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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WhaleTeq Co. LTD
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system,
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either expressed or implied, including, but not limited to, the implied warranties of merchantability
or fitness for a particular purpose.
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made to the information herein; these changes will be incorporated in future revisions of this
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The following trademarks are used in this document:
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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