Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K961644
    Device Name
    MINIOX 3000 OXYGEN MONITOR
    Manufacturer
    MINE SAFETY APPLIANCES, CO.
    Date Cleared
    1996-07-25

    (87 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINE SAFETY APPLIANCES, CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiniOX® 3000 Oxygen Monitor provides continuous, direct monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia machines), respiratory therapy (e.g., respirators, ventilators, pediatric incubators), and oxygen therapy (e.g., oxygen tents). The MiniOX® 3000 Oxygen Monitor is to be used by trained health care professionals under the supervision, or on the order. of a physician in a hospital (or other clinical setting) and during emergency transport.
    Device Description
    Battery operated and microprocessor controlled, the MiniOX® 3000 Oxygen Monitor measures oxygen concentrations in the 0 - 100% range. The performance features include a calibration function; high and low oxygen concentration alarms; low and depleted battery alarms: oxygen sensor indicator: automatic error detection: battery test and oxygen concentration alarm test. The calibration function allows calibration of the device against room air (21% O.) or 100% O2. Audible and visual alarms alert the operator when monitor calibration is required. High and low oxygen concentration alarms may be set in the ranges of 19%-100% (high alarm) and 18%-99% (low alarm) or the default high/low settings may be used (50% and 18% respectively). Audible and visual alarms activate when oxygen concentrations fall below the preset (or default) low alarm setting or rise above the preset (or default) high alarm setting. The MiniOX® 3000 Oxygen Monitor detects low and depleted battery conditions and activates audible and visual alarms. The MiniOX® 3000 Oxygen Monitor also alarms for sensor disconnection or malfunction and for various internal operating errors. The MiniOX® 3000 Oxygen Monitor conducts self checks at power-up (battery installation), turn-on, and during operation. Additionally, the monitor has two operator initiated test functions. The Alarm Test verifies the operation of the high and low oxygen level alams; the Battery Test assesses the relative remaining battery life. The MiniOX® 3000 Oxygen Monitor consists of two components: the instrument and the oxygen sensor. The portable, hand-held instrument features a touch sensitive keypad; a liquid crystal display (LCD) that shows monitor status, continuous oxygen concentrations, and preset alarm levels; and two red light emitting diodes (LED) which serve as visual alarms. The back of the instrument case has a bail bar which allows the instrument to "stand" on a horizontal surface during monitoring operations. A plastic wedge on the back of the instrument slides into an optional bracket for mounting the instrument on a horizontal or vertical pole. The oxygen sensor used in the MiniOX® 3000 Oxygen Monitor is the same oxygen sensor used in Mine Safety Appliances Company oxygen monitoring medical devices for the past 15 years. Connected to the instrument by a coiled cable, the galvanic oxygen sensor consists of a deflector assembly and a plastic housing containing two electrodes. A coiled cable connects the sensor to the instrument. Plugs at each end of the cable snap into jacks (one located in the sensor housing and one located in the instrument) and are held securely in place by twist collars. In addition to the mounting bracket, the device has two accessories: a tee adapter and a retaining strap. The oxygen sensor is introduced into a breathing circuit through a Mine Safety Appliances Tee Adapter which connects two lengths of tubing. The sensor/tee assembly is positioned with the sensor deflector pointing downward to ensure that moisture does not collect on the sensor membrane. A Retaining Strap ensures that the sensor remains securely in place in the Tee Adapter.
    Ask a Question

    Page 1 of 1