WHALETEQ MECG 2.0 User manual

MECG 2.0 Test System | User Manual
0
WHALETEQ
Multichannel ECG Test System
(MECG 2.0)
User Manual
Revision 2022-05-22
PC Software Version 2.0.10.6

MECG 2.0 Test System | User Manual
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Copyright (c) 2013-2022, All Rights Reserved.
WhaleTeq Co. LTD
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system,
or translated into any language or computer language, in any form, or by any means, electronic,
mechanical, magnetic, optical, chemical, manual or otherwise, without the prior written permission
of 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.
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.

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Contents
1Introduction.........................................................................................5
1.1 System Description ....................................................................................6
1.2 Application Revision Update......................................................................7
2Hardware Specifications ....................................................................7
3Start to Use MECG 2.0........................................................................9
3.1 Software Installation...................................................................................9
3.1.1 System Requirements .....................................................................................................9
3.1.2 MECG 2.0 Software.........................................................................................................9
3.1.3 First Time Using WhaleTeq Product - USB Driver Installation..........................................9
3.1.4 First Time using WhaleTeq Product –Microsoft .Net Framework 4.0 Installation...........10
3.2 Set up.......................................................................................................10
3.3 Environment, Noise reduction..................................................................11
3.4 Live Update Application/ Firmware ..........................................................11
3.5 Manually Update Firmware/DAC Compensation File ..............................12
3.5.1 How to Update Firmware...............................................................................................13
3.5.2 How to Update DAC Compensation File........................................................................14
4Software Development Kit（SDK）.................................................15
5Calibration and Validation................................................................15
5.1 Self-Calibration.........................................................................................16
6Standalone Behavior ........................................................................19
7Software Operation...........................................................................20
7.1 Main screen..............................................................................................20
7.2 CTS/CSE Database .................................................................................21
7.3 Load ECG Source from File.....................................................................22
7.3.1 WhaleTeq Format..........................................................................................................23
7.3.2 EDF Format...................................................................................................................23
7.4 Display Parameters / Output Waveforms.................................................24
7.5 Other Waveforms.....................................................................................25
7.6 Command Replay ....................................................................................26
7.7 Graph View...............................................................................................27
8Trouble Shooting..............................................................................28
8.1 Long-term tests (continuous) streaming ..................................................29
9Caution ..............................................................................................29
10 Ordering Information........................................................................30
10.1 Standard accessories...............................................................................30
10.2 Optional Software and Accessories.........................................................30

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11 Version Information..........................................................................30
12 Contact WhaleTeq.............................................................................30

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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 .........................................................................28
Table 7: Version Information .....................................................................30

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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’’ Button ...........................................................................13
Figure 6: “Update F/W” Window ................................................................13
Figure 7: ‘’Confirm update’’ Window..........................................................14
Figure 8: Firmware Updating.....................................................................14
Figure 9: Firmware Update Completed .....................................................14
Figure 10: Self-calibration settings ............................................................17
Figure 11: Connection to a multimeter ......................................................18
Figure 12: Measure the DC mV.................................................................18
Figure 13: Main screen..............................................................................20
Figure 14: WhaleTeq Format.....................................................................23
Figure 15: ‘’ECG File Load’’ Window.........................................................23
Figure 16: ‘’License Activation’’ Window ...................................................24
Figure 17: Display Parameters / Output Waveforms.................................24
Figure 18: Other Waveforms .....................................................................25
Figure 19: View ECG waveforms ..............................................................28

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1 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
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 offset
2
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 embedded
3
theCAL,ANE andbiologicalECGwaveformsfrom
the CTS database referred to in IEC60601-2-25:2011 (formerly IEC 60601-2-
51).
A custom design module has been developed to work with a large number of
waveforms from Physio net 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 ([e-mail]) for a
custom designed PC software to interface between the waveforms required
and the USB module.
1
Applied to the ±2.5mV range, to cover all CAL, ANE waveforms except CAL30000 and CAL50000.
2
In the recommended circuit of IEC 60601-2-51, the Wilson Terminal offset is provided in hardware. This
configuration was found to add errors in V1 to V6 of up to 20µV.
3
The term “embedded” here means the raw digital data is embedded in the software and cannot be
accessed directly. Raw digital data cannot be released due as it is propriety data.

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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).
Figure 1: System Description
The PC 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, 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 “Physio net” 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 data
4
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).
4
In a normal “12 lead” ECG, four of the waveforms (Lead III, aVR, aVL and aVF) can all be derived from
the other leads (Lead I, Lead II, V1 ~ V6). Therefore the so called “12 lead ECG” can be produced from
8 channels. See also IEC 60601-2-51 Annex II circuit.
ECG device
under test
(DUT)
USB 2.0
3-10 lead
electrodes
Multichannel
Test Unit
(Test Unit)
Host PC
(PC)

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1.2 Application Revision Update
Associated with software release 1.6.0.0, the following features were
included:
-The reverse WilsonTerminal offset is nowimplemented in softwarerather
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
Table 1: Specifications
Item
Details / Reference
Value
Output
channels
The 8 output channels are provided
through a network as specified in IEC
60601-2-51 to provide signals to 10
lead electrodes; in the device under
test, this will be displayed as 12 leads.
8 outputs
10 lead electrodes
12 leads
Voltage
accuracy5
IEC 60601-2-51 specifies a limit of
±1%, but does not provide a lower limit
(all systems must have a lower limit).
For MECG 2.0,
±1% for values
greater or equal to
5
The accuracy specification is for a single point. Since the tests in IEC 60601-2-25:2011 are effectively
for 2 points, the applied error can be theoretically twice the declared values. However, the probability of
this is very small, and most cases 2 points will be within the required above specification.

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An inferred specification of 1% ±5µV is
derived from the device under test
specification in IEC 60601-2-51 of 5%
±25µV.
500μV and ±5μV for
values under
500μV. For MECG
2.0 (2020), ±1% for
values greater or
equal to 100μV and
±5μV for values
under 100μV.
Output voltage
resolution
MECG 2.0 uses 12-bit DAC and
MECG 2.0 (2020) uses 16-bit DAC.
2.4µV for MECG
2.0 and 0.15µV for
MECG 2.0 (2020)
Output voltage
The output voltage on most of the
database/ECG is +5mV~-5mV.
±5mV
Output noise
level 0-150Hz
Output noise should not influence the
test. A value a 5µV is suitable for this
requirement. Can be verified by
monitoring the signal in the device
under test using a “diagnostic” filter
setting.
<5µV
Time accuracy
IEC 60601-2-51 does not provide any
limits. An inferred limit from the device
under test. An inferred limit of ±1% is
used (see ). The system’s design
accuracy exceeds 0.1% as a 100ppm
crystal reference is used.
±1%
Sampling rate
A maximum sampling rate of 1kHz
matches the sampling rates of ECG
files.
1kHz
(8 channels)
Power supply
Powered from the USB supply (5V
0.2A)
N/A
Environment
Intended for normal laboratory
environment. The selection of critical
components such as reference
voltages, DAC, precision resistors are
known to be stable in the range
shown.
15-30°C
10-95% RH

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3 Start to Use MECG 2.0
3.1 Software Installation
3.1.1 System Requirements
The Multichannel ECG system uses a normal PC to interface and controls
the USB module. The PC should meet the following requirements
6
:
-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 software can be obtained from the enclosed CD or download from the
WhaleTeq website.
․Download software from the WhaleTeq website.
․Unzip the file and double click the installation file
․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.
6
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”). PCs with only 512MB or less installed and are running several other programs (in
particular, Internet Explorer), may exceed the available RAM, requiring access to the hard drive and
dramatically impacting speed. In this case, streaming interruptions and other problems may occur. See
Trouble shooting section for more details.

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⚫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
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.
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 WhaleTeq Multichannel ECG 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 WhaleTeq software.

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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:
1 - RA
4 - RL
7 - V3 (V4)
10 - V6 (V1)
2 - LA
5 - V1 (V6)
8 - V4 (V3)
3 - LL
6 - V2 (V5)
9 - V5 (V2)
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 WhaleTeq MECG test unit, 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.
Metal bench, metal sheet or foil
Figure 2: Set up a noise-free test environment
3.4 Live Update Application/ Firmware

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MECG 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.
Figure 3: Update Application/ Firmware
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
[e-mail] 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.
Not Support Firmware Update
Support Firmware Update
Figure 4: Firmware Update Window

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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.
Figure 5: ‘’About’’ Button
Step 2.
Click the “Update F/W” button and select the firmware image file
Figure 6: “Update F/W” Window
Step 3.
The application will show an information dialog. After pressing “OK”, the
updating operation cannot be terminated.

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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 whichis sent in the shipping notice
email. This avoids the need to re-publish the MECG PC 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
equipment. The file is approximately 220kB (compensation data for 8 channels
with 4096 codes for each).

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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 software is running, it reads the serial number of the MECG
equipment connected, 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 MECG2.0. 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

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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
Please contact WhaleTeq for obtaining the PC software with “calibration
mode”, 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 8845A
7
. 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
7
The Fluke 8845A has an accuracy specification equivalent to ±3.5µV on the 100mV range which is
suitable for this calibration.

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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 software, set “Square, 0.1 Hz, 5 mV” and click “Load”, then
click “Play” as the figure below:
Figure 10: Self-calibration settings
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
5 mV peak-peak value.

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Figure 11: Connection to a multimeter
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 8.33 mV peak-peak value.
Figure 12: Measure the DC mV
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.