đź“‹ FDA Reference
esprit ventilator with nico-esprit interface option model v1000
Respironics California
Summary: The Esprit Ventilator with Nico-Esprit Interface is a respiratory support device used in various clinical settings to assist patients with breathing. It is primarily used by respiratory therapists and intensivists.
FDA Clearance Information
Pathway
510K
Number
K041412 ↗
Decision Date
June 18, 2004
Product Code
CBK
Device Class
Class 2
Evidence
0 studies
The Esprit Ventilator, manufactured by Respironics California, was cleared through the FDA 510k pathway on June 18, 2004. It is a Class 2 medical device under product code CBK.
What It Is
The Esprit Ventilator is a sophisticated respiratory support device designed to assist or fully control a patient's breathing. It integrates with the Nico-Esprit Interface to provide advanced monitoring and ventilation options. This device is capable of delivering precise volumes and pressures, making it suitable for a wide range of patients, from neonates to adults, who require mechanical ventilation.
Clinical Applications
The Esprit Ventilator is commonly used in intensive care units (ICUs), emergency departments, and during surgical procedures requiring anesthesia. It is essential for managing patients with respiratory failure, chronic obstructive pulmonary disease (COPD), or during postoperative recovery. The device is used by respiratory therapists, anesthesiologists, and critical care physicians to ensure adequate ventilation and oxygenation.
Indications for Use
The FDA indications suggest that the Esprit Ventilator is intended for patients who need mechanical ventilation support due to conditions like respiratory failure or other breathing difficulties. It is suitable for both acute and chronic respiratory conditions.
Practical Considerations
The Esprit Ventilator is known for its versatility and compatibility with various patient interfaces, including masks and endotracheal tubes. Clinicians should be familiar with its settings and modes to optimize patient care. Regular maintenance and calibration are essential for accurate performance.
Frequently Asked Questions
What is the Esprit Ventilator used for?
The Esprit Ventilator is used to provide mechanical ventilation support for patients with respiratory insufficiency or failure.
What specialties typically use this device?
This device is typically used by respiratory therapists, intensivists, and anesthesiologists in settings such as ICUs and emergency departments.
What are the FDA-cleared indications?
The device is indicated for patients requiring mechanical ventilation support, including those with respiratory failure or other breathing difficulties.
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.