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ZONDAN

    Measurement range and accuracy of HR (This item is corresponding part of 4.4.4.5 as per production standard)

    Adult


    Pediatric


    Neonate



    ECG alarm limit accuracy (This item is corresponding part of 4.4.1.6.2 as per production standard)






















    Gain control and stability test (This item is corresponding part of 4.4.1.7.5.a as per production standard)

    The Measurement Mode: Gain Control Function











    HR alarm start-up time detected (This item is corresponding part of 4.4.1.6.4；4.4.1.6.5；4.4.1.6.6 as per production standard)

    The Measurement Mode: Time of Starting Alarm After Asystole Happened, while the HR Alarm Set is 60bpm




    Measurement for HR range (This item is corresponding part of 4.4.4 as per production standard YZB/0038-2011)

    The Measurement Mode - Adult













    The Measurement Mode - Paediatric




    Actual Result Pass / Fail







    The Measurement Mode - Neonate














    SPO2 (This item is corresponding part of 4.4.6 include 4.4.6.1.1 as per production standard)

    Signal Simulation Resource Set: 75bpm 60%




    Signal Simulation Resource Set: 75bpm 65%




    Signal Simulation Resource Set: 75bpm 70%




    Signal Simulation Resource Set: 75bpm 80%




    Signal Simulation Resource Set: 75bpm 98%




    Signal Simulation Resource Set: 75bpm 100%




    PR test (This item is corresponding part of 4.4.7 include 4.4.7.1 as per production standard )

    PR measurement range and accuracy
    Signal Simulation Resource Set: 25bpm 98%




    Signal Simulation Resource Set: 30bpm 98%




    Signal Simulation Resource Set: 60bpm 98%




    Signal Simulation Resource Set: 120bpm 98%




    Signal Simulation Resource Set: 200bpm 98%




    Signal Simulation Resource Set: 200bpm 98%




    Signal Simulation Resource Set: 250bpm 98%





    Normal working status display test (This item is corresponding part of 4.6 as per production standard）

    Operation: Connecting Spo2 probe with monitor to measurement signal, it should be display Spo2 value, PR value, Waveform.

    Blood pressure Test (This item is corresponding part of 4.4.5.1.2 as per production standard )

    Measurement Mode - Adult40~270 (Unit: mmHg)

    Simulation Pressure Measurement: 60/30(40)

    Allowable Deviation: ±3


    Simulation Pressure Measurement:120/80(90)

    Allowable Deviation: ±3


    Simulation Pressure Measurement: 255/195(215)

    Allowable Deviation: ±8


    Measurement Mode - Peadiatric 40~200 (Unit: mmHg)

    Simulation Pressure Measurement: 60/30(40)

    Allowable Deviation: ±3


    Simulation Pressure Measurement:100/65(75)

    Allowable Deviation: ±3


    Simulation Pressure Measurement: 200/150(165)

    Allowable Deviation: ±6


    Measurement Mode - Neonate 40~135 (Unit: mmHg)

    Simulation Pressure Measurement: 60/30(40)

    Allowable Deviation: ±3


    Simulation Pressure Measurement:100/65(75)

    Allowable Deviation: ±3


    Simulation Pressure Measurement: 120/80(90)

    Allowable Deviation: ±3



    Static pressure adjustment measurement (4.4.5.1.1) (Unit：mmhg)

    Pressure Value(1) (100-120)（Allowable deviation ± 2)

    120


    Pressure Value(2) (180-200) (Allowable deviation ± 2)

    200


    Pressure Value (3) (250-270) (Allowable deviation ± 2)

    255



    Temperature test(This item is corresbonding part of 4.4.8 include 4.4.8.1;4.4.8.2 as per production standard)

    Temp measurement range and deviation measurement

    Simulation Temperature Measurement Set: 25.0℃

    Allowable Deviation: ± 0.2℃


    Simulation Temperature Measurement Set: 30.0℃

    Allowable Deviation: ± 0.2℃


    Simulation Temperature Measurement Set: 35.0℃

    Allowable Deviation: ± 0.2℃


    Simulation Temperature Measurement Set: 37.5℃

    Allowable Deviation: ± 0.1℃


    Simulation Temperature Measurement Set: 40.0℃

    Allowable Deviation: ± 0.2℃


    Simulation Temperature Measurement Set: 48.0℃

    Allowable Deviation: ± 0.2℃


    ETCO2 Test(This item is corresponding part of 4.4.9.1as per production standard)

    In the measurement range of 0-99mmHg, measured with standard 5% CO2 gas inspection tooling, there should be a corresponding value of end-breath carbon dioxide of 38mmHg ± 2 mmHg


    Measure the actual end-breathing carbon dioxide of the human body. The inhaled carbon dioxide concentration in the atmosphere should be 32-42mmHg


    Recorder Test(This item is corresbonding part of 4.6 as per production standard

    It should be able to record patient information, waveforms, parameters, etc. on the display screen, and print clearly, completely, and without garbled characters

    Open the printer door or remove the printer, the monitor will have a corresponding alarm prompt