Description

Indications for Use / Intended Use

The Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.

Contraindications

The Camino ICP Monitor and its accessories are contraindicated for use in a Magnetic Resonance (MR) environment.

Intended User

The Camino ICP Monitor is intended to be used by the following qualified medical and biomedical professionals:

• A qualified physician should perform the placement and handling of the catheters.

• Designated qualified hospital staff (e.g. neurosurgeon, nurse, intensivist, trauma physician, or physician’s assistant) should perform the operation of the monitor.

Intended Patient Population

Patients undergoing treatment with this monitor under the cranial applications are expected to have had a TBI, undergone a major neurosurgical procedure, or some other traumatic, ischemic or hemorrhagic incident requiring controlled monitoring of ICP and brain temperature.

Description of the Camino ICP Monitor

The Camino ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports the following catheters:

• Series of Camino Fiber Optic Catheters (110-4 series) for measuring both ICP and temperature.

• Camino Flex Catheter for measuring ICP values.

All Natus Neuro catheters measure their respective values at the tip of the catheter. This design eliminates the need for a fluid-filled system to communicate pressure (and carry pressure waves) to an external transducer.

Key Functions of Monitor

During clinical use, the Camino ICP Monitor provides several key functions to facilitate the process for monitoring and analyzing patient data:

• Touch screen interface for evaluating patient ICP/ICT data and setting patient parameters.

• Physiological alarm that activates if the patient’s Mean ICP value exceeds a user-specified limit for more than 5 seconds.

• Rechargeable lithium ion battery that supplies power to monitor during patient transport.

• Storage of patient’s ICP trend data for up to 5 days.

• Outputs for transferring patient data to a patient bedside monitor.

• Outputs for extracting patient data to remote media types via USB drive or digital streaming.