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510(k) Data Aggregation

    K Number
    K072200
    Device Name
    STIMLAB
    Manufacturer
    MICROPACE PTY. LTD.
    Date Cleared
    2007-10-26

    (79 days)

    Product Code
    JOQ
    Regulation Number
    870.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROPACE PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StimLab Cardiac stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electrical conduction.
    Device Description
    The StimLab™ is an EPS320 cardiac stimulator modified by the addition of a remote bedside touch monitor. The system consists of a manually controllable pulse generator issuing standard cardiac pacing pulses, normally controlled by a separate computer containing a graphic touch user interface and pre-programmed complex stimulation patterns suited to electrophysiology (EP) studies. In the StimLab™, a second remotely locatable beside control touch screen duplicates the video display and touch controls allowing verification and control of stimulator settings from two locations, one typically located in an electrophysiology laboratory central control room and the second at the operating table. The device is not a life support device and makes no diagnoses.
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    K Number
    K011826
    Device Name
    EPS320 CARDIAC STIMULATOR
    Manufacturer
    MICROPACE PTY. LTD.
    Date Cleared
    2002-01-24

    (227 days)

    Product Code
    JOQ
    Regulation Number
    870.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROPACE PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.
    Device Description
    The Micropace EPS320 Cardiac Stimulator (Clinical Stimulator) is an external programmable computerised diagnostic cardiac stimulator. It is used in specialised hospital electrophysiological diagnostic laboratories by specialist cardiologists to electrically stimulate the heart to initiate and terminate tachyarrhythmias and allow measurement of refractory and conduction properties of the heart by third party equipment. The EPS320 system consists of a Stimulus Generator Unit (SGU) comprising of a manufactured metal instrument case and a standard IBM clone type Personal Computer (PC), the two interconnected by a serial data connection. The device has two independent fully programmable and isolated constant current pulse generator channels intended for temporary programmacro and locativa third party transvenous intracardiac electrodes. The pacing stimulus is output via a Stimulus Connection Box and may typically be routed to the intravenous pacing electrodes via third party electronic switching equipment. During normal operation of the EPS320, custom software on the PC provides keyboard input device and a graphical user interface which the operator uses to control the stimulation process in real time. The custom PC software interprets the user instructions and sends specific real-time commands to the I he ousehi I O software and and to control its function and generate appropriate pacing stimulus pulses. The two isolated outputs can deliver stimulus pulse widths from 0.5ms to 10ms, adjustable in 0.5 to 1ms steps with current amplitudes adjustable from 0.1mA to 25mA in steps of 0.1mA. Current delivery is limited within the specified range by a maximum available output voltage of 26V. The EPS320 is not a life support device and may be used only in the presence of a backup cardiac THE LE SES IS .In case of failure of mains power supply, malfunction of the PC or its software, or loss of the data link, the SGU can operate independently of the PC in the Manual Backup mode, powered by an internal backup battery. This operational mode can provides regular pacing stimuli at intervals and pulse current amplitudes programmable from and displayed on the SGU's front panel. It may be used to briefly support a bradycardic patient until temporary external pacing is established using an approved temporary pacemaker. A secondary electrically self-contained Emergency Fixed Pace approved willing the front of the SGU may be used for the same purpose in case of loss of normal SGU function.
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