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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. The CereLink ICP Extension cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is indicated for use in the ICU or Operating Room (OR) environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions: - Displays ICP Waveform - Displays Mean ICP numeric - Displays the historic mean pressure as a trend - Displays trend statistics (Pressure Time Dosage (PTD), time above threshold, boxplot, histogram) - Stores 14-days' worth of mean ICP values - Stores 24 hours of pressure waveform - Can capture and store screen-shots - Can download various data to a USB device for printing or analysis - Real-time data streaming of mean ICP and waveform via USB connection - Connect to external patient monitor The CereLink ICP Monitor can be transported with the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with a CereLink ICP Extension Cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable; the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables.

The Bactiseal Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. The Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid (CSF) is indicated. The Bactiseal Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

The Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter include a ventricular and/or distal (peritoneal) drainage catheter that are used as part of a CSF shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system, which is then implanted in the patient's brain. The ventricular catheter diverts the excessive CSF from the ventricles of the brain through the valve. After passing through the valve, the excessive CSF is drained through the distal (peritoneal) drainage catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Bactiseal silicone catheters have been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have tantalum "dots" incorporated onto the silicone tubing to aid in positioning of the catheter. The Bactiseal Catheters and Bactiseal Endoscopic Ventricular Catheter are made of radiopaque silicone tubing, and the Bactiseal Barium Striped Catheters are made of clear silicone tubing with radiopaque striping. The Bactiseal Endoscopic Ventricular Catheter has a slit in the tip of the ventricular catheter in order for the catheter to be placed with the use of an endoscope.

The Bactiseal EVD Catheter and Bactiseal Clear EVD Catheter sets are indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

The Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid. The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains barium sulfate for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.

The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

The Certas Plus Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Certas Plus Programmable Valve, to another body cavity where it is subsequently absorbed. The Certas Plus Programmable Valves can be set to eight different performance settings for intraventricular pressure and drainage of CSF. The performance settings of the valves can be set preoperatively and can also be noninvasively changed postimplantation by using the Certas Tool Kits. The Certas Tool Kits employ magnetic force to select one of eight settings.

The Codman Hakim Precision Fixed Pressure Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. The Codman Hakim Programmable Valves Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

The Codman Hakim® Precision Fixed Pressure and Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Hakim Precision Valve or Hakim Programmable Valve, to another body cavity where it is a subsequently absorbed. Both the Codman Hakim Precision Fixed Pressure and Programmable Valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The Hakim Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges. The Codman Hakim Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman Hakim Programmable Valves can be adjusted to 18 different opening pressure settings.

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.

The CereLink ICP Monitor is indicated for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions: - Displays ICP Waveform . - Displays Mean ICP numeric . - Displays the historic mean pressure as a trend . - Displays trend statistics (Pressure Time Dosage (PTD) , time above threshold, boxplot, . histogram) - Stores 14-days' worth of mean ICP values . - . Stores 24 hours of pressure waveform - Can capture and store screen-shots 9 - . Can download various data to a USB device for printing or analysis - Real-time data streaming of mean ICP and waveform via USB connection . - Connect to external patient monitor . The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with an CereLink ICP extension cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor (cleared via K173192). The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (cleared via K183406); the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables (cleared via K152670).