Depuy Synthes CODMAN MICROSENSOR Bedienungsanleitung Seite 2

ENGLISH
IMPORTANT INFORMATION
Please read before use
CODMAN MICROSENSOR
Basic Kit REF 626631
Description
The CODMAN MICROSENSOR Basic Kit, catalog no.
626631, consists of the CODMAN MICROSENSOR
ICP Transducer and a 14-gauge Tuohy needle with
stylet. See Figure 1.
The CODMAN MICROSENSOR ICP Transducer
is a catheter with a microminiature strain gauge
pressure sensor mounted at one end and an electrical
connector at the other end. It is designed for use with
the ICP EXPRESS Monitor, catalog no. 82-6634 (117
®
VAC) and 82-6635 (230 VAC) or any other suitable
Codman pressure monitoring interface or device.
The CODMAN MICROSENSOR Basic Kit is designed
for use with the CODMAN
catalog no. 82-6607. The drill facilitates access to
the intraparenchymal area. The drill is also available
as a component of the CODMAN Cranial Access Kit,
catalog no. 82-6612, 82-6614, and 82-6616.
Indications
Use of the CODMAN MICROSENSOR Basic
Kit is indicated when direct ICP monitoring is
required. The kit is indicated for use in both
subdural and intraparenchymal pressure monitoring
applications only.
The technical performance characteristics of the
CODMAN MICROSENSOR have been evaluated for
a maximum monitoring period of up to 30 days. Use
clinical judgment to determine the implantation time of
this product based on experience and consideration
of any other relevant clinical factors.
Contraindications
This kit is not designed, sold, or intended for any use
except as indicated.
This kit is not designed, sold, or intended for use as a
therapeutic device.
WARNINGS
Take extreme care to avoid damage to the dura and
underlying cerebrum.
®
Cranial Hand Drill,
®
The use of electrosurgical equipment, e.g., monopolar,
bipolar, diathermy, can cause damage to the
CODMAN MICROSENSOR Transducer and/or the ICP
EXPRESS Monitor. This could lead to permanent or
temporary disabling of either device.
Before conducting an MRI procedure on a patient with
an implanted CODMAN MICROSENSOR Transducer,
read the MRI Information section. Failure to read and
strictly adhere to these guidelines can result in serious
injury to the patient.
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.
Avoid direct contact with the sensing element at the
transducer tip. Care must be taken at all times during
handling of the transducer to protect the tip from
impact. Damage could result.
Do not hit the transducer tip with the stylet. Damage
could result.
It is essential to maintain strict sterile technique during
transducer placement.
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,
which are identified with the ESD symbol. (Refer to
Electrostatic Discharge (ESD) Information section.)
Take care when tying sutures onto the sensor. Tying
sutures too tightly can collapse the wall of the sensor
body, causing damage to internal wires.
The transducer must be zeroed at atmospheric
pressure prior to implantation.
The transducer tip must remain wet during the zeroing
process.
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.
The transducer can be damaged if exposed to
pressures over 1250 mmHg (166,650 Pa).
Do not forcibly pull or jerk the transducer catheter.
Do not expose the transducer to solvents or cleaning
agents, including alcohol; these may cause damage
leading to inaccurate ICP measurements.
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