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1. Note for most tests CAL ANE waveforms are alternates For two tests may be required 201 12 4 102 3 test of lead networks and 201 12 4 105 3 test of ringing from mains notch filter 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 use WhaleTeq CMRR 2 0 for these tests Clause s Limitations Notes For 201 12 4 10 large dc offset test the SECG is limited to 1Vdc However this is almost certainly enough to exceed the point of saturation For the test circuit in figure 201 110 switch position 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 See section 3 2 for notes on switching between P1 P2 and P6 No known limitations AJ Single Channel ECG Test System User Manual WHALETEQ IEC 60601 2 47 2012 201 12 4 all tests except No known limitations Ambulatory CMRR use WhaleTeg CMRR 2 0 for these tests For all 201 12 1 101 database tests use WhaleTeg MECG 2 0 for these tests ANSI AAMI EC 13 All performance tests See below for Clauses 2002 R 2007 C2008 except CMRR and as noted 5 1 4 n and 5 2 9 1 f g left j General limitation this equipment is designed for use with isolated ECG circuits as are generally provided for medical ECG If applied to a no
2. Display IEC60601 2 25 jEC60601 2 27 EC60601 2 47 20mm mV 10mm mV 4mmimV 201 124 101 Indication of inoperable electrocardiograph Parameter Settings 201 12440232 Goldberger and CAL10000 CAL20000 CAL50000 LA Vi OV2 OV3 OV4 OV5 RET CAL10000 0 9 mV lt Vp ORS lt 1 1 mV PASS RA R RA R GYS BILEDI CAL20000 1 8 mV lt Vp ORS lt 2 2 mV PASS 60 BPM 201 124 1024 Recovery time Parameter Settings Pulse Width S2 post ve hes 7 nr 201 124 103 7 C204 THF RAIE cut y gd Input im n 1007 ms on shorted RLN 5 47nF output UNCG9601 g 31 53 307 2 peda ce aramealne Settings n 201 12 4 105 2 S A z ME Overload tolerance QRS D Paci Snige pulse QRS oaos acing Amplitude Pacing Duration TR pulse Mains Fi ney Filter Off 1002 ms 0S mv 20 gt ms fa gaen 1eguency scans Parameter Settings S 201 124 106 2 T Wave Overshoot Time Constant Pacing Rate 020 mv 0S ms BPM e spe 2011241071114 High freguency response Parameter Settings 201424107 1 4 2 Low frequency impulse response Parameter Settings 2 8 SECG 4 0 L05 5 lead Options The standard equipment covers 12 leads 10 terminals Lower cost versions have 5 leads This option is identical except that the output relays have not been fitted The outputs are as follow 5 lead Output to RA LA LL RL and V1 only switched impedance in the same terminals The breakout box ter
3. This will open another window display the details of each test steps for your engineering needs 201 12 4 102 3 2 Goldberger and Wilson leads 1 Select special waveform CAL 10000 CAL20000 CAL50000 as the out 2 Select RA LA LL V1 V2 V3 V4 V5 or V6 as the output lead wire 3 Measure Vp Peak voltage of R wave and S wave Measure Vp CAL10000 0 9 mV lt Vp ORS lt 1 1 mV PASS 1 8 mV lt Vp ORS lt 2 2 mV PASS CAL50000 4 5 mV lt Vp QRS lt 5 5 mV PASS RA Measure LA Measure LL Measure lead fil V1 Measure lead V1 V2 Measure lead V2 V3 Measure lead V3 V4 Measure lead V4 VS Measure lead V5 V5 Measure lead V5 V6 Measure lead V6 2011241024 Recovery time 201 12 4 103 Input impedance Parameter Settings 201 12 4 106 2 Overtoad tolerance Mains Frequency Filter Off Parameter Settings 5 201 124 106 2 Channel crosstalk Parameter Settings 201424107 11 freguency response Parameter Settings 201124107 11 2 Low frequency impulse response Parameter Setters A Step 7 _ When you have completed testing click Finish and proceed to the next desired test 25 aT WHALETEQ Single Channel ECG Test System User Manual 201 12 4 102 3 2 Goldberger and Wilson LEADS Parameter Setting Main Function Select Special Special CAL20000 4mVpp Waveform Pass Criterion Measure lead 9mm 0 9mV lt Vp 1 QRS lt 11mm 1 1mV
4. It is limited to 1000mV The Common mode to RL N places the 300mV offset in series with the RL N as per IEC 60601 2 25 switch position C in Figure 201 110 Switch position A in Figure 201 110 of IEC 60601 2 25 is not implemented This is considered an error in the test circuit as the output will be loaded by R2 resulting in a reduction in the applied voltage of 2 1 Instead users should continue to test with the DC offset in series as per Figure 201 106 2 6 3 Input impedance test This check box allows the user to switch in an impedance of 620kO 4 7nF in series with the main function for testing the input impedance of the ECG device under test When the check box is ticked the impedance is shorted The 300mVdc offset can be used in conjunction with this test Helen 2 6 4 Output lead electrode Output Lead Electrode This section allows the user to select which lead electrode the output is connected to e g terminal P1 in the IEC 60601 2 25 Figure 201 106 Unselected electrodes are connected to the system ground terminal P2 in Figure 201 106 More than one lead electrode may be selected For example if it is desired to have Lead I and Lead II have a positive indication LA and LL can be selected Note In version 4 0 the signal can no longer be output to RL since this is normally not used for measurement 16 aT WHALETEQ Single Channel ECG Test System User Manual 2 6 5 Lead electrode impedance
5. gt 22 aaa Pass results of calibration are automatically copied to the notepad and stored in a text file at c WhaleTeq SECG_Cal_yyyymmdd txt where yyyymmdd is the date based on the PC s system If a fixed width font such as Courier New is used the data appears aligned The following manual procedure is retained here for reference and explanation The calibration mode does not include pacemaker rise time which is included in the manual procedure here 37 aT WHALETEO Calibration procedure Parameter Nominal value tolerance RL N 51kQ 1 resistance Lead 47nF 2596 impedance capacitors Input 620kN 1 impedance resistor Input 4 7nF 5 impedance Capacitance Precision 1000 1 0 1 divider ratio 100kQ 100Q Single Channel ECG Test System User Manual The 51kQ can be measured between any lead electrodes and RL N terminals Note the resistors used are usually accurate to 0 1 but the measured value will be closer to 51 22kOdue to the inclusion of a 2200 resistor used for dc offset This remains in tolerance The 47nF can be measured between RA and RL N using a calibrated capacitance meter at 1kHz This can be measured as follows e Set Main function to Off e Set output to RA e Open switch S2 input impedance test e Measure the resistance between RA and LL Measure as for the 620kO above using a capacitance meter at 1kHz Note there is ab
6. 2014 01 01 Re layout and produce in production line AJ Single Channel ECG Test System User Manual WHALETEQ 2014 05 01 Release new software option SECG Assistant for quick preset parameter settings for IEC60601 2 25 2 27 and 2 47 2014 09 01 Release new software version 4 9 1 0 Add Load ECG file function and it allows users to upload and play your own ECG files with Text amp Binary formats Multiple language support Add Simple Chinese and Traditional Chinese 2 Setup 2 1 Software installation 2 1 1 System requirements The Single Channel ECG system uses a normal PC to interface and control the USB module The PC should meet the following requirements Windows PC XP or later Microsoft NET 2 0 or higher Administrator access if necessary for installation of software driver 512MB RAM or higher Free USB port 2 1 2 _SECG 4 0 PC Software Software can be downloaded from the WhaleTeg website Download i Click the Download link and download the file onto your computer i Browse to the download location i Unzip the file SECG_AP_V5 0 0 1 zip to your destination folder i Open the destination folder and make sure the all files are unzipped in the same folder i Double click on the SingleChannelECG exe to execute the SECG4 0 program 2 Relative to normal PC processing there is no special use of PC speed However there has been noted a slow increase in system RAM usage over long per
7. Active Key D9F8E5A65C1FD67999B7 2 7 2 SECG Assistant Operation Step 1 Click the SECG Assistant button to initiate the SECG Assistant software from the main screen The first thing you will see is that we have pre programmed all the test clauses required for testing your ECG Additionally all parameters within the test clause are listed clearly for your reference Compare to others you can save valuable time from sorting through all the standards to find out the specific requirements 23 aT WHALETEQ Single Channel ECG Test System User Manual Step 2 All test clauses in IEC 60601 2 25 27 and 47 are programmed for your convenience to test your ECG Choose IEC60601 2 25_ EC60601 2 27 IEC60601 2 47 201 12 4 101 Indication of inoperable electrocardiograph Parameter Setti 201 12 4 102 3 2 the specific test clause you needed Goldberger and Wilson leads Seagal Wevelans CAL10000 CAL20000 CAL50000 the Goldberger and Wilson leads is ee et ein ct er area Ca oe used as an example RUN Test Sequence Pass Criterion 201 12 4 102 4 Recovery time Parameter Settings 201 12 4 103 Input impedance Parameter Settings Step 3 201 12 4 105 2 ae Overload tolerance After you have selected the specific ee z test clause you can see that all MENAS _ Parameter Settings necessary parameters have been pre iat programmed for that clause Choose
8. Not used in Version 4 0 In version 3 0 the user could select to include 51k 47nF in series with the output electrodes as reguired in IEC 60601 2 51 However all standards are now harmonized and use the same test circuit with 51k 47nF only in RL neutral electrode 2 6 6 Pacing parameters Pacing Amplitude Pacing Duration Sinlge pulse z Double pulse o mw 202 ms C pee cledd e Double pulse Overshoot Time Constant Pacing Rate 250ms advanced 0H ms 60 BPM fy Synchroriaed with main function In general a pacemaker pulse can be added to any main function sine triangle ECG etc with the following parameters Pacing amplitude This can be set in steps of 2 ranging from 700 to 700mV When set to zero the pacing function is turned off regardless of other pacemaker settings When set at 2 or 2mV the pacing pulse comes from the main 1000 1 divider which is accurate to better than 1 For settings above 2mV the output comes from Ch2 which has a design accuracy of 196 or 25mV Pacing Duration Can be set between 0 1 and 2 0ms covering the range reguired by all standards Overshoot time Settings from 2ms to 100ms creates an overshoot constant according to Method A of IEC 60601 2 27 0 25 of the pacing amplitude or 2mV whichever is smaller Pacing rate If the Synchronized with main function checkbox is synchronized with ticked the pacing pulse will be synchronized with the main function mai
9. an error which has been corrected in the 2011 edition In that edition the system is adjusted to provide an 80 of the display at 10mm mV However the 2011 edition does not verify the range is 5mV or the rate of change So we can expect this test to be modified again in the future 50 102 3 Input impedance For this test noise can be a problem due to the large imbalance in impedance to each lead electrode Increased efforts to screen the environment may be necessary The ac filter should be enabled It is easy to overlook that the test is reguired at both 0 67Hz and 40Hz Generally there is no measurable reduction at 0 67Hz however at 40Hz around 1096 reduction in the signal when S2 is opened is normal For ease of measurement time base settings should be adjusted to suit the freguency e g use 12 5mm s for 0 67Hz and 50mm s for 40Hz 50 102 4 Input noise For this test the USB module can be disconnected from the PC to eliminate any possible noise source In the unpowered condition all inputs are connected to RL N through 51kO 47nF resistors are reguired by the standard Measurement of noise using printouts or screen may be difficult even at maximum sensitivity as the pixels resolution may be close to the limit Options include scanning of printouts or using special software which allows the raw data to be inspected 7 An imbalance of impedance degrades the eguipment common mode rejection ration which is the
10. case repeat the process ensuring sufficient time for the PC to recognize the USB module prior to starting the WhaleTeq software 2 3 Connecting to the ECG For connecting the ECG device under to the USB module use the ECG breakout box provided If purchase includes only the SECG then the breakout box for 12 leads will have 10 terminals corresponding to RA LA up to V6 If the purchased set includes the WhaleTeg CMRR 2 0 then there may be additional terminals for CMRR use only and also an additional breakout box only for CMRR purpose This will depend on the set and standards selected For SECG use only the box marked for General purpose and use only the terminals marked for RA V6 Alternately the ECG device under test can be directly connected to the USB module using a male D15 connector The pin outs are 10 AJ Single Channel ECG Test System User Manual WHALETEQ 1 RA 4 RL 7 V4 10 V1 o o 2 LA 5 V6 8 V3 11 NC 3 LL 6 V5 9 V2 12 GND Note for systems after 2011 09 10 V1 V6 are reversed as shown above Also pin 12 is the system ground 11 AJ Single Channel ECG Test System User Manual WHALETEQ 2 4 Environment noise reduction A noise free environment is necessary for testing ECG equipment This can be achieved relatively easily by a using a metal bench or metal sheet underneath the ECG device under test and the WhaleTeg SECG test unit and b connecting SECG GND termi
11. components tested is such that no effect 30 80 RH design not from the environment is tested expected Safety EMC standards No applicable safety standards maximum internal voltages 12Vdc For EMC no testing performed CE marking based on careful selection of parts including USB protection IC as well as special filters to reduce noise from microprocessor 8MHz and DC DC converter 200kHz Due to the low volume of production testing is not warranted Additional specifications may be provided on request 1 5 Revision history 2011 11 23 Software upgrade for the following e Correct setting of T wave amplitude during Auto Pacing mode previous software set this to 0 0mV should be 0 2mV Correct mode selection due to addition of ANSI AAMI exponential waveform in the main function list some automated features selected the incorrect mode 2011 09 26 Software upgrade for the following Added functions for ANSI AAMI EC 13 2011 08 11 Software upgrade for the following e Reduction in streaming interruptions Software controlled calibration procedure Added new software functions for IEC 60601 2 27 2011 heart rate testing Updated software functions to better suit IEC 60601 2 51 2012 09 07 Editorial corrections add new section for options 2012 07 19 Updated for SECG 4 0 2012 08 29 Corrected editorial errors change pictures diagrams to SECG 4 0 and added section on terminals P1 P2 and P6
12. reason why the CMRR test is performed with 51kO in one lead only A value of 620kO is very large and hence noise is to be expected An improved test would see the 620kO 4 7nF split into a balanced 310kO 2 35nF in each lead which would still allow input impedance to be measured 31 aT WHALETEO Single Channel ECG Test System User Manual 50 102 5 50 102 6 50 102 8 a 51 102 7 Time base Multichannel cross talk Gain control and stability Freguency response For this test refer to Table 110 in IEC 60601 2 51 to understand the relationship between voltages applied to lead electrodes and the LEADS indicated on the screen With the test as initially instructed there should be no indication on LEAD I of the display All other LEADS Il lll etc should have some indication The 2011 edition has completely updated this test and is worth checking for reference Use either a triangle or sine wave not specified in the standard as the selection does not impact the test Printing devices may have some variation particular around page folds so it is important to test using the 25Hz waveform in the standard However for testing the screen it may be that the width of line prevents individual lines from being seen clearly The nature of the screen is such that variations are not expected so a test at 1Hz e g a 100ms rectangle pulse with a freguency of 1Hz may be sufficient to measure the actual time base Al
13. standards terminals P1 P2 and P6 are defined However in some of the tests it is unclear if unused electrodes should be connected to terminal P2 or P6 IEC 60601 2 25 Clause 201 12 4 103 Input impedance provides an example case At first the test states that Compliance is checked using the test circuit of Figure 201 106 In that figure it clearly states that terminals P1 and P2 are for LEAD WIRES while P6 is intended only for the NEUTRAL ELECTRODE or RL N However the test then goes on to say Connect the sine wave signal generator to any tested LEAD P1 and P2 with all other LEAD WIRES connected to the N RL LEAD WIRE P6 The interpretation here is complicated as a LEAD refers to the displayed ECG waveform not specific electrodes Using Table 201 106 we can infer that for example LEAD V1 involves V1 RA LA LL but not V2 V6 The interpretation could be then that V1 should be connected 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 Similarly the test for multichannel crosstalk uses confusing English Connect all unused PATIENT ELECTRODE connections via P2 to the NEUTRAL ELECTRODE through a parallel combination of a 51 kO resistor and a 47 nF capacitor This could be interpreted to mean
14. 27 a T wave component is not required In this case set the T wave to zero 3 To minimise ringing due to ECG notch filters rectangle pulses have a rise time of 1ms This means that a 20ms rectangle pulse will actually have a 21ms base and a 19ms at the top of the pulse This definition ensures that the pulse integral matches the setting e g a 3mV 100ms pulse will have an integral of 300uVs 4 Note the sampling rate is limited to 0 2ms Therefore a 2ms pulse will have limited time resolution gt This range has increased to include 10ms to allow for the new heart rate test in IEC 60601 2 27 2011 a ORS of 10ms should not provide any heart rate 15 aT WHALETEQ Single Channel ECG Test System User Manual 2 6 2 DC offset setting This function allows the operator to switch in a dc offset In the default condition not variable only 300mV O or DC Offset Setting of 300mV can be set In this mode the dc offset is sourced from an E internal super capacitor which at least 3 minutes of accurate j Common mode and stable 300mVdc offset to be placed in series with the main to RLZ WN G 3 waveform without impacting the quality of that main waveform The capacitor is charged while not in use i e when the setting is zero In the variable mode the dc offset is provided by a second channel This mode is intended only for investigation into the point in which LEADS OFF or similar alarms are provided
15. 40H H Freguency scans Sine Sat 067 He Stop 150 0041 He Duration Ws E ECG 3 30bpm 305 Scan Frequency Hz BFM Single Channel ECG Test System User Manual Baseline reset test sine wave only When checked the parameters are ignored and a large signal of 1Vpp 0 354Vrms is applied It is intended to test the ECG s response to overload in particular automated resetting of baseline due to high pass filtering When unchecked the system reverts to the previous settings e g 1mVpp 10Hz signal Mains frequency of the test can be selected from 50Hz or 60Hz Mains noise ECG 2 27 waveform only When checked adds small sine wave at mains freguency of 50Hz or 60Hz Range is from 0 05 0 2mVpp additional range added for EC 13 Note settings of 80Hz and 100Hz are used for calibration of capacitors only not intended for testing ECGs AAMI EC 13 Drift test ECG 2 27 waveform only when checked adds 4mVpp 0 1Hz triangle waveform to the ECG signal for testing baseline drift Dynamic Range Test Square wave only when checked adds a 1mVpp waveform at the frequency indicated 20 30 or 40Hz intended for combination with an adjustable sguare wave for testing Clause 51 107 2 in IEC 60601 2 51 Freguency scans Sine may be used with IEC 60601 2 51 tests or to test systems with extended freguency response This system uses a fixed sampling rate of 5kHzwhich has been found to reduce problems of beating fro
16. EQ Ise Japan 2 Date yyyy mm dd 2013 07 19 3 Reference equipment MQ 014 4 Room temperature C 27 5 Room humidity RH Sem m 51 6 Tests by Peter Selvey 7 SECG Serial No a 2013 011 See 8 RL Resistance kQ 51 00 1 51 20 0 4 Pass 9 Input imp rest kQ 620 0 1 620 1 0 0 Pass 10 RL Capacitance nF 47 0 5 46 8 0 45 Pass 11 Input imp cap nF 4 70 5 4 78 1 7 Pass 12 Change to mVdc oan aa None es reguired 13 Output voltage mVpp 0 500 0 502 0 4 Pass 14 Output voltage mVpp 1 000 1 001 0 1 Pass 15 Output voltage mVpp 2 000 2 005 0 2 Pass 16 Output voltage mVpp 3 000 3 011 0 4 Pass 17 Output voltage mVpp 4 000 4 007 0 2 Pass 18 Output voltage mVpp 5 000 5 009 0 2 Pass 19 Output voltage mVpp 7 000 7 011 0 2 Pass 20 Output voltage mVpp 10 000 10 004 0 0 Pass 21 Fixed DC offset mV 300 0 300 0 0 0 Pass 22 Variable DC offset mV 200 5 197 14 5 Pass 23 Variable DC offset mV 600 5 598 0 3 Pass 24 Variable DC offset mV 1000 5 998 0 2 Pass 25 Variable DC offset mV 200 5 204 2 0 Pass 26 Variable DC offset mV 600 5 604 0 7 Pass 27 Variable DC offset mV 1000 5 1003 0 3 Pass 28 Pre divider out Vdc 10 000 10 003 Sam 29 Divider ratio 1000 0 2 1000 1 0 0 Pass 30 Frequency Hz 10 00 1 10 004 0 0 Pass 31 Frequency Hz 40 00 1 40 018 0 0 Pass 32 Overall Result 22
17. a powerful tool to help your product satisfied with below standards IEC60601 2 25 2011 Co py t h e Ha rdwa re ID an d sen d it to Particular requirements for the basic safety and essential performance of electrocardiographs service whaleteq com to request an 1EC60601 2 27 2011 Particular requirements for the basic safety and essential performance of Act i ve K ey electrocardiographic monitoring equipment 1EC60601 2 47 2012 Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems Try it now or contact Whaleteg to active the full feature set Hardware ID 6E5FEBFC6613F31FBFF Active Key 22 aT WHALETEQ Single Channel ECG Test System User Manual Step 2 An unigue Active Key will be send to you SECG Assistant is a powerful tool to help your product satisfied with below standards j j i j IEC60601 2 25 2011 Via email Enter the Active Key and click Particular requirements for the basic safety and essential performance of the Active button a IEC60601 2 27 2011 Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment Your SECG Assistant is now activated cyng nr eg Particular reguirements for the basic safety and essential performance of ambulatory electrocardiographic systems Try it now or contact Whaleteg to active the full feature set Active Assistant Hardware ID 6E5FEBFC6613F31FBFF
18. aa 201 12 4 107 1 1 2 Low frequency impulse response Parameter Settings 201 12 4 107 2 Linearity and dynamic range Parameter Settings 201 12 4 108 3 2 Recording Parameter Settings 201 12 4 109 the desired setting under Parameter Settings to proceed Step 4 After you have chosen the desired a C6001 020 JEC00601 2 4 parameter settings you can expand Pass FM eee Criterion for further measurement P ADANG A VEn refe rences j Special VALORS CAL10000 CAL20000 CAL50000 Output Lead RA OLA OLL 5V1 OV2 OV3 OV4 OVS OVE 4 Pass Criterion Measure Vp CAL10000 0 9 mV lt Vp QRS lt 1 1 mV PASS CAL20000 1 8 mV lt Vp QRS lt 2 2 mV PASS CAL50000 4 5 mV lt Vp ORS lt 5 5 mV PASS RA Measure lead ll LA Measure lead LL Measure lead Ill V1 Measure lead V1 V2 Measure lead V2 V3 Measure lead V3 V4 Measure lead V4 V5 Measure lead V5 V5 Measure lead V5 V6 Measure lead V6 201 12 4 102 4 Recovery time Parameter Settings 201 12 4 103 Input impedance Parameter Settings 201 12 4 105 2 Overload tolerance Mains Frequency Filter Off Parameter Settings 201 12 4 106 2 Channel crosstalk Parameter Settings 201 12 4 107 1 1 1 High frequency response Parameter Settings 201 12 4 107 1 1 2 Low frequency impulse response Parameter Settings ANa AN AAT Step 5 _ Click RUN to execute the test per your specified settings A new window will pop up to display the crucial
19. at can affect the heart rate Therefore separately out testing for 22mV is recommended Based on experience it is recommended to have a change interval of at least 30s With the selected time users should verify by simulation that the trend mode will clearly show up problems e g deliberately set a wrong heart rate for 10s and verify this is detectable Note that most patient monitors will have problems with the overshoot function Users should experiment first to find the overshoot that the patient monitor can handle or test this separately limit the overshoot time to Oms only Recommended use for Auto Heart Rate As above tests for the Auto Heart Rate are intended for use with trend monitoring on a patient monitor and should be grouped according to heart rates 20 aT WHALETEQ Single Channel ECG Test System User Manual 2 6 10 Load ECG File This function is implemented on the Special Waveforms C Special form In that form a new button is created and a text box CALD5000 1mVpp The button name in code is Load ECG Select Special Waveform Special Waveforms E Special IEC 60601 2 27 Special IEC amp 0601 2 51 Note ANE20000 waveform originally included has AAMI 3A IEC A1 CALO5000 1mV UN been deleted The test to determine the AAMI3B IEC AZ CAL10000 2mVipp extent of ringing from mains notch fiters should be performed with a multichannel device AAMI 3C EC A3 CAL20000 4m pp and all 12 displayed l
20. ccceeeseaaesssssseeeeeeseeeeeeaaas 22 2 7 2 SECG Assistant Operation ssnsscvesvessevoasedcnsedsovensnssnaesveesvsuvonsecesvantereubassmaasveneesdeveuneasavers 23 2 3 SECG 4 0 LOB b5 lead OptioriS ein DU GYG NU isendi nrerin aniidae i iiia 26 3 Testing to IEC and AAMI standards i eniiAF CYF NSAN YW YAR GNSS ANN CRWN GANN CNAU ADNA ARA GNU WAA DWY OFN CNFAo 27 3 1 Relation between IEC figures and WhaleTeg SECG ccccccccsssecceteeseeeeeeeeseceseeeeecesseeeeeeees 27 3 2 Terminals P1 P2 and PG wivcssicenssccsdscvowssencsavsedaaveedsvecvaveacsavanbidedvdersisatiaddnwdvdesscsavensdiodwerssovncsoases 28 3 3 TEC GOGOL 2 2 T un ueeiu enn E reaR E REER y NN ERNEIEREN RET EEEN EA EEEE EERE RR 29 4 Calibration software validation siscssisscsssssocansescsaradescenasdensgueadiguounadestauessaansassdeaueeeasesesasavenseunaseenses 37 5 TOUDE S NOONE oeann EE R Aa E i a HI 40 6 COM 0 eae e1 a a 4 NR YCS E O E E FY FFF PF E FFYN ee 40 AJ Single Channel ECG Test System User Manual WHALETEQ 1 Introduction 1 1 Basic concept The WhaleTeq Single Channel ECG Test System 4 0 provides a single waveform to one or more lead electrodes of diagnostic ambulatory or monitoring ECGs for testing to IEC particular standards The following diagram shows the single channel concept ECG device under test Figure 1 Single channel concept Via a SECG 4 0 the system produces arbitrary waveforms streamed from the PC with digital to analogu
21. d by 2096 5096 and 10096 However at 1096 the displayed value is typically only 4mm peak to peak and there may not be sufficient resolution to accurately perform the test For this reason it is recommended to reverse the order starting at 10096 working down to 1096 Note this has been corrected in the 2011 edition Filter settings should have no impact on the results for the non linearity test but may impact the relationship between set values and displayed values For this reason a wide filter diagnostic is recommended for which set values should match displayed values The test for sensitivity must be performed with the 1mVpp 20Hz sine wave easy to overlook as the previous test used a triangle wave Patient monitors with a monitor filter setting may have some reduction or variation at 20Hz due to the filter s characteristics rather than any measurement error in the input circuit Comparison of results at different freguencies e g Hz or a diagnostic filter setting will give clause as to whether any reduction or increase is due to the measurement circuit or filter response The standard asks to adjust the sensitivity of the eguipment so that a 10mVpp signal covers 8096 of the display However most patient monitors do not have continuously adjustable sensitivities and come with fixed values such as 2 5 10 and 20mm mV 30 aT WHALETEQ Single Channel ECG Test System User Manual This is
22. de Single Channel ECG Test System User Manual WHALETEQ WHALETEQ Single Channel ECG Test System SECG 4 0 User Manual For Software Revision 4 9 x x a WHALETEQ ko i i ww Ny 29 SECG 4 0 act i Single Channel ECG Test Unit 4 0 En For IEC60601 2 25 2 27 2 47 2 51 eis tea ANSI AAMI EC11 EC13 g g 2 ER o oS gt 8 a etn Revision 2015 09 22 AJ Single Channel ECG Test System User Manual WHALETEQ 1 ARISES EO EE S ARPEI E E ET TST E PA FE FAN tus FERN FN E A ETT 3 T D eCOM na Y A FO E EO AO OO 3 1 2 Standards ApplicatiOf iiiiI aeu Y YY R AN YND WD AGRO WNNAN RNA ADNAU NDWNNAN YND WnRANGRAWNNDNRSRWDNANNNDWNNON DNA DRAW LAWN AOD 4 1 3 Block diagram USB Module OVErVieW cccccccccccecccecceececeeeeeececeeeeeeeecececeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 5 1 4 Main specifications uses O ni DF GR DN DO TG GC dU FM 7 TS ISVS IOI SEU FFEFRYN E FREE FERF FE NER sa sapienadaeeent eaneienads tne 8 2 STe T FR PH IO RE RAN RS A RH TR ANN RH PIE YY NN YF Y ANN YY 9 2L lt a a alk SNS talla COM ER NERTH NR FFF FFR NAY YNYR YO YNN 9 2 1 1 System MEOH INGINIGIIES GR RO Go GDG SOROD CEG Ga 9 2 12 SECG4AO PC SOMWA nner eee ee RD CD Gai SE A EDD FD O 9 LL33 USB diver 1 sssr rebien EEF TW ANF RYFEDD 10 Died SOL UID FER YMI EF DA FICER RIF T RF AFR EFA ERTH TH HF FT FFF NEFYN 10 23 Comecing 19 the ea see Y FFCD RH REF NY FFY HAN Y HR FFY RF 10 2 4 Environment noise red
23. e 4 Wait for the recognition sound 5 Start WhaleTeg software USB module stops Move the main function mode to Off and then responding return to the function being used If this does not work close WhaleTeg software disconnect the USB module reconnect the USB module and re start the USB module 6 Contact details WHALETEQ Co LTD service whaleteq com 886 2 2550 1239 8F 3 No 106 Minquan W Rd Taipei City 10361 Taiwan 40
24. e conversion at up to 5V which is then applied to a precision 1000 1 divider to produce the voltages at up to 5mV level 10mVpp The SECG 4 0 contains resistor capacitor networks dc offset pacing circuit and relay switching to provide the full range of single channel performance tests in IEC standards as described in Section 1 1 2 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 with Section 1 2 The system does not provide CMRR tests this requires a special noise free box available from WhaleTeg Multichannel waveforms such as the CTS Atlas CSE AHA MIT databases this requires a multichannel system available from WhaleTeg aY WHALETEQ Single Channel ECG Test System User Manual 1 2 Standards Application The following table shows the standards for which this system has been designed for and includes any limitations IEC 60601 2 25 2011 Diagnostic IEC 60601 2 27 2011 Patient monitoring 201 12 4 All performance tests except CMRR test and baseline noise use WhaleTeq CMRR 2 0 for this And any test referring to the CTS atlas CAL ANE waveforms CSE database for this use WhaleTeq MECG 2 0
25. eads Lead ll lll aVR awF aVL W1 W6 i cted for ringing AAMI 3D EC A4 CAL50000 10mVpp cli id a la AAMI 4A IEC B1 AAMI 44 IEC B1 x2 mr Two Tma are available AAMI 4A IEC B1 2 Text txt Ascii file Windows line breaks LF CF AAMI 4B IEC B2 first line is sample rate Hz second line number of samples AAMI 4B IEC B2 x2 following lines are samples in microvolts AAMI 4B IEC B22 one sample per line Binary files bin Bytes 1 2 are sample rate Hz Bytes 3 5 are number of samples x2 double amplitude for tachycardia portion only z Following bytes mE samples 2 bytes per sample 2 half amplitude for tachycardia portion only all data is bigendian high byte first 2 s compliment The Load ECG function supports two formats Text and Binary files Text txt Ascii file Windows line breaks LF CF first line is sample rate Hz second line number of samples following lines are samples in microvolts one sample per line Binary files bin Bytes 1 2 are sample rate Hz Bytes 3 6 are number of samples Following bytes are samples 2 bytes per sample all data is bigendian high byte first 2 s compliment 21 aT WHALETEQ Single Channel ECG Test System User Manual 2 7 Software Options SECG Assistant SECG Assistant software option is a companion software add on to enhance the function of SECG 4 0 It supports ECG the latest ECG standard
26. erator to select the main waveform to be used in the test from the following Waveform Description Sample waveform type Output 20 r T r oo oo 10 20 20 40 so Time c Output 20 Rectangle pulse Triangle pulse Special Basic sine wave according to the amplitude mVpp and frequency Hz or bpm Basic triangle wave according to the amplitude in mVpp and frequency Hz or bpm Basic square wave according to the amplitude in mVpp and frequency Hz or bpm A rectangular pulse according to the amplitude setting pulse width and pulse repetition rate frequency Hz or bpm A triangle pulse according to the amplitude setting base pulse width and pulse repetition rate frequency Hz or bpm Exponential waveform used to test AAMI EC13 Clause 5 9 2 8 e Hysteresis test set amplitude to 1 5mV pulse width 50ms Waveform according to IEC 60601 2 27 Figure 113 and 119 with adjustable parameters for amplitude mVpp A range of stored waveforms including ANSI AAMI waveforms for testing Clause 6 8 of IEC 60601 2 27 and some selected CAL waveforms from IEC 60601 2 51 For these waveforms the amplitude and frequency settings have no effect Single Channel ECG Test System User Manual 14 aT WHALETEQ Single Channel ECG Test System User Manual Parameters Main parameters Amplitude 1004 mv Amplitude Adjusts the waveform amplitude from 0 t
27. information about your test such as parameter settings and pass criterion for your confirmation All 24 aT WHALETEQ Single Channel ECG Test System User Manual other settings will be set by the SECG Assistant per specific standard requirements 201 12 4 102 3 2 Goldberger and Wilson LEADS Parameter Setting Main Function Output Lead Special CAL20000 4mVpp ha SS Pass Criterion Measure lead 9mm 0 9mV lt Vp l QRS lt 11mm 1 1mV sented Finish 5 20mm mV 10mm mV 4mm mV IEC60601 2 25 IEC60601 2 27 IEC60601 2 47 201124101 Indication of inoperable electrocardiograph Parameter Settings 20142440232 Goldberger and Willson leads U eter Settings cal Waveform CAL10000 CAL20000 CALSO000 ulput Lead ORA SLA LL GVI OV2 OVI OV4 OVS OVE Measure Vp CAL10000 0 9 mV lt Vp ORS lt 1 1 mV 1 8 mV lt Vp ORS lt 2 2 mV lt Vp QRS lt 5 PASS PAS ia AAMIEC 13 Orif test 0 1Hz 4m V triangle wave 201 12 4 105 2 j Overtoad tolerance ars Denton Pacing Amplitude Pacing Duration Mains Freq Filter Off 1002 ms 0S mv 20 ms Paramete Settings Double puie 201 12 4 106 2 T Wave Overshoot Time Constant Pacing Rate Channel crosstalk 0205 mv 0 ms 60 BPM _ ees Soe 201124 107111 h response Parameter Settings 201 12 4 107 1 1 2 Low impulse response Step 6 You may view the actual execution seguence by clicking Test Seguence
28. iods of time up to 30 40MB related to MS Windows garbage collection PCs with only 512MB or less installed and are running several other programs in particular Internet Explorer may exceed the available RAM requiring access to the hard drive and dramatically impacting speed In this case streaming interruptions and other problems may occur AJ Single Channel ECG Test System User Manual WHALETEQ 2 1 3 USB driver installation The system uses a USB mode called CDC which emulates a serial COM port for which Microsoft Windows already has the driver for this installed However it is necessary to link the test unit to this driver which follows a process similar to installing a driver A copy of the linking file mchpcdc inf can be downloaded from WhaleTeg website When the USB module is first connected select manual installation and point to folder containing the above linking file Continue to follow instruction There may be a warning that the driver is not recognized by Windows which can be ignored This linking file is provided by Microchip for use with PIC microprocessors having in built USB function 2 2 Setup Connect the USB module test unit to any USB socket of the PC Note if the socket is changed it may take the PC a short amount of time to recognize and connect to the system Run the WhaleTeq Single Channel ECG software If the USB module is not recognized a message will be displayed In this
29. irtually all patient monitors use this exception making the clause not applicable 50 102 10 Common mode Test requires a separate box available from rejection ratio WhaleTeg 50 102 11 Baseline reset For this test use the Baseline reset test checkbox as shown in Section 2 6 8 Special functions Prior to using this checkbox set up a 10Hz 1mVpp sine wave as instructed The 1V overload will be present whenever checkbox is ticked The mains freguency can be selected from 50 or 60Hz The selection of freguency is not critical for the test 50 102 12 Pacemaker pulse This test may require settings in the patient display capability monitor to be enabled 33 aT WHALETEO 50 102 13 50 102 14 Rejection of pacemaker pulses Synchronizing pulse for cardioversion Single Channel ECG Test System User Manual To perform this test correctly the pacemaker pulses should be applied without any other signal However this may be an error in the standard as one of the effects of pacemaker pulses can be to distort the ECG signal It is recommended to perform the test together with a 1mVpp ECG 2 27 signal In order to test according to the standard it is also possible to select any function sine triangle ECG etc and simply set the amplitude to zero 0 00mV Settings associated with the pacing function can be found in Section 0 Pacing parameters Again this test may require special settings i
30. l actually appear higher than the ORS with an amplitude of 1mV due to the characteristics of Figure 119 Note In the future it is planned to update this table to the IEC 60601 2 27 2011 edition 36 aT WHALETEO 4 Calibration software validation Single Channel ECG Test System User Manual The WhaleTeq SECG 4 0 has undergone a detailed system validation including software A report for this can be provided on request Prior to shipping each unit is tested for component values and output voltages using a calibrated precision multi meter As WhaleTeq cannot provide ISO 17025 accredited calibration laboratories which are required to follow ISO 17025 should perform calibration either periodically or on a before use basis following normal procedures and practice The extent of calibration may be limited depending on the needs of the laboratory As the calibration procedure is complicated a software assisted calibration mode is provided The software sets up the SECG as required for the particular tests and instructs the user on what measurement to make e g measure resistance between RA and RL The user then enters the results into the form provided and the software checks if the results are within allowable limits When complete the No Item Nominal Limit Result Error Verdict 1 Test location s MEDT
31. m other digital sources If beating still occurs a separate analogue input at BNC1 is provided to allow testing with analogue type function generators ECG can be used for testing IEC 60601 2 27 heart rate below 30bpm as indicated in the standard 0730bpm over 30s As a frequency of O is infinitely long the scan starts at 3bpm 19 aT WHALETEQ Single Channel ECG Test System User Manual 2 6 9 Auto Pacing Auto Heart Rate Cal Mode Auto Pacing This opens a new window for automatically Auto Pacing cycling though all the combinations required for pacemaker testing in IEC 60601 2 27 Clause 50 102 13 Auto Heart Rate Calibration Mode Auto neat Rate This opens a new window for automatically cycling though all the combinations reguired SECG Assistant for heart rate testing in IEC 60601 2 27 Clause 50 102 15 Calibration mode Opens a new window see Section 0 Recommended use for Auto Pacing This option is intended to be used in conjunction with a trend mode in a patient monitor If the patient monitor can reject pacing pulses the heart rate should not be affected Therefore the test should be set up with a mode that has a constant heart rate For the tests in IEC 60601 2 27 the tests can be grouped into synchronized heart rate and pacing is 60Obpm and asynchronous heart rate 30 bpm pacing 80 bpm In addition 2mV pacing pulse uses a separate range Changing to this range can cause switching transients th
32. minals and impedance for terminals can be made according to request For the 5 lead options the standard breakout box provides 5 terminals RA LA LL RL V1 plus an terminal connected to the circuit ground not switched no impedance This can be used for calibration or as needed during tests It is the same point as the GND 4mm terminal near the USB socket The software will detect the option when the USB module is connected and disable the related software features such as switching for output and lead impedance The calibration routine is modified for this equipment Where the calibration routine indicates connection to RL and RL is not provided or switched connect to the circuit ground using the breakout box terminal if provided or the 4mm socket marked GND 26 aT WHALETEQ Single Channel ECG Test System User Manual 3 Testing to IEC and AAMI standards 3 1 Relation between IEC figures and WhaleTeg SECG As of 2012 all IEC standards have harmonized the test circuits There remains some variation in the switch and parts numbering however the circuit layout and parts are effectively identical To be flexible the WhaleTeg equipment does not use the switch nomenclature in the standards Rather the user should simply follow the effective settings For example IEC 60601 2 27 may say Close switches S S2 and S4 which means connect the function generator short out both input impedance and dc offset f
33. n the patient monitor There are a large amount of combinations reguired for this test An Auto Pacing function see 2 6 9 has been provided to reduce operator time in testing However some experimentation is recommended to decide on groups of settings which suit the patient monitor Settings associated with the pacing function can be found in Section 0 Pacing parameters Pacing overshoot recharge time constant is limited to Method According 50 102 13 k see Section 1 2 in this manual for explanation This test reguires the measurement of delay between the real ECG signal and the pulse output by the patient monitor for interfacing to 34 aT WHALETEO 50 102 15 50 102 15 Heart rate range accuracy and ORS detection range Heart rate range accuracy and ORS detection range Single Channel ECG Test System User Manual other medical devices The real ECG signal can be monitored at BNC2 Oscilloscope Single Channol ECG Test Unit 4 0 123 5 i Ch1 For FECA 1 225 2 2 2AT 51 ADAAN PCH wg 2 Rec aay mue Teor ymi Cor MEDTOO Synchronization pulse Patient monitor For this test the ECG 2 27 function should be used with the T Wave amplitude to zero while the heart rate freguency amplitude and ORS duration are adjusted over the range reguired by the standard The test for heart rates between 0 30bbpm over 30s can be performed with the Ra
34. n 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 main function e g 80 bpm as 17 aT WHALETEQ Single Channel ECG Test System User Manual required by IEC 60601 2 27 100bpm according to IEC 60601 2 51 Single Double This group selects whether single or double pulses are pulses 150ms and required according to IEC 60601 2 27 If double pulses 250ms advanced are reguired they can be 150 or 250ms advanced 2 6 7 Output graphic display The output display provides an image similar to that provided by ECGs The sensitivity of the display range may be set at 4mm mV 10mm mV or 20mm mV to cover the full range of waveforms offered by the system The time rate is fixed The output display uses the same data as used in the DAC output and serves as a cross check of the selected waveform and also allows the user to view the original waveform as filters in the ECG device under test can substantially alter the waveform Pacing pulses are shown in purple For Version 4 0 the output range is fixed at 5mV 18 aT WHALETEQ 2 6 8 Special functions Special functions E n agel reset test 1 pp S0Hz 60Hz Mains noise P L aneo Ome Mains Frequency for above 8 50Hz 60Hz 80Hz C 100Hz C AAMI EC 13 Drift test 0 1Hz 4mV triangle wave _ Dynamic Range Test IECS0601 2 51 51 107 2 Amplitude Frequency 105 mv
35. n isolated circuit the noise may be excessive 1 3 Block diagram USB Module overview The following is a simplified block diagram of the system inside the USB module 1000 1 Additional Divider input BNC1 100kO Precision dc 620kO 4 7nF 0 196 offset Test for input 300mV impedance Output RA V6 10 lead Channel A 1000 1 electrodes 5V or Divider 100kO 0 196 Output lead dc Output offset and 620k 4n7 impedance switching network switching 51kO 47nF 2 5V or 1 25V Pre divider monitor BNC2 10 1 divider Channel B 9000 via 10V analogue switch 1000 0 1 1 5 1 4 n Fast QRS The sampling rate is limited to 0 2ms some distortion of the pulse is possible below 6ms 5 2 9 1 f g Functionality is not included at this time note the test is not applicable to most ECG systems AJ Single Channel ECG Test System User Manual WHALETEQ Additional input to allow connection to an external function generator e g analogue type if aliasing is suspected Precision divider ensures that 1V in 1mV out 20 296 Allows monitoring of the applied signal ao iz T pre divider Mm 3 SECG 4 0 ud 1V 1mV output am Single Channel ECG Test Unit 4 0 En j For IEC60601 2 25 2 27 2 47 2 51 gis ad ANSI AAMI EC11 EC13 Bie Us g s For noise ae aw WHALETEQ Ay eee reduction Connects to the PC via USB 2 0 AJ Single Channel ECG Test Sys
36. nal to the sheet and also the frame ground or EP terminal of the ECG device under test i 8 SECG4 0 LONG i anon ida oy ZONE Single Channel ECG Test Unit 4 0 For IEC60601 2 25 2 27 2 47 2 51 ANSVAAMI EC11 EC13 aw wT ECG Device Frame ground Under test or EP terminal ECG lead electrodes RA LA LL N V1 V27V37 V4 V5 ve ONS a asn lachnea hoovmton rom MEDTEQ Metal bench metal sheet or foil 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 620kO is in series the imbalance in impedance can cause high noise For this test the ac filter may be turned on If the noise is still excessive move to an electrically quiet environment or increase the size of the metal sheet underneath and around the set up 12 aT WHALETEQ Main screen Parameter settings DC offset settings Single Channel ECG Test System User Manual Selects the lead electrode which the output is switched to Selects the main function waveform type such as sine triangle ECG etc Selects the pulse width for rectangle and triangle pulse only Selects the parameters related to the ECG waveform IEC 60601 2 27 Amplitude 1 00 7 mv Freguenc
37. o 10mV at a Frequency 0 01mV resolution For all waveforms the amplitude represents 10044 Hz the peak to peak value For example for a 1mV sine wave the 604 apy actual waveform varies between 0 5mV and 0 5mV This correlates with testing reguirements in standards Pulse Width 10044 ms Frequency The frequency can be set in either Hz or beats per Ss minute BPM Changing one will automatically change the other aa to match For pulse waveforms rectangle triangle ECG the 1007 ms frequency can also be referred to as the pulse repetition rate or T Wave o heart rate For some pulse settings the frequency is limited to 02044 mV _ prevent overlapping pulses Pulse Width Applies to rectangle triangle and exponential pulse waveforms only For the rectangle pulse width is defined as the time between crossing the 5096 point in rising and falling edges of the pulse For triangle pulses the setting matches the base of the triangle pulse For exponential pulse the set pulse width is time constant Pulse width can be set to down to 2ms QRS Duration Allows the setting of the QRS component of the ECG wave in IEC 60601 2 27 in the range of 10 to 120ms matching the requirements of the standard T Wave 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 2 5mV For the heart rate accuracy test in IEC 60601 2
38. out 100pF stray capacitance in the circuit which is included in the measurement However even with this the measured result is within the limit Resistance values are specified as 100kO and 1000 z 0 196 but these cannot be verified once in circuit An alternate method is used to verify the accurate ratio e Set up a 10mVpp 0 1Hz square wave to output RA Using the Fluke 8845A or equivalent precision meter measure and record the peak to peak voltage at BNC2 by zeroing during the negative cycle and measuring at the positive cycle nominally 10Vpp Repeat this measurement at the output between RA and LL nominally 10mV 38 aT WHALETEO Single Channel ECG Test System User Manual e Calculate the ratio and confirm it is 1000 1 40 296 Output voltage DC offset fixed 300mV DC variable Output frequency Setting 1 300mV 1 Setting t5mV or 1 Setting 1 Method e Set up 0 5mVpp 0 1Hz square wave output to RA e Measure the peak to peak output between RA and LL using the Fluke 8845A or equivalent record this as output mVpp e Repeat for 1 2 5 and 10mVpp e Confirm all values are within 1 or 5uV of the set value Note the Fluke 8845A has suitable accuracy at 10mVpp but has borderline accuracy at 1mVpp and lower An alternate method is to measure the output at BNC2 and then use the divider ratio above Method e Set the equipment to Off e Select 300mV e Measure the voltage bet
39. r rhythm the list of Main Functions see 2 6 1 These waveforms have been obtained from the Physionet website 6 8 2 bb 5 Response time The results of this test can occasionally be on to a change in the limit It is possible to have time delays of up heart rate to 1s between changing the rate on the PC and the actual output as the WhaleTeg system implement changes only at the end of a cycle to ensure a smooth transition It is also possible to have delays of several seconds in the patient monitor If the result is within 1s of the limit more accurate methods may be needed such as oscilloscope monitoring of the real time ECG signal at BNC2 and using this to determine the start time 6 8 2 bb 6 Time to alarm The waveforms required to verify manufacturer for tachycardia claims B1 B2 with half and double amplitude can be accessed using Special button in the Main Function These waveforms are downloaded from Physionet website and are identical to the AAMI ANSI waveforms Note that the preceding normal condition 80bpm 29 aT WHALETEO 50 102 1 50 102 2 Accuracy of signal reproduction sensitivity non linearity Input dynamic range and differential offset voltage Single Channel ECG Test System User Manual is already built into the waveform as downloaded from the Physionet website For non linearity the standard reguires tests starting with 1096 of the display device followe
40. s IEC60601 2 25 2011 IEC60601 2 27 2011 IEC60601 2 47 2012 with detailed preset parameter settings and actual test sequence for testing needs 2 7 1 Activate the SECG Assistant Software Once you have installed the SECG4 0 you may also activate your purchased SECG Assistant Software Please follow the two simple steps below to activate your SECG Assistant Software Main Function Parameters DC Offset Output Lead Blectrode Lead Bectrode impedance Special functions r e or Amplitude Seting RA R AR Baseine reset test A 1Vpp SOH2 6OMz Sine 1 00 mv 0 mv LAC Mans nose LL F 5060Hz 010 mv Trangie Freguency Varisbie vi 2 Common mode Square 1 00 2 He to RLIN v2 60 BPM v3 Pulse Waveforms input impedance Test va NS ne vs a 0 1M2 smv triangle wave Rectangle Pulse Pulse Width 1002 ms on shorted AL N Exponentai a Amplitude Frequency i 10 gt mV 40 gt Hz ve S2 poston J 620k04 7nF Dynamic Range Test RECSO601 2 S1 31 107 2 ECG 2 27 QRS Duration Pacing Amplitude Pacing Duration Show Timer 1002 ms 0 mv 207 ms Special CAL05000 1mMVpp Select Special 0202 mv 02 ms 60 BPM Waveform T Wave Overshoot Time Constant Pacing Rate test First click on the SECG Assistant bottom to launch SECG Assistant Software When you launch your SECG Assistant Software for the first time you will be prompted to enter your Active Key Ste p 1 SECG Assistant is
41. simply use the diagram as shown since the diagram already has 51kO 47nF between P2 and P6 or it could mean an additional 51kO 47nF or could even mean connecting unused LEAD wires to P6 directly Currently the SECG provides switching for LEAD wires between terminals P1 and P2 only It is technically complicated to provide switching for LEAD wires to P6 it would reguire an additional set of relays It is the opinion of WhaleTeg that the standard writers intended that only P1 and P2 be used for LEAD wires as per the diagram and additionally that using terminal P6 for unused LEAD wires will have negligible impact on the test 28 aT WHALETEQ Single Channel ECG Test System User Manual If users would like to test with unused electrodes connected to P6 it should be possible to create a simple extension to the terminal marked RL N P6 for connecting unused electrodes 3 3 IEC 60601 2 27 Please note this section is written for IEC 60601 2 27 2005 In order to meet publishing deadlines it is not yet updated to the latest standard However the concepts remain the same The following table provides some guidance on actual tests to IEC 60601 2 27 including highlighting some apparent limitations in the standard cave te AO O 6 8 2 bb 4 Heart rate The waveforms reguired to verify manufacturer accuracy in claims A1 to A4 originally from ANSI AAMI response to can be accessed using Special button under irregula
42. te scan ECG check box in the list of Special Functions For best results the Main Function should be Off before starting the test This function starts at 3bpm since Obpm is infinitely long As for 50 102 13 there are a large amount of combinations reguired for the main rate test An Auto Heart Rate function see 2 6 9 has been provided to reduce operator time in testing It is recommended to use only one heart rate and vary the other settings amplitude and ORS duration It should be noted that main difficult of the patient monitor will be at the lowest amplitudes 0 5mVpp and longest QRS durations 120ms as this produces the weakest slope which patient monitors use to trigger the heart rate Note the waveform in Figure 119 is not a simple triangle pulse and the peak of the waveform is 0 875 of the amplitude setting Some manufacturers may have based their 35 aT WHALETEQ Single Channel ECG Test System User Manual design on a simple triangle pulse which may continued explain small differences in test results 50 102 16 Output display No special guidance 50 102 17 Tall T wave This test is intended to verify that the patient rejection monitor shows the correct heart rate in the presence of a high T wave At some point most patient monitors will treat the high T wave as new ORS pulse and hence double count the heart rate e g display 160bpm for an 80bpm input Note a T wave of 1mV wil
43. tem User Manual WHALETEQ 1 4 Main specifications In general the system has been designed to the standards above taking into account Clause 201 5 4 in IEC 60601 2 25 and IEC 60601 2 27 Below includes these parameters and also other system parameters necessary for testing For reference the system capability is provided notes Main output voltage 1 for amplitudes of accuracy 0 5mVpp or higher Main output voltage 2 5uV In version 4 0 a single resolution output range is used DAC resolution repetition rate accuracy Pulse duration timing 1ms 0 2ms accuracy excluding pacing accuracy Pacing pulse amplitude 2mV pulse 1 2mV pulse 0 3 accuracy range gt 2mV pulse 10 100mV pulse 1 or Range 2mV to 700mV Pacing pulse Rise fall time 5us characteristics Overshoot lt 1 Settling time lt 196 Pacing pulse overshoot intentional Resistor tolerance Precision 1000 1 divider 0 12 P m Sample rate 5kHz 0 1 5kHz 0 05 50ppm DC offset fixed noise 300mV 1 300mV 20 196 free sourced from internal super capacitor DC offset variable may Setting 1 or 3mV Setting 1 or 3mV include up to 50uVpp noise AJ Single Channel ECG Test System User Manual WHALETEQ Power supply USB 5Vdc supply no Typical load lt 0 25A up separate power supply to 0 45A is possible if all required relays are turned on 0 5A high power mode Environment 15 30 C by design not Selection of
44. ternately reduce the freguency by half 12 5Hz at which individual lines should be visible A common complication with this test is which filter settings to use as patient monitors often have a variety of filters AIso mains notch filters may impact the test result with different results for 50Hz and 60Hz settings In order to cover normal use a minimum test in monitor filter with and without notch filters is recommended Note 2011 edition states that ac filters should be off if selectable 32 aT WHALETEQ Single Channel ECG Test System User Manual For the test of Method B Figure 112 use a triangle pulse waveform and adjust the pulse width to both 20ms and 200ms 50 102 8 b Impulse This test is only reguired for eguipment with response either a diagnostic filter or an ST filter setting which extends the low freguency response down to 0 05Hz A monitor filter setting or any filter above 0 05Hz will fail the test Both simulations and test experience indicate that the typical 0 05Hz filter will only marginally pass the test At the same time the 0 1mV 100uV offset and slope are difficult to measure accurately For most accurate results access to raw data may assist in determining compliance 50 102 9 Calibration The standard appears to reguire a calibration voltage voltage but in the last sentence provides an exception for patient monitors that provide a gain indication V
45. uction iu LLALL ILL CGG GL GL CCG LLC L LLC LG LC LLL LL LL LLA LL LL FF eion 12 PE VUNG SO CIM FEARN NYFFRYN NF FI NON Y PEY NYFFRYN FFAN A FFF RT 13 2 6 Description of Functional groups ccccsssseccccseseceecaeeecccaeeccesaeeeceeseueeceessuaeeessuaecessuaeeeetes 14 2 6 1 Main function main WaVEFOFM s cccccccccsssseecccecceeeeeeecceeeaeeseeceeeeeaueseeeeeeesuagseseees 14 26 2 DCoffset setting ee Yd ressent RN ARDD ARAN US ODD ARAN NUDD Dd RAN NN O SUR AR 16 2 6 3 Wnputimpeda iCe test uei FeNdywan ca Ad YOA NENN LYNN ATA AYN RHNNA WN DATA WORN isinisi assises NAWN GEN OC YNDE 16 2 64 Output lead electrodEs cun Ydd AF CYFA GU DEFOD FR NGR Fy 16 2 6 5 Lead electrode impedance cccsssecccccesscccceesscceceesececeeeseceseueecceseuasecessueeeessugeeeenes 17 20 6 PACING parameta ne i eT SO CANWN GTA SAN E 17 2 6 7 Output graphic display ccccccccsssecceceessececeescccceeeeecesseesceeseueeeeessueecesseeeeeessageeeeees 18 20 5 SOS Cle UNCON Cd Y YR Td OO Yo EG 19 2 6 9 Auto Pacing Auto Heart Rate Cal Mode ceccccessccccsseccesecceeeceeeeecesseecetseecesseeeenen 20 2 6 10 Load ECG File FE m m OT 21 2 7 Software Options SECG Assistant cccccsssascdvasiissecssdascandasiaconsagsscinwsstavanssgsacauasdsarsenadsaniensdeareds 22 2 7 1 Activate the SECG Assistant Software ccccccccssssssssssseeeeeeec
46. unctions With the concept of the test in mind and some experience with using the WhaleTeg system this translation becomes second nature The following table provides a cross references between switches and terminals referred to in the three IEC ECG related standards the intended function and settings in WhaleTeq s Single Channel ECG 2 25 2 27 2 47 WhaleTeq SECG Figure106 vee Figure101 Settings Connects the Automatically connected function generator when function is to the ECG selected Shorts out the The SECG automatically 100kQ allows large selects Ch1 for small signals signals and Ch2 for large signals Shorts the 620kO Input impedance S2 used for the input checkbox default impedance test condition is shorted offset circuit DC offset is set to zero S4 3 S4 Sets the polarity of Automatically selected if the dc offset DC offset is set to 300mV P1 P1 P1 Output signal Any selected output lead WAN electrode is connected to P1 Circuit ground Any unselected output lead electrode is connected to P2 6 f no large signal is reguired Ch2 is switched out by relay to avoid noise from Ch2 Ch1 is always connected 27 aT WHALETEQ Single Channel ECG Test System User Manual Neutral electrode Terminal RL N in the RL N with series breakout box pin 4 is 51k 47nF permanently connected to GND P3 via 51k 47nF 3 2 Terminals P1 P2 and P6 According to the test circuits in all three
47. ween RA and LL Note the DC offset is sourced from an internal super capacitor which will discharge after 10min Tests in the standard are typically lt lt 2 minutes Use the following procedure Set the equipment to Off Select the Variable checkbox Set to 200mV dc offset Confirm the value is 20045mV Repeat for 600 1000 200 600 and 1000mV Method e Set up 1mVpp 40Hz sine wave e Measure the freguency at BNC2 using any appropriate meter Note this verifies the system clock is accurate Verification of other freguencies or timing is not as this is covered by software validation although users are free to measure 39 aT WHALETEQ Single Channel ECG Test System User Manual other frequencies and timing The use of 40Hz is recommended to avoid beating with mains frequency Pacemaker Voltage The pacemaker pulse can be observed directly pulse 10 pulse at the terminals RA and LL with the output to characteristics width 1 RA terminal Use a setting of 700mV 2ms so rise time the pulse can clearly be seen above any lt 10us oscilloscope noise Measure the amplitude overshoot rise and fall time and overshoot lt 5 settling time lt 5us 5 Trouble shooting USB module test unit Recognition of USB devices needs to be done in not recognized USB order driver is installed 1 Close WhaleTeg software if open correctly 2 Disconnect the USB module for 2s 3 Reconnect the USB modul
48. y Triangle Sguare Per latest standards 51k 47nF in RL N P amp tecainebortiy Input Impedance Tes Mm W 620k0 4 7nF on shorted Pulse Waveforms Triangle Pulse 5 Exponential ECG 2 27 QRS Duration Pacing Amplitude Pacing Duration G Sinlge pulse Show Ti 100 2 ms Double puise E Show Timer o mv 2 0 ms 150ms advanced 5 Special g i Double pulse Overshoot Time Constant Pacing Rate 250ms advanced CAL05000 1mVpp 0S ms 60 BPM Synchronised El with main function Pacing Amplitude 0 0 7 Automatic Display 20mmmv J 10mm mV Mains Freguency for above 50Hz 60Hz Amplitude l Frequency 1 027 mv 40 Hz Frequency scans E Sine Start 0 67 Hz Stop 150 00 gt Hz Duration wis E ECG 3 30bpm 30s Scan Freguency Hz Auto Pacing Auto Heart Rate Calibration Mode Reset to Defaults SECGAssistantll SECGAssistant Provides a semi real time graphical display of the current signal Parameters related to pacemaker pulses No longer used for Version 4 0 Selects if 620kO 4 7nF is in circuit for input impedance test Special functions Automated functions SECG Assistant Page 13 of 40 aT WHALETEQ 2 6 Description of Functional groups 2 6 1 Main function main waveform This group allows the op

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