Codman MICROSENSOR 82-6632 Manual Del Usuario página 5

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
CODMAN MICROSENSOR
Plastic Skull Bolt Kit
Description
The CODMAN MICROSENSOR
Bolt Kit, catalog number 82-6632, consists of
the CODMAN MICROSENSOR ICP Transducer,
an Adult and Pediatric Skull Bolt, a Tuohy-Borst
adapter mounted on the catheter portion of the
transducer and a Disposable ICP Screw Handle,
sold separately for facilitating bolt removal
(see Figure 1).
The CODMAN MICROSENSOR ICP Transducer
is a catheter with a microminiature silicon strain
gauge type sensor mounted at one end and an
electrical connector at the other end. It is designed
for use with the CODMAN
Monitor, catalog numbers 82-6634 (117 VAC)
and 82-6635 (230 VAC). In conjunction with the
ICP EXPRESS Monitor, the MICROSENSOR™
may be interfaced to a wide variety of patient
monitoring systems for ICP waveform display, or
for consolidation of ICP data with other vital signs
information.
The CODMAN MICROSENSOR Plastic Skull Bolt
is designed to be used with the CODMAN Cranial
Hand Drill, catalog number 82-6607.
CAUTION: Bolt fit can be compromised if used
with other drills.
The skull bolts are preassembled with one thrust
washer and one sealing washer. Skull bolts are
supplied with spacing washers, male LUER-LOK
caps, and obturators (see Figure 2).
Indications
Use of the CODMAN MICROSENSOR Plastic Skull
Bolt is indicated when direct intracranial pressure
(ICP) monitoring is required. The kit is indicated
for use in both subdural and intraparenchymal
pressure monitoring applications.
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Plastic Skull
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ICP EXPRESS
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Contraindications
Insertion of the skull bolt is contraindicated in
children less than one year of age.
This device is not designed, sold, or intended for
any use except as indicated.
This device is not designed, sold or intended for
use as a therapeutic device.
Compatibility of implantable catheter-tipped
pressure transducers with magnetic resonance
imaging (MRI) has not been determined.
WARNINGS
Installation of the skull bolt must be performed
with the bolt held within 10° of the perpendicular
to the incision site. Installing at an angle can result
in fracture of the device or in an inadequate seal
between the washer and the skull.
Do not remove the thrust washer or the sealing
washer that are preassembled on the skull bolt,
as this can result in an inadequate seal between
the washer and the skull.
Excessive torque applied to the skull bolt during
insertion can cause breakage. This device is
designed to break off at the area between the
hexagonals, if excessive torque is applied. The
lower portion of the screw can then be removed,
using the screw handle.
The use of electrosurgical equipment (e.g.,
Monopolar, Bipolar, Diathermy) can cause damage
to the ICP MICROSENSOR and/or ICP EXPRESS
Monitor. This could lead to permanent or
temporary disabling of either device.
Precautions
Inspect the sterile package carefully. Do not use if:
• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed.
It is essential to maintain strict sterile technique
during bolt application and transducer placement.
All procedures must be performed by a qualified
neurosurgeon using standard surgical procedure.
The neurosurgeon is responsible for taking
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appropriate steps and procedures to avoid
infections and complications.
Bolt fit can be compromised if used with
other drills.
Do not strongly pull or jerk the catheter.
The transducer can break if exposed to pressures
over 1250 mm Hg (166650 Pa).
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