WHALETEQ MECG 2.0 Multichannel ECG Test System User Manual

WhaleTeq Co. LTD
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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.

This document could contain technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be incorporated in future revisions of this document. WhaleTeq Co. LTD. is under no obligation to notify any person of the changes.

The following trademarks are used in this document:

is a registered trademark of WhaleTeq Co. LTD

All other trademarks or trade names are property of their respective holders.

1. Introduction

The WhaleTeq Multichannel ECG Test System (MECG 2.0) 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 output divider circuits and networks to provide greater accuracy. For Version 2.0, released in November 2012, the IEC 60601-2-51 circuit was further modified with DAC compensation 1 and electronic Wilson Terminal offset2 to further improve the accuracy of the system in the very low voltage area, for example, to ensure an accurate ST segment in V1 ~ V6 around 200µV. Both versions are identical from the user interface.

The standard range is ±5mV to cover the waveforms in IEC 60601-2-25:2011. Systems with wider ranges can be provided on request.
The system makes use of continuous streaming of digital data over a USB connection, with test unit providing a stable real-time output with crystal oscillator accuracy and internal checks to ensure that no data is lost.

All waveforms are looped to the beginning when the end of the file is reached.

The system has embedded3 the CAL, ANE and biological ECG waveforms from the CTS database referred to in IEC 60601-2-25:2011 (formerly IEC 60601-2-51).

A custom design module has been developed to work with a large number of waveforms from PhysioNet website (Format 16 and Format 212), including directly linking with the website and downloading the necessary files.

It is expected that users will have specific applications and waveforms for testing the equipment. Contact WhaleTeq (service@whaleteq.com) for a custom designed PC software to interface between the waveforms required and the USB module.

1.1 System Description

The system consists of the host PC (PC), the “Multichannel ECG Test Unit” (MECG 2.0) and the ECG device under test (DUT).

The MECG 2.0 software currently allows the user to select the waveform from one of three sources:
CTS database (as per IEC 60601-2-25:2011)
This includes the ANE, CAL and biological waveforms as detailed in the standard. Once selected there is no need to adjust anything.
Fixed waveforms (sine, triangle, square, pulse)
This allows the adjustment of amplitude and frequency by the user according to settings on the screen. These waveforms are intended for reference only, but could be used for some “single channel” performance tests.

Biological waveforms from the “PhysioNet” website

This allows the loading of files based on Format 16 or 212 format (other formats may be considered on request).
Once the waveform is selected and the user presses the “Play” button, the waveforms are streamed to the test unit. The test unit converts these to 8 analog channels of data4 at signal levels 500 times higher than the final output (e.g. for 1mVpp output, the intermediate output is 500mVpp). These 8 signals are then placed through a precision dividers and network as described in Annex II of IEC 60601-2-51, to produce the low-level signals necessary for 10 lead electrodes (12 lead ECG).

1.2 Application Revision Update

Associated with software release 1.6.0.0, the following features were included:
– The reverse Wilson Terminal offset is now implemented in software rather than hardware, to reduce errors associated with the hardware circuit
– DAC compensation is applied for equipment with serial Nos 2012-008 and higher
– The 1.25mv range is disabled (2.5mV with DAC compensation now achieves the required accuracy).

The software detects which serial number is attached and applies for the appropriate compensation. 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 Update DAC Compensation File’’ to update the DAC compensation file.

2. Hardware Specifications

3. Start to Use MECG 2.0

3.1 Software Installation

3.1.1 System Requirements

Users need a PC to control the multichannel ECG system (MECG 2.0) through its USB port. The PC should meet the following requirements6:
– Windows PC (XP or later, suggest to use the genuine version)
– Microsoft .NET 4.0 or higher
– Administrator access (essential for installing software/driver)
– 512MB RAM or higher
– USB port

3.1.2 MECG 2.0 Software

The MECG 2.0 software can be downloaded from WhaleTeq’s official website.
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Download the MECG 2.0 software from WhaleTeq’s official website.
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Unzip the file and double click the installation file
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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® USB driver.

Microsoft Windows 8 and Windows 8.1

Windows 8 and Windows 8.1 can’t recognize MECG 2.0, please download “mchpcdc.inf” from WhaleTeq website. This driver is provided by Microchip® for using with PIC microprocessors having built-in USB function.
As mchpcdc.inf provided by Microchip® does not contain digital signature, please disable driver signature enforcement in Windows 8 and Windows 8.1.
When the USB module is connected for the first time, select manual installation, and point to the folder containing the above file. Then continue to follow the instructions to finish the installation. There may be a warning that the driver is not recognized by Windows®, and this can be ignored.

Microsoft Windows 7

Windows 7 can’t recognize MECG 2.0, 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. Then continue to follow the instructions to finish the installation. There may be a warning that the driver is not recognized by Windows®, and this can be ignored.

3.1.4 First Time using WhaleTeq Product – Microsoft .Net Framework 4.0 Installation

The MECG 2.0 software is developed by Microsoft .Net Framework 4.0. If the MECG 2.0 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.

3.2 Set up

Connect the USB module (test unit) to any USB socket of the PC.

Note: if the socket is changed, it may take the PC a short amount of time to recognize and connect to the system.

Run the MECG 2.0 software. If the USB module is not recognized, a message will be displayed. In this case, repeat the process, ensuring sufficient time for the PC to recognize the USB module prior to starting the MECG 2.0 software.

For connecting the ECG device under to the USB module, use the “ECG breakout box” provided. Alternately the ECG device under test can be directly connected to the USB module using a male D15 connector. The pinouts are:

Note:

For systems after September 2011, V1 ~ V6 are reversed as shown in the brackets.

3.3 Environment, Noise reduction

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 MECG 2.0, and also connecting together the ground as shown:

With this setup, 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.

3.4 Live Update Application/ Firmware

The MECG 2.0 will auto-check if your application/firmware is the latest version. If a new version application/firmware is found, you will be prompted to update to the version.

3.5 Manually Update Firmware/DAC Compensation File

Firmware Update can only be supported with specific hardware and firmware. If your device doesn’t support this function, please contact WhaleTeq service@whaleteq.com for more information.

Question:

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’’ step 1 to learn where the ‘’About’’ dialog is.

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.
Click on the icon in the windows title bar to show the system menu, and click the system menu -> “About…” to show the About dialog.

Step 2.
Click the “Update F/W” button and select the firmware image file

Step 3.
The application will show an information dialog. After pressing “OK”, the updating operation cannot be terminated.

Step 4.
Wait for Firmware Update completed.

Step 5.
Please restart the system to complete firmware update process.

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. This avoids the need to re-publish the MECG 2.0 software with each serial number.
The file is named “MECG_DACyynnnnn.txt” with yy as the year and nnnn as the sequential serial number, as shown on the label at the button of the MECG 2.0. The file is approximately 220kB (compensation data for 8 channels with 4096 codes for each).
For users with serial numbers dated before WME2101-XXXXXX (the MECG 2.0 purchased before 2021), if the testing requires, please update the DAC compensation file.

To update the file, please follow the steps below:

1. Copy the file to the “C:\Whaleteq\” folder.
2. When the MECG 2.0 software is running, it reads the serial number of the connected MECG 2.0, and looks for the corresponding DAC compensation file.

If the file is found, the following text will appear in the title:
“WHALETEQ Multichannel ECG Simulator V2.0.2.3 (with DAC Compensation)”

If the file is not detected, the software will keep running, but the text will be:

“WHALETEQ Multichannel ECG Simulator V2.0.2.3 (Without DAC Compensation)”
DAC compensation is most likely to be of interest only for testing against the CTS database in IEC 60601-25:2011, and its applicability also depends on the measurements made by the ECG under test. DAC compensation is typically less than 10μV for any individual point. This could affect, for example, the accuracy of measurements made in the ST segment.

For users applying tests with waveforms based on real biological recordings, the recording itself contains noise well in excess of 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.

4. Software Development Kit (SDK)

WhaleTeq provides Windows SDK (Software Development Kit) for MECG 2.0. 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. Support C/C++ header, C# interface, third party tools and script language integration such as Python.

5. Calibration and Validation
As per ISO/IEC 17025, the system should be calibrated either before use or on a periodic basis. For the system critical aspects are voltage and time accuracy.
Whaleteq original calibration service is equipped with calibration equipment specially designed for physiological simulator to ensure the accuracy of calibration, and can calibrate the offset value of the device within the original specification of Whaleteq. Under normal use, the device is recommended to be calibrated once a year. 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.

5.1 Self-Calibration

Self-calibration assists the user calibrates MECG 2.0 before testing.

Output Voltage Confirmation

Accuracy requirement specification

IEC 60601-2-25:2011, Clause 201.5.4 cc) requires that voltages applied are accurate within ±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. All values are taken with respect to the baseline.

Overview/ Explanation

Download the MECG 2.0 software from WhaleTeq’s official website which produces a slow 0.1Hz square wave with an amplitude as set on the display. For example, with 0.2mV setting, the output will slowly cycle between 0.000mV and 0.200mV, changing every 5s.

User shall confirm that the value is the same as set on the screen using a precision multimeter of accuracy equivalent to the Fluke 8845A7. To eliminate the effect of small dc offsets (which are not relevant to ECG equipment), the meter should be zeroed during the time in which a nominal 0.000mV is output (time in which the value is close to 0.000mV).
Each of the 8 outputs must be tested individually (LA, LL, V1 ~ V6), using RL as the reference. For V1~V6, the output will be 5/3 (1.6666…) higher than the setting, due to Wilson Terminal offset. For example, a setting of 5mVpp will result in an output of 8.333mV.

During shipping, the full values of 0.5, 1, 2, 3 and 5mV with both negative and positive values a checked (a total of 5 x 2 x 8 = 80 points). For regular calibration, the user may limit the check to +2mV and +5mV (total 2 x 8 = 16 points), as the intermediate values are unlikely to change, and the values at 2, 5mV are within 0.1% of the shipping test.

Equipment required

Precision 6 ½ digit multimeter (DMM), such as a Fluke 8845A, 100mV range (or lower if provided).

Method

1. Through MECG 2.0 software, set “Square, 0.1Hz, 5 mV” and click “Load”, then click “Play” as the figure below:

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.: -2.5mV), with reading taken from the other phase (e.g.: +2.5mV) to obtain the 5mV peak-peak value.

3. Connect the multimeter to the RA and V1 jacks of the MECG 2.0 to measure the DC mV. It should be in ±1% of 8.33 mV [V1 = V1 + (RA+LA+LL)/3 = 5 + (0+5+5)/3 = 8.33 mV] as the figure below. Then set the multimeter to zero (delta function) at one phase (e.g.: -4.17mV), with reading taken from the other phase (e.g.: +4.16mV) to obtain the 8.33mV peak-peak value.

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.

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.
General description of method

Connect a meter to terminals V1 and RL, using a meter which can detect frequency from signals around 10mVrms.
To verify the frequency, the sine or square function can be utilized. The selected frequency should be higher to allow accurate measurement. A frequency of 40Hz is suitable for this purpose. The digital nature of the system is that only one point needs to be confirmed.

Equipment required

Any suitable meter that can measure frequency with an uncertainty of ±0.2% at 40Hz.

Method

1.Select “Sine” from the “Other functions” section
2.Set the amplitude 10mVpp
3.Set the frequency to 40Hz
4.Press the “Load” button
5.Press the “Start” button
6.Connect the frequency meter to LEAD I monitor (if provided) or V1
7.Measure the frequency and confirm it is within ±1% of the setting

6. Standalone Behavior

To support subclause 202.6.2.1.10 and 202.6.2.6 in IEC 60601-2-25. The
MECG 2.0 (with firmware version 2.3 or above) is kept outputting the
CAL20110 signal after power-on, and stopped outputting the signal after
connecting to MECG 2.0 software.

7. Software Operation

7.1 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 PC
03- Display Parameters: Set the parameters about screen display

04 – Output Waveform: Start and stop the waveform output
05 – Other Waveforms: Select other waveforms such as Sine, triangle (press “Load” to load them into memory and screen)
06 – Command Replay: Use “Command” to auto display waveform
07 – Graph View: Graphs of the output waveforms (for reference only)

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:

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 MECG 2.0 software can work directly with the website, the user does not need any knowledge about the PhysioNet site, file formats and the like. However, note that there are many formats and options available. The current MECG 2.0 works with Format 16 and Format 212 with common options.

7.3.1 WhaleTeq Format

The WhaleTeq text format is defined as follows:

WhaleTeq format supports sample rate from 100Hz ~ 1000Hz.
Do not change the keywords, including “start”, “Lead I”, “Lead II”, and “V1” to “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.

Connect the MECG 2.0 to a PC and click ‘’EDF’’, then the ‘’License Activation’’ pop-up window shows.

To purchase this authorization code, please contact WhaleTeq and provide the ID of your MECG 2.0.

7.4 Display Parameters / Output Waveforms

The output and display can be controlled as follows:

7.5 Other Waveforms

Basic waveforms are selectable as below:

7.6 Command Replay

To increase test efficiency, the MECG 2.0 provides “Command Replay” feature. Edit your test sequences with command script, and automatically output the setting waveforms.
The command script could be automatically generated while the user operates the MECG 2.0. This means the user could operate the test procedure for the one time, then edit, save and replay the script.
Supported Command Scripts:

Below is a demo for command script:

7.7 Graph View

By default, the 12-lead ECG waveforms are all displayed in the main window. To get more details of the waveforms, you can double-click one of the waveform graphs to show the ECG Signal dialog.

8. Troubleshooting

8.1 Long-term tests (continuous) streaming

While modern PCs give the appearance of real time, the core structure does not guarantee interruption free streaming of serial data to a peripheral. Previous versions of the MECG 2.0 have incorporated a feature to detect interruptions, stop streaming and inform the user.

Since August 2011, this feature has been modified so that the system simply records the time and duration of the streaming interruption. In many cases, the interruptions are rare and short (<20ms), and unlikely to influence the outcome of a test. When a streaming error occurs, “PC delay(s) detected” message is shown on the bottom left corner, and button “Show PC Delays” appears to allow the user to view the delays.

9. Caution

➢ Before using products, use a grounded wrist strap or touch a grounded safely object or a metal object, such as the power supply case, to avoid damaging them due to static electricity.
➢ 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.
➢ 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.
➢ The professional testing instrument, not a medical device, is for testing only, and will not involve human or clinical use.

10. Ordering Information

10.1 Standard Package

12. Contact WhaleTeq

WHALETEQ Co., LTD service@whaleteq.com |

(O)+886 2 2517 6255

8F., No. 125, Songjiang Rd., Zhongshan Dist.,

Taipei City 104474, Taiwan

Specifications

Product Name: MECG 2.0
Brand: WhaleTeq
Type: Multichannel ECG Test System
PC Software Version: 2.0.12.1 (Version 2024-10-15)
Trademark: MECG 2.0 is a registered trademark of WhaleTeq Co. LTD

Product Usage Instructions

1. Software Installation

Follow the provided instructions to install the software on your computer.

2. Set Up

Connect the MECG 2.0 hardware to your computer following the setup guide.

3. Environment and Noise Reduction

Ensure the environment is suitable for accurate readings and reduce noise interference.

4. Live Update Application/Firmware

Update the application and firmware as per the provided guidelines.

5. Manually Update Firmware/DAC Compensation File

Refer to the manual for detailed steps on updating firmware and DAC compensation file.

6. Software Development Kit (SDK)

Explore the SDK for advanced development options.

7. Calibration and Validation

Perform self-calibration as instructed to ensure accurate readings.

8. Standalone Behavior

Understand how the MECG 2.0 operates in standalone mode.

Frequently Asked Questions

Q: How do I troubleshoot the MECG 2.0?

A: Refer to the troubleshooting section in the user manual for detailed steps to address common issues.

Documents / Resources

WHALETEQ MECG 2.0 Multichannel ECG Test System [pdf] User Manual
MECG 2.0 Multichannel ECG Test System, MECG 2.0, Multichannel ECG Test System, ECG Test System, Test System, System

References

User Manual

WHALETEQ MECG 2.0 Multichannel ECG Test System

USER MANUAL