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Integra Licox® Single Lumen Bolt Brain Tissue Oxygen and Temperature Bolt Kit


  • Accurate measurement of brain tissue oxygen (Pbt02) and brain temperature.
  • Excellent long term stability.
  • Design allows for monitoring of multiple parameters through one burr hole.
  • Provides reliable, reproducible probe positioning.
  • Unique hermetic seal for tight closure and infection control.
  • Supplied Sterile.
  • Complete IntegraLicox® Kit with single lumen bolt and combined oxygen and temperature catheter.
  • Probe must be stored between 2° and 10° C.

Part Number: IP1P


Indications For Use:
The Integra 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. Integra 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.


Contradictions:
This device is not intended for any use other than that indicated.


Warnings:
  • The use of excessive force on the components of the Integra Licox system, introducer, sensor, cables or monitor may cause damage. All mechanical features of the Integra Licox system can be operated without the use of excessive force.
  • The anesthetic gas halothane disturbs measurement with all types of polarographic oxygen sensors. After an initial exposure time of 5 to 20 minutes, the displayed oxygen value is overestimated; this effect is usually reversible. However, other common anesthetic gases such as nitrous oxide (N2O), enflurane and isoflurane can be used without impairing the accuracy of the measurement.
  • Strong electrical interference (e.g., during cauterization) can cause a disturbance of the measurement that outlasts the interference by a few seconds.
  • Measurement errors can exceed label claims after five days of continuous operation.
  • Only original Integra Licox parts may be used with the system. This applies in particular to probes, cables and the power supply.
  • When the front panel switch is used to input intracranial temperature to the Integra Licox CMP monitor, differences between the set temperature and the actual intracranial temperature will lead to measurement errors. For example if the set temperature is one degree higher than the tissue temperature, the displayed oxygen value will be underestimated by approximately 4%.
  • Cables, including extension cables, with damaged isolation jacketing must not be used. Connector contacts must be cleaned after coming into contact with saline solutions or body fluid. Measurement error can occur if these recommendations are not observed.
  • Probe extension cables may not be used when their connectors are wet or damp. Measurement errors can occur if this recommendation is not observed.
  • Do not overtighten hex nut in the drill stop to avoid the possibility of stripping the thread.
  • Do not bend the probe around a radius of curvature of less than 2 mm. If the probe is bent upon itself, the oxygen reading will be interrupted until the catheter position is corrected.
  • Facilities for the neurosurgical treatment of an intracranial bleed must be available in the hospital.
  • In general, there is a risk of infection due to use of intracranial catheters. It is recommended that Integra Licox probes not be left in tissue for more than 5 days.
  • In rare cases, for example if microvasculature is disrupted during implantation a small hemorrhage which may not be detected by CT scanning can occur. The oxygen tension indicated is normally below its value in surrounding non-affected tissue if the blood infiltration surrounding the puncture is thicker than approximately 100 ?m.
  • If the patient has enlarged or shifted ventricles, the probe or its introducer may puncture the lateral ventricle when inserted (the probe tip reaches approximately 35mm below the dura level). If this occurs, the probe will create a channel that directly connects the ventricular system with the subarachnoid space, bypassing the natural CSF pathways. Because of the pressure difference between the lateral ventricle and the subarachnoid space, it is possible that cerebrospinal fluid from the ventricle could flow along the probe. The measured value would correspond to the oxygen partial pressure of the cerebrospinal fluid and would not be representative of the tissue.


Precautions:
  • These directions are to be used in conjunction with the Integra Licox PMO.BOX or Integra Licox CMP Operations Manual.
  • This product is intended for use only with the catheters/probes specified herein.
  • After implantation of a probe it takes 1 to 2 minutes before the local brain oxygen tension is correctly displayed. However, due to the micro trauma of implantation, the initial values displayed may not represent the oxygen tension of the surrounding tissue. After implantation, the tissue stabilization time (time until the oxygen tension values are representative of the surrounding region of the brain) may be as long as two hours.
  • When using the Integra Licox PMO.BOX and/or Integra Licox CMP monitor, the power supply and the cable connectors for both monitors must be protected against moisture.
  • The Integra Licox CMP monitor must be switched off, at the rear of the monitor, before cables are connected or disconnected.
  • Do not attempt to disassemble the introducer.
  • Only use the probe if its sterile packaging is not open, damaged or broken.
  • Only use the probe before the expiration date labeled on the package.
  • Only use the pO2 probe if it has been stored cool at a temperature between 2ºC and 10ºC.
  • Do not discard the pO2 probe packaging before the probe smart card has been removed from the packaging.
  • Use only the smart card supplied with the probe (see serial number on probe and card). Use of the wrong smart card can cause measurement errors.
  • The smart card is not required if using the Integra Licox PMO.BOX monitor.
  • Do not cut or tear the catheter body. A catheter with a cut or torn body will no longer function.
  • The introducer bolt may not fit correctly, become stuck or even break if excessive force is applied.
  • Use the drill bit provided. If a drill bit other than that delivered with the kit is used, the hole may be too large or too small. Please note: The drill bit supplied with Integra™ Camino® ICP catheters may be significantly smaller than any supplied with Integra Licox introducer kits.
  • In order to avoid hemorrhage in the area of implantation, blood coagulation must be carefully monitored when measuring in the brain during total body hypothermia, or in patients in hepatic coma or suffering from other diseases which could impair coagulation.
  • If the dura is not incised (with a small cutting instrument) before the stylet is advanced, the dura could be torn away from the skull, possibly resulting in hemorrhage.
  • The device must not be placed too near the sagittal line in order to avoid the sagittal sinus and major cerebral veins near the sagittal line.
  • The introducer must be sealed to avoid infection. If the seal is not made, cerebrospinal fluid may appear within the outer tube of the introducer. The compression cap must be tightened further to avoid leakage (see directions for use).
  • The actual position of the sensor must be considered for interpretation of data. It is always possible that the sensor has displaced from the intended location.
  • When monitoring is complete, remove probes and introducer prior to bolt removal.
  • The tip of the oxygen sensing catheter may not lie in the cerebral white matter after implantation if it is inserted within a sulcus of the brain or if the brain is severely atrophied. In this case the probe may not respond to an oxygen challenge performed after the initial stabilization time of at least 20 minutes. The location of the probe may be verified via CT scan. Remove probe if it does not respond to the oxygen challenge or if its tip is not within parenchyma or lies on the surface of brain. Please note that if the probe tip lies within the cortex, the measured oxygen values may be higher and less stable than measurements made with the probe tip within the white matter.




For complete product information, please see the Instructions for Use accompanying each product.
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