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510(k) Data Aggregation
K Number
K983862Device Name
CLOUD 1 HUMIDIFICATION SYSTEM
Manufacturer
Date Cleared
1999-05-24
(203 days)
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
RESPIRATORY SUPPORT PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cloud 1 Humidification System is intended to warm and humidify gas before it is delivered to the airway of a patient requiring mechanical ventilation or ventilatory assistance.
Device Description
The Cloud 1 Humidification System is used to deliver heat energy and humidity to a patient's proximal airway in those instances where the patient's natural mechanisms of heat retention and humidification are bypassed by intubation. The system consists of a humidifier that creates water vapor at an elevated temperature and mixes the vapor with air from a ventilator and a specialized breathing circuit including a heating element in either the inspiratory limb or both the inspiratory and expiratory limbs. The water content of the air exiting the humidifier is close to saturation at a desired proximal airway temperature. The breathing circuit heater adds heat energy to the air/vapor mixture as it travels from from the humidifier to the patient's proximal airway and, optionally, from the patient's airway to the ventilator expiratory valve. By reducing the temperature loss in the breathing tube, condensation of water vapor (rainout) is minimized resulting in safer operation and reduced clinical maintenance of the system.
The proposed system is a dual microprocessor controlled system with multiple redundant alarm and system check features. The humidification system uses the Vapor Phase transfer chamber concept that provides a physical separation between the water compartment and the vapor compartment by means of a hydrophobic membrane. This separation assures that a large bolus of liquid water cannot enter the patient's breathing circuit due to tipping of the humidifier. The construction of the chamber's membrane and the relatively high operating temperature allows the use of low cost distilled water instead of sterile water as is more commonly used in humidifiers.
The proposed system uses a breathing circuit heater assembly that supports heater elements in the center of the inspiratory air flow with a polymer web. The heater elements are placed such that they cannot touch the wall of the breathing circuit tube, reducing the chance for the heater melting through the tube wall and creating a circuit leak. Locating the heater elements at the center of the tube optimizes heat transfer to the airflow, reducing the operating temperature of the heater elements, further reducing chance of melting the breathing tube. The heater element employs straight wires instead of the more conventional spiral wound wires to reduce the risk of hot spot formation due to uneven spiral pitch winding and subsequent melting of the heater assembly and/or breathing circuit tube.
The support web serves as a structure to connect and support temperature sensors (thermistors), two extending to the proximal end of the heater assembly and another at the distal end of the heater assembly. The proximally located sensors measure proximal airway temperature (PAT) while the distally located sensor measures the chamber output temperature (COT). Additional conductive wires are extruded in the assembly support ribbon to electrically connect the PAT sensors to a cable assembly molded in the distal end. The cable assembly plugs into the humidifie/heated wire controller.
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