Adverse Events - Depuy Synthes CODMAN MICROSENSOR Bedienungsanleitung

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 Conditional
Safe Use may result in serious injury
to the patient.
The CODMAN MICROSENSOR is MR Conditional.
MRI SAFETY INFORMATION:
Non-clinical testing 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 tesla only.
• Maximum spatial gradient magnetic field of
1000 G/cm (10 T/m).
• Maximum gradient field slew rate of 170 T/m/s.
• 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).
• Horizontal cylindrical bore MRI scanner.
• 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 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. Set MRI parameters, as follows:
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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