whaleteq company profile en 201221

© 2020 WhaleTeq All Rights Reserved 1

Verify and Validate Your Product Design with Ease

WHALETEQ Company Profile and Introduction


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


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


Medical Device

Manufacturer

Consumer Electronic

ManufacturerLaboratory

Business Strategy


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


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


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


Vital Signs Simulator | Database Analyzer Software

ECG/EKG Testing


ECG/EKG Applications


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

https://www.whaleteq.com/en/Products/Detail/45/SECG%205.0%20AIO#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/18/SECG%204.0#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/19/MECG%202.0#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/27/RDCA%20Database%20Comparison%20Software#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/28/CDCA%20Database%20Comparison%20Software#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/40/CMRR%203.0+#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/21/CMRR%202.0#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/23/HFCN%20Test%20Fixture#tag=proOverview


Vital Signs Simulator

EEG Testing


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


https://www.whaleteq.com/en/Products/Detail/42/CMRR%203.0E#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/43/CMRR%203.0+#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/29/SEEG%20100#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/41/SEEG%20100E#tag=proOverview



Wearable Device Testing


Vital Signs Monitoring Wearable


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.


https://www.whaleteq.com/en/Products/Detail/20/HRS200#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/26/HRS100+#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/31/AECG100#tag=proOverview

https://www.whaleteq.com/en/Products/Detail/31/AECG100#tag=proOverview



ESU Accessories Testing


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.

https://www.whaleteq.com/en/Products/Detail/30/HFPA150#tag=proOverview


Medical Compliance Assistant Software

ECG, EEG and CMRR Assistant


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


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



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


China YY/JJ Standards



TRF Generator


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



Medical Standard Reference Table


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)


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)


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)


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


201.12.4.4.104 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)


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


IEC80601-2-26:2019 (EEG)

IEC60601-2-26:2012 (EEG)


[email protected]

www.whaleteq.com

+886-2-2596-0701

We Simplify and Explain the Procedures to Save Your Time

mailto:[email protected]

http://www.whaleteq.com/

whaleteq company profile en 201221

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