MRI SAFETY OF THE LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT INCLUDING THE MODEL CC1.P1 OXYGEN AND TEMPERATURE PROBE AND MODEL VK5.2 PARENTERAL PROBE GUIDE AT 1.5 TESLA

It is important to read and understand this document in its entirety before conducting an MRI (magnetic resonance imaging) procedure on a patient with an implanted Licox CC1.P1 Oxygen and Temperature Probe. Failure to strictly adhere to these guidelines may result in serious injury to the patient.

This information applies to the following Integra products:
Model IT2 Complete Brain Tunneling Probe Kit, consisting of
Model CC1.P1 Oxygen and Temperature Probe
Model VK5.2 Parenteral Probe Guide

WARNINGS

-These guidelines apply to MRI procedures conducted using 1.5 Tesla MR System, ONLY.
-Testing has not been performed on other MR Systems and therefore should not be used.
-Use only normal operating mode. Do not perform MR scans in the 1st level or higher level control mode.
-Disconnect all cables and patient monitoring devices from the Licox CC1.P1 probe prior to entering the MRI environment. Failure to do so may result in serious injury to the patient. It is not possible to monitor brain oxygen tension during MRI procedures using this device.
-The position or orientation of the Licox CC1.P1 catheter and VK5.2 Parenteral Probe Guide does not impact their MRI Safety characteristics.

DO NOT EXCEED AN RF (RADIO FREQUENCY) WHOLE BODY AVERAGED SAR (SPECIFIC ABSORPTION RATE) OF 1.0 W/Kg IN THE HEAD OR BODY DURING THE MRI PROCEDURE.

OVERVIEW
The Licox IT2 Complete Brain Tunneling Probe Kit including the CC1.P1 Oxygen and Temperature Probe and VK5.2 Parenteral Probe Guide were subjected to MRI testing, which included radio frequency induced heating, magnetically induced displacement force and torque to demonstrate that these components were considered "MR Conditional" as defined in ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment using a 1.5-Tesla MR system, ONLY. Testing has not been performed on other MR Systems and therefore should not be used.

This document outlines recommended guidelines and specific conditions under which the Licox IT2 Complete Brain Tunneling Probe Kit has been shown to pose minimal risk to a patient undergoing an MRI procedure.

Deviation from these guidelines may increase the potential for serious harm to the patient. MRI conditions utilizing MR systems with higher or lower static magnetic fields have not been assessed for the Licox IT2 Complete Brain Tunneling Probe Kit and, as such, must be avoided to ensure patient safety.

MRI and LICOX IT2 INTERACTIONS

MRI INDUCED HEATING
Under certain conditions, RF fields generated by MRI can induce substantial currents in metallic components contained within medical device products. This may rapidly produce significant heating of a device. Failure to follow the recommendations contained in this communication may result in the generation of thermal lesions and serious patient harm.

MAGNETIC FIELD INTERACTIONS -
Magnetic materials contained within an implanted device may experience translational attraction or rotational forces when brought into the static magnetic field of an MR system. The Licox CC1.P1 Probe contains magnetic material and has been shown in safety testing to not be substantially affected by translational attraction and torque related to exposure to a 1.5 Tesla static magnetic field of an MR system.

IMAGE ARTIFACTS
The presence of the Licox CC1.P1 Probe will cause minor artifacts on the MR image. It is up to the discretion of the interpreting physician to determine if the location of the sensor is in the area of imaging interest and whether it will adversely affect the quality of the diagnostic information required from the MRI procedure.

The Licox CC1.P1 connector will cause substantial artifacts and distortion on the MR image. As such, position the connector away from the anatomy of interest during the MRI procedure.

PROCEDURE -
In addition to standard safety procedures for MRI, the following precautions must be followed specific to the Licox IT2 product:
1. Inform the patient of the potential risks of undergoing an MRI procedure with this device. Disconnect all cables and patient monitoring devices attached to the Licox IT2 prior to transporting the patient into the MRI environment.
2. Use only the following types of radio frequency (RF) coils for the MRI procedure: -Transmit/receive RF body coil
-Transmit body coil/receive-only head coil
-Transmit/receive head coil
-Transmit/receive lower extremity coil - for imaging of lower extremities only, not for imaging the head of patients.
3. Set MRI parameters to the lowest usable whole body averaged SAR level.
THIS MUST NOT EXCEED A WHOLE BODY AVERAGED SAR OF 1.0 W/kg IN THE HEAD OR BODY to minimize the risk of excessive heating of device components.
4. Verify that the MR system has appropriately calculated and updated the SAR value after all parameter changes have been made. Ensure that the proper patient weight is used for the SAR calculations.
5. For head scans using the transmit body coil the local SAR must be less than 2.0-W/kg.
6. A knowledgeable MRI expert (e.g., MRI physicist, MRI-trained radiologist) must verify that all set-up steps and settings have been properly implemented and checked prior to performing the MRI procedure.
7. If conscious and alert, provide the patient with a means of alerting the MRI system operator of unusual sensations. Instruct the patient to watch for sensations such as overheating or shock. Terminate the MRI procedure immediately if so notified by the patient.
8. Monitor the patient continuously during the MRI examination and be prepared to stop and respond in the event of an emergency

MR healthcare professionals are advised to contact the manufacturer to ensure that the latest safety information is obtained and carefully followed in order to ensure patient safety relative to the use of an MR procedure.

REFERENCES

http://integralife.com

Licox MR Safety Fact Sheet: Licox IT2 Complete Brain Oxygen and Temperature Tunneling Probe Kit