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directlink icp module directlink icp extension cable patient monitor interface cables
Medos International Sarl
Summary: The DirectLink ICP Module by Medos International is a medical device used for intracranial pressure monitoring. It is primarily used by neurosurgeons and critical care specialists to monitor patients with head injuries or conditions affecting brain pressure.
FDA Clearance Information
Pathway
510K
Number
K152670 ↗
Decision Date
January 22, 2016
Product Code
GWM
Device Class
Class 2
Evidence
0 studies
The DirectLink ICP Module was cleared through the FDA 510(k) pathway on January 22, 2016. Manufactured by Medos International Sarl, it is classified as a Class 2 device under product code GWM.
What It Is
The DirectLink ICP Module is a device designed to measure intracranial pressure (ICP) in patients. It works by interfacing with patient monitors through specialized cables, providing real-time data on the pressure within the skull. This information is crucial for managing patients with traumatic brain injuries, hydrocephalus, or other conditions that can lead to increased intracranial pressure.
Clinical Applications
This device is commonly used in neurosurgery and intensive care settings. It is essential for monitoring patients with severe head trauma, brain tumors, or after neurosurgical procedures. The device helps clinicians make informed decisions about interventions to reduce intracranial pressure, thereby preventing further brain injury.
Indications for Use
The FDA indications suggest that this device is intended for patients who require continuous monitoring of intracranial pressure. This includes individuals with traumatic brain injuries, brain tumors, or other neurological conditions that could lead to increased pressure within the skull.
Practical Considerations
The DirectLink ICP Module is compatible with various patient monitors, requiring specific interface cables for connection. Clinicians should ensure proper calibration and setup to obtain accurate readings. The device is typically used in conjunction with other monitoring equipment in a critical care environment.
Frequently Asked Questions
What is the DirectLink ICP Module used for?
It is used for monitoring intracranial pressure in patients with conditions like head trauma or brain tumors.
What specialties typically use this device?
Neurosurgeons and critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing continuous intracranial pressure monitoring, such as those with traumatic brain injuries or neurological conditions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.