How does the Vapor-Clean remove anesthetic vapors?
The Vapor-Clean filter canisters contain granules of medical grade activated charcoal. Volatile anesthetic vapor molecules are captured and held by the activated charcoal granules.
Can the Vapor-Clean be reused?
No. The Vapor-Clean is a single patient use device. A new set of Vapor-Clean filters should be used for each patient. At the conclusion of the anesthetic procedure, the Vapor-Clean filters should be discarded.
Can the Vapor-Clean be used if Malignant Hyperthermia (MH) is detected intra-operatively?
Yes. Installation of the Vapor-Clean intra-operatively removes residual anesthetic vapors emitted by the anesthesia gas machine as well as vapors emitted by the patient. Placement of the Vapor-Clean at any time ensures that no vapor will be inhaled by the patient.
Does the Vapor-Clean work with all anesthetic gases? Yes. The Vapor-Clean has been tested and proven effective at removing >99% of isoflurane, sevoflurane and desflurane.
What is the shelf life of the Vapor-Clean? The shelf life is a guaranteed minimum of two years.
How soon after installation of the Vapor-Clean is the anesthesia gas machine free of trace anesthetic vapors?
Tests showed that the concentration of vapor was less than 5 parts per million in less than 2 minutes.
Why does the Vapor-Clean include two activated charcoal filters? The primary reason for including two filters is to increase anesthetic gas removal in the intra-operative application. Additionally, the dual filter prevents inhalation of vapor in case one of the anesthesia machine’s non-rebreathing valves fails. An additional safety reason for the dual filter configuration is to minimize the possibility of inadvertent placement of a single charcoal filter on only the expiration hose port.
Has the Vapor-Clean been cleared by the Food and Drug administration? Yes. The Vapor-Clean has been cleared by FDA for removal of unwanted anesthetic vapors. The 510(k) clearance number is K092031.
During development, was the Vapor-Clean tested on actual malignant hyperthermia-susceptible patients? No. The Vapor-Clean was not tested on actual MH susceptible patients. However, it has been demonstrated effective at removing >99% of anesthetic vapors in rigorous bench testing, and has been used successfully on many MH-susceptible patients worldwide since its introduction.
The Vapor-Clean filters are marked inspiratory and expiratory - are they actually different? What happens if I put the inspiratory Vapor-Clean on the expiratory port and vice versa?
The inspiratory and expiratory Vapor-Clean filters are identical - the labeling is for instructional purposes only. If the inspiratory Vapor-Clean is placed on the expiratory port and vice versa, and the error is discovered during the procedure, we recommend leaving them on as they were originally placed and not changing them. If they were switched during the middle of the procedure, the patient would then begin breathing off the "dirty" side of the Vapor-Clean that had been filtering gas. This could potentially expose them to anesthetic gas.
Which anesthesia gas machines require Vapor-Clean filters? Published studies show that the newer Draeger anesthesia gas machines (Primus, Apollo, Fabius) and GE-Ohmeda (Aestiva) require 50-75 minutes of continuous gas flush at 10 L/min before residual vapor concentrations are less than the save level of 5 parts per million. It is likely that other new machines that contain plastic parts require similar preparation times.
What is the source of residual anesthetic vapor in the anesthesia gas machine? Plastic parts (valves, tubing, bellows, etc.) within the anesthesia gas machine absorb anesthetic vapor. These absorbed gases are then slowly released when the machine is used for a new patient during a subsequent anesthetic procedure.
Does use of the Vapor-Clean during a MH case eliminate the need for dantrolene to be given?
No. The Vapor-Clean only clears the anesthesia machine of trace anesthetic agents that can trigger MH. Dantrolene is still required to treat the disease process of MH.