Product Catalog 2021 Test Solutions - WhaleTeq USA
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Test Solutions for
Medical Device Manufacturers
2021
Product Catalog
ECG EEG Wearable SpO2 Respiration
Device
INDEX
WhaleTeq
Company Profile 2
WhaleTeq
Global Customers 3
Medical Device Test Solutions
ECG Technology 4
Medical Device Test Solutions
EEG Technology 24
Medical Device Test Solutions
ESU Active Accessories 30
Health Wearables Test Solutions
ECG, PPG and PWTT Technologies 34
Medical Standard
Cross-reference Table 44
WHALETEQ Co., LTD is a professional test solution provider founded in September 2013. We
design, produce, and sell test solutions including test equipment, compliance testing software
and associated services for medical device manufacturers.
Our core competency comes from helping customers
to verify and validate product design with ease. We ensure your design and development
process to meet ISO13485 validation requirements and we make your regulatory compliance
and production run testing more efficient.
WhaleTeq WHALETEQ Co., LTD concentrates on providing test solutions for vital signs devices and we
are determined to assist the industry to release more medical devices with reliability and
Company Profile accuracy!
2
Verify and Validate Your Product Design with Ease
WhaleTeq Global Customers
WhaleTeq has been working for ECG standard testing tools for years and now
is the global leading test solution provider offering qualified test tools for
manufacturers, certification laboratories, and regulation testing institutes.
In 2014, we proudly released the test solution for health wearables. The PPG
heart rate simulator HRS200 is the first tester to verify optical heart rate with
adjustable parameters. In 2018, WhaleTeq launched the industry-leading
multifunction tester AECG100 with ECG, PPG heart rate, PPG SpO2, PWTT
and respiration test modes for verifying vital signs monitoring system of
wearable device.
Till now, over 600 customers around 35 countries already adopted WhaleTeq’s
test solutions and proved it’s effective to reduce test efforts in R&D, QA,
compliance and production line testing.
Test Solutions for
Medical Device Manufacturers
3
Medical Device Test Solutions
ECG Technology
Including ECG performance tester, ECG database player,
database comparison software, common mode rejection
ratio tester and IEC TRF (Test Report Form) generator
software.
Compliant with the requirements of international medical
standards of IEC 60601-2-25, -2-27, -2-47, YY1079, YY1139,
YY0782, YY0885, etc.
4
Verify and Validate Your Product Design with Ease
Test Solutions for
Medical Device Manufacturers
SECG 5.0 AIO CMRR 3.0+ SECG Assistant RDCA
ECG Performance Tester Common Mode Rejection Ratio Tester SECG Enhancement Software Pack Rhythm Database Compliance
Analyzer Software
SECG 4.0 HFCN CDCA TRF Generator
ECG Performance Tester High Frequency Coupling Network CTS / CSE Database Compliance IEC Test Report Form Generator
Test Fixture Analyzer Software Software
MECG 2.0
ECG Database Player
5
ECG
SECG 5.0 AIO
ECG Performance Tester
The most advanced ECG simulator with the capabilities of
adding noise, respiration and lead-off simulations. Designed
for R&D and compliance testing.
• Built-in test circuits per defined in ECG standards
• Adjustable parameters and selectable options enable to verify DUT with flexibility
• Multiple noise simulations - EMG/Motion/Baseline drift
• Various Signal Simulations - Impedance Type Respiration, Wave Modulation Type
(Baseline/Amplitude/Frequency) Respiration and lead-off simulation
• Auto-sequence function assist to conduct semi-automated tests
• Load and play recorded or programmed waveforms
• Software Development Kit (SDK) allows to develop customized or automated test
software with less efforts.
Compliance
IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-47, AAMI
Medical
Standard Coverag
e
EC11, AAMI EC13, YY1079, YY1139, YY0782, YY0885, JJG 760
R&D
, and JJG 1042
6
Verify and Validate Your Product Design with Ease
SECG 5.0 AIO Specifications
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
±2mV pulse: ±1%
±2mV pulse: ±0.3%
Pacing pulse amplitude accuracy, range >2mV pulse: ±10% Range:
100mV pulse: ±1% or ±5mV
±2mV to ±700mV
Rise/fall time 5µs
Pacing pulse characteristics Overshoot
ECG
SECG 4.0
ECG Performance Tester
The ECG simulator designed for performance testing.
Suitable for compliance and production line testing.
• Single channel performance tester for diagnostic ECG, monitoring ECG and
ambulatory ECG.
• Built-in test circuits per defined in ECG standards.
• Excellent shielding and grounding design makes amplitude and frequency
accuracy < ± 1%.
• DC offset and pacemaker signal output can be adjustable.
• Load ECG file function enables to load and replay recorded or programmed
waveforms.
• Offer alternative input of external generator for arbitrary waveforms.
• Software Development Kit (SDK) assists user to develop customized or
automated test software with less efforts.
Compliance
Production
Medical IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-47, AAMI
Line
Standard Coverag
e
EC11, AAMI EC13, YY1079, YY1139, YY0782, YY0885, JJG 760
, and JJG 1042
8Verify and Validate Your Product Design with Ease
SECG 4.0 Specifications
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
±2mV pulse: ±1% >2mV pulse: ±10% Range: ±2mV to ±2mV pulse: ±0.3% 100mV pulse: 1%
Pacing pulse amplitude accuracy, range
±700mV or ±5mV
Pacing pulse characteristics Rise/fall time 5µs OvershootECG
MECG 2.0
ECG Database Player
The ECG database player designed for system alidation and
software algorithm evaluation.
Suitable for R&D and compliance testing.
• Load and replay multi channel ECG waveforms for diagnostic and ambulatory ECG.
• Output analog signals simultaneously up to 8 channels and support 12 lead ECG.
• Embedded CAL, ANE, NST and biological waveforms.
• Directly support AHA, MIT, CU, NST, ESC and PhysioNet format databases
• Support digital file playback function for user to repeatedly play clinical-recorded or
programmed waveforms.
• Extreme output voltage resolution - 0.15μV for MECG 2.0 (2020)
• Command replay function enables to program test sequences with commands.
• Software Development Kit (SDK) allows to develop customized or automated test
software with less efforts.
Medical IEC 60601-2-25, IEC 60601-2-47, AAMI EC57,
Compliance
Standard Coverag
e
YY0782 and YY0885
R&D
10Verify and Validate Your Product Design with Ease
MECG 2.0 Supported Medical Databases
DB Full Name of Database Purpose Source # of Records Standards Test Requirements by standards
19 (3 ANA waveforms and 16
CTS Clinical Trial Subject Calibration and Analytical ECGs Corscience IEC60601-2-25 Amplitude ,global interval and duration
CAL waveforms)
Common Standards for Quantitative
CSE Biological ECGS INSERM 100 IEC60601-2-25 Global interval
Electrocardiography
Evaluation of Ventricular
AHA American Heart Association ECRI 80 (35 min each) IEC60601-2-47 QRS, HR, VEB, VF
Arrhythmia Detectors
MIT- Massachusetts Institute of Technology –
Arrhythmia Database MIT-BIH 48 (30 min each) IEC60601-2-47 QRS, HR, VEB, VF,SVEB, AF
BIH Beth Israel Hospital
Sustained Ventricular
CU Creighton University MIT-BIH 35 (8 mins each) IEC60601-2-47 VF
Arrhythmia Database
Noise database (only supplied 12 ECG (30 min each) + 3
NST Noise Stress Test MIT-BIH IEC60601-2-47 QRS, HR, VEB, SVEB, AF
with the MIT–BIH database) noise
ESC European Society of Cardiology ST-T Database CNR, MIT-BIH 90 (2 hour each) IEC60601-2-47 ST segment deviations or changes
MECG 2.0 Specifications
Item Details / Reference Value
The 8 output channels are provided through a network as specified in IEC 60601-2-51 to provide signals to 10 lead
Output channels 8 outputs/10 lead electrodes/12 leads
electrodes; in the device under test, this will be displayed as 12 leads.
For MECG 2.0, ±1% for values greater or equal to 500μV
IEC 60601-2-51 specifies a limit of ±1%, but does not provide a lower limit (all systems must have a lower limit). An and ±5μV for values under 500μV. For MECG 2.0 (2020),
Voltage accuracy
inferred specification of 1% ±5µV is derived from the device under test specification in IEC 60601-2-51 of 5% ±25µV. ±1% for values greater or equal to 100μV and ±5μV for
values under 100μV.
Output voltage
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)
resolution
Output voltage The output voltage on most of the database/ECG is +5mV~-5mV. ±5mV
Output noise level Output noise should not influence the test. A value a 5µV is suitable for this requirement. Can be verified by monitoringECG
CMRR 3.0+
Common Mode Rejection
Ratio Tester
The CMRR Tester Combining Accuracy, Convenience
and Test Automation All Together
• CMRR Tester designed for diagnostic ECG, monitoring ECG, ambulatory ECG and
EEG monitor.
• Extreme shielding structure, built-in sine wave generator and Vc voltage
measurement circuit assure the accuracy of output signal.
• Exclusive shielding covers can be added for higher CMRR requirement
• Touch screen maximizes the test efficiency in standalone operation.
• PC software operation allows to control and conduct test via mouse clicks.
• Optional Standard Assistant software pack simplifies the medical standard with
test sequences, options, parameters and pass criterions.
• Software Development Kit (SDK) assists user to develop customized or automated
test software with less efforts.
Compliance
Production
R&D
Line
IEC 60601-2-25, IEC 60601-2-27, IEC60601-2-47,
Medical
Standard Coverag
e
IEC 60601-2-26, YY1079, YY1139, YY0782, YY0885,
AAMI EC11, and AAMI EC13
12Verify and Validate Your Product Design with Ease
CMRR 3.0+ Specifications
Item Option Specifications
Supply voltage 0.5 / 2.828 / 20 / 2 / (70.71) (Vrms) ±1%
CM point voltage 1.414 / 10/ 1/ (35.355) (Vrms) ±1% ( 0.25Vrms ±2% )
Frequency 50 / 60 / 100 /120 (Hz) ±1%
Electrode with
Change electrode via the touch screen of CMRR 3.0+ None/RA/LA/LL/V1/V2/V3/V4/V5/V6 /ALL
Impedance
Electrode without
Change electrode via the touch screen of CMRR 3.0+ RA/LA/LL/V1/V2/V3/V4/V5/V6
Impedance
Imbalance
51kΩ 51kΩ ±1%
impedance, R
Imbalance
47nF 47nF ± 5%
impedance, C
DC offset Internal battery powered, can be added on RA/ LA/LL/V1~V6 300mV ± 1% Up to 40hrs with intermittent use
100 pF capacitor Use 11:1 (110MΩ:10MΩ) voltage divider to measure indirectly 100pF ± 5%
Intended for normal laboratory environment. The selection of critical components is known to be 15-30°C
Environment
stable in the range shown. The 110MΩ divider may be affected by high humidity in excess of 85% 10-75% RH
CMRR Assistant Software Pack Allows User to Test with Ease
Follow the instruction step by step Detailed test sequences for user to
to proceed required tests test with confidence
13ECG
HFCN Test Fixture
High Frequency Coupling
Network Test Fixture
Designed for testing electrosurgical interference
with ECG devices and patient monitor
• Elaborated design offers convenience and safety.
• Dual module design supports different standard requirements.
• Built-in impedance 51k/47nF for skin impedance simulation.
• Simulate 1mV ECG signal for electrosurgical interference suppression (ESIS).
• Power rating >300W and resistor inductanceVerify and Validate Your Product Design with Ease
HFCN Test Fixture
Completely Compliant with :
• ESIO test of IEC 60601-2-25, IEC 60601-2-27, YY1079 and AAMI EC13
• ESIS test of YY1079 and AAMI EC13
15ECG
SECG Assistant
ECG Software Enhancement Pack
Increase the Test Efficiency with Less Efforts
• Optional Software enhancement pack for SECG 4.0 test system.
• Simplify test sequences of medical standards into adjustable parameters,
selectable options, test procedures and pass criterion.
• Assist user to get acquainted with medical standards and improve the overall
testing time.
Medical IEC60601-2-25, IEC60601-2-27, IEC60601-2-47,
Standard Coverag
e
YY1079, YY1139, YY0782, YY0885, JJG760 and
JJG1042
Compliance
16Verify and Validate Your Product Design with Ease
Click to Complete the Required Tests with
Proper Parameters
Test Procedures and Pass Criterion to be Displayed for User
to Test with Ease
17ECG
CDCA
CTS / CSE Medical Database
Compliance Analyzer Software
A Quick Tool to Compare with Medical Databases
and Perfect Algorithm
• Support digital and analog data input to ensure your algorithm fully meet the
standard requirements.
• Test data can be imported automatically via the pre-defined file format or
input manually.
• Intuitive software interface allows user to complete the comparison within a
few mouse clicks.
• Comparison result can be exported to a report file.
Medical IEC60601-2-25 and YY0782
Standard Coverag
e
Compliance
R&D
18Verify and Validate Your Product Design with Ease
Supported Standards and Test Clauses
Standard Test Clause
201.12.1.101.2 Requirements for amplitude measurements
IEC60601-2-25: 2011 201.12.1.101.3.1 Requirements for absolute interval and wave duration Measurements
201.12.1.101.3.2 Requirements for interval measurements on biological ECGS
50.101.2 Requirements for amplitude measurements 振幅测量的要求
YY 0782-2010 50.101.3.1 Requirements for absolute interval and wave duration Measurements 绝对间期和波形时限测量的要求
(IEC60601-2-51: 2003) 50.101.3.2 Requirements for interval measurements on biological ECGS 实际人体心电图时限测量的要求
50.101.4 Requirement for Noise 抗噪声测量稳定性的公布要求
4 Steps to Complete the Database Comparison
1
3 STEP 1 Select standard and test clause
2
2 Click “Import Testing Data "button to get ECG testing
STEP
4 data
STEP 3 Click “Compare” button to start the comparison
4 Get comparison result. The result can be exported to a
STEP
report file.
19ECG
RDCA
Rhythm Database Compliance
Analyzer Software
A Quick Tool to Compare with Medical Databases
and Perfect Algorithm
• Support digital and analog data input to ensure your algorithm fully meet the
standard requirements.
• AI sync function unifies original TAF into comparable TAF.
• Error data and error timing can be displayed for advanced algorithm
improvement
• Intuitive software interface allows user to complete the comparison within a
few mouse clicks.
• Comparison result is identical with PhysioNet WFDB library software and can
be exported to a report file.
Medical IEC60601-2-47, AAMI EC57
Standard Coverag
e
Compliance
and YY0885
R&D
20Verify and Validate Your Product Design with Ease
Supported Standards and Test Clauses
Standard Test Clause Clause Name
IEC60601-2-47 : 2012 201.12.1 Accuracy Controls and Instruments
ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST segment measurement Algorithms
YY0885-2013 50.101 自动分析
AI Sync Function Assists to Get a Comparable TAF
Optimize the label position and time difference of Test
Annotation File at your fingertips
4 Steps to Complete the Database Comparison
3
2 STEP 1 Get Test Annotaion File (TAF) from ECG DUT
STEP 2 Load TAF of ECG DUT
3 Compare TAF with RDCA built-in Referernce
STEP
1 Annotation File (RAF)
4 Get comparison result. The result can be
Test Annotation File 4 STEP
exported to a report file.
21ECG
TRF Generator
The ultimate test solution for compliance testing - Simplify
all your efforts conducting testing and generating TRF report.
Work with SECG 5.0 AIO, SECG 4.0, CMRR 3.0+ and CMRR 3.0.
• Reduce test efforts and obtain qualified TRF report with consistency
• Complete questionnaire to determine product characteristics and relevant test
clauses
• Click the test table to control test equipment to initiate designated test directly
• Database testing results from RDCA/CDCA can be imported
• The report format can be updated in accordance with the latest IEC TRF report
Medical IEC60601-2-25,
Standard Coverag
e
IEC60601-2-27,
IEC60601-2-47
Compliance
22Verify and Validate Your Product Design with Ease
Easiest Way to Conduct Testing and Generate IEC TRF Report
STEP 1 Fill in the questionnaire to determine product characteristics
4
2
2 Select the test clause and click the test table to conduct
STEP
testing
3 Import database comparison results from RDCA/CDCA if
STEP
necessary
3
4
STEP Click TRF Whole Report to generate IEC TRF report
1
Test Report Example
23Medical Device Test Solutions
EEG Technology
Including EEG performance tester and EEG CMRR tester.
Compliant with IEC 80601-2-26
24Verify and Validate Your Product Design with Ease
Test Solutions for
Medical Device Manufacturers
SEEG 100E CMRR 3.0E
EEG Performance Tester EEG Common Mode
Rejection Ratio Tester
25EEG
SEEG 100E
EEG Performance Tester
Your EEG Simulator Designed for R&D, Regulatory
Compliance and Production Run Testing
• Designed for the latest EEG standard IEC 80601-2-26:2019
• Sophisticated electrical and shielding design enables the test system to
output 1μV signal
• 9 channels with auto-select switches for user to test performance individually
• Built-in test circuits as defined in EEG standards with selection of 620kΩ/4.7nF
for input impedance test
• Able to load and replay files in PhysioNet's EDF format, binary format and text
format.
• IEC 80601-2-26 helper simplifies the medical standard with test sequences,
options, parameters and pass criterions.
• Software Development Kit (SDK) assists user to develop customized or
automated test software with less efforts.
Compliance
Production
Medical IEC 80601-2-26
R&D
Standard Coverag
e
Line
26Verify and Validate Your Product Design with Ease
Simple and Effective Tool to Verify EEG Performance
Adjustable parameters per
IEC 80601-2-26 required
Load customized waveform
format
Real-time waveform display
Easy to download PhysioNet waveforms Optional IEC 60601-2-26 helper simplifies
via EDF File Manager the medical standard into required
parameters, test sequences and pass criteria
SEEG 100E Speicifications
Parameter Specifications
Main output voltage accuracy ±1% for amplitudes of 50 µVpp or higher
Main output voltage resolution (DAC resolution) 0.5µV
Frequency / pulse repetition rate accuracy ±1%
Pulse duration / timing accuracy ±1ms
Resistor tolerance ±1%
Capacitor tolerance ±5%
Precision 500:1 divider (50KΩ:100Ω ) ±0.2%
Sample rate 5kHz ± 0.1%
DC offset (fixed, noise free, from internal super capacitor) 150mV ± 1%
DC offset (variable, may include up to 50µVpp noise) Setting ±1% or ±3mV
Power supply USB +5Vdc supply (no separate power supply required) 0.5A (high power mode)
27EEG
CMRR 3.0E
EEG Common Mode Rejection
Ratio Tester
The EEG CMRR Tester Combining Accuracy,
Convenience and Test Automation All Together
• Extreme shielding structure, built-in sine wave generator and Vc voltage
measurement circuit assure the accuracy of output signal.
• Touch screen maximizes the test efficiency in standalone operation.
• PC software operation allows to control and conduct test via mouse clicks.
• Optional Standard Assistant software pack simplifies the medical standard
with test sequences, options, parameters and pass criterions.
• Software Development Kit (SDK) assists user to develop customized or
automated test software with less efforts.
Medical IEC 80601-2-26
Compliance
Production
Standard Coverag
e
R&D
Line
28Verify and Validate Your Product Design with Ease
CMRR 3.0E Specifications
Item Option Specifications
Supply voltage 0.5 / 2.828 / 20 / 2 / (70.71) (Vrms) ±1%
CM point voltage 1.414 / 10/ 1/ (35.355) (Vrms) ±1% ( 0.25Vrms ±2% )
Frequency 50 / 60 / 100 /120 (Hz) ±1%
Electrode with Impedance Change electrode via the touch screen of CMRR 3.0E None/RA/LA/LL/V1/V2/V3/V4/V5/V6 /ALL
Electrode without Impedance Change electrode via the touch screen of CMRR 3.0E RA/LA/LL/V1/V2/V3/V4/V5/V6
Imbalance impedance, R 10kΩ 10kΩ ±1%
Imbalance impedance, C 47nF 47nF ± 5%
DC offset Internal battery powered, can be added on RA/ LA/LL/V1~V6 150mV ± 1% Up to 40hrs with intermittent use
100 pF capacitor Use 11:1 (110MΩ:10MΩ) voltage divider to measure indirectly 100pF ± 5%
Intended for normal laboratory environment. The selection of critical components is known
Environment to be stable in the range shown. The 110MΩ divider may be affected by high humidity in 15-30°C 10-75% RH
excess of 85%
CMRR Assistant Software Pack Allows User to Test with Ease
Follow the instruction Detailed test sequences for user to
step by step to proceed test with confidence
required tests
29Medical Device Test Solutions
ESU Active Accessories
Compliant with IEC 60601-2-2 and capable of generating
signals with frequency ranging from 50 kHz to 5 MHz,
producing current over 200 mArms, and sine wave with
THD < 0.3%.
30Verify and Validate Your Product Design with Ease
Test Solutions for
Medical Device Manufacturers
HFPA150
Neutral Electrode Impedance Tester
31Accessories
ESU
HFPA150
Neutral Electrode Impedance Tester
Simple and Convenient NE Contact Impedance Tester
• Designed according to IEC60601-2-2:2009 clause 201.15.101.6 for testing NE contact
impedance
• Outputs 200mA into 0-50 Ω load from 50kHz to 5MHz
• Equipped with DDS (direct digital synthesis) technology for a stable frequency output
• Inbuilt current monitor port eliminating the need for expensive current probes
Medical IEC 60601-2-2
Standard Coverag
e
Compliance
32Verify and Validate Your Product Design with Ease Required Test Equipment Combination 201.15.101 NEUTRAL ELECTRODES HFPA150 Oscilloscope 201.15.101.6 NE contact impedance ● ● HFPA150 Test Setup HFPA150 Specifications Parameter Specifications Frequency range 50 kHz to 5 MHz Maximum voltage 11 Vrms (~31 Vpp), ≥ 50 Ω Maximum Current >200 mArms, ≤ 50 Ω Waveform Sine Frequency Response < ±0.8 dB, 50 Ω THD
Health Wearables Test Solutions
ECG, PPG and PWTT
Technologies
Designed for verifying vital signs monitoring system of
wearable device, providing ECG, PPG heart rate, PWTT,
SpO2 and respiration test modes
34Verify and Validate Your Product Design with Ease
Test Solutions for
Medical Device Manufacturers
HRS200 HRS100+ AECG100
Advanced PPG Heart Rate Simulator PPG Heart Rate Simulator ECG, PPG Heart Rate, PWTT, SpO2
and Respiration Multifunction Tester
35HRS200
Advanced PPG Heart Rate Simulator
Verify and Validate Heart Rate Measurement
Function of Your Wearable Device Effectively
• Built-in LED outputs adjustable PPG waveform signals as the reflected optical signal of
different human skin tones
• Built-in photodiode can detect and display DUT LED behavior and brightness
• Adjustable parameters includes heart rate (BPM), reflected skin brightness (DC), arterial
blood volume change (AC) and Perfusion Index (AC/DC)
• Raw data playback function assists to validate heart rate monitoring system and
improve algorithm effectively
• Command mode function allows to conduct test quickly and repeatedly
• Noise simulation with adjustable amplitude parameter
• Playback capability of 40 clinical-recorded PPG databases. 25 PPG records are with
arrhythmia symptoms as AF, APC, VPC and 1st AV block
• Software Development Kit (SDK) assists user to develop customized or automated test
software with less efforts
R&D
36Verify and Validate Your Product Design with Ease
The Effective Tool for Validation and Verification
Various types of waveforms with noise Raw-data playback function allows to Easy to use commands to create
simulation play recorded or programmed waveform customized test sequences Built-in 40 clinical database records
repeatedly (Optional)
HRS200 Specifications
Parameters Supported range / types Accuracy
BPM 30 – 300 BPM ( PC Software ); 30~240 BPM ( Standalone Usage ) ±1 BPM
DC - HRS mode 1 – 20 Level N/A
- Fine Tune mode 100 mV – 2500 mV ±5 mV
PI - HRS mode 0.1% – 20% ( AC/DC, differs with DC level ) N/A
AC - Fine Tune mode 0.75 mV – 25 mV ( BNC measurement is magnified 100 times ) ±0.05 mV
Lumen 50 – 800 Lux ( 5 mm from diffusion film ) ±3 %
Light Wavelength 525nm ±10 nm
51 dB (with USB isolator) N/A
Power - USB Type B N/A
- Battery AAA Battery x 3 N/A
Size (W x H x D) 13.5 (cm) x 7.6 (cm) x 6.12 (cm) N/A
Temperature 10 °C ~ 40 °C N/A
37HRS100+
PPG Heart Rate Simulator
Verify Heart Rate Measurement Function of Your
Wearable Device Effectively
• Built-in LED outputs adjustable PPG waveform signals as the reflected optical
signal of different human skin tones
• Built-in photodiode can detect and display DUT LED brightness
• Adjustable parameters includes heart rate (BPM), reflected skin brightness (DC),
arterial blood volume change (AC) and Perfusion Index (AC/DC)
• Command mode function allows to conduct test quickly and repeatedly
• Software Development Kit (SDK) assists user to develop customized or
automated test software with less efforts
Production
Line
38Verify and Validate Your Product Design with Ease
The Effective Tool for Verification
Adjustable DC, PI and BPM parameters with the Easy to use commands to create customized test
bright detection function of DUT LED sequences
HRS100+ Specifications
Parameters Supported range / types Accuracy
BPM 30 – 300 BPM (PC Software); 30~240 BPM (Standalone Usage) ±1 BPM
DC 1 – 20 Level N/A
PI 0.1% – 20% (AC/DC, differs with DC level) N/A
Lumen 50 – 800 Lux (5 mm from diffusion film) ±3 %
Light Wavelength 525nm ±10 nm
51 dB (with USB isolator) N/A
Power - USB Type B N/A
- Battery AAA Battery x 3 N/A
Size (W x H x D) 13.5 (cm) x 7.6 (cm) x 6.12 (cm) N/A
Temperature 10 °C ~ 40 °C N/A
39AECG100
The Innovative Simulator to Output
ECG and PPG Analog Signals
Simultaneously
Adjustable time difference parameters to generate
various Pulse Wave Transit Time (PWTT) Signals
• AECG100 main console unit includes ECG module with built-in test circuits with auto-select
switches per ECG standard required
• PPG-1R-525 module offers optical waveforms simulating PPG heart rate signals
• PPG-2R-880 and PPG-2R-940 module offer red and infrared optical waveforms for SpO2 testing
• Adjustable PWTT parameters allows user to check and improve the algorithm of blood pressure
applications
• Test parameters in each test mode can be saved and integrated as a series of customized test
sequences for improving the testing efficiency
• Waveform player function reproduces and repeats recorded or programmed waveforms
• AECG Assistant software pack simplifies test sequences of medical standards into adjustable
parameters, selectable options, test procedures and pass criterion
• Software Development Kit (SDK) assists user to develop customized or automated test software
with less efforts
Compliance
Production
R&D
Line
Medical
Standard Coverag
e
IEC 60601-2-47, China YY0885
40Verify and Validate Your Product Design with Ease
AECG100 Test System
AECG100 ECG Module PPG-1R-525 Module PPG-2R-880 / 940 Module
• Built-in photodiode and green LED • Built-in photodiode, Red LED and IR LED
• Photodiode detects DUT's LED brightness • Photodiode detects DUT's LED
and behaviors brightness and behaviors
• Green LED simulates PPG heart rate signals • Red LED and IR LED simulates SpO2
with various parameters signals with various parameters
ECG Test Mode
Adjustable test parameters and various
USB waveforms are designed to meet the
Connection
requirements of IEC 60601-2-47 and
China YY0885 medical standards
Pulse Wave Transit Time Test Mode
• Output ECG and PPG analog signals
simultaneously
• Time difference between ECG and PPG
USB waveforms can be adjustable.
Connection
41Accessories
AECG100
ESU
Reflectance SpO2 Test Mode
• SpO2 test mode is only available when connecting
USB
with R/IR PPG module
Connection
• Adjustable AC, DC and PI values in both channels
• User can import and play programmed R-curve
Reflectance PPG Heart Rate Test Mode
USB
Connection • Adjustable PPG waveforms and parameters
• Offer basic waveforms and simulated noise signals
42Verify and Validate Your Product Design with Ease
Auto-sequence Test Mode
• Program a test of selected test items in preferred
USB sequence and duration time.
Connection
• Simply click Play button to proceed required tests
AECG100 Assistant Software
Simplify test clauses into parameters, selectable options, test procedures and pass criterion.
Simply click to conduct the required test clause with confidence.
Software Development Kit
• All test parameters correspond to specific SDK commands
• DLL�Dynamic-link library) shared library supports efficient program binding and version upgrade
• Support C/C++ header and C# interface
• Easy for user to develop customized or automated testing software
43Medical Standard
Cross-reference Table
Medical
Standard Coverag
e
44Verify and Validate Your Product Design with Ease
Test Solutions for
Medical Device Manufacturers
ECG Medical Standard Cross-reference Table
• IEC60601-2-25:2011 (DIAGNOSTIC ECG) • JJG 760-2003 心电监护仪 • YY0782-2010 记录和分析型单道和多道心电图机
• IEC60601-2-27:2011, 3RD EDITION • JJG 1041-2008 数字心电图机 • YY0885–2013 (IEC60601-2-47: 2001) 动态心电图机
(MONITORING ECG) • JJG 1042-2008 动态 ( 可移动 ) 心电图机 • YY1079–2008 (ANSI/AAMI EC13: 2002) 心电监护仪
• IEC60601-2-47:2012 (AMBULATORY ECG) • YY1139–2013 (ANSI/AAMI EC11:1991) 心电诊断设备
EEG Medical Standard Cross-reference Table
• IEC 60601-2-26:2012
• IEC 80601-2-26:2019
45ECG Medical Standard Cross-
reference Table
IEC60601-2-25:2011 (DIAGNOSTIC ECG)
Test Clause SECG 5.0 AIO MECG 2.0 CMRR 3.0+ CDCA HFCN
201.12.1.101.2 Requirements for amplitude measurements ● ●
201.12.1.101.3.1 Requirements for absolute interval and wave duration
● ●
measurements
201.12.1.101.3.2 Requirements for interval measurements on biologi-cal ECGS ● ●
201.12.4.101 Indication of inoperable ELECTROCARDIOGRAPH ●
201.12.4.102.3.2 Goldberger and Wilson LEADS ● ●
201.12.4.102.4 Recovery time ●
201.12.4.103 Input impedance ●
201.12.4.105.1 COMMON MODE REJECTION ●
201.12.4.105.2 Overload tolerance ●
201.12.4.105.3 FILTERS (including line frequency interference FIL-TERS) ●
201.12.4.106.1 NOISE level ●
201.12.4.106.2 CHANNEL crosstalk ●
201.12.4.107.1.1.1 High frequency response ●
201.12.4.107.1.1.2 Low frequency (impulse) response ●
201.12.4.107.1.2 Test with calibration ECGS ● ●
201.12.4.107.2 Linearity and dynamic range ●
201.12.4.108.3.2 Recording speed ●
201.12.4.109 Use with cardiac pacemakers ●
202.6.2.101 Eelectrosurgery interference ●
46Verify and Validate Your Product Design with Ease
ECG Medical Standard Cross-
reference Table
IEC60601-2-27:2011, 3RD EDITION (MONITORING ECG)
Test Clause SECG 5.0 AIO CMRR 3.0+ HFCN
201.7.9.2.9.101 b), 4) - Heart rate meter accuracy and response to irregular rhythm ●
201.7.9.2.9.101 b), 5) - Response time of heart rate meter to change in heart rate ●
201.7.9.2.9.101 b), 6) - Time to alarm for tachycardia ●
201.11.8 - Interruption of the power supply / SUPPLY MAINS TO ME EQUIPMENT ●
201.12.1.101.1 Accuracy of signal reproduction ●
201.12.1.101.2 Input dynamic range and differential offset voltage ●
201.12.1.101.3 Input impedance ●
201.12.1.101.4 Input NOISE ●
201.12.1.101.5 Multichannel crosstalk ●
201.12.1.101.6 GAIN control and stability ●
201.12.1.101.7 Sweep speed ●
201.12.1.101.8 Frequency and impulse response ●
201.12.1.101.9 GAIN INDICATOR ●
201.12.1.101.10 Common mode rejection ●
201.12.1.101.11 Baseline reset ●
201.12.1.101.12 Pacemaker pulse display capability ●
201.12.1.101.13 Rejection of pacemaker pulses ●
201.12.1.101.14 Synchronizing pulse for cardioversion ●
201.12.1.101.15 Heart rate range, accuracy, and QRS detection range ●
201.12.1.101.16 Channel height and aspect ratio ●
201.12.1.101.17 Tall T-wave rejection capability ●
202.6.2.101 Electrosurgery interference ●
47ECG Medical Standard Cross-
reference Table
IEC60601-2-47:2012 (AMBULATORY ECG)
Test Clause SECG 5.0 AIO MECG 2.0 CMRR 3.0+ RDCA
201.12.1.101.1.2.1 The accuracy of QRS detection ● ●
201.12.1.101.1.2.2 The accuracy of heart rate measurements ● ●
201.12.1.101.1.2.3 The accuracy of VEB detection ● ●
201.12.1.101.1.2.4 Claime to detect ventricular flutter or fibrilla-tion (VF) ● ●
201.12.1.101.1.2.5 Claimed to detect supraventricular ectopic beats, or atrial flutter or fibrillation
● ●
(AF), claimed to measure ST SEGMENT deviations or to detect ST SEGMENT changes
201.12.1.101.1.5.1 Required statistics ● ●
201.12.1.101.1.5.2 Requirements for all arrhythmia algorithms ● ●
201.12.1.101.1.5.3 Requirements for algorithms with optional capabilities ● ●
201.12.1.101.1.6 Simulated test patterns ● ●
201.12.1.101.2.1 Use of standard databases ● ●
201.12.1.101.2.2 Use of annotation files ● ●
201.12.1.101.2.3 Beat-by-beat comparison ● ●
201.12.1.101.2.3.1 General description ● ●
201.12.1.101.2.3.2 Method for beat-by-beat comparison ● ●
201.12.1.101.2.3.3.1 Heart rate measurement ● ●
201.12.1.101.2.4 Run-by-run comparison ● ●
201.12.1.101.2.4.1 General description ● ●
201.12.1.101.2.4.2 Terms and symbols ● ●
201.12.1.101.2.4.3 Run sensitivity summary matrix ● ●
201.12.1.101.2.4.4 Run positive predictivity summary matrix ● ●
201.12.1.101.2.5 VF and AF comparisons ● ●
48Verify and Validate Your Product Design with Ease
ECG Medical Standard Cross-
reference Table
IEC60601-2-47:2012 (AMBULATORY ECG)
Test Clause SECG 5.0 AIO MECG 2.0 CMRR 3.0+ RDCA
201.12.1.101.3 Physician report – minimum requirements ● ●
201.12.1.101.3.1 Heart rate ● ●
201.12.1.101.3.2 Supraventricular ectopy ● ●
201.12.1.101.3.3 Ventricular ectopy ● ●
201.12.1.101.3.4 Bradycardia data ● ●
201.12.1.101.3.5 PAUSES ● ●
201.12.1.101.3.6 ST SEGMENT shifts ●
201.12.1.101.3.7 ECG hard copy ● ●
201.12.1.101.2.3.3.2 - Heart rate variability or RR interval vari-ability test Patterns ●
201.12.4.4.101 Linearity and dynamic range ●
201.12.4.4.102 Input impedance ●
201.12.4.4.103 Common mode rejection ●
201.12.4.4.104 GAIN accuracy ●
201.12.4.4.105 GAIN stability ●
201.12.4.4.106 System noise ●
201.12.4.4.107 Multichannel crosstalk ●
201.12.4.4.108 Frequency response ●
201.12.4.4.109 Function in the presence of pacemaker pulses ●
201.12.4.4.110 Timing accuracy ●
201.12.4.4.111 GAIN settings and switching ●
201.12.4.4.112 Temporal alignment ●
49ECG Medical Standard Cross-
reference Table
JJG 760-2003 心电监护仪
Test Clause SECG 4.0 CMRR 3.0+
5.3.3.1.1 电压测量误差的检定 – 步进增益转换式 ●
5.3.3.1.2 电压测量误差的检定 – 连续可调增益转换式 ●
5.3.3.2 极化电压引起的电压测量偏差的检定 ●
5.3.3.3 噪声电平的检定 ●
5.3.3.4 扫瞄速度误差的检定 ●
5.3.3.6.1 监护导联幅频特性的检定 ●
5.3.3.6.2 标准心电导联幅频特性的检定 ●
5.3.3.7 共模抑制比的检定 ●
5.3.4.1 心率显示值误差的检定 ●
5.3.4.2 心率显报警发生时间检定 ●
5.3.4.3 心率报警预置值的检定 ●
5.3.5.1.1 电压测量误差的检定 – 步进增益转换式 ( 描笔式心电图记录部分 ) ●
5.3.5.1.2 电压测量误差的检定 – 连续可调增益转换式 ( 描笔式心电图记录部分 ) ●
5.3.5.2 记录速度误差的检定 ( 描笔式心电图记录部分 ) ●
5.3.5.3 时间常数的检定 ( 描笔式心电图记录部分 ) ●
5.3.5.4 滞后 ( 描笔式心电图记录部分 ) ●
5.3.5.5.1 监护导联幅频特性的检定 ( 描笔式心电图记录部分 ) ●
5.3.5.5.2 标准心电导联幅频特性的检定 ( 描笔式心电图记录部分 ) ●
5.3.5.6 移位非线性偏差的检定 ●
5.3.5.7 基线漂移的检定 ●
5.3.5.8 共模抑制比的检定 ●
50Verify and Validate Your Product Design with Ease
ECG Medical Standard Cross-
reference Table
JJG 1041-2008 数字心电图机
Test Clause SECG 4.0 CMRR 3.0+
4.1 内定标电压误差 ●
4.2 输入电压范围 ●
4.3 耐极化电压 ●
4.4 加权系数误差 ●
4.5 内部噪声电平 ●
4.6 波形识别能力与幅度 - 时间参数测量 ●
4.7 幅频特性 ●
4.8 时间常数 ●
4.9 心率测量误差 ●
4.10 共模抑制比 ●
51ECG Medical Standard Cross-
reference Table
JJG 1042-2008 动态 ( 可移动 ) 心电图机
Test Clause SECG 4.0 CMRR 3.0+
4.1 最大输入范围 ●
4.2 最小描记灵敏阈 ●
4.3 耐极化电压 ●
4.4 输入阻抗 ●
4.5 灵敏度误差 ●
4.6 灵敏度稳定度 ●
4.7 定标电压 ●
4.8 频率响应 ●
4.9 过冲 ●
4.1 滞后 ●
4.12 硬拷贝描记速度误差 ●
4.13 道间串扰 ●
4.14 共模抑制比 ●
4.15 系统噪声电平 ●
4.16 起搏脉冲顺应性及检测能力 ●
52Verify and Validate Your Product Design with Ease
ECG Medical Standard Cross-
reference Table
YY0782-2010 记录和分析型单道和多道心电图机
Test Clause SECG 5.0 AIO MECG 2.0 CMRR 3.0+ CDCA
50.101 心电图的自动量测 ●
50.101.1 用来评估心电图自动测量准确性的标准数据库 ●
50.101.2 振幅测量的要求 ●
50.101.3.1 绝对间期和波形时限测量的要求 ●
50
工 50.101.3.2 实际人体心电图时限测量的要求 ●
作 50.101.4 抗噪声测量稳定性的公布要求 ●
數
據 50.102 心电图的自动解释 ●
的
準 50.102.1 衡量心电图自动诊断准确度指标的定义 ●
確 50.102.2 公开预期用途 ●
性
50.102.3.1 形态诊断用心电图数据库 ●
50.102.3.2 公开解释诊断准确性的要求 ●
50.102.4.1 节律诊断用心电图数据库 ●
50.102.4.2 公开节律诊断准确性的要求 ● ●
51.101.2.2.1 Goldberger 及 Wilson 导联 ●
51.101.2.3 恢复时间 ●
51.102.1 输入阻抗和导联网络阻抗 ●
51.104.2 灵敏度的稳定性 ●
51.104.3 灵敏度的精确度 ●
51.105.1 共模抑制 ●
51.105.2 过载容限 ●
51
危 51.106.4 基线 : 噪声电平 ●
险
输 51.106.5 描记速度与轨迹宽度 ●
出
51.106.6 多道心电图机的道间干扰 ●
的
防 51.107.1.1.1 高频响应 ●
护
51.107.1.1.2 低频 ( 脉冲 ) 响应 ●
51.107.2 线性和动态范围 ●
51.107.3 最小信号响应 ●
51.108.4.1 直角坐标，描记点的对齐 ●
51.108.4.4 记录速度 ●
51.109.1 在有心脏起搏器的情况下使用 – 心电波形失真 ●
51.109.2 在有心脏起搏器的情况下使用 – 起搏脉冲的可见性 ●
53ECG Medical Standard Cross-
reference Table
YY0885–2013 (IEC60601-2-47: 2001) 动态心电图机
Test Clause SECG 5.0 AIO MECG 2.0 CMRR 3.0+ RDCA
50.101 自动分析 ● ●
50.101.1 用于评估自动分析的标准数据库 ● ●
50.101.2 性能报告要求 ● ●
50 50.101.2.1 用于性能测试的标准数据库 ● ●
工 50.101.2.2 记录比对结果 ● ●
作 50.101.2.3 统计 ● ●
數
50.101.2.4 测试方法 ● ●
據
的
50.101.3.1 心率 ● ●
準 50.101.3.2 室上性异位 ● ●
確 50.101.3.3 心室异位 ● ●
性 50.101.3.4 心动过缓数据 ● ●
50.101.3.5 停搏 ● ●
50.101.3.6 ST 段偏移 ● ●
50.101.3.7 ECG 备份 ● ●
51.5.1 动态输入范围 ●
51.5.2 输入阻抗 ●
51.5.3 共模抑制 ●
51
51.5.4 增益准确度 ●
危
险 51.5.5 增益稳定性 ●
输 51.5.6 定标信号 ●
出 51.5.7 系统噪声 ●
的
51.5.8 道间干扰 ●
防
护
51.5.9 频率响应 ●
51.5.10 最小检测信号 ●
51.5.11 起搏脉冲显示能力 ●
51.5.15 时间轴对齐 ●
54Verify and Validate Your Product Design with Ease
ECG Medical Standard Cross-
reference Table
YY1079–2008 (ANSI/AAMI EC13: 2002) 心电监护仪
Test Clause SECG 5.0 AIO CMRR 3.0+ HFCN
4.1.2.1 c) 高大 T 波的抑制能力 ●
4.1.2.1 e) 心率计准确度和对心律不齐的响应 ●
4.1.2.1 f) 心率计对心率变化的响应时间 ●
4.1.2.1 g) 心动过速报警的启动时间 ●
4.1.4 起搏器脉冲抑制能力 ●
4.1.4.3 起搏脉冲检测器对快速心电图信号的抑制 ●
4.2.2 过载保护 ●
4.2.5.1 QRS 波幅度和宽度范围 ●
4.2.5.2 工频电压容差 ●
4.2.5.3 漂移容差 ●
4.2.6 心率计的范围和准确度 ●
4.2.7.3 报警限误差 ●
4.2.7.4 心动停止报警的启动时间 ●
4.2.7.5 心率低报警的启动时间 ●
4.2.7.6 心率高报警的启动时间 ●
4.2.7.7 报警静音 ●
4.2.8.1 输入动态范围 ●
4.2.8.2 输入阻抗 ●
4.2.8.3 系统噪声 ●
4.2.8.4 多通道串扰 ●
4.2.8.5 增益控制和稳定性 ●
4.2.8.6 时间基准选择和准确度 ●
4.2.8.7 输出显示 ●
4.2.8.8 输入信号重建准确度 ●
4.2.8.9 定标电压 ●
4.2.8.10 共模抑制 ●
4.2.8.11 基线控制和稳定度 ●
4.2.8.12 起搏脉冲显示能力 ●
5.2.8.13 ESIO/ESIS tests ● 55ECG Medical Standard Cross- EEG Medical Standard Cross-
reference Table reference Table
YY1139–2013
(ANSI/AAMI EC11:1991) 心电诊断设备 IEC 60601-2-26:2012
Test Clause SECG 5.0 AIO CMRR 3.0+ Test Clause SEEG 100 CMRR 3.0+
4.2.3 输入动态范围 ● 201.12.1.101.1 Accuracy of signal
●
4.2.4.1 增益设置和准确度 ● reproduction
4.2.4.4 增益稳定性 ● 201.12.1.101.2 Input dynamic range and
●
differential offset voltage
4.2.5 时间基准选择和准确度 ●
201.12.1.101.3 Input noise ●
4.2.6.3 轨迹宽度和可视性 ●
201.12.1.101.4 Frequency response ●
4.2.6.4 直角坐标 / 记录点对齐 ●
201.12.1.101.4 Common mode rejection ●
4.2.7.1 系统误差 ●
4.2.7.2 频率和脉冲响应 ●
4.2.7.3 导联权重因子 ●
4.2.7.4 滞后 ● IEC 80601-2-26:2019
4.2.8 定标电压 ●
Test Clause SEEG 100E CMRR 3.0E
4.2.9 输入阻抗 ●
201.12.1.102 Accuracy of amplitude and
4.2.11 共模抑制 ● ●
rate of variation
4.2.12.1 电缆，电路和输出显示噪声 ● 201.12.1.103 Input dynamic range and
●
4.2.12.2 多通道串扰 ● differential offset voltage
4.2.13.1 基线控制和稳定度 : 复位 ● 201.12.1.104 Input noise ●
4.2.14.1 过载保护 : 交流电压 ● 201.12.1.105 Frequency response ●
4.2.14.3 起搏脉冲显示能力 ● 201.12.1.106 Common mode rejection ●
56Ikonix USA
28105 N. Keith Drive
Lake Forest, IL 60045 USA
Telephone +1-877-301-6335
Fax +1-847-367-4080
Email info@ikonixusa.com
Verify and Validate Your Product Design with Ease
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