Principles Of Operation - Integra NeuroSciences OSV II Instrucciones De Uso

Sterile - Sterilized with ethylene oxide gas. Non pyrogenic. Radiopaque. For single use only. Do not use open or
damaged packages. Do not resterilize.
WARRANTY DISCLAIMER AND LIMITATION OF REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR OTHER WARRANTY ON INTEGRA NEUROSCIENCES PRODUCTS
DESCRIBED IN THESE INSTRUCTIONS FOR USE. UNDER NO CIRCUMSTANCES SHALL INTEGRA
NEUROSCIENCES IMPLANTS BE LIABLE FOR MEDICAL EXPENSES OR ANY DIRECT, INDIRECT,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY
SPECIFIC LAW. NO PERSON HAS ANY AUTHORITY TO BIND INTEGRA NEUROSCIENCES
IMPLANTS TO ANY REPRESENTATION OR WARRANTY CONCERNING INTEGRA NEUROSCIENCES
IMPLANTS PRODUCTS EXCEPT AS SPECIFICALLY SET FORTH HEREIN.
Descriptions and specifications appearing in Integra NeuroSciences printed matter, including this publication, are
meant solely to generally describe the product at the time of manufacture and do not constitute any express warranties.
Integra NeuroSciences hydrocephalus valve systems, components and accessories are designed to perform reliably over
an extended period of time. However, any implanted component may have to be replaced at any time because of failure
or for medical reasons, and the patient and/or the patient's family should be made aware of this possibility.
Rx only.
Note - After implantation, complete the patient identification card for the patient or family.
Product returns to Integra NeuroSciences: Contact your local Representative for instructions on return of products.
DESCRIPTION
The OSV II hydrocephalus Valve System is an implantable device for controlled cerebrospinal fluid (CSF) drainage from
the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike
conventional valves, the OSV II is a variable resistance valve which maintains a drainage rate close to the CSF secretion
rate (20 ml/hr) within the physiological range of intracranial pressure (ICP). The mechanism incorporates a safety
pressure relief mode to prevent accidental intracranial hypertension.
Configurations
The system is available in different configurations; a system generally consists of a ventricular (proximal) catheter, a
valve unit, and a drainage (distal) catheter. Some configurations contain an antechamber or a burr hole cap.
Configurations consisting of one-piece (integral), and two-piece (separate ventricular catheter) systems are available.
Included with the OSV II systems that have a ventricular catheter are one introducing rod or one ventricular catheter
introducer, one Luer connector, one straight connector and one Right-Angle Guide (RAG). Configurations with a burr
hole cap contain burr hole reservoirs. Configurations without a ventricular catheter do not contain a ventricular catheter
introducer (or rod), or Right-Angle Guide. A malleable tunneler is supplied with some configurations for subcutaneous
tunneling of the distal tubing. Marked ventricular catheters feature radiopaque length markings at 2 cm intervals from the
tip. Connectors are designed for use with 1.1 to 1.4 mm inner diameter silicone elastomer tubings.

Principles of Operation

A variable flow restrictor (Figure 1) consists of a silicone elastomer diaphragm (4), synthetic ruby seat (5), and notched
pin (6). The diaphragm reacts to differential pressure (DP) variations. The seat is inserted into the center of the
diaphragm. As pressure varies, the clearance between the seat and the pin increases or decreases depending on seat
movement along the pin. A typical flow/pressure curve is shown in Figure 2.
Note - Differential pressure/flow characteristics for each valve are verified to be within specification at time of
manufacture.
The three stages of operation of the OSV II are defined below:
Stage I - Low Differential Pressure
This stage begins when the flow rate through the valve reaches 5ml/hr (DP will be between 30 and 80 mm H
valve remains in Stage I with CSF flow rates up to 18 ml/hr (DP will be between 40 and 120 mm H
Stage II - Flow Regulation
When the DP increases, the valve operates as a variable resistance flow regulator. At DP ranges between 120 and
300 mm H 0, the valve restricts flow between 18 and 30 ml/hr.
2
4
English
0). The
2
0).
2