The Accurate and Compliant Test Solution Provider 2018 Product Catalog
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02 03 05 06 WhaleTeq Company Profile WhaleTeq Global Customers WhaleTeq Test Solutions WhaleTeq Medical Device Test Solution 06 ECG Technology 22 EEG Technology 26 ESU Active Accessories 30 WhaleTeq Healthcare Wearable Test Solution 30 PPG Technology 36 ECG, PPG and PWTT Technology 42 Medical Standard Cross-reference Table 1
WhaleTeq Company Profile The Accurate and Compliant Test Solution Provider WhaleTeq Co., Ltd. is founded by a team of experts specializing in test equipment and medical certifications. We strive to offer simple, accurate, and compliant test solutions to help customers save time, increase design quality, and go to market with efficiency. We design, produce, and sell reliable test solutions for medical devices and healthcare wearables all around the world since 2013. 2
WhaleTeq Global Customers WhaleTeq has been devoting to ECG standard testing tools for years and is the global leading provider offering qualified test tools for medical device manufacturers and laboratories. In 2014, we expanded our product lines to provide test solutions of healthcare wearables. During the period we firstly launched the optical heart rate simulator with PPG technology, capable of verifying heart rate accuracy in a measurable way. Till now, over 400 customers in 30 countries already adopted WhaleTeq's test solutions and proved WhaleTeq is capable of delivering effective test tools to reduce customer's efforts in testing. 3
WhaleTeq provides test solutions of accuracy and compliance with medical standards We strive to make your work easy. With our test solutions, engineers will be able to focus either on product design or product quality. No extra efforts getting acquainted with the standards and regulations. Also, our test solutions are also proved to be simple and accurate to decrease operating costs in the production line. WhaleTeq provides total test solutions for R&D, quality assurance, and production line! - founder of WhaleTeq, Nathan Lin 4
WhaleTeq Test Solutions Medical Device Test Solutions In accordance with international and China medical standards, WhaleTeq launched a series of test solutions regarding performance tests, database playback, database comparison and common mode rejection ratio test. Waveforms and parameters are all followed the requirement of medical standards. Healthcare Wearable Test Solutions Along with the popularization of telemedicine and IoT, new medical technology is going to be emerging in a foreseen future. Although there're no regulations or standards yet, WhaleTeq provides test solution of various test parameters and raw-data playback function to allow user to identify the specification and characteristics of DUT. 5
Medical Device Test Solution ECG Technology Including ECG performance tests, database waveform simulation, database comparison and common mode rejection ratio test. Compliant with the requirements of international medical standards of IEC 60601-2-25, -2-27, -2-47, YY1079, YY1139, YY0782, YY0885, etc. 6
SECG 4.0 ECG Performance Tester SECG Assistant SECG Enhancement Software Pack MECG 2.0 ECG Database Player CDCA CTS/CSE Database Compliance Analyzer Software CMRR 3.0 Common Mode Rejection Ratio Tester HFCN High Frequency Coupling Network Test Fixture RDCA Rhythm Database Compliance Analyzer Software 7
SECG 4.0 ECG Performance Tester Standard Coverage: IEC 60601-2-25 IEC 60601-2-27 IEC 60601-2-47 AAMI EC11 AAMI EC13 AAMI EC38 AAMI EC57 YY1079 YY1139 YY0782 YY0885 JJG 760 JJG 1042 The Accurate and Comprehensive Tool Designed for ECG Compliance Tests Features and Benefits 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 allows output amplitude and frequency accuracy < ± 1%. DC offset and pacemaker signal output can be adjustable. Load and replay customized ECG waveforms. Alternative input of external generator for arbitrary waveforms. Software Development Kit (SDK) allows user to develop customized automatic test software with less efforts. 8
We Simplify and Explain the Procedures to Save Your Time SECG 4.0 Specifications Parameter Main output voltage accuracy Main output voltage resolution (DAC resolution) Specifications ±1% for amplitudes of 0.5mVpp or higher 2.5µV Frequency / pulse repetition rate accuracy ±1% Pulse duration / timing accuracy (excluding pacing) Pacing pulse width accuracy Pacing pulse amplitude accuracy, range Pacing pulse characteristics ±1ms ±5µs ±2mV pulse: ±1% >2mV pulse: ±10% Range: ±2mV to ±700mV Settling time <1% Overshoot <1% Rise/fall time 5µs Pacing pulse overshoot (intentional) Method A according to IEC 60601-2-27 Resistor tolerance ±1% Capacitor tolerance ±5% Precision 1000:1 divider (100KΩ:100Ω) ±0.1% Sample rate 5kHz ± 0.1% DC offset (fixed, noise free, sourced from internal super capacitor) DC offset (variable, may include up to 50µVpp noise) Power supply Environment 300mV ± 1% Setting ±1% or ±3mV USB +5Vdc supply (no separate power supply required) 0.5A (high power mode) 15 ~ 30 C 30 ~ 80% RH 9
MECG 2.0 ECG Database Player Standard Coverage: IEC 60601-2-25 IEC 60601-2-47 AAMI EC57 YY0782 YY0885 A True Analog ECG Database Generator for Your System Validation and Software Algorithms Evaluation Features and Benefits ECG database generator for diagnostic and ambulatory ECG. Generate waveforms simultaneously up to 8 channels and support 12 lead ECG. Embedded CAL, ANE, NST and biological waveforms. Directly support AHA, MIT, CU and PhysioNet format databases Extreme accuracy of output voltage accuracy < ± 8uV. Support raw-data playback function for user to play recorded waveforms from clinical trials. Software Development Kit (SDK) allows user to develop customized automatic test software with less efforts. 10
We Simplify and Explain the Procedures to Save Your Time MECG 2.0 Supported Medical Databases DB Full Name of Database Purpose Source # of Records Standards Test Requirements by standards CTS Clinical Trial Subject Calibration and Analytical ECGs Corscience 19 (3 ANA waveforms and 16 CAL waveforms) IEC60601-2-25 Amplitude,global interval and duration CSE Common Standards for Quantitative Electrocardiography Biological ECGS INSERM 100 IEC60601-2-25 Global interval AHA American Heart Association Evaluation of Ventricular Arrhythmia Detectors ECRI 80 (35 min each) IEC60601-2-47 QRS, HR, VEB, VF MIT- BIH Massachusetts Institute of Technology Beth Israel Hospital Arrhythmia Database MIT-BIH 48 (30 min each) IEC60601-2-47 QRS, HR, VEB, VF,SVEB, AF CU Creighton University Sustained Ventricular Arrhythmia Database MIT-BIH 35 (8 mins each) IEC60601-2-47 VF NST Noise Stress Test Noise database (only supplied with the MIT BIH database) MIT-BIH 12 ECG (30 min each) + 3 noise IEC60601-2-47 QRS, HR, VEB, SVEB, AF ESC European Society of Cardiology ST-T Database CNR, MIT- BIH 90 (2 hour each) IEC60601-2-47 ST segment deviations or changes MECG 2.0 Specifications Item Details / Reference Value Output Channels The 8 output channels are provided through a network as specified in IEC 60601-2-51 to provide signals to 10 lead electrodes; in the device under test, this will be displayed as 12 leads. 8 outputs 10 lead electrodes 12 leads Voltage accuracy IEC 60601-2-51 specifies a limit of ±1%, but does not provide a lower limit (all systems must have a lower limit). An inferred specification of 1% ±5µV is derived from the device under test specification in IEC 60601-2-51 of 5% ±25µV. ±1% (>800µV) ±5µV ( <500µV) ±8µV (<800µV) Output noise level 0-150Hz Output noise should not influence the test. A value 5µV is suitable for this requirement. Can be verified by monitoring the signal in the device under test using a diagnostic filter setting. <5µV Time accuracy IEC 60601-2-51 does not provide any limits. An inferred limit from the device under test. An inferred limit of ±1% is used. The system s design accuracy exceeds 0.1% as a 100ppm crystal reference is used. ±1% Sampling rate A maximum sampling rate of 1kHz matches the sampling rates of ECG files. 1kHz (8 channels) Power supply Powered from the USB supply (5V 0.2A) N/A Environment Intended for normal laboratory environment. The selection of critical components such as reference voltages, DAC, precision resistors are known to be stable in the range shown. 15-30 C 10-95% RH 11
CMRR 3.0 Common Mode Rejection Ratio Tester Standard Coverage: IEC 60601-2-25 IEC 60601-2-27 IEC60601-2-47 IEC 60601-2-26 YY1079 YY1139 YY0782 YY0885 ANSI / AAMI EC11 ANS I / AAMI EC13 The CMRR Tester Combining Accuracy, Convenience and Test Automation All Together Features and Benefits Designed for ECG, Patient Monitor, Holter and EEG CMRR and system noise testing. Double shielding structure to avoid internal and external noise interference. Built-in calibrated sine wave generator and Vc voltage measuring circuit to assure output accuracy level Adjustable knobs to select test standards and test parameters in standalone usage. CMRR Assistant software pack to simplify the standard into adjustable parameters and selectable options. Software Development Kit (SDK) allows user to develop customized automatic test software with less efforts. 12
We Simplify and Explain the Procedures to Save Your Time CMRR 3.0 Specifications Item Option Specifications Supply voltage 0.5 / 2.828 / 20 / 2 / (70.71) (Vrms) ±1% CM point voltage 1.414 / 10/ 1/ (35.355) (Vrms) ±1% ( 0.25Vrms ±2% ) Frequency 50 / 60 / 100 /120 (Hz) ±1% Electrode with Impedance Using knob to change electrode None/RA/LA/LL/V1/V2/V3/V4/V5/V6 /ALL Electrode without Impedance Using knob to change electrode RA/LA/LL/V1/V2/V3/V4/V5/V6 Imbalance impedance, R 51kΩ 51kΩ ±1% Imbalance impedance, C 47nF 47nF ± 5% DC offset Internal battery powered, can be added on RA/ LA/LL/V1 300mV ± 1% Up to 40hrs with intermittent use Voltage divider 11:1 using 110MΩ:10MΩ Ratio accuracy ±2% Environment Intended for normal laboratory environment. The selection of critical components is known to be stable in the range shown. The 110MΩ divider may be affected by high humidity in excess of 85% 15-30 C 10-75% RH CMRR Assistant Software Pack Allows User to Test with Ease Follow the instruction step by step to proceed required tests Detailed test sequences for user to test with confidence 13
HFCN Test Fixture High Frequency Coupling Network Test Fixture Standard Coverage: IEC60601-2-25 IEC60601-2-27 YY1079 AAMI EC13 Designed for testing electrosurgical interference with ECG devices and patient monitor Features and Benefits Elaborated design offers convenience and safety. Dual modules to support different standard requirements. Built-in skin impedance 51k/47nF. Simulate 1mV ECG signal for ESIS. Power rating >300W and resistor inductance <5μH. 14
We Simplify and Explain the Procedures to Save Your Time HFCN Test Fixture Completely Compliant with: ESIO test of IEC 60601-2-25, IEC 60601-2-27, YY1079 and AAMI EC13 ESIS test of YY1079 and AAMI EC13 15
SECG Assistant SECG Software Enhancement Pack Standard Coverage: IEC60601-2-25 IEC60601-2-27 IEC60601-2-47 YY1079 YY1139 YY0782 YY0885 JJG760 JJG1042 Increase the Test Efficiency with Less Efforts Features and Benefits Software enhancement pack to use with SECG 4.0. Simplify test sequences of medical standards into parameters and selectable options. Assist user to get acquainted with medical standards and decrease the overall testing time. 16
We Simplify and Explain the Procedures to Save Your Time Click to Complete the Required Tests with Proper Parameters Test Procedures and Pass Criterion to be Displayed for User to Test with Ease 17
CDCA CTS/CSE Medical Database Compliance Analyzer Software Standard Coverage : IEC 60601-2-25 YY 0782 A Quick Tool to Compare Database Test Result and Perfect Algorithm Features and Benefits Support digital and analog data input to ensure your algorithm fully meet the standard requirements. Test data can be imported automatically via the pre-defined file format or input manually. Intuitive software interface allows user to complete the comparison within a few mouse clicks. Comparison result can be exported to a report file. 18
We Simplify and Explain the Procedures to Save Your Time Supported Standards and Test Clauses Standard Test Clause 201.12.1.101.2 Requirements for amplitude measurements IEC60601-2-25: 2011201.12.1.101 201.12.1.101.3.1 Requirements for absolute interval and wave duration Measurements 201.12.1.101.3.2 Requirements for interval measurements on biological ECGS 50.101.2 Requirements for amplitude measurements 振幅测量的要求 YY 0782-2010 (IEC60601-2-51: 2003) 50.101 50.101.3.1 50.101.3.2 50.101.4 Requirements for absolute interval and wave duration Measurements 绝对间期和波形时限测量的要求 Requirements for interval measurements on biological ECGS 实际人体心电图时限测量的要求 Requirement for Noise 抗噪声测量稳定性的公布要求 4 Steps to Complete the Database Comparison 1 2 3 4 1 2 3 4 Select standard and test clause Click Import Testing Data "button to get ECG testing data Click Compare button to start the comparison Test Result to be displayed or exported to a report file 19
RDCA Rhythm Database Compliance Analyzer Software Standard Coverage : IEC 60601-2-47 ANSI / AAMI EC57 YY 0885 A Quick Tool to Compare Database Test Result and Perfect Algorithm Features and Benefits Support digital and analog data input to ensure your algorithm fully meet the standard requirements. AI sync function unifies original TAF into comparable TAF. Discrepancy data and discrepancy 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. 20
We Simplify and Explain the Procedures to Save Your Time Supported Standards and Test Clauses Standard Test Clause Clause Name IEC60601-2-47 : 2012 201.12.1 Accuracy Controls and Instruments ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST segment measurement Algorithms YY0885-2013 50.101 自动分析 AI Sync function intelligently optimize the label position and time difference of TAF file 4 Steps to Complete the Database Comparison 3 2 1 Test Annotation File 4 1 2 3 4 Get Test Annotaion File (TAF) from ECG DUT Load TAF of ECG DUT Compare TAF with RDCA built-in Referernce Annotation File (RAF) Get Comparision Result 21
Medical Device Test Solution EEG Technology Including EEG performance test and compliant with international medical standard of IEC 60601-2-26 22
SEEG100 EEG Performance Tester 23
SEEG 100 EEG Performance Tester Standard Coverage : IEC 60601-2-26 Your EEG Simulator Designed for Regulation Testing Features and Benefits Designed according to latest EEG regulation standard IEC 60601-2-26:2012 Sophisticated electrical design enables the test system to output 1µV signal 9 channels with auto-select switches for users to test performance individually Built-in test circuits as defined in EEG standards with selection of 620kΩ/4.7nF for input impedance test Good shielding and grounding designs allow for higher accuracy A real-time single channel player for PhysioNet's EDF format waveforms and text/binary format waveforms IEC 60601-2-26 helper makes the test sequences easier than ever 24
We Simplify and Explain the Procedures to Save Your Time Simple and Effective Tool to Verify EEG Performance Adjustable parameters per IEC 60601-2-26 required Load customized waveform format Real-time waveform display Easy to download PhysioNet waveforms via EDF File Manager Optional IEC 60601-2-26 helper simplifies the medical standard into required parameters, test sequences and pass criteria SEEG 100 Specifications Parameter Main output voltage accuracy Main output voltage resolution (DAC resolution) Specifications ±1% for amplitudes of 0.2mVpp or higher 0.5µV Frequency / pulse repetition rate accuracy ±1% Pulse duration / timing accuracy ±1ms Resistor tolerance ±1% Capacitor tolerance ±5% Precision 1000:1 divider (100KΩ:100Ω) ±0.2% Sample rate 5kHz ± 0.1% DC offset (fixed, noise free, sourced from internal super capacitor) Power supply Environment 300mV ± 1% USB +5Vdc supply (no separate power supply required) 0.5A (high power mode) 15 ~ 30 C 30 ~ 80% RH 25
Medical Device Test Solution ESU Active Accessories Designed for IEC 60601-2-2 and Capable of generating signals with frequency ranging from 50 khz to 5 MHz, producing current over 200 marms, and sine wave with THD < 0.3%. 26
HFPA150 Neutral Electrode Impedance Tester 27
HFPA150 Neutral Electrode Impedance Tester Standard Coverage : IEC 60601-2-2 Simple and Convenient NE Contact Impedance Tester Features and Benefits 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 28
We Simplify and Explain the Procedures to Save Your Time Required Test Equipment Combination 201.15.101 NEUTRAL ELECTRODES HFPA150 Scope DC PS Thermal meter 201.15.101.6 NE contact impedance HFPA150 Test Setup HFPA150 Specifications Parameter Frequency range Maximum voltage Maximum Current Waveform Frequency Response THD Impedance Auxiliary equipment for contact impedance test Specifications 50 khz to 5 MHz 11 Vrms (~31 Vpp), 50 Ω >200 marms, 50 Ω Sine < ±0.8 db, 50 Ω <0.3% (-50.4 db), at 200 marms, 50 Ω, 1 MHz <3.2Ω + j0.4 μh Oscilloscopes (Ch1 connects with voltage probe to measure voltage, Ch2 connects with HFPA150 current monitoring BNC connector to measure the current value) Accuracy < ± 5% Frequency Range Connector Type Power Source Environment 50 khz to 5 MHz BNC Power Adapter Input: 100 240 V, 50/60 Hz Output: 12 VDC / 2 A 15 ~ 30 C 30 ~ 80% RH 29
Healthcare Wearable Test Solution PPG Technology Designed for wearable with heart rate measurement function. WhaleTeq s PPG heart rate simulator not only offers adjustable parameters but also several features to verify your wearable design. 30
HRS200 Advanced PPG Heart Rate Simulator HRS100+ PPG Heart Rate Simulator 31
HRS200 Advanced PPG Heart Rate Simulator Effectively Verify Accuracy and Algorithm of Wearable with Heart Rate Measurement Function Features and Benefits Built-in LED to generate PPG waveform signals as the reflected optical signal of human skin Built-in photodiode to detect and display DUT LED behavior and brightness Built-in 40 clinical database records for AF, APC, VPC, and 1stAV block Adjustable parameters of heart rate (BPM), reflected skin brightness and PI (AC/DC) Raw data playback to validate system and improve algorithm effectively Command mode allows to conduct test quickly and repeatedly Noise simulation with adjustable amplitude parameter 32
We Simplify and Explain the Procedures to Save Your Time The Effective Tool for Validation and Verification Various types of waveforms with noise simulation Raw-data playback function allows to play recorded clinical waveforms repeatedly Easy to use commands to create customized test sequences Built-in 40 clinical database records (Optional) HRS200 Specifications Parameters Supported range / types Accuracy BPM 30 300 BPM ( PC Software ); 30~240 BPM ( Standalone Usage ) ±1 BPM DC - HRS mode - Fine Tune mode 1 20 Level 100 mv 2500 mv N/A ±5 mv PI - HRS mode 0.1% 20% ( AC/DC, differs with DC level ) N/A AC - Fine Tune mode 0.75 mv 25 mv ( BNC measurement is magnified 100 times ) ±0.05 mv Lumen 50 800 Lux ( 5 mm from diffusion film ) ±3 % Light Wavelength 525nm ±10 nm PD Sampling Rate <8 ksps ( Normal Mode of PC Software ) 30 ksps ( High Resolution Mode of PC software ) ±5μS S/N Ratio >51 db (with USB isolator) N/A Power - USB - Battery Type BAA battery x 3 N/A N/A Size (W x H x D) 13.5 (cm) x 7.6 (cm) x 6.12 (cm) N/A Temperature 10 C ~ 40 C N/A 33
HRS100+ PPG Heart Rate Simulator Effectively Verify Accuracy of Wearable with Heart Rate Measurement Function Features and Benefits Built-in LED to generate PPG waveform signals as the reflected optical signal of human skin Built-in photodiode to detect and display DUT LED behavior and brightness Adjustable parameters of heart rate (BPM), reflected skin brightness and PI (AC/DC) 34
We Simplify and Explain the Procedures to Save Your Time The Effective Tool for Validation and Verification Adjustable DC, PI and BPM parameters with photodiode detection function Easy to use commands to create customized test sequences HRS100+ Specifications Parameters Supported range / types Accuracy BPM 30 300 BPM (PC Software); 30~240 BPM (Standalone Usage) ±1 BPM DC 1 20 Level N/A PI 0.1% 20% (AC/DC, differs with DC level) N/A Lumen 50 800 Lux (5 mm from diffusion film) ±3 % Light Wavelength 525nm ±10 nm PD Sampling Rate <8 ksps (Normal Mode of PC Software) 30 ksps (High Resolution Mode of PC software) ±5μS S/N Ratio >51 db (with USB isolator) N/A Power - USB - Battery Type BAA battery x 3 N/A N/A Size (W x H x D) 13.5 (cm) x 7.6 (cm) x 6.12 (cm) N/A Temperature 10 C ~ 40 C N/A 35
Healthcare Wearable Test Solution ECG, PPG and PWTT Technology Designed for wearable with measurement function of multiple vital signs. WhaleTeq AECG series provide ECG, PPG and PWTT signals to verify system performance and algorithm thoroughly. 36
AECG100 ECG, PPG and PWTT Multifunction Tester 37
AECG100 The Innovative Simulator to Output ECG and PPG Analog Signals Simultaneously Standard Coverage : IEC 60601-2-47, China YY0885 Adjustable time difference parameters to generate various Pulse Wave Transit Time (PWTT) Signals Features and Benefits 38 Compatible with healthcare wearables with ECG and PPG technologies. AECG100 includes ECG module of built-in test circuits with auto-select switches per ECG standard required and PPG module of carrying single channel or dual channel optical signals. AECG100 single channel PPG module offers optical waveforms simulating heart rate signals and dual channel PPG module offers optical waveforms simulating SpO2 signals. Exclusive adjustable PWTT parameters allows user to improve the blood pressure measurement algorithm effectively. Test parameters can be saved and loaded as a series of customized test sequences to decrease labor time and prevent from human negligence. Raw-data playback reproduces and repeats precious recorded waveforms from clinical trials in a easy way. AECG Assistant software pack helps user to proceed IEC and YY standard tests by clicking a few mouse clicks. Software Development Kit (SDK) allows user to develop customized and automatic test program with less efforts.
We Simplify and Explain the Procedures to Save Your Time AECG100 Test System AECG100 Green LED PPG Module AECG100 ECG Module Built-in photodiode and green LED Photodiode detects DUT's LED brightness and behaviors Green LED simulates PPG heart rate signals with various parameters AECG100 Red and IR LED PPG Module Built-in photodiode, Red LED and IR LED Photodiode detects DUT's LED brightness and behaviors Red LED and IR LED simulates SpO2 signals with various parameters ECG Test Mode Adjustable test parameters and various waveforms are designed to meet the requirements of IEC 60601-2-47 and China YY0885 medical standards USB Connection Pulse Wave Transit Time Test Mode Output ECG and PPG analog signals simultaneously Time difference between ECG and PPG waveforms can be adjustable. USB Connection 39
We Simplify and Explain the Procedures to Save Your Time Reflective SpO2 Test Mode SpO2 test mode is only available when connecting with R/IR PPG module Adjustable AC, DC and PI values in both channels User can import and play programmed R-curve USB Connection PPG Heart Rate Test Mode Adjustable PPG waveforms and parameters Offer basic waveforms and simulated noise signals USB Connection Auto-sequence Test Mode Program a test of selected test items in preferred sequence and duration time. Simply click Play button to proceed required tests USB Connection 40
We Simplify and Explain the Procedures to Save Your Time AECG Assistant Software Simplify medical standards into parameters and selectable options. Simply click to proceed the required test with confidence. Software Development Kit All test parameters correspond to specific SDK commands Allow PC to communicate with DUT and receive raw data from DUT through SDK and USB connection User can develop automatic testing software to control AECG100 and DUT DLL(Dynamic-link library) shared library supported for efficient program binding and version upgrade Support C/C++ header and C# interface 41
42 ECG Medical Standard Cross-reference Table
The Accurate and Compliant Test Solution Provider 43
We Simplify and Explain the Procedures to Save Your Time IEC60601-2-25:2011 (DIAGNOSTIC ECG) Test Clause SECG 4.0 MECG 2.0 CMRR 3.0 CDCA 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 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 IEC60601-2-27:2011, 3RD EDITION (MONITORING ECG) Test Clause SECG 4.0 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 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 44
We Simplify and Explain the Procedures to Save Your Time IEC60601-2-47:2012 (AMBULATORY ECG) Test Clause SECG 4.0 MECG 2.0 CMRR 3.0 RDCA 201.12.1.101.1.2.1 The accuracy of QRS detection O 201.12.1.101.1.2.2 The accuracy of heart rate measurements O 201.12.1.101.1.2.3 The accuracy of VEB detection O 201.12.1.101.1.2.4 Claime to detect ventricular flutter or fibrillation (VF) 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 201.12.1.101.1.5.1 Required statistics O 201.12.1.101.1.5.2 Requirements for all arrhythmia algorithms O 201.12.1.101.1.5.3 Requirements for algorithms with optional capabilities O 201.12.1.101.1.6 Simulated test patterns O 201.12.1.101.2.1 Use of standard databases O O 201.12.1.101.2.2 Use of annotation files O 201.12.1.101.2.3 Beat-by-beat comparison O 201.12.1.101.2.3.1 General description O 201.12.1.101.2.3.2 Method for beat-by-beat comparison O 201.12.1.101.2.3.3 Heart rate, and heart rate or RR interval variability O 201.12.1.101.2.3.3.1 Heart rate measurement O 201.12.1.101.2.3.3.2 Heart rate variability or RR interval variability measurement test Patterns O 201.12.1.101.2.4 Run-by-run comparison O 201.12.1.101.2.4.1 General description O 201.12.1.101.2.4.2 Terms and symbols O 201.12.1.101.2.4.3 Run sensitivity summary matrix O 201.12.1.101.2.4.4 Run positive predictivity summary matrix O 201.12.1.101.2.5 VF and AF comparisons O 201.12.1.101.3 Physician report minimum requirements O 201.12.1.101.3.1 Heart rate O 201.12.1.101.3.2 Supraventricular ectopy O 201.12.1.101.3.3 Ventricular ectopy O 201.12.1.101.3.4 Bradycardia data O 201.12.1.101.3.5 PAUSES O 201.12.1.101.3.6 ST SEGMENT shifts O 201.12.1.101.3.7 ECG hard copy O 201.12.4.4 Incorrect output 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 45
We Simplify and Explain the Procedures to Save Your Time YY0782-2010 记录和分析型单道和多道心电图机 Test Clause SECG 4.0 MECG 2.0 CMRR 3.0 CDCA 50.101 心电图的自动量测 O 50.101.1 用来评估心电图自动测量准确性的标准数据库 O 50.101.2 振幅测量的要求 O 50.101.3.1 绝对间期和波形时限测量的要求 O 50 工作數據的準確性 50.101.3.2 实际人体心电图时限测量的要求 O 50.101.4 抗噪声测量稳定性的公布要求 O 50.102 心电图的自动解释 O 50.102.1 衡量心电图自动诊断准确度指标的定义 O 50.102.2 公开预期用途 O 50.102.3.1 形态诊断用心电图数据库 O 50.102.3.2 公开解释诊断准确性的要求 O 50.102.4.1 节律诊断用心电图数据库 O 50.102.4.2 公开节律诊断准确性的要求 O 51.101.2.2.1 Goldberger 及 Wilson 导联 O O 51.101.2.3 恢复时间 O 51.102.1 输入阻抗和导联网络阻抗 O 51.104.2 灵敏度的稳定性 O 51.104.3 灵敏度的精确度 O 51.105.1 共模抑制 O 51.105.2 过载容限 O 51 危险输出的防护 51.106.4 基线 : 噪声电平 O 51.106.5 描记速度与轨迹宽度 O 51.106.6 多道心电图机的道间干扰 O 51.107.1.1.1 高频响应 O 51.107.1.1.2 低频 ( 脉冲 ) 响应 O 51.107.2 线性和动态范围 O 51.107.3 最小信号响应 O 51.108.4.1 直角坐标, 描记点的对齐 O 51.108.4.4 记录速度 O 51.109.1 在有心脏起搏器的情况下使用 心电波形失真 O 51.109.2 在有心脏起搏器的情况下使用 起搏脉冲的可见性 O 46
We Simplify and Explain the Procedures to Save Your Time YY0885 2013 (IEC60601-2-47: 2001) 动态心电图机 Test Clause SECG 4.0 MECG 2.0 CMRR 3.0 CDCA 50.101 自动分析 O 50.101.1 用于评估自动分析的标准数据库 O O 50.101.2 性能报告要求 O 50.101.2.1 用于性能测试的标准数据库 O O 50 工作数据的准确性 50.101.2.2 记录比对结果 O 50.101.2.3 统计 O 50.101.2.4 测试方法 O 50.101.3.1 心率 O 50.101.3.2 室上性异位 O 50.101.3.3 心室异位 O 50.101.3.4 心动过缓数据 O 50.101.3.5 停搏 O 50.101.3.6 ST 段偏移 O 50.101.3.7 ECG 备份 O 51.5.1 动态输入范围 O 51.5.2 输入阻抗 O 51.5.3 共模抑制 O 51.5.4 增益准确度 O 51 危险输出的防护 51.5.5 增益稳定性 O 51.5.6 定标信号 O 51.5.7 系统噪声 O 51.5.8 道间干扰 O 51.5.9 频率响应 O 51.5.10 最小检测信号 O 51.5.11 起搏脉冲显示能力 O 51.5.15 时间轴对齐 O 47
We Simplify and Explain the Procedures to Save Your Time YY1079 2008 (ANSI/AAMI EC13: 2002) 心电监护仪 Test Clause SECG 4.0 CMRR 3.0 4.1.2.1 c) 高大 T 波的抑制能力 O 4.1.2.1 e) 心率计准确度和对心律不齐的响应 O 4.1.2.1 f) 心率计对心率变化的响应时间 O 4.1.2.1 g) 心动过速报警的启动时间 O 4.1.4 起搏器脉冲抑制能力 O 4.1.4.3 起搏脉冲检测器对快速心电图信号的抑制 O 4.2.2 过载保护 O 4.2.5.1 QRS 波幅度和宽度范围 O 4.2.5.2 工频电压容差 O 4.2.5.3 漂移容差 O 4.2.6 心率计的范围和准确度 O 4.2.7.3 报警限误差 O 4.2.7.4 心动停止报警的启动时间 O 4.2.7.5 心率低报警的启动时间 O 4.2.7.6 心率高报警的启动时间 O 4.2.7.7 报警静音 O 4.2.8.1 输入动态范围 O 4.2.8.2 输入阻抗 O 4.2.8.3 系统噪声 O 4.2.8.4 多通道串扰 O 4.2.8.5 增益控制和稳定性 O 4.2.8.6 时间基准选择和准确度 O 4.2.8.7 输出显示 O 4.2.8.8 输入信号重建准确度 O 4.2.8.9 定标电压 O 4.2.8.10 共模抑制 O 4.2.8.11 基线控制和稳定度 O 4.2.8.12 起搏脉冲显示能力 O 48
We Simplify and Explain the Procedures to Save Your Time YY1139 2012 (ANSI/AAMI EC11:1991) 心电诊断设备 Test Clause SECG 4.0 CMRR 3.0 4.2.3 输入动态范围 O 4.2.4.1 增益设置和准确度 O 4.2.4.4 增益稳定性 O 4.2.5 时间基准选择和准确度 O 4.2.6.3 轨迹宽度和可视性 O 4.2.6.4 直角坐标 / 记录点对齐 O 4.2.7.1 系统误差 O 4.2.7.2 频率和脉冲响应 O 4.2.7.3 导联权重因子 O 4.2.7.4 滞后 O 4.2.8 定标电压 O 4.2.9 输入阻抗 O 4.2.11 共模抑制 O 4.2.12.1 电缆, 电路和输出显示噪声 O 4.2.12.2 多通道串扰 O 4.2.13.1 基线控制和稳定度 : 复位 O 4.2.14.1 过载保护 : 交流电压 O 4.2.14.3 起搏脉冲显示能力 O 49
We Simplify and Explain the Procedures to Save Your Time JJG 760-2003 心电监护仪 Test Clause SECG 4.0 CMRR 3.0 5.3.3.1.1 电压测量误差的检定 步进增益转换式 O 5.3.3.1.2 电压测量误差的检定 连续可调增益转换式 O 5.3.3.2 极化电压引起的电压测量偏差的检定 O 5.3.3.3 噪声电平的检定 O 5.3.3.4 扫瞄速度误差的检定 O 5.3.3.6.1 监护导联幅频特性的检定 O 5.3.3.6.2 标准心电导联幅频特性的检定 O 5.3.3.7 共模抑制比的检定 O 5.3.4.1 心率显示值误差的检定 O 5.3.4.2 心率显报警发生时间检定 O 5.3.4.3 心率报警预置值的检定 O 5.3.5.1.1 电压测量误差的检定 步进增益转换式 ( 描笔式心电图记录部分 ) O 5.3.5.1.2 电压测量误差的检定 连续可调增益转换式 ( 描笔式心电图记录部分 ) O 5.3.5.2 记录速度误差的检定 ( 描笔式心电图记录部分 ) O 5.3.5.3 时间常数的检定 ( 描笔式心电图记录部分 ) O 5.3.5.4 滞后 ( 描笔式心电图记录部分 ) O 5.3.5.5.1 监护导联幅频特性的检定 ( 描笔式心电图记录部分 ) O 5.3.5.5.2 标准心电导联幅频特性的检定 ( 描笔式心电图记录部分 ) O 5.3.5.6 移位非线性偏差的检定 O 5.3.5.7 基线漂移的检定 O 5.3.5.8 共模抑制比的检定 O 50
We Simplify and Explain the Procedures to Save Your Time JJG 1041-2008 数字心电图机 Test Clause SECG 4.0 CMRR 3.0 4.1 内定标电压误差 O 4.2 输入电压范围 O 4.3 耐极化电压 O 4.4 加权系数误差 O 4.5 内部噪声电平 O 4.6 波形识别能力与幅度 - 时间参数测量 O 4.7 幅频特性 O 4.8 时间常数 O 4.9 心率测量误差 O 4.10 共模抑制比 O JJG 1042-2008 动态 ( 可移动 ) 心电图机 Test Clause SECG 4.0 CMRR 3.0 4.1 最大输入范围 O 4.2 最小描记灵敏阈 O 4.3 耐极化电压 O 4.4 输入阻抗 O 4.5 灵敏度误差 O 4.6 灵敏度稳定度 O 4.7 定标电压 O 4.8 频率响应 O 4.9 过冲 O 4.1 滞后 O 4.12 硬拷贝描记速度误差 O 4.13 道间串扰 O 4.14 共模抑制比 O 4.15 系统噪声电平 O 4.16 起搏脉冲顺应性及检测能力 O 51
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