Integra Codman CereLink Manual De Instrucciones página 7

Codman CereLink
®
ICP Sensor
Plastic Skull Bolt Kit
IMPORTANT INFORMATION
Please Read Before Use
Description
The Codman CereLink ICP Sensor Plastic Skull Bolt Kit consists of an intracranial
® ™
pressure (ICP) sensor with a Tuohy-Borst adapter mounted on the catheter, one adult
and one pediatric skull bolt with spacing washers, and a disposable ICP screw handle for
facilitating bolt removal (see Figure 1).
The Codman CereLink ICP Sensor (ICP Sensor) is a nylon tube with a microminiature
strain gauge pressure transducer (sensing element) mounted at one end and an electrical
connector at the other end. It is designed for use with a Codman intracranial pressure
monitoring device.
The single lumen plastic skull bolt is designed for use with the Codman
Drill and Codman Drill Bits. The drill facilitates access to the intraparenchymal area. The
drill and bits are sold separately and are also available as components of the Codman
Cranial Access Kit.
The skull bolts are preassembled with one thrust washer and one sealing washer. Skull
bolts are supplied with spacing washers, male luer caps, and obturators (see Figure 2).
Indications
Use of the ICP Sensor Plastic Skull Bolt Kit is indicated when direct ICP monitoring is
required. The kit is indicated for use in both subdural and intraparenchymal pressure
monitoring applications only.
Contraindications
Use of the skull bolt is contraindicated in children less than one year of age.
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.
Installation of the skull bolt must be performed with the bolt held within 10 degrees 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 still be removed using the screw handle.
™
Cranial Hand
®
Before conducting an MRI procedure on a patient with an implanted ICP Sensor, 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 expiration date has passed.
Avoid direct contact with the transducer (sensing element) at the tip of the device. Care
must be taken at all times during handling of the ICP Sensor to protect the tip from
impact. Damage could result.
Do not hit the ICP Sensor tip with the stylet. Damage could result.
It is essential to maintain strict sterile technique during bolt insertion and device
placement.
The use of a defibrillator or any electrosurgical equipment; e.g., monopolar, bipolar,
diathermy, can cause damage to the ICP Sensor. This could lead to permanent or
temporary disabling of the ICP Sensor.
Exposure to electrostatic discharge (ESD) energy could damage this device. High levels of
ESD could damage the electronic components and cause the ICP Sensor 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 device's electrical connector
pins, which are identified with the ESD symbol. (Refer to Electrostatic Discharge (ESD)
Information section ).
Finger-tighten all luer fitting connections on the Tuohy-Borst adapter prior to use.
Connections could loosen during shipping and handling.
Bolt fit can be compromised if used with drills other than those sold by Codman
separately or as part of the Codman Cranial Access Kit.
The ICP Sensor must be zeroed at atmospheric pressure prior to implantation.
The ICP Sensor tip must remain wet during the zeroing process.
Do not submerge the tip of the ICP Sensor vertically in a deep pool or cup of sterile water
or sterile saline. Doing so will impose a hydrostatic pressure on the ICP Sensor that is
higher than atmospheric zero, resulting in an inaccurate zero reference.
The ICP Sensor can be damaged if exposed to pressures over 1250 mmHg (166,650 Pa).
Do not forcibly pull or jerk the ICP Sensor. Excessive force can result in fracture of the ICP
Sensor or unintended withdrawal from the skull bolt.
Do not expose the ICP Sensor to solvents or cleaning agents, including alcohol; these
may cause damage leading to inaccurate ICP measurements.
Read all instructions included with the ICP monitoring device prior to use.
6
EN – ENGLISH