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user manual - SOLIC Medical Equipment

1. A L E TS EMT aR E a TEC ESTEE DITE E 3 E nl L E E sl p gera p gs Ej jp tac oe Epor EF ESTE IIS LS PAPAS SI ERIT SEMIS E ERR LUE ERE REL RR ES Ear Mur poet E H Bi FERES SIS e 3 IEEE AEE 3 LT L Wu pui HE HE BE pt TT RT Tt Tt ETTET 5 Patt EEL T el T efi CO EE 0 67 100 2 50 Exam 2010 07 19 18 45 Print 2010 07 19 18 46 PCECG2 02 SEMIP1 5 H So BR ae aay aia nial opel RE lt Figure 6 10 Wave the First Page 44 SE 1010 User Manual Operation Instructions for Resting ECG 201002240000 Lily Green Normal Analysis Print P Page i Zoomin Zoom Gut Close 12 lead ECG Report ID 201002240000 Green Sex Fem ale ear Departme
2. ES FIRES Vis ERR ESTEE ERR E ES E EE EEG TES EE EE EE TESTES Fs i TEE EET AE E Ita as 3 1 5 bitten oro rc E ee 1 a 4 E 588 EE eel Oe eee ES ULL IM LL A IL mud A YS e EE EE EE EE ER E IM S n l Ue La Ee T ER Figure 6 6 Wave Review Interface Click on Exit to return to the ECG sampling interface 6 5 7 Stopping Sampling Data After clicking on the Start button there are two ways to stop sampling data 1 The system will stop sampling ECG data and display the ECG analysis interface automatically aft
3. 4 4 0 0 20000000000 6 V IDOL S dterbon 7 Chapter 2 Introduce ee eee 8 8 22 ECG Sampling oe oe 10 13 Chapter 3 Assembling SE 1010 PC ECG 5 2 15 Chapter 4 Installing SE 1010 PC ECG 5 17 4A System Runnin ooo cos evt tta ee eens 17 4 1 1 Requirements on the Hardware of the 17 4 1 2 Requirements on the Software of the 17 4 2 About Installation Interfaee sce eost cred aes Fre tacui 18 Chapter 5 Preparations Before 2 255 eaaet 19 D Pre Pari Pate ous uia en dea d atid 19 3S1 Instrucime the Pate DE dre didnt 19 QNNM 19 5 2 Connecting the Patient Cable to the 2222000000001 19 5 3 Attaching Electrodes
4. 0 0 67 100Hz ACSO Exam 2010 07 19 18 45 Print 2010 07 19 18 47 5 is PCECG2 02 SEMIP1 5 Figure 6 13 QT Dispersion Preview Interface 6 6 3 Analyzing Frequency ECG Click on the Frequency ECG button to open the Frequency ECG interface Frequency ECG displays characteristic waves of ECG signal spectrum There are two tabs on the Frequency ECG interface Two leads compare and 12 lead power spectrum 6 6 3 1 About Two lead Comparison Interface The two lead comparison interface displays the power spectrum phase shift amplitude shift coherence impulse response and correlation functions of ECG waves as Figure 6 14 shows _ 48 SE 1010 User Manual Operation Instructions for Resting ECG 201002240000 Lily Green FCG w 1 9 Normal Analysis OTD FCG HF ECG Measure Preview Print Report Save Exit Two leads compare 12 lead power spectrum Power Spectrum II V 5 Ls 5210 TU B Impulse Response PIH RD NW Figure 6 14 Frequency ECG Two lead Comparison Interface Every parameter of Frequency ECG 1 shown in the following table Designation Definition 12 If the first peak value 15 lower than 90 of the second peak value it is positive Otherwise it is minus The first peak 1 too low or disappears The frequency value TN of the first peak s position 60 heart r
5. 30mm mV Hint 300mm s Other Result Rhythm and Arrhythmia ORS Deviation Ventricular Hypertrophy ar Atrioventricular Block Intraventricular Conductio Myocardial injury Myocardial Infarction I II III avr Glossary Figure 6 18 HF ECG Analysis Interface The ECG wave between the two green lines is the present one lt Click on 7 to select other ECG waves Select the present lead in the pull down list 53 SE 1010 User Manual Operation Instructions for Resting ECG Limb lead I3 mm mV omm You can choose the lead group the gain and the speed of the waves displayed in the bottom part of the HF ECG analysis interface I II III avR avF V1 4 YS V6 TOL N 0 0 0 0 3 0 0 0 0 0 0 0 3 5 0 0 0 0 0 0 0 0 0 0 0 0 0 B 0 0 0 0 0 0 0 0 0 0 0 0 0 is the statistic data of beadings notches and slurs You can change a value by double clicking on the value Click on the Preview button to open the HF ECG preview interface Newt aoe Zoomin Zemou Close is the toolbar the HF ECG preview interface 1 Click on the Zoom In button on the toolbar to magnify the preview page 2 Click on the Zoom button on the toolbar to minify the preview page 3 Click on the Close button to close the HF ECG preview interface and return to the previous interface
6. 78 FE 80 To Te UCU SCPIISO ead Lo 81 7 5 1 Viewing the Heart Rate and the Blood Pressure 82 155 2 Niew ine Other Information aaa d ut i led 83 83 95 85 86 87 1 laneis 88 PLADO Summary de PER pco 88 ace oda 9 LIS View Review Interlace ve dup de cod DEUS 93 7 9 2 About Trend Intetfab6e vo 96 ACT 96 97 TI Gand a casts 97 SAV INS ECO R SD OLS 98 TXS 98 Chapter o osaa oS N E 99 Sal Searchme Patient 99 5 Patient TUE ctu TN 101 5 9 Delete RECO IS 102 Soe Delenn s Patient Recobds eate on es teen aede
7. e esee essa 126 11 1 Cleaning and Maintaining the 11 126 VI 11 2 Cleaning and Maintaining the Patient Cable and Reusable Electrodes 126 WES BYE eso 27 Chapter 1240666600165 eee ere 128 Chapter 13 Warranty and Service Policy PR eaae eranl ege ae aes ee auis 129 E 129 ete 129 Chapter 14 Recommended Optional 1 131 Appendix 1 Technical Specifications 2 22 0 133 AN IS Spe ClC 1019 133 2 CU etes tue 133 3 Physical Speci lt Cats ue eset ap dut udo dut tds 134 AJ Power supply Specificallofis uei oe bU REPRE ERE DURUM E 134 A s Performance auctio n e CI UI D NM e CEU 134 Appendix 2 EMC Informati n 136 Appendix INANE 140 SE 1010 User Manual Safety Guidance Chapter 1 Safety Guidance This chapter provides important safet
8. Set filters the sample setup interface Figure 9 2 DFT Filter 112 SE 1010 User Manual Configuring the System DFT filter greatly reduces the baseline fluctuations without affecting ECG signals There are two options Weak and Strong Note If DFT filter is set to Strong the ECG data displayed on the screen is 0 85 seconds later than the real time ECG data if DFT filter is set to Weak the ECG data displayed on the screen is 1 8 seconds later than the real time ECG data EMG Filter EMG filter suppresses the disturbance caused by strong muscle tremor The cutoff frequency can be set to 25Hz 35Hz or 45Hz Lowpass Filter Lowpass filter restricts the bandwidth of input signals The cutoff frequency can be set to 75Hz 100Hz or 150Hz All the input signals whose frequency is higher than the setting cutoff frequency will be attenuated AC Filter AC filter suppresses AC interference without attenuating or distorting ECG signals There are two options 50Hz and 60Hz 9 2 2 Setting Sampling Time You can enter the normal ECG sampling time manually The range 15 0 10 min You can enter HRV sampling time manually The range is 1 15min You can set the HRV analysis lead to one of the 12 standard leads I II III aVR aVL aVF V1 V2 V3 V4 V5 or V6 9 2 3 Setting Lead Sequence You can set Lead sequence to Standard or Cabrera and the lead groups are displayed or printed in the cor
9. You choose the speed and the gain of the displayed waves 201002240000 Lily Green TVCG gt CG SAECG Measure Preview Print Report Save Exit Ses EER EE EEA EEH BH HE G H EEE LEER EH ED E view M 10mm mV gt Figure 6 28 Time Vector Interface Click on the Preview button to display the TVCG preview interface t Page n Pane zoom Foon 0 5 Close is the toolbar on the TVCG preview interface 1 Click on the Zoom In button on the toolbar to magnify the preview page 2 Click on the Zoom Out button on the toolbar to minify the preview page 3 Click on the Close button to close the TVCG preview interface and return to the previous interface SE 1010 User Manual 201002240000 Lily Green TVCG Next Page Report ID 201002240000 Sex Fem ale 5 Department Room No HR LH es EE Sq T psp gu EIS T p IO mm Beams p qp T E ESL p FE pup p pp LG qe E Em p E pu p pp p ge 3 p ESL ELS p EL 8j PEL ell J TE HH A A tt e E a a aa EE DLL T D ESL OEE EE EEL TETI TME ET EE
10. 64 6 0 7 5 Displayme 3D Vector BCG eoo eai OD RE UD aes 65 6 6 74 Previewmbe Vector BOG aues oat dude eet aea 66 6 0 5 Analy zine Time Vector EC Gr ii eer SEP UR 66 6 6 9 Analyzing Signal Averaged 68 6 6 9 1 About the Time Domain 222 4 8 69 6 6 9 2 About the Frequency Domain Interface 69 6 6 9 3 Previewing Signal Averaged ECO imoseach ieee a ee i aE 70 0 0 10 Printing REPOS etii pendente endet 71 TC Ci CDOT resina R S 12 6 amplins 5 TALEC T 73 Chapter 7 Operation Instructions for Exercise ECG 1 1 2 74 Tl Viewing Lead Placement Information orte eto Ete e Poetas ere n 74 7 2 Selecting a Patient Record to Start a New 75 HR er 76 2 Oe ie NOrmal B 76 1 2 Detin a PEOLOCOL OE REESE abu ou I SER t iio tuu 77 752 25 et nb DP Sampling T4 7 2 0 BP MOUS ode en eri ui ult ode 77 A 78 butenne New Patient InfotmatiOD x eco ep et dee Wegen
11. User Manual Operation Instructions for Exercise ECG 7 2 3 Setting a Protocol Please select a protocal Bruce Ellestad Select a protocol from the pull down list Kattus lt 7 2 4 Setting Post J Select a Post J value from the Post J pull down list on the Exercise ECG Setting interface Post J is the length after J point of the ST segment You can set Post J to Oms 20ms 40ms 60ms or 80ms Note J Point is the connection point between the end of QRS complex and the start of ST segment It is the standard point to fix the position of ST segment in this system Please select the proper option based on the patient s actual ECG waves 7 2 5 Setting BP Sampling Mode Select a sampling mode from sampling list BP sampling made Monitor enter once per stage BP Monitor enter Protocol drives BP Monite BP Monitor enter ance Monitor enter once every three minute BP Monitor enter once every four minutes BP Monitor enter ance every five minutes BP Monitor enter once every six minutes BP Monitor enter once every seven minute jer stage 7 2 6 Setting BP Triggering Mode BP triggering mode Square Wave You can set the BP triggering mode to Square wave QRS on the Exercise ECG Setting interface SE 1010 User Manual Operation Instructions for Exercise ECG 7 2 7 Setting Auto Printing select Auto print to
12. Green TT 11 45 Print 2010 07 20 11 47 HERE NE ID 201002240000 Figure 7 4 Current Wave Report Note The diagnosis result is displayed in the diagnosis field of the summary report Interface IS 2 About ST Analysi 7 9 1 Click on the ST analysis button to display the ST analysis interface 91 SE 1010 User Manual Operation Instructions for Exercise ECG 201002240000 Lily Green ST analysis e gt a Laf 21 AJ 2 b SN AA Summary ST analysis ALL View Trend Measure Preview Print Report Save Exit Bruce Supine Pretest 78bpm 9 ST Ascend D 40mwv v2 24 42 00 00 BP mmHg 120 78 0 090 Max ST Descend 0 13mv aVR Est dais 20 13 p Ae ST 0 00mV ST 0 27mV ST Slope 1 01miv s ST Slope 1 01mv s ST Slope 0 38mv s ST Slope 2 05miv s dear sans avt Ah ST 0 07mV ST 0 40m ST 0 12 ST Slope O 6 0mv s ST Slope 0 54mv s ST Slope 3 20mv s ST Slope 1 10mv s o 00m A sT 0 04 ST D 32mV pep sT 0 06 ST Slope 0 09mv s ST Slope 0 13mv s ST Slope 2 77mv s ST Slope 0 5 0miv s Post 1 80 5 Figure 7 5 ST Analysis Interface 2 Click on Pretest to display 12 lead ST analysis waves of the pretest phase 3 Click on Exercise to display 12 lead ST analysis waves of the exercise phase 4 Click on Recovery to display 12 lead ST analysis waves of the recovery phase 5 Click on Previous Page Next
13. 79 SE 1010 User Manual Operation Instructions for Exercise ECG 7 4 Pre sampling ECG 201004140066 Lily Green 36Year po yp 4 6 2 M 1 1o00Hz Template Trend Compare 42 156 Stage time Exercise Time Max ST mv Min ST mV Sys Dia KPa 00 00 00 00 0 00 I 0 00 I O O Total Time Bruce PvC min Speed mph Slope 96 um v 00 00 0 0 0 Figure 7 1 Pre Sampling Interface 1 Select a display mode from the display mode pull down list 2 5mmriyrm y l1 mm m 2 Select a gain from the gain pull down list 20mm mv 2S mim s 3 Select a speed from the speed pull down list 80 SE 1010 User Manual Operation Instructions for Exercise ECG 4 Select a lowpass filter from the lowpass filter pull down list 150 2 7 5 Pretest Phase Notes 1 If the test time exceeds 40 minutes the system will enter the monitoring status Data will not be saved or printed any more 2 The length of the pretest phase 1 not fixed but it should be no less than 15 seconds When the tracings are satisfying and you have specified the desired settings you can start the pretest Click on the Pretest button on the pre sampling interface
14. SE 1010 PC ECG Release 1 7 with Software Revision 2 02 About this Manual P N 01 54 106666 17 Release Date July 2010 O Copyright EDAN INSTRUMENTS INC 2008 2010 AII rights reserved Statement This manual will help you understand the operation and maintenance of the product better It 1s reminded that the product shall be used strictly complying with this manual User s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS INC hereinafter called EDAN can not be held liable EDAN owns the copyrights of this manual Without prior written consent of EDAN any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability performance of the equipment 1f Assembly operations extensions re adjust
15. 102 8 3 2 Deleting Examination Records of a Patient oerte e etes 102 SA Selecting a Paent ReCOLG tesi as 102 5 9 Merging Examination Records ciet een vin ER editas 103 8 6 Comparing Two Examination 103 8 7 Importing ECG Data into the Data Manager 104 8 8 Exporting ECG Data from the Data Manager Interface 105 5 9 Viewinb an Examimalom edu Meo 106 Chapter 9 Configuring the System 107 ae 107 2E Basic InfOtfnatioti co 108 92152 Semne TD 109 110 110 111 9 1 6 Specifying the Storage Path of the ECG 111 112 92 etta s eret 112 22 SEMNE Sample be 113 a 113 9 2 4 Setting Pacemaker Detection Oo 113 02 5 Sselune TIS Caleulatton Dead 114 9 2 6 Selecting Auto Printing When Detecting Arrhythmia eese 114 9 2 7 Setting Auto Upload When Stopping 114 9 2 8 Seting
16. SE 1010 User Manual Operation Instructions for Resting ECG 6 6 3 2 About 12 lead Power Spectrum Interface The 12 lead power spectrum interface displays the power spectrum of 12 lead ECG waves m 201002240000 Lily Green FCG _ o Ej T 9 05 Normal Analysis OTD Measure Preview Print Report Save Exit Two leads compare 12 lead power spectrum 1 0 5 10 15 20 25 0 5 10 L5 20 25 Bd 0 5 10 ES 20 25 0 5 10 15 20 25 0 5 10 15 20 25 0 5 10 15 20 25 aVR 4 0 5 10 15 20 25 0 5 10 15 20 25 i 5 10 15 20 25 0 5 10 15 20 25 avF i V6 0 5 10 15 20 25 0 5 10 15 20 25 Figure 6 15 Frequency 12 lead Power Spectrum 6 6 3 3 Previewing Frequency ECG Click on the Preview button to open the Frequency preview interface Two Page oom In Out Frequency ECG preview interface is the toolbar on the 1 Click on the Zoom In button on the toolbar to magnify the preview page 2 Click on the Zoom Out button on the toolbar to minify the preview page 3 Click on the Close button to close the Frequency ECG preview interface and return to the previous interface EP SE 1010 User Manual Operation Instructions for Resting ECG 201002240000 Lily Green FCG Seles Print P Next Page PrevPage TwoPage Zoom In Zoom Out FCG Report 10 201002240000 Geen Sex Female Depa
17. SE 1010 User Manual Technical Specifications Appendix 1 Technical Specifications A1 1 Safety Specifications IEC 60601 1 1988 A1 A2 EN 60601 1 1990 1 2 Comply with IEC EN60601 1 2 2001 A1 IEC EN60601 2 25 ANSI AAMI EC11 IEC EN60601 2 51 Anti electric shock type Class II Anti electric shock degree CF Degree of protection against harmful ingress of water Disinfection sterilization Refer to the user manual for details method Degree of safety of application in the presence of flammable gas Ordinary equipment Sealed equipment without liquid proof Equipment not suitable for use the presence of flammable gas Working mode Continuous operation Group I Class A Patient OLA AC lt 10 DC Leakage uires lt 50uA AC lt 50 DC Patient lt 10 AC lt 10 DC Auxiliary A1 2 Environment Specifications AUC APE 455 isi c carm name OFT 25 93 25 80 Relative Humidity Non Condensing Non Condensing Atmospheric Pressure 700hPa 1060hPa 860hPa 1060hPa 133 SE 1010 User Manual Technical Specifications A1 3 Physical Specifications Dimensions 148 mm L x100 mm W x 40 mm 5 81nx3 9inx 1 6in Weight Approx 210g 0 44165 A1 4 Power Supply Specifications Operating Voltage 110V 240V Operating Frequency 50 Hz 60 Hz Power Supply DC 5V ECG Sampling Box Input Power 1 VA MAX 0 5 VA
18. User Defined 2 VCG TVYCG SAECOG Room Race BP j mmHg Medication Height cm Physician Weight Kg Technician Risk Indicators Symotam Cigarette Typical angina Congenital heart disease angina Hypertension Asymptomatic Hvperlipemia Family medical history EE 9 1 5 Setting Language You can set the language to Chinese or English Note To validate the language setup after setting you should exit the system and open it again 9 1 6 Specifying the Storage Path of the ECG Data Click on the Browse button on the basic information setup interface Figure 9 1 to assign the storage path 111 SE 1010 User Manual Configuring the System 9 2 Sample Setup system Setting Basic Information Sample Setting Device Printer Setting Others Filter Setting t Weak Strong EMG Lowpass Filter 100 2 Filter t 60Hz Sampling Time Others Resting ECG Lead sequence Standard 10 5 L z Min PACE detection Weak 1 HRY analysis lead H HR calculation H x Auto printing when arrhythmia Auto upload when sampling stops Background grid Anti aliasing QRS Voce Cancel Figure 9 2 Sample Setup Interface 9 2 1 Setting Filter Filter Setting DFT t Weak Strong EMG Lowpass Filter 10DHz Filter
19. ior Resting De dede 20 Ledid SY LT 21 5 3 2 Frank WEA Sy SCCM 22 3 2 5Xttachine Tdeetrodes to tHE Pale mE ei West t 22 5 4 Attaching Electrodes to the Patient for Exercise 24 S S Inspection TES caeca 26 Chapter 6 Operation Instructions for Resting ECG ccce ecce ee 28 6 1 Viewing Lead Placement 2 40 0 0000000000000000 8 00 0000000 000 29 6 2 Selecting a Patient Record to Start New 29 6 3 New Patient Information oe 32 GA Selecune Sampling bae ee tee tiers 34 6 5 Sample RESNE BC OI nis t peque 34 Display NOC tn E nun utet issue 35 6 5 2 Speci ow pass PAGES 36 2 Ib y 36 etc 36 6 5 5 Recordine ECO 36 0 5 0 Freezing and Previe wine s ie tetto Itti 37 6 5 7 Sloppine Sampling 38 0 5 5 Printing Waves 38 CO TAZA E T D e tms 39 0 61 Analy zine Normal ECO a eet p ea te ee PI bn pn be eie 39 View the Way CLOMM 4 39 6 6 1 2 About the Av
20. ESSE E EL et ee sete ee ee ee ER Hu E DSL DL ESL EA LELS L BLA LS En dogs SET 0 67 100Hz 50 Exam 2010 07 19 18 51 Print 2010 07 19 18 54 PCECG2 02 1 5 Figure 6 29 Time Vector Preview Interface Operation Instructions for Resting ECG Eek 6 6 9 Analyzing Signal Averaged ECG SAECG is also called Ventricular Late Potential VLP Click on SAECG to open the SAECG analysis interface The SAECG analysis interface includes two tabs Frequency domain 68 Time domain and SE 1010 User Manual Operation Instructions for Resting ECG 6 6 9 1 About the Time Domain Interface Click on the Time domain tab to open the time domain interface 201002240000 Lily Green SAECG BER Y L xj N TVCG SAECG Measure Preview Print Report Save Exit Time domain Frequency domain standa 250mm s 100 ett Standard QRS 137ms Total QRS 94ms Below 400 25ms x Lead Ej Last 40ms 541 26uV Noise 3 05uV Filter 40 250Hz Total beat 5 IIR filter 40 250Hz 250mm s 1000mmj mv f Filter 40 250HzFilter TRIN Figure 6 30 Time Domain Interface There are four vertical lines and
21. 0 4 ris 0 4 avr 0 4 10 21 40 min 10 21 30 40 min 0 4 0 4 Template ST Trend iz Compare Template ST Trend U Compare 7 5 4 Printing the Pretest Report 1 The pretest report will be printed automatically 14 seconds after the beginning of the pretest phase 2 Or you can click on the Print button to print the pretest report 7 6 Exercise Phase Note If the test time exceeds 40 minutes the system will enter the monitoring status Data will not be saved or printed any more 1 Instruct the patient to use the treadmill ergometer Then click on the Exercise button to enter the exercise phase Or the system will enter the exercise phase automatically after reaching the set pretest time 85 SE 1010 User Manual Operation Instructions for Exercise ECG 2 View the heart rate and BP of the patient For details see Section 7 5 1 Viewing the Heart Rate and the Blood Pressure Notes 1 If the current heart rate exceeds the target heart rate the hint The current HR has exceeded the target HH will appear on the sampling interface and the background color of the heart rate field will change from white to yellow 2 When the current heart rate exceeds the target heart rate click on the Recovery button to enter the recovery phase and observe the waveforms 3 View other information For details see Section 7 5 2 Viewing Other Information 4 Edit the waveform For details see Section 7
22. 0 78 0 78 0 40 0 11 NES Stagel 03 00 120 0 78 0 78 0 40 0 08 Stage2 03 00 120 0 78 0 78 0 40 0 08 C 78 Stage3 03 00 120 0 78 0 78 0 40 0 08 C Stage4 03 00 120 0 78 0 78 0 40 0 08 BP 120 78mmHg Stages 03 00 120 0 78 0 78 0 40 D 08 C Stage6 01 02 120 0 78 0 78 0 40 0 08 Max ST 0 40 Recovery 01 00 120 0 78 0 78 0 40 D 08 C Recovery 01 02 ec 0 0 00 0 00 lt Workload 19 0METs 00 00 00 05 1 pretelt Diagnosis I 2 3 4 5 Glossary Other Result Rhythm Arrhy QRS Deviation Ventricular Hyper Atrioventricular B 4 a Figure 7 2 Summary Interface Click on the Measure button and then click on one point on the wave and then drag the mouse to another point The distance amplitude difference and heart rate between the two points will be displayed 2 If a treadmill is used view the stage stage time speed slope workload METs BP HR Max ST and Min ST in every stage of the exercise test in the list If an ergometer is used view the stage stage time power BP HR PVC Max ST and Min ST in every stage of the exercise test in the list 3 Click on a stage the scroll bar of the wave field will be scrolled to the ECG waves of the stage 4 Right click on a wave and then click on the pop up Add Comment menu Then you can enter the co
23. 201002240000 Lily Green 36Year It is presampling now please click on Start button to begin record Sampling Time 10s SPESE IRE TRE IRE b start di ee E V3 6 2 v 10 DEEN IFEN IAEN IAEN d Lb ub 100Hz M Figure 6 4 Pre Sampling Interface 6 5 1 Specifying Display Mode There are five display modes including 12 1 6 2 3 4 6 1 and 3 1 When the display mode is set to 12 1 12 channel ECG waves are displayed on one screen simultaneously When the display mode is set to 6 2 12 channel ECG waves are displayed in 2 groups of 6 on one screen When the display mode is set to 3 4 12 channel ECG waves are displayed in 4 groups of 3 on one screen When the display mode is set to 6 1 6 channel ECG waves are displayed on one screen 35 SE 1010 User Manual Operation Instructions for Resting ECG When the display mode is set to 3 1 3 channel ECG waves are displayed on one screen simultaneously 6 5 2 Specifying Lowpass Filter Lowpass Filter restricts the bandwidth of input signals The cutoff frequency can be set to 25Hz 35Hz 45Hz 75Hz 100Hz or 150Hz The input signals whose frequency is higher than the set cutoff frequency will be attenuated 6 5 3 Specifying Gain 10mm mwv 5rmmiyrmwv You can set the indic
24. Create Type is set to Auto Create the patient ID can be automatically generated according to the examination date When ID Create Type is set to Manually input you should enter the patient ID manually on the Patient information interface When ID Create Type is set to Auto increase the patient ID can be increased by one automatically 109 SE 1010 User Manual Configuring the System 9 1 3 Setting Name Mode If you select First Name Last Name the Patient Name textbox on the Patient information interface will change into the First Name and Last Name textboxes Patient information Patient ID 201005250001 00259 0 LastName Age year E HRY ECG E VCG TVCG SAECG User Defined 1 User Defined 2 Race BP mmHg Medication Height cm Physician Weight Kg Technician Risk Indicators Symptom Cigarette Typical angina Congenital heart disease angina Hypertension Asymptomatic Hvperlipemia Family medical history 9 1 4 Selecting D O B If you select D O B the D O B textbox appears on the Patient information interface and the Age textbox becomes unavailable 110 SE 1010 User Manual Configuring the System Patient information Patient ID 1201005250001 Resting ECG Patient Sex Male Depart User Defined 1
25. Diagnosis Sinus Rhythm Flat T v 6 Right Axis Deviatian Save Other Result Rhythm and Arrhythmia QRS Deviation ventricular Hypertrophy ani Atrioventricular Black Intraventricular Conduction Myocardial injury Myocardial Infarction Glossary E E SE 1010 User Manual Operation Instructions for Resting ECG To Edit the Diagnosis Result 1 Enter your own opinions in the diagnosis textbox and then click on the Save button 2 Or double click on the necessary results required to be added in the Glossary textbox and the selected results will be displayed in the diagnosis textbox and then click on the Save button 6 6 1 2 About the Average Template Interface Click on the Average Template tab on the normal ECG analysis interface to open the average template interface Figure 6 8 You can analyze average templates on this interface 201002240000 Lily Green Normal Analysis 5 m Report Save Exit QTD FCG HF ECG Mormal Analysis Measure Preview Print Waveform Average Template Detail information 200mm s 100mm m 3 Heart Rate B 76 P Duration ms TI PR Int ms 160 QRS Dur ms an QT QTc ms 365 412 P QRS T deg 68 98 33 Rv5 SVi mV 1 965 0 446 lt a Diagnosis Sinus Rhythm Flat T V6 Right Axis Deviation Glossary Other Result Rhythm and Arrhythmia QRS Devia
26. E E BENE E BENE ES 895 03 m E E EN Bi EE iens beter al BN E m 0 32 100 2 5 Exam 2009 06 03 1 10 38 Print 2010 0720 1 10 24 ECG2 02 5 Figure 6 24 Preview Interface 6 6 7 Analyzing Vector ECG Click on the VCG button on the ECG analysis interface to display the VCG analysis interface Vector ECG You can choose the plane C P loop Vector Loop displays 3D image of ECG activity Frontal F Horizontal H Sagittal s ALL and the vector loop oop C T Loop f ALL Frontal F on the VCG analysis interface Plane choices include Horizontal H Sagittal S and ALL Loop choices include P loop QRS loop T loop and ALL SE 1010 User Manual Operation Instructions for Resting ECG 6 6 7 1 Displaying Vector with Plane and Loop set the plane to ALL and the loop to ALL Figure 6 25 displays Vector ECG with the plane of ALL and the loop of ALL 201002240000 Lily Green E TVCG SAECG Measure Preview Print Report Save Exit 20 mm mv 78 46 Vector Loop P loop QRS Loop C T Loop f ALL Auto Diagnosis Left Ventricular Hypertrophy Inferior Infarction Anteros
27. ECG sampling box firmly and keep it far away from the power cord SE 1010 User Manual Preparations Before Operation 4 Electrodes Check whether all electrodes are connected to lead wires of the patient cable correctly Ensure that the electrodes do not contact 5 Patient The patient should not come into contact with conducting objects such as earth metal parts etc Ensure the patient is warm and relaxed and breathes calmly WARNING 1 The system is intended to be used by qualified physicians or personnel professionally trained They should be familiar with the contents of this user manual before operation 2 Before connecting the device to the power line make sure that the voltage and frequency ratings of your power line match those indicated on the device label For details see Appendix 1 Technical Specifications 3 Before use the system patient cable electrodes etc should be checked Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or the performance NUN SE 1010 User Manual Operation Instructions for Resting ECG Chapter 6 Operation Instructions for Resting ECG Eici Double click on the shortcut icon 355 is the desktop icon for SE 1010 ECG on the desktop Tool Melp 00 4 New Patient STAT ECG Data Manager System Setting Lead Placement Exit E
28. Format Paper landscape Color white blacl w Auto baseline Adjustment Sequence sequential Background grid Auto gain change Cancel Figure 9 4 Printer Setting Interface 9 4 1 Choosing Patient Information to be Printed The patient information is displayed on the preview interface and in the report printed out It includes the height weight room number BP race and medication which are optional 119 SE 1010 User Manual Configuring the System 9 4 2 Choosing Diagnosis Information to be Printed The diagnosis information 1s displayed on the preview interface and in the report printed out Position Mark should be selected together with Average template because the position mark 1s only used to mark the position of ECG waves the average template Select Auto Diagnosis to display diagnosis results on the preview interface and in the report printed out Select Minnesota code to display Minnesota code 9 4 3 Setting Rhythm Lead The rhythm lead can be one of 12 standard leads I II III aVR aVL aVF V2 V3 V4 V5 or V6 When the printing mode is set to 3x4 1 or 6x2 1 the rhythm lead selected in the Rhythm list box will be printed out When the printing mode 15 set to 3x43 3 rhythm leads selected the Rhythm1 Rhythm2 and Rhythm3 list boxes will be printed out 9 4 4 Defining Printing Format 1 The paper form can be set to landscape or portrait 2 The printing col
29. MIN A1 5 Performance Specifications Display System name Patient ID Patient name Hear rate Display mode Printing mode Display Content Speed Gain Lowpass Filter Hint information ECG waves Recording Paper A4 recording paper Paper Width 210 mm A4 Paper Speed 5 mm s 10 mm s 12 5 mm s 25 mm s 50 mm s 2399 Date Time Printing Speed Filter Symbol Heart Rate Patient ID Sex Age Lead Mark Lead Wave Average Template Wave or Rhythm Lead Wave Measurement Result Record message and Interpretation Information Result option etc Channel 3 6 12 channels auto baseline adjustment ey SE 1010 User Manual Technical Specifications Memory Memory Storage amount depends on PC machine ECG Sampling Box Performance Leads Mode 12 standard leads Cabrera leads Acquisition Mode simultaneously 12 leads sample Frequency 1000 Hz A D Resolution 24 bits Time Constant gt 32 9 Frequency Response 0 05 Hz 150 Hz 3 dB Gain 2 5 mm mV 5 mm mV 10 mm mV 20 mm mV Input Impedance gt 50 10Hz Input Circuit Current 0 05 uA Input Voltage Range lt 5 mVpp Calibration Voltage mV 2 DC Offset Voltage 500mV lt ISuVp p Work Frequency Filter DFT Filter weak strong LOWPASS Filter 25 Hz 35 Hz 45 Hz 75 Hz 100 Hz 150 Hz CMRR gt 110 dB Pacemaker Detection Amplitude 2 to 700 mV sampling Frequency 10 000 sec channel Note Test
30. RR Interval to Minimum RR Interval 140 SE 1010 PC ECG User Manual Abbreviation 141 01 54 106666 17 REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany www com cn TEL 449 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipment Park Nanhai Rd 10192 Shekou Nanshan Shenzhen 518067 PR CHINA Email info edan com cn TEL 86 755 2689 8326 FAX 86 755 2689 8330
31. Resting ECG LF norm standard LF power HF norm standard HF power H Doctor Diagnosis Field 1 Enter your own opinions in the Auto diagnosis textbox and then click on the Save button 2 Or double click on the necessary results required to be added in the Glossary textbox and the selected results will be displayed in the Auto Diagnosis textbox and then click on the Save button 6 6 5 2 Editing the HRV Waveform on the Waveform Interface 201002240000 Lily Green HRV 2 aj o HRY HRT Measure Preview Print Report Save Auto diagnosis result Waveform 00 00 00 20 ned Next Page 00 30 00 40 00 50 01 00 01 10 DEEN A E em 01 20 eie 01 30 pee ere esed 101 40 c cree t 101 50 A D DAR D A 8 02 20 ceps Figure 6 21 Waveform Interface of HRV 4 waveform 15 displayed on Waveform interface Figure 6 21 1 You can drag the mouse on the interface to choose the wave field to be printed Then click on the Print button to print the selected wave field 2 Click on Previous Page or Next Page to display the waves of the previous or next page 57 SE 1010 User Manual Operation Instructions for Resting ECG 6 6 5 3 Previewing HRV Click on the Preview button to open the
32. Room Mo PA een 7 MD IL m ee NR a Rt ss por cs Mec pm a bes s e ds s sd hs eens s s bed FFFFEFEPRPPPFR FFFFPRPPPPPREPE 0 Ed sas ze en fenes fpe e epe ERE 8 DEP cad E EP t tt e tet So eee eee eee Es ese eee een ed espe es BEEP PSREEE Department E Ei ni li Bil 3 Sex Fem ale B DER a DET E EUR B E D D ER EE ERE ER DRE DRE HLLLEPLLLE HLLLLLBLLLLIELLLLELL Ei EH puppes pepe Ae ee ae a ps ess e e e pe pep ps peek 8 EL tT 15S LIELISE LL LEELLLLLI IL LL LM us 8 eo Fp FE PP FP PR t m 2
33. Supporting many kinds of treadmills and ergometers G Providing classical exercise protocols new exercise protocols can be added to the system ST segment analysis and measurement of 12 lead waveforms while sampling ECG ST position is adjustable while sampling ECG G Providing summaries ST analysis wave reviews and trends G Providing specific statistic data of each lead in each stage G Providing average waves of each lead in each stage for you to observe the changes of ST segments among different stages SE 1010 ECG User Manual Assembling SE 1010 PC ECG System Chapter 3 Assembling SE 1010 PC ECG System 2 N 5 AC Q Patient Cable for Resting ECG Patient Cable for Exercise ECG 5 ECG Sampling Box Cable for Exercise ECG k Cable for Resting ECG For resting ECG 1 Insert plug 1 of the patient cable into socket 3 of the ECG sampling box SE 1010 PC ECG User Manual Assembling SE 1010 PC ECG System 2 Insert plug 8 of the cable into socket 4 of the ECG sampling box 3 Insert plug 9 of the cable into the USB socket of the PC 4 Connect a printer to the PC 5 Insert the LPT softdog into the parallel interface of the PC or insert the USB softdog into the USB socket of the PC 6 Make sure that the above parts are properly connected and then connect the PC and the printer to the power supply For exercise ECG 1 Insert plug 2 of the patient cable into socket 3 of the ECG s
34. are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and SE 1010 PC ECG SE 1010 PC ECG 1s intended for use in an electromagnetic environment in which radiated disturbances are controlled The customer or the user of SE 1010 PC ECG can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and SE 1010 PC ECG as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated m maximum 150 to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2These guidelines may not apply in all situations Electromagnetic propagation 1 affected by absorption and reflection from structures objects and people 139 SE 1010 PC ECG User Manual Abbreviation Appendix 3 Abbreviation Dominant Direction of the Average Integrated ECG d Vectors Ratio of Maximum
35. cable to the ECG sampling box when the system is powered on do not disconnect the USB cable from the ECG sampling box 2 It is not necessary or recommended to regularly disconnect the USB cable from the ECG sampling box Disconnect the USB cable from the PC if necessary Back Panel Patient Cable Socket v Applied part of type CF with defibrillator proof SE 1010 User Manual Introduction N Caution Patient Cable Socket 15114113 1121111101 9 Definitions of corresponding pins LEM EE quu F HL C3 V3 C5 V5 R RA RF N RL or NC s ww pw vu e wem _ Note The left side of is European standard and the right side is American standard Top Panel and Bottom Panel Screw Label Decorative Chip SE 1010 User Manual Introduction WARNING 1 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configuration shall comply with the valid version of the standard IEC EN 60601 1 1 Therefore anybody who connects additional equipment to the signal input or output connector to configure a medical system must make sure that it complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt consult our technica
36. conducting objects Electrodes with defibrillator protection should be used while defibrillating The disposable electrodes can only be used for one time Electrodes of dissimilar metals should not be used otherwise it may cause a high polarization voltage Do not touch the patient bed table or the system simultaneously while using the system together with a defibrillator If reusable electrodes with electrode gel are used during defibrillation the ECG recovery will take more than 10 seconds The manufacturer recommends the use of disposable electrodes at all times Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configuration shall comply with the valid version of the standard IEC EN 60601 1 1 Therefore anybody who connects additional equipment to the signal input or output connector to configure a medical system must make sure that it complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt consult our technical service department or your local distributor SE 1010 User Manual Safety Guidance 21 22 23 WARNING The summation of leakage current should never exceed leakage current limits while several other units are used at the same time The equipment is protected again
37. page 2 Click on the Zoom Out button on the toolbar to minify the preview page 3 Click on the Close button to close the VCG preview interface and return to the previous interface 201002240000 Lily Green Next Page mu oe BEC Direction cow e d m m mw RE RE RN REOS eravasns m 2e oa ms oss M 3c dh Direction Cur cow um 3 006 EISE TTL LES T EL TE ESI FE AT HHHEEHHHEHHREHHHERHHEHHEBIEHE EH HH E A e 1 ow VEN E I eA PUA EPD SRA IE EREN ee IR es ae SEE EHEC wel ue SE eem ine Hnt Left ntricular Hypertrophy Inferior Infarction Petemseptal Myocardial Infarction possible coronary artery disease 0 67 100Hz 50 Exam 2010 07 19 18 51 Print 2010 07 19 18 53 PCECG2 02 SEMIP1 5 Figure 6 27 VCG Preview Interface Plane is ALL amp loop is ALL 6 6 8 Analyzing Time Vector ECG Click on the TVCG button on the ECG analysis interface to display the TVCG analysis interface Time Vector ECG is Vector ECG including time factor As Figure 6 28 shows you can observe waves of X lead Y lead Z lead X Y lead X Z lead and Z Y lead 66 SE 1010 User Manual Operation Instructions for Resting ECG 10
38. use in the electromagnetic environment specified below The customer or the user of SE 1010 PC ECG should assure that it 1s used such an environment Elect ti Immunity test IEC 60601 test level Compliance level environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Power frequency 50Hz magnetic field IEC 61000 4 8 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 NOTE 6 kV contact 8 kV air 6 kV contact 8 kV air 2 kV for power Not applicable supply lines 1 line to line 2 kV line to groud Not applicable lt 5 Ur gt 95 dip in for 0 5 cycle Not applicable 40 60 dip in for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 gt 95 dip in for 5 sec 137 Floors should be wood concrete or ceramic tile If floor are covered with synthetic material relative humidity should be at least 30 Mains power quality should be that of a typical commercial hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical typical hospital location in a commercial environment Mains power quality should be that of a typical commercial hos
39. 0 Manufacturer h p cosmos sports amp medical gmbh Germany CE marking Ergometer Model sana bike 120F sana bike 150F sana 250F Manufacturer ergosana gmbh Germany CE marking Model ergoselect 100P 100K ergoselect 200P 200K Manufacturer ergoline gmbh Germany CE marking Model Corival Manufacturer Lode B V The Nettherlands CE marking STRESS BP Model Manufacturer SunTech Medical Inc USA CE Certificate and FDA 510 k clearance Isolating Transformer Model ES710 Manufacturer BenDer Inc Deutschland 131 SE 1010 ECG User Manual Recommended Optional Accessories Electrical Outlet Power Consumption no less than 4500VA Special use for medical equipment Printer Model HP2035 HP5568 Manufacturer HP Company USA Model CANON3500 CANON1800 Manufacturer CANON Company Japan WARNING 1 The electrical outlet and the isolating transformer shall only be used for supplying power to the part of the system 2 It will harm the wall outlet to connect the non medical electrical equipment of the PC ECG system directly to the wall outlet because the non medical electrical equipment of the system is intended to be powered by using the electrical outlet and the isolating transformer 3 An additional multiple portable socket outlet or extension cord shall not be connected to the system 4 The electrical outlet and the isolating transformer shall not be placed on the floor 132
40. 2 Data Manager Interface Last day Last 1 week Last 1 month Last 3 months 1 Select a search item in the pull down list on the Data Manager interface Then all the patient records which meet the search condition are listed in the patient information list Search Department Diagnosis 2 Or select a search item in the pull down list enter the corresponding information in the right textbox and then click on the Search button All the patient records which meet the conditions will be displayed in the patient information list 3 Or click on Advanced Search to display the Search Condition window Enter the search 30 SE 1010 User Manual Operation Instructions for Resting ECG conditions and click on the Search button and all the patient records which meet the conditions will be displayed in the patient information list Search Condition Pat ID Examination Time 1 2000 4 14 2010 range Diagnosis 4 Click on the patient record in the patient information list and click on the Select button to open the Patient information interface Or double click on the patient record in the patient information list to open the Patient information interface saje SE 1010 User Manual Operation Instructions for Resting ECG Patient information Examin Exa Patient 10 2 zr Resting ECG Patient Name ily Gree
41. 201002240000 Lily Green HRV m 4 XA E HRY HRT Measure Preview Print Report Save Exit Auto diagnosis result waveform RR Histogram Histogram of RR Difference HR trend Sampling tim 300 TE oe Total Beat 389 Heart Rate B 78 J Average RR i 769 94 4 AB Max RR inter 828 Min RR 610 71 71 57 Max Min 1 357 L4 cx e x a Auto diagnosis 24 24 19 0 0 500 1000 1500 2000 400 240 80 80 240 400 0 60 120 180 240 300 RR interval ms RR difference Sampling time s Poincare plots Modified Poincare plots Spectral analysis cio erac fce xus 2o ee icc a Glossary 100 15 Other Result 30 5 pog E I MPa caca Rhythm and Arrhythmia 1200 aci 200 i F psica i an e 22 9 QRS Deviation nde dud Sale eat ventricular Hypertrophy ar soot 4 41 2 DAT 2 200 1 uer eee eee ee eee 15 3 Atrioventricular Block MN ee E Prod a E pe EET Intraventricular Conductior ee T er 43 is t Myocardial injury 30 8396 1 15 5496 Myocardial Infarction 00 600 200 0 200 600 1000 56 SE 1010 User Manual Operation Instructions for
42. 5 3 Editing the Waveform 5 Click on the Print button to print the exercise report 6 The system will enter the next stage of the exercise phase automatically after the set time of this stage 1s over Or click on the Exercise or Next button to enter the next stage of the exercise phase manually 7 Click on the Keep button and the system enters the Keep state The hint Keep will be displayed the speed power field The Next button becomes unavailable In this state the system will not follow the previous settings to change the speed and grade of the treadmill but keep the current speed and grade until this button 1s pressed again 7 7 Recovery Phase 1 When the current heart rate exceeds the target heart rate click on the Recovery button to enter the recovery phase Or the system will enter the recovery phase automatically after the set exercise test time 1s over 2 View the heart rate and BP of the patient For details see Section 7 5 1 Viewing the Heart Rate and the Blood Pressure Note If the current heart rate exceeds the target heart rate the hint The current HR has exceeded the target HR will appear on the sampling interface and the background color of the heart rate field will change from white to yellow 3 View other information For details see Section 7 5 2 Viewing Other Information 4 Edit the waveform For details see Section 7 5 3 Editing Waveform 5 Click on the Print button to p
43. 542 SE 1010 User Manual Operation Instructions for Resting ECG 201002240000 Lily Green HF ECG BER High Frequency ECG Report ID 201002240000 Name Lilhy Green Sex Fem ale amp ei35Y ear Department Room No Bome p R Bi pl ps prom E S p gs EHE BET E AI SH ff pel SL LE EE ER ERE EE IR E Es RES PES DUET d E ES E DRE GR ER E ERR RA E I E RU ER S RR RE HE heH Physician Hin r u m fave on ave ve vo ve vs ve ro 0 3 0 67 100Hz 50 Exam 2010 07 19 18 45 Print 2010 07 19 18 50 PCECG2 02 1 5 Figure 6 19 HF Report 6 6 5 Analyzing HRV Click on HRV to display the ECG analysis interface The HRV ECG analysis interface includes two tabs Auto diagnosis result and Waveform Notes 1 The HRV sampling time can be set on the sample setup interface 2 The HRV analysis lead can be selected on the sample setup interface 55 SE 1010 User Manual Operation Instructions for Resting ECG 6 6 5 1 Editing the HRV Data on the Analysis Interface
44. 7 9 9 Exiting the Analysis Interface Click on the Exit button on the analysis interface to return to the initial interface 98 SE 1010 User Manual Processing Patient Records Chapter 8 Processing Patient Records Click on the Data Manager button on the initial interface Figure 6 1 to open the Data Manager interface Figure 8 1 Data Manager Search Name Advanced Search Physician Examination patinets with no examination Last day Modify Exercise ECG 201002230001 James Smith Male 28Year HRV 201002240000 Lily Green Female 36Year Resting ECG VCG TVCG SAECG Delete Select Merge Assign Examination ID Examination Figure 8 1 Data Manager Interface Click on a patient record in the patient information list and then all the examination records of the patient will be displayed in the examination record list Note Click on an option in the patient information list such as ID name etc and then all the patient records will be arranged in sequence 8 1 Searching Patient Records 1 Select a search item in the pull down list on the Data Manager interface Then all the patient records which meet the search condition are listed in the patient information 99 SE 1010 User Manual Processing Patient Records list Department Diagnosis 2 Or select a search item in the pull down list enter the corresponding information in
45. 82 00 188 00 107 00 189 00 187 00 191 00 197 00 86 00 PR ms 168 00 172 00 156 00 151 00 162 00 158 00 156 00 159 00 160 00 164 00 169 00 152 00 QT ms 357 00 354 00 449 00 370 00 365 00 362 00 296 00 365 00 363 00 362 00 356 00 274 00 ORS 84 00 78 00 94 00 94 00 93 00 93 00 93 00 96 00 96 00 91 00 79 00 92 00 22 00 27 00 23 00 8 00 26 00 18 00 23 00 23 00 24 00 35 00 26 00 13 00 STj 0 008 0 036 0 005 0 010 0 000 0 023 0 020 0 131 0 116 0 060 0 036 0 005 ST1 0 046 0 048 0 010 0 040 0 024 0 010 0 030 0 254 0 215 0 138 0 076 0 033 5 2 0 088 0 081 0 003 0 086 0 039 0 038 0 022 0 342 0 311 0 200 0 116 0 063 ST3 0 125 0 129 0 002 0 123 0 062 0 058 0 010 0 498 0 455 0 301 0 176 0 088 ST20 0 038 0 038 0 015 0 028 0 022 0 013 0 035 0 216 0 175 0 113 0 061 0 018 Other Resuel ST40 0 056 0 051 0 015 0 040 0 032 0 015 0 035 0 264 0 220 0 151 0 089 0 033 ST60 0 071 0 073 0 007 0 061 0 034 0 028 0 035 0 312 0 273 0 180 0 111 0 048 iis 5780 0 095 0 106 0 002 0 093 0 047 0 048 0 032 0 377 0 341 0 231 0 141 0 068 B 1 Atrioventricular Block Intraventricular Conduction Myocardial injury Myocardial Infarction Fl El RR RR RID RE Export Excel Figure 6 9 Normal Detail Information Interface Click on the Export Excel button to export an Excel file To Edit Diagnosis Result on the Detail Information Inte
46. Analysis Interface A HRT Tachogram B Individual PVC C Risk Factors You can select Average Histogram or Single Histogram Click on Previous PVC to view the previous PVC Click on Next PVC to view the next PVC Click on the Preview button to open the HRT preview interface Page Prev Pace 2 ZeomGut Close toolbar on the HRT preview interface 1 Click on the Zoom In button on the toolbar to magnify the preview page 2 Click on the Zoom Out button on the toolbar to minify the preview page 3 Click on the Close button to close the HRT preview interface and return to the previous interface 60 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 0906031028 James Smith HRT SEE Next Page A wa Page Zoom In Zoom Out Close HRT report 1D 090603 1028 Name James Smith Sex Male Age 62Year Departmert Risk Indicators gt 0 S 2 5ms beat ean HR gt 7 5bpm 936 936 320 401 322 940 944 940 371 979 984 967 981 977 967 Ages 55 years ode View Average Histogram 2 3 4 5 7 8 3 10 12 13 14 15 Average 937 936 936 559 1287929 320 901 922 940 344 340 371 373 984 367 381 377 967 946 Min 937 936 936 559 1287329 920 901 922 340 344 340 371 373 384 367 381 977 967 346 Max 937 936 936 559 1287929 920 901 922 940 344 340 371 373 384 367 381 377 967 346 HE RHE Ed a 5 Eg p
47. Back Ground e rn UD ARRIERE 114 0 2 9 Seting se ern uL ent Sehen eh 114 2 2 10 Selecung ORS VOICE 114 DEVICE SC UID 115 a 115 9 3 2 Seting Device D a t p ERE 116 9 3 3 Setting COM Port of Sample Treadmill BP Monitor 116 iced oap estet tate peas 116 1 14 New 116 9 3 2 2 ime 117 9 345 Protocol 118 9 3 4 4 Restoring the Factory 119 PRIME 119 9 4 1 Choosing Patient Information to be 119 9 4 2 Choosing Diagnosis Information to be 120 20 4 3 Setung Led tret tatnen tme Ete lote bon ecl Rate 120 244 De linimno Prittine sius ot 120 DU e dads es 121 JOD T i rm 122 9 7 Moditymo the GlOSSat yi ees eet eds vea ees ner a a eet desean 123 Chapter TO Hint Information eo iSi Nena Ries ERES Neuere iei pese eos 124 Chapter 11 Cleaning and
48. CG wave of one lead from the beginning of the exercise test to the end 2 Select a lead from the lead pull down list to view the ECG wave of the lead Smm im 3 Select a gain from the gain pull down list 10mm mv 4 Click on one point on the wave and drag the mouse to another point and then the selected 94 SE 1010 User Manual Operation Instructions for Exercise ECG range will be marked with two red lines 201002240000 Lily Green ALL View a eea gt L Summa ST analysis ALL View Trend ECG Strip Measure Preview Print Report Save Exit 00 00 00 50 01 40 02 30 03 20 04 10 05 00 05 50 06 40 07 30 age Next Page Then click on the Zoom in button to display the amplified ECG segment s Z NE Drag the bottom scroll bar to view the whole amplified ECG waves 5 The all view interface displays ECG waves of 400 seconds ECG waves exceeding 400 905 SE 1010 User Manual Operation Instructions for Exercise ECG seconds can be reviewed by clicking on the Previous Page Next Page button 7 9 4 About Trend Interface Click on the Trend button to display the trend interface 201002240000 Lily Green STj Trend zm Summar ST analysis ALL View Trend ECG Strip Measure Preview Print Report Save Exit 10 20 30 40min Figure 7 7 Trend Interface You can observe 12 lead trend of the exercise t
49. DAN mi PC ECG SE 1010 Figure 6 1 Initial Interface The toolbar contains six buttons From left to right they are New Patient STAT ECG Data Manager System Setting Lead Placement and Exit Below the toolbar the software name version number and copyright information can be seen Click on Help H to see the help information Click on the Exit button on the initial interface to exit the system 24085 SE 1010 User Manual Operation Instructions for Resting ECG 6 1 Viewing Lead Placement Information 1 Click on the Lead Placement button on the initial interface to display the Lead Placement window Lead Placement Wilson lead system Frank lead system Exercise ECG lea 4 d 2 Click on Wilson lead system Frank lead system or Exercise lead system to view the lead placement information in the corresponding system 6 2 Selecting a Patient Record to Start a New Test Click on the Data Manager button on the initial interface Figure 6 1 to open the Data Manager interface Figure 6 2 SE 1010 User Manual Operation Instructions for Resting ECG Data Manager 4 JE Search Physician Examination patinets with no examination Physician Last day 201002230001 James Smith Male 28Y ear 201002240000 Lily Green Female 36Year Modify Delete Select Merge Assign lt gt Examination ID Examination Import Figure 6
50. Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level each frequency range Interference may occur in the vicinity of equipment marked with following symbol o NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation 1 affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic 138 SE 1010 PC ECG User Manual EMC Information environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength the location in which SE 1010 PC ECG 15 used exceeds the applicable RF compliance level above SE 1010 PC ECG should be observed to verify normal operation If abnormal performance 15 observed additional measures may be necessary such as reorienting or relocating SE 1010 PC ECG Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that
51. Figure 7 1 to enter the pretest phase Exercise ECG 201004140066 Lily Green 36Year e Template Trend Compare 8 156 Stage time Supine Exercise Time Max ST mV Min ST mV Sys Dia mmHg 90 01 00 00 00 0 40 V2 0 01 aVL 120 76 Total Time Bruce PuC min Speed mph Slope ENSE 5 01 00 0 0 0 0 0 1 SE 1010 User Manual Operation Instructions for Exercise ECG 7 5 1 Viewing the Heart Rate and the Blood Pressure lt 156 1 View the heart rate in the heart rate field The middle number is the current heart rate and the right number 1s the target heart rate The symbol __ xo shows the percentage of the current heart rate to the target heart rate and the blue part indicates the current heart rate Note If the current heart rate exceeds the target heart rate the hint The current HR has exceeded the target HR will appear on the sampling interface and the background color of the heart rate field will change from white to yellow Sys Dia mmHg 120 76 2 View the blood pressure in the field The left number 15 the systolic pressure and the right number 1s the diastolic pressure The displayed blood pressure will be updated every set time period Clicking on the BP button can update the displayed blood pressure manually Double click on the BP field on the ECG sampling interface to open the following dialog box and then enter the blood pressure manually If you se
52. File Edit View Favorites Tools Help d Je Search ls Folders Hab Address 3 Printers and Faxes Printer Tasks Add printer See what s printing Select printing preferences 2 3 Pause printing Share this printer Sharing Rename this printer Use Printer Offline Delete this printer as Set printer properties Pause Printing Create Shortcut Delete Rename Other Places Properties gt Control Panel Scanners and Cameras E Documents 4 Mv Pickures My Computer 2 Click on the Print button on the analysis interface to print an ECG report 3 Or click on the Print button on the preview interface to print an ECG report 6 6 11 Saving ECG Reports You can click on the Report Save button Feport Save to save ECG reports The report format includes PDF WORD JPG and BMP Click on the Browse button to choose the save path and click on OK to save the sampled data to the designated directory During the saving course the system will give the hint information Report Save File Lily Green 201002240000 6 Resting womp Send Saving D Documents and Settings edan Desktop D XDacuments and Settingsxedan sDesktopsLily Green 201002240000 6 Resting ECG doc Cancel Nom SE 1010 User Manual Operation Instructions for Resting ECG If you select Send the sampled data will be sent by email outloo
53. HRV preview interface preview interface 1 Click on the Zoom In button on the toolbar to magnify the preview page 2 Click on the Zoom Out button on the toolbar to minify the preview page 3 Click on the Close button to close the HRV preview interface and return to the previous interface 201002240000 Lily Green HRV 3 Print P Next Page Page Two Zoom In Zoom Out HRY report Ip 201002240000 Green Sex Fem ale Department Room No Time Domain Parameter RR Histogram Histogram of RR Difference HR trend 118 Sampling Time 300 s Total Beat Number 1252 Heart Rate 8 BPM Average RR d ms Max RR interval 828 ms Min RR interval 610 ms 1 357 47 47 SDNN 51 334 RMSSD 6 675 ms 94 71 71 Heart Rate BPM 24 24 Frequency Domain Parameter 0 Total P 293 6 ms 500 1000 1500 2000 400 240 80 80 240 400 60 120 180 240 300 otal Power 293 6 ms ms LF 128 9 ms ms RR interval rs RR difference Sampling time s HF 112 4 ms ms LFnorm 44 0 nu HFnorm 38 4 nu LF HF 11 1 Poincare plots Modified Poincare plots Spectral analysis Diagnosis 0 0 Bs 00 01 02 03 04 05 400 800 1200 1600 2000 7104550 600 2000 200 600 1000 0 67 100Hz 4250 Exam 2010 07 19 19 04 Print 2010 07 19 19 06 2 02 SEMIP1 5 Figure 6 22 HRV Preview Interface the First Page 6 6 5 4 Printi
54. Page to display 12 lead ST analysis waves of every 10 seconds 6 Click on Max ST Ascend to display the Max ST ascending waves 7 Click on Max ST Descend to display the Max ST descending waves 8 Double click on the wave of a lead the amplified wave of the lead and the calibration lines will be displayed Drag the calibration lines on the wave and the ST value will change Click on the OK button and then the Save button becomes available Click Save to save the modifications 09 SE 1010 User Manual Operation Instructions for Exercise ECG SI Analysis cee Ee Eee Eee Ee Ee cer Ee Fe cee Eee Eee Eee ERE Ee Le EE ER ber ST D 11mv EE Ed a Uie IS E E BEES EG CHER SE EE E E EE e Fee Eee Eee EE E ERR ERE ec fee Goel e ES A C E E Cancel 7 9 3 About View Review Interface 1 Click on the View button to display the all view interface 93 SE 1010 User Manual Operation Instructions for Exercise ECG 201002240000 Lily Green ALL View SEE lt 3 x uf SEV Summar ST analysis ALL View Trend ECG Strip Measure Preview Print Report Save Exit II 00 00 5mm m evious Page Next Page Figure 7 6 All View Interface The all view interface displays the E
55. User defined 2 You can input other related information such as patients medical records User defined 1 and User defined 2 can be set on the basic information setup interface Figure 9 1 Before setting them the two items on the Patient information interface are unavailable For details please refer to Section 9 1 1 Setting Basic Information Note On the Patient information interface patient ID is a must You can use the number generated by the system or input a number manually Patient ID can be a random character string excluding V P lt gt and T 2 Input additional information such as BP height weight medication and race 3 Select risk indicators and symptoms 11 5 SE 1010 User Manual Operation Instructions for Resting ECG 6 4 Selecting Sampling Type You can select a sampling type on the Patient information interface Resting ECG HRY ECG WOG T CG SAECG 6 5 Sampling Resting ECG After inputting the patient information click on the OK button on the Patient information interface to open the ECG sampling interface Before sampling if you do not connect the PC to the ECG sampling box the following hint will up A Hint Please make sure the USE line has been connected IF possible please re connect it The system begins to pre sample ECG OA SE 1010 User Manual Operation Instructions for Resting ECG Resting ECG
56. ailures and possible health hazards Clean the patient cable with a clean soft cloth Do not use the detergent containing alcohol to clean the patient cable Integrity of the patient cable including the main cable and lead wires should be checked regularly Make sure that it 1 conductible Do not drag or twist the patient cable with excessive stress while using it Hold the connector plugs instead of the cable when connecting or disconnecting the patient 126 SE 1010 User Manual Cleaning and Maintenance cable Align the patient cable to avoid twisting knotting or crooking at a closed angle while using Store the lead wires in a big wheel Once damage or aging of the patient cable is found replace it with a new one immediately Remove the remainder gel from the electrodes with a clean soft cloth first Take suction bulbs and metal cups of chest electrodes apart and take clamps and metal parts of limb electrodes apart Clean them in warm water and make sure that there 1s no remainder gel Dry the electrodes with a clean dry cloth or air dry naturally CAUTION 1 The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal 2 The disposable electrodes can only be used for one time 11 3 Disinfection To avoid permanent damage to the equ
57. ampling box 2 Insert plug 5 of the cable into socket 4 of the ECG sampling box 3 Insert plug 6 of the cable into the USB socket of the PC 4 Connect plug 7 of the cable to the BP monitor WARNING Only stress BP monitors can be used 5 Connect a treadmill or an ergometer to the PC 6 Connect a printer to the PC 7 Insert the LPT softdog into the parallel interface of the PC or insert the USB softdog into the USB socket of the PC 8 Make sure that the above parts are properly connected and then connect the PC treadmill ergometer and printer to the power supply WARNING 1 Use a special grounded socket to get accurate voltage and current 2 When using a notebook computer with a two prong plug please connect a grounded printer to avoid power interference SE 1010 User Manual Installing SE 1010 PC ECG Software Chapter 4 Installing SE 1010 PC ECG Software 4 1 System Running Environment 4 1 1 Requirements on the Hardware of the PC tm ink jet printer of more than 600dpi or laser printer Printer Recommend HP2035 5568 CANON3500 CANON1800 Displ 17 TFT 1024x768 resolution 19 TFT 1440x900 resolution 16 bit actual color regular icon and font setup 4 1 2 Requirements on the Software of the PC Windows XP PROFESSIONAL SP2 SP3 Windows Vista 32 64 bit or Windows 7 32 64 bit MSDE2000 Microsoft SQL Server 2000 Desktop Engine or Microsoft SQL Server 2005 E
58. anual Preparations Before Operation electrodes to the lead wires 2 Clean the electrode areas on the body surface with 75 alcohol 3 Attach the disposable electrodes to the electrode sites Note The quality and the placement of the electrode will directly influence the quality of exercise ECG The wrong placement and use of electrodes will cause incorrect analysis results WARNING 1 Make sure that all electrodes are connected to the patient correctly before operation 2 Make sure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objects CAUTION The disposable electrodes can only be used for one time 5 5 Inspection Before Test In order to avoid safety hazards and get good ECG records the following inspection procedure is recommended before operation 1 Environment Make sure that there 1s no electromagnetic interference source around the equipment especially large medical electrical equipment such as electrosurgical equipment radiological equipment magnetic resonance imaging equipment etc Switch off these devices when necessary Keep the examination room warm to avoid muscle action voltages in ECG signals caused by cold 2 Power Supply Check whether the power cord is connected well The grounded outlet should be used 3 Patient Cable Check whether the patient cable is connected to
59. aring Two Examination Records Press the Ctrl button on the keyboard and select two examination records and then click on the Compare button to display the Compare interface Note Please select two records with the same examination item You can select the lead to be compared from the lead pull down list Then the waves of the selected lead of the two examination records will be displayed on the interface You can drag the scroll bar on the bottom to view all the waves of the selected lead 103 SE 1010 User Manual Processing Patient Records Please select the compare lead BE PS RE 8 7 Importing Data into the Data Manager Interface Click on the Import button on the Data Manager interface Figure 8 1 to open the following window Select the data to be imported and click on the Select button to import the data into the Data Manager interface Choose folder Look in GILE JGLERS ERJGLER 100531 11500 1 HR V Lily Green 201002240000 1 Exercise ECG dat 104 SE 1010 User Manual Processing Patient Records If the data to be imported exists on the Data Manager interface the following hint will pop up 1 201004280000 2010 04 28 17 28 The exists continue to import Mo Click on the Yes button to import the data Click on the No button to cancel the operation Note Only ECG data in DAT format can be imported 8 8 Exp
60. asing the system will automatically make the waveform smooth Deselect Anti aliasing the system will not make the waveform smooth 9 2 10 Selecting QRS Voice If you select QRS Voice there will be a beep when an wave 15 detected 114 SE 1010 User Manual Configuring the System 9 3 Device Setup System Setting Basic Information Sample Setting Device Printer Setting Others GOT Sampling Device Device Type Treadmill IDP12 wired Sampling Box Device TMX425 Sampling Part COMO Trece COMI Protocol Bruce BP manitar 2 Modify Restore the default Figure 9 3 Device Setup Interface 9 3 1 Setting Sampling Device Select device from the Sampling Device Sampling Device 0 12 wired Sampling Box wired Sampling DP12 wired Sampling Box pull down list SE serial Machine DEMO on the device setup interface Figure 9 3 115 SE 1010 User Manual Configuring the System 9 3 2 Setting Device Type Mode Select device type mode from Device Type Device pull down list Device Type Treadmill Device 400 on the device setup interface Figure 9 3 9 3 3 Setting COM Port of Sample Treadmill BP Monitor Sampling Part 1 Treadmill COM2 Set COM of sampling treadmill BP monitor in p PEE on the device setup interface Figure 9 3 To guarantee the system s prope
61. ate For example if Power the frequency value of the first peak s position 15 1 2 the Spectrum heart rate 1 72 5 10 If the peak value of any peak behind the fifth peak is higher than the first peak value it 1s positive Otherwise it is minus n If the distances between peak values are not equal it 15 positive Otherwise it is minus 49 SE 1010 User Manual Operation Instructions for Resting ECG If the phase shift in the range of 6 18Hz exceeds 90 degrees Phase Shift it is positive Otherwise it is minus If the coherence value of the fundamental the position of the first peak power spectrum is less than 0 8 it is positive Otherwise 1t 1s minus Coherence If there are four twists and turns with peak to valley interval gt 0 5 or five twists and turns with peak to valley interval 70 1 the range of 10 20Hz it is positive Otherwise it is minus If the main peak the middle upends the downward peak value 1s higher than the upward peak value it 1s positive Impulse Otherwise it 1 minus Response If there is a peak around the main peak higher than 60 of the main peak it is positive Otherwise it is minus If the main peak in the middle upends it is positive Otherwise 1t 1 minus Correlation If the main peak in the middle deviates from the origin and Function the baseline it 1 positive Otherwise it 1 minus VXY The main peak is like the letter 50
62. ated length of ImV on the paper You can set the gain to 2 5mm mV 5mm mV 10mm mV 20mm mV 6 5 4 Specifying Speed 25mm s 5 rmrmm s You can set the paper speed to 5mm s 10mm s 12 5mm s 25mm s 50mm s 6 5 5 Recording ECG Data When the pre sample ECG waves are steady you can click on the Start button to save the sampled ECG data to the designated directory Please refer to data saving specification in Section Age SE 1010 User Manual Operation Instructions for Resting ECG 9 1 5 Specifying the Storage Path of the ECG Data Resting ECG 201002240000 Lily Green 36Year Resting ECG sampling now Sampling 1 05 NBT DOREA PADA BAN PARA D 00 05 eet d d Pf E tu Freeze Freeze rere HEE SRE X 25 5 10 pug 100 2 Figure 6 5 ECG Sampling Interface Note After you click the Start button the system will save the sampled ECG data If you don t click on the Start button the system won t save the sampled ECG data 6 5 6 Freezing and Previewing ECG Click on the Freeze button on the ECG sampling interface Figure 6 5 the system will display the Wave review interface 37 SE 1010 User Manual Operation Instructions for Resting ECG Wave review BER EE EH d
63. ccording to local regulations for separate collection after its useful life Federal US law restricts this device to sale by or on the order Rx only U S uu of a physician SE 1010 User Manual Introduction Chapter 2 Introduction SE 1010 PC ECG has similar functions with an ordinary electrocardiograph ECG data can be sampled analyzed and stored 1n a PC and it can be saved in PDF Word BMP or JPG format ECG waves can be frozen and reviewed Auto measurement and diagnosis are available and the diagnosis template can be edited When a patient with coronary heart disease runs the added heart load will cause myocardium hypotension and then the ECG will change abnormally Therefore with the function of exercise ECG SE 1010 PC ECG can also be used to diagnose concealed coronary heart disease and atypical angina pectoris prescribe the workload for patients with myocardial infarction before they leave hospital and assess the effect of the treatment Note The exercise ECG function is optional It is available only if you purchased this function With SE 1010 PC ECG doctors workload can be reduced greatly WARNING 1 This system is intended for use on adult and pediatric patients only 2 Ensure that there is no other database software in the PC in which our software will be installed Note This system is not designed for direct cardiac application 2 1 SE 1010 PC ECG System SE 1010 PC ECG system in
64. cleaning or maintaining the system turn off the system power and remove the power cable Prevent the detergent from seeping into the equipment while cleaning Avoid pouring liquid on the equipment while cleaning and do not immerse any parts of the equipment into any liquid Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes Removing all dust from the exterior surface of the equipment with a soft brush or cloth or with a soft cloth which is slightly dampened with a mild detergent solution or cool disinfector Especially the tie in and the panel edge should be noticed Any remainder of detergent should be removed from the unit and the patient cable after cleaning Do not use chloric disinfectant such as chloride sodium hypochlorite etc SE 1010 User Manual Safety Guidance 1 2 3 Preparation and Operation Warnings for Exercise 10 11 12 13 14 15 16 17 18 19 20 WARNING Ensure that the main unit and the treadmill are effectively grounded Test the emergency stop switch of the treadmill before using the system During the exercise testing ensure that there are at least 2 experienced physicians present One of them observes the patient and deals with the emergency Make sure that there is necessary valid first aid equipment such as the defibrillator the blood pressure meter etc and necessary valid medication in the exercise testing room T
65. cludes the following equipment gt PC in which PC ECG software is installed Manually Configured ECG Sampling Box Printer Manually Configured Treadmill or Ergometer Manually Configured Patient Cable Electrodes Softdog Note If the PC is not purchased from our company we will not be held responsible for the maintenance of the PC hardware or the operating system SE 1010 User Manual Introduction SE 1010 PC ECG System Treadmill or Ergometer Manually Configured Serial Cable for 0 exercise only Patient Cable ECG Cable BP Monitor PC Manually ECG Sampling Box Manually Configured ECG Configured Cable USB Cable for exercise ECG only Printer Manually Configured WARNING The system should be installed by a qualified service engineer Do not power on the system until all cables are properly connected and verified SE 1010 User Manual Introduction 2 2 ECG Sampling Box Appearance ECG Sampling Box Appearance Front Panel USB Socket Explanation When the ECG sampling box is powered by the PC the lamp will be lit Connecting to the USB socket of the PC with a USB cable SE 1010 User Manual Introduction USB Socket Definitions of corresponding pins OK S C 1 2 7 GND WARNING 1 When the computer connected to the USB cable is powered on do not connect the USB
66. d ECG Click on the Preview button to display the SAECG preview interface Ping Prev Page Two Page Zoomin ZoomGut e toolbar on the SAECG preview interface 1 Click on the Zoom In button on the toolbar to magnify the preview page 2 Click on the Zoom Out button on the toolbar to minify the preview page 3 Click on the Close button to close the SAECG preview interface and return to the previous interface 70 SE 1010 User Manual Operation Instructions for Resting ECG 201002240000 Lily Green SAECG wo Page Zoom In Zoom Out Close Ne t Page SAECG Report Ip 201002240000 Geen Sex Fem ale Department ERN She eT AU eg jv ei Je 1 1 en 1 0mmim 100mrm mv 1000mmim 25mmis 100mmi s 10 0mrmis 1000mmim 200 5 VCG 3D Graph 40 250Hz 301 6 90 2 20Hz 150Hz 180Hz Standard QRS 3 i 3 054 Total QRS 3 Fi 40 250Hz Below 400 5 5 Last 40ms 0 67 100Hz 50 Exam 2010 07 19 18 51 Print 2010 07 19 18 58 PCECG2 02 SEMIP1 5 Figure 6 32 Signal Averaged ECG Report 6 6 10 Printing ECG Reports 1 Choose Start gt Printers and Faxes and then right click on the icon of the printer used and select Set as Default Printer Then close the Printers and Faxes interface NE SE 1010 User Manual Operation Instructions for Resting ECG Printers and Faxes
67. d Service Policy Chapter 13 Warranty and Service Policy 13 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects 1n materials and workmanship that occur within warranty period The warranty period begins on the date the products are shipped to distributors The warranty 15 void in case of a damage caused by handling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because of defective materials components or workmanship and the warranty claim 15 made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product 15 being repaired 13 2 Service Policy repairs on products must be performed or approved by EDAN Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall be exclusively be performed by EDAN certified service personnel If the product fails to function properly or if you need assistance service or spare parts contact EDAN s service center A representative will assist you troubleshoo
68. e 293 SE 1010 User Manual Operation Instructions for Exercise ECG Comment Please enter the comment 3 Click on the Template button and the average waves of 12 leads and the calibration lines will be displayed The average waves will be updated every 10 seconds Right click on the average wave field to display the lead group menu and then you can select other leads Select Compare to compare the current ST segments with the average beats of the sampled data in the first stage of the pretest phase Double click on the average wave of a lead the amplified average wave of the lead and the calibration lines will be displayed You can drag the calibration lines on the wave The average wave will be updated every 10 seconds Ed EE 4 t 84 SE 1010 User Manual 4 Click on the ST Trend button to display the ST trend Right click on the ST trend field to display the lead group menu and then you can select other leads Operation Instructions for Exercise ECG rv rv 0 4 0 4 I 0 T lt 10 20 30 4 min 11 20 30 apmin 0 4 0 4 mi rs 0 4 0 4 0 10 20 3l 40 m 10 20 3l 40 0 4 0 4 mi rv 0 4 0 4 10 2 30 40 10 2 30 40 0 4 0 4 mV T Previous lead 0 4 avR 1 4 Mext lead Di 10 20 3l 40 10 20 30 40 0 4 0 4 rs rv 0 4 0 4 0 0 10 20 3l 40 10 2 30 40 0 4
69. e examination record list on the Data Manager interface Figure 8 1 If it is a normal ECG record the normal ECG analysis interface will pop up If it is an HRV record the HRV analysis interface will pop up Then you can do the corresponding operation to the examination record For more information about the operation please refer to Section 6 6 Analyzing ECG Data and Section 7 9 About Analysis Interface 106 SE 1010 User Manual Configuring the System Chapter 9 Configuring the System Click on the System Setting button on the initial interface Figure 6 1 to open the System Setting interface There are six tabs on the System Setting interface Basic Information Sample Setting Device Print Setting Others and GDT After you modify some information on the System Setting interface 1 Click on the OK button to save these modifications and exit 2 Or click on the Cancel button to cancel these modifications and exit 9 1 Basic Information Setup Click on the Basic Information tab on the System Setting interface to display the basic information setup interface 107 SE 1010 User Manual Configuring the System System Setting Basic Information Sample Setting Device Printer Setting Others GDT Basic Information Hosptial Physician Technician User Defined 1 User Defined 2 NEN ID Create Auto Create Manually input Auto increa
70. ea on the chest surface with alcohol 2 Daub the round area of 25mm diameter on each electrode area with gel evenly 3 Place a small amount of gel on the brim of the chest electrode s metal cup 4 Place the electrode on the chest electrode area and squeeze the suction bulb Unclench it and the electrode 1 adsorbed on the chest 5 Attach all chest electrodes in the same way Chest Electrode Only for C5 in Frank Lead System Snap Banana Socket Adapter Disposable Electrode Disposable Electrode Connection 1 Connect the snap banana socket adapter to the lead wire xD SE 1010 User Manual Preparations Before Operation 2 Connect the snap banana socket adapter to the disposable electrode 3 Clean the electrode area at the back midline with 75 alcohol 4 Attach the disposable electrode to the electrode area at the back midline The quality of ECG waveform will be affected by the contact resistance between the patient and the electrode In order to get a high quality ECG the skin electrode resistance must be minimized while connecting electrodes WARNING 1 Make sure that all electrodes are connected to the patient correctly before operation 2 Make sure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objects CAUTION The disposable electrodes can only be used for one time 5 4 Attaching El
71. ectrodes to the Patient for Exercise The identifiers and color codes of electrodes used comply with IEC EN requirements In order to avoid incorrect connections the electrode identifiers and color codes are specified in Table 5 2 Moreover the equivalent codes according to American requirements are given in Table 5 2 too xA s SE 1010 User Manual Preparations Before Operation Table 5 2 Electrodes and their identifiers and color codes European American Ot e a e oom Lm p wemer The Precordial Electrodes Positions on Body Surface Fourth intercostal space at the right border of the sternum C2 Fourth intercostal space at the left border of the sternum C3 Fifth rib between C2 and C4 C4 Fifth intercostal space on the left midclavicular line C5 Left anterior axillary line at the horizontal level of C4 Left midaxillary line at the horizontal level of C4 The Extremity Electrodes Positions on Body Surface R L below the right left clavicle N F below the right left rib The quality of ECG waveform will be affected by the contact resistance between the patient and the electrode In order to get a high quality ECG the skin electrode resistance must be minimized while connecting electrodes Electrodes Connection 1 Align all lead wires of the patient cable to avoid twisting and connect the disposable 25 SE 1010 User M
72. eptal Myocardial Infarction possible coronary artery disease 20 mm mVv 0 3596 Glossary Other Result Rhythm and Arrhythmia QRS Deviation ventricular Hypertrophy and trioventricular Block Intraventricular Conduction B Myocardial injury Myocardial Infarction i 2 2 A 222 Fl EI REL RI RET RD RT IE Figure 6 25 Vector ECG Plane of ALL and Loop of ALL A Vector ECG of Frontal F B Vector ECG of Horizontal H C Vector ECG of Sagittal S D Average templates of X Y and Z leads Double click on this figure to display the magnified average template You can drag these lines marked P2 S and T2 on the wave With the change of the line position the corresponding parameter values change E Click on the Parameter button to display the following Vector ECG parameter list 2455 SE 1010 User Manual Operation Instructions for Resting ECG Vector Parameter 12 16 Direction CCW CAN ots om 60 022 007 6 061 13 O62 204 Te 0 045 ae ae 64 2 21 179 Statvi ms o 030 37 037 0 42 Ccw EE NEN NI The position of maximal amplitude of QRS P T loop mV 63 SE 1010 User Manual Operation Instructions for Resting ECG 0 04 amplitude The amplitude at 0 04s from QRS loop 0 04 angle The angle at 0 04s from QRS loop Start Vector Start point o
73. er the ECG sampling time 1s over For details on setting ECG sampling time see Section 9 2 2 Setting Sampling Time 2 Before the ECG sampling time is over you can click on the Stop button to stop sampling data and the ECG analysis interface will pop up automatically 6 5 8 Printing ECG Waves Click on the Print button on the ECG sampling interface to print the ECG waves Note You can set the printer type on the print setup interface There are two options white black and color The report color is defined by setting the printer type and can be observed on the preview interface For details on setting the printer type see Section 9 4 38 SE 1010 User Manual Operation Instructions for Resting ECG Printer Setup 6 6 Analyzing ECG Data You can open the ECG analysis interface in one of the following three ways 1 Click on the Start button and then the system will stop sampling ECG and display the ECG analysis interface automatically after the sampling time 1 over 2 Or click on the Stop button to stop sampling after clicking on the Start button and the system will display the ECG analysis interface automatically 3 Or double click on an examination record in the examination record list on the Data Manager interface Figure 6 2 to open the ECG analysis interface When the sampling type 15 Resting the analysis interfaces include Normal ECG QT Dispersion Frequency ECG and H
74. erape Template Intettace icc oe ot te 42 6 6 1 3 About the Detail Information 43 6 6 1 4 Previewing Normal ete tes o kn teres etna en a Ru eds 44 6 6 2 OL DISDEESIOD e reet oS deed 45 6 6 2 1 Editing Waveform the QT Dispersion 46 0 2 JA OT Value 47 6 6 2 5 Previewine O DDISDOLSIOD ue deett epe ponet 47 Analy zing Prequency BOO e ectetuer steve theo bote Vi tea iiis 48 6 6 3 1 About Two lead Comparison Interface 48 6 6 3 2 About 12 lead Power Spectrum 51 6 6 5 5 Previewing Frequency ECG uec m ned mrt ete tan enu v eta dae e nent ve 51 6 6 4 Analyzing High Frequency EE eene essent nana 53 0 VICINAE HR eR mms 55 6 6 5 1 Editing the HRV Data on the Analysis 56 6 6 5 2 Editing the HRV Waveform on the Waveform Interface 57 00 53 PECVICW 58 6 0 5 4 Frinn HRV 58 HR Eea 59 Vector tace 61 6 6 7 1 Displaying Vector ECG with Plane 62 6 6 7 2 Displaying Vector ECG with Frontal Plane and QRS Loop
75. est on the trend interface The horizontal coordinates indicate test time but the units of the vertical coordinates are different on different trend interfaces 7 9 5 About ECG Strip Interface Click on the ECG Strip button to display the ECG strip interface 96 SE 1010 User Manual Operation Instructions for Exercise ECG 201002240000 Lily Green ECG Strip e y lt e uf ahs sn i Summar ST analysis ALL View Trend ECG Strip Measure Preview Print Report Save Exit 0 0mph Bruce Supine Pretest 76bpm 00 15 BP mmHg 120 78 0 0 24 42 Figure 7 8 Strip Interface 1 Click on Pretest to display strip waves of the pretest phase 2 Click on Exercise to display strip waves of the exercise phase 3 Click on Recovery to display strip waves of the recovery phase 4 Click on Previous Page Next Page to display strip waves of every 30 seconds 7 9 6 Previewing ECG Reports Click on the Preview button to preview an ECG report 7 9 7 Printing ECG Reports You can print an ECG report by clicking on the Print button For details please refer to Section 6 6 10 Printing ECG reports 97 SE 1010 User Manual Operation Instructions for Exercise ECG 7 9 8 Saving ECG Reports You can save an ECG report by clicking on the Report Save button For details please refer to Section 6 6 11 Saving ECG reports
76. f ORS loop ST Vector The position of ST vector in vector loop Length Width The ratio of length to width in T loop T R angle The degree between the Max vector of T loop and the Max vector of QRS loop degree F Click on 3D to display the 3D VCG graph G Diagnosis Field 1 Enter your own opinions in the Auto Diagnosis textbox and then click on the Save button 2 Or double click on the necessary results required to be added in the Glossary textbox and the selected results will be displayed in the Auto Diagnosis textbox and then click on the Save button 6 6 7 2 Displaying Vector ECG with Frontal Plane and QRS Loop 201002240000 Lily Green VCG Efex xj OX gt mw amp SAECG Measure Preview Print Report Save Exit Frontal F Horizontal H Sagittal s ALL vector Loop mm 0 QRS Loop C e 20 mm mVv NN Auto Diagnosis Left Ventricular Hypertrophy Inferior Infarction Anteroseptal Myocardial Infarction possible coronary artery disease 4 4 4 4 4 4 4 4 a i a e E E 5 5 Save Glossary Other Result Rhythm and Arrhythmia QRS Deviation ventricular Hypertrophy and Atrioventricular Block Intraventricular Conduction B Myocardial injury Myocardial Infarction Figure 6 26 Vector ECG Frontal amp QRS loop The percen
77. he time mode to 24Hour or 12Hour Set the date mode to mm dd yyyy dd mm yyyy or yyyy mm dd Set the color of the background waves grid Smm grid 1mm mark and text If you want to change a color double click on the color block to display the Color interface and then you can select your favorite color Click on the Default button to restore the default colors 121 SE 1010 User Manual Configuring the System 9 6 GDT Setup system Setting Basic Information Sample Setting Device Printer Setting Others SUT GDT Path suffis Input file name Output file ee a anene Figure 9 6 GDT Setup Interface Select On GDT to enable GDT features Click on the Browse button and then appoint the path to exchange files with EDP Fill in the Input file name textbox to set command file name assigned by EDP to the PC ECG system Fill in the Output file name textbox to set data file name that is used by the PC ECG system to transmit the result data to EDP Enter ECG ID to set GDT ID assigned to the system which will be entered in field 8315 or 8316 in the GDT protocol Enter EDP ID to set GDT ID of the EDP system which will be entered in field 8315 or 8316 in the GDT protocol 122 SE 1010 User Manual Configuring the System 9 7 Modifying the Glossary Er Mew Patient STAT Data Management System Setup Lead Placement Edit Diagnosi
78. idaxillary line at the horizontal level of C4 SE 1010 User Manual Preparations Before Operation 5 3 2 Frank Lead System FRANK lead system is usually adopted when PC ECG is used to produce VCG The conventional letter designations for the electrodes and their respective positions are E C2 at the front midline 5 at the back midline at the right mid axillary line A C4 at the left mid axillary line C C3 at 45 angle between the front midline and the left mid axillary line F on the left leg N on the right leg H on the back of the neck The first five electrodes E M I A and C are all located at the same transverse level approximately at the interspace between the fourth rib and the fifth rib 5 3 3 Attaching Electrodes to the Patient For Limb Electrodes Connecting to a Lead Wire Reed Clamp 1 Clean the electrode area which is in a short distance above the ankle or the wrist with alcohol aa SE 1010 User Manual Preparations Before Operation 2 Daub the electrode area on the limb with gel evenly 3 Place a small amount of gel on the metal part of the limb electrode clamp 4 Connect the electrode to the limb and make sure that the metal part 15 placed on the electrode area above the ankle or the wrist 5 Attach all limb electrodes in the same way For Chest Electrodes Suction Bulb Cup Connecting to a Lead Wire 1 Clean the electrode ar
79. ient record from the database to start a new test The operation steps are the same as those of resting ECG For details refer to Section 6 2 Selecting a Patient Record to start a New Test 2 Select Exercise ECG on the Patient information interface Resting Exercise ECG HRY ECG WOG TVCG SAECG 3 Click on OK on the Patient information interface to open the Exercise ECG Setting interface After setting the parameters click on the OK button to open the pre sampling interface 75 SE 1010 User Manual Operation Instructions for Exercise ECG Exercise ECG Setting Target Max Predicted HE 220 Age Target Max Predicted HR 85 95 Normal BPimmHg Max value 220 90 Min 110 j 60 Please select a protocol Please select Post J Bruce BP sampling mode BP triggering made BP Monitar enter once per stage Square Wave Auto print Cancel 7 2 1 Setting Target HR The system applies the following formulas to calculate the target heart rate Target HF Max Predicted HR 220 Age Target HR Predicted 85 220 and 85 are default values and you can modify them different situations on the Exercise ECG Setting interface 7 2 2 Setting Normal BP set the normal BP range on the Exercise ECG Setting interface When the patient s BP exceeds the normal BP range the system will consider it as abnormal status 76 SE 1010
80. igh Frequency ECG HF When the sampling type is HRV ECG the ECG analysis interfaces include Heart Rate Variability and Heart Rate Turbulence When the sampling type is VCG TVCG SAECG the ECG analysis interfaces include Vector ECG Time Vector ECG and Signal Averaged ECG 6 6 1 Analyzing Normal ECG Click on the Normal Analysis button to open the normal ECG analysis interface There are three tabs Waveform Average Template and Detail information 6 6 1 1 Viewing the Waveform Click on the Waveform tab on the normal ECG analysis interface to open the Waveform interface Figure 6 7 2 30 SE 1010 User Manual Operation Instructions for Resting ECG EE 201002240000 Lily Green Normal Analysis af En as Analysis Measure Preview Print Report Save Exit Waveform Average eee Detail TET 25mm s 10 6 2 Re Sample Upload Heart Rate B P Duration ms 111 PR Int ms 160 QRS Dur ms 90 QT QTc ms 365 412 P ORS T deg 68 98 33 RND SViumwv 1 965 0 4 Sinus Rhythm Flat T V6 Right Axis Deviation Glossary Other Result Rhythm and Arrhythmia QRS Deviation Ventricular Hypertrophy Atrioventricular Block Intraventricular Conduction Myocardial injury Myocardial Infarction Figure 6 7 Normal Waveform Interface You can choose a speed a gain and a display mode for the displa
81. ipment disinfection can be performed only when it 15 considered as necessary according to your hospital s regulations Before disinfection clean the equipment first Then wipe the surfaces of the unit and the patient cable with hospital standard disinfectant CAUTION Do not use chloric disinfectant such as chloride sodium hypochlorite etc 127 SE 1010 PC ECG User Manual Accessories Chapter 12 Accessories WARNING Only the patient cable and other accessories supplied by the manufacturer can be used Or else the performance and electric shock protection can not be guaranteed Table 12 1 Standard Accessory List DP12 ECG Sampling Box 02 01 210039 Softdog USB 01 18 047225 Patient Cable European Standard 01 57 106902 for resting test Patient Cable American Standard 01 57 107048 for resting test Limb Electrode 01 57 040162 Chest Electrode 01 57 040163 Resting ECG External USB Cable 01 13 036134 Portable Bag 11 56 078136 Table 12 2 Optional Accessory List Softdog USB 01 18 047229 Patient Cable 01 57 109850 exercise ECG Electrode 01 57 040171 exercise Disposable Frosting Film for Skin Preparation 01 57 107418 Computer Exercise ECG External USB Cable 01 13 036135 11 18 052208 Lenovo Qitian M6900 Snap Banana Socket Adapter 01 13 107449 MSB1212 Disposable Electrode 01 57 040171 128 SE 1010 PC ECG User Manual Warranty an
82. k express when it is saved to the designated directory During the saving and sending course the system will give the hint information Notes 1 In Windows 7 Vista only if OUTLOOK EXPRESS is installed can the report be sent by emall 2 Before saving reports you should install the Microsoft Word or PDFCreator software in the PC otherwise Report Save can not be realized 6 7 Sampling STAT ECG Click on the STAT ECG button on the initial interface Figure 6 1 to sample normal ECG directly without entering new patient information or selecting an existing patient record from the database before sampling The system will automatically distribute a new patient ID Los SE 1010 User Manual Operation Instructions for Exercise ECG Chapter 7 Operation Instructions for Exercise ECG The exercise ECG function 15 optional It is available only if you purchased this function 7 1 Viewing Lead Placement Information 1 Click on the Lead Placement button on the initial interface to display the Lead Placement window Lead Placement Wilson lead system Frank lead system Exercise ECG lea 4 d 2 Click on Exercise ECG lead system to view the lead placement information As SE 1010 User Manual Operation Instructions for Exercise ECG Lead Placement C4 cscs Frank lead system Exercise ECG lead system 4 d 7 2 Selecting a Patient Record to Start a New Test 1 You can select a pat
83. l service department or your local distributor 2 he summation of leakage current should never exceed the leakage current limit while several other units are used at the same time 2 3 Features gt gt gt gt gt gt gt gt gt gt gt Powerful functions friendly interfaces and easy operation 3 6 12 channel ECG waves are displayed and printed simultaneously ECG waves can be frozen and reviewed Supporting auto measurement and diagnosis Measurement point adjustment and re analysis manual measurement with an electronic ruler of high precision Perfect data management and processing functions Reports can be printed in PDF Word JPG or BMP format supporting multi language Updated to be a network electrocardiograph transmitting ECG data over LAN or WAN or INTERNET Automatic baseline adjustment for optimal printing High performance filters guarantee stable ECG waveforms Real time analysis real time displaying and printing 12 lead simultaneous ECG waveforms Nine analysis functions including Normal ECG Frequency ECG High Frequency ECG SE 1010 User Manual Introduction Dispersion Vector ECG Time Vector ECG analysis HRV analysis and Signal Averaged ECG Only for resting ECG The following features are only for the exercise test function of SE 1010 PC ECG G Automatically controlling and adjusting the speed and the elevation of the treadmill G
84. ments modifications or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument 15 used accordance with the instructions for use Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Terms Used in this Manual This guide 1s designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure Table of Contents 1 UM SANCTUS MB UC 1 1 2 ANIONS E Quiet 1 1 2 T G neral WAT MIN 1 12 2 Gener auti nd 3 1 2 3 Preparation and Operation Warnings for Exercise 2 22221 5 1 2 4 Contraindications for Exercise
85. mment in the Comment dialog box Click on the OK button and the comment will be displayed on the wave 88 SE 1010 User Manual Operation Instructions for Exercise ECG 5 Enter diagnosis results in the Diagnosis textbox and then click on Save 6 Or double click on the necessary results required to be added in the Glossary textbox and the selected results will be displayed in the Diagnosis textbox and then click on the Save button 7 Click on the Preview button to display the Print Set window Print 5et Summary Report t Current Wave Cancel Select Summary Report or Current Wave Click on the OK button to open the preview interface 89 Operation Instructions for Exercise SE 1010 PC ECG User Manual m 4 gt 3 J J J 1 L tL L 1 111 L L de l Lah 1 ee ee 4 4 Figure 7 3 Summary Report 90 Operation Instructions for Exercise SE 1010 PC ECG User Manual 12 lead ECG Report eet ee s es eese es s ese es ese o EET races ks ess ess ess ec be re ree e ess s NR IIT T
86. n Exercise ECG Age 36 Year C HRY ECG Depart ex 9 UU SE User Defined 1 User Defined 2 Room Race e Bp m Medication Height 168 cm Physician e Weight 65 Technician e Risk Indicators Symptom Cigarette Typical angina Diabetes Cancel Non typical angina Congenital heart disease Nn angina Hypertension t Asymptomatic Hvperlipemia a Family medical history els Figure 6 3 Patient Information Interface 6 3 Entering New Patient Information If the patient is new one you can click on New Patient button NeW initial interface Figure 6 1 to display the Patient information interface 00 SE 1010 User Manual Operation Instructions for Resting ECG Patient information Patient ID 201005250001 Resting ECG Patient Name Ewercige ECG Age ECG 5 C VCG TVCG SAECG User Defined 1 User Defined 2 Room Ma Race mmHg Medication Height cm Physician Weight Kg Technician Risk Indicators Symptom Cigarette Typical angina Congenital heart disease t Mn angina Hypertension Asymptomatic Hvperlipemia L Family medical history Then you need to input the patient s related information 1 Input basic information such as patient ID name sex age etc User defined 1 and
87. n list 8 3 2 Deleting Examination Records of a Patient The operation methods of deleting examination records are similar to those of deleting patient records 8 4 Selecting a Patient Record Click on a patient record in the patient information list on the Data Manager interface and click on the Select button to display the Patient information interface Then click on the OK button the system will sample ECG data of the patient 102 SE 1010 User Manual Processing Patient Records Patient information Examin Dia Patient ID 201002240000 00000000000 Resting ECG i SSSR Patient Name ily Green 0505025 5 05 2 n 222901 36 vear ECG nc Female Depart TM C MOUO TVCOGISAECG User Defined 1 User Defined 2 Room Race e Bp o O mmHg Medication Height 159 cm Physician B Weight B5 Kg Technician B Risk Indicators Symptom Cigarette C Typical angina Congenital heart disease Mo angina Asymptomatic Hyperlipemia Family medical history others Hypertension 8 5 Merging Examination Records Click on an examination record in the examination record list on the Data Manager interface and click on the Merge Assign button to display the Patient information interface Input a patient ID and click on the OK button to assign the examination record selected to this patient 8 6 Comp
88. ndications 1 9 iw 49 Acute MI within 2 days High risk unstable angina Hemodynamic compromise caused by uncontrolled cardiac arrhythmia Active endocarditis oymptomatic severe aortic stenosis Decompensated symptomatic heart failure Acute pulmonary embolus or pulmonary infarction Acute noncardiac disorder that may affect exercise performance or be aggravated by exercise eg infection renal failure thyrotoxicosis Acute myocarditis or pericarditis 10 Physical disability that would preclude safe and adequate test performance 11 The patient opposes the test Relative Contraindications 1 49 Left main coronary stenosis or its equivalent Moderate stenotic valvular heart disease Electrolyte abnormalities Tachyarrhythmias or bradyarrhythmias Atrial fibrillation with uncontrolled ventricular rate Hypertrophic cardiomyopathy Patients can not cooperate because of mental impairment High degree AV block SE 1010 User Manual Safety Guidance 1 3 List of Symbols Equipment or part of CF type with defibrillator proof Consult Instructions for Use Serial Number Date of Manufacture Manufacturer Authorized Representative the European Community The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices It indicates that the device should be sent to the special agencies a
89. ng HRV Wave Click on one point on the wave and then drag the mouse to another point on the Waveform interface Figure 6 21 Then click on Print to print the selected range 58 SE 1010 User Manual Operation Instructions for Resting ECG 6 6 6 Analyzing HRT Heart Rate Turbulence is a physiological biphasic response of the sinus node to the premature ventricular contractions It includes a short initial acceleration followed by a deceleration of the heart rate HRT can be quantified by two numerical parameters namely the Turbulence Onset and the Turbulence Slope Turbulence Onset TO Turbulence Onset TO is the percentage difference between the heart rate after PVC and the heart rate before PVC It is calculated by using the equation TO RR2 2 RR 1 2 RR 1 100 2 and 1 are the last two normal intervals before PVC and and RR2 are the first two normal intervals after PVC Positive values of Turbulence Onset indicate the deceleration while negative values indicate the acceleration of the sinus rhythm Turbulence Slope TS Turbulence Slope TS corresponds to the steepest slope of the linear regression line for each sequence of five consecutive normal intervals in the local tachogram The Turbulence Slope calculations are based on the averaged tachogram and expressed in ms per RR interval Filters The algorithm of quantification can deliver usable re
90. nication between the ECG sampling box and the serial port 1s interrupted 1 Reconnect the sampling box to the PC 2 Click on the Device tab on the System Setting interface of the PC ECG system and check whether the sampling device 15 set correctly Overload The direct current offset voltage on an electrode 1 too high Fail to open the treadmill ergometer port Fail to open the COM port which controls the Please make sure the treadmill ergometer has treadmill ergometer Reconnect the been connected to the computer and the port treadmill ergometer to the PC and set the COM setting 1s right port correctly Fail to open the BP monitor port Please make Fail to open the COM port which controls the sure the BP monitor has been connected to the blood pressure Reconnect the BP monitor to the computer and the Port set is right PC and set the COM port correctly The current HR has exceeded the target Current heart rate value exceeds the target heart rate value The diastolic BP has exceeded the normal Diastolic blood pressure exceeds the normal BP range range The systolic BP has exceeded the normal range Systolic blood pressure exceeds the normal BP range Sorry Can not Connect to the DataBase MSDE 2000 or SQL Server 2005 Express is not started up 124 SE 1010 User Manual Hint Information Fail to create database The system fails to create database Communication error Plea
91. nt Room No HR 76 bpm Diagnosis P Duration 111 ms Sinus Rhythm PR Int 160 ms Flat T v6 QRS Dur 30 ms Right Axis Deviation QT QTc 365 412 ms P ORS T Axis 68 98 33 deg R V5 51 1 965 0 446 mv 5 1 2 411 mV R V6 5V2 1 033 1 887 mV Physician 0 67 100Hz ACS0 Exam 18 45 Print 2010 07 19 18 47 2 02 SEMIP1 5 Figure 6 11 Average Template amp Position Marker the Second Page 6 6 2 Analyzing QT Dispersion Click on the QT Dispersion button to open the QT Dispersion interface QT Dispersion The difference between the largest QT interval and the shortest QT interval based on the synchronous 12 lead surface ECG The QT interval is a measurement of the time difference between the start of the Q wave and the end of the T wave 45 SE 1010 User Manual Operation Instructions for Resting ECG II 201002240000 Lily Green QTD v ah 1 _ Normal OTD HF ECG Measure Preview Report Save Exit ee 10 Limb lead Figure 6 12 QT Dispersion Interface 6 6 2 1 Editing Waveform on the QT Dispersion Interface There are red and blue triangle icons on top of the displayed ECG waves You can click on the triangle icon to change the color represents the current chosen wave V represents the position of R wave 10mm mV Li You can set the speed and the gain of the displayed wave
92. ol Name textbox Pratacal Marne Add stage Delete stage 2 Right click on the grid to display the menu click on Add Stage and enter information in the grid 3 Set the auto printing time of 12 lead ECG reports the 12 lead ECG Report First and 12 lead ECG Report Repeat columns 4 Set the auto BP sampling time in the BP First or BP Repeat columns 5 After entering all the information click on the OK button 9 3 4 2 Modifying a Protocol 1 Select a protocol from the Protocol pull down list on the device setup interface Figure 9 3 Then click on the Modify button to display the Edit Protocol interface 117 SE 1010 User Manual Configuring the System Edit the protocol Protocol Pretest Supine Pretest Sitting 0 0 Pretest Standing 0 0 Pretest Deep Breath 0 0 Pretest Warm up Exercise Stagel Exercise Stagee Exercise Stages Exercise Stage4 Exercise Stages Exercise Stage Exercise Stage Recovery Recovery 1 Recovery Recoveryz Recovery Recovery3 Hint 1 Right click the mouse to add or remove the stage 2 Double click the mouse modify the stage information 3 12 lead ECG report First Repeats is the auto printing time of ECG report of each stage please don t set the time longer than the stage time 4 BPiFirst Repeat is the auto measuring time of BP of each stage please don t set the time longer than the stage time 2 Double click on an op
93. one horizontal fixed measurement line on this interface You can drag the green vertical lines on the ECG wave and then the corresponding parameters in the right part will change Filter 40 250HzFilter w 25 250HzFilter 40 250HzFilter Select a filter in the Filter pull down list 6 6 9 2 About the Frequency Domain Interface Click on the Frequency domain tab to open the frequency domain interface 69 SE 1010 User Manual Operation Instructions for Resting ECG 201002240000 Lily Green SAECG i LS 1 wi Q gt m amp TVCG SAECG Measure Preview Print Report Save Exit Time domain Frequency domain Standard Unfiltered Title pata 250mmj s 100mm Standard QRS 137ms Total QRS 94ms Below 40Uy 25ms Last 40ms 541 26uV Noise 3 05uV Total beat 5 Initial Window 451715 57915 Window Width 128ms Number of Steps 40 Step Increment 2 Current Lead X Window Type Blackman Harris o a ae a on on an o Sp LEES er PP DM cm SS SSS SS SES See E E E E E UU E ES a co 4 See A Figure 6 31 Frequency Domain Interface You can drag the green vertical lines on the ECG wave and the corresponding parameters in the right part and the 3D graph in the bottom part will change 6 6 9 3 Previewing Signal Average
94. or can be set to white black or color Note If the printing color is set to color but a black and white printer is used the report printed will be illegible 3 Select Background grid and the background grid will be printed the report Deselect Background grid and the background grid won t be printed in the report 4 Select Auto gain change and the gain will be changed automatically 5 Select Auto baseline change the baseline will be adjusted automatically 6 Set Sequence to sequential or synchronous When Sequence is set to sequential the lead group 1 printed one by one in a certain sequence The start time of a lead group 1s just the end time of the previous lead group When Sequence 1 set to synchronous all leads are printed simultaneously The start time of each group 15 the same 120 SE 1010 User Manual Configuring the System 9 5 Other Setup system Setting Basic Information Sample Setting Device Printer Setting Others Color set Height em Background color Weight Kg v Wave color Ium BP mmHg Gird calori 5mm Speed mph M Grid color 1mm Slope p Mark color Time 24Hour Text Color Date yyyy mm dd Default Cancel Figure 9 5 Other Setup Interface Set the height unit to cm inch or mm Set the weight unit to Kg g or Pound Set the BP unit to KPa or mmHg Set the speed unit to Km h or mph Set the grade unit to or degree Set t
95. orting ECG Data from the Data Manager Interface Select examination records and click on the Export button on the Data Manager interface Figure 8 1 to open the following window Assign the file name saving path and export file format SCP FDA XML DICOM dat and then click on the OK button to export the data into the selected path At the same time the patient information of these records will be exported Report Save File Lily Green 201002240000 1 Exercise dat Saving ID NDacuments and Settingsyedan Desktop D SDocuments and Settingssedan sDesktopsLily Green 201002240000 1 Exercise ECG dat Cancel When the export is successful the hint information will be displayed If you select SCP and Compress the compressed SCP file will be exported 105 SE 1010 User Manual Processing Patient Records Report Save File Lily Green 201002240000 12 Exercis Saving D Documents and Settings edan Desktop D SDocuments and Settings edan DesktopsLily Green 201002240000 12 Exercise ECG scp Note Only if the export file format is set to SCP can the Compress check box be displayed 8 9 Viewing an Examination Record Click on a patient record the patient information list and then all the records of the patient will be displayed in the examination record list Select All records and all the examination records will be displayed the examination record list Double click on an examination record th
96. pital environment If the user of SE 1010 PC ECG requires continued operation during power mains interruptions it 15 recommended SE 1010 PC be powered from an uninterruptible power supply or a battery Ur 1s the a c mains voltage prior to application of the test level SE 1010 PC ECG User Manual EMC Information Guidance and manufacture s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity SE 1010 PC ECG 15 intended for use in the electromagnetic environment specified below The customer or the user of SE 1010 PC ECG should assure that 1t 1 used 1n such an environment Immunity IEC 60601 test level Compliance environment test level guidance Portable and mobile RF communications equipment should be used no closer to any part of SE 1010 PC ECOG including cables than the recommended separation distance calculated from the equation applicable Conducted RF 3 Vims to the frequency of the transmitter IEC61000 4 6 150 kHz to 80 MHz Recommended separation distance 1 2 Radiated 3 V m IEC61000 4 3 80 MHz to 2 5 GHz d 124P 80 MHz to 800 MHz d 22 4 P 800 MHz to 2 5 GHz Where P 1s the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and is recommended separation distance in metres
97. print ECG reports automatically 7 3 Entering New Patient Information If the patient 1 a new one 1 Click on the New Patient button Fatient the initial interface Figure 6 1 to display the Patient information interface Then enter the patient information The operation steps are the same as those of resting ECG For details refer to Section 6 3 Entering New Patient Information Notes 1 Patient ID and age must be entered 2 Please enter the correct patient age which has direct relationship with the calculation of the target heart rate 2 Select Exercise ECG on the Patient information interface Resting ECG Exercise ECG HRY ECG OG TYCO SAECO 3 Click on OK on the Patient information interface to open the Exercise ECG Setting interface After setting the parameters click on the OK button to open the pre sampling interface For details on setting the parameters on the Exercise ECG Setting interface please refer to 7 2 Selecting a Patient Record to Start a New Test 78 SE 1010 User Manual Operation Instructions for Exercise ECG Exercise ECG Setting Target Max Predicted HE 220 Age Target Max Predicted HR 85 95 Normal BPimmHg Max value 220 90 Min 110 j 60 Please select a protocol Please select Post J Bruce BP sampling mode BP triggering made BP Monitar enter once per stage Square Wave Auto print Cancel
98. r operation one of the preconditions is to ensure that the connection between the peripheral equipment and the PC accords with the setup in the software For example if you set the treadmill port to COM2 on the device setup interface you should connect the treadmill to 2 of the PC if you set the BP monitor port to COMI on the device setup interface you should connect the BP monitor to COMI of the PC 9 3 4 Setting a Protocol Protocol Bruce Ellestad kattus Modified Bruce Naughton 2 0 Naughton N 3 0 Select a protocol from the Protocol pull down list on the device setup interface Figure 9 3 You can also add a new protocol or modify a protocol 9 3 4 1 Creating a New Protocol Click on the New button on the device setup interface Figure 9 3 to enter the Edit the protocol interface 116 SE 1010 User Manual Configuring the System Edit the protocol Protacal j Stage tim Speedimph Slopet96 12 lead ECG Report 12 lead ECG Report BP First Hint 1 Right click the mouse to add or remove the stage 2 Double click the mouse modify the stage information 3 12 lead ECG repartriFirst Repeat is the auto printing time of ECG report of each stage please don t set the time longer than the stage time 4 BPiFirst Repeat is the auto measuring time of BP of each stage please don t set the time longer than the stage tima l Enter the protocol name in the Protoc
99. reaking characteristics d Verify that the device functions properly as described in the instructions for use Test the protection earth resistance according to IEC EN 60601 1 Limit 0 1 ohm f Test the earth leakage current according to IEC EN 60601 1 Limit NC 500 pA SFC 1000 pA SE 1010 User Manual Safety Guidance 10 11 12 13 14 CAUTION g Test the enclosure leakage current according to IEC EN 60601 1 Limit NC 100 SFC 500 pA h Test the patient leakage current according to IEC EN 60601 1 Limit NC a c 10 d c 10 pA SFC a c 50 uA d c 50 uA i Test the patient auxiliary current according to IEC EN 60601 1 Limit NC a c 10 d c 10 pA SFC a c 50 uA d c 50 uA j Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC EN 60601 1 Limit 50 pA CF The data should be recorded in an equipment log If the equipment is not functioning properly or fails any of the above tests the equipment has to be repaired The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal Precautionary maintenance of this system including periodically cleaning and checking the appearance can be finished by users because this maintenance does not touch the interior Before
100. responding sequence listed the following table Lead Sequence Lead Sequence Lead group 1 Lead group 2 Lead group 3 Lead group 4 Standard I II aVR aVL aVF V1 V2 V3 V4 V5 V6 aVL I aVR aVF V1 V2 V3 V4 V5 V6 9 2 4 Setting Pacemaker Detection When PACE detection is set to Strong the pacemaker signals are easy to be detected 113 SE 1010 User Manual Configuring the System When PACE detection is set to Weak the pacemaker signals are not easy to be detected 9 2 5 Setting HR Calculation Lead You can set the HR calculation to one of the 12 standard leads I II HI aVR aVL aVF V1 V2 V3 V4 V5 or 9 2 6 Selecting Auto Printing When Detecting Arrhythmia When Auto printing when arrhythmia is selected if Arrhythmia ECG data including Ventricular Tachycardia 5 gt PVCS gt 3 Paired PVCS Bigeminy Trigeminy ON T single PVC and Missed Beat 1s detected during the sampling course printing will be triggered automatically 9 2 7 Setting Auto Upload When Stopping Sampling When Auto upload when sampling stops is selected the date will be uploaded to ENS after sampling is stopped 9 2 8 Setting Background Grid Select Background Grid the grid on the background of the ECG sampling interface will be displayed Deselect Background Grid the grid on the background of the ECG sampling interface will not be displayed 9 2 9 Setting Anti aliasing Select Anti ali
101. rface For details refer to Section 6 6 1 1 Viewing the Waveform 243 2 SE 1010 User Manual Operation Instructions for Resting ECG 6 6 1 4 Previewing Normal ECG Click on the Preview button to display the normal ECG preview interface v zu Jut Page Prey Page Two Page Zoomin Zoom Gut Close is the toolbar on the normal ECG preview interface 1 Click on the Next Page button on the toolbar to switch to the next preview page 2 Click on the Two Page button on the toolbar to preview two pages on one screen simultaneously 3 Click on the Zoom In button on the toolbar to magnify the preview page 4 Click on the Zoom Out button on the toolbar to minify the preview page 5 Click on the Close button to close the normal ECG preview interface and return to the previous interface 201002240000 Lily Green Normal Analysis Next Page Page Two Page Zoom In 12 lead ECG Report ID 201002240000 Name Lily Green Sex Fem ale ear Department Room Mo HR 76 bom Diagnosis P Duration 111 ms Sinus Rhythm PR Int 160 ms Flat T V6 QRS Dur 30 ms Right Axis Deviation QT QTc 365 412 ms P QRS T Axis 68 98 33 deg R V5 541 1 965 0 446 mV 541 2 411 mV R V6 1 033 1 887 mV Physician ETT Ret E EE EIS ELT ETE E S p EL EIE BR ctl a E ad E
102. rint the recovery report 6 The system will enter the next stage of the recovery phase automatically after the set time of this stage 1s over Or click on the Recovery button or click on the Next button to enter the next stage of the recovery phase manually 6 SE 1010 User Manual Operation Instructions for Exercise ECG Note If the test time exceeds 40 minutes the system will enter the monitoring status Data will not be saved or printed any more 7 6 Exiting the Exercise Test During the exercise test click on the STOP button to display the following dialog box Enter the reasons for termination in the dialog box or select a reason from the pull down list Then click on the OK button to open the analysis interface The reason for termination will be displayed in the summary report Please enter the for termination Please enter the reasan far terminatian SE 1010 User Manual Operation Instructions for Exercise ECG 7 9 About Analysis Interface 7 9 1 About Summary Interface 1 Click on Summary to open the summary interface aga 201002240000 Lily Green Summary v A af RS 2 RAE LL Summar ST analysis ALL View Trend ECG Strip Measure Preview Print Report Save Exit Stage Stage time min sec BP mmHg Heart Rat Max ST Ascend Max ST Descend Protocol Bruce Supine 01 31 120
103. rodes greet the patient and explain the procedure Explaining the procedure decreases the patient s anxiety Reassure the patient that the procedure 15 painless Privacy is important for relaxation When possible prepare the patient in a quiet room or area where others can t see the patient Make sure that the patient is comfortable The more relaxed the patient 1s the less the ECG will be affected by noise 5 1 2 Preparing the Skin Thorough skin preparation is very important The skin is a poor conductor of electricity and frequently creates artifacts that distort the ECG signals By performing methodical skin preparation you can greatly reduce the possibility of noise caused by muscle tremor and baseline drift ensuring high quality ECG waves There is natural resistance on the skin surface due to dry dead epidermal cells oils and dirt To prepare the skin Shave hair from electrode sites 1f necessary Excessive hair prevents a good connection 2 Wash the area thoroughly with soap and water 3 Dry the skin with a gauze pad to increase capillary blood flow to the tissues and to remove the dead dry skin cells and oils 5 2 Connecting the Patient Cable to the Electrodes WARNING The performance and electric shock protection can be guaranteed only if the original patient cable and electrodes of the manufacturer are used The patient cable includes main cable and lead wires which can be connected to electrodes according to the color
104. rtment Power Spectrumt II Power Spectrum V5 1 2 1 5 10 TU 1 2 1 5 10 TU 20 Phase Shift QXY Impulse Response PIH RV RD NW 20 Coherence RF 0 67 100Hz ACSO Exam 2010 07 19 18 45 Print 2010 07 19 18 49 PCECG2 02 SEMIP1 5 Figure 6 16 Two lead Comparison Report 201002240000 Lily Green FCG Print P Prey Page Two Zoom In Zoom Gut FCG Report 10 201002240000 Green Sex Female Department Room No 0 67 100Hz ACSO Exam 2010 07 19 18 45 Print 2010 07 19 18 49 PCECG2 02 SEMIP1 5 Figure 6 17 12 lead Power Spectrum Report 252 SE 1010 User Manual Operation Instructions for Resting ECG 6 6 4 Analyzing High Frequency ECG In a conventional electrocardiogram only these ECG signals of which the amplitude 1s in the millivolt range and the frequency 15 less than 100 Hz are visible Those ECG signals of which the amplitude is in the microvolt range and the frequency is between 150Hz and 250 7 are invisible If these invisible high frequency components are abnormal it 1 the indication of myocardial ischemia or myocardial infarction HF is to detect high frequency components of QRS such as notches slurs and beadings Click on the HF ECG button to open the HF ECG analysis interface 201002240000 Lily Green ECG Normal Analysis Measure Preview 1i0mm mV 25mmy s Limb lead 0 05 IB Ki B
105. s The lead number and the lead type of the displayed ECG waves can also be chosen EET SE 1010 User Manual Operation Instructions for Resting ECG 6 6 2 2 About QT Value Lead 1 358 360 350 358 avL 358 avF 360 1 377 v2 366 v3 363 v4 355 v5 354 353 27 QT values of 12 leads and QT dispersion QTd displayed as the left figure shows 6 6 2 3 Previewing QT Dispersion Click on the Preview button on the QT Dispersion interface to open the QT Dispersion preview interface Print Newt Pane Zoomin Zemou Close is the toolbar the QT Dispersion preview interface 1 Click on the Zoom In button on the toolbar to magnify the preview page 2 Click on the Zoom Out button on the toolbar to minify the preview page 3 Click on the Close button to close the QT Dispersion preview interface and return to the previous interface SATs SE 1010 User Manual Operation Instructions for Resting ECG 201002240000 Lily Green QTD Next Page QTD Report ID 201002240000 Name Lily Geen Sex Female Department ELTE Im E EF E EIE Epp p per Eu ij X eaten ds uj HF r SS eg ee ee oe EM a ee ee LL E Bil LA aT GTN AHHA
106. s Template Exit X Click on Edit Diagnosis Template in the Tool F pull down list on the initial interface Figure 6 1 and then the Edit Diagnosis Template window appears Edit Diagnosis Template Rhythm and Arrhythmia ORS Deviation Ventricular Hypertrophy and Atrium Overload Atrioventricular Black Intraventricular Conduction Block Myocardial injury Myocardial Infarction 1 Select an item such as Other Result Enter your own opinions the bottom textbox and then click on the Add button The content entered will be added under Other Result 2 Click on the diagnosis information required to be deleted and then click on the Delete button to delete the selected information 3 Click on the Save button to save these modifications 123 SE 1010 User Manual Hint Information Chapter 10 Hint Information Hint information and the corresponding causes provided by the system are listed as follows Table 10 1 Hint Information and Causes Lead off X Electrodes fall off the patient or the patient cable falls off the ECG sampling box It is pre sampling now please click on Start to During the pre sampling course begin recording Can t find the sentinel The sentinel 1s not installed The sentinel setting 1 wrong The sentinel is set wrongly Hint Please make sure the USB line has been The USB cable is disconnected or the connected If possible please re connect it commu
107. s and identifiers SE 1010 User Manual Preparations Before Operation Main Cable Lead Wires Screw Connecting to Electrodes Connecting to the ECG Sampling Box Patient Cable for Resting ECG Main Cable Lead Wires Screw Connecting to Electrodes Connecting to the ECG Sampling Box Patient Cable for Exercise ECG 1 Connect the patient cable to the ECG sampling box For details see Chapter 3 Assembling SE 1010 PC ECG System 2 Align all lead wires of the patient cable to avoid twisting and connect the lead wires to the corresponding electrodes according to the colors and identifiers Firmly attach them 5 3 Attaching Electrodes for Resting ECG The identifiers and color codes of electrodes used comply with IEC EN requirements In order to avoid incorrect connections the electrode identifiers and color codes are specified in Table 5 1 Moreover the equivalent codes according to American requirements are given in Table 5 1 too 20 SE 1010 User Manual Preparations Before Operation Table 5 1 Electrodes and Their Identifiers and Color Codes mem 5 3 1 Wilson Lead System C1 Fourth intercostal space at the right border of the sternum C2 Fourth intercostal space at the left border of the sternum C3 Fifth rib between C2 and C4 C4 Fifth intercostal space on the left midclavicular line C5 Left anterior axillary line at the horizontal level of C4 C6 Left m
108. se Language FirstNamerLastName English Data Saving Path Figure 9 1 Basic Information Setup Interface 9 1 1 Setting Basic Information Enter information in the Hospital Name Physician Technician User Defined 1 or User Defined 2 textbox on the basic information setup interface Figure 9 1 When you fill in the User Defined 1 2 textbox the corresponding items on the Patient information interface will change into what is filled For example when you enter aa in the User Defined 1 textbox and enter bb in the User Defined 2 textbox on the basic information setup interface Figure 9 1 the corresponding items on the Patient information interface will be aa and bb respectively 108 SE 1010 User Manual Configuring the System Patient information Patient ID 1201005250001 Patient Age Year ECG Male WOOG TVCG SAECT Room Race BP j mmHg Medication Height cm Physician Weight Kg Technician Risk Indicators Swmptom Cigarette Typical angina Congenital heart disease angina Hypertension Asymptomatic Hvperlipemia Family medical histary Others IEEE Note Click on the New Patient button on the initial interface to open the Patient information interface as the above figure shows 9 1 2 Setting ID Mode set ID Create Type to Auto Create Manually input or Auto increase When ID
109. se check the USB The USB cable falls off the PC during the cable sampling process According to IEC EN 60601 1 8 the characteristics of the visual alarm signals hint information are listed 1n Table 10 2 Table 10 2 Characteristics of Visual Alarm Signals Hint Information Alarm Category Indicator Color Flashing Frequency Duty Cycle 125 SE 1010 User Manual Cleaning and Maintenance Chapter 11 Cleaning and Maintenance CAUTION Turn off the system power and drag the power cable out from the socket before cleaning or disinfection 11 1 Cleaning and Maintaining the Treadmill Daily Cleaning and Maintenance 1 Wipe the treadmill with a clean soft cloth to remove dust moisture and sweat stain 2 Wipe the handrail of the treadmill with a clean soft cloth damped in non caustic neutral detergent 3 Do not pour or spray detergent onto the treadmill directly Weekly Cleaning and Maintenance 1 Clean dust around the treadmill with a dust collector 2 Check whether the emergency stop switch 1 valid 3 Check the tightness degree of the running belt Semiyearly Cleaning and Maintenance 1 Lubricate the screws 2 Valuate the state of the treadmill 11 2 Cleaning and Maintaining the Patient Cable and Reusable Electrodes WARNING Failure on the part of the responsible individual hospital or institution employing this equipment to implement a satisfactory maintenance schedule may cause undue equipment f
110. sis EN i Normal Analysis QTD FCG HF ECG Measure Preview Print Waveform Average Template Detail information Report Save Exit I II avF vi v2 v3 v4 V5 V6 Heart Rate B 76 Type Rs Rs rsr rS rs RS RS RS RS qRs P Duration ms 111 Pa m 0 068 0 158 0 100 0 100 0 033 0 130 0 063 0 053 0 073 0 076 0 070 0 055 Int ms 160 Pa mv 0 000 0 000 0 000 0 000 0 000 0 000 0 050 0 000 0 000 0 000 0 000 0 000 ORS 90 0 556 1 045 0 788 0 035 0 279 0 881 0 229 0 927 0 886 1 914 1 965 1 093 QT QTc ms 365 412 Ra mv 0 000 0 000 0 000 0 338 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 P QRS T deg 68 98 33 Sa mV 0 496 0 204 0 000 0 730 0 550 0 000 0 446 1 887 1 459 0 976 0 529 0 239 RV5 SVi1 mV 1 965 0 446 v Sa 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 B Ta mV 0 226 0 206 0 045 0 211 0 130 0 083 0 012 0 755 0 651 0 450 0 289 0 005 s 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 Diagnosis Pd ms 115 00 110 00 103 00 103 00 108 00 110 00 108 00 120 00 118 00 118 00 116 00 108 00 Sinus Rhythm Qd ms 0 00 0 00 29 00 0 00 0 00 28 00 0 00 0 00 0 00 0 00 0 00 20 00 Flat T V6 Rd ms 32 00 43 00 65 00 19 00 33 00 65 00 30 00 31 00 41 00 47 00 39 00 35 00 Right Axis Deviation Rd ms 0 00 0 00 0 00 39 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 Td ms 186 00 195 00 265 00 196 00 1
111. st malfunctions caused by electrosurgery according to the clause 36 202 101 in the standard IEC60601 2 25 To the patient with a pacemaker the results given by the system may be invalid 1 2 2 General Cautions CAUTION Federal US law restricts this device to sale by or on the order of a physician Avoid liquid splash and excessive temperature temperature must be kept between 5 and 40 during operation Do not use the system in a dusty environment with bad ventilation or in the presence of corrosive Make sure that there is no intense electromagnetic interference source around the system such as radio transmitters mobile phones etc Attention large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equipment is likely to bring electromagnetic interference Before use the system the patient cable electrodes etc should be checked Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or the performance The following safety checks should be performed at least every 24 months by a qualified person who has adequate training knowledge and practical experience to perform these tests a Inspect the equipment and accessories for mechanical and functional damage b Inspect the safety related labels for legibility c Inspect the fuse to verify compliance with the rated current and circuit b
112. sults only if the triggering event 15 a true PVC not an artifact T wave or similar In addition the sinus rhythms just before and after PVC must be free from arrhythmia artifacts and false classifications In order to fulfill these requirements we use filters which exclude RR intervals with the following characteristics from the HRT calculation gt lt 300ms gt gt 2000ms gt gt 200ms difference to the preceding sinus interval gt gt 20 difference to the reference interval mean of the last 5 sinus intervals In addition we limit the HRT calculations to PVCs with gt aminimum prematurity of 20 and gt apost extrasystole interval which is at least 20 longer than the normal interval 59 SE 1010 User Manual Operation Instructions for Resting ECG Click on HRT to display the HRT analysis interface NH 0906031028 James Smith PREJES 9 2 HRV HRT Measure Preview Print Report Save Mode View lt Average Histogram Single Histogram Risk Indicators gt 0 0 1 0000 TS z2 5ms b 11 9 Mean HR 75b 62 Age gt 65 years 52 C MM 4 Figure 6 23
113. t the BP sampling mode to Manually Enter BP on the Exercise ECG Setting interface clicking on the BP button can also open the following dialog box Please enter BP value Swvs DiacmmHg o Note If the systolic pressure or the diastolic pressure exceeds the normal BP range the hint The systolic diastolic BP has exceeded the normal range will appear on the sampling interface and the background color of the BP field will change from white to yellow 2 95 SE 1010 User Manual Operation Instructions for Exercise ECG 7 5 2 Viewing Other Information 1 If a treadmill is used view other information such as the stage time exercise time total time PVC min speed slope and Max ST Min ST 2 If an ergometer is used view other information such as the stage time exercise time total time power RPM and Max ST Min ST Note Total time is counted from the beginning of the pretest phase to the end of the exercise test 7 5 3 Editing the Waveform 1 Click on the Freeze button to freeze waves on the current screen and the Wave review interface pops up Wave review Click on Exit to return to the ECG sampling interface 2 Click on the Comment button to display the Comment dialog box Enter the comment in the Comment dialog box Click on the OK button and the comment will be displayed on the ECG waves on the analysis interfac
114. t values of 0 00 69 06 13 88 and 17 05 in the square represent the area 64 SE 1010 User Manual Operation Instructions for Resting ECG percentages of QRS loop in every quadrant 20 mm mvV indicates the magnified multiple gain The red curve 1s QRS loop You can click on the Zoom in button or the Zoom out button to change the gain of the displayed graphics You can click on the Play button to watch the forming process of the ORS loop 6 6 7 3 Displaying 3D Vector ECG Click on 3D to display the 3D VCG graph 3D Three Dimensional Vector Loops This function allows you to observe the Vector ECG 1n three dimensions Check Rotation and then you can rotate the whole picture to see all directions of the vector loops Check Axis to display the axes Check Plane to display the planes m 30 Other functions Preview Print Click on Save to save the graph on the current screen Click on Preview to preview the 3D graph Click on Print to print the 3D graph Click on Return to return to the ECG analysis interface 255 SE 1010 User Manual Operation Instructions for Resting ECG 6 6 7 4 Previewing Vector ECG Click on the Preview button to open the VCG preview interface t Page oom Pit Hert Pres Page Page Live Page Zoomin Close is the toolbar on the VCG preview interface 1 Click on the Zoom In button on the toolbar to magnify the preview
115. the accuracy of input signal reproduction according to the methods described in clause 4 2 7 2 in ANSI AAMI EC11 1991 R 2001 and the result complies with clause 3 2 7 2 in ANSI AAMI EC11 1991 R 2001 135 SE 1010 PC ECG User Manual EMC Information Appendix 2 EMC Information Guidance and manufacture s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission SE 1010 PC ECG 1 intended for use in the electromagnetic environment specified below The customer or the user of SE 1010 PC ECG should assure that it is used in such an environment RF emissions SE 1010 PC ECG uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission Class A SE 1010 PC ECG 1 suitable for use in all CISPR 11 establishments other than domestic and those Harmonic emissions directly connected to the public low voltage Not applicable e IEC 61000 3 2 power supply network that supplies buildings Voltage fluctuations used for domestic purposes flicker emissions Not applicable IEC 61000 3 3 136 SE 1010 PC ECG User Manual EMC Information Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity SE 1010 PC ECG 1 intended for
116. the right textbox and then click on the Search button All the patient records which meet the conditions will be displayed in the patient information list 3 Or click on Advanced Search to display the Search Condition window Then enter the search conditions Click on the Search button and all the patient records which meet the conditions will be displayed in the patient information list Search Condition Pat ID Examination Time Age range Diagnosis 100 SE 1010 User Manual Processing Patient Records Physician Examination Examination Exercise ECG P HRY Resting ECG 4 you can click on Physician or Examination Record VCG TVCG SAECG choose the doctor name or examination types all the patient records which meet the conditions will be displayed in the patient information list 5 Select The patients with no examination and then the patient records which are registered but not examined will appear in the patient information list 8 2 Modifying Patient Records Click on a patient record in the patient information list on the Data Manager interface and then click on the Modify button to display the Patient information interface Then you can modify the information of the patient on the Patient information interface Click on the OK button to save these modifications Patient information Patient 10 Resting ECG Patient Name Greer E
117. ting the problem and will make every effort to solve it over the phone or Email avoiding potential unnecessary returns In case a return can not be avoided the representative will record all necessary information and will provide a Return Material Authorization RMA form that includes the appropriate return address and instructions An RMA form must be obtained prior to any return Freight policy Under warranty the service claimer 15 responsible for freight amp insurance charges when a return is shipped to EDAN for service including custom charges EDAN 1 responsible for freight insurance amp custom charges from EDAN to service claimer 129 SE 1010 PC ECG User Manual Warranty and Service Policy Out of warranty the service claimer 1s responsible for any freight insurance amp custom charges for product Contact information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN service department at support edan com cn 130 SE 1010 PC ECG User Manual Recommended Optional Accessories Chapter 14 Recommended Optional Accessories Treadmill Model TM 400 Manufacturer Edan Inc China CE marking Model Valiant Manufacturer Lode B V The Nettherlands CE marking Model TMX425 TMX425C TMX425CP Manufacturer Full Vision Inc USA CE marking Model mercury med 4 0 mercury 4
118. tion ventricular Hypertrophy Atrioventricular Block Intraventricular Conduction Myocardial injury Myocardial Infarction 3B 8 8 gt Figure 6 8 Normal ECG Average Template Interface To Edit Waveform on the Analysis Interface Lead 1 i m 92 3 vs ve You can press a lead button in to display magnified average templates of this lead When you press ALL magnified average templates of all leads will be overlapped with the same central axis You can set the speed and the gain of average templates SE 1010 User Manual Operation Instructions for Resting ECG You can drag marker lines of P1 P2 S and T2 on average templates is the start point of P wave P2 is the end point of P wave Q marks the position of point S marks the position of S point is start point of T wave and T2 15 the end point of T wave Dragging these marks can move these lines and the corresponding parameter values will change To Edit Diagnosis Result on the Average Template Interface For details refer to Section 6 6 1 1 Viewing the Waveform 6 6 1 3 About the Detail Information Interface Click on the Detail information tab on the normal ECG analysis interface to open the detail information interface This interface displays lead parameter values as Figure 6 9 shows 201002240000 Lily Green Normal Analy
119. tion of the phase row to be modified in the protocol list and the Pretest Pretest Exercise pull down list will be displayed Select a phase and it will be displayed in the corresponding grid 3 Double click on the grid to be modified input new information and click on any other grid to save the information Add stage Delete stage 4 Right click on the grid to display the menu click on Add Stage and enter information in the grid 5 Set the auto printing time of 12 lead ECG reports in the 12 lead ECG Report First and 12 lead ECG Report Repeat columns 6 Set the auto BP sampling time in the BP First or BP Repeat columns 7 Click on the OK button to confirm or click on the Cancel button to cancel modifications 9 3 4 3 Deleting a Protocol Select a protocol from the Protocol pull down list on the device setup interface Figure 9 3 Then click on the Delete button to delete the protocol 118 SE 1010 User Manual Configuring the System 9 3 4 4 Restoring the Factory Settings Click on the Restore the default button to resume the factory settings 9 4 Printer Setup System Setting Basic Information Sample Setting Device Printer Setting others Patient information Diagnosis Height Weight BP Pace Position Mark Auto Diagnosis Average template Medication Minnesota code Room Rhythm lead set Rhvthmi 1 Ehythmz Rhythms v5 Print
120. urn off the system power and disconnect the power cord from the wall outlet after using the system Press down the emergency stop switch of the treadmill before defibrillating to avoid the hazard to the patient and the operator Keep the four feet of the treadmill on a horizontal place and make sure it s stably working Make sure that the power cable of the treadmill is grounded Don t use other electrical equipment with the same power supply line Keep the power cable far away from the running treadmill area and the heat surface Examine the treadmill carefully before using it Do not do an exercise test if the treadmill is wet Do not use the treadmill in the open air The patient undergoing stress exercise testing should wear suitable clothes and shoes During the stress exercise testing the patient should not get on or off the treadmill Remind patients to take care not to fall down from the treadmill Keep hands hair jewelry and loose clothing away from moving parts of the treadmill After the exercise phase slow the speed of the treadmill to the minimum and then stop the treadmill Children are prohibited from approaching the treadmill alone Don t insert anything into the treadmill or place anything on its surface Press down the emergency stop switch to stop the treadmill immediately the emergency happens SE 1010 User Manual Safety Guidance 1 2 4 Contraindications for Exercise ECG Absolute Contrai
121. ven by the system should be examined based on the overall clinical condition of the patient and it can not substitute for regular checking 4 This system is not intended for treatment 5 This system is not designed for direct cardiac application SE 1010 User Manual Safety Guidance 10 11 12 13 14 15 16 17 18 19 20 WARNING EXPLOSION HAZARD Do not use the system in the presence of flammable anesthetic mixtures with oxygen or other flammable agents SHOCK HAZARD The power receptacle must be a hospital grade grounded outlet Never try to adapt the three prong plug to fit a two slot outlet Do not use this system in the presence of high static electricity or high voltage equipment which may generate sparks In order to avoid being burnt please keep the electrodes far away from the radio knife while using electrosurgical equipment Only the patient cable supplied by the manufacturer can be used Or else the performance and electric shock protection can not be guaranteed Turn off the system power and remove the power cable before servicing or maintaining the system Please do not operate the system during servicing or before it is running normally Make sure that all electrodes are connected to the patient correctly before operation Ensure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other
122. xercise ECG CO HRY ECG Female Depart WOG TVCG SAECG User Defined 1 User Defined 2 Room Race mmHg Medication Height 159 cm Physician Weight 65 Kg Technician Risk Indicators Symptom Cigarette t Typical angina Congenital heart disease angina Hypertension Asymptomatic Hvperlipemia CC Family medical history SUIS 101 SE 1010 User Manual Processing Patient Records 8 3 Deleting Records Note The deletion of records is permanent and you can t restore the records deleted Please use this operation cautiously 8 3 1 Deleting Patient Records Click on a patient record in the patient information list on the Data Manager interface and then click on the Delete button to delete the patient record from the patient information list At the same time all the examination records of the patient will be deleted To select multiple patient records simultaneously you can click on the first patient record to be deleted in the patient information list and press the Shift button on the keyboard and then click on the last patient record to be deleted the patient information list You can also press the Ctrl button on the keyboard and then select the patient records one by one After selecting all the patient records to be deleted click on the Delete button to delete all the patient records selected from the patient informatio
123. xpress CAUTION 1 Ensure that there is no other database software in the PC in which our software will be installed 2 Ensure that there is a graphic driver installed in the PC Otherwise the displayed ECG waves may be abnormal SE 1010 PC ECG User Manual Installing SE 1010 PC ECG Software 4 2 About Installation Interface CD into CD ROM double click on Setup exe on the installation CD to open the following installation interface Install PC ECG PC ECG SE 1010 Figure 4 1 Installation Interface Click on the Install button to install PC ECG Click on the Next button continually during installation After installing PC ECG click on the Install button on the installation interface Then the Environment Detection interface pops up Check the installing status of all the components If the Environment Detection interface shows that a certain component needs to be installed please install it manually Note During the installation in Windows 7 Vista only if Add user to the SQL Server Administrator role is selected can the database be available Click on the Help button to see the installation guide For details on installing SE 1010 software please refer to lt lt SE 1010 PC ECG Installation Guide gt gt SE 1010 User Manual Preparations Before Operation Chapter 5 Preparations Before Operation 5 1 Preparing the Patient 5 1 1 Instructing the Patient Before attaching the elect
124. y information related to the use of SE 1010 PC ECG 1 1 Intended Use SE 1010 PC ECG is a PC based diagnostic tool intended to acquire process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test SE 1010 PC ECG 1s intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals The cardiogram recorded by SE 1010 PC ECG can help users to analyze and diagnose heart disease However the ECG with measurements and interpretive statements 1s offered to clinicians on an advisory basis only 1 2 Warnings and Cautions To use the system safely and effectively firstly be familiar with the operation method of Windows and read the user manual in detail to be familiar with the proper operation method for the purpose of avoiding the possibility of system failure The following warnings and cautions must be paid more attention to during the operation of the system Notes 1 This system is not intended for home use 2 The pictures and interfaces in this manual are for reference only 1 2 1 General Warnings WARNING 1 The system is intended to be used by qualified physicians or personnel professionally trained They should be familiar with the contents of this user manual before operation 2 Only qualified service engineers can install this equipment and only service engineers authorized by the manufacturer can open the shell 3 The results gi
125. yed waves Click on the Measure button on the Waveform interface Figure 6 7 Click on one point on the wave and then drag the mouse to another point The distance amplitude difference and heart rate between the two points will be displayed Notes 1 You can measure the distance between any two points more than once after running the ruler The last measure track and data will be displayed after the measurement 2 Only ECG waves can be measured Click on Re Sample and then the system can re sample ECG data Click on Re Diagnosis and then the system can re diagnose the 10s ECG data on the screen automatically Click on Upload to upload the ECG data to ENS The common parameters are displayed in the circle in Figure 6 7 These parameters are as follows 40 SE 1010 User Manual Operation Instructions for Resting ECG QRS Dur QRS complex duration of the current lead QT QTc Q T interval of the current lead Normalized QT interval P QRS T Dominant direction of the average integrated ECG vectors The amplitude of R wave of V5 lead the amplitude of S RVS SV1 wave of V1 lead The amplitude of R wave of V5 lead plus the amplitude of RV5 SV1 S wave of V1 lead The amplitude of R wave of V6 lead the amplitude of S RV6 SV2 wave of V2 lead Double click on a parameter and then you can modify it Then click on the Save button to save the modification To Edit Diagnosis Result on the Waveform Interface

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