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

WhaleTeq ECG test solution is exclusively for manufacturers and certification laboratories. Our test solution verifies ECG devices with the most advanced assistant software, including performance tester SECG 5.0 AIO and SECG 4.0, ECG database player MECG 2.0, common mode rejection ratio tester CMRR 3.0+, medical database comparison software RDCA/CDCA and HFCN test fixture.

Moreover, WhaleTeq TRF Generator software is the ultimate test solution for compliance testing required by IEC 60601-2-25, IEC 60601-2-27, and IEC 60601-2-47 - simplifies all your efforts to conduct testing and generate TRF reports, and works with the SECG 5.0 AIO, the SECG 4.0, and the CMRR 3.0+.

Common Mode Rejection Ratio (CMRR)

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.

SEEG 100E

High-performance device specially designed for EEG testing and calibration

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-2TF-660 2.0

Transmittance SpO2 Module

With accumulated knowledge of test equipment and medical regulations, WhaleTeq offers a series of test systems for verifying all kinds of wearable devices. While the HRS series adopt Photoplethysmography (PPG) technology to verify the HRM accuracy of wearable devices, the AECG100 not only generates accurate PPG signals but also can output ECG and PPG signals simultaneously with the capability of adjusting Pulse Wave Transit Time (PWTT), managing to evaluate and improve either the system performance or the algorithm of blood pressure or arteriosclerosis. 

To meet mass-production needs from manufacturers, the WECG400, the first parallel testing ECG tester designed for production lines, can simultaneously test ECG function on up to 4 wearable devices with a single computer to accelerate testing time and optimize testing efficiency.

AECG100

The Innovative simulator to output ECG and PPG analog signals simultaneously

BPA700 NIBP Simulator & Analyzer

The ISO/TS 81060-5-compliant NIBP simulator is designed to simulate various blood pressure and measurement scenarios while providing compliance tests according to IEC 80601-2-30 and YY9706.230 medical standards.
This significantly boosts the efficiency of blood pressure monitor development and compliance verification processes.

Highlights

Flexible Pulse Envelope Settings and Test Automation

 
BPA700 NIBP Simulator & Analyzer with Flexible Pulse Envelope Settings and Test Automation
  • Adjustable pulse envelope to customize simulated blood pressure
  • Software development kits (SDKs) for developing automated testing programs
  • Auto Sequence function — creates automated testing without coding

Reliable Repeatability and Reproducibility Ensures Compliance

BPA700 NIBP Simulator & Analyzer Reliable Repeatability and Reproducibility Ensures Compliance
  • NIBP simulator standard ISO/TS 81060-5 compliant
  • Optional Standard Assistant Software — simplifies the IEC 80601-2-30 and YY9706.230 compliance tests and exports test reports  >> Learn More
  • A wide range of dynamic and static pressures simulates various blood pressure levels

 

Industry-first Validation Using Raw Data Playback

BPA700 NIBP Simulator & Analyzer with Industry-first Validation Using Raw Data Playback
  • Raw data playback — testing with blood pressure raw data allows NIBP algorithm optimization and lower clinical trial costs
  • Raw data recording — creates databases for future validation

UDiBar

WhaleTeq’s UDiBar is a labeling software designed specifically for medical device manufacturers, helping you quickly create and manage labels that comply with UDI regulations. From UDI code design, label version control to printing records and traceability queries, you can finish them all in one place, helping you quickly establish compliance processes with minimal investment and reducing the risk of errors.
  • UDI Encoding and Labeling
  • UDI Label Printing
  • UDI Database Management
  • Flexible Configuration of Database Backup
  • UDI Barcode Check
Details

The standard requires the manufacturer to test the thermal performance and contact impedance in regard to NE (Neutral Electrode). WhaleTeq developed the HFPA150, a neutral electrode impedance tester, to test as per the requirements of IEC 60601-2-2. Furthermore, two neutral electrode tests can be completed along with the HFPA150 and specified equipment.

HFPA150

The simple and convenient neutral electrode contact impedance tester.
  • Designed according to IEC 60601-2-2:2009 clause 201.15.101.6 for testing NE contact impedance
  • Outputs 200mA into 0—50Ω load from 50kHz—5MHz
  • Equipped with DDS (direct digital synthesis) technology for a stable frequency output
  • Inbuilt current monitor port eliminating the need for expensive current probes
Details