How Supplied - Integra OCS2PND Instrucciones De Uso

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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