Codman MICROSENSOR Bedienungsanleitung Seite 6

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
CODMAN MICROSENSOR
Ventricular Catheter Kit
Description
The CODMAN MICROSENSOR
Catheter Kit, catalog no. 82-6633, consists of
the CODMAN MICROSENSOR ICP Transducer,
a 35 cm ventricular catheter with female LUER-LOK
connector, a Tuohy-Borst adapter with drainage port,
a split trocar, a 10-gauge ventricular needle and
a 15 cm stylet (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 ICP EXPRESS
®
catalog numbers 82-6634 (117 VAC) and 82-6635
(230 VAC). In conjunction with the ICP EXPRESS
Monitor, the MICROSENSOR
a wide variety of patient monitoring systems for ICP
waveform display, or for consolidation of ICP data
with other vital signs information.
Indications
Use of the CODMAN MICROSENSOR Ventricular
Catheter Kit is indicated when direct intracranial
pressure (ICP) monitoring is required. The kit
is indicated for use in intraventricular pressure
monitoring and cerebral spinal fluid (CSF) drainage
applications.
Contraindications
Monitoring of intracranial pressure through
the use of ventriculostomy techniques may be
contraindicated (e.g., with conditions such as
encephalitis, brain swelling secondary to trauma,
diffuse encephalopathies, and Reye's syndrome).
Ventriculostomy is contraindicated in patients
with a coagulopathy.
Use of the CODMAN MICROSENSOR Ventricular
Catheter Kit is contraindicated in children less than
one year of age.
®
Ventricular
®
®
Monitor,
®
may be interfaced to
™
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
Take extreme care to avoid damage to the dura and
underlying cerebrum.
Failure to immerse the transducer tip in sterile
water/sterile saline while zeroing may result in
inaccurate ICP measurements.
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 ventriculostomy and subsequent transducer
placement. Due to the possibility of cerebral
hemorrhage or extracerebral hemorrhage or
any other complications, all procedures must
be performed by a qualified neurosurgeon. The
neurosurgeon is responsible for taking appropriate
steps and procedures to avoid infections and
complications.
Silicone has a low cut and tear resistance; therefore
care should be exercised when placing ligatures so
as not to tie them too tightly. The use of stainless
steel ligatures on silicone rubber is not advised.
Use extreme care to prevent the ventricular catheter
from coming in contact with bare fingers, towels,
drapes, talc, or any other linty or granular surface.
Silicone rubber is highly electrostatic and, as a result,
attracts airborne particles and surface contaminants
that could produce tissue reaction.
The transducer can break if exposed to pressures
over 1250 mm Hg (166650 Pa).
Do not strongly pull or jerk the transducer catheter.
The MICROSENSOR must be zeroed at atmo-
spheric pressure prior to implantation.
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