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510(k) Data Aggregation

    K Number
    K050107
    Device Name
    HARVARD 2 SYRINGE PUMP, MODEL 2001-001
    Manufacturer
    HARVARD CLINICAL TECHNOLOGY
    Date Cleared
    2005-02-11

    (24 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARVARD CLINICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Harvard 2 provides intravenous, intra-arterial, or epidural delivery of drugs or other parenteral fluids when administered by health care professionals such as physicians and nurses.
    Device Description
    The Harvard Pump is intended for the delivery of parenteral fluids. It accommodates syringe sizes from 1 through 60 ml from multiple manufacturers. Its user interface consists of an active matrix color LCD display with two rotary knobs for controling pump peration. The rotary Data Entry knob provides scrolling and selection of data and menu items as well as state Jection. The knob is turned to scroll, and pressed for selection. The rotary Function knob controls the state (Purge, Setup, Stop, Run and Bolus) of the pump. The pump has several microprocessors, one master which controls operation of the device, one pump processor which controls the operation of the motor and sensors specific to the syringe drive mechanism, and one upervisor which monitors the status of the system. The pump has sensors which permit its microprocessors to determine the syringe size loaded, determine if the I ne pain nas securely captured by the pusher block assembly, measure occlusion force and calculate the proper rate and distance the plunger of the syringe must travel to cause an infusion of fluid at a given rate and volume. The pump provides for bidirectional remote communications via an RS232 serial port. The pump may be used with The Harvard Library, an optional computer program which runs on MS Windows based personal computers. The Harvard Library is capable of downloading and uploading drug information in the form of a drug library to and from the pump. After downloading, the drug library is resident in flash memory within the pump, enabling the pump to provide drug specific defaults for drug concentrations, pumping rates, bolus amounts, and bolus times. Barcode versions of the pump provide a laser scanning barcode reader is used to scan a label placed on the syringe which selects a drug from the pump's resident drug library. This allows the pump to retrieve from its internal memory the drug's specific parameters such as concentration, infusion rate etc. in an effort to minimize user input errors.
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    K Number
    K033054
    Device Name
    HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
    Manufacturer
    HARVARD CLINICAL TECHNOLOGY
    Date Cleared
    2003-12-16

    (78 days)

    Product Code
    MEA, FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARVARD CLINICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Harvard 1: The Harvard 1 is designed to provide, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less. Harvard 1 with PCA: Harvard 1 with PCA is designed provide patient controlled analgesia, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products, or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 with PCA is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less.
    Device Description
    The Harvard Pump is intended for the delivery of parenteral fluids. It accommodates syringe sizes from 1 through 60 ml from multiple manufacturers. Its user interface consists of an active matrix color LCD display with two rotary knobs for controling pump operation. The rotary Data Entry knob provides scrolling and selection of data and memu items as well as state selection. The knob is turned to scroll, and pressed for selection. The rotary Function knob controls the state (Purge, Setup, Stop, Run and Bolus) of the pump. The pump has several microprocessors, one master which controls operation of the device, one pump processor which controls the operation of the motor and sensors specific to the syringe drive mechanism, and one supervisor which monitors the status of the system. The pump has sensors which permit its microprocessors to determine the syringe size loaded, determine if the syringe plunger is securely captured by the pusher block assembly, measure occlusion force and calculate the proper rate and distance the plunger of the syringe must travel to cause an infusion of fluid at a given rate and volume. The pump provides for bidirectional remote communications via an RS232 serial port. The Harvard 1 with PCA extends the Harvard 1 functionality to include Patient Controled Analgesia capability through the addition of an optional PCA pendent and PCA cover and lock assembly. PCA capability allows the patient to request delivery of a dose of pain medication from a regimen prescribed by the physician. The pump may be used with The Harvard Library, an optional computer program which runs on MS Windows based personal computers. The Harvard Library is capable of downloading and uploading drug information in the form of a drug library to and from the pump. After downloading, the drug library is resident in flash memory within the pump, enabling the pump to provide drug specific defaults for drug concentrations, pumping rates, bolus amounts, and bolus times. Barcode versions of the pump provide a laser scanning barcode reader is used to scan a label placed on the syringe which selects a drug from the pump's resident drug library. This allows the pump to retrieve from its internal memory the drug's specific parameters such as concentration, infusion rate etc. In an effort to minimize user input errors.
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