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510(k) Data Aggregation

    K Number
    K981999
    Device Name
    ALBATECH PERSONAL MONITOR
    Manufacturer
    Date Cleared
    1998-09-04

    (88 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALBATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Albacomp Personal Monitor is intended to display video images while mounted on the user's head.
    Device Description
    In endoscopic procedures the conventional video monitors are placed away from the site of the operation. As a result, the surgeon has to constantly divide his/her attention between the conventional monitor that shows the endoscopic image and the site of the operation. The remote location of the monitor and its orientation in the surgical setting have an effect on both the doctor's perception of the surgical field, and the difficulties encountered when interacting with it. Much of the difficulty encountered by a surgeon when learning the techniques of videoendoscopy, relates to the disconnection between instrument movements on the video monitor and the doctor's hand movements. With the displacement and axial rotation of the monitor, the doctor must re-learn the image to tissue relationship at each procedure, and witheach manipulation of the camera. With this decoupled image, the hand-eye coordination of the doctor suffers. For example, with a 90 degree rotation of the camera, an intended movement South to North direction, will result in a display movement in an East to West direction, presenting the doctor with a working field that is difficult to comprehend. The Albacomp Personal Monitor projects a high resolution color video image that appears in the surgeon's line of sight in a viewing angle comparable to watching a 26" television from 2 meters (6.5 feet) away. The video image is see-around; it blocks only the area where the image appears; otherwise users are free to view the surrounding environment. The Albacomp Monitor provides an added convenience to surgeons compared to conventional monitors. The device enables the surgeon to maintain the endoscopic image in the surgeon's line of site regardless of where he/she is looking. The Albacomp Personal Monitor can receive video signals from any video source. The signals are converted in the controller unit into signals the driving electronics of LCD displays require. The Albacomp Personal Monitor is a monoscopic binocular displays with a relatively narrow field of vision. The Albacomp Personal Monitor takes standard video signals and displays them on a small TFT-LCD display that can be connected to any standard video source. The Albacomp Personal Monitor consists of a monitor block, eyeglasses, cable and controller box. The monitor block contains the display for Albacomp Personal Monitor, a backlight and its driver for the LCD, and a system of lenses and mirrors that project the display image onto the retina of the eyes. The light beams coming from the display are reflected in two directions by dividing mirrors placed in front of the display. The monitor block has a mounting slot that fits into the vertical nose piece of the eyeglasses. The controller box contains the video input demodulator unit and the driving electronics of the LCD display. The LCD direct display control signals are sent through a flexible shielded cable to the displays. The eyeglasses have adjustable temple pieces and each unit comes with a commercially available 9V AC-DC adaptor with low EMI. All components and accessories of the device are marketed as non-sterile.
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