Integra Codman CereLink Manual Del Usuario página 6

EN – ENGLISH
Codman CereLink
®
ICP Sensor
Metal Skull Bolt Kit
IMPORTANT INFORMATION
Please Read Before Use
Description
The Codman CereLink ICP Sensor Metal Skull Bolt Kit consists of an intracranial
® ™
pressure (ICP) sensor, skull bolt with integrated compression cap and optional washer,
obturator/dura pierce, and drill bit with depth guide and hex wrench (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 ICP Sensor Metal Skull Bolt Kit is designed for use with the Codman
Drill. 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 bolt is preassembled with a washer for optional use in adjusting the depth of
the bolt and a compression cap for securing the ICP Sensor in place. An obturator/dura
pierce is also provided for clearing the passage for the ICP Sensor and piercing the dura
(see Figure 2).
Indications
Use of the ICP Sensor Metal 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.
Excessive torque applied to the skull bolt during insertion can cause breakage.
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,
5
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Cranial Hand
®
• 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 ICP Sensor
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 ICP Sensor. High
levels of ESD could damage the electronic components and cause the 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 ICP Sensor's
electrical connector pins, which are identified with the ESD symbol. (Refer to Electrostatic
Discharge (ESD) Information section).
Bolt fit can be compromised if used with drills other than those provided in this kit or 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.
Adverse Events
The following Adverse Events may occur with the use of the ICP Sensor:
• Hemorrhage*
• Infection
• Subcutaneous CSF leakage
• Neurological sequelae
*Subarachnoid, intracerebral, or extracerebral hemorrhage may occur at the site of device
placement (either skull, cortical, or dural areas). Testing of the blood clotting factor
should be conducted on patients before insertion.