Parallel testing ecg tester for wearable device production lines (11 pages)
Summary of Contents for WHALETEQ MECG 2.0
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MECG 2.0 Test System | User Manual WHALETEQ Multichannel ECG Test System (MECG 2.0) User Manual Revision 2022-05-22 PC Software Version 2.0.10.6...
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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.
MECG 2.0 Software ......................9 3.1.3 First Time Using WhaleTeq Product - USB Driver Installation .......... 9 First Time using WhaleTeq Product – Microsoft .Net Framework 4.0 Installation ... 10 3.1.4 3.2 Set up ....................... 10 3.3 Environment, Noise reduction ..............11 3.4 Live Update Application/ Firmware ............
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MECG 2.0 Test System | User Manual 11 Version Information ................30 12 Contact WhaleTeq ................30...
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MECG 2.0 Test System | User Manual List of Table Table 1: Specifications ................. 7 Table 2: CTS/CSE Database ..............21 Table 3: Load ECG Source from File ............22 Table 4: Supported Command Scripts ............26 Table 5: Demo for Command Script ............27 Table 6: Trouble Shooting .................
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MECG 2.0 Test System | User Manual List of Figure Figure 1: System Description ..............6 Figure 2: Set up a noise-free test environment ......... 11 Figure 3: Update Application/ Firmware ............ 12 Figure 4: Firmware Update Window ............12 Figure 5: ‘’About’’...
MECG 2.0 Test System | User Manual Introduction The WhaleTeq Multichannel ECG Test System provides a full 12 lead waveforms for testing diagnostic, ambulatory or monitoring ECG, for testing to IEC particular standards. Version 1.0 was designed according to the circuit in IEC 60601-2-51, modified by using precision, low offset op-amps (<0.5µV) and 0.1% resistors in the...
MECG 2.0 Test System | User Manual 1.1 System Description The system consists of the host PC (PC), the “Multichannel ECG Test Unit” (Test Unit) and the ECG device under test (DUT). 3-10 lead electrodes Multichannel ECG device USB 2.0...
Equipment with serial numbers earlier than 2012- 008 will continue to operate with the software as before. As MECG 2.0 is equipped with a 12-bit DAC, it is must to use the DAC compensation file. For users purchasing MECG 2.0 in 2020 (serial number as ME2001-XXXXXX), if the testing requires, please refer to 3.5.2 ‘’How to...
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MECG 2.0 Test System | User Manual 500μV and ±5μV for An inferred specification of 1% ±5µV is values under 500μV. For MECG derived from the device under test specification in IEC 60601-2-51 of 5% 2.0 (2020), ±1% for ±25µV.
․ When the installation process is completed, click the MECG 2.0 icon on the desktop to execute or select MECG 2.0 software in the start menu 3.1.3 First Time Using WhaleTeq Product - USB Driver Installation If Windows device manager can’t recognize WhaleTeq product, please follow the below instructions to Install Microchip®...
3.1.4 Installation WhaleTeq software is developed by Microsoft .Net Framework 4.0. If MECG 2.0 PC software fails to execute properly, please check whether Microsoft .Net Framework 4.0 or higher versions was installed in the operation system. If your PC hasn’t installed Microsoft .Net Framework 4.0 or higher versions, please download from Microsoft website.
A noise free environment is necessary for testing ECG equipment. This can be achieved relatively easily by using a metal bench or metal sheet underneath the ECG device under test, the WhaleTeq MECG test unit, and also connecting together the ground as shown:...
How to check whether your MECG 2.0 supports firmware update or not? Answer: Connect the MECG 2.0 to a PC and go to the ‘’About’’ dialog to check if ‘’F/W Version’’ and ‘’H/W Version’’ show. Please see ‘’3.5.1 How to Update Firmware’’...
MECG 2.0 Test System | User Manual Caution: There are risks of losing data if improper options are performed during the Firmware Update period. 3.5.1 How to Update Firmware If the device supports “Firmware Update” feature, here are the steps to update the device firmware: Step 1.
MECG 2.0 Test System | User Manual Figure 7: ‘’Confirm update’’ Window Step 4. Wait for Firmware Update completed. Figure 8: Firmware Updating Step 5. Please restart the system to complete firmware update process. Figure 9: Firmware Update Completed 3.5.2 How to Update DAC Compensation File The DAC compensation data is stored in a file which is sent in the shipping notice email.
10µV, so that DAC compensation is irrelevant. DAC compensation data will be kept by WhaleTeq, so that any time if the data is lost (e.g.: transferring to a new PC), a copy can be requested.
±1%. Since no minimum limit is stated (and it is impossible to apply ±1% for very small voltages), WhaleTeq has applied a rule of 20% of the EUT limit. This is effectively ±5µV for up to 500µV, ±8µV from 500 to 800µV and ±1% for values above 800µV.
2. Connect a multimeter to the RA and LA jacks of the MECG 2.0 to measure the DC mV. It should be in ±1% of 5 mV as the figure below. The MECG 2.0 output amplitude gives alternating 5s (0.1 Hz square wave) phases at -2.5mV and +2.5mV, so set the multimeter to zero (delta function) at one phase (e.g.:...
4. Repeat step 3 to connect the multimeter to the RA and V2, and then the V3 to V6 of the MECG 2.0 to measure the DC mV. All the V2 to V6 should be in ±1% of 8.33 mV.
MECG 2.0 Test System | User Manual ⚫ Frequency/Time Confirmation Accuracy requirement specification Time accuracy is not specified in IEC 60601-2-25:2011. Based on the requirements for the device under test, a time accuracy of ±1ms over a 100ms period (equivalent to ±1%) should be sufficient.
MECG 2.0 Test System | User Manual Software Operation 7.1 Main screen Figure 13: Main screen 01- CTS/CSE Database: Load a built-in waveform from the CTS or CSE 02- Get Source from file: Load an ECG waveform from Physionet or local...
MECG 2.0 Test System | User Manual 7.2 CTS/CSE Database Press the “CTS/CSE Database” button, a new screen will open allowing the user to select from the 19 CTS and 100 CTE database waveforms, as explained below: Table 2: CTS/CSE Database After selecting the desired waveform, press the “Load Waveform”...
MECG 2.0 Test System | User Manual 7.3 Load ECG Source from File This function is set up to work with popular waveforms from the PhysioNet website and other databases. As the software can work directly with the website, the user does not need any knowledge about the PhysioNet site, file formats and the like.
“V6”, or the data file cannot be correctly loaded. 7.3.2 EDF Format The MECG 2.0 software supports loading and playing EDF file format. To enable this function, you must purchase an additional authorization code. After this function is enabled, click ‘’EDF’’ to load and play the EDF file, and the PhysioNet Non-Invasive Fetal ECG Database (nifecgdb) can be downloaded and played directly in the MECG 2.0 software.
MECG 2.0 Test System | User Manual Connect the MECG 2.0 to a PC and click ‘’EDF’’, then the ‘’License Activation’’ pop-up window shows. Figure 16: ‘’License Activation’’ Window To purchase this authorization code, please contact WhaleTeq and provide your MECG ID.
MECG 2.0 Test System | User Manual Waveforms can be started or stopped at anytime. ․ The output can be started from a mid- point in the file with “Play (Graph)” button, but adjusting the starting point “Graph Start (s)” of the graphs prior to pressing play.
MECG 2.0 Test System | User Manual Note : The frequency range is 0.1~100 Hz, the frequency resolution is 0.1Hz/step. 7.6 Command Replay To increase test efficiency, MECG provides “Command Replay” feature. Edit your test sequences with command script, and automatically output the setting waveforms.
MECG 2.0 Test System | User Manual LoadWhaleteq Waveform Load the WhaleTeq _TXT Waveform file (*.txt) format waveform D:\WhaleteqM LoadWhaleteq_TXT file path path on your (*.txt) file on local ECG\MECG_227 local PC ECG_.txt Start outputting the loaded ECG signal StartPlay...
MECG 2.0 Test System | User Manual Figure 19: View ECG waveforms Trouble Shooting Table 6: Trouble Shooting Problem Resolution USB module (test unit) Recognition of USB devices needs to be done in not recognized (USB order: driver is installed...
➢ WhaleTeq does not recommend to connect test equipment with DUT to conduct Electrostatic Discharge (ESD) test. This may cause unexpected damages to test equipment.
MECG 2.0 Test System | User Manual ➢ Warranty void if QC PASS label is removed or tampered with. ➢ The professional testing instrument, not a medical device, is for testing only, and will not involve human or clinical use.
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