Integra Licox® Brain Tissue Oxygen Monitoring System
Limits uncertainty as it empowers clinicians to achieve early detection of hypoxic or ischemic events.
The LICOX® Brain Tissue Oxygen Monitoring System continuously monitors brain oxygen partial pressure (PtO2) and intracranial temperature. In patients who have sustained a traumatic brain injury or cerebral vascular event, the Licox® system provides clinicians with early warnings of hypoxic events, allowing more timely intervention to restore oxygen delivery to the brain. The Licox® is available in bolted (e.g. IM3STEU) or tunneled (IT2EU) versions.
The Licox® PtO2 Monitor
- Quick setup
- Intuitive design
- Convenient data export
Licox® is the most widely studied4 and documented direct cerebral tissue oxygen monitoring device:
- Oxygen monitoring is recommended by the Guidelines for the Management of Severe Traumatic Brain Injury 3rd Edition (Level III).1
- The combined use of PtO2 and ICP, along with other parameters, was found to have the best predictive accuracy.2
- PtO2 monitoring technology detects short episodes of cerebral hypoxia, which are not detected by other monitoring modalities.3
- Magnitude and duration of cerebral hypoxia have prognostic relevance.3
Refeferences:
1. Bratton SL, Chestnut RM, Ghajar J, et al. Guidelines for the management of severe traumatic brain injury. X. Brain oxygen monitoring and thresholds. J Neurotrauma 2007; 24 Suppl 1: S65-70.
2. Low D, Kuralmani V, Ng SK, Lee KK, Ng I, Ang BT. Prediction of outcome utilizing both physiological and biochemical parameters in severe head injury. J Neurotrauma 2009; 26(8):1177-82.
3. Sarrafzadeh AS, Kiening KL, Callsen TA, Unterberg AW. Metabolic changes during impending and manifest cerebral hypoxia in traumatic brain injury. Br J Neurosurg 2003; 17(4): 340-6.
4. Lang et al, Systematic and Comprehensive Literature Review of Publications on Direct Cerebral Oxygenation Monitoring, The Open Critical Care Medicine Journal, 2013, 6, 1-24
Indications
Indications For Use – the Licox Brain Oxygen Monitoring System (IM3STEU, IT2EU & IP2P):
- The Licox Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. Licox System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
Indications For Use – the Camino Intracranial Pressure Monitoring Kit (1104L/B/BT/H/HMT/G)
- The Camino® Intracranial Pressure & Temperature Monitoring Kits & Catheters are indicated for use by a qualified Neurosurgeon for measurement of intracranial pressure & temperature in the parenchyma, subarachnoid space, ventricles, subdural space (post craniotomy) and for cerebrospinal fluid drainage. The Camino® Intracranial Pressure Monitoring Catheter with Licox® IMC Bolt fitting (model L) is intended to be used only through a Licox® Brain Oxygen Monitoring System Bolt. The Camino Micro Ventricular Pressure Monitoring Kit (model HM) and Bolt Pressure-Temperature Monitoring Kit (model HMT) are intended to be used with an external drainage system as indicated by individual manufacturers.
Indications For Use – the Integra Camino® ICP Monitor (Product code CAM02):
- The Integra Camino® ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.
Indications For Use – the Integra Licox® PtO2 Monitor (Product Code LCX02)
- The Integra Licox® PtO2 Monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement.
- Monitor values are relative within an individual, and should not be used as the sole basis for determining a diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
Contraindications
Contraindications – the Licox Brain Oxygen Monitoring System (IM3STEU, IT2EU & IP2P)
- Licox products are not intended for any use other than that indicated.
- Contraindications for device insertion into the body apply, e.g. coagulopathy and/or susceptibility to infections or infected tissue. A platelet count of less than 50 000 per μl is considered a contraindication. This value may differ according to different hospital Protocols
Contraindications – the Camino Intracranial Pressure Monitoring Kit (1104L/B/BT/H/HMT/G)
- This device is not intended for any use other than that indicated.
- Magnetic Resonance Imaging (MRI) Safety Information: The Camino 1104L) is MR Unsafe. Do not bring catheter or accessories into the MR environment.
Contraindications – the Integra Camino® ICP Monitor (Product code CAM02)
- The Integra Camino® ICP Monitor and its accessories are contraindicated for use in a Magnetic Resonance (MR) environment.
Contraindications – the Integra Licox® PtO2 Monitor (Product Code LCX02)
- The Integra Licox® PtO2 Monitor and its accessories are contraindicated for use in a Magnetic Resonance (MR) environment.
Ordering Information
| Catalog numbers | LICOX MONITOR |
|---|---|
| LCX02 | LICOX MONITOR |
| Catalog numbers | LICOX MONITOR CABLES & ACCESSORIES |
|---|---|
| BAT1001 | LCX02 BATTERY |
| EXPORTCAB | LCX02 USB |
| MONPWR | LCX02 POWER CABLE |
| PMIOMPM1 | CABLE LCX02 PATIENT MONITOR INTERFACE CABLE |
| BC10S | TEST PROBE FOR ELECTRICAL SAFETY CHECK |
| BC10PA | MONITOR CABLE OXYGEN |
| BC10PV | MONITOR EXTENSION CABLE OXYGEN |
| BC10R | TEST PROBE OXYGEN |
| BC10TA | MONITOR CABLE TEMPERATURE |
| BC10TV | MONITOR EXTENSION CABLE TEMPERATURE |
| BC10 PMO | Y CABLE |
| PMOCAB | PROBE TO INTERFACE CABLE |
| Catalog numbers | OXYGEN & TEMPERATURE PROBE |
|---|---|
| C8B | TEMPERATURE PROBE |
| CC1SB | OXYGEN PROBE |
| CC1P1 | COMBINED OXYGEN AND TEMPERATURE PROBE |
| Catalog numbers | BOLD KIT & COMPLETE SYSTEMS & TUNNELING SYSTEMS |
|---|---|
| IM1 | SINGLE LUMEN INTRODUCER KIT |
| IM1S | SINGLE LUMEN INTRODUCER KIT & OXYGEN PROBE |
| IM2EU | DUAL LUMEN INTRODUCER KIT |
| IM2SEU | DUAL LUMEN INTRODUCER KIT & OXYGEN PROBE |
| IM3EU | TRIPLE LUMEN INTRODUCER KIT |
| IM3SEU | TRIPLE LUMEN INTRODUCER KIT & OXYGEN PROBE |
| IM3STEU | TRIPLE LUMEN INTRODUCER KIT & OXYGEN PROBE & TEMPERATURE PROBE |
| IP1 | SINGLE LUMEN INTRODUCER KIT |
| IP1P | SINGLE LUMEN INTRODUCER KIT & COMBINED OXYGEN & TEMPERATURE PROBE |
| IP2 | DUAL LUMEN INTRODUCER KIT |
| IP2P | DUAL LUMEN INTRODUCER KIT & COMBINED OXYGEN AND TEMPERATURE PROBE |
| IT2EU | COMPLETE BRAIN TUNNELING PROBE KIT |
| VK52 | PARENCHYMAL PROBE GUIDE |
Product Catalogues
Regulatory Information
Class I, IIa, IIb or III devices
LCX02, CAM02 & Accessories
Integra LifeSciences (Ireland) Ltd,
IDA Business & Technology Park,
Sragh • Tullamore • Co Offaly, Ireland
Licox® Probes, introducers and kits
Integra NeuroSciences Implants (France) S.A.S.,
2905, route des Dolines • 06921 Sophia Antipolis CEDEX • France
CAMINO® probes (1104L/B/BT/H/HMT/G)
Integra NeuroSciences
5955 Pacific Center Blvd.
San Diego, CA 92121 • USA
Integra LifeSciences Services (France) SAS
Immeuble Sequoia 2 • 97 allée Alexandre Borodine
Parc technologique de la Porte des Alpes
69800 Saint Priest • FRANCE
Phone: +33 (0)4 37 47 59 00 • fax: +33 (0)4 37 47 59 99
integralife.eu
Legal information
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.
• Consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.
• Non contractual document. Integra reserves the right, without prior notice, to modify the products in order to improve their quality.
• Warning: Applicable laws restrict these products to sale by or on the order of a physician.
Products mentioned in this document are CE class I, IIa, IIb, and III devices. Please contact Integra customer service should you need any additional information on devices classification. All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on Medical Devices, and its relatives, unless specifically identified as “NOT CE MARKED.”
Licox is a registered trademark of Integra Lifesciences Corporation or its subsidiaries in the United States and/or other countries. Camino, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries.
© 2016 Integra LifeSciences Corporation. All rights reserved. Last revision date: 12/2016. 0557040-1-EN
Document for use in Europe, Middle-East & Africa only
For complete product information, please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.
