to the curvature of the skull.
The Contour-Flex Valve is made of materials that are known not to interfere with CT scans or MRI imaging. Caution
should be exercised to ensure that the device is not connected to components that may contain interfering or non-
compatible materials.
The entire bottom surface of the Contour-Flex Valve is constructed of barium-sulfate impregnated silicone elastomer. It
also contains polyester reinforced sheeting, which is fully encapsulated by silicone elastomer to prevent contact with
tissues or fluids.
The Contour-Flex Valve may be flushed in either the proximal or distal direction by pressing one of the occluders on the
valve and pressing the reservoir. The reservoir is designed to allow penetration with a 25-gauge or smaller beveled
needle. The reservoir contains a polypropylene needle guard to prevent overpenetration of the needle. The valve
membrane is further protected from needle punctures by a rigid polypropylene cartridge.
Materials in contact with body tissues or body fluids are silicone elastomer with or without barium sulfate,
polypropylene, silicone ink and stainless steel.
Reservoir
Silicone Dome
Reinforced Polypropylene
Sheeting Needle Guard
Tantalum
Pressure Dots
Silicone
Membrane
Fig. 1
2
English
Tantalum Directional
Arrow
Occluder
Outlet
Connector