SYSTEM OVERVIEW
• 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
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.
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C. Avoid prolonged skin
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