OCS2PND Ojemann Cortical Stimulator Instructions for Use Rev July 2009

English

THE NON DISPOSABLE OJEMANN CORTICAL STIMULATOR PROBE OCS2PND IS NOT STERILE AND MUST BE STERILIZED PRIOR TO USE. CONTENTS MUST BE REMOVED FROM PACKAGE BEFORE STERILIZATION. REUSABLE. DESCRIPTION The OCS2PND probe is a bipolar stimulating probe for cortical stimulation with malleable tips for precise localization. The OCS2PND probe has 2 mm diameter polished balls, spaced 5 mm apart, at the tip of the stimulator probe. It has a 310cm cord with two electrically shrouded banana plugs for attachement to the Ojemann Cortical Stimulator OCS2. The OCS2P probe is intended to be used only with the Ojemann Cortical Stimulator OCS2 (sold separately). The OCS2PND, non disposable probe, is supplied non-sterile and must be sterilized before use. Materials with patient contact: stainless steel. The handle is made with silicone elastomer. INDICATIONS The OCS2PND Bipolar Probe is intended for use with the Ojemann Cortical Stimulator OCS2 for intraoperative cortical stimulation mapping to aid in cortical resections in the vicinity of the essential cortex. CONTRAINDICATIONS This device is not intended for any use other than that indicated. WARNINGS: • Devices used on patients suspected or confirmed of having Creutzfeldt-Jakob disease cannot be disinfected and must be discarded after use. • When stimulating, keep the Ojemann Cortical Stimulator Probe in firm contact with cortical tissue. Avoid incidental contact of the Probe with the cortical surface. COMPLICATIONS, ADVERSE EVENTS Complications associated with cortical stimulators may occur during the use of this device. Complications include, but are not limited to: pain, infection, burns, neurological complications, mechanical or electrical failure and complications associated with anesthesia. PRECAUTIONS These Instructions for Use are to be used in conjunction with the OCS2 Ojemann Cortical Stimulator Operator’s Manual . INSTRUCTIONS FOR USE 1. 2. 3. 4.

STERILIZE the OCS2PND probe. Connect the probe to the Ojemann Cortical Stimulator OCS2 according to the Ojemann Cortical Stimulator Operator’s Manual (product sold separately). Prepare the Ojemann Cortical Stimulator OCS2 for use by referring to the OCS2 Operator’s Manual. After the desired current setting on the Ojemann Cortical Stimulator OCS2 is determined, place the Ojemann Cortical Stimulator Probe tips in position on the patient and set the Output Selector toggle switch to the ON position. The Ojemann Cortical Stimulator OCS2 is now delivering stimulation current to the patient. Refer to the Operator’s Manual for complete instructions.

WARNING: When stimulating, keep the Ojemann Cortical Stimulator Probe (OCS2PND) in firm contact with cortical tissue. Avoid incidental contact of the OCS2PND Probe with the cortical surface. Refer to the Ojemann Cortical Stimulator Operator’s Manual for complete instructions.

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HOW SUPPLIED Integra NeuroSciences Ojemann Cortical Stimulator Probe OCS2PND is provided non sterile. It is packaged in a poly bag, enclosed in a rigid box. PROBE STERILIZATION PROCEDURE THE OJEMANN CORTICAL STIMULATOR PROBE (OCS2PND) IS SUPPLIED NON-STERILE AND MUST BE CLEANED AND STERILIZED BEFORE USE. • Initial Probe Sterilization: Gently wipe the device with a lint free material impregnated with isopropyl alcohol. Wrap and sterilize the product in the following validated hospital sterilization cycle: - the OCS2PND can be steam sterilized by autoclave at 134°C (273°F) for 18 minutes. - the OCS2PND can also be sterilized at low temperature gas plasma. Sterilization was validated with Sterrad 100S Sterilization System (Advanced Sterilization Products). The validated cycle is: 10 min pre-exposure plasma phase followed by two identical exposure phases (6 min injection, 2 min diffusion and 2 min plasma). • Decontamination / Resterilization: Thoroughly scrub the Ojemann Cortical Stimulator Probe with a non- aldehydic disinfectant. Decontaminate according to the following procedures: Soak product 20 minutes in a non-aldehydic alkaline detergent. Rinse with non-pyrogenic sterile water. Soak product one hour in Sodium Hydroxide 1 N solution. Rinse with non-pyrogenic sterile water. Autoclave 18 minutes at 134°C (273°F). Integra NeuroSciences recommends that information on the original Lot Number be noted on a label affixed to the package of the hospital-resterilized product. • Examination of Device: The OCS2PND probe is reusable up to a recommended average life of 5 uses. Before each use, inspect the device for evidence of connector distortion or insulation deterioration such as cracks or fraying. The probe should not be used if such deterioration is discovered. CAUTION: Do not flash autoclave the Ojemann Cortical Stimulator Probe OCS2PND. To prevent deformation, the OCS2PND probe should be sterilized horizontally without constraint. CAUTION: Excessive bending may damage the OCS2PND probe. STORAGE Store in a cool, dry place. PRODUCT INFORMATION DISCLOSURE INTEGRA HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA EXCLUDES ALL WARRANTIES, WHETHER EXPRESSED OR IMPLIED, 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 HAVING RECEIVED PROPER TRAINING IN THE USE OF THE DEVICE. Returned Goods Policy 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 of product defect. Determination of a product defect will be made by Integra NeuroSciences. Products will not be accepted for replacement if they have been in the possession of the customer for more than 90 days.

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Product Order Information All products can be ordered through your Integra NeuroSciences NeuroSpecialist 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: 1-609-275-5363

Integra NeuroSciences Implants S.A. 2905 Route des Dolines 06921 Sophia Antipolis cedex, France Telephone: +33 4 93 95 56 00 Fax: +33 4 93 65 40 30

Date of revision: July 2009

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Integra LifeSciences Services (France) Immeuble Séquoia 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest, France Telephone: +33 4 37 47 59 00 Fax: +33 4 37 47 59 99

SYMBOLS/SYMBOLES/SYMBOLE/SIMBOLI/SIMBOLOS/SYMBOLEN

Rx ONLY Caution Federal (USA) law restricts this device to sale by or on the order of a physician. REF Catalog number Référence du catalogue Katalognummer Codice catalogo Número de catálogo Catalogus nummer

Use by Utiliser jusque Verfallsdatum Utilizzare entro la data di scadenza Usese hasta la fecha Uiterste gebruiks datum

LOT

Lot number Numéro de lot Lot-Nummer Numero di lotto Número de lote Lot nummer

Latex Latex free Sans latex Latexfreier Senza lattice Sin Látex Latex vrij

NON STERILE Non Sterile Non Stérile Nicht Steril Non Sterile No Estéril Niet Steriel

Manufacturer Fabricant Hersteller Fabbricante Fabricante Fabrikant

Attention, refer to accompanying instructions for use Attention, voir notice d’instructions Achtung, siehe Gebrauchsanleitung Attenzione, consultare le istruzioni per l’uso Atención, ver instrucciones de uso Let op, raadpleeg de bijgaande gebruiksaanwijzing voor gebruik

The Integra wave logo is a trademark of Integra LifeSciences Corporation. © 2009 Integra LifeSciences Corporation. All Rights Reserved.