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510(k) Data Aggregation

    K Number
    K112133
    Device Name
    OASYS SURGICAL LIGHT CONTROLLER
    Manufacturer
    OASYS HEALTHCARE
    Date Cleared
    2012-03-01

    (219 days)

    Product Code
    FTA
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    OASYS HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OASYS Surgical Light Controller Software allows the control of surgical lights during a procedure from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light.
    Device Description
    The OASYS Surgical Light Controller allows the control of surgical lights from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light. It works with surgical lights from many vendors. The OASYS Surgical Light Controller communicates with the target surgical light using serial or Ethernet communications. All communications include error and exception handling. The safety features and controls of the surgical light take precedence over these communications. This software controlling the Surgical Light is written with C# and XML data structures that run on Windows Embedded 7. The software is an optional module to the OASYS View OR Control application. OASYS View is a medical control application that allows for simple and streamlined management of an operating room. The software allows users to: - Enable video routing from any source device to any destination device - Preview selected sources on-screen - Adjust image settings for video sources - Change picture-in-picture capabilities on supported displays - Control camera settings including: - Panning & tilting - Zooming - Focusing - Presets - Operate medical-grade video recorders - Select and listen to audio from an iPod or external audio device - Engage in video conference calls The software communicates with the light over a serial connection (RS485). Parameters are passed over a socket. The software manages the send and receive buffers to ensure effective communications. Data transmission is verified through the use of checksums and status commands. The software allows for the Surgical Light to be initialized at run time. Default settings, such as brightness, are initialised on the Surgical Light. During normal operation, commands are passed back and forth based upon operator interaction with the graphical user interface. There are no patient contacting components.
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