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WHALETEQ SECG 5.0 AIO, User Manual

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WHALETEQ SECG 5.0 AIO User Manual Download Page 27

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SECG 5.0 AIO | User Manual

Language Selection

SECG 5.0 AIO has 3 different languages for selection. Press the button and select the 
required language.

Standard Assistant

SECG 5.0 AIO is equipped the new medical standard assistant software supporting IEC 60601-
2-25/27/47and YY1079/0782/0885. The testing parameters, options, procedures and pass 
criteria are exclusively programmed for test clauses in different medical standards. This is to 
assist user to simplify the test effort. 

The new medical standard assistant software shall be purchased separately from SECG 5.0 
AIO. 

Summary of Contents for SECG 5.0 AIO

Page 1: ...SECG 5 0 AIO User Manual WHALETEQ Single Channel ECG Test System SECG 5 0 AIO User Manual Version 2020 12 31 Software Version 1 1 22 9 ...

Page 2: ... Product Microsoft Net Framework 4 0 Installation 11 Connecting to the ECG 12 Set up a Low noise Test Environment 12 Software Update 12 Main Screen 13 Description of Functional Groups 14 2 6 1 Signal Parameters 14 2 6 2 Signal add on 17 2 6 3 Output Lead Electrode 20 2 6 4 Output Summary 20 2 6 5 Output Waveform Display 20 2 6 6 Play Stop Button 21 Special Functions 21 2 7 1 Standard Waveforms 21 ...

Page 3: ... SECG 5 0 AIO 31 Terminals of P1 P2 and P6 32 4 Software Development Kit SDK 32 5 Calibration and Validation 32 6 Trouble Shooting 33 7 Caution 33 8 Ordering Information 33 Standard accessories 33 Optional Software and Accessories 34 9 Version information 34 10 Contact WhaleTeq 34 ...

Page 4: ...ange of single channel performance tests in IEC YY JJG standards The basic range of tests in the standards include for example Sensitivity accuracy of the mV mm indication Frequency response sine wave and impulse tests Input impedance Noise Multichannel cross talk Accuracy of heart rate indication Pacemaker rejection Tall T wave rejection For a full list of tests refer to the standard together wit...

Page 5: ...ion A is not provided This is considered an error in the standard due to the loading effect of R2 Instead the DC offset is provided in series with output as per Figure 201 106 IEC 60601 2 27 2011 Patient monitoring 201 7 9 2 9 101 b 4 and 6 special test waveforms for Figure 201 101 201 12 1 101 all performance tests except baseline noise and CMRR tests No known limitations IEC 60601 2 47 2012 Ambu...

Page 6: ...output 1mV 1mV output RCA2 Monitor x 250 To monitor the applied signal 1mV 250mV output 3 USB Type B receptacle connector To connect with PC and allow PC software to control SECG 5 0 AIO Before operating PC software mode it requires to switch to PC left side of DIP SWITCH and an additional description SIMULATION MODE will be shown on the title bar of touch screen ...

Page 7: ...bility Notes Main output voltage accuracy 1 for amplitudes of 0 5mVpp or higher 0 3 Main output voltage resolution DAC resolution N A 2 5µV Frequency pulse repetition rate accuracy 1 0 1 Pulse duration timing accuracy excluding pacing 1ms 0 2ms Pacing pulse width accuracy 5µs 1µs Pacing pulse amplitude accuracy range 2mV pulse 1 2mV pulse 10 Range 2mV to 700mV 2mV pulse 0 3 100mV pulse 1 or 5mV Pa...

Page 8: ...m2 300V 105 Length 3m MAX Note Use the power cord with the plug style that matches the power socket where the equipment is located and the compatible power cord corresponds to the AC voltage of the power outlet and has been approved by and complies with the safety standards in the country of purchase Product Label Separate equipment from other waste The equipment that needs to be recycled includes...

Page 9: ...by conductive dust rain or snow Pollution degree Pollution degree 2 as defined in IEC 61010 1 The evaluation is limited to indoor and dry environments Cleaning method Please keep the surface of the product clean and dry Please remove the input signal before cleaning the product Please check the instrument frequently as required by the operating conditions To clean the external surface follow these...

Page 10: ...B port 2 1 2 SECG 5 0 AIO PC Software Installation Please follow the below steps to download and execute SECG Software Download SECG 5 0 software from WhaleTeq website Open the file explorer and select to the download location Extract the file to your assigned folder Open the destination folder and make sure the all files are unzipped in the same folder Double click on SingleChannelECG5 0 exe to e...

Page 11: ...ue to follow the instructions to finish the installation There may be a warning that the driver is not recognized by Windows and this can be ignored Please click here to watch the tutorial video Microsoft Windows 7 Windows 7 can t recognize SECG unit please download mchpcdc inf from WhaleTeq website This driver is provided by Microchip for using with PIC microprocessors having built in USB functio...

Page 12: ...e frame ground or EP terminal of the ECG device under test With this set up turn the ECG device under test to maximum sensitivity turn off the ac filters if possible and confirm that the level of noise is acceptable for tests For most tests this set up is satisfactory without any special efforts However for the input impedance test with the 620kΩ is in series the imbalance in impedance can cause h...

Page 13: ...ad the latest software from WhaleTeq website Extract the zip file to a USB flash disk and make sure this APK file is in the root directory Once you plug this USB flash disk into SECG 5 0 AIO a notification window shall prompt to update to the latest software Press install to complete the process Main Screen ...

Page 14: ... is limited to prevent overlapping pulses Amplitude Adjusts the waveform amplitude from 0 to 20mV at a 0 01mV resolution For all waveforms the amplitude represents the peak to peak value For example for a 1mV sine wave the actual waveform varies between 0 5mV and 0 5mV This correlates with testing requirements in standards Pulse Width Applies to rectangle triangle and exponential pulse waveforms o...

Page 15: ...val current QRS value 900ms T Duration Allows setting of the amplitude of the T Wave in ECG waveforms to verify tall T wave rejection ability of patient monitors according to IEC 60601 2 27 Maximum amplitude is 5mV For the heart rate accuracy test in IEC 60601 2 27 a T wave component is not required In this case set the T wave to zero As IEC60601 2 27 requires a special waveform please turn on the...

Page 16: ...Hz or BPM Rectangle pulse Parameters are amplitude mVpp pulse width ms and frequency Hz or BPM Triangle pulse Parameters are amplitude mVpp pulse width ms and frequency Hz or BPM Exponential Parameters are amplitude mVpp pulse width ms and frequency Hz or BPM ECG This waveform is based on IEC60601 2 27 Figure 201 110 and 201 113 Parameters are amplitude mVpp and frequency Hz or BPM QRS interval an...

Page 17: ...set The maximum voltage is 1000mV In the condition of setting DC offset to 300mV the DC offset is sourced from an internal super capacitor which at least 3 minutes of accurate and stable 300mVdc offset to be placed in series with the main waveform without impacting the quality of that main waveform Pacing Waveform Parameters ...

Page 18: ...eates an overshoot according to Method A of IEC 60601 2 27 0 25 of the pacing amplitude or 2mV whichever is smaller Pacing rate synchronized with main function If the Synchronized with main function checkbox is ticked the pacing pulse will be synchronized with the main function such as the ECG waveform in IEC 60601 2 27 If this box is not ticked the user can set the pacing rate independent of the ...

Page 19: ...e changes of human breathing via variable resistance The change is based on a basic resistance level with variations Frequency of resistance variation is the same as the preset respiration frequency Wave Modulation Method Baseline Simulate the human breathing changes via baseline changes of ECG waveform Amplitude Simulate the human breathing changes via the amplitude of ECG R wave Frequency Simula...

Page 20: ...idea of the waveform details User can also click Save as Script to save the waveform settings as an individual file The script file can be loaded in the auto sequence function Please refer to section 2 7 6 for details 2 6 5 Output Waveform Display The output display provides an image similar to that provided by ECGs The sensitivity of the display range may be set at 5mm mV 10mm mV or 20mm mV to co...

Page 21: ...equires to press the STOP button first and then adjust the waveform settings Special Functions 2 7 1 Standard Waveforms SECG 5 0 is loaded with a series of waveforms including ANSI AAMI waveforms partial CAL waveforms and HRV patten waveforms 2 7 2 File Replay Select the file for playback in this window Currently support file formats for txt bin hea and edf and the maximum sampling numbers are 100...

Page 22: ...ls As SECG 5 0 AIO is a single channel simulator the number is 1 as a fixed value Signal Description The description text for the signal sample data 1 The raw data unit is mV and the data range for ECG testing is 20 20 mV sample data 2 The raw data unit is mV and the data range for ECG testing is 20 20 mV sample data N The raw data unit is mV and the data range for ECG testing is 20 20 mV RAW Data...

Page 23: ...is bigendian high byte first 2 s compliment The maximum size of loaded file is 100 million samples 2 7 3 NST Noise This is to superimpose NST noise to testing signal Provide EM Electrode Motion Artifact BW Baseline Wander and MA Muscle Noise for selection Operation Procedures 1 Select Waveform User can select waveform in Standard or File Replay tab 2 Select noise type 3 Adjust SNR parameter ...

Page 24: ...diate change of switch and the heart rate shall be affected Hence we suggest to conduct an individual test for 2mV In our experience we suggest the interval for at least 30 seconds User shall conduct a quick test to verify the trend mode can display the issue ex Set a wrong heart rate for 10 seconds and assure the patient monitor can detect the wrong heart rate Please note that most patient monito...

Page 25: ...rt rate lower than 30 BPM Elapsed time of 0 30BPM is over 30 seconds As 0 refer to infinite frequency the scan shall start at 3 BPM Sine Scan This is for IEC60601 2 51 test or to verify the frequency response As SECG use fixed sampling rate for 5Khz this shall reduce the beating issue from other digital sources ...

Page 26: ...o open the selected output electrode so that ECG device can check the electrodes automatically 2 7 6 Auto Sequence This function is to load up to 1 000 script files for playback The testing time for each script file can be set and the sequences can be saved to file ...

Page 27: ... AIO is equipped the new medical standard assistant software supporting IEC 60601 2 25 27 47and YY1079 0782 0885 The testing parameters options procedures and pass criteria are exclusively programmed for test clauses in different medical standards This is to assist user to simplify the test effort The new medical standard assistant software shall be purchased separately from SECG 5 0 AIO ...

Page 28: ...t with WhaleTeq and confirm the medical standards your required to test Step 2 An email will be sent to your mailbox Please save the attachment file to the root directory of a USB drive Then plug the USB drive to SECG 5 0 AIO An update window shall be displayed Press OK to active the software 2 9 2 Standard Assistant Software Please follow the operation instruction 1 Select the required medical st...

Page 29: ...Page 29 of 34 SECG 5 0 AIO User Manual 2 Preset the function parameters of ECG DUT 3 Select test clause 4 Click the test column ...

Page 30: ...automatically 6 Fill in the test value 7 Export Test Values After completed all the required test the test values can be saved and exported to a file User can use WhaleTeq TRF generator software to import the test values and generate IEC format test report accordingly ...

Page 31: ...eferred to in the three IEC ECG related standards the intended function and settings in WhaleTeq s Single Channel ECG 2 25 Figure106 2 27 Figure105 2 47 Figure101 Function WhaleTeq SECG Settings S2 S S2 Connects the function generator to the ECG Automatically connected when function is selected S5 S1 None Shorts out the 100kΩ allows large signals The SECG automatically selects Ch1 for small signal...

Page 32: ...to P1 with RA LA and LL to P2 and V2 V6 are connected to terminal P6 along with RL N A more reasonable interpretation would be to follow the diagram and test each LEAD wire in turn first RA then LA LL V1 etc with all unused LEAD wires connected to P2 4 Software Development Kit SDK WhaleTeq provides Windows SDK Software Development Kit for SECG 5 0 AIO test system All test parameters correspond to ...

Page 33: ... to conduct Electrostatic Discharge ESD test This may cause unexpected damages to test equipment Please contact WhaleTeq for alternatives before ESD test For operating Firmware Update feature there are risks of losing data if improper options are performed during the Firmware Update period Warranty void if QC PASS label is removed or tampered with If the equipment is used in a manner not specified...

Page 34: ...t Software SECG5 Assistant YY0782 SECG Assistant Software SECG5 Assistant YY0885 9 Version information Version Modify content Issue date 20200928 First release 20200928 20201231 Add Chap 1 6 1 7 1 8 Chap 5 Calibration and Validation Chap 6 Trouble shooting Chap 7 Caution Chap 8 Ordering information Chap 9 Version information Remove Chap 1 9 Merged to Chapter 7 Notes 20201231 10 Contact WhaleTeq WH...

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