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510(k) Data Aggregation

    K Number
    K103142
    Device Name
    SPACELABS MULTI-PARAMETER MODULE
    Manufacturer
    SPACELABS HEALTHCARE, INC.
    Date Cleared
    2011-03-03

    (129 days)

    Product Code
    DSI, DQA, DSK, DXG, DXN, FLL
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPACELABS HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
    Device Description
    The Spacelabs Multi-parameter Module provides monitoring capability for the following parameters: ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. It is a "plug-in" module that is used in conjunction with a Spacelabs Monitoring Station such as the Model 91387. The patient is connected to the Spacelabs Multi-parameter Module via parameter-specific cables/sensors which provide the monitor with the patient's physiological data. The physiological data for each active parameter is accumulated by the Spacelabs Multi-parameter Module, and sent to the monitor which performs any necessary analysis and provides both waveform data and numeric values for display on the monitor screen. The monitor provides the display and printing capabilities for the care provider. Setting of alarm limits, enabling or disabling alarm monitoring, and definition of alarm responses are determined on a parameter-byparameter basis, and can be defined by the user for each parameter. In general, alarm limits can be set to provide the user with both audible and visible indications of the alarm condition. Each parameter provides a hierarchy of menu structures and keys that are activated through controls of the monitor by touching the monitor screen. Each parameter provides the capability to output recordings of selected information to a variety of recording devices. Recordings are available using the Spacelabs Monitor internal printer, network printers, and the Intesys Clinical Suite Print Manager Model 91881. Recordings can be automatically generated by each of the parameter's alarm managers or manually generated. The Spacelabs Multi-parameter Module utilizes the same technology for each parameter as utilized by the predicate device.
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