whaleteq company profile en 201221
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© 2020 WhaleTeq All Rights Reserved 1
Verify and Validate Your Product Design with Ease
WHALETEQ Company Profile and Introduction
© 2020 WhaleTeq All Rights Reserved 2
Established in 2013 by experts of test equipment and
device certifications
Focus on vital signs technologies - ECG, EEG, PPG Heart Rate, PPG SpO2, PWTT, NIBP and AED
Provides compliance, performance, and algorithm
testing equipment and software
Designed for R&D, QA, QE, Production Line, and After-sales Services
Vital Signs Simulator | Compliance Assistant Software
Medical Device Manufacturersfor
About WhaleTeq
© 2020 WhaleTeq All Rights Reserved 3
ECG Heart Rate Simulator
PPG Heart Rate Simulator
Air Pressure Analyzer
Dynamic Pressure Analyzer
Reflective Type Analyzer
Transmissive Type Analyzer
ECG Simulator for Performance Testing
ECG Database Player for Algorithm Testing
Algorithm Analysis Software
CMRR Tester
ECG Respiration Simulator
PPG Respiration Simulator
EEG Simulator for Performance Testing
Defibrillator Analyzer
AED Analyzer
Heart Rate
Blood Pressure
Respiration
SpO2
AED
EEG
ECG/EKG
Focus on Verifying Vital Signs Devices
© 2020 WhaleTeq All Rights Reserved 4
Medical Device
Manufacturer
Consumer Electronic
ManufacturerLaboratory
Business Strategy
© 2020 WhaleTeq All Rights Reserved 5
Since 2013, more than 500 clients from 35 countries, whose domains include
manufacturers (medical device, wearable device, IC chipset), certification laboratories,
universities, research institutes...etc. have adopted WhaleTeq test solutions.
WhaleTeq Now
© 2020 WhaleTeq All Rights Reserved 6
2. Compliance
1. R&D
4. Regulation
3. Clinical Trail 5. Production
6. After Service
NIBPSpO2ECG/EEG Wearable Device AED
Medical DeviceQuality Management System
GMPISO13485
- Hardware Verification (Filter, Amp, ADC…)
- Software Verification (Function, Reliability…)
- Algorithm Verification (Accuracy…)
- Specification Verification
- Performance Test (IEC60601-2-X)
- Algorithm Test (IEC60601-2-X)
IEC Test Report Form
Report Generator Software
- Assembly Quality Testing
- IQC Testing
Function Test
WhaleTeq Test Solution Scope
© 2020 WhaleTeq All Rights Reserved 7
ECG/EKGTesting
EEGTesting
Wearable Device Testing
ESUTesting
➢ Hardware and System
Performance Testing
➢ Algorithm Testing
➢ CMRR Testing
➢ Electrosurgical
Interference Testing
➢ Hardware and System
Performance Testing
➢ CMRR Testing
➢ PPG Heart Rate Testing
➢ PPG SpO2 Testing
➢ ECG Hardware and
Performance Testing
➢ PWTT Testing
➢ NE Contact
Impedance Testing
Vital Signs Simulator | Medical Database Analyzer Software
ECG/EKGHardware and System Performance Testing
EEGHardware and System Performance Testing
ECGCMRR Testing
Medical Standard Compliance Assistant Software
TRF Generator Software
Regulatory Compliance Assistant Software
Compliance
Compliance
R&D
Compliance
Production Line
EEGCMRR Testing
WhaleTeq Test Solution Portfolio
© 2020 WhaleTeq All Rights Reserved 8
Vital Signs Simulator | Database Analyzer Software
ECG/EKG Testing
© 2020 WhaleTeq All Rights Reserved 10
Performance Testing
The Simulator Designed for ECG Performance Testing
Algorithm Testing
ECG Database Player with Extreme Accuracy for Up to 12 Leads Analog Signal Output
ECG Database Analyzer Software for Ambulatory ECG
ECG Database Comparison Software for Diagnostic ECG
CMRR Testing
The CMRR Tester Suitable for ECG Compliance Tests
The Innovative CMRR Tester Designed for Test Automation and Compliance Tests
Electrosurgical Interference Testing
Test Fixture For Electrosurgical Interference Testing
The Innovative Stand-alone Simulator Designed for ECG Performance Testing
SECG 5.0 AIO SECG 4.0
MECG 2.0 RDCA CDCA
CMRR 3.0+ CMRR 2.0 HFCN
2020
Simulator and Database Analyzer Software
© 2020 WhaleTeq All Rights Reserved 12
Hardware and System Performance Testing
CMRR Testing
The Simulator Designed for EEG Performance Testing of IEC60601-2-26:2012
The Simulator Designed for EEG Performance Testing of IEC80601-2-26:2019
The Innovative CMRR Tester Designed for Test Automation and IEC60601-2-26 Compliance Tests
The Innovative CMRR Tester Designed for Test Automation and IEC80601-2-26 Compliance Tests
CMRR 3.0E CMRR 3.0+
SEEG 100SEEG 100E
Vital Signs Simulator
© 2020 WhaleTeq All Rights Reserved 15
PPG Heart Rate
ECG, PPG Heart Rate, PPG SpO2, Respiration and PWTT
ECG | PPG Heart Rate | PWTT | Respiration ECG | PPG Heart Rate | PPG SpO2 | PWTT | Respiration
Advanced PPG heart rate simulator to verify accuracy and algorithm of wearable with heart rate measurement function.
PPG heart rate simulator designed for verifying wearable with heart rate measurement function.
HRS200 HRS100+
AECG100-1R AECG100-2R
The Innovative simulator to output ECG and PPG analog signals simultaneously. Adjustable time difference parameters to generate various Pulse Wave Transit Time (PWTT) signals.
Vital Signs Simulator
© 2020 WhaleTeq All Rights Reserved 17
NE Contact Impedance Testing
HFPA150
◼ 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.
© 2020 WhaleTeq All Rights Reserved 18
Medical Compliance Assistant Software
ECG, EEG and CMRR Assistant
© 2020 WhaleTeq All Rights Reserved 19
Hardware and System Performance Testing
CMRR Testing
SECG 4.0Assistant Software
SEEG 100EAssistant Software
SEEG 100Assistant Software
SECG 5.0 AIOAssistant Software
CMRR 3.0+Assistant Software
CMRR 3.0EAssistant Software
Wearable Testing
AECG100Assistant Software
2020
Medical Standard Assistant Software
© 2020 WhaleTeq All Rights Reserved 20
Test Values can be Saved and
Exported to TRF Generator
Select Test Standard
Select Test Clause Click Test Table to Initiate
Click Stop to End the TestTest Value Can be Saved
SECG 5.0 AIO Assistant Software
IEC60601-2-25, IEC60601-2-27,
IEC60601-2-47, YY0782,
YY0885, YY1079
Medical Standard Assistant Software
© 2020 WhaleTeq All Rights Reserved 21
SECG 4.0 Assistant Software
Simplify and Explain Medical
Standards to Reduce Test Efforts
IEC60601-2-25,
IEC60601-2-27,
IEC60601-2-47,
YY1079, YY1139,
YY0782, YY0885,
JJG760, JJG1042
Supported Standards
IEC Standards
Medical Standard Assistant Software
China YY/JJ Standards
© 2020 WhaleTeq All Rights Reserved 23
TRF Generator
◼ Capable of importing test data from Medical Standard Assistant software or
conducting the test clause directly
◼ With the test data, user just needs to complete the questionnaire and generate TRF
report by one mouse click
◼ Assist user to obtain TRF report complied with regulatory requirements and minimize
the test efforts effectively
◼ To assure the report compliance, TRF format can be updated via internet access when
modifications are made.
2020
Regulatory Compliance Assistant Software
© 2020 WhaleTeq All Rights Reserved 25
Test Clause SECG 5.0 AIO MECG 2.0 CMRR 3.0+ CDCA HFCN
201.12.1.101.2 Requirements for amplitude measurements O O
201.12.1.101.3.1 Requirements for absolute interval and wave duration measurements O O
201.12.1.101.3.2 Requirements for interval measurements on biological ECGS O O
201.12.4.101 Indication of inoperable ELECTROCARDIOGRAPH O
201.12.4.102.3.2 Goldberger and Wilson LEADS O O
201.12.4.102.4 Recovery time O
201.12.4.103 Input impedance O
201.12.4.105.1 COMMON MODE REJECTION O
201.12.4.105.2 Overload tolerance O
201.12.4.105.3 FILTERS (including line frequency interference FILTERS) O
201.12.4.106.1 NOISE level O
201.12.4.106.2 CHANNEL crosstalk O
201.12.4.107.1.1.1 High frequency response O
201.12.4.107.1.1.2 Low frequency (impulse) response O
201.12.4.107.1.2 Test with calibration ECGS O O
201.12.4.107.2 Linearity and dynamic range O
201.12.4.108.3.2 Recording speed O
201.12.4.109 Use with cardiac pacemakers O
202.6.2.101 Eelectrosurgery interference O
IEC60601-2-25:2011 (DIAGNOSTIC ECG)
© 2020 WhaleTeq All Rights Reserved 26
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 O
201.7.9.2.9.101 b), 5) - Response time of heart rate meter to change in heart rate O
201.7.9.2.9.101 b), 6) - Time to alarm for tachycardia O
201.12.1.101.1 - Accuracy of signal reproduction O
201.12.1.101.2 - Input dynamic range and differential offset voltage O
201.11.8 - Interruption of the power supply / SUPPLY MAINS TO ME EQUIPMENT O
201.12.1.101.1 Accuracy of signal reproduction O
201.12.1.101.2 Input dynamic range and differential offset voltage O
201.12.1.101.3 Input impedance O
201.12.1.101.4 Input NOISE O
201.12.1.101.5 Multichannel crosstalk O
201.12.1.101.6 GAIN control and stability O
201.12.1.101.7 Sweep speed O
201.12.1.101.8 Frequency and impulse response O
201.12.1.101.9 GAIN INDICATOR O
201.12.1.101.10 Common mode rejection O
201.12.1.101.11 Baseline reset O
201.12.1.101.12 Pacemaker pulse display capability O
201.12.1.101.13 Rejection of pacemaker pulses O
201.12.1.101.14 Synchronizing pulse for cardioversion O
201.12.1.101.15 Heart rate range, accuracy, and QRS detection range O
201.12.1.101.16 Channel height and aspect ratio O
201.12.1.101.17 Tall T-wave rejection capability O
202.6.2.101 Electrosurgery interference O
IEC60601-2-27:2011 (MONITORING ECG)
© 2020 WhaleTeq All Rights Reserved 27
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 O O
201.12.1.101.1.2.2 The accuracy of heart rate measurements O O
201.12.1.101.1.2.3 The accuracy of VEB detection O O
201.12.1.101.1.2.4 Claim to detect ventricular flutter or fibrillation (VF) O O
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
O O
201.12.1.101.1.5.1 Required statistics O O
201.12.1.101.1.5.2 Requirements for all arrhythmia algorithms O O
201.12.1.101.1.5.3 Requirements for algorithms with optional capabilities O O
201.12.1.101.1.6 Simulated test patterns O O
201.12.1.101.2.1 Use of standard databases O O
201.12.1.101.2.2 Use of annotation files O O
201.12.1.101.2.3 Beat-by-beat comparison O O
201.12.1.101.2.3.1 General description O O
201.12.1.101.2.3.2 Method for beat-by-beat comparison O O
201.12.1.101.2.3.3.1 Heart rate measurement O O
201.12.1.101.2.4 Run-by-run comparison O O
201.12.1.101.2.4.1 General description O O
201.12.1.101.2.4.2 Terms and symbols O O
201.12.1.101.2.4.3 Run sensitivity summary matrix O O
201.12.1.101.2.4.4 Run positive predictivity summary matrix O O
IEC60601-2-47:2012 (AMBULATORY ECG)
© 2020 WhaleTeq All Rights Reserved 28
Test Clause SECG 5.0 AIO MECG 2.0 CMRR 3.0+ RDCA
201.12.1.101.2.5 VF and AF comparisons O O
201.12.1.101.3 Physician report – minimum requirements O O
201.12.1.101.3.1 Heart rate O O
201.12.1.101.3.2 Supraventricular ectopy O O
201.12.1.101.3.3 Ventricular ectopy O O
201.12.1.101.3.4 Bradycardia data O O
201.12.1.101.3.5 PAUSES O O
201.12.1.101.3.6 ST SEGMENT shifts O
201.12.1.101.3.7 ECG hard copy O O
201.12.1.101.2.3.3.2 - Heart rate variability or RR interval variability test Patterns O
201.12.4.4.101 Linearity and dynamic range O
201.12.4.4.102 Input impedance O
201.12.4.4.103 Common mode rejection O
201.12.4.4.104 GAIN accuracy O
201.12.4.4.105 GAIN stability O
201.12.4.4.106 System noise O
201.12.4.4.107 Multichannel crosstalk O
201.12.4.4.108 Frequency response O
201.12.4.4.109 Function in the presence of pacemaker pulses O
201.12.4.4.110 Timing accuracy O
201.12.4.4.111 GAIN settings and switching O
201.12.4.4.112 Temporal alignment O
IEC60601-2-47:2012 (AMBULATORY ECG)
© 2020 WhaleTeq All Rights Reserved 29
Test Clause SEEG 100E CMRR 3.0E HFCN-E
201.12.1.102 Accuracy of amplitude and rate of variation O
201.12.1.103 Input dynamic range and differential offset voltage O
201.12.1.104 Input noise O
201.12.1.105 Frequency response O
201.12.1.106 Common mode rejection O
202.8.101 Disturbances from HF SURGICAL EQUIPMENT O
Test Clause SEEG 100 CMRR 3.0+
201.12.1.101.1 Accuracy of signal reproduction O
201.12.1.101.2 Input dynamic range and differential offset voltage O
201.12.1.101.3 Input NOISE O
201.12.1.101.4 Frequency response O
201.12.1.101.5 Common mode rejection O
IEC80601-2-26:2019 (EEG)
IEC60601-2-26:2012 (EEG)
© 2020 WhaleTeq All Rights Reserved 30
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