WHALETEQ SECG 5.0 AIO User Manual
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WHALETEQ SECG 5.0 AIO User Manual

Single channel ecg test system
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SECG 5.0 AIO | User Manual
WHALETEQ
Single Channel ECG Test System
(SECG 5.0 AIO)
User Manual
Version 2020-12-31
Software Version 1.1.22.9

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Summary of Contents for WHALETEQ SECG 5.0 AIO

  • Page 1 SECG 5.0 AIO | User Manual WHALETEQ Single Channel ECG Test System (SECG 5.0 AIO) User Manual Version 2020-12-31 Software Version 1.1.22.9...

  • Page 2: Table Of Contents

    2.1.2 SECG 5.0 AIO PC Software Installation................10 2.1.3 First Time Using WhaleTeq Product – USB Driver Installation........11 2.1.4 First Time Using WhaleTeq Product – Microsoft .Net Framework 4.0 Installation..11 Connecting to the ECG ..................12 Set up a Low-noise Test Environment..............12 Software Update ....................
  • Page 3 SECG 5.0 AIO | User Manual Relation between IEC figures and WhaleTeq SECG 5.0 AIO ........ 31 Terminals of P1, P2 and P6.................. 32 Software Development Kit (SDK)...............32 Calibration and Validation ................32 Trouble Shooting ..................33 Caution ....................33 Ordering Information................33 Standard accessories................... 33 Optional Software and Accessories..............

  • Page 4: Introduction

    Device Under Test (Figure 1) Single Channel Concept Via a SECG 5.0 AIO, the system produces voltage up to 40 mVpp. The SECG 5.0 AIO contains resistor/capacitor networks, dc offset, pacing circuit and relay switching to provide the full range of single channel performance tests in IEC/YY/JJG standards.

  • Page 5: Standard/Application

    SECG 5.0 AIO | User Manual Standard/Application The following table shows the standards for which SECG 5.0 AIO has been designed for, and includes any limitations: Standard Clause(s) Limitations/Notes IEC 60601-2-25:2011 201.12.4: All performance tests For 201.12.4.101 (large dc (Diagnostic) except：...

  • Page 6: Secg 5.0 Aio Overview Of Ecg Module

    USB Type B receptacle connector: To connect with PC and allow PC software to control SECG 5.0 AIO. Before operating PC software mode, it requires to switch to PC (left side of DIP SWITCH) and an additional description “SIMULATION MODE” will be shown on the title bar of touch screen.

  • Page 7: Main Specifications

    SECG 5.0 AIO | User Manual 4. Reserved output port 5. HDMI output port ： When connecting to the external display device via HDMI interface, please do connect a mouse via USB type A connector for the normal operation. 6. USB Type A receptable connector: To connect with flash disk or mouse 7.

  • Page 8: Product Label

    SECG 5.0 AIO | User Manual Environment 15 ~ 30°C (by design) 5〜40℃ 30 ~ 80% RH (by design) 50〜80％RH altitude < 2000M Overvoltage CAT II Size(L x W x H) 27X16X22 CM Weight 3.5 KG Power Supplier Input: 100-240Vac 1.5A 50~60Hz Output : 12V，3.33A...

  • Page 9: Pollution Degree

    SECG 5.0 AIO | User Manual Pollution Degree Pollution measurement for the surrounding environment and inside the product. Generally, the internal environment of a product is considered the same as its external environment. This product is only suitable for the evaluated environment.

  • Page 10: Set Up

    2 Set Up Software Installation 2.1.1 System Requirements The single channel ECG system SECG 5.0 AIO can be operated via the touch screen or PC software via USB connection PC Requirements： Windows PC (Windows 7 or later, suggest to use the genuine version) Microsoft .NET 4.0 or higher...

  • Page 11: First Time Using Whaleteq Product - Usb Driver Installation

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

  • Page 12: Connecting To The Ecg

    (a) using a metal bench or metal sheet underneath the ECG device under test and the WhaleTeq SECG test unit, and (b) connecting SECG 5.0 AIO GND terminal to the sheet and also the frame ground (or EP terminal) of the ECG device under test:...

  • Page 13: Main Screen

    Below is the instruction for updating to the latest software: Download the latest software from WhaleTeq website. Extract the zip file to a USB flash disk and make sure this APK file is in the root directory. Once you plug this USB flash disk into SECG 5.0 AIO, a notification window shall prompt to update to the latest software.

  • Page 14: Description Of Functional Groups

    SECG 5.0 AIO | User Manual Select waveform signal types and parameters Select add-on signals (DC offset, pacing, noise….) Select the output lead electrode Detailed parameters of output waveform The real time display of output waveform Function tap (Waveform, Special Function and Assistant)
  • Page 15 SECG 5.0 AIO | User Manual ECG Waveform Parameters P Amplitude: 0~2mV; P Duration: 50~100ms; PR Interval: 10~200ms QRS Duration: QRS duration range of ECG waveform is 10~200ms, matching the requirements of the standard. ST Deviation：-1~1mV; QT Interval： current QRS value~900ms T Duration：Allows setting of the amplitude of the T-Wave in ECG waveforms, to verify tall...
  • Page 16 SECG 5.0 AIO | User Manual Waveform Description Waveform Example Parameters are Sine amplitude (mVpp) and frequency (Hz or BPM) Parameters are Triangle amplitude (mVpp) and frequency (Hz or BPM) Parameters are Square amplitude (mVpp) and frequency (Hz or BPM)

  • Page 17: Signal Add-On

    SECG 5.0 AIO | User Manual 2.6.2 Signal add-on DC Offset This function allows the operator to switch in a dc offset. The maximum voltage is 1000mV. In the condition of setting DC offset to 300mV, the DC offset is sourced from an internal “super capacitor”...
  • Page 18 SECG 5.0 AIO | User Manual In general, a pacemaker pulse can be added to any main function (sine/triangle/ECG etc.). Please refer to Table 2 for the pacing parameters. Pacing Amplitude This can be set in steps of 2 ranging from -700 to +700mV When set to zero the pacing function is turned off regardless of other pacemaker settings.
  • Page 19 SECG 5.0 AIO | User Manual ECG Special Add-on Parameters AAMI EC 13 Drift Test: (ECG 2-27 waveform only): when checked adds 4mVpp 0.1Hz triangle waveform to the ECG signal (for testing baseline drift). Respiration: Provide resistant method and wave modulation method to simulate the change during human breathing.

  • Page 20: Output Lead Electrode

    SECG 5.0 AIO | User Manual 2.6.3 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 21: Play/Stop Button

    SECG 5.0 AIO | User Manual 2.6.6 Play/Stop Button After adjusting waveform settings, user shall press the PLAY button to output the testing signal. If user want to change the waveform settings, it requires to press the STOP button first and then adjust the waveform settings.
  • Page 22 PC system. If PC system has available memory for 1Gb, the maximum number of single channel sample data would be 131,072. ⚫ Number of Signals: As SECG 5.0 AIO is a single-channel simulator, the number is 1 as a fixed value. ⚫...

  • Page 23: Nst Noise

    SECG 5.0 AIO | User Manual …… Binary files (*.bin) - Bytes 1-2 are sample rate (Hz) - Bytes 3-6 are number of samples - Following bytes are samples, 2 bytes per sample - all data is bigendian (high byte first), 2's compliment The maximum size of loaded file is 100 million samples.

  • Page 24: Auto

    SECG 5.0 AIO | User Manual 2.7.4 Auto Within this function user can select 3 different kinds of auto testing: Auto Pacing Preset all the required combination for pacing test. For IEC60601-2-27 test, please turn on the option of IEC 60601-2-27 ECG Waveform in Signal Parameter (refer to section 2.6.1). The auto pacing test shall be conducted with patient monitor with trend mode.
  • Page 25 SECG 5.0 AIO | User Manual Frequency Scan: ECG Scan This can be used for IEC 60601-2-27 test for heart rate lower than 30 BPM (Elapsed time of 0〜30BPM is over 30 seconds） As 0 refer to infinite frequency, the scan shall start at 3 BPM.

  • Page 26: Lead Off

    SECG 5.0 AIO | User Manual 2.7.5 Lead OFF This is to open the selected output electrode so that ECG device can check the electrodes automatically. 2.7.6 Auto Sequence This function is to load up to 1,000 script files for playback. The testing time for each script file can be set and the sequences can be saved to file.

  • Page 27: Language Selection

    SECG 5.0 AIO | User Manual Language Selection SECG 5.0 AIO has 3 different languages for selection. Press the button and select the required language. Standard Assistant SECG 5.0 AIO is equipped the new medical standard assistant software supporting IEC 60601- 2-25/27/47and YY1079/0782/0885.

  • Page 28: Active Secg Standard Assistant

    Step 2. An email will be sent to your mailbox. Please save the attachment file to the root directory of a USB drive. Then plug the USB drive to SECG 5.0 AIO. An update window shall be displayed. Press OK to active the software.
  • Page 29 SECG 5.0 AIO | User Manual 2． Preset the function parameters of ECG DUT 3． Select test clause 4． Click the test column Page 29 of 34...
  • Page 30 7． Export Test Values After completed all the required test, the test values can be saved and exported to a file. User can use WhaleTeq TRF generator software to import the test values and generate IEC format test report accordingly.

  • Page 31: 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 32: Terminals Of P1, P2 And P6

    LEAD wire in turn (first RA, then LA, LL, V1 etc) with all unused LEAD wires connected to P2. 4 Software Development Kit (SDK) WhaleTeq provides Windows SDK (Software Development Kit) for SECG 5.0 AIO test system. All test parameters correspond to specific SDK commands and DLL (Dynamic-link library) shared library can be used for efficient program binding and version upgrade.

  • Page 33: Trouble Shooting

    SECG 5.0 AIO | User Manual If you need more in-depth calibration methods, please link to WhaleTeq's official website to download the calibration file. 6 Trouble Shooting Problem Resolution The software screen appears Please make sure that the switch on the back of SIMULATION MODE SECG 5.0 AIO is switched to AIO mode.

  • Page 34: Optional Software And Accessories

    SECG 5.0 AIO | User Manual Optional Software and Accessories ✓ SECG Assistant Software: SECG5 Assistant-E25 ✓ SECG Assistant Software: SECG5 Assistant-E27 ✓ SECG Assistant Software: SECG5 Assistant-E47 ✓ SECG Assistant Software: SECG5 Assistant-YY1079 ✓ SECG Assistant Software: SECG5 Assistant-YY1139 ✓...

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