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Purpose: The purpose of the Ceramatec family of galvanic oxygen sensors is to be the oxygensensing component in a finished medical device that monitors oxygen concentration. Function: The Ceramatec galvanic oxygen sensors are used in finished medical device products such as oxygen monitors, oxygen analyzers, ventilators and humidifiers. Target Patient Population: The target patient population consists of those patients who require the oxygen concentration in their breathing environment to be monitored. Environment of Use: The Ceramatec family of galvanic oxygen sensors is used in finished medical devices (i.e., oxygen monitors, oxygen analyzers, ventilators, etc.) in patient environments whose temperatures range from 5 ℃ - 40 ℃ and from 5% - 95% relative humidity (non-condensing). Device Claims: The Ceramatec family of galvanic oxygen sensors consists of oxygen sensing components in finished medical devices that have the indication or claim of monitoring oxygen concentration in the patients' breathing environment.

Ceramatec galvanic oxygen sensors are lead-oxygen batteries consisting of a lead anode and an oxygen cathode. The oxygen cathode is to be made up of gold and an aqueous electrolyte solution. The gold electrode is in close proximity to a non-porous fluoropolymer membrane. Oxygen permeating through the membrane is reduced electrochemically at the gold electrode. An electronic network, consisting of one or more resistors and/or thermistors for temperature compensation, is connected between the cathode and anode which allows the lead-oxygen battery to continually discharge in the presence of oxygen. The said network may reside either within the sensor or be incorporated in an attached analyzer. The current that flows through the device is proportional to the partial pressure of oxygen of the gas in contact with the fluoropolymer membrane. An attached analyzer detects the oxygen concentration by measuring the voltage between the ends of the resistor network.

The intended use of the Ceramatec® Handi oxygen analyzer is to monitor the oxygen concentration in the patient-breathing environment.

The Ceramated Handi oxygen analyzer is comprised of a galvanic oxygen sensor and an analyzer module. The galvanic oxygen sensor produces a millivolt output that is proportional to the partial pressure of oxygen in the monitored gas. The analyzer module contains an electronic circuit that converts the millivolt output of the sensor to a digital percent-oxygen reading on a liquid-crystal display (LCD).