WHALETEQ SECG 4.0 User manual

SECG 4.0| User Manual
WHALETEQ
Single Channel ECG Test System
(SECG 4.0)
User Manual
2021-11-26

SECG 4.0| User Manual
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WhaleTeq Co. LTD
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SECG 4.0 | User Manual
Contents
1Introduction ..................................................................................... 7
1.1 Basic concept .............................................................................. 7
1.2 Standards/Application ................................................................ 8
1.3 Block diagram/SECG 4.0 Module overview .............................. 10
1.4 Main specifications ................................................................... 11
2Set up..............................................................................................13
2.1 Software installation................................................................. 13
2.1.1 System requirements................................................................ 13
2.1.2 SECG 4.0 Software Installation ................................................. 13
2.1.3 USB Driver Installation.............................................................. 14
2.1.4 Microsoft .Net Framework 4.0 Installation .............................. 15
2.2 Connecting to the ECG.............................................................. 15
2.3 Environment, noise reduction .................................................. 16
2.4 Firmware Update ...................................................................... 17
2.4.1 Firmware Update Instruction.................................................... 17
2.5 Main Screen .............................................................................. 20
2.6 Description of Functional groups.............................................. 21
2.6.1 Main function (main waveform)............................................... 21
2.6.2 Main Parameters ...................................................................... 23
2.6.3 DC Offset Setting....................................................................... 24
2.6.4 Input Impedance Test ............................................................... 24
2.6.5 Output Lead Electrode.............................................................. 25
2.6.6 Pacing parameters .................................................................... 25
2.6.7 Output graphic display.............................................................. 27
2.6.8 Special functions ....................................................................... 28
2.6.9 Other Function (Auto Pacing, Auto Heart Rate, Cal. Mode)..... 29
2.6.10 Load ECG File ............................................................................ 30
2.7 Software Options –SECG Assistant .......................................... 31
2.7.1 Activate the SECG Assistant Software ...................................... 31
3Testing to IEC and AAMI standards ..................................................33
3.1 Relation between IEC figures and WhaleTeq SECG.................. 33
3.2 Terminals P1, P2 and P6............................................................ 34
4Software Development Kit...............................................................36
5Calibration, software validation.......................................................36

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SECG 4.0 | User Manual
5.1 Self-Calibration.......................................................................... 40
6Trouble shooting .............................................................................43
7Cautions ..........................................................................................44
8Purchasing Information ...................................................................45
8.1 Standard accessories................................................................. 45
8.2 Purchase software and accessories .......................................... 45
9Version information.........................................................................45
10 Contact WhaleTeq ...........................................................................46

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SECG 4.0 | User Manual
List of Table
Table 1: Standard/Application........................................................... 8
Table 2: Main Specification ............................................................. 11
Table 3: H/W F/W Version............................................................... 18
Table 4: Main waveform.................................................................. 21
Table 5: Pacing Parameter............................................................... 25
Table 6: Cross-References Between Switches and Terminals......... 33
Table 7: Calibration procedure........................................................ 37
Table 8: Trouble Shooting................................................................ 44
Table 9: Version Information........................................................... 45

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SECG 4.0 | User Manual
List of Figure
Figure 1: Single-channel Concept ...................................................... 7
Figure 2: Simplified Block Diagram.................................................. 10
Figure 3: SECG 4.0 Module .............................................................. 10
Figure 4: Noise Reduction Environment Setup ............................... 16
Figure 5: Firmware Update Confirmation ....................................... 17
Figure 6: Function Table .................................................................. 18
Figure 7: Update F/W Button. ......................................................... 18
Figure 8: Information Dialog............................................................ 19
Figure 9: Firmware Updating........................................................... 19
Figure 10: Firmware Update Completion........................................ 19
Figure 11: Main Screen.................................................................... 20
Figure 12: Main Parameters ............................................................ 23
Figure 13: DC Offset Setting ............................................................ 24
Figure 14: Input Impedance Test..................................................... 24
Figure 15: Output Lead Electrode.................................................... 25
Figure 16: Pacing Parameter ........................................................... 25
Figure 17: Output Graphic Display .................................................. 27
Figure 18: Special Function.............................................................. 28
Figure 19: Other Function................................................................ 29
Figure 20: Load ECG File .................................................................. 30
Figure 21: Load ECG File Button ...................................................... 30
Figure 22: Activate the SECG Assistant Software Button................ 31
Figure 23: Hardware ID.................................................................... 32
Figure 24: Activate Key.................................................................... 32
Figure 25: Software Assisted Calibration Mode.............................. 37
Figure 26: SECG 4.0 Interface .......................................................... 41
Figure 27: Self-Calibration Setup..................................................... 41
Figure 28: SECG 4.0 ±300 mV DC offset........................................... 42
Figure 29: DC Voltage Verification (300mV).................................... 42
Figure 30: Self-Calibration Setup..................................................... 43
Figure 31: DC Voltage Verification (>300mV).................................. 43

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SECG 4.0 | User Manual
1Introduction
1.1 Basic concept
The WhaleTeq Single-channel ECG Test System 4.0 (SECG 4.0) provides a
single waveform to one or more lead electrodes of diagnostic, ambulatory, or
monitoring ECGs, for testing IEC/YY/JJG 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
RA
LA
LL
RL
V1
V2
V3
V4
V5
V6
ECG device
under test

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SECG 4.0 | User Manual
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 refer to
CMRR 3.0 on WhaleTeq website)
-Multichannel waveforms, such as the CSE, AHA, MIT databases (this
requires a multichannel system, please refer to MECG 2.0 on
WhaleTeq website)
1.2 Standards/Application
The following table shows the standards for which this system has been
designed for including any limitations:
Table 1: Standard/Application
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
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.)

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SECG 4.0 | User Manual
Standard
Clause(s)
Limitations / Notes
201.12.4.105.3 test of
ringing from mains
notch filter)
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 (use
WhaleTeq CMRR3.0 for
these tests)
No known limitations
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:
Figure 2: Simplified Block Diagram
Figure 3: SECG 4.0 Module
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)
(BNC2)
(BNC1)