WHALETEQ SECG 4.0 User Manual
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WHALETEQ SECG 4.0 User Manual

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SECG 4.0| User Manual
WHALETEQ
Single Channel ECG Test System
(SECG 4.0)
User Manual
2021-11-26

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Summary of Contents for WHALETEQ SECG 4.0

  • Page 1 SECG 4.0| User Manual WHALETEQ Single Channel ECG Test System (SECG 4.0) User Manual 2021-11-26...
  • Page 2 WhaleTeq Co. LTD. Disclaimer WhaleTeq Co. LTD. provides this document and the programs "as is" without warranty of any kind, either expressed or implied, including, but not limited to, the implied warranties of merchantability or fitness for a particular purpose.

  • Page 3: Table Of Contents

    Software Options – SECG Assistant .......... 31 2.7.1 Activate the SECG Assistant Software ........31 Testing to IEC and AAMI standards ..........33 Relation between IEC figures and WhaleTeq SECG ....33 Terminals P1, P2 and P6 ............34 Software Development Kit ............... 36...
  • Page 4 SECG 4.0 | User Manual Self-Calibration ................40 Trouble shooting ................43 Cautions ..................44 Purchasing Information ..............45 Standard accessories..............45 Purchase software and accessories .......... 45 Version information ................. 45 10 Contact WhaleTeq ................46...
  • Page 5 SECG 4.0 | User Manual List of Table Table 1: Standard/Application ............8 Table 2: Main Specification ............. 11 Table 3: H/W F/W Version ............... 18 Table 4: Main waveform ..............21 Table 5: Pacing Parameter ............... 25 Table 6: Cross-References Between Switches and Terminals ..33 Table 7: Calibration procedure ............
  • Page 6 Figure 25: Software Assisted Calibration Mode ......37 Figure 26: SECG 4.0 Interface ............41 Figure 27: Self-Calibration Setup ............. 41 Figure 28: SECG 4.0 ±300 mV DC offset ........... 42 Figure 29: DC Voltage Verification (300mV) ........42 Figure 30: Self-Calibration Setup ............. 43...

  • Page 7: Introduction

    SECG 4.0 | User Manual Introduction Basic concept The WhaleTeq Single-channel ECG Test System 4.0 (SECG 4.0) provides a single waveform to one or more lead electrodes of diagnostic, ambulatory, or monitoring ECGs, for testing IEC/YY/JJG standards. The following diagram...

  • Page 8: Standards/Application

    SECG 4.0 | User Manual For a full list of tests, refer to the standard together with Section 1.2. The system does not provide: CMRR tests (this requires a special noise free box, please refer to CMRR 3.0 on WhaleTeq website) Multichannel waveforms, such as the CSE, AHA, MIT databases (this requires a multichannel system, please refer to MECG 2.0 on...
  • Page 9 SECG 4.0 | User Manual Standard Clause(s) Limitations / Notes 201.12.4.105.3 test of ringing from mains notch filter) IEC 60601-2-27:2011 201.7.9.2.9.101 b), 4) No known limitations (Patient monitoring) and 6) (special test waveforms for Figure 201.101) 201.12.1.101, all performance tests...

  • Page 10: 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) Figure 2: Simplified Block Diagram For noise reduction Connects to the PC via USB 2.0...

  • Page 11: 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.
  • Page 12 SECG 4.0 | User Manual System capability / Parameter Specification notes DC offset (fixed, noise 300mV ± 1% 300mV ±0.1% free, sourced from internal super capacitor) DC offset (variable, Setting ±1% or ±3mV Setting ±1% or ±3mV may include up to 50µVpp noise)

  • Page 13: Set Up

    SECG 4.0 | User Manual 2 Set up Software installation 2.1.1 System requirements The Single-channel ECG system uses a normal PC to interface and control the USB module. PC requirements: - Windows PC (Windows 7 or later, suggest to use the genuine version) - Microsoft .NET 4.0 or higher...

  • Page 14: Usb Driver Installation

    SECG 4.0 | User Manual If SECG software can’t be executed properly or this is the firsttime using WhaleTeq product, please refer to below two sections to confirm that USB driver and Microsoft .Net Framework 4.0 are all installed. 2.1.3 USB Driver Installation If Windows device manager can’t recognize WhaleTeq product,...

  • Page 15: Microsoft .Net Framework 4.0 Installation

    2.1.4 Microsoft .Net Framework 4.0 Installation WhaleTeq software is developed by Microsoft .Net Framework 4.0. If SEEG software fails to launch properly, please check whether Microsoft .Net Framework 4.0 or higher versions was installed in the operation system.

  • Page 16: Environment, Noise Reduction

    (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 device under test:...

  • Page 17: Firmware Update

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

  • Page 18: Table 3: H/W F/W Version

    Step 2. “About” button is popped up. Press “Update F/W” button. Figure 7: Update F/W Button. Step 3. Go to WhaleTeq website, refer to the below table to download compatible Firmware file. Table 3: H/W F/W Version Hardware Version Firmware Version 4.4 or above...

  • Page 19: Figure 8: Information Dialog

    SECG 4.0 | User Manual Step 4. Back to SECG AP, select the downloaded firmware file. Step 5. The AP will show an information dialog. After pressing “OK”, the operation cannot be cancelled. Figure 8: Information Dialog Step 6. Wait for firmware update complete.

  • Page 20: Main Screen

    SECG 4.0 | User Manual Main Screen Figure 11: Main Screen 01 – Main Function：Select 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.

  • Page 21: Description Of Functional Groups

    SECG 4.0 | User Manual 08 – Pulse Waveforms：Select the pulse waveform type. “Pulse Width” is a related parameter. 09 – Input Impedance Test：Select if 620kΩ/4.7nF is in circuit (for input impedance test). 10 – ECG 2-27：A special waveform related to the ECG waveform (IEC 60601-2-27).
  • Page 22 SECG 4.0 | User Manual Waveform Description Sample waveform type Rectangle A rectangular pulse, pulse according to the amplitude setting, pulse width (ms) and pulse repetition rate (frequency, Hz or BPM) Triangle A triangle pulse, pulse according to the amplitude setting, base...

  • Page 23: Main Parameters

    SECG 4.0 | User Manual 2.6.2 Main Parameters Amplitude: Adjust the waveform amplitude from 0 to 10mV at a 0.01mV resolution. For all waveforms, the amplitude represents the peak-to-peak value. For example, for a 1mV sine wave, the actual waveform varies between +0.5mV and -0.5mV.

  • Page 24: Dc Offset Setting

    SECG 4.0 | User Manual T Wave: Allow setting of the amplitude of the T-Wave in ECG waveforms, to verify tall T-wave rejection ability of patient monitors according to IEC 60601-2-27. The maximum amplitude is 2.5mV. For the heart rate accuracy test in IEC 60601-2-27, a T-wave component is not required.

  • Page 25: Output Lead Electrode

    SECG 4.0 | User Manual 2.6.5 Output Lead Electrode This section allows the user to select which lead electrode the output is connected to (e.g., terminal P1 in the IEC 60601-2-25, Figure 201.106). Unselected electrodes are connected to the system ground (terminal P2 in Figure 201.106).
  • Page 26 SECG 4.0 | User Manual Parameter Description Pacing Duration Can be set between 0.1 and 2.0ms, covering the range required by all standards. Overshoot time Settings from 2ms to 100ms, creates an overshoot constant according to Method A of IEC 60601-2-27 (0.25 of the pacing amplitude or 2mV, whichever is smaller).

  • Page 27: Output Graphic Display

    SECG 4.0 | User Manual 2.6.7 Output graphic display Figure 17: Output Graphic Display The output display provides an image similar to that provided by ECGs. The sensitivity of the display range may be set at 4mm/mV, 10mm/mV, or 20mm/mV to cover the full range of waveforms offered by the system. The time rate is fixed.

  • Page 28: Special Functions

    SECG 4.0 | 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 a particular automated resetting of baseline (due to high pass filtering).

  • Page 29: Other Function (Auto Pacing, Auto Heart Rate, Cal. Mode)

    SECG 4.0 | User Manual ECG: can be used for testing IEC 60601-2-27 heart rate below 30 BPM as indicated in the standard (0~30 BPM over 30s). As a frequency of “0” is infinitely long, the scan starts at 3 BPM.

  • Page 30: Load Ecg File

    SECG 4.0 | User Manual Note that most patient monitors will have problems with the overshoot function. Users should experiment first to find the overshoot that the patient monitor can handle, or test this separately (limit the overshoot time to 0ms only).

  • Page 31: Software Options - Secg Assistant

    Software Options – SECG Assistant SECG Assistant software option is a companion software add-on to enhance the function of SECG 4.0. It supports IEC60601-2-25/27/47, YY 1079/1139/0782/0885, and JJG 760/1042. What’s more, it also supports IEC60601-2-26. SECG Assistant software allows the user to save a lot of testing time.

  • Page 32: Figure 23: Hardware Id

    SECG 4.0 | User Manual Step 1: Copy the Hardware ID / SECG Device ID and send it to service@whaleteq.com to request for an Active Key. Figure 23: Hardware ID Step 2: A unique Active Key will be sent to the user via email.

  • Page 33: 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.

  • Page 34: Terminals P1, P2 And P6

    SECG 4.0 | User Manual -2-25 / -2-27 / -2-47 / Function WhaleTeq SECG Figure106 Figure105 Figure101 Settings impedance test. Shorts out the Automatically DC offset selected if DC circuit offset is set to zero Sets the Automatically polarity of the...
  • Page 35 SECG 4.0 | User Manual However the test then goes on to say: Connect the sine wave signal generator to any tested LEAD (P1 and P2) with all other LEAD WIRES connected to the N (RL) LEAD WIRE (P6) The interpretation here is complicated as a “LEAD” refers to the displayed ECG waveform, not specific electrodes.

  • Page 36: Software Development Kit

    5 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 37: Table 7: Calibration Procedure

    SECG 4.0 | User Manual Figure 25: Software Assisted Calibration Mode The user then enters the results into the form provided, and the software checks if the results are within allowable limits. 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...
  • Page 38 SECG 4.0 | User Manual Nominal Parameter value, Method tolerance Lead 47nF ±5% The 47nF can be measured between RA impedance and RL/N using a calibrated capacitance capacitors meter, at 1kHz. Input 620kΩ±1% This can be measured as follows: • Set Main function to “Off”...
  • Page 39 SECG 4.0 | User Manual Nominal Parameter value, Method tolerance Output Setting ±1% Method: • Set up 0.5mVpp 0.1Hz square wave, voltage output to RA • Measure the peak to peak output between RA and LL, using the Fluke 8845A or equivalent, record this as output mVpp •...

  • Page 40: Self-Calibration

    <5µs Self-Calibration Self-calibration assists the user calibrates SECG 4.0 before testing. 1. Set up the parameters of the SECG 4.0 AP to “Square, 5 mV, 0.1 Hz” and output to the RA lead electrode as the figure shown below:...

  • Page 41: Figure 26: Secg 4.0 Interface

    2. Connect the multimeter (Please use the models which are 6 1/2 (6 1/2 digits) or more) to RA and LA of SECG 4.0, and measure the DC mV. The value should be in 1% of 5 mV because the output amplitude of SECG 4.0 gives alternating 5s (0.1 Hz square wave) phases at -2.5mV and...

  • Page 42: Figure 28: Secg 4.0 ±300 Mv Dc Offset

    RA ”. Figure 29: DC Voltage Verification (300mV) 5. Connect the multimeter to RA and LA of SECG 4.0 and measure the DC voltage. The value should be in 1% of 300 mV. The setup is shown in the below figure.

  • Page 43: Figure 30: Self-Calibration Setup

    7. Use the same way as above to check the DC voltage with the multimeter. The above steps assist the user to make sure SECG 4.0 is outputting correct signals before the test. Reminder: Self-calibration is to facilitate the user to quickly confirm the...

  • Page 44: Trouble Shooting

    Please refer to the contact information and contact Whaleteq for the original calibration service. Note: if Whaleteq detects that the components of the device are damaged and makes it impossible to adjust, it shall be sent back for maintenance.

  • Page 45: Purchasing Information

    SECG 4.0 | User Manual unexpected damages to test equipment. Please contact WhaleTeq for alternatives before ESD test. For operating “Firmware Update” feature, there are risks of losing data if improper options are performed during the Firmware Update period. Warranty void if QC PASS label is removed or tampered with.

  • Page 46: Contact Whaleteq

    SECG 4.0 | User Manual Chap 9 Version information 20210629 20210629 Chap 7 Cautions 20211126 20211203 Chap 5.1 Self-calibration 10 Contact WhaleTeq WHALETEQ Co., LTD service@whaleteq.com | (O)+886 2 2517 6255 8F., No. 125, Songjiang Rd., Zhongshan Dist., Taipei City 104474, Taiwan...

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