Adverse Events - Codman MICROSENSOR Manual

The MICROSENSOR transducer tip must remain
wet during the zeroing process.
Exposure to electrostatic discharge (ESD) energy
could damage this device. High levels of ESD
could damage the electronic components and
cause the transducer to be rendered inaccurate
or inoperable. Take all precautions to reduce the
buildup of electrostatic charge during the use of
this product and avoid touching the transducer
connector pins. Refer to Electrostatic Discharge
(ESD) Information section.
The use of a defibrillator or any electrosurgical
equipment; e.g., monopolar, bipolar, diathermy,
can cause damage to the MICROSENSOR. This
could lead to permanent or temporary disabling of
the sensor.

Adverse Events

Hemorrhage may occur at the site of transducer
placement from either the skull, cortical or dural
areas. Testing of the blood clotting factor should
be conducted on patients before insertion.
Decisions regarding the possibility of
subarachnoid, intracerebral or extracerebral
hemorrhage at the site of placement are the sole
responsibility of the attending neurosurgeon.
Infection, subcutaneous CSF leakage, and
neurological sequelae are potential complications
of this procedure.
Connecting and Zeroing the Transducer
CAUTION: Read all instructions included with the
ICP EXPRESS Monitor prior to use.
CAUTION: The MICROSENSOR must be zeroed
at atmospheric pressure prior to implantation.
1. Connect the MICROSENSOR to the
ICP EXPRESS Monitor using the appropriate
sterile transducer interface cable. Use cable
model 82-6636. The cable must be sterilized
prior to use. Refer to product insert provided
with the cable for sterilization information.
2. If applicable, connect the ICP EXPRESS Monitor
to an available pressure channel on an external
patient monitor using a CODMAN Patient Monitor
Interface Cable. CAUTION: Use CODMAN
Patient Monitor Interface Cables only with the
patient monitors for which they are specifically
designed and designated. Secure the two
locking screws on the cable to prevent inadvertent
disconnection during use.
3. Proceed to zero and calibrate the external patient
monitor according to the instructions provided with
the ICP EXPRESS Monitor, as well as the external
patient monitor manufacturer's instructions.
4. Prepare to zero the MICROSENSOR by laying
the tip of the transducer (or ventricular catheter)
in a shallow pool of sterile water or sterile saline.
The accompanying sterile blister package has
a marked well that is suitable for this procedure.
Pour sufficient sterile water/sterile saline into
the well; then lay at least a 5 cm section of the
transducer (or ventricular catheter) horizontally
just under the surface of the sterile water/sterile
saline. CAUTION: Do not submerge the tip of
the transducer or catheter vertically in a deep
pool or cup of sterile water/sterile saline.
Doing so will impose a hydrostatic pressure on
the transducer diaphragm that is higher than
atmospheric zero, resulting in an inaccurate
zero reference.
5. While keeping the tip of the MICROSENSOR
(or ventricular catheter) flat in the sterile water/
sterile saline, proceed to zero the MICROSENSOR
according to the instructions provided with
the ICP EXPRESS Monitor. CAUTION: The
MICROSENSOR transducer tip must remain
wet during the zeroing process.
6. Record the three-digit zero reference number
provided by the ICP EXPRESS Monitor. Mark the
number on the MICROSENSOR connector housing
or patient's chart for future reference.
General Surgical Procedure
The following is a general guide for informational
purposes only. The surgeon may wish to alter
details in accordance with his or her own clinical
experience and medical judgment. This device
is not designed, sold, or intended for use as
a therapeutic device.
Measuring Subdural Pressure
1. Following craniotomy and bone flap removal,
connect and zero the transducer. Refer to the
Connecting and Zeroing the Transducer section.
2. Choose the burr hole through which the
transducer will be placed, and bevel the edge
on the side the transducer will exit to facilitate
transducer removal.
3. Use the Tuohy needle to tunnel under the
scalp from the craniotomy site to the desired
transducer exit site.
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