Integra Codman CereLink 826850 Guia De Inicio Rapido página 6

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Codman CereLink
®
ICP Sensor
Basic Kit
IMPORTANT INFORMATION
Please Read Before Use
Description
The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP
® ™
Sensor) and a 14-gauge Tuohy needle with stylet (see Figure 1).
The 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 Basic Kit is designed for use with the Codman® Cranial Hand Drill. The drill
facilitates access to the intraparenchymal area. The drill is also available as a component
of the Codman Cranial Access Kit.
Indications
Use of the ICP Sensor 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.
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.
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 ventriculostomy and subsequent
transducer 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.
5
™
Exposure to electrostatic discharge (ESD) energy could damage this ICP Sensor. 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 ICP Sensor's
electrical connector pins, which are identified with the ESD symbol. (Refer to Electrostatic
Discharge (ESD) Information section).
Take care when tying sutures around the ICP Sensor. Tying sutures too tightly can collapse
the wall of the ICP Sensor tubing, causing damage to internal wires.
The device 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 device.
Do not expose the device 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.
MRI Information
Read and understand this document in its entirety prior to
performing a Magnetic Resonance Imaging Procedure on a patient
with an implanted ICP Sensor. Failure to adhere to the Conditions
MR Conditional
for Safe Use may result in serious injury to the patient.
The ICP Sensor Ventricular Catheter is MR Conditional.
MRI SAFETY INFORMATION:
Non-clinical testing has demonstrated that the ICP Sensor is MR Conditional. A patient
implanted with this device can be safely scanned in an MR system which meets or is
operated under the following conditions:
• Static magnetic field of 1.5 T and 3 T only
• Maximum spatial gradient magnetic field of 1,000 G/cm (10 T/m)
• Maximum gradient field slew rate of 200 T/m/s