Novus NL850-9010 Instrucciones De Uso página 6

Failure of the shunting system may be
evidenced by any or all of the following:
continuing symptoms of increased
intracranial pressure, the subcutaneous
exudation of CSF along the pathway of
the shunt and leakage of fluid through
the surgical wound. These failures
require immediate replacement of the
shunting system or of the affected
component.
Product Information
Disclosure
Integra NeuroSciences has
exercised reasonable care in the
choice of materials and
manufacture of this product. Integra
NeuroSciences excludes all
warranties, whether expressed or
implied by operation of law or
otherwise, including, but not limited
to any implied warranties of
merchantability or fitness for a
particular purpose. Integra
NeuroSciences shall not be liable for
any incidental or consequential loss,
damage, or expense, directly or
indirectly arising from use of this
product. Integra NeuroSciences
neither assumes or authorizes any
other person to assume for it, any
other or additional liability or
responsibility in connection with this
device.
Product Order Information
All products can be ordered through
your Integra NeuroSciences Neuro
Specialist or customer service
representative or by contacting :
Integra NeuroSciences
311 Enterprise Drive
Plainsboro, NJ 08536 USA
Telephone: 1-800-654-2873
Outside the US: 1-609-275-0500
Fax: 609-275-5363
or
Integra NeuroSciences
Newbury Road, Andover
Hampshire SP10 4DR England
Tel: +44(0) 1264-345-700
Fax: +44 (0) 1264-332-113
Caution: Federal (USA) law restricts
this device to sale by or on the order
of a physician. Do not use if the
package has been opened or
damaged.
Symbols Used On Labeling
See instructions for use
Expiration date
Do not reuse after
2
opening
Lot number
LOT
Sterile unless package is
STERILE EO
opened or damaged.
Method of sterilization-
ethylene oxide.
Product complies with
0123
requirements of directive
93/42/EEC for medical
devices.
Bibliography
Chapman PH, Cosman ER, Arnold MA.
"The Relationship Between Ventricular
Fluid Pressure and Body Position in
Normal Subjects and Subjects with
Shunts; a Telemetric Study.
Neurosurgery, 26(1990), 181-189.
Foltz, Eldon L. and David B. Shurtleff.
"Conversions of Communicating Hydro-
cephalus to Stenosis or Occlusion of the
Aqueduct During Ventricular Shunt,"
Journal of Neurosurgery, 24 (1966), 520-
529.
Hassan M, Hagashi S, Yamashita J.
"Siphon-Reducing Devices in Normal-
Pressure Hydrocephalus" Journal of
Neurosurgery, 84 (1996), 634-641.
Ignelzi, Ronald J. and Wolff M. Kirsch.
"Follow-up Analysis of Ventriculoperi-
toneal and Ventriculoatrial Shunts for
Hydrocephalus," Journal of Neurosurgery,
42 (June, 1975), 679-682.
Illingworth, Robin D., Valentine Logue,
Lindsay Symon, et al. "The Ventriculo-
caval Shunt in the Treatment of Adult
Hydrocephalus: Results and Complica-
tions in 101 Patients," Journal of
Neurosurgery, 35 (December, 1971), 681-
685.
Kuwamura, K.; Kokunal, T. "Intraventric-
ular Hematoma Secondary to a Ventric-
uloperitoneal Shunt," Neurosurgery. 1982
March: 10(3); 384-386.
6
Little, John R., Albert L. Rhoton, Jr.,
and James F. Mellinger. "Comparison
of Ventriculoperitoneal and
Ventriculoatrial Shunts for
Hydrocephalus in Children," Mayo
Clin. Proc., 47 (June, 1972), 396-
401.
McCullough, David C, John L. Fox, et
al. "Effects of CSF Shunts on Intra-
cranial Pressure and CSF
Dynamnics," Cisternography and
Hydrocephalus, edited by John C.
Harbert. Springfield, Illinois 1972.
Milhorat, Thomas H. Hydrocephalus
and the Cerebrospinal Fluid. The
Williams and Wilkins Co. Baltimore,
1972.
Portnoy, Harold D., Rudolf R. Schulte,
John L. Fox, et al. "Anti-Siphon and
Reversible Occlusion Valves for
Shunting in Hydrocephalus and
preventing Post-Shunt Subdural
Hematomas," Journal of
Neurosurgery, 38 (June, 1973), 729-
738.
Portnoy, Harold D. and Paul D.
Croissant. "Combined Drainage of
Ventricular and Subdural Fluid,"
Surgical Neurology, 2 (January,
1974), 41-42.
Pudenz, Robert H. "The Ventriculo-
Atrial Shunt," Journal of
Neurosurgery, 25 (1966), 602-608.
Sugar, Oscar and Orville T. Bailey.
"Subcutaneous Reaction to Silicone in
Ventriculoperitoneal Shunts," Journal
of Neurosurgery, 41 (September,
1974), 367-371.