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510(k) Data Aggregation

    K Number
    K012691
    Device Name
    MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
    Date Cleared
    2002-12-20

    (493 days)

    Product Code
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUTRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Monsoon Universal Jet Ventilator is designed to use for bronchoscopy and laryngoscopy. Jet ventilation applied with the Monsoon Universal Jet Ventilator is useful in airway surgery, as it is performed in thoracic surgery units and ENT surgery. Jet ventilation is the optimal ventilation technique during the application of LASER light, where the presence of an ETT bears the risk for ignition, airway fire and burn injuries. Jet ventilation is useful for the removal of foreign bodies from the airway (e.g. after accidental aspiration of foreign bodies) via rigid bronchoscopes, for supplemental oxygenation during lung surgery (when the operated lung must be recruited for additional oxygenation, but may not be ventilated conventionally for surgical reasons), for surgery of the lower trachea close to the carina (when during the reconstruction phase, no tight airway sealing can be achieved), for radiation therapy of lung metastasis (when the tidal movements of the chest during spontaneous respiration or conventional ventilation would preclude the focusing of the radiation beam onto the target. The Monsoon Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy in a hospital or other clinical setting.
    Device Description
    In the past time, a jet ventilator system consisted of a jet ventilator and a humidifier, both made as individual units in separate enclosures. Now, those components in electronics became smaller and smaller, both units have been put together in one enclosure. One of the key features of the MONSOON is the safety concept to avoid having excessive pressures occurring in the patient's airways. To reach this goal, a high pressure resistant sensor with excellent resolution in the working range of 1 to 200 cmH2O is used. Another new feature in airway pressure measurement is the use of a small bias flow going through the airway pressure line, to eliminate the dead-space of the airway pressure line. In addition, the bias flow avoids, bacteria and humidity going back into the machine, creating contamination. If the airway pressure line is occluded, the bias flow makes the pressure rising and the ventilation is stopped immediately. A large screen displays the main parameters of ventilation and allows quick information of the anaesthetist about the status of the ventilation. A graphic indication of the airway pressure makes quantitative reading possible and allows quick access for parameter changes. Special functions are activated in menus and displayed on the screen. The MONSOON has a built in blender, which allows concentrations between 21 and 100 % oxygen. The access for changes is via a knob on the front panel. This parameter is accessible without going into menus, to allow a rapid change in case of emergency. The MONSOON uses an oxygen sensor, which is calibrated each time the unit, is switched on. If the ventilator can't reach the selected FiQ2, an alarm message appears on the screen, informing about a problem in the qas supply. The MONSOON has an additional outlet for gas, which can be adjusted from 0 to 70 LPM and a concentration between 21 % and 100 %. This feature allows mask ventilation of the patient for induction in anaesthesia or for emergency ventilation with a manual breathing bag. The MONSOON is equipped with a heating and humidification system, controlled by the microprocessor, which automatically adjusts the water injection and temperature of the jet gas. The water supply is based on the minute volume and therefore quarantees an efficient climatisation of the gas. In the MONSOON, the gas is preheated prior the injection of the water and therefore a saturation of the gas is achieved much easier. On the ventilator, all changes affecting the minute volume are controlled by the microprocessor, resulting in a reduction or increase of water injection. The temperature is controlled by a PT-100 temperature sensor and for safety; a thermostatic switch shuts down the heating system in case of a system failure. If the water supply is occluded or the bottle is empty, an alarm message on the screen informs the operator. The MONSOON has a small roller pump mounted on the right side of the unit, allowing easy access. A standard IV set is used to connect the bottle with the pump inlet. Microprocessor and Memory: H8 532 (manufactured by Hitachi) Clock frequency 10MHz Memory devices: 27C512 (several types available) 64kB EPROM DS1386 (manufactured by Dallas) 32kB RAM timekeeper external watchdog Sensors: 200 cmH2O pp-pressure sensor (Honeywell) monitoring pressure condition in Jet tube sampling on jet frequency max 2.5 samples per second, 200 cmH2O pip-pressure sensor (Honeywell) monitoring pressure condition 10 ms, 72.5 PSI driving-pressure sensor (Honeywell) monitoring driving pressure sampling rate maximum 200 ms, 142 cmH2O differential pressure sensor (Honeywell) monitoring jet flow in Jet tube sampling rate depending on jet frequency max 2.5 samples per second, 142 cmH2O differential pressure sensor (Honeywell) monitoring bypass flow in Jet tube sampling rate 10 ms, PT 100 temperature sensor (Jumo) regulates temperature of heating system sampling rate 500ms, EPL 10 Bubble detector (Argus) water detector sampling rate 100 ms.
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    K Number
    K012693
    Device Name
    MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
    Date Cleared
    2002-08-01

    (352 days)

    Product Code
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUTRONIC MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MISTRAL Universal Jet Ventilator is designed to use for short term application in bronchoscopy and laryngoscopy. Jet ventilation applied with the Mistral Universal Jet Ventilator is useful in airway surgery, as it is performed in thoracic surgery units and ENT surgery. Jet ventilation is the optimal ventilation technique during the application of LASER light, where the presence of an ETT bears the risk for ignition, airway fire and burn injuries. Jet ventilation is useful for the removal of foreign bodies from the airway (e.g. after accidental aspiration of foreign bodies) via rigid bronchoscopes, for supplemental oxygenation during lung surgery (when the operated lung must be recruited for additional oxygenation, but may not be ventilated conventionally for surgical reasons), for surgery of the lower trachea close to the carina (when during the reconstruction phase, no tight airway sealing can be achieved), for radiation therapy of lung metastasis (when the tidal movements of the chest during spontaneous respiration or conventional ventilation would preclude the focusing of the radiation beam onto the target. The Mistral Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy for applications up to 45 minutes duration on adults in a hospital or other clinical setting.
    Device Description
    The MISTRAL is a Universal Jet Ventilator. Key features include airway pressure measurement using a high pressure resistant sensor, a medium sized screen display for ventilation parameters and airway pressure graphics, a built-in air/oxygen blender allowing concentrations between 21 and 100% oxygen with an oxygen sensor, a bypass flow outlet for mask ventilation, a microprocessor (H8 532) and memory (27C512, DS1386), and various sensors (200 cmH2O pp-pressure sensor, 72.5 PSI driving-pressure sensor). It also includes fault detection for sensors and gas input, alarm functions for high PP pressure, system malfunctions, ventilation issues, FiO2 not adjustable, low O2 pressure, low air pressure, low battery, power failure, and maintenance required, and error functions for sensor malfunctions.
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