Adverse Events - Integra CODMAN MICROSENSOR Manual Del Usario

Read all instructions included with the monitoring
display device prior to use.

Adverse Events

The following Adverse Events may occur with the use
of the CODMAN MICROSENSOR:
• Hemorrhage*
• Infection
• Subcutaneous CSF leakage
• Neurological sequelae
*Subarachnoid, intracerebral, or extracerebral
hemorrhage may occur at the site of transducer
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 CODMAN MICROSENSOR.
Failure to adhere to the Conditions for
MR
Safe Use may result in serious injury
Conditional
to the patient.
The CODMAN MICROSENSOR is MR Conditional.
MRI SAFETY INFORMATION:
Non-clinical testing has demonstrated that the
CODMAN MICROSENSOR is MR Conditional.
A patient implanted with this device can be safely
scanned in an MR system which meets or is operated
under the following conditions:
• Static magnetic field of 1.5 and 3 tesla only.
• Maximum spatial gradient magnetic field of
1000 G/cm (10 T/m).
• Maximum gradient field slew rate of 170 T/m/s.
• Horizontal cylindrical bore MRI scanner.
• Maximum MR system reported, whole body
averaged specific absorption rate (SAR) of
2.0 W/kg (Normal Operating Mode), for 15 minutes
of continuous scanning.
• Special positioning of the CODMAN MICROSENSOR
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 ICP EXPRESS 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
CODMAN MICROSENSOR 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 as
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 CODMAN MICROSENSOR.
PREPARATION FOR THE MRI
PROCEDURE:
1. Immediately prior to entering the MRI suite, verify
that the CODMAN MICROSENSOR is functioning
properly. DO NOT perform an MRI procedure if
the CODMAN MICROSENSOR is damaged or
otherwise not functioning properly.
2. Disconnect all cables and patient monitoring
devices attached to the CODMAN MICROSENSOR
prior to transporting the patient into the MRI suite.
DO NOT bring the ICP EXPRESS Monitor, cables or
other accessories into the MRI suite.
3. Special positioning of the
CODMAN MICROSENSOR is required to ensure
patient safety during the MRI procedure. The
CODMAN MICROSENSOR must be placed in
a specific geometry to minimize the potential
for excessive heating of the sensor tip. Coil the
tubing of the CODMAN MICROSENSOR 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 7). Do not perform
MRI with the CODMAN MICROSENSOR 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 CODMAN MICROSENSOR electrical connector
with coiled tubing and the patient's scalp. Secure
in place using tape (see Figure 7). Use care when
removing the tape to prevent damage to the
CODMAN MICROSENSOR.
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 manufacturer's
published value and location of the peak SG that
is accessible to the patient.
b. Maximum gradient field slew rate of 170 T/m/s.
c. Maximum MR system reported, whole body
averaged specific absorption rate (SAR) of 2.0
W/kg (Normal Operating Mode), for 15 minutes
of continuous scanning.
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