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type 9292 interface capnograph
S & W Medico Teknik
Summary: The Type 9292 Interface Capnograph by S & W Medico Teknik is a medical device used to monitor CO2 levels in patients' exhaled breath, primarily used by anesthesiologists and critical care specialists.
FDA Clearance Information
Pathway
510K
Number
K896737 ↗
Decision Date
February 28, 1990
Product Code
CCK
Device Class
Class 2
Evidence
0 studies
The Type 9292 Interface Capnograph was cleared via the FDA 510(k) pathway on February 28, 1990, by S & W Medico Teknik. It is classified as a Class 2 device under product code CCK.
What It Is
The Type 9292 Interface Capnograph is a medical device designed to measure the concentration of carbon dioxide in exhaled air, providing real-time monitoring of a patient's ventilatory status. It works by analyzing the CO2 levels in the breath, which is crucial for assessing respiratory function. This device is particularly useful in settings where continuous monitoring of respiratory status is required, such as during anesthesia or in intensive care units.
Clinical Applications
This capnograph is commonly used in operating rooms and intensive care units to monitor patients under anesthesia or those requiring mechanical ventilation. It is essential for anesthesiologists to ensure adequate ventilation and for critical care specialists managing patients with respiratory compromise. The device is also used in emergency departments and during patient transport to monitor respiratory status in real-time.
Indications for Use
The FDA indications for this device include monitoring of CO2 levels in patients' exhaled breath, which is crucial for patients undergoing anesthesia or those with respiratory conditions. It is used to ensure proper ventilation and detect any abnormalities in respiratory function.
Practical Considerations
The Type 9292 Interface Capnograph typically integrates with existing anesthesia machines or ventilators. It is important to ensure compatibility with other equipment in use. Clinicians should be familiar with the calibration and maintenance requirements to ensure accurate readings.
Frequently Asked Questions
What is the Type 9292 Interface Capnograph used for?
It is used to monitor carbon dioxide levels in exhaled breath, providing real-time data on a patient's ventilatory status.
What specialties typically use this device?
Anesthesiologists and critical care specialists commonly use this device in operating rooms and intensive care units.
What are the FDA-cleared indications?
The device is indicated for monitoring CO2 levels in exhaled breath to assess respiratory function, particularly during anesthesia and in critical care settings.
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.