A traumatic brain injury (TBI) occurs every 15 seconds in the United States and moderate to severe cases require long-term care in the Neuro ICU. A patient with TBI may stay in the Neuro ICU for a week or longer because of the risk of secondary brain injury, hypoxia and hypotension.

The CereLink® ICP Monitoring System provides uncompromised advanced continuous ICP monitoring for such patients. And it does so with minimal drift, Magnetic Resonance (MR) conditional capability* and with advanced data presentation features.i ii

Here are four important video how-tos for getting the most out of CereLink and its unique features.

Monitor Set-Up and Operational Review

Utilizing the Data Marker

Synchronizing the CereLink® ICP Monitor to the Bedside Monitor

Zeroing the CereLink® ICP Sensor

*The CereLink ICP Sensor is MR Conditional and the CereLink ICP Monitor is contraindicated for use in a Magnetic Resonance (MR) environment.  See Instructions for Use for complete product information and specific MRI Safety Information. Read and understand the IFU in its entirety prior to performing a Magnetic Resonance Imaging Procedure on a patient with an implanted CereLink® ICP Sensor. Failure to adhere to the Conditions for Safe Use may result in serious injury to the patient.

Consult the Instructions for Use for complete indications, warnings and precautions.

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.
  • The ICP Monitor contains a lithium ion battery:
  • Do not open the battery compartment or attempt to replace the battery while monitoring a patient or while the device is connected to the AC Power Supply.
  • Use in extreme conditions (e.g., extreme temperature, high humidity, deep discharge) may decrease battery performance.
  • Do not puncture the battery.
  • Do not dispose of in fire.
  • Do not short circuit battery contacts as battery may get hot, leak, ignite or explode.
  • Use only Codman approved batteries listed in Recommended Accessories and Reordering Information section. Use of another battery may present a risk of fire or explosion.
  • The device may become warm during normal operation and surface temperatures may reach up to 50°C. Avoid prolonged skin contact with the device (less than 5 minutes) to reduce heat-related concerns. The device complies with user-accessible surface temperature limits defined by the International Standards for Safety (IEC 60601-1).

Precautions

  • When using the CereLink ICP Monitor, always handle with care.
  • Routinely inspect all electrical plugs and connections; do not use if damaged.
  • Use only Codman approved accessories with the ICP Monitor, including Extension Cable, Interface Cables, ICP Sensors, Power Supply and Battery, listed in the Recommended Accessories and Reordering Information section.
  • To prevent injury to the patient, user or other persons, make sure that the battery cover is closed securely during use of the ICP Monitor.
  • When clamping the ICP Monitor to the IV pole, always verify that it is secure to prevent injury to the patient, user, or other persons, or damage to the ICP Monitor.
  • Ensure the CereLink Power Supply is grounded (See Figure 14 in Initial Setup):
  • Use only the CereLink Power Supply, which provides three or more electrical pins/contacts depending on the geographical region.
  • Connect the CereLink to only “hospital grade” or “hospital only” receptacles.
  • Do not attempt to bypass the grounding contact on the CereLink Power Supply by using an adapter.
  • NOTE: Failure to properly connect the CereLink ICP Monitor to a grounded power supply can affect the accuracy and performance of the pressure readings.
  • Ensure patient monitor is connected to a properly grounded power supply.
  • The connectors for both the Interface Cable and the Extension Cable must be properly aligned with the receptacles on the ICP Monitor before pushing these parts together. DO NOT twist the connectors. Twisting the connector in this manner will damage the pins and can lead to product malfunction.
  • The signal processing algorithms used to detect and display physiological pressure data may vary among patient bedside monitors of different make and model. Therefore, pressure data displayed by the ICP Monitor may not always be consistent with the data displayed on an externally connected patient bedside monitor. Refer to the patient bedside monitor manufacturer’s instruction manual for specific details regarding signal processing, calibration and accuracy.
  • The ICP Sensor must be zeroed at atmospheric pressure prior to implantation.
  • This device should be used in environments that meet the electromagnetic environment – guidance in Appendix A of this manual.
  • Exposure to electrostatic discharge (ESD) energy could damage the ICP Sensor connected to this device. Please refer to the ICP Sensor IFU for more information.
  • The ICP Sensor is susceptible to damage from defibrillation. The sensor may need to be replaced before ICP monitoring can resume.
  • Disconnect the ICP Monitor from the ICP Sensor before utilizing any electrosurgery equipment. The use of electrosurgical equipment (e.g., Monopolar, Bipolar, Diathermy) can cause damage to both the ICP Monitor and ICP Sensor if left connected.
  • Only use the USB port to download or stream data. The only devices that can be connected to the USB port are:
  • USB memory stick or USB flash drive.
  • USB to serial adapter (refer to Recommended Accessories section) connected to a computer that is properly grounded. (See Figure 23 in Appendix C)
  • Always disconnect the ICP Monitor from the power supply before wiping external surfaces.
  • Do not sterilize the ICP Monitor.

iCereLink bench test shows (2 stdev) of ±2.2 mmHg over 7 days and 3.8mmHg (4 stdev) over 7 days.

iiCereLink system IFUs

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