WHALETEQ SECG 4.0 User Manual
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WHALETEQ SECG 4.0 User Manual

Single channel ecg test system
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SECG 4.0 | User Manual
WHALETEQ
Single Channel ECG Test System
(SECG 4.0)
User Manual
(Revision 2020-12-31)

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  • Page 1 SECG 4.0 | User Manual WHALETEQ Single Channel ECG Test System (SECG 4.0) User Manual (Revision 2020-12-31)

  • Page 2: Table Of Contents

    2.1.3 First Time Using WhaleTeq Product - USB Driver Installation .............10 2.1.4 First Time Using WhaleTeq Product – Microsoft .Net Framework 4.0 Installation .....11 2.2 Connecting to the ECG ......................11 2.3 Environment, noise reduction....................11 2.4 Firmware Update ........................13 2.4.1...

  • Page 3: Introduction

    (Figure 1) Single channel concept Via a SECG 4.0, the system produces arbitrary waveforms (streamed from the PC with digital to analogue conversion) at up to ±5V, which is then applied to a precision 1000:1 divider to produce the voltages at up to ±5mV level (10mVpp).

  • Page 4: Standards/Application

    SECG 4.0 | User Manual Multichannel waveforms, such as the CSE, AHA, MIT databases (this requires a multichannel system, please reference MECG 2.0 on WhaleTeq website) Standards/Application The following table shows the standards for which this system has been designed...
  • Page 5 SECG 4.0 | User Manual (use WhaleTeq CMRR3.0 for these tests) IEC 60601-2-47:2012 201.12.4, all tests except No known limitations (Ambulatory) CMRR (use WhaleTeq CMRR 3.0 for these tests) For all 201.12.1.101 database tests, use WhaleTeq MECG 2.0 for these tests.

  • Page 6: Block Diagram/Secg 4.0 Module Overview

    SECG 4.0 | User Manual Block diagram/SECG 4.0 Module overview The following is a simplified block diagram of the system inside the SECG 4.0 module: (BNC1) (BNC2) For noise reduction Connects to the PC via USB 2.0 Allows monitoring of...

  • Page 7: Main Specifications

    SECG 4.0 | User Manual Main specifications In general, the system has been designed to the standards above, taking into account Clause 201.5.4 in IEC 60601-2-25 and IEC 60601-2-27. Below includes these parameters and also other system parameters necessary for testing. For reference the system capability is provided.

  • Page 8: Cautions

    ➢ WhaleTeq does not recommend to connect test equipment with DUT to conduct Electrostatic Discharge (ESD) test. This may cause unexpected damages to test equipment. Please contact WhaleTeq for alternatives before ESD test.

  • Page 9: Set Up

    If SECG software can’t be executed properly or this is the first time using WhaleTeq product, please refer to below two sections to confirm that USB driver and Microsoft .Net Framework 4.0 are all installed. Relative to normal PC processing, there is no special use of PC speed. However, there has been noted a slow increase in system RAM usage over long periods of time up to 30-40MB (related to MS Windows “garbage collection”).

  • Page 10: First Time Using Whaleteq Product - Usb Driver Installation

    Microsoft Windows 7 ․ Windows 7 can’t recognize SEEG unit, please download “mchpcdc.inf” from WhaleTeq website. This driver is provided by Microchip® for using with PIC microprocessors having built-in USB function. ․ When the USB module is connected for the first time, select manual installation, and point to the folder containing the above file.

  • Page 11: First Time Using Whaleteq Product - Microsoft .Net Framework 4.0 Installation

    (a) using a metal bench or metal sheet underneath the ECG device under test and the WhaleTeq SECG test unit, and (b) connecting SECG GND terminal to the sheet and also the frame ground (or EP terminal) of the ECG...
  • Page 12 SECG 4.0 | User Manual ECG Device Frame ground or EP terminal Under test Metal bench, metal sheet or foil With this set up, turn the ECG device under test to maximum sensitivity, turn off the ac filters (if possible) and confirm that the level of noise is acceptable for tests. For most tests, this set up is satisfactory without any special efforts.

  • Page 13: Firmware Update

    How to check your SECG 4.0 have supported Firmware Update? Answer: Connect the SECG 4.0 device to PC. Go to “About” dialog, then check whether the “F/W Version” and “H/W Version” buttons are hidden. (Please watch Step 1 in below section for where to find “About” dialog.)

  • Page 14: How To Update Firmware

    Firmware Update period. 2.4.1 How to update Firmware If your SECG 4.0 support “Firmware Update” feature. Below is the step by step instruction for how to update firmware: Step 1. Connect the SECG 4.0 device to PC, then open SECG application with version 5.0.0.6 or higher.
  • Page 15 Single Channel ECG Test System | User Manual Step 2. “About” dialog is popped up. Record the “H/W Version”, then press “Update F/W” button. Step 3. Go to WhaleTeq website, reference below table to download compatible Firmware file. Hardware Version Firmware Version 4.4 or above 2.8 or above...

  • Page 16: Main Screen

    Single Channel ECG Test System | User Manual Step 6. Wait for firmware update complete. Step 7. Please restart the SECG system to complete firmware update process. Main Screen...
  • Page 17 Single Channel ECG Test System | User Manual 01 – Main Function： Selects the main function (waveform) type, such as sine, triangle etc. 02 – Main Parameters： General parameters for main waveform and pulse waveforms. 03 – DC Offset： Dc offset settings. 04 –...

  • Page 18: Description Of Functional Groups

    Single Channel ECG Test System | User Manual Description of Functional Groups 2.6.1 Main function (main waveform) This group allows the operator to select the main waveform to be used in the test, from the following: Waveform Description Sample waveform type Sine Basic sine wave, according to...
  • Page 19 Single Channel ECG Test System | User Manual waveform. For these waveforms, the amplitude and frequency settings have no effect. Main parameters Amplitude: Adjusts the waveform amplitude from 0 to 10mV at a 0.01mV resolution. For all waveforms the amplitude represents the peak to peak value.

  • Page 20: Dc Offset Setting

    Single Channel ECG Test System | User Manual 2.6.2 DC offset setting This function allows the operator to switch in a dc offset. In the default condition (not variable), only +300mV, 0 or -300mV can be set. In this mode, the dc offset is sourced from an internal “super capacitor”...

  • Page 21: Lead Electrode Impedance

    Single Channel ECG Test System | User Manual 2.6.5 Lead electrode impedance Not used in Version 4.0. In version 3.0, the user could select to include 51k/47nF in series with the output electrodes, as required in IEC 60601-2-51. However, all standards are now harmonized and use the same test circuit, with 51k/47nF only in RL (neutral electrode).

  • Page 22: Output Graphic Display

    Single Channel ECG Test System | User Manual required by IEC 60601-2-27, 100bpm according to IEC 60601-2-51). Single/Double This group selects whether single or double pulses are pulses, 150ms and required according to IEC 60601-2-27. If double pulses are 250ms advanced required, they can be 150 or 250ms advanced.

  • Page 23: Special Functions

    Single Channel ECG Test System | User Manual 2.6.8 Special functions Baseline reset test (sine wave only): When checked the parameters are ignored and a large signal of 1Vpp (0.354Vrms) is applied. It is intended to test the ECG’s response to overload, in particular automated resetting of baseline (due to high pass filtering).

  • Page 24: Auto Pacing, Auto Heart Rate, Calibration Mode

    Single Channel ECG Test System | User Manual 2.6.9 Auto Pacing, Auto Heart Rate, Calibration Mode Auto Pacing: This opens a new window for automatically cycling though all the combinations required for pacemaker testing in IEC 60601-2-27 (Clause 50.102.13). Auto Heat Rate: This opens a new window for automatically cycling though all the combinations required for heart rate testing in IEC 60601-2-27 (Clause 50.102.15).

  • Page 25: 2.6.10 Load Ecg File

    Single Channel ECG Test System | User Manual 2.6.10 Load ECG File This function is implemented on the “Special Waveforms” form. In that form, a new button is created and a text box. The button name in code is “Load ECG” The “Load ECG”...

  • Page 26: Software Options - Secg-Assistant

    Single Channel ECG Test System | User Manual Software Options – SECG-Assistant SECG-Assistant software option is a companion software add-on to enhance the function of SECG 4.0. It supports ECG the latest ECG standards with International and China version. For International ECG standards: IEC60601-2-25:2011, IEC60601-2-27:2011, IEC60601-2-47:2012 with detailed preset parameter settings and actual test sequence for testing needs.
  • Page 27 Single Channel ECG Test System | User Manual Step 1: Copy the Hardware ID / SECG Device ID and send it to service@whaleteq.com request an Active Key. Step 2: A unique Active Key will be send to you via email. Enter the Active Key and click the Active button.

  • Page 28: Secg-Assistant Operation

    License is bound with computer License is bound with SECG 4.0 If you would like to change the License bound way from computer to SECG 4.0, contact Whaleteq for upgrade your SECG 4.0 at service@whaleteq.com. 2.7.2...
  • Page 29 Single Channel ECG Test System | User Manual Step 2: All test clauses in are programmed for your convenience to test your ECG. Choose the specific test clause you needed, the Goldberger and Wilson leads is used as an example. Step 3: After you have selected the specific test clause, you can see that all...
  • Page 30 Single Channel ECG Test System | User Manual Step 4: After you have chosen the desired parameter settings, you can expand "Pass Criterion" for further measurement references. Step 5: Click “RUN” to execute the test per your specified settings. A new window will pop-up to display the crucial information about your test such as, parameter settings and pass criterion for your confirmation.
  • Page 31 Single Channel ECG Test System | User Manual Step 6: You may view the actual execution sequence, by clicking “Test Sequence”. This will open another window display the details of each test steps for your engineering needs. Step 7: When you have completed testing, click “Finish” and proceed to the next desired test.

  • Page 32: Testing To Iec And Aami Standards

    To be flexible, the WhaleTeq equipment does not use the switch nomenclature in the standards. Rather, the user should simply follow the effective settings. For example, IEC 60601-2-27 may say “Close switches S, S2 and S4 …”...

  • Page 33: Terminals P1, P2 And P6

    It is technically complicated to provide switching for LEAD wires to P6 (it would require an additional set of relays). It is the opinion of WhaleTeq that the standard writers intended that only P1 and P2 be used for LEAD wires (as per the diagram), and additionally that using terminal P6 for unused LEAD wires will have negligible impact on the test.

  • Page 34: Iec 60601-2-27

    It is possible to have time delays of up heart rate to 1s between changing the rate on the PC and the actual output, as the WhaleTeq system implement changes only at the end of a cycle to ensure a smooth transition. It is also possible to have delays of several seconds in the patient monitor.
  • Page 35 Single Channel ECG Test System | User Manual is already built into the waveform (as downloaded from the Physionet website). 50.102.1 Accuracy of For non-linearity, the standard requires tests signal starting with 10% of the display device followed reproduction by 20%, 50% and 100%. However, at 10% the (sensitivity, displayed value is typically only 4mm (peak to non-linearity)
  • Page 36 Single Channel ECG Test System | User Manual This is an error which has been corrected in the 2011 edition. In that edition the system is adjusted to provide an 80% of the display at 10mm/mV. However, the 2011 edition does not verify the range is ±5mV or the rate of change.
  • Page 37 Single Channel ECG Test System | User Manual 50.102.5 Multichannel For this test, refer to Table 110 in IEC 60601-2- cross talk 51 to understand the relationship between voltages applied to lead electrodes, and the LEADS indicated on the screen. With the test as initially instructed, there should be no indication on LEAD I of the display.
  • Page 38 50.102.10 Common mode Test requires a separate box available from rejection ratio WhaleTeq. 50.102.11 Baseline reset For this test use the “Baseline reset test” checkbox as shown in Section 2.6.8 (Special functions). Prior to using this checkbox, set up a 10Hz, 1mVpp sine wave as instructed.
  • Page 39 Single Channel ECG Test System | User Manual To perform this test correctly, the pacemaker pulses should be applied without any other signal. However, this may be an error in the standard as one of the effects of pacemaker pulses can be to distort the ECG signal. It is recommended to perform the test together with a 1mVpp “ECG 2-27 signal”.
  • Page 40 Single Channel ECG Test System | User Manual other medical devices. The real ECG signal can be monitored at BNC2: Oscilloscope Synchronization pulse Patient monitor 50.102.15 Heart rate range, For this test, the “ECG 2-27” function should be accuracy, and used, with the “T Wave”...
  • Page 41 Single Channel ECG Test System | User Manual design on a simple triangle pulse which may (continued) explain small differences in test results. 50.102.16 Output display No special guidance. 50.102.17 Tall T-wave This test is intended to verify that the patient rejection monitor shows the correct heart rate in the presence of a high T-wave.

  • Page 42: Software Development Kit

    C# interface, and can also be integrated with third-party tools and script languages. Calibration, software validation The WhaleTeq SECG 4.0 has undergone a detailed system validation including software. A report for this can be provided on request. Prior to shipping, each unit is tested for component values and output voltages, using a calibrated precision multi-meter.
  • Page 43 When complete, the results of calibration are automatically copied to the notepad and stored in a text file at: c:\WhaleTeq\SECG_Cal_yyyymmdd.txt where “yyyymmdd” is the date based on the PC’s system. If a fixed width font such as “Courier New”...
  • Page 44 Single Channel ECG Test System | User Manual • Open switch S2 (input impedance test) • Measure the resistance between RA and LL Input 4.7nF±5% Measure as for the 620kΩ above, using a impedance capacitance meter at 1kHz. Note: there is capacitance about 100pF stray capacitance in the circuit which is included in the measurement.
  • Page 45 Single Channel ECG Test System | User Manual • Measure the voltage between RA and LL Note: the DC offset is sourced from an internal super capacitor which will discharge after ~10min. Tests in the standard are typically <<2 minutes. DC variable Setting ±5mV Use the following procedure:...

  • Page 46: Troubleshooting

    USB module stops Move the main function mode to “Off” and then responding return to the function being used. If this does not work, close WhaleTeq software, disconnect the USB module, reconnect the USB module and re-start the USB module. Purchasing Information Standard accessories ✓...

  • Page 47: Version Information

    Modify Content Issue Date 20201231 Add - 2020/12/31 Chap 4 Software Development Kit（SDK） Chap 7 Purchasing information Chap 8 Version information Contact Details WHALETEQ Co., LTD service@whaleteq.com | (O)+886 2 2596 0701 9F, No.27, Minquan W. Rd., Taipei City 10452, Taiwan...

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