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headphones patient alert standalone interface
Neocoil
Summary: The headphones patient alert standalone interface by Neocoil is a device used to alert patients during medical procedures, particularly in tumor ablation. It is primarily used by clinicians in radiology and oncology settings.
FDA Clearance Information
Pathway
510K
Number
K133670 ↗
Decision Date
July 24, 2014
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on July 24, 2014. Manufactured by Neocoil, it is classified as a Class 2 device under product code LNH.
What It Is
The headphones patient alert standalone interface is designed to provide auditory alerts to patients during medical procedures. It serves as a communication tool, ensuring patients can receive important instructions or alerts from clinicians, particularly during procedures where patient movement must be minimized. The device is standalone, meaning it does not require integration with other systems, making it versatile for various clinical environments.
Clinical Applications
This device is commonly used in interventional radiology and oncology, especially during tumor ablation procedures where maintaining patient stillness is crucial. It is suitable for outpatient settings, hospitals, and specialized cancer treatment centers. The device helps ensure patient safety and communication during procedures that require precise targeting and minimal movement.
Indications for Use
The FDA-cleared indications suggest this device is intended for use in procedures where patient alertness and communication are critical, particularly in tumor ablation. It is designed for patients undergoing treatments that require them to remain still while still being able to receive auditory alerts.
Practical Considerations
The device is typically compatible with standard clinical audio systems and does not require specialized installation. It is important to ensure the headphones fit comfortably on the patient to avoid discomfort during prolonged procedures. Clinicians should verify compatibility with existing equipment to ensure seamless operation.
Frequently Asked Questions
What is the headphones patient alert standalone interface used for?
It is used to provide auditory alerts to patients during medical procedures, ensuring communication and safety, particularly in tumor ablation.
What specialties typically use this device?
The device is primarily used in radiology and oncology, especially during interventional procedures like tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring patient alertness and communication, particularly in tumor ablation contexts.
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.