Integra OCS2PND Instrucciones De Uso página 2

THE NON DISPOSABLE OJEMANN CORTICAL STIMULATOR PROBE OCS2PND IS NOT STERILE
CONTENTS MUST BE REMOVED FROM PACKAGE BEFORE STERILIZATION.
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. STERILIZE the OCS2PND probe.
2. Connect the probe to the Ojemann Cortical Stimulator OCS2 according to the Ojemann Cortical Stimulator
Operator's Manual (product sold separately).
3. Prepare the Ojemann Cortical Stimulator OCS2 for use by referring to the OCS2 Operator's Manual.
4. 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.
AND MUST BE STERILIZED PRIOR TO USE.
REUSABLE.
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