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510(k) Data Aggregation

    K Number
    K965117
    Device Name
    LIFE SUPPORT FOR TRAUMA AND TRANSPORT
    Manufacturer
    NORTHROP GRUMMAN CORP.
    Date Cleared
    1998-06-26

    (553 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHROP GRUMMAN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Life Support for Trauma and Transport (LSTAT) is a portable system to provide in a single platform, Intensive Care Unit (ICU) functionality for adult patients. Its use is to provide physiological monitoring, upper airway or gastrointestinal drainage suction, automated external defibrillation, IV fluid and drug administration, ventilation and oxygen delivery for use in hospitals, aircraft, ambulances, field hospitals and extended care facilities. It is for use on any adult patient weighing more than 90 pounds. Operating power is applied to unconscious, pulseless and apneic patients from internal rechargeable batteries. The LSTAT Model 9601 is used to support resuscitation, stabilization, and transport of adult trauma victims or patients needing physiological monitoring and treatment capabilities of a hospital intensive care unit or trauma care unit for pre-operative, intraoperative, and post operative support during pre, intra, and post-transport phases. The indications for use of selected subsystems/capabilities are dictated by medical protocol, but in general LSTAT use may be anticipated for victims of: combat/civilian casualty, trauma, respiratory distress, pneumothorax, severe fluid loss, cardiac emergency, or unstable clinical presentation.
    Device Description
    The LSTAT Model 9601 is a portable individualization intensive care unit that incorporates resuscitative and life-sustaining medical devices within a single composite structure assembly. Physically, the LSTAT Model 9601 is a highly instrumented patient transport platform (interfaced to a NATO litter) with medical devices incorporated within its composite structure assembly. Figure 16-2 shows the appearance of the LSTAT assembly whose unique outer moldline and low profile are defined for military transport compatibility (height = 13.2 inches, length = 86.8 inches, and width = 23.0 inches without patient). Device interfaces are colocated to favor awareness and controls in the "anestheologist position" during intra-operative procedures. The LSTAT incorporates six portable patient monitoring/treatment subsystems/ capabilities and five utilities/support subsystems as identified below. The LSTAT Medical Subsystems include: 1. Physiological Monitoring a. ECG b. NIBP c. Invasive Blood Pressure (BP) (two channels) d. Temperature 2. Blood Chemistry Assessment (in vitro) 3. Suction 4. Automated External Defibrillator (AED) 5. IV Fluid Administration (and IV drugs) 6. Ventilator a. On-board compressor (for medical air only) b. Oxygen-air blending c. Patient ventilation (controllable: mandatory or assist) d. Ventilation assessment: airway pressure, airway pCO2 and EtCO2, airway flow and tidal volume, and oxygen saturation (pulse oximeter) The LSTAT Utilities/Support Subsystems include: 7. Structure (including NATO litter) 8. Oxygen 9. Electrical Power 10. Environmental Control Subsystem (ECS) 11. Data Logging and Display Subsystem (DDLS) including a secondary display
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