WHALETEQ SECG 4.0 User manual

SECG 4.0 | User Manual
WHALETEQ
Single Channel ECG Test System
(SECG 4.0)
User Manual
(Revision 2020-12-31)

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SECG 4.0 | User Manual
Contents
1 Introduction....................................................................................................3
1.1 Basic Concept..........................................................................................................................3
1.2 Standards/Application ............................................................................................................4
1.3 Block diagram/SECG 4.0 Module overview.............................................................................6
1.4 Main specifications .................................................................................................................7
1.5 Cautions ..................................................................................................................................8
2 Set Up.............................................................................................................9
2.1 Software Installation...............................................................................................................9
2.1.1 System Requirements...................................................................................................................9
2.1.2 SECG 4.0 Software Installation......................................................................................................9
2.1.3 First Time Using WhaleTeq Product - USB Driver Installation .....................................................10
2.1.4 First Time Using WhaleTeq Product –Microsoft .Net Framework 4.0 Installation .....................11
2.2 Connecting to the ECG ..........................................................................................................11
2.3 Environment, noise reduction...............................................................................................11
2.4 Firmware Update ..................................................................................................................13
2.4.1 How to update Firmware............................................................................................................14
2.5 Main Screen ..........................................................................................................................16
2.6 Description of Functional Groups .........................................................................................18
2.6.1 Main function (main waveform).................................................................................................18
2.6.2 DC offset setting .........................................................................................................................20
2.6.3 Input impedance test..................................................................................................................20
2.6.4 Output lead electrode.................................................................................................................20
2.6.5 Lead electrode impedance..........................................................................................................21
2.6.6 Pacing parameters ......................................................................................................................21
2.6.7 Output graphic display................................................................................................................22
2.6.8 Special functions.........................................................................................................................23
2.6.9 Auto Pacing, Auto Heart Rate, Calibration Mode........................................................................24
2.6.10 Load ECG File ..............................................................................................................................25
2.7 Software Options –SECG-Assistant ......................................................................................26
2.7.1 Activate the SECG-Assistant Software.........................................................................................26
2.7.2 SECG-Assistant Operation...........................................................................................................28
3 Testing to IEC and AAMI standards.................................................................32
3.1 Relation between IEC figures and WhaleTeq SECG...............................................................32
3.2 Terminals P1, P2 and P6........................................................................................................33
3.3 IEC 60601-2-27......................................................................................................................34
4 Software Development Kit.............................................................................42
5 Calibration, software validation.....................................................................42
6 Troubleshooting............................................................................................46
7 Purchasing Information .................................................................................46
7.1 Standard accessories.............................................................................................................46
7.2 Optional Software and accessories.......................................................................................46
8 Version Information ......................................................................................47
9 Contact Details..............................................................................................47

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SECG 4.0 | User Manual
1 Introduction
1.1 Basic Concept
The WhaleTeq Single Channel ECG Test System 4.0 provides a single waveform to
one or more lead electrodes of diagnostic, ambulatory or monitoring ECGs, for testing
to IEC/YY/JJG particular standards. The following diagram shows the single channel
concept:
(Figure 1) Single channel concept
Via a SECG 4.0, the system produces arbitrary waveforms (streamed from the PC
with digital to analogue conversion) at up to ±5V, which is then applied to a precision
1000:1 divider to produce the voltages at up to ±5mV level (10mVpp).
The SECG 4.0 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 as described in Section 1.2.
The basic range of tests in the standards include, for example:
- Sensitivity (accuracy of the mV/mm indication)
- Frequency response (sine wave, and impulse tests)
- Input impedance
- Noise
- Multichannel cross talk
- Accuracy of heart rate indication
- Pacemaker rejection
- Tall T-wave rejection
For a full list of tests, refer to the standard together with Section 1.2.
The system does not provide:
- CMRR tests (this requires a special noise free box, please reference CMRR
3.0+ on WhaleTeq website)
RA
LA
LL
RL
V1
V2
V3
V4
V5
V6
ECG device
under test

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SECG 4.0 | User Manual
- Multichannel waveforms, such as the CSE, AHA,MIT databases (this requires
a multichannel system, please reference MECG 2.0 on WhaleTeq website)
1.2 Standards/Application
The following table shows the standards for which this system has been designed
for, and includes any limitations:
Standard
Clause(s)
Limitations / Notes
IEC 60601-2-25:2011
(Diagnostic)
201.12.4: All performance
tests
Except：
◆CMRR test and
baseline noise
➔use WhaleTeq
CMRR 3.0
◆Test referring to the
CTS atlas (CAL/ANE
waveforms)*, CSE
database
➔use WhaleTeq
MECG 2.0
*Note: for most tests
CAL/ANE waveforms are
alternates. For two tests
may be required
(201.12.4.102.3, test of
lead networks; and
201.12.4.105.3 test of
ringing from mains notch
filter)
For 201.12.4.101 (large dc
offset test), the SECG is
limited to ±1Vdc.
However, this is almost
certainly enough to
exceed the point of
saturation.
For the test circuit in
figure 201.110, switch
position A is not
provided. This is
considered an error in
the standard due to the
loading effect of R2.
Instead the DC offset is
provided in series with
output as per Figure
201.106.
(See section 3.2 for notes
on switching between
P1, P2 and P6.)
IEC 60601-2-27:2011
(Patient monitoring)
201.7.9.2.9.101 b), 4) and
6) (special test waveforms
for Figure 201.101)
201.12.1.101, all
performance tests except
baseline noise and CMRR
No known limitations

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SECG 4.0 | User Manual
(use WhaleTeq CMRR3.0
for these tests)
IEC 60601-2-47:2012
(Ambulatory)
201.12.4, all tests except
CMRR (use WhaleTeq
CMRR 3.0 for these tests)
For all 201.12.1.101
database tests, use
WhaleTeq MECG 2.0 for
these tests.
No known limitations
ANSI/AAMI EC 13
2002/(R)2007/C2008
All performance tests
except CMRR and as noted
left.
See below for Clauses
5.1.4 n) and 5.2.9.1 f), g)
1
General limitation: this equipment is designed for use with isolated ECG circuits, as
are generally provided for medical ECG. If applied to a non-isolated circuit, the noise
may be excessive.
1
5.1.4 n) Fast QRS: The sampling rate is limited to 0.2ms, some distortion of the pulse is possible
below 6ms.
5. 2.9.1 f), g): Functionality is not included at this time; note the test is not applicable to most ECG
systems

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SECG 4.0 | User Manual
1.3 Block diagram/SECG 4.0 Module overview
The following is a simplified block diagram of the system inside the SECG 4.0
module:
(BNC1)
(BNC2)
Additional input to allow connection to an
external function generator (e.g. analogue type if
aliasing is suspected). Precision divider ensures
that 1V in = 1mV out (±0.2%)
Connects to the
PC via USB 2.0
For noise
reduction
Allows monitoring of
the applied signal
pre-divider
(1V = 1mV output)

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SECG 4.0 | User Manual
1.4 Main specifications
In general, the system has been designed to the standards above, taking into
account Clause 201.5.4 in IEC 60601-2-25 and IEC 60601-2-27. Below includes these
parameters and also other system parameters necessary for testing. For reference
the system capability is provided.
Parameter
Specification
System capability /
notes
Main output voltage
accuracy
±1% for amplitudes of
0.5mVpp or higher
±0.3%
Main output voltage
resolution
(DAC resolution)
2.5µV
In version 4.0, a single
output range is used
Frequency / pulse
repetition rate accuracy
±1%
±0.1%
Pulse duration / timing
accuracy (excluding
pacing)
±1ms
±0.2ms
Pacing pulse width
accuracy
±5µs
±1µs
Pacing pulse amplitude
accuracy, range
±2mV pulse: ±1%
>2mV pulse: ±10%
Range: ±2mV to ±700mV
±2mV pulse: ±0.3%
100mV pulse: ±1% or
±5mV
Pacing pulse
characteristics
Rise/fall time 5µs
Overshoot <1%
Settling time <1%
Pacing pulse overshoot
(intentional)
Method A according to
IEC 60601-2-27
Resistor tolerance
±1%
±0.5%
Capacitor tolerance
±5%
±5%
Precision 1000:1 divider
(100KΩ:100Ω )
±0.2%
±0.1%
Sample rate
5kHz ± 0.1%
5kHz ± 0.05% (50ppm)
DC offset (fixed, noise
free, sourced from
internal super capacitor)
300mV ± 1%
300mV ±0.1%
DC offset (variable, may
include up to 50µVpp
noise)
Setting ±1% or ±3mV
Setting ±1% or ±3mV

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Power supply
USB +5Vdc supply (no
separate power supply
required)
0.5A (high power mode)
Typical load<0.25A, up
to 0.45A is possible if all
relays are turned on
Environment
15 ~ 30°C (by design, not
tested)
30 ~ 80% RH (design not
tested)
Selection of components
is such that no effect
from the environment is
expected.
Safety, EMC standards
No applicable safety standards (maximum internal
voltages 12Vdc)
For EMC no testing performed. CE marking based on
careful selection of parts, including USB protection
IC, as well as special filters to reduce noise from
microprocessor (8MHz) and DC/DC converter
(200kHz).
1.5 Cautions
➢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.

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SECG 4.0 | User Manual
2 Set Up
2.1 Software Installation
2.1.1 System Requirements
The Single Channel EEG system uses a normal PC to interface and control
the USB module.
PC requirements:
-Windows PC (Windows 7 or later, suggest to use the genuine version)
-Microsoft .NET 4.0 or higher
-Administrator access (essential for installing software, driver, and
Microsoft .Net Framework)
-1.5 GHz CPU or higher
-1GB RAM or higher
2
-USB port
2.1.2 SECG 4.0 Software Installation
Please follow the below steps to download and execute SECG Software.
․Download SECG software from WhaleTeq website.
․Browse to the download location
․Unzip the file to your destination folder
․Open the destination folder and make sure the all files are unzipped in
the same folder
․Double click on the SingleChannelECG.exe to execute the SECG4.0
program
If SECG software can’t be executed properly or this is the first time using
WhaleTeq product, please refer to below two sections to confirm that
USB driver and Microsoft .Net Framework 4.0 are all installed.
2
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.

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SECG 4.0 | User Manual
2.1.3 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 10
As Windows 10 has built-in Microchip® USB Driver, there’re no needs to
install any drivers. It just takes a while for Windows Device manager to
recognize and install the driver.
Microsoft Windows 8 and Windows 8.1
․Windows 8 and Windows 8.1 can’t recognize SEEG unit, 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. Please click here to watch the tutorial video.
․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. Please click here to watch the tutorial video.
Microsoft Windows 7
․Windows 7 can’t recognize SEEG unit, 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. Please click here to watch the tutorial video.

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SECG 4.0 | User Manual
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 SEEG
software fails to launch properly, please check whether Microsoft .Net
Framework 4.0 or higher versions was installed in the operation system.
If your PC does not install Microsoft .Net Framework 4.0 or higher versions,
please download from Microsoft website. Please click here to watch the
tutorial video (from 2:03).
2.2 Connecting to the ECG
For connecting the ECG device under to the USB module, use the “ECG breakout box”
provided. The ECG breakout box includes:
(1) RA~V6 terminals: Total 10 terminals, corresponding to the 10 electrodes
of 12-lead ECG (or fewer lead channel ECG)
(2) GND terminal: The terminal connected to ground.
(3) CMRR Imbalance with DC: The terminal is only used with CMRR 2.0 for
CMRR testing purpose.
Alternately the ECG device under test can be directly connected to the USB module
using a male D15 connector. The pin outs are:
1-RA 4 –RL 7 –V4 10 - V1
2-LA 5 –V6 8 –V3 11- NC
3-LL 6 –V5 9 –V2 12- GND
2.3 Environment, noise reduction
A noise free environment is necessary for testing ECG equipment. This can be
achieved relatively easily by (a) using a metal bench or metal sheet underneath the
ECG device under test and the WhaleTeq SECG test unit, and (b) connecting SECG
GND terminal to the sheet and also the frame ground (or EP terminal) of the ECG
device under test:

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SECG 4.0 | User Manual
With this set up, 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. However for the
input impedance test with the 620kΩ is in series the imbalance in impedance can
cause high noise. For this test, the ac filter may be turned on. If the noise is still
excessive, move to an electrically quiet environment or increase the size of the
metal sheet underneath and around the set up.
Frame ground
or EP terminal
Metal bench, metal sheet or foil
ECG Device
Under test

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Single Channel ECG Test System | User Manual
2.4 Firmware Update
Firmware Update only can be supported with specific hardware and firmware, so:
1. The feature can’t be supported by SECG 3.0 or before version.
2. Firmware update has been supported from March 2017. If your SECG 4.0
doesn’t support the feature, please contact WhaleTeq for upgrade at
[email protected]om.
Question:
How to check your SECG 4.0 have supported Firmware Update?
Answer:
Connect the SECG 4.0 device to PC. Go to “About” dialog, then check whether
the “F/W Version” and “H/W Version” buttons are hidden. (Please watch Step
1in below section for where to find “About” dialog.)

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Single Channel ECG Test System | User Manual
Not Support Firmware Update
Support Firmware Update
Caution: There are risks of losing data if improper options are performed during
the Firmware Update period.
2.4.1 How to update Firmware
If your SECG 4.0 support “Firmware Update” feature. Below is the step by step
instruction for how to update firmware:
Step 1.
Connect the SECG 4.0 device to PC, then open SECG application with version
5.0.0.6 or higher. Move the cursor to System Menu Bar, right click your mouse.
Then there will show up a menu, select “About”.

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Single Channel ECG Test System | User Manual
Step 2.
“About” dialog is popped up. Record the “H/W Version”, then press “Update
F/W” button.
Step 3.
Go to WhaleTeq website, reference below table to download compatible
Firmware file.
Hardware Version
Firmware Version
2.7
4.4 or above
2.8 or above
5.5 or above
Step 4.
Back to SECG application, select the downloaded firmware file.
Step 5.
The application will show an information dialog. After pressing “OK”, the
operation cannot be cancelled.

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Single Channel ECG Test System | User Manual
Step 6.
Wait for firmware update complete.
Step 7.
Please restart the SECG system to complete firmware update process.
2.5 Main Screen

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Single Channel ECG Test System | User Manual
01 –Main Function：
Selects the main function (waveform) type, such as sine, triangle
etc.
02 –Main Parameters：
General parameters for main waveform and pulse waveforms.
03 –DC Offset：
Dc offset settings.
04 –Output Lead Electrode：
Selects the lead electrode which the output is switched to.
05 –Special Functions：
The functions for special test, such as frequency scan.
06 –Automated Functions ：
Provide automated test with different arrange combinations.
07 –SECG Assistant：
Step by step guidance for standard performance tests. “SECG
Assistant” is for IEC, and “SECG Assistant II” is for YY and JJG (China
standard).
08 –Pulse Waveforms：
Select the pulse waveform type. “Pulse Width” is a related
parameter.
09 –Input Impedance Test：
Selects if 620kΩ/4.7nF is in circuit (for input impedance test).
10 –ECG 2-27：
A special waveform related to the ECG waveform (IEC 60601-2-
27). QRS Duration and T Wave are the parameters for this
waveform.
11 –Special Waveform：
Provide CAL and AAMI waveforms. “Load ECG” function, the
function allows customer to play their own waveform, is also
provided here.
12 –Pacemaker Parameters：
Parameters related to pacemaker pulses.
13 –Output Waveform：
Provides a semi-real time graphical display of the current signal.

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Single Channel ECG Test System | User Manual
2.6 Description of Functional Groups
2.6.1 Main function (main waveform)
This group allows the operator to select the main waveform to be used in the test,
from the following:
Waveform
type
Description
Sample waveform
Sine
Basic sine wave, according to
the amplitude (mVpp) and
frequency (Hz or bpm)
Triangle
Basic triangle wave, according
to the amplitude (in mVpp)
and frequency (Hz or bpm)
Square
Basic square wave, according
to the amplitude (mVpp) and
frequency (Hz or bpm)
Rectangle
pulse
A rectangular pulse, according
to the amplitude setting, pulse
width (ms) and pulse
repetition rate (frequency, Hz
or bpm)
Triangle
pulse
A triangle pulse, according to
the amplitude setting, base
pulse width (ms) and pulse
repetition rate (frequency, Hz
or bpm)
Exponential
Exponential waveform, used to
Hysteresis test, according to the
amplitude (mVpp) and
frequency (Hz or bpm)
ECG
Waveform according to IEC
60601-2-27, Figure 201.110
and 201.113, with adjustable
parameters for amplitude
(mVpp), frequency (Hz or
bpm), QRS duration and T
wave amplitude
Special
A range of stored waveforms
including ANSI/AAMI
waveforms, some selected CAL
waveforms, and loaded

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Single Channel ECG Test System | User Manual
waveform. For these
waveforms, the amplitude and
frequency settings have no
effect.
Main parameters
Amplitude: Adjusts the waveform amplitude from 0 to 10mV at a
0.01mV resolution. For all waveforms the amplitude represents the
peak to peak value. For example, for a 1mV sine wave the actual
waveform varies between +0.5mV and -0.5mV. This correlates with
testing requirements in standards.
Frequency: The frequency can be set in either Hz or beats per
minute (BPM). Changing one will automatically change the other to
match. For pulse waveforms (rectangle, triangle, ECG), the
frequency can also be referred to as the pulse repetition rate, or
heart rate. For some pulse settings the frequency is limited to
prevent overlapping pulses.
Pulse Width: Applies to rectangle, triangle and exponential pulse waveforms only.
For the rectangle, pulse width is defined as the time between crossing the 50% point
in rising and falling edges of the pulse
3
. For triangle pulses, the setting matches the
base of the triangle pulse. For exponential pulse, the set pulse width is time constant.
Pulse width can be set to down to 2ms
4
.
QRS Duration: Allows the setting of the QRS component of the ECG wave in IEC
60601-2-27, in the range of 10 to 120ms, matching the requirements of the standard
5
.
T Wave: allows setting of the amplitude of the T-Wave in ECG waveforms, to verify
tall T-wave rejection ability of patient monitors according to IEC 60601-2-27.
Maximum amplitude is 2.5mV. For the heart rate accuracy test in IEC 60601-2-27, a
T-wave component is not required. In this case, set the T-wave to zero.
3
To minimise ringing due to ECG notch filters, rectangle pulses have a rise time of 1ms. This means
that a 20ms rectangle pulse will actually have a 21ms base and a 19ms at the top of the pulse. This
definition ensures that the pulse integral matches the setting, e.g. a 3mV 100ms pulse will have an
integral of 300µVs.
4
Note the sampling rate is limited to 0.2ms. Therefore a 2ms pulse will have limited time resolution.
5
This range has increased to include 10ms to allow for the new heart rate test in IEC 60601-2-27:2011
(a QRS of 10ms should not provide any heart rate).

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Single Channel ECG Test System | User Manual
2.6.2 DC offset setting
This function allows the operator to switch in a dc offset. In the
default condition (not variable), only +300mV, 0 or -300mV can be
set. In this mode, the dc offset is sourced from an internal “super
capacitor” which at least 3 minutes of accurate and stable 300mVdc
offset to be placed in series with the main waveform, without
impacting the quality of that main waveform. The capacitor is
charged while not in use (i.e. when the setting is zero).
In the variable mode, the dc offset is provided by a second channel. This mode is
intended only for investigation into the point in which “LEADS OFF” or similar alarms
are provided. It is limited to 1000mV.
The “Common mode to RL/N” places the 300mV offset in series with the RL/N as per
IEC 60601-2-25, switch position C in Figure 201.110.
2.6.3 Input impedance test
This check box allows the user to switch in an impedance of
620kΩ//4.7nF in series with the main function, for testing the
input impedance of the ECG device under test. When the check
box is ticked, the impedance is shorted. The ±300mVdc offset
can be used in conjunction with this test.
2.6.4 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).
More than one lead electrode may be selected. For example,
if it is desired to have Lead I and Lead II have a positive
indication, LA and LL can be selected.
Note: In version 4.0, the signal can no longer be output to RL, since this is normally
not used for measurement.