Test Solutions Medical Device Manufacturers Product Catalog Wearable Device
Open the catalog to page 1Medical Device Test Solutions ECG Technology Medical Device Test Solutions / Medical Device Test Solutions / Health Wearables Test Solutions ECG, PPG and PWTT Technologies Medical Standard Cross-reference Table
Open the catalog to page 3WHALETEQ 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 Company Profile WHALETEQ Co., LTD concentrates on providing test solutions for vital...
Open the catalog to page 4Verify 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,...
Open the catalog to page 5Including 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. OWSETT UTSKRIFT ,££2. FRYS TEST MODUS
Open the catalog to page 6Verify and Validate Your Product Design with Ease Test Solutions Medical Device Manufacturers Common Mode Rejection Ratio Tester SECG Assistant SECG Enhancement Software Pack RDCA Rhythm Database Compliance Analyzer Software High Frequency Coupling Network IEC Test Report Form Generator Test Fixture Analyzer Software MECG 2.0 ECG Database Player
Open the catalog to page 7SECG 5.0 AIOECG Performance TesterThe 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...
Open the catalog to page 8Verify and Validate Your Product Design with Ease SECG 5.0 AIO Specifications Parameter System Capability / Notes Main output voltage accuracy Main output voltage resolution (DAC resolution) Frequency / pulse repetition rate accuracy Pulse duration / timing accuracy (excluding pacing) Pacing pulse width accuracy Pacing pulse amplitude accuracy, range Pacing pulse characteristics Rise/fall time 5µs Overshoot <1% Settling time <1% Pacing pulse overshoot (intentional) Resistor tolerance Capacitor tolerance Sample rate DC offset (fixed, noise free, sourced from internal super capacitor) DC offset...
Open the catalog to page 9SECG 4.0ECG Performance TesterThe 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...
Open the catalog to page 10Verify and Validate Your Product Design with Ease SECG 4.0 Specifications Parameter Specification System Capability / Notes Main output voltage accuracy Main output voltage resolution (DAC resolution) Frequency / pulse repetition rate accuracy Pulse duration / timing accuracy (excluding pacing) Pacing pulse width accuracy Pacing pulse amplitude accuracy, range Pacing pulse characteristics Rise/fall time 5qs Overshoot <1% Settling time <1% Pacing pulse overshoot (intentional) Resistor tolerance Capacitor tolerance Precision 250:1 divider Sample rate DC offset (fixed, noise free, sourced from internal...
Open the catalog to page 11MECG 2.0ECG Database PlayerThe 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 - 0.15pV...
Open the catalog to page 12Verify and Validate Your Product Design with Ease MECG 2.0 Supported Medical Databases DB Full Name of Database Clinical Trial Subject Calibration and Analytical ECGs Biological ECGS Common Standards for Quantitative Electrocardiography American Heart Association Massachusetts Institute of Technology – Beth Israel Hospital Creighton University Noise Stress Test European Society of Cardiology Evaluation of Ventricular Arrhythmia Detectors Arrhythmia Database Sustained Ventricular Arrhythmia Database Noise database (only supplied with the MIT–BIH database) ST-T Database Test Requirements by standards...
Open the catalog to page 13CMRR 3.0+Common Mode Rejection Ratio TesterThe 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...
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