Mri Safety Information; How Supplied - Integra OSV II Lumbar Valve Systems Mode D'emploi

MRI SAFETY INFORMATION

Non-clinical testing has demonstrated that the implanted OSV II Valve systems components are MR CONDITIONAL. A patient
with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 3.0 T or less
• Maximum spatial field gradient of 3500 gauss/cm (35 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Mode)
Do not take non-implanted accessories used to aid in introduction of the shunt device such as stylets and catheter guide into the
MR environment. They have not been evaluated for safety in the MR environment.
Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than 0.4 ºC after
15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the OSV II Valve system extends approximately 10 mm from the device when
imaged with a gradient echo pulse sequence and a 3.0 T MRI system.

HOW SUPPLIED

Integra OSV II Lumbar Valve Systems are supplied sterile and non-pyrogenic in a double-wrap packaging.
Disposal
After patient use, the system must be handled as biohazardous material and disposed of in accordance with applicable Federal,
State, local, or international environmental requirements following facility protocols.
PRODUCT INFORMATION DISCLOSURE
INTEGRA HAS EXERCISED REASONABLE CARE IN THE CHOICE OF MATERIALS AND MANUFACTURE OF THIS PRODUCT. IN-
TEGRA 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
SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY
ARISING FROM USE OF THIS PRODUCT. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME FOR IT ANY
OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS. INTEGRA INTENDS THAT
THIS DEVICE SHOULD BE USED ONLY BY PHYSICIANS WITH EDUCATIONAL AND TRAINING BACKGROUND ENABLING THE
PROPER USE OF THE DEVICE.
Returned Goods Policy
Authorization from customer service must be obtained prior to returning product.
Sterile products must be returned in unopened packages with manufacturer's seals intact to be accepted for replacement or
credit unless returned due to a complaint or product defect. Determination of a product defect will be made by Integra.
Credit will be issued for goods returned prior to 90 days from ship date and may be subject to a restocking charge of up to 20%.
This assumes that the product returned is not damaged and can be verified to have not been used or opened.
Product Order Information
All products can be ordered through your Integra NeuroSpecialist or customer service representative or by contacting:
Integra LifeSciences Corporation
311 Enterprise Drive
Plainsboro, NJ 08536, U.S.A.
Telephone: 1-800-654-2873
Outside the US: +1-609-275-0500
Fax: +1-609-275-5363
Date of revision: January 2015
Integra NeuroSciences Implants (France) S.A.S.
2905 Route des Dolines
06921 Sophia Antipolis CEDEX, France
Telephone: +33 (0) 4 93 95 56 00
Fax: +33 (0) 4 93 65 40 30
Integra LifeSciences Services (France)
Immeuble Séquoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest, France
Telephone: +33 (0) 4 37 47 59 00
Fax: +33 (0) 4 37 47 59 99
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