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ambu paedi anaesthesia system
Narco Air-Shields
Summary: The Ambu Paedi Anaesthesia System is a non-rebreathing valve system used in pediatric anesthesia. It is designed for use by anesthesiologists and other trained clinicians to manage ventilation in young patients during surgical procedures.
FDA Clearance Information
Pathway
510K
Number
K792499 ↗
Decision Date
December 19, 1979
Product Code
CAI
Device Class
Class 1
Evidence
0 studies
The Ambu Paedi Anaesthesia System was cleared through the FDA 510k pathway on December 19, 1979. It is manufactured by Narco Air-Shields and classified as a Class 1 medical device.
What It Is
The Ambu Paedi Anaesthesia System is a specialized non-rebreathing valve system used in pediatric anesthesia. It helps deliver anesthetic gases to young patients while allowing for accurate monitoring of exhaled gases. The system includes a breathing balloon in the inspiratory limb, which is crucial for its function, particularly in maintaining low fresh gas flow settings to minimize gas-shunting.
Clinical Applications
This device is commonly used in pediatric surgical settings where anesthesia is required. It is particularly useful in operating rooms and intensive care units for managing ventilation in children. Anesthesiologists and pediatric specialists utilize this system to ensure safe and effective delivery of anesthetic gases while monitoring exhaled volumes and compositions.
Indications for Use
The FDA indications suggest this device is intended for use in pediatric patients requiring anesthesia. It is suitable for procedures where precise control and monitoring of anesthetic gases are critical, particularly in young or small patients.
Practical Considerations
The Ambu Paedi Anaesthesia System is designed for pediatric use, so it is typically smaller in size. It is compatible with standard anesthetic machines and requires careful adjustment of fresh gas flow to prevent gas-shunting. Clinicians should be trained in its use to ensure optimal performance.
Related Literature
The linked study investigated the performance of the Ambu Paedi Anaesthesia System in measuring expired minute volume during anesthesia. It found that at low fresh gas flow settings, the system effectively minimized gas-shunting, making it reliable for analyzing exhaled gases. However, at higher flow rates, significant gas-shunting occurred, which could lead to measurement inaccuracies. The study was limited by its small sample size and focus on a single volunteer.
Frequently Asked Questions
What is the Ambu Paedi Anaesthesia System used for?
It is used for delivering and monitoring anesthetic gases in pediatric patients during surgical procedures.
What specialties typically use this device?
Anesthesiologists and pediatric specialists in surgical and intensive care settings.
What are the FDA-cleared indications?
The device is indicated for use in pediatric anesthesia to manage and monitor ventilation and anesthetic gas delivery.
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.