System Overview; Intended User; Indications For Use; Contraindications - Integra Codman CereLink Bedienungsanleitung

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SYSTEM OVERVIEW

The small profile and light weight of the ICP Monitor make it ideal for monitoring ICP during patient transport.
Included with the ICP Monitor is one AC Power Supply, a rechargeable battery and one CereLink ICP Extension Cable (Extension Cable)
used to connect the ICP Sensor to the ICP Monitor. During the ICP Sensor zeroing process, the ICP Monitor automatically stores the
zero-reference value in a memory element embedded in the ICP Sensor. This feature allows the user to reconnect the ICP Sensor to the
same or different ICP Monitor without having to readjust the zero-reference value.
CereLink Patient Monitor Interface Cables (Interface Cables) are available separately for connecting and synchronizing the ICP
Monitor to a variety of compatible patient bedside monitors.
Additional AC power supply (REF 82-6822), battery replacements (REF 82-6824) and Extension Cable (REF 82-6845) are also available
separately. Contact your local Codman sales representative for full details.
Please see Recommended Accessories and Reordering Information section for a list of compatible ICP Sensors, cables and additional
accessories.

Intended User

The ICP Monitor is designed for worldwide use in a clinical setting by qualified medical personnel, including the neurosurgeon, nurse,
intensivist, trauma physician or other advanced-practice provider, who perform the operation of the ICP Monitor and placement of the ICP
Sensors.

Indications for Use

The ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard
physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for
displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.

Contraindications

The ICP Monitor is contraindicated for use in a Magnetic Resonance (MR) environment. Refer to the ICP Sensor IFU for MR environment
use.
MR Information
The ICP Monitor is MR Unsafe. Do not bring the ICP Monitor or accessory cables into the MR environment.
WARNINGS
• Read the entire instruction manual before attempting to operate the ICP Monitor.
• Always zero the ICP Sensor prior to implantation. Never attempt to re-zero a sensor while implanted inside the patient.
• Always verify physiological alarm limits are set appropriately for each patient prior to treatment. The physiological alarm can be
disabled by manually turning it off or by selecting extreme limits.
• Use of the ICP Monitor is restricted to one patient at a time.
• Maintain strict sterile technique when connecting the ICP Sensor to the ICP Extension Cable. The ICP Extension Cable can be
sterilized before use if desired, and has been tested to withstand 100 autoclave cycles. Cable performance beyond 100 autoclave
cycles has not been evaluated. Refer to the ICP Sensor IFU and to the ICP Extension Cable IFU for more information.
• Do not cover the ICP Monitor's vents because it will increase internal temperature and cause overheating and possible device
failure.
• Keep device away from fluid sources.
• Modification or disassembly of the ICP Monitor (including power supply, cables and sensors) is not permitted. Unauthorized
modifications to the ICP Monitor can cause a malfunction resulting in serious patient injury, damage to internal circuitry or
electric shock.
• Explosion Hazard: Do not use in the presence of flammable materials (e.g., anesthetics, solvents, cleaning agents and endogenous
gases).
• Electrical Shock Hazard:
• Use only Codman approved power supplies listed in Recommended Accessories and Reordering Information section.
Use of another power supply may not provide electrical isolation from supply mains and protection against electrical
hazards.
• Do not remove side, front or rear panels. Contact Technical Support for service and repair.
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