WHALETEQ SECG 5.0 AIO User manual

SECG 5.0 AIO | User Manual
WHALETEQ
Single Channel ECG Test System
(SECG 5.0 AIO)
User Manual
Version 2020-12-31
Software Version 1.1.22.9

Page 2 of 34
SECG 5.0 AIO | User Manual
Contents
1 Introduction .............................................................................................. 4
Basic concept ........................................................................................................ 4
Standard/Application ............................................................................................ 5
SECG 5.0 AIO Overview of ECG Module ................................................................ 6
I/O Interface Overview.......................................................................................... 6
Main Specifications ............................................................................................... 7
Product Label ........................................................................................................ 8
Pollution Degree ................................................................................................... 9
Cleaning method ................................................................................................... 9
2 Set Up ......................................................................................................10
Software Installation........................................................................................... 10
2.1.1 System Requirements...................................................................................................10
2.1.2 SECG 5.0 AIO PC Software Installation..........................................................................10
2.1.3 First Time Using WhaleTeq Product –USB Driver Installation......................................11
2.1.4 First Time Using WhaleTeq Product –Microsoft .Net Framework 4.0 Installation.......11
Connecting to the ECG ........................................................................................ 12
Set up a Low-noise Test Environment.................................................................12
Software Update .................................................................................................12
Main Screen ........................................................................................................ 13
Description of Functional Groups ....................................................................... 14
2.6.1 Signal Parameters.........................................................................................................14
2.6.2 Signal add-on ................................................................................................................17
2.6.3 Output Lead Electrode..................................................................................................20
2.6.4 Output Summary ..........................................................................................................20
2.6.5 Output Waveform Display............................................................................................20
2.6.6 Play/Stop Button ..........................................................................................................21
Special Functions.................................................................................................21
2.7.1 Standard Waveforms....................................................................................................21
2.7.2 File Replay.....................................................................................................................21
2.7.3 NST Noise...................................................................................................................... 23
2.7.4 Auto ..............................................................................................................................24
2.7.5 Lead OFF .......................................................................................................................26
2.7.6 Auto Sequence..............................................................................................................26
Language Selection ............................................................................................. 27
Standard Assistant .............................................................................................. 27
2.9.1 Active SECG standard assistant.....................................................................................28
2.9.2 Standard Assistant Software.........................................................................................28
3 Testing to IEC and AAMI Standards ...........................................................31

Page 3 of 34
SECG 5.0 AIO | User Manual
Relation between IEC figures and WhaleTeq SECG 5.0 AIO................................ 31
Terminals of P1, P2 and P6.................................................................................. 32
4 Software Development Kit (SDK)...............................................................32
5 Calibration and Validation ........................................................................32
6 Trouble Shooting ......................................................................................33
7 Caution ....................................................................................................33
8 Ordering Information................................................................................33
Standard accessories........................................................................................... 33
Optional Software and Accessories..................................................................... 34
9 Version information..................................................................................34
10 Contact WhaleTeq ....................................................................................34

Page 4 of 34
SECG 5.0 AIO | User Manual
1 Introduction
Basic concept
The WhaleTeq Single Channel ECG Test System 5.0 (SECG 5.0 AIO) 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 5.0 AIO, the system produces voltage up to 40 mVpp. The SECG 5.0 AIO 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.
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 low-noise test equipment, please to CMRRseries
test systems 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)
RA
LA
LL
RL
V1
V2
V3
V4
V5
V6
ECG
Device Under Test

Page 5 of 34
SECG 5.0 AIO | User Manual
Standard/Application
The following table shows the standards for which SECG 5.0 AIO 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
series tester
◆Test referring to the CTS
atlas (CAL/ANE
waveforms)*, CSE database
➔use WhaleTeq MECG
series tester
*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.
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 tests
No known limitations
IEC 60601-2-47:2012
(Ambulatory)
201.12.4, all tests except CMRR
test
No known limitations
ANSI/AAMI EC 13
2002/(R)2007/C2008
All performance tests except
CMRR test and as noted right
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

Page 6 of 34
SECG 5.0 AIO | User Manual
SECG 5.0 AIO Overview of ECG Module
I/O Interface Overview
1. Power Connector
2. RCA1 Monitor x 1: To monitor the actual signal output. (1mV = 1mV output)
RCA2 Monitor x 250: To monitor the applied signal. (1mV = 250mV output)
3. USB Type B receptacle connector: To connect with PC and allow PC software to control
SECG 5.0 AIO. Before operating PC software mode, it requires to switch to PC (left side
of DIP SWITCH) and an additional description “SIMULATION MODE” will be shown on
the title bar of touch screen.

Page 7 of 34
SECG 5.0 AIO | User Manual
4. Reserved output port
5. HDMI output port ：When connecting to the external display device via HDMI
interface, please do connect a mouse via USB type A connector for the normal
operation.
6. USB Type A receptable connector: To connect with flash disk or mouse
7. Network connection port
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)
N/A
2.5µV
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 250:1 divider
±0.1%
±0.05%
Sample rate
5kHz ± 0.1%
10kHz ± 0.05% (50ppm)
DC offset (fixed, noise free,
sourced from internal super
capacitor)
300mV ± 1%
300mV ±0.1%
DC offset (variable, up to
1000mV, may include up to
50µVpp noise)
Setting ±1% or ±3mV
Setting ±1% or ±3mV

Page 8 of 34
SECG 5.0 AIO | User Manual
Environment
15 ~ 30°C (by design)
30 ~ 80% RH (by design)
5〜40℃
50〜80％RH
altitude < 2000M
Overvoltage CAT II
Size(L x W x H)
Weight
-
27X16X22 CM
3.5 KG
Power Supplier
-
Input: 100-240Vac 1.5A
50~60Hz
Output : 12V，3.33A
Power cable Note
-
SVT/ 18AWG/300V/105 ℃
or
H05VV-F / 0.75mm2 /
300V/105 ℃
Length 3m MAX
Note: Use the power cord with the plug style that matches the power socket where the
equipment is located and the compatible power cord corresponds to the AC voltage of the
power outlet and has been approved by, and complies with, the safety standards in the
country of purchase.
Product Label
Separate equipment from other waste. The equipment that needs to be
recycled includes: host, wire, power supply
Warning, please refer to the manual
Product serial number 2D Barcode

Page 9 of 34
SECG 5.0 AIO | User Manual
Pollution Degree
Pollution measurement for the surrounding environment and inside the product. Generally,
the internal environment of a product is considered the same as its external environment.
This product is only suitable for the evaluated environment.
Pollution Degree 1: No pollution or only dry, nonconductive pollution occurs. The pollution
has no effect.
Pollution Degree 2: Normally only nonconductive pollution occurs. Temporary conductivity
caused by condensation is to be expected.
Pollution Degree 3: Conductive pollution or dry nonconductive pollution that becomes
conductive due to condensation occurs. To be found in industrial environment or
construction sites (harsh environments).
Pollution Degree 4: The pollution generates persistent conductivity caused by conductive
dust, rain, or snow.
Pollution degree
Pollution degree 2 (as defined in IEC 61010-1). The evaluation is limited to indoor and dry
environments.
Cleaning method
Please keep the surface of the product clean and dry. Please remove the input signal before
cleaning the product. Please check the instrument frequently as required by the operating
conditions. To clean the external surface, follow these steps:
1. Use a lint-free cloth to wipe the dust on the outside of the instrument. Pay attention to
avoid scratching the display filter made of plastic.
2. Use a soft cloth dampened with water to clean the instrument. The cleaning effect is
better with 75% isopropyl alcohol aqueous solution.
Note.
When cleaning the exterior, avoid wetting the inside of the device. Only moisten a dry cloth
or cotton swab with an appropriate amount of cleaning solution. To avoid damage to the
instrument, please do not expose it to various sprays, liquids or solvents, and do not use any
corrosive or chemical cleaning products.

Page 10 of 34
SECG 5.0 AIO | User Manual
2 Set Up
Software Installation
2.1.1 System Requirements
The single channel ECG system SECG 5.0 AIO can be operated via the touch screen or PC
software via USB connection
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
-USB port
2.1.2 SECG 5.0 AIO PC Software Installation
Please follow the below steps to download and execute SECG Software.
․Download SECG 5.0 software from WhaleTeq website
․Open the file explorer and select to the download location
․Extract the file to your assigned folder
․Open the destination folder and make sure the all files are unzipped in the same folder
․Double click on SingleChannelECG5.0.exe to execute SECG 5.0 AIO PC software
If SECG software can’t be executed properly or this is the first time using
WhaleTeq product, please refer to below two sections (2.1.3 and 2.1.4) to confirm that USB
driver and Microsoft .Net Framework 4.0 are all installed.