Integra Codman CereLink Manual De Instrucciones página 8

EN – ENGLISH
Adverse Events
The following Adverse Events may occur with the use of the ICP Sensor:
• Hemorrhage*
• Infection
• Subcutaneous CSF leakage
• Neurological sequelae
*Subarachnoid, intracerebral, or extracerebral hemorrhage may occur at the site of device
placement (either skull, cortical, or dural areas). Testing of the blood clotting factor should
be conducted on patients before insertion.
MRI Information
Read and understand this document in its entirety prior to
performing a Magnetic Resonance Imaging Procedure on a patient
with an implanted ICP Sensor. Failure to adhere to the Conditions
MR Conditional
for Safe Use may result in serious injury to the patient.
The ICP Sensor is MR Conditional.
MRI SAFETY INFORMATION:
Non-clinical testing has demonstrated that the ICP Sensor is MR Conditional. A patient
implanted with this ICP Sensor can be safely scanned in an MR system which meets or is
operated under the following conditions:
• Static magnetic field of 1.5 T and 3 T only
• Maximum spatial gradient magnetic field of 1,000 G/cm (10 T/m)
• Maximum gradient field slew rate of 200 T/m/s
• Horizontal cylindrical bore MRI scanner
• Maximum MR system reported, whole body averaged specific absorption rate (SAR)
of 2.0 W/kg or head SAR of 3.2 W/kg
• MRI scan duration shall not exceed 15 minutes of continuous scanning
• Special positioning of the ICP Sensor is required to ensure patient safety during the
MRI procedure (see PREPARATION FOR THE MRI PROCEDURE below for specific
instructions)
• WARNING: Do not bring the monitor, cables or other accessories such as Tuohy
needles, trocar or stylet into the MRI suite
• WARNING: Do not use Transmit / Receive or Transmit-only RF Head coils; only use
Transmit / Receive RF Body coil or Transmit RF Body coil / Receive-only RF Head coil
• WARNING: Do not scan a patient with an elevated body temperature
MRI-Related Heating
Under the scanning conditions defined above, the ICP Sensor is expected to produce a
maximum temperature rise of less than 2°C after 15 minutes of continuous scanning.
The effects of scanning beyond 15 minutes are undetermined.
Artifact Information
In non-clinical testing, the maximum artifact size was seen on the gradient echo pulse
sequence at 3T and extends to a zone approximately 2 mm relative to the size and shape
of the ICP Sensor.
Preparation for the MRI Procedure:
1. Immediately prior to entering the MRI suite, verify that the ICP Sensor is
functioning properly. DO NOT perform an MRI procedure if the ICP Sensor is
damaged or otherwise not functioning properly.
2. Disconnect all cables and patient bedside monitoring devices attached to the
ICP Sensor prior to transporting the patient into the MRI suite. DO NOT bring the
Monitor, cables or other accessories into the MRI suite.
3. Special positioning of the ICP Sensor is required to ensure patient safety during the
MRI procedure. The ICP Sensor must be placed in a specific geometry to minimize
the potential for excessive heating of the ICP Sensor tip. Coil the tubing of the ICP
Sensor near the base of the electrical connector into 5 or 6 loops approximately
6 cm in diameter and center on top of the patient's head (see Figure 8). Do not
perform MRI with the ICP Sensor in a "straight line" configuration (i.e., uncoiled).
Failure to follow this guideline can result in serious injury to the patient.
4. Insert a dry gauze pad at least 1 cm thick between the ICP Sensor electrical connector
with coiled tubing and the patient's scalp. Secure in place using tape (see Figure 8).
Use care when removing the tape to prevent damage to the ICP Sensor.
5. Do not exceed the following MRI parameters during imaging:
a. Maximum spatial gradient magnetic field of 1,000 G/cm (10 T/m). The
highest SG magnetic field is commonly located off-axis, at a side wall,
and near the opening of the bore of the scanner. Please refer to MRI
manufacturers published value and location of the peak SG that is
accessible to the patient.
b. Maximum gradient field slew rate of 200 T/m/s.
c. Maximum MR system reported, whole body averaged specific absorption
rate (SAR) of 2.0 W/kg or head SAR of 3.2 W/kg.
Electrostatic Discharge (ESD) Information
CAUTION: Exposure to electrostatic discharge (ESD) energy could
damage this ICP Sensor. High levels of ESD could damage the electronic
components and cause the ICP Sensor to be rendered inaccurate or
inoperable. Take all precautions to reduce the buildup of electrostatic
charge during the use of this product.
• Provide patient grounding (e.g., grounding straps on gurneys).
• Avoid the use of materials that could generate ESD during patient movement and
transport; e.g., nylon transfer boards with bedding.
• Before touching the patient, caretakers should discharge ESD buildup by touching a
grounded metal surface, such as a bed rail.
It is recommended that all hospital personnel in contact with these devices receive an
explanation of the ESD symbol and training in ESD precautionary procedures. Training
should include, at a minimum, an introduction to electrostatic discharge, when and
why it occurs, precautionary measure, and the damage that can be done to electronic
components if touched by a user who is electrostatically charged.
Avoid touching the connector pins, which are identified with the ESD symbol, before
following ESD precautionary procedures. Avoid touching the ICP Sensor tip (sensing
element) at all times.
How Supplied
This ICP Sensor is intended for SINGLE USE ONLY; DO NOT RESTERILIZE.
Integra single use devices have not been designed to undergo or withstand any form
of alteration, such as disassembly, cleaning or resterilization, after a single patient use.
These devices are intended to come into contact with the central nervous system and the
ability does not currently exist to destroy possible contaminates such as those causing
Creutzfeldt-Jakob Disease. Reuse can also compromise device performance and any usage
beyond the design intent of this single-use device can result in unpredictable use hazards
or loss of functionality.
Integra will not be responsible for any product that is resterilized, nor accept for credit or
exchange any product that has been opened but not used.
As long as the individual package is not damaged or opened, the product is sterile.
All components have been tested and were determined to be nonpyrogenic, except for
the electrical connector of the ICP Sensor, the disposable ICP handle, and the silicone
tubing used for packaging, which are not tested.
The ICP Sensor is packaged using a combination of recyclable and non-recyclable
materials. Recycle or dispose of all packaging waste in accordance with hospital
procedures and regulations.
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