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    5388 Medtronic

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    Alexandra Janic
    This document outlines testing procedures to be performed on a medical device during an annual visual and functional inspection. It includes testing the device's rate response at various atrial and ventricular pulse rates, current output levels for atrial and ventricular pacing, and sensitivity thresholds. Measurements are taken and compared to specified tolerance ranges to ensure proper functioning.

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    5388 Medtronic

    Uploaded by

    Alexandra Janic
    71 views2 pages
    This document outlines testing procedures to be performed on a medical device during an annual visual and functional inspection. It includes testing the device's rate response at various atrial and ventricular pulse rates, current output levels for atrial and ventricular pacing, and sensitivity thresholds. Measurements are taken and compared to specified tolerance ranges to ensure proper functioning.

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    5388 medtronic

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    This document outlines testing procedures to be performed on a medical device during an annual visual and functional inspection. It includes testing the device's rate response at various atrial and ventricular pulse rates, current output levels for atrial and ventricular pacing, and sensitivity thresholds. Measurements are taken and compared to specified tolerance ranges to ensure proper functioning.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    71 views2 pages

    5388 Medtronic

    Uploaded by

    Alexandra Janic
    This document outlines testing procedures to be performed on a medical device during an annual visual and functional inspection. It includes testing the device's rate response at various atrial and ventricular pulse rates, current output levels for atrial and ventricular pacing, and sensitivity thresholds. Measurements are taken and compared to specified tolerance ranges to ensure proper functioning.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    You are on page 1of 2

    1 year

    Visual inspection – Technical Manual.

    Visual inspection – inscriptions, information and warning signs are properly and completely fixed.

    Visual inspection – check for mechanical damage to the device.

    Visual inspection – inspection of battery compartment and battery connection for corrosion and other
    contamination.

    Functional inspection – faultless self-test at power-up.

    Functional inspection – front panel dials, keys, and displays.

    Functional inspection – inspection of all connections and cables.

    Functional inspection – examination of warnings.

    Rate test (Atrial Rate) – (at 30 ppm) verify that the measured atrial pulse interval is within specified
    tolerance. 27 – 33 ppm

    Rate test (Atrial Rate) – (at 120 ppm) verify that the measured atrial pulse interval is within specified
    tolerance. 108 – 132 ppm

    Rate test (Atrial Rate) – (at 200 ppm) verify that the measured atrial pulse interval is within specified
    tolerance. 180 – 220 ppm

    Rate test (Ventricular Rate) – (at 30 ppm) verify that the measured ventricular pulse rate is within
    specified tolerance. 27 – 33 ppm

    Rate test (Ventricular Rate) – (at 120 ppm) verify that the measured ventricular pulse rate is within
    specified tolerance. 108 – 132 ppm

    Rate test (Ventricular Rate) – (at 200 ppm) verify that the measured ventricular pulse rate is within
    specified tolerance. 180 – 220 ppm

    Rapid atrial pacing test – (at 350 ppm) verify on the analyzer that the atrial rate is within the specified
    tolerance. 332 – 368 ppm

    Rapid atrial pacing test – (at 800 ppm) verify on the analyzer that the atrial rate is within the specified
    tolerance. 760 – 840 ppm

    Ventricular current output – (at 1.0 mA) verify that the measured outputs are within specified limits.
    0.9 – 1.1 mA

    Ventricular current output – (at 5.0 mA) verify that the measured outputs are within specified limits. 4.5
    – 5.5 mA

    Ventricular current output – (at 10.0 mA) verify that the measured outputs are within specified limits.
    9.0 – 11.0 mA
    Ventricular current output – (at 25.0 mA) verify that the measured outputs are within specified limits.
    22.5 – 27.5 mA

    Atrial current output – (at 1.0 mA) verify that the measured outputs are within specified limits. 0.9 –
    1.1 mA

    Atrial current output – (at 5.0 mA) verify that the measured outputs are within specified limits. 4.5 – 5.5
    mA

    Atrial current output – (at 10.0 mA) verify that the measured outputs are within specified limits. 9.0 –
    11.0 mA

    Atrial current output – (at 20.0 mA) verify that the measured outputs are within specified limits. 18.0 –
    22.0 mA

    Atrial sensitivity – (at 1.0 mV) verify the sensing threshold falls within the range specified. 0.75 – 1.25
    mV

    Atrial sensitivity – (at 2.0 mV) verify the sensing threshold falls within the range specified. 1.50 – 2 .50
    mV

    Atrial sensitivity – (at 5.0 mV) verify the sensing threshold falls within the range specified. 3.75 – 6.25
    mV

    Atrial sensitivity – (at 10.0 mV) verify the sensing threshold falls within the range specified. 7.5 – 12.5
    mV

    Ventricular sensitivity – (at 1.0 mV) verify the sensing threshold falls within the range specified. 0.75 –
    1.25 mV

    Ventricular sensitivity – (at 3.0 mV) verify the sensing threshold falls within the range specified. 2.25 –
    3.75 mV

    Ventricular sensitivity – (at 10.0 mV) verify the sensing threshold falls within the range specified. 7.50 –
    12.50 mV

    Ventricular sensitivity – (at 20.0 mV) verify the sensing threshold falls within the range specified. 15.00
    – 25.00 mV

    Off current drain (optional) – Specification ≤ 150 μA.

    On current drain (optional) – verify default settings of: rate = 80 bpm, Atrial Output = 10 mA, Ventricular
    Output = 10 mA.

    On current drain (optional) – verify that the DC current drawn is ≤ 3 mA.

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