Whaleteq

Whaleteq

Whaleteq Co., LTD is a professional test solution provider founded in September 2013. They design, produce, and sell test solutions including test equipment and associated services for medical devices.

Established by a team of experts specialised in test equipment and medical certification, Whaleteq strives to offer simple, accurate, and compliant test solutions.

  • WHALETEQ offers compliant and accurate test solutions complied with medical standards.
  • WHALETEQ provides test management tool and remote control service through Internet and big data, to follow the principle of product life cycle defined in medical regulations.
  • WHALETEQs test solutions can save customers labor and time studying medical standards. Customer can allocate resources for developing and verifying product in a better way.

PRODUCTS

  • SECG 5.0 AIO
  • SECG 4.0
  • MECG 2.0
  • CMRR 3.0+
  • HFCN Test Fixture
  • SECG Assistant Software
  • CDCA Database Comparison Software
  • RDCA Database Comparison Software
  • TRF Generator

WhaleTeq ECG test solution is exclusively designed for manufacturers and certification laboratories.

Moreover, WhaleTeq TRF Generator software is 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. Support IEC60601-2-25, IEC60601-2-27 and IEC60601-2-47.

Our test solution can be used for verifying your ECG devices with the most advanced assistant software – including performance tester SECG 5.0 AIO, ECG database player MECG 2.0, common mode rejection ratio tester CMRR 3.0+, medical database comparison software RDCA/CDCA and HFCN test fixture. It simply puts the completed testing and verification tool in your hands. The ECG test solution is compliant with regulatory required testings such as IEC 60601-2-25, -2-27, -2-47; AAMI/ANSI EC11, EC13 ; China YY1079, YY1139, YY0782 and YY0885, providing the confidence and convenience for quality assurance.

MECG 2.0 (ECG / EKG Testing)

The ECG database player designed for system validation and software algorithm evaluation. Suitable for R&D and compliance testing. Compliant with IEC 60601-2-25, IEC 60601-2-47, ANSI / AAMI EC57, YY0782 and YY0885.
  • 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 – 0.15?V for MECG 2.0 (2020)
  • Command replay function enables to program test sequences with commands.
  • Software Development Kit (SDK) allows to development of customized or automated test software with fewer efforts

Datasheet

SECG 5.0 AIO (ECG / EKG Testing)

The ECG simulator designed for ECG performance testing. Capable of adding noise, respiration and lead-off simulations. Flexible operation modes for standalone or PC software. Suitable for R&D and compliance testing. Compliant with IEC60601-2-25, -2-27, -2-47, YY1079, YY1139, YY0782, YY0885, JJG760, JJG1041, JJG1042, GB9706.25, GB10793, ANSI/AAMI EC11, EC13
  • Built-in test circuits per defined in ECG standards.
  • Adjustable parameters and selectable options enable to verify DUT with flexibility.
  • Multiple noise simulations – Electrode Motion Artifact / Muscle Noise / Baseline Wander.
  • 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.
  • Optional Standard Assistant software pack simplifies the medical standard with test sequences, options, parameters and pass criterions.

Datasheet

  • SEEG 100
  • SEEG 100E
  • CMRR 3.0+
  • CMRR 3.0E
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WhaleTeq offers EEG test solutions compliant with the performance testing requirements of IEC 60601-2-26:2012 and IEC 80601-2-26:2019.

Multiple parameters allow user to test EEG performance with flexibilities. Meanwhile, user is able to download and play PhysioNet EEG Motor Movement/Imagery Database or CHBMIT Scalp EEG Database within a few clicks.

On top of that, User can also play programmed or recorded waveform files. WhaleTeq EEG test solutions assist to verify EEG performance with efficiency and effectiveness.

Whaleteq EEG

SEEG 100

The EEG performance tester designed for regulation testing. Standard Coverage : IEC 60601-2-26:2012, JJG 1043, JJF 1388, JJF 1390.
Applicable for R&D, compliance and production line testing
Whaleteq EEG

SEEG 100E

The EEG performance tester is compliant with the test requirements of IEC 80601-2-26:2019 and applicable for R&D, compliance and production line testing.
Whaleteq EEG

CMRR 3.0+

The CMRR tester combining accuracy,convenience and test automation all together. Compliant with IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-47, IEC 60601-2-26, YY1079, YY1139, YY0782, YY0885, ANSI / AAMI EC11, ANSI / AAMI EC13. Applicable for R&D, compliance and production line testing.
Whaleteq EEG

CMRR 3.0E

The EEG CMRR tester combining accuracy,convenience and test automation all together. Compliant with IEC80601-2-26:2019 and applicable for R&D, compliance and production run testing
  • PPG-2TF-660 Transmission SpO2 Module
  • PPG-2R-880/PPG-2R-940 Reflective SpO2 Module
Whaleteq Oximeter

There are two operational principles for the oximeter: transmission and reflection, and the former mostly applies to finger clip oximeters while the latter is commonly used in wearable devices. WhaleTeq provides performance test modules PPG-2TF-660 and PPG-2R-880/940 for the two types respectively. Working with the AECG100 main console, the performance test modules can simulate signals such as heart rate, PPG, PWTT, and SpO2 to assist customers in verification and validation to improve product reliability and quality.

WhaleTeq collects the testing needs and pain points of oximeter developers during development, and designs the first SpO2 product performance test system, especially for engineers, to provide the testing functions required for the development of oximeters:

1. Arbitrarily adjustable parameters in a wide range and precise values.

2. Raw data playback to test consistency.

3. Provides SDK supporting multiplatform for engineers to flexibly develop testing programs.

PPG-2R-880/940 Reflective SpO2Module Operational Principle

AECG100 Test System Operational Principle.

PPG-2TF-660 Transmission SpO2Module Operational Principle

*The number of illustrated LEDs on the DUT and PPG-2TF-660 is for reference only. The illustration aims to indicate optical heart rate signals or SpO2simulation.

  • AECG100
  • HRS200
  • HRS100+

WhaleTeq PPG Simulator series is the test instrument designed for wearable with PPG HRM function and PPG sensor manufacturers. It is used in production / QA / R&D to verify PPG HRM function. The series uses optical signals with different modes and parameters to simulate different skin tones.

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HRS200
Advanced PPG heart rate simulator to verify accuracy and algorithm of wearable with heart rate measurement function. Suitable for R&D and production line testing

Datasheet

HRS100+

PPG Heart Rate Simulator designed for wearable with heart rate measurement function. Applicable for production line testing.

Datasheet

Health Wearables Testing (AECG100)

Datasheet

The Innovative simulator to output ECG and PPG analog signals simultaneously. Adjustable time difference parameters to generate various Pulse Wave Transit Time (PWTT) signals. Standard Coverage: IEC 60601-2-47, China YY0885. Applicable for R&D, compliance and production line testing
  • 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 SpO2testing
  • Adjustable PWTT parameters allows user to check and improve the algorithm of blood pressure applications
  • Developing R curves of device under test (DUT) for SpO2monitors’ verification and validation testing
  • 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
  • DFS200 Defibrillator / AED Handheld Tester
  • DFS100 Defibrillator / AED Handheld Tester
  • DFS360 Defibrillator / AED Production Line Tester
  • AIMS-AED intelligent management system
  • WAIOT-N / AED NB-IoT Module

WAIOT-N / AED NB-IoT Module

Datasheet

Whaleteq Defibrilator

DFS360 Defibrillator / AED Production Line Tester

Datasheet

DFS100 Defibrillator / AED Handheld Tester

The AED inspection tester easily and quickly verifies whether the installed AED is functioning normally. It is suitable for all AED brands on the market and is dedicated to after-sales service. It generates three kinds of ECG signals, VT, VF, and NSR. In addition, it can receive AED defibrillation shocks. The user may define pass-criteria of AED shock energy to ensure that the AED works in the normal range.

  • Applicable to all AED brands on the market
  • With 3 ECG modes: VT (ventricular tachycardia), VF (ventricular fibrillation) or NSR (normal sinus rhythm)
  • The colors of the LED light indicate whether the shock energy meets self-defined pass-criteria
  • Self-defined pass-criteria range can be adjusted between 40 and 360 joules
  • Arbitrary connection without distinguishing polarity
  • The product is only 330g and can be operated with one hand
  • Plenty of air outlet improve heat dissipation and dust-proof
  • Safety design in line with international standards to ensure user safety
  • Detachable cables for easy storage
    Note: The DFS100 PC Software is solely for customized setting. It does not include testing functions.

Datasheet

HFPA150

The standard required that the manufacturer to test the thermal performance and contact impedance in regards to NE (Neutral Electrode).

WhaleTeq already developed HFPA150, a neutral electrode impedance tester, to test as per requirements of IEC60601-2-2.

Furthermore, 2 netual electrode tests can be completed along with HFPA150 and specified equipment.

Whaleteq
Whaleteq

HFPA150

Simple and convenient neutral electrode contact impedance tester. Standard Coverage : IEC 60601-2-2

  • Designed according to IEC60601-2-2:2009 clause 201.15.101.6 for testing NE contact impedance.
  • Outputs 200mA into 0-50 ? 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,

Datasheet

Establishing UDI is the most important task for medical device manufacturers at present. However, there is no system on the market that can manage UDI digitally. Manufacturers need to gather relevant departments to spend a lot of time discussing and formulating processes and forms. Using Excel can’t meet the traceability and management requirements of ISO13485 / QMS, and there is also a risk of typos and data missing.

UDiBar- UDI generator and label management system can quickly solve the above-mentioned problems. UDiBar not only conforms to the world’s trend of digitalization, but also integrates UDI regulatory requirements, helping users to complete UDI editing and create compliant barcodes effectively. Users can design and edit label base maps. By using a database, users can also manage and track production barcodes efficiently, transferring the data to a format that conforms to the national medical database. This system can also be combined with ERP to effectively reduce labor costs.

RDCA Database Comparison Software

A quick tool to compare database test result and perfect algorithm. Standard Coverage : IEC 60601-2-47, ANSI / AAMI EC57, YY 0885. Applicable for R&D and compliance testing.

  • Support comparisons of TAF (Test Annotation File), which is generated by DUT algorithms from either digital or analog database signal input, to RAF (Reference Annotation File).
  • 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.
Whaleteq Software