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The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.

The Chartis Console is an integrated, self-contained, 12 VDC powered system designed to be used in the bronchoscopy suite in conjunction with the Chartis Catheter. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Cathter isolates the lung compartment of interest. The hardware components of the Console translate air flow and pressure detected through the Chartis Catheter into electrical signals. The Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.

The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.

The Chartis™ Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Catheter lumen during spontaneous respiration.

The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.

The Chartis Catheter consists of two components which are pouched separately and provided to the user in a single shelf carton with the Instructions for Use. These two components are the Chartis Catheter and the Connector Set. The Catheter is the patient contact component while the Connector Set acts to connect the Chartis Catheter to the Chartis Console (which is documented in a concurrent 510(k) submission). The system is designed to be used by experienced bronchoscopists during a diagnostic bronchoscopy in a hospital bronchoscopy suite for functional assessment of air pressures and flows in isolated lung compartments.