Unit of Measure | Conversion | Net / Gross Weight (lbs) | Volume (cubic ft) | Dimensions (inch) L x W x H | GTIN |
---|---|---|---|---|---|
Each (EA) | 1.0 Each | 0.0 / 1.85 | 0.347 | 0.0 x 0.0 x 0.0 | |
Case (CS) | 5.0 Each | 0.0 / 9.25 | 1.736 | 20.0 x 15.0 x 10.0 |
Packaging | 5 Each / Case |
Manuf / Supplier | Integra Lifesciences Corp |
Manuf / Supplier # | INS5HND |
The Integra Cranial Access Kit allows for access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
This product is not designed, sold, or intended for use except as indicated.
Patients undergoing external CSF drainage and ICP monitoring must be kept under close supervision with trained personnel familiar with the use of monitoring techniques. All personnel should be familiar with the information provided in this booklet. Extreme care should be taken during the preparation and performance of the drilling procedure to maintain sterile technique. The hand drill with variable chuck and drill bit assembly must be used properly to prevent penetration or damage to the dura.
Inform the patient or his/her representatives of possible complications associated with use of this system. Cranial Access components should avoid contact with lint, glove talc, and other surface contaminants. Contents of the kit are sterile if the package is unopened and undamaged. Use aseptic technique throughout this procedure. The drill, with drill bit, adjustable chuck and adjustable stop must me used properly in order to prevent drilling too deeply and causing injury or damage to the dura, cortex and cortical vessels. Maintain insertion site with meticulous redressing according to physicians orders. Avoid over drainage of CSF during placement of ventricular catheters. The kit is designed for single use only. Do not re-sterilize. This product is intended for single use only. Reuse of the device can result in contamination and/or disease transmission. This product should not be re-sterilized. Re-sterilization may affect the performance characteristics and the safety of the device.