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Manual - EDAN USA

1. You press Print button to print the current window Click on the Ruler button on the Compare window 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 ey Sp a ce HH Distente 3066rhs 2 2mv 19 6bpm 113 ES NM Heart Rate B P Duration ms PR Int ms QRS Dur ms QT QTc ms P QRS T deg RV5 SVvi mVv 5 5 1 6 5 2 Heart Rate B P Duration ms PR Int ms QRS Dur ms QT QTc ms P QRS T deg RV5 SV1 mV RV54 SVi mV Heart Rate B P Duration ms PR Int ms QRS Dur ms QT QTc ms P QRS T deg RV5 SVvi mVv RV5 SV1 mV RV6 SV2 mV Heart Rate B P Duration ms PR Int ms QRS Dur ms QT QTc ms P QRS T deg RV5 SVi mVv RV54 SVi mVv RV6 SV2 mV Processing Patient Records 99 155 82 362 396 54 28 66 1 244 0 561 1 805 1 012 0 000 364 401 55 29 66 1 33870 553 1 883 1 033
2. 142 Chapter TO Hint Information 144 Chapter 11 Cleaning Care and Maintenance eee e eee e eee eee e eee eee eee ee eee esses e eee eeee 146 11A Cleanine and Maintamine the Tread ne teg ea easet 146 11 2 Cleaning and Maintaining the Patient Cable and Reusable Electrodes 146 147 Chapter 12 ACCOSSOFIGS 148 Chapter 15 Warranty A Ser VICE 150 150 15 2 E T ee ee 150 Chapter 14 Recommended Optional 1 1 151 Appendix 1 Technical Specifications 153 Aklo ey ope CaO 153 A12 Environment Specifications ee nee Ee MEER RM SE 153 Ads Physical SDecHite at ons xoa eie 154 AT 4 Power Supply Specifications aee e eorr Re em Ebene 154 Pld Perfomnance Specifica HONS r 154 Appendix ZEMO Inforimaliolk eei 157 Appendix 32 ON 162 SE
3. F E LHEBEELHELBEBEGIEBELLELELELEBE E ES us B H E H bal mi E E EA EET HELLE DIETS 214 OE EE RC 1 ld EH AE 25559 H E A P E E E Ej B m BN EB E ES En EU H En H a 1 ES Nu a a E E E m H H B E H B B E p B E i E i u m arfa ave vi va va va vs ve a Report Confined By 0 67 100Hz AC50 Exarunation 2012103 23 10 19 Print 2012 05 30 13 40 PC BOG2 11 SEMIP1 61 Figure 6 20 HF ECG Report 6 6 5 Analyzing HRV Click on HRV to display the HRV ECG analysis screen The HRV ECG analysis screen includes two tabs Auto diagnosis result and Waveform NOTE 1 The HRV sampling time can be set in the Sample Setting window 2 HRV analysis lead can be selected the Sample Setting window 70 SE 1010 PC ECG User Manual Operation Instructions for Re
4. Age 35 Year HRY ECG Dept Room Physician Pacemaker 110 SE 1010 PC ECG 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 screen 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 1n the patient information list and press the Shift button on the keyboard and then click on the last patient record to be deleted in 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 information 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 The deletion of an examination record cannot delete the corresponding patient information 8 4 Selecting a Patient Record Click on a patient r
5. 5 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 7 Analyzing Vector ECG Click on the VCG button on the ECG analysis screen to display the VCG analysis screen Vector ECG displays 3D image of ECG activity Frontal F Horizontal H Sagittal s ALL You can choose the plane and the vector loop Vector Loop P loop QRS Loop T Loop ALL on the VCG analysis screen Plane choices include Frontal F Horizontal H Sagittal S and ALL Loop choices include P loop QRS loop T loop and ALL 6 6 7 1 Displaying Vector with Plane and Loop Set the plane to ALL and the loop to ALL A B 201002240000 Lily Green FCG E a 18 zo 2 SAECG Measure Preview Print Report Save Exit Frontal F Horizontal H Sagittal S ALL 20 20 94 1696 99 4095 Vector Loop P loop QRS Loop T Loop f ALL Diagnosis Normal 100 5 10 Bagittal S 20 mm mv 0 0096 G Glossary Other Result Rhythm and Arrhythmia QRS Deviation Ventricular Hypertrophy and Atrioventricular Block Intraventricular Conduction B Myocardial injury Myocardial Infarction Figure 6 24 Vector ECG Plane of ALL and Loop of ALL 46 5 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG Figure 6 24 displays Vector ECG with the plane o
6. YE Print Farmat Orient landscape Baseline Adjustment Horizontal Sequence sequential Auto gain change Paper Size Ad Color Report Hint Report Confirmed B Background grid Cancel Figure 9 4 Print Setting Window 9 4 1 Choosing Patient Information to be Printed The default items of the patient information are Department Room No and Physician You can also select the additional information such as FirstName LastName Date of Birth height weight BP race medication Pacemaker Technician and Ref Physician The patient information items you selected will be displayed in the Patient Information window and the report printed out 131 SE 1010 PC ECG User Manual Configuring the System If you select First Name Last Name the Patient Name textbox in the Patient Information window will change into the First Name and Last Name textboxes Patient Information 201002040000 S Resting ECG qu Exercise ECG Gender 3 Age 35 Year Dept Foom Ma YOG TYG SAECO ap Pacemaker If you select D O B the D O B textbox appears in the Patient Information window and the Age textbox becomes unavailable Patient Information ID 201002040000 Resting ECG Exercise ECO Gender AYA Je TE HRY Dos rm vear Dept YOG TOG SAEC Room Physician Pacemaker 9 4 2 Choosing Diagnosis Information
7. beo 49 0 52 SPECI TOW pass asset rao p matu n rU ale 50 0 5 3 S DE aiu onte 50 S DeCILV IDE IS DES Qs 50 51 6 5 6 Breezins and Preyiewind BG CI E ntu 51 uideat n Mp Cote a oni e nea Me cadit 22 0 5 9 Printing BCG WAVES uisi deed ett e aeter epe pes dee eundo 53 S dI BI Een 53 6 6 1 Analyzing Normal 53 6 6 Vel Vie wile oues s asd 54 6 6 1 2 About the Average Template 56 6 6 1 3 About the Detail Information 58 6 6 1 d About Rhythm Wave WNdOW ui ated 59 6 6 1 5 Previewing Normal BCG iuo detto etin poem e 59 6 6 2 Analyzing OT DISDCISIOB t b BOR itt aras 61 6 6 2 1 Editing Waveform the QT Dispersion 62 06 02 2 NbOUL OT etes itn haee tn bene 62 6 6 2 3 Previewine OT Dispersion ou Pa itx 63 6 6 3 Amalvziue Prequency EC Q s us diaeta 64 6 6 3 1 Abo
8. t 103 end 105 49 9 106 79 6 Previewilpe BCCrReDOLHS uci tauri ette tede m and BR eee orn I 106 1 9 PIU ECT REDO 107 Ne ECO REPOS ER exce 107 ODE xtti atento 107 Chapter 8 Processing Patient Records 1 ss e ee eeeee 108 Sal 5earchine Patient Records deest e D mtu NN Dee 108 8 2 Modifying Patient 110 Gro Deletmp RECCO 111 6 31 Deletme Patent e 111 8 3 2 Deleting Examination Records of a 111 De ROCO doi denial ode fotu tdi tue du 111 5 9 Mereitio Examination Records eir rtt epe n Raetia 112 8 6 Comparing Two Examination Records 112 8 7 Importing ECG Data into the Data Manager Screen 114 8 8 Exporting ECG Data from the Data Manager 116 6 9 Viewino an 117 Chapter 9 Configuring the 11 SED 118 Dl Seting sn etit ne 119 9 1 2 Setun
9. A ST analysis ALL View Measure Preview Print Report Save Exit Brace Bh Prete st 60bpm D 0mph 4 00 15 BP mmH 120 70 0 0 A A avF Recovery Next Page Figure 7 8 ECG Strip Screen Click on Pretest to display 12 lead strip waves of the pretest phase Click on Exercise to display12 lead strip waves of the exercise phase Click on Recovery to display12 lead strip waves of the recovery phase 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 106 Operation Instructions for Exercise ECG SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 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 7 9 8 Saving ECG Reports You can save an report by clicking on the Report Save button For details please refer to Section 6 6 11 Saving ECG reports 7 9 9 Exiting the Analysis Screen Click on the Exit button on the analysis screen to return to the previous screen 107 SE 1010 ECG User Manual Processing Patient Records Chapter 8 Processing Patient Records Click on the Data Manager button on the main screen Figure 6 1 to open the Data Manage
10. 201002240000 Lily Green VCG VCG Report Department Room No AS US dm gt E 3 Ue a 4 0 67 100Hz 50 Exarnination 201 2 03 23 11 37 Print 2012 05 30 13 43 PC ECG2 11 SEMIPI 61 Figure 6 26 VCG Preview Screen Plane is ALL amp loop is ALL 6 6 8 Analyzing Time Vector ECG Click on the TVCG button on the ECG analysis screen to display the TVCG analysis screen Time Vector ECG is Vector ECG including time factor As Figure 6 27 shows you can observe waves of X lead Y lead Z lead X Y lead X Z lead and Z Y lead somm s M 10 You can choose the speed and the gain of the displayed waves 1 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG L 201002240000 Lily Green SAECG Measure Preview Beles 2 b Print Report Save Exit View SOmm s 10 x Z 2 a Zz y Figure 6 27 Time Vector ECG Screen Click on the Preview button to display the TVCG preview screen Ner Fage Fage Two Fage Zoomin ZoomOut Close the toolbar on the TVCG preview screen 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 screen and return to t
11. 7 5 3 Editing the Waveform l Click on the Freeze button to freeze waves on the current screen and the Wave review window pops up Wave review 905 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG Click on the Print button to print the current waveform Click on Exit to return to the ECG sampling screen 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 screen 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 ST ST ag em eH 0 1 17 ST 0 117 0 0 ave ST D 123mV ar 0 00mi ST D 11mW avi ST 0 06 ST 0 06 Ti FA
12. Cancel If the data to be imported exists on the Data Manager screen the following hint will pop up P The file already exists replace it or If you press Yes button imported record will replace file with same name 0 1 Success to import 0 files has been imported 0 files hasn t be imported 1 files has been imported twice Cancel 0 1 E data 200906030006 Lily Green dat Fail to imp Success import 0 files has been imported 1 files hasn t be imported O files has been imported twice Cancel NOTE Only ECG data in DAT format can be imported 115 SE 1010 PC ECG User Manual Processing Patient Records 8 8 Exporting ECG Data from the Data Manager Screen Select examination records and click on the Export button on the Data Manager screen Figure 8 1 to open the following window Assign the file name saving path and export file format SCP FDA XML DICOM dat pdf 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 Eeport Save Sle 20111212 1134 20100224000D dat Saving path ECG Export ECG Export 20111212 1134 201002240000 dat When the export is successful the hint information will be displayed If you select SCP and Compress the compressed SCP file will be exported Keport Save File Name 20111212 1134 201002
13. Part Number Serial Number Date of Manufacture Manufacturer Authorized Representative in 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 according 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 of a physician SE 1010 PC ECG User Manual Class Transmission Status Indicator of Bluetooth Burglar Lock Power Supply Indicator of DX12 Receiver Safety Guidance SE 1010 ECG 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 PC and it can be saved in PDF Word BMP or JPG format waves can be frozen and reviewed Auto measurement and diagnosis are available and the diagnosis template can be edited SE 1010 PC ECG can also be invocated by Smart ECG Net version 1 3 or above 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 my
14. 250mm s 1000mm m Filter 40 2S50H2Filter Figure 6 29 Time Domain Window Every parameter of SAECG is shown in the following table RS 1 l hree 1 f Standard QRS Q 5 interva s measured on three quadrature leads before filtering Total QRS The total QRS time for filtering and superimposing QRS waveform The time of amplitude that is below 40uV for filtering and superimposing QRS waveform The root mean square of amplitude in the last 40ms for Last 40uV filtering and superimposing QRS waveform xu Below 40nV SE 1010 PC ECG User Manual Operation Instructions for Resting ECG Filter 40 250HzFilter 25 250HzFilter 40 2 50HzFilter Select a filter the Filter pull down list The top of the Time domain window 15 the window of standard superimposed QRS waveform The left green line 1s the starting point of standard unfiltered QRS waveform and the right green line 1s the end point You can respectively drag the two green lines to change QRS duration The bottom of the Time domain window is the window of standard superimposed QRS waveform after filtering The left green line is the starting point of standard filtered QRS waveform and the right green line 1s the end point You can respectively drag the two green lines to change QRS duration and then the corresponding parameters in the right part will also change 6 6 9 2 About the Frequency Domain Window Click on the Frequency domain tab to open
15. Definitions of corresponding pins Ses mo sma CUm _ 2 C3 V3 7 or NC 3 ww s x Je pee Pp _ or NC 10 15 NOTE The left side of is European standard and the right side is American standard Top Panel and Bottom Panel Screw Label Decorative Chip 15 SE 1010 PC ECG 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 technical service department or your local distributor 2 f multiple instruments are connected to a patient the sum of the leakage currents may exceed the limits given in the IEC EN 60601 1 and may pose a safety hazard Consult your service personnel 2 3 DX12 ECG Sampling Boxes of Wireless System DX12 Transmitter Appearance 16 SE 1010 ECG User Manual Introduction Front Panel Patient Cable Socket z PATIENT ff
16. 3 Patient Cable Check whether the patient cable is connected to the ECG sampling box firmly and keep it far away from the power cord 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 NU SE 1010 PC ECG User Manual Preparations Before Operation 5 7 Setting DX12 Transmitter for Wireless System 5 e Switch on DX12 receiver and install batteries on DX12 transmitter Press to start up DX12 transmitter and then the company information and the main screen will be displayed N gt RLFCLC gp C3 C4
17. E E LE mug 16 815 5 E 3 S RE a il sas eque pes E pun Ep deed EB Ee ee FF LLL EE EM ER EXE iii 8 al x a Hr e mum E E 8 m 3 AER AB AEE URO EEN ENA ARE DTA IF I ras ET a Ee ETT x Exeniation 2012 03 25 13 20 Print 20134030 1428 2 SEMIPI 61 B i Be H EE EEH EEH E H EBEH H E RE EE E ES i r e memm 1 5 JL mum EEE mmm my m 1 4 BERN dH EHE ae Bae BUE ER I EE HE WB ES RR 2 EU EB B a Figure 7 4 Current Wave Report NOTE The diagnosis result is displayed in the diagnosis field of the summary report 7 9 2 About ST Analysis Screen 1 Click on the ST analysis button to display the ST analysis screen 201002240000 Lily Green SI analysis 22 Y gt D lt A Ar lt E P 4 L gt Summary analysis ALL View end E trir Measure
18. Treadmill 1 MEN BP monitor come Restore the default Advanced Setup Figure 9 3 Device Setup Window 9 3 1 Setting Sampling Device Sampling Device IDx12 Wireless Sampling Box wired Sampling Box DP12 wired Sampling SE serial Machine Select a sample device from the Sampling Device pull down list EP Dxl2 Wireless Sampling in the Device window Figure 9 3 124 SE 1010 PC ECG User Manual Configuring the System When DX12 wireless sampling box is selected you can click on the Address button to view the receiver address You can match the transmitter and receiver based on the address Sampling Device 012 Wireless Sampling Box scdress 0016 4001236 from the Sampling Device pull down list 9 3 2 Setting Device Type Mode Select device type mode from Device Type Device pull down list Device Type Treadmill Device TM 400 9 3 3 Setting COM Port of Sample Treadmill BP Monitor Select the COM port for sampling treadmill BP monitor from the corresponding pull down lists Sampling Part Treadmill 2 BP monitor To guarantee the system s proper operation one of the preconditions 1 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 2 you should connect the treadmill to COM2 of t
19. User Manual EDANUSA SE 1010 PC ECG Version 20 About this Manual P N 01 54 106666 20 Release Date June 2012 O Copyright EDAN INSTRUMENTS INC 2008 2012 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 adjustments modi
20. 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 1s 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 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 150 SE 1010 PC ECG User Manual Recommended Optional Accessories Chapter 14 Recommended Optional Accessories Treadmill Model TM 400 Manufacturer EDAN INSTRUMENTS INC China CE marking Model Valiant Manufacturer Lode B V The Nettherlands CE marking Model h p cosmos all medical models with coscom interface Manufacturer Full Vision Inc USA CE marking Model mercury med 4 0 mercury 4 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
21. check the backup status according to the progress bar or you can stop backup at any times System Setting Sample Setting Device Printer Setting Output File Data Maintence gpr gt Database Rebuild Rebuild Database Data Backup Reminded Backup Periad None Last Backup Time 2010 12 03 TT 12052100 The system will back up the data files for the latest time 1f you do not change the path 138 SE 1010 PC ECG User Manual Configuring the System You can also set the reminded backup period to remind you back up the data files at any time The default system reminded period 15 None you can also select 7 days 14 days 30 days or you can define it manually Please enter the remind period Remind period 9 7 Setup System Setting Device Print Setting Output File Data Maintenance GOT Others GDT Path suffis Input file name DP EKG 00 DT Output file EDP t 001 Output GOT file when sampling stops Output GOT file when making diagnoses Figure 9 7 GDT Setup Window 139 SE 1010 PC ECG User Manual Configuring the System select 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
22. 2 Cese SAECG Report Lily Green Female 35Year ID 201002240000 Department Room No 10mmim 100mmim 1000mmim 25mims 100mmis 100mmis 1000mm m 200mm s 3D Graph 40 250Hz Standard QRS 18ms 4 Total QRS 101 Filter 40 250Hz Below 40uv 32ms Total beat 178 Last 40 15 844 Diagnosis Report Confirmed By 0 67 100Hz 50 Exarnination 2012 03 23 11 37 Print 2012 05 30 13 44 ECG2 11 5 61 Figure 6 31 Signal Averaged ECG Report ed SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 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 window Printers and Faxes Fie Edit wiew Favorites Tools Help Bath gt 2 Search ls Falders Address 5 Printers and Faxes Y 19 acro accuset v2 3 Printer Tasks Lame 6 4 Ready Add printer LE See what s printing Select printing preferences ey Pause printing Pause Printing 4 Share this print ij Share this printer Rename this printer Use Printer Offline Delete this printer Create Shortcut ey Set printer properties Delete Rename Other Places Properties gt Control Panel Scanners and Cameras E Documents Bl My Pictures Computer 2 Click on the Print button
23. PC Operating Frequency 50 Hz 60 Hz DP12 ECG DC 5V sampling Box Input Power 1 VA MA X 0 5 VA MIN Input Power 2x1 5V Excell Alkaline AA IEC LR6 DX12 transmitter MP Operation life of battery gt 12 hours DC 5V Power Supply DX12 receiver Input Power 350mW 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 Width 210 295mm A4 216 279mm Letter 154 SE 1010 PC ECG User Manual Technical Specifications Paper Speed 5 mm s 10 mm s 12 5 mm s 25 mm s 50 mm s 395 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 and Interpretation Information Result option etc Record message Channel 3 6 12 channels auto baseline adjustment HR Recognition Technique Peak peak detection HR Range 30 BPM 300 BPM Accuracy 1 BPM Memory Memory Storage amount depends on PC machine ECG Sampling Box Performance Leads Mode 12 standard leads Cabrera leads Acquisition Mode simultaneously 12 leads DP12 ECG sampling box 1 000 sec channel Sample Frequency DX12 transmitter 10 000 sec channel sampling 500 sec channel analysis DP12 ECG sampling box 24 bits A D Resolution DX12 transmitter 18 bits Frequen
24. ergoline gmbh Germany CE marking Model Manufacturer Lode B V The Nettherlands CE marking 151 SE 1010 PC ECG User Manual Hecommended Optional Accessories STRESS BP Model Manufacturer SunTech Medical Inc USA CE Certificate and FDA 510 k clearance Isolating Transformer Model ES710 Manufacturer BenDer Inc Deutschland Electrical Outlet Power Consumption no less than 4500VA Special use for medical equipment Printer Model HP2010 HP2035 Manufacturer HP Company USA Model CANON 1P1980 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 lt 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 electrical outlet and the isolating transformer shall not be placed on the floor 152 SE 1010 PC ECG User Manual Technical Specifications Appendix 1 Technical Specifications A1 1 Safety Specifications IEC EN 60601 1 A1 A2 IEC EN 60601 1 2 IEC EN60601 2 25 ANSI AAMI IEC EN60601 2 51 Anti electric shock type Cla
25. 1 501 370 407 54 28 66 1 244 0 561 1 805 1 012 0 000 366 406 55 29 66 1 330 0 553 1 883 1 033 1 501 SE 1010 PC ECG User Manual Processing Patient Records 8 7 Importing Data into the Data Manager Screen Click on the Import button on the Data Manager screen Figure 8 1 to open the following window Choose folder Look in GILE JGLERG ERIGLER 1003111500 1 HRY dat Lily Green 201002240000 1 Exercise ECG dat Select data to be imported and click on Select button to import data into Data Manager screen 1 1 Success to import 1 files has been imported 0 files hasn t be imported O files has been imported twice Cancel To import multiple examination records simultaneously you can click on the first examination record to be imported and press the Shift button on the keyboard and then click on the last examination record to be imported You can also press the Ctrl button on the keyboard and then select the examination records one by one After selecting all the examination records to be imported click on the Select button to import all the examination records into the Data Manager screen If all the data are successfully imported into the screen the following hint will pop up 114 SE 1010 PC ECG User Manual Processing Patient Records 13 14 Success to import 13 files has been imported 0 files hasn t be imparted 1 files has been imported twice
26. 6 1 Analyzing Normal ECG Click on the Normal Analysis button to open the normal ECG analysis screen There are four tabs Waveform Average Template Detail information and Rhythm Wave tf SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 1 1 Viewing the Waveform Click on the Waveform tab on the normal ECG analysis screen to open the Waveform window Figure 6 8 EE 201002240000 Lily Green Normal Analysis FCG HF ECG Jo d Normal Analysis QTD Waveform Average Template Detail information Rhythm wave 25mm s 10mm mV 6 2 Re Sample 2 WM b Measure Preview Print Report Save Exit PR ms 158 QRS ms 86 QT QTc ms 360 360 50 43 49 1 110 0 56 Save Glossary Other Result Rhythm and Arrhythmia QRS Deviation ventricular Hypertrophy Atrioventricular Block Intraventricular Conduc Myocardial injury Myocardial Infarction gt Hex Be e Re e Be eR eR AR Figure 6 8 Normal ECG Waveform Window You can choose a speed a gain and a display mode for the displayed waves Click on the Measure button in the Waveform window Figure 6 8 Click on one point on the wave and then drag the mouse to another point The distance amplitude difference and hear
27. Block Myocardial injury Myocardial Infarction 1 Adding an item Enter a diagnosis item such as aa in the textbox and then click on the Add button The added item will be displayed in the Edit Diagnosis Template window 142 SE 1010 PC ECG User Manual Configuring the System Edit Diagnosis Template aa Other Result Rhythm and Arrhythmia ORS Deviation Ventricular Hypertrophy and Atrium Overload Atriaventricular Black Intraventricular Conduction Block Myocardial injury Myocardial Infarction 2 Adding a subitem Click on the item you wanted to add a subitem enter a diagnosis subitem such as bb in the textbox and then click on the Add button The added subitem will be displayed under aa Edit Diagnosis Template bh Other Result Rhythm and Arrhythmia ORS Deviation Ventricular Hypertrophy and Atrium Overload Atrioventricular Black Intraventricular Conduction Block Myocardial injury Myocardial Infarctian 3 Deleting an item Click on the item you wanted to delete from the Edit Diagnosis Template window and then click on the Delete button to delete this item 4 Save the settings Click on the Save button to save these modifications SE 1010 ECG 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 Ca
28. ECG waves on the ECG sampling screen NOTE 1 You can set the printer type on the Printer and Faxes screen For details please refer to Section 6 6 10 Printing ECG Reports 2 report can be printed white black or color The report color is defined by setting the printer type and can be observed on the preview screen For details please refer to Section 9 4 4 Print Setup 6 6 Analyzing ECG Data You can open the ECG analysis screen in one of the following three ways 1 Click on the Start button and then the system will stop sampling ECG and display ECG analysis screen automatically after the sampling time 15 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 screen automatically 3 Or double click on an examination record in the examination record list on the Data Manager screen Figure 6 3 to open the ECG analysis screen When Resting 1 selected as the sampling type the analysis screens include Normal ECG QT Dispersion QTD Frequency ECG FCG and High Frequency ECG HF When HRV ECG 1s selected as the sampling type the ECG analysis screens include Heart Rate Variability HRV and Heart Rate Turbulence HRT When VCG TVCG SAECG is selected as the sampling type the ECG analysis screens include Vector ECG VCG Time Vector ECG TVCG and Signal Averaged ECG 6
29. Fr bg S TE D 0SmWw Template Trend Compare 96 SE 1010 ECG User Manual 4 Click on the ST Trend button to display the ST trend Right click on the ST trend field to Operation Instructions for Exercise ECG display the lead group menu and then you can select other leads 0 4 I 0 4 I o 0 10 20 30 40min 10 20 30 0 4 0 4 0 4 Il 0 4 II o 0 10 20 30 omn 10 20 30 omn 0 4 0 4 Lead k my 0 4 IH 0 4 DI o M 10 20 30 omn 10 20 30 0 4 0 4 0 4 avR 0 4 r 2 10 20 30 omn 10 21 30 omn 0 4 0 4 rv 0 4 avL 0 4 avL 0 10 20 30 omn iD 20 30 0 4 D 4 mit mi 0 4 avF 0 4 avr 2z 0 5 10 20 30 omn 10 20 30 0 4 0 4 Template ST Trend B Compare Template ST Trend compare 7 5 4 Printing the Pretest Report l 2 The pretest report will be printed automatically 14 seconds after the beginning of pretest phase Or you can click on the Print button to print the pretest report 7 6 Exercise Phase l 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 View the heart rate and BP of the patient For details please refer to Section 7 5 1 Viewing the Heart Rate and the Blood Pres
30. Insert the Sentinel into the USB socket of the PC Make sure that the above parts are properly connected and then connect the PC and the printer to the power supply For Exercise ECG of wireless system Insert plug 1 of patient cable into socket 2 of DX12 transmitter Insert DX12 transmitter into pocket 3 of DX12 belt and then wear the belt around waist Insert plug 8 of the cable into socket 6 of the DX12 receiver Insert plug 9 of the cable into the USB socket of the PC Connect plug 10 of the cable to the BP monitor Connect a treadmill or an ergometer to the PC Connect a printer to the PC Insert the Sentinel into the USB socket of the PC Make sure that the above parts are properly connected and then connect the PC treadmill ergometer and printer to the power supply WARNING Use a special grounded socket to get accurate voltage and current When using a laptop with a two prong plug please connect a grounded printer to avoid power interference Only stress BP monitors can be used 24 SE 1010 PC ECG 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 CPU Pentium P4 Celeron D 310 or above System Memory RAM 512MB or above Main Board Recommend the main board of Intel chipset Hard Disk 40G or above ink jet printer of more than 600dpi or laser p
31. be kept between 20 and 55 during transportation and storage 2 Do not use the equipment in a dusty environment with bad ventilation or in the presence of corrosive 3 Make sure that there is no intense electromagnetic interference source around the equipment such as radio transmitters or mobile phones etc Attention large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equipment etc is likely to bring electromagnetic interference 4 Ruptured fuse must only be replaced with that of the same type and rating as the original 5 he 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 Batteries are hazardous waste Do NOT dispose of them together with house hold garbage At the end of their lives hand the batteries over to the applicable collection points for the recycling of waste batteries For more detailed information about recycling of this product or battery please contact your local Civic Office or the shop where you purchased the product 6 Federal U S law restricts this device to sale by or on the order of a physician 1 2 4 Operation for Wireless System WARNING 1 Make sure that there is no intense electromagnetic interference source around the wireless system 2 Do not open the battery
32. conditions Click on the Search button and all the patient records which meet the conditions will be displayed in the patient information list NOTE User defined 1 and User defined 2 are unavailable before they are set in the Basic Information window Figure 9 1 Search Condition Pat ID Mame Examination Time 2000 1 1 2011 12 20 Age range Department M Diagnosis 109 SE 1010 PC ECG User Manual Processing Patient Records Physician Examination 2 Examination Exercise ECG HRY Resting ECG 4 Or you can click on Physician or Examination E VCG TVCG SAECG and then 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 screen and then click on the Modify button to display the Patient Information window Then you can modify the information of the patient in the Patient Information window If the patient has more than one record the modification 15 only for the selected record Click on the OK button to save these modifications Patient Information ID 3 Resting ECG Name Exercise ECG Gender
33. cover of the transmitter during operation SE 1010 PC ECG User Manual Safety Guidance 1 2 5 Preparation and Operation Warnings for Exercise 10 11 12 13 14 WARNING Test the safety stop mushroom type and safety stop cord type of the treadmill before using the system During the exercise test 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 defibrillators blood pressure meters etc and necessary valid medication in the exercise test room Turn off the system power and disconnect the power cord from the wall outlet after using the system Make sure that the power is turned off and the power cord is disconnected from the AC socket before defibrillation Keep the four feet of the machine on the ground and make sure that it s stably working The treadmill must be powered by the specific power outlet Examine the treadmill ergometer carefully before using it The patient undergoing the exercise test should wear suitable clothes and shoes Keep hands hair jewelry and loose clothing away from moving parts Don t let the patient stand on the running belt when starting the treadmill The patient should stand on the foot rails and hold the handrails during start up Wait until the running belt is moving before placing feet on the belt To avoid the static el
34. name that is used by the PC ECG system to transmit the result data to EDP Enter ECG ID to set 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 Select Output GDT file when sampling stops the system will automatically output GDT files when sampling stops Select Output GDT file when making diagnoses the system will automatically output GDT files when making diagnoses 9 8 Other Setup System Setting Device Print Setting Output File Data Maintenance GDT ventes Bm Color set eig Background color weight Kg mmHg mph z Wave color Grid colori 5mm Grid colori imm Mark color 24 YYYY MM DD Text calar Default Please Set System Password Wave Width Set Password Grid Widtht Smm immi Figure 9 8 Other Setup Window 140 SE 1010 PC ECG User Manual Configuring the System 9 8 1 Setting Unit and Color 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 the 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 5mm grid 1mm mark and text If you want to change a color double cli
35. of Wireless System Treadmill or Ergometer Manually Configured Serial Cable Patient Cable Exercise PC Manually DXI2 Configured DX12 Receiver ECG Cable Transmitter Exercise USB Cable ECG Cable Printer Manually BP Monitor Configured 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 s SE 1010 ECG User Manual Introduction 2 2 DP12 ECG Sampling Box of Wired System DP12 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 PC ECG User Manual Introduction USB Socket WARNING 1 When the computer connected to the USB cable is powered on do not connect the USB cable to the DP12 ECG sampling box when the system is powered on do not disconnect the USB cable from the ECG sampling box 2 lt is not necessary or recommended to regularly disconnect the USB cable from the DP12 ECG sampling box Disconnect the USB cable from the PC if necessary Back Panel Patient Cable Socket Applied part of type CF with defibrillator proof N Caution 14 SE 1010 ECG User Manual Introduction Patient Cable Socket 15114 13 12 11110 9
36. on the analysis screen to print an ECG report 3 Or click on the Print button on the preview screen to print ECG report 6 6 11 Saving ECG Reports You can click on the Report Save button Save to save 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 86 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG Eeport Save File Name 20111220 1124 201002240000 worn Send Saving path C NPC ECG Export CAPE ECG Export 20111220 1124 201002240000 doc If you select Send the sampled data will be sent OUTLOOK EXPRESS Windows XP or Window Live Mail Windows 7 Vista when it 1s saved to the designated directory During the saving and sending course the system will give the hint information NOTE In Windows 7 Vista only if Window Live Mail is installed can the report be sent by email 6 7 Sampling STAT ECG Click on the STAT ECG button on the main screen 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 87 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG Chapter 7 Operation Inst
37. please click on Pretest to begin recording pp EELLLLLLELELELELE aa d Lab b J IRERE AN 25meys imame Template Trend Compare amp 157 Stage time Supine Exercise Time ST mv STi Sys Dia mmHg 00 07 00 00 0 00 1 0 00 I 0 Total Time Bruce Pvc min Speek mph Slope 5 E 00 07 0 0 0 0 0 Figure 7 1 Pre Sampling Screen Click on Pretest Exercise Recovery to enter the relevant phase 92 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 1 Selecta display mode from the display mode pull down list 84241 10mm mV 2 5mmyrm 10 Select a gain from the gain pull down list 2 3 Select a speed from the speed pull down list 4 Select lowpass filter from the lowpass filter pull down list 115092 7 5 Pretest Phase Click on Print to print the wave of 10 seconds before you click on Print Click on Keep the system will keep staying in the current phase and the current speed and slope will also be kept until you click on Keep again Click on Next the system will enter next phase stage NOTE 1 If the test time exceeds 40 minutes the system will enter the monitoring status Data will not be saved analyzed or printed any more 2 The length of the pretest phase is not fixed but
38. r Patient Cable Socket wj Applied part of type CF with defibrillator proof Caution Definitions of corresponding pins NOTE The left side of is European standard and the right side is American standard ds SE 1010 ECG User Manual Introduction DX12 Receiver Appearance USB Socket USB Socket SE 1010 PC ECG User Manual Introduction Lock 2 4 Features Powerful functions friendly windows 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 19 SE 1010 ECG User Manual Introduction 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 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 QT Dispersion Vector ECG Time Vector ECG HRT analysis HRV analysis and Signal Averaged ECG Only for resting ECG The f
39. review rint Report Save xi Bruce Bir Et Exercise 60bpm 17mph ST Ascend 0 02mV V2 04 49 00 07 BP mmHg 120 70 10 0 ax ST Descend 000mV T N 0 00 AERE STi D DOmV as ST D D1mV a ina Ba ST 02 ST Slope 0 06mv s ST Slope 0 25mv s ST Slope 0 19mv s ST Slope 0 63mv s li 0 D mVv sd i ST 0 00mV ve ST 0 027 gr 0 01mv ST Slope 0 31mwvjs ST Slope 0 50mv s ST Slope 0 19mwv s ST Slope 0 06mv s ST Slope 0 25mwv s TH W ST 0 00mV E ST 0 00 ST D 02mV To Ji D 01mVv ST Slope 0 25mv s ST Slope 0 57mv s ST Slope 0 19mv s Post j 40ms Figure 7 5 ST Analysis Screen 101 EU ue A SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG Click on Pretest to display 12 lead ST analysis waves of the pretest phase Click on Exercise to display 12 lead ST analysis waves of the exercise phase Click on Recovery to display 12 lead ST analysis waves of the recovery phase Click on Previous Page Next Page to display 12 lead ST analysis waves of every 10 seconds Click on Max ST Ascend to display the Max ST ascending waves Click on Max ST Descend to display the Max ST descending waves You can double click on the wave to select the PostJ value on the ST analysis screen Double click on the wave of a lead the amplified wave of the lead and the calibration lines will be displayed Drag the calibra
40. the patient cable to avoid twisting and connect the disposable electrodes to the lead wires 2 Cleanthe 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 3 disposable electrodes can only be used for one time 234 SE 1010 PC ECG User Manual Preparations Before Operation 5 6 Inspection Before Test In order to avoid safety hazards and get good ECG records the following inspection procedure 15 recommended before operation 1 Environment Make sure that there 1 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
41. the toolbar on the QT Dispersion preview screen 1 Click on Print P to print the report Click on Next Page Prev Page to switch to the previous next preview page Click on Two Page to preview two pages on one screen simultaneously Click on Zoom In Zoom Out to magnify minify the preview page iu Click on Close to close preview screen and return to previous screen 201002240000 Lily Green QID Nest Page Page Two Zoom Zoom QTD Report Lily Green Female 35Y ear ID 201002240000 Department Room No p Eel c 7 mum rl Len Mel LL GI mI B S a ESI hub ef a esp pee pe el eee ee et D 67 100Hz 50 Exarunation 2012 03 23 10 19 Print 2012 05 30 13 35 PC ECG211 1 61 Figure 6 14 QT Dispersion Preview Screen 63 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 3 Analyzing Frequency ECG Click on the FCG button to open the Frequency ECG screen Frequency ECG displays characteristic waves of ECG signal spectrum There are two tabs on the Frequency ECG screen Two leads compare and 12 lead power spectrum 6 6 3 1 About Two lead Comparison Window The two lead comparison win
42. 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 1s 10 600s You can enter HRV sampling time manually The range is 1 15min You can enter the sequence mode time manually The range 1s 10 900s 9 2 3 Others Lead Sequence You can set Lead sequence to Standard or Cabrera and the lead groups are displayed or printed in the corresponding sequence listed the following table Lead Sequence Lead group 1 Lead group 2 Lead group 3 Lead group 4 Standard I II aVR aVL aVF VI V2 V3 V4 V5 V6 Cabrera aVL I aVR II aVF V1 V2 V3 V4 V5 V6 122 SE 1010 PC ECG User Manual Configuring the System HR Calculation You can set the HR calculation to one of the 12 standard leads I aVR aVL aVF V2 V3 V4 V5 or V6 HR Analysis Lead You can
43. to during the operation of the system 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 zs SE 1010 PC ECG User Manual Safety Guidance WARNING 3 EXPLOSION HAZARD Do not use the system in the presence of flammable anesthetic mixtures with oxygen or other flammable agents 4 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 5 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 The system has been safety tested with the recommended accessories peripherals and leads and no hazard is found when the system is operated with cardiac pacemakers or other stimulators 6 Make sure that all electrodes are connected to the patient correctly before operation 7 Ensure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objects 8 If reusable electrodes with electrode gel are used during defibrillation the system recovery will tak
44. zs SE 1010 PC ECG User Manual Preparations Before Operation 1 Clean the electrode area the chest surface with alcohol 2 Daub the round area of 25mm diameter on each electrode area with gel evenly 3 Placea 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 is 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 44 Disposable Electrode Connection 1 Connect snap banana socket adapter to the lead wire 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 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 3 disposable electrodes can only be
45. 0 PC ECG as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated m MERE 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter d 12 P 1 2 2 3 For transmitters rated at 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 15 the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1At 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 15 affected by absorption and reflection from structures objects and people 161 SE 1010 PC ECG User Manual Abbreviation Appendix 3 Abbreviation Abbreviation Statement ECG Electrocardiograph Electrocardiogram Vector ECG Time Vector ECG FCG Frequency ECG ORS Dur ORS Complexes Duration Interval of the Current Lead Normalized QT Interval Dominant Direction of the Average Integrated ECG P ORS T Vectors hr e mmm 0 162 SE 1010 PC ECG User Manual Abbreviation HF norm standard HF Power Foot Augmented Lead Left Arm Augmented Lead Right Arm Augmented Le
46. 02 1 451 0 970 0 522 0 234 a SS eE ui S a 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 Ta mV 0 239 0 193 0 042 0 221 0 137 0 077 0 013 0 738 0 649 0 450 0 281 0 163 Diagnosis 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 Sinus Rhythm Pd ms 116 00 108 00 103 00 116 00 103 00 106 00 108 00 122 00 122 00 120 00 114 00 116 00 Right Axis Deviation Qd ms 0 00 22 00 28 00 35 00 0 00 28 00 0 00 0 00 0 00 0 00 0 00 19 00 Rd ms 34 00 35 00 67 00 46 00 34 00 69 00 29 00 31 00 40 00 47 00 41 00 36 00 R d ms 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 Td ms 179 00 191 00 268 00 177 00 178 00 182 00 116 00 189 00 189 00 189 00 197 00 195 00 PR ms 165 00 158 00 158 00 165 00 158 00 156 00 158 00 160 00 162 00 165 00 170 00 160 00 QT ms 360 00 363 00 456 00 358 00 366 00 359 00 288 00 364 00 361 00 361 00 357 00 366 00 QRS 88 00 92 00 95 00 88 00 95 00 97 00 92 00 95 00 92 00 89 00 80 00 91 00 VAT 24 00 11 00 22 00 27 00 26 00 17 00 22 00 23 00 23 00 35 00 28 00 14 00 STj 0 015 0 020 0 000 0 023 0 007 0 007 0 019 0 124 0 101 0 051 0 030 0 005 STi 0 056 0 035 0 012 0 056 0 032 0 012 0 029 0 249 0 196 0 124 0 068 0 031 ST2 0 088 0 078 0 003 0 096 0 042 0 043 0 022 0 335 0 284 0 186 0 111 0 061 Glossary ST3 0 133 0 113 0 005 0 133 0 069 0 058 0 009 0 496 0 430 0 2
47. 1010 PC ECG User Manual Safety Guidance Chapter 1 Safety Guidance This chapter provides important safety 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 15 offered to clinicians on an advisory basis only WARNING 1 This system is not designed for intracardiac use or direct cardiac application This system is not intended for home use This system is not intended for treatment or monitoring This system is intended for use on adult and pediatric patients only pub e N The results given by the system should be examined based on the overall clinical condition of the patient and they can not substitute for regular checking 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
48. 240000 SCP Compress Saving path ECG Expart CPC ECGSE porta0111212 1134 201002240000 scp cancer NOTE Only if the export file format is set to SCP can the Compress check box be displayed If you select pdf the pdf file will be exported only for Resting ECG and Exercise ECG You need to enter the analysis screen to export pdf files for HRV ECG VCG TVCG and SAECG 116 SE 1010 PC ECG User Manual Processing Patient Records 8 9 Viewing an Examination Record Click on a patient record in 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 in the examination record list Double click on an examination record in the examination record list on the Data Manager screen Figure 8 1 If it is a Resting ECG record the Resting ECG analysis screen will pop up If it is an HRV record the HRV analysis screen will pop up If it is a VCG TVCG SAECG record VCG TVCG SAECG analysis screen will pop up If it is Exercise ECG record the Exercise ECG analysis screen will pop up Then you can do the corresponding operation to the examination record For details please refer to Section 6 6 Analyzing ECG Data and Section 7 9 About Analysis Screen 117 SE 1010 PC ECG User Manual Configuring the System Chapter 9 Configuring the System Click on the System Setti
49. 5 120 0 70 0 60 0 02 0101 D Max ST 0 04mV Min ST 0 02 lt gt Max Workload 7 0METs 00 00 00 05 Diagnosis bretest 1 II Glossary Other Result aVR 4 Rhythm and Arrhythmia ORS Deviation Ventricular Hypertrophy and Atrium Atrioventricular Block 5 Intraventricular Conduction Block Myocardial injury Myocardial Infarction avF 6 lt gt 4 Figure 7 2 Summary Screen Click on the Measure button 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 treadmill is used view the stage stage time speed slope workload METs BP PVC Max ST and Min ST in every stage of the exercise test in the list If an ergometer 1 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 Double 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 comment in the Comment dialog box Click on the OK button and the comment will be displayed on the wave Right click on the comment and then you can click on the Delete Comment button to delete the comment 99 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 5 Enter diagnosis resul
50. 89 0 175 0 085 Other Result ST20 0 041 0 025 0 015 0 038 0 024 0 000 0 034 0 211 0 168 0 104 0 058 0 021 Rhythm and Arrhythmia 5740 0 063 0 038 0 017 0 061 0 037 0 012 0 034 0 264 0 218 0 144 0 083 0 033 QRS Deviation ST60 0 078 0 058 0 007 0 078 0 039 0 025 0 034 0 309 0 266 0 171 0 106 0 048 Ventricular Hypertrophy ST80 0 100 0 088 0 007 0 103 0 052 0 043 0 029 0 375 0 329 0 221 0 135 0 068 Atrioventricular Block Intraventricular Conductic Myocardial injury Myocardial Infarction gt 4 Export Excel Figure 6 10 Normal ECG Detail Information Window Click on the Export Excel button to export an Excel file To Edit Diagnosis Result in the Detail Information Window For details please refer to Section 6 6 1 1 Viewing Waveform SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 1 4 About the Rhythm Wave Window Click on the Rhythm Wave tab on the normal ECG analysis screen to open the Rhythm wave window This window displays rhythm wave as Figure 6 11 shows 201002240000 Lily Green Normal Analysis _ Normal Analysis QTD FCG HF ECG Measure Preview Report Save Waveform Average Template Detail information Rhythm wave I P ms 96 00 00 PR ms 168 QRS ms 87 QT QTc ms 357 357 P QRS T deg 50 43 49 00 10 Rv5 Svi mV 1 110 0 56z CV 3 fet
51. Age range Department M Diagnosis 4 Click on the patient record in the patient information list and click on the Select button to open the Patient Information window Or double click on the patient record in the patient information list to open the Patient Information window Patient Information ID Resting ECG Name uum C Exercise ECG Gender Age 35 Year Dept VOS TVCG SAECG Physician Pacemaker Figure 6 4 Patient Information Window 43 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 3 Entering New Patient Information 6 3 1 Entering New Patient Information Manually If the patient is a new one you can click on the New Patient button Mew Patient the main screen Figure 6 1 to display the Patient Information window Patient Information ID 20100204000 Resting ECG Name fr ci ECG Gender Age 35 Year C HRY ECS Dept Room Physician Pacemaker Then you need to input the patient s related information 1 Enter basic information such as patient ID name sex and age User defined 1 and User defined 2 You can input other related information such as patients medical records User defined 1 and User defined 2 can be set in the Basic Information window Figure 9 1 Before setting them the two items in the Patient Information window a
52. C5 H Figure 5 1 Main Screen When the main screen 15 displayed press to switch the leads If the Bluetooth connection icon 2 is not displayed on the main screen you have to match the device manually Operation instructions are as follows EK L F C1 Ci C4 C5 sem 1 SE 1010 PC ECG User Manual Preparations Before Operation aom m 1 Press to enter the menu screen la EDAN Auto Sleep Language Set Back Figure 5 2 Menu Screen oo wj TM 2 Press to display Match Device item in black and then press to open the screen with a prompt Inquiring ELIAN Language Lead Electrode 3178 SE 1010 PC ECG User Manual Preparations Before Operation 3 When the receiver is found the address of DX12 receiver will be displayed on the screen in 10 seconds Press 5 to start up the Bluetooth connection The Bluetooth connection E will be displayed on the main screen of DX12 transmitter and the Bluetooth status indicator illuminates in kelly when DX12 transmitter and DX12 receiver are matched successfully The Bluetooth status indicator blinks when a data transmission builds between DXI2 transmitter and DX12 receiver The system will return to the previous menu if no DX12 receiver 15 found NOTE Select the receiver address displayed in the PC ECG software when receiving more than o
53. EL TL GT IS LLL HIE TER EE DL LES e TEET E HESS ES SER S d E EE EE E EE canran P i i E EC GR E E ld eS SERRE RSE E E E E E 1 BED m a E 1 E Jd mt x in ca 5 1 PT a LL dif em a cd at an I A eR Hm lz ls ie le SG ld ae oom Gs ZB ER DR RR ER EG UE ER ET ES En fi e gt d EL PU IGI OIL DOLI t 0 67 100 50 Exarination 201 2 03 23 10 53 Print 2012 05 30 13 42 PC ECG2 11 SEMIPI lt Figure 6 23 HRV Preview Screen 6 6 6 Analyzing HRT Click on HRT to display the HRT ECG analysis screen 201002240000 Lily Green 3 c HRY HRT Measure Preview Print Report Save Exit Mode view e C Single Histogr
54. Manual Operation Instructions for Resting ECG The system begins to pre sample ECG Resting ECG 201002240000 Lily Green 36Year It is presampling now please click on Start button to begin record E Sampling 1 05 II 2 r e ea EE EAE e ee 5 fb IPEA I 6 2 M 25mm s 1 mm m 6 i A s 100Hz B Figure 6 5 Pre Sampling Screen 6 5 1 Specifying Display Mode There are eight display modes including 12 1 6 2 3 4 6 1 3 1 3 4 1 3 4 3 and 6 2 1 When the display mode 15 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 49 SE 1010 PC ECG 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 When the display mode is set to 3 4 1 12 channel ECG waves are displayed in 4 groups of 3 and one rhythm lead on one screen When the display mode 15 set to 3 443 12 channel ECG waves are displayed in 4 groups of 3 and three rhythm leads on one screen When the display mode 15 set to 6 2 1 12 chann
55. Previewing ECG Click on the Freeze button on the ECG sampling screen Figure 6 6 the system will display the Wave review window The system can review a 3 minute at least waveform counted from before clicking on the Freeze button for 3 minutes You can review the waveform by dragging the scrollbar and you can print the current waveform by clicking on the Print button NOTE Printing ECG reports in the Wave review window are only available for Resting ECG and Exercise ECG 5 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG Fave review Figure 6 7 Wave Review Window Click on Exit to return to the ECG sampling screen NOTE The display modes in the Wave review window are the modes you select on the ECG sampling screen 3 1 and 6 1 display modes are displayed 3 4 and 6 2 modes 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 screen automatically after the sampling time 15 over For details please refer to 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 screen will pop up automatically 52 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 5 8 Printing ECG Waves Click on the Print button on the ECG sampling screen to print the
56. R The system applies the following formulas to calculate the target heart rate Target HF Max Predicted HR 220 Age Target HR Max Predicted 85 220 and 85 are default values and you modify them different situations in the Exercise ECG Setting window 7 2 2 Setting Normal BP Set the normal BP range in the Exercise ECG Setting window When the patient s BP exceeds the normal BP range the system will consider it as abnormal status 7 2 3 Setting a Protocol Please select a protocol Bruce Ellestad Select a protocol from the pull down list jJ 7 2 4 Setting Post J Select a Post J value from the Post J pull down list in the Exercise ECG Setting window 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 patients actual ECG waves 90 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 7 2 5 Setting BP Sampling Mode Select a BP sampling mode from the BP sampling mode list BP sampling made BP Monitor enter once per stage Monitor enter Protocol drives BP Monite BP Monitor enter ance Monitor enter ance every three minute BP Monitor enter once every four min
57. Trend ECG Strip Measure Preview Print Report Save Exit II 00 00 01 05 989 02 00 05 00 06 00 07 00 08 00 09 00 sever zonin previous page Then click on the Zoom in button to display the amplified ECG segment 01 12 01 19 10mm mVv 25mmy s a Drag the bottom scroll bar to view the whole amplified ECG waves 5 The ALL View screen displays ECG waves of 450 seconds 50 seconds in one line and at least 9 lines in one page ECG waves exceeding 450 seconds can be reviewed by clicking on the Previous Page Next Page button 104 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 7 9 4 About Trend Screen Click on the Trend button to display the STj Trend screen 201002240000 Lily Green SIj Irend l Seles m Preview Report Save Exit ALL View ST analysis Measure Figure 7 7 STj Trend Screen You can observe 12 lead trend of the exercise test on the STj Trend screen The horizontal coordinate indicates test time but the unit of the vertical coordinate 1s different on different trend screens Click on Zoom In or Zoom Out button to adjust the value on the vertical coordinate 105 SE 1010 ECG User Manual 7 9 5 About Strip Screen Click on the ECG Strip button to display the ECG Strip screen 201002240000 Lily Green ECG Strip ps le I b y NT uy A S
58. ad C w Alternating Current Universal Serial Bus 163 P N 01 54 106666 20 EDANLUSA 4901 Morena Blvd Suite 505 www edanusa com San Deigo CA 92117 Tel 888 850 4597
59. am Previous Risk Indicators gt 0 0 TS z2 5ms b 11 9 Mean HR 75b 62 4ge gt 65 years 36 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG You can select Average Histogram or Single Histogram in Mode View field Click on Next PVC or Previous PVC to see the Next or Previous PVC wave and the relevant histogram Click on the Preview button to open the HRT preview screen HRT preview screen 1 Click on Print P to print the report Click on Next Page Prev Page to switch to the previous next preview page Click on Two Page to preview two pages on one screen simultaneously Click on Zoom In Zoom Out to magnify minify the preview page M uid Click on Close to close the preview screen and return to the previous screen 2701002740000 Lily Green HRT Report Lily Gren 36Y ear ID 201002240000 Department Surgery Room Ho 5az beat Mean Aver age Hi Average 936 936 559 1257 929 920 901 922 940 944 940 Min 937 936 935 558 1287 929 920 901 922 940 944 840 937 936 936 559 1267 929 920 901 922 940 944 940 0 32 00 C50 Examination 2009 06 05 10 58 Print 201 11 51 PE SEMIP161
60. arcode NOTE If the two dimensional bar code reader is used you should install Symbol COM Port Emulation Drive manually For details please refer to SE 1010 PC ECG Installation Guide 2 Connect the bar code reader to the PC 3 Log into the PC ECG software 4 When the main screen or the Patient Information window is displayed scan the patient s bar code with the bar code reader and then the patient information will appear in the corresponding boxes of the Patient Information window NOTE 1 Only bar code readers recommended by the manufacturer can be used 2 Only the basic information of the patient can be scanned by the bar code reader AT SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 4 Selecting Sampling Type You can select a sampling type in the Patient information window Resting ECG t Exercise HRY BOG WOG TVCG SAECG 6 5 Sampling Resting ECG After inputting the patient information click on the OK button in the Patient information window to open the ECG sampling screen Before sampling if you do not connect the PC to the ECG sampling box the following hint will pop up AN Hint Please make sure the USE line has been connected IF possible please re cannaect it If the system is invocated by Smart ECG Net but the system integration is not activated the following hint will pop up AN Please enable System Integration Ag SE 1010 PC ECG User
61. c immunity 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 1t 1 used 1n such an environment Immunity Compliance Electromagnetic environment IEC 60601 test level test level guidance Portable and mobile RF communications equipment should be used no closer to any part of SE 1010 PC ECG including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 212 P Conducted RF 3 Vims IEC61000 4 6 150 kHz to 80 MHz d 124P 80 to 800 MHz Radiaed nF d 22 34 P 800 MHz to 2 5 GHz IEC61000 4 3 80 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and 18 recommended separation distance in metres m 159 SE 1010 PC ECG User Manual Information Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with following symbol NOTE 1 At 80 MHz and 800 MEZ the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation 1 affected by absorption and reflection
62. ck on the color block to display the Color window and then you can select your favorite color Click on the Default button to restore the default colors 9 8 2 Setting System Password You can set a system password to avoid the system setting being modified Click on the Set Password button in the Others window enter the same password for twice and then the system password 1 set successfully System Password Setting Enter Password Enter password again cancel After a successful password setting you should have a correct password to enter the System Setting window Otherwise the system will give hint information to prevent your access 9 8 3 Setting Wave Width and Grid Width You can adjust Wave Width Grid Width 5mm and Grid Width 1mm of report by using the up or down arrow The adjustable range 1s 1 5 NOTE width may vary with the type of printer 41 SE 1010 PC ECG User Manual Configuring the System 9 9 Modifying the Glossary a PC eee Mew Patient STAT Data Management System Setup Lead Placement Edit Diagnosis Template Exit Click on Edit Diagnosis Template from the Tool F pull down list on the main screen 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
63. cted to electrodes according to the colors and identifiers Connecting to the ECG Sampling Box Connecting to Electrodes Main Cable V Lead Wires Patient Cable of Wireless System 1 Connect patient cable to DX12 transmitter of wireless system For details see Section 3 2 Assembling Wireless System 2 Align all lead wires of the patient cable to avoid twisting and connect the lead wires to corresponding electrodes according to the colors and identifiers Firmly attach them 5 4 Attaching Electrodes for Resting 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 Table 5 1 Electrodes and Their Identifiers and Color Codes WILSON FRANK Color Code Color Code va c Brow Wee Bosse aes s a c wmv 29 SE 1010 PC ECG User Manual Preparations Before Operation 5 4 1 Wilson Lead System Wilson 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 o
64. cy Response 0 05 Hz 150 Hz 3 dB 5 mV mn ON 20 DP12 ECG sampling box250 MQ 10Hz Input Impedance DX12 transmitter gt 20 MQ 10Hz Input Circuit Current 0 05 uA Input Voltage Range lt 5 mVpp Calibration Voltage 1 mV 2 DP12 ECG sampling box 600mV DC Offset Voltage DX12 transmitter 500mV DP12 ECG sampling box lt 12 5uVp p DX12 transmitterz15u Vp p 155 SE 1010 PC ECG User Manual Technical Specifications Work Frequency Filter DFT Filter weak strong LOWPASS Filter 25 Hz 35 Hz 45 Hz 75 Hz 100 Hz 150 Hz DP12 ECG sampling box gt 110 dB CMRR DX12 transmitter gt 100 dB Pacemaker Detection DP12 ECG sampling box 2 to 700 mV Amplitude DX12 transmitter 2 to 500 mV Sampling Frequency 10 000 sec channel NOTE Test the accuracy of input signal reproduction according to the methods described in clause 4 2 7 2 in ANSI AAMI EC11 1991 R 2001 R 2007 and the result complies with clause 3 2 7 2 in ANSI AAMI EC11 1991 R 2001 R 2007 156 SE 1010 PC ECG User Manual 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 15 intended for use the electromagnetic environment specified below The customer or the user of SE 1010 PC ECG should assure that it is used such an envir
65. d IEC EN 60601 1 1 If in doubt consult our technical service department or your local distributor 23 Connecting any accessory such as external printer or other device such as the computer to this electrocardiograph makes a medical system In that case additional safety measures should be taken during installation of the system and the system shall provide a Within the patient environment a level of safety comparable to that provided by medical electrical equipment complying with IEC EN 60601 1 and b Outside the patient environment the level of safety appropriate for non medical electrical equipment complying with other IEC or ISO safety standards 24 All the accessories connected to system must be installed outside the patient vicinity if they do not meet the requirement of IEC EN 60601 1 SE 1010 PC ECG User Manual Safety Guidance WARNING 25 You should purchase computer printer treadmill ergometer BP monitor and bar code reader from the manufacturer Otherwise the manufacturer will not be held responsible for the maintenance of the PC hardware operating system and other accessories 26 11 multiple instruments are connected to a patient the sum of the leakage currents may exceed the limits given in the IEC EN 60601 1 and may pose a safety hazard Consult your service personnel 2 Connecting to other devices may decrease the antistatic gradation of the system during operation 1 2 2 Li ion Battery Care Warnin
66. dow displays the power spectrum phase shift amplitude shift coherence impulse response and correlation functions of ECG waves as Figure 6 15 shows i ss Analysis Measure Preview Print Report Save Exit Two leads compare 12 lead power 201002240000 Lily Green FCG Power Spectrum II V5 1 2 1 M 5 10 TU Rv RD NW Figure 6 15 Frequency ECG Two lead Comparison Window 64 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG Every parameter of Frequency ECG is shown in the following table If the first peak value is lower than 90 of the second peak 1 2 i ee value it is positive Otherwise it is minus The first peak is too low or disappears The frequency value of the first peak s position 60 heart rate For example if Power the frequency value of the first peak s position is 1 2 the Spectrum heart rate 1s 72 5 10 If the peak value of any peak behind the fifth peak is higher than the first peak value it is positive Otherwise it 1s minus If the distances between peak values are not equal it is positive Otherwise it 15 minus If the phase shift in the range of 6 18Hz exceeds 90 degrees it 1 positive Otherwise it 1 minus Phase Shift Coherence If the coherence value of the fundamental the position of the first peak in power spectrum is less than 0 8 i
67. e and enter information in the grid Set the auto printing time of 12 lead ECG reports in the 12 lead ECG Report First and 12 lead ECG Report Repeat columns Set the auto BP sampling time in the BP First or BP Repeat columns Click on the OK button to confirm or click on the Cancel button to cancel modifications 127 SE 1010 PC ECG User Manual Configuring the System 9 3 4 3 Deleting a Protocol Select a protocol from the Protocol pull down list and then click on the Delete button to delete the protocol NOTE You can t delete default protocols Bruce and IsoPower 9 3 4 4 Restoring the default protocol Click on the Restore the default button to resume the default protocol 9 3 5 Advanced Setup Click on Advanced Setting input the correct password in the pop up textbox and then click on the OK button 9 3 5 1 Setting Access Network Click on the Access Network Setting tab to display the following window Advanced Setting Access Network Setting Barcode Setting Device ID Output Path C SENData 128 SE 1010 PC ECG User Manual Configuring the System Only if Enable System Integration 1 selected can Device ID and Output Path be set Device ID and Output Path should be set to the same values as those of Smart ECG Net Otherwise data of this system can not be uploaded to Smart ECG Net system normally If the System Integration 15 activated the system will save two copies of data one 15
68. e TD MOG Ss iet eR eap E OE 120 2 aces saat teint a 120 9 1 4 Specifying the Storage Path of the ECG Data 120 9 2 dtple ID ocn DI IMS 121 PAIGE tit t tint eiu ues 121 22 2 SUMS Sample T He o eet Debet m cto tecta eis 122 122 9 2 4 Selecting Auto Printing When Detecting 123 22 5 setune Backer Oui OTI oio e 123 9 20 CUTS ANANAS HB aoreet oett eate ca meteor aha haga ea ute oae ue dann Go 123 2 ORS VOICE zen 123 9 2 8 Selecting Sequence Mode When 123 Ded DEVICE D 124 ut 124 9 3 2 Setting Device dO E 125 9 3 3 Setting COM Port of Sample Treadmill BP 125 9 3 4 Seine a PROLOG ON 125 9 94 1 Creaung 3 New Protocol sent ettet t RU 126 9 23 22 MOGI Ly MES Proloco utet s ete 127 9305 5 128 2 59 44 Re
69. e default file name 15 Exam Time ID and exists between every two fields You can also modify the file name manually such as Name ID Exam Time Each field includes ID name exam time age and sex items you can randomly use these items to combine a file name but you should select at least one 1tem as a file name NOTE When you select FirstName LastName in the Print Setting window name will be divided into two parts When the file name is empty the system will give hint information 134 SE 1010 PC ECG User Manual Configuring the System 9 5 2 Setting PDF JPG select Output PDF when making diagnosis the system will automatically output files PDF format when making diagnoses select Output JPG when making diagnosis the system will automatically output files in JPG format when making diagnoses 9 5 3 Setting SCP select Data Compression the system will automatically output files in SCP format of data compression Deselect Data Compression the system will output files SCP format without data compression select Output when sampling finishes the system will automatically output files SCP format when sampling finishes Deselect Output when sampling finishes the system will not output files in SCP format when sampling finishes select Output when making diagnosis the system will automatically output files SCP format when making diagnoses Deselect Output when making diagnosis the system wil
70. e language to Chinese or English NOTE To validate the language setup after setting you should restart the system 9 1 4 Specifying the Storage Path of the ECG Data Click on the Browse button in the Basic Information window Figure 9 1 to assign the storage path 120 SE 1010 PC ECG User Manual 9 2 Sample Setup System Setting Configuring the System Basic Information Sample Setting Device Print Setting Output File Data Ma gt Filter Setting DFT EMG I Lowpass Filter Filter f Sampling Time Resting ECG 10 5 HE vCG SAECG 190 c Auto printing when arrhythmia Background grid Anti aliasing ORS Voce Sequence Mode When Sampling E Min Strong 10DHz t amp Hz Others Lead sequence HR calculation HRY analysis lead Figure 9 2 Sample Setup Window 9 2 1 Setting Filter Filter Setting DFT C Weak EMG Lowpass Filter 10DHz Filter f Strong Set filters in the Sample Setting window Figure 9 2 121 Standard hd Cancel SE 1010 PC ECG User Manual Configuring the System DFT Filter DFT filter greatly reduces the baseline fluctuations without affecting ECG signals There are two options Weak and Strong NOTE 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
71. e more than 10 seconds The manufacturer recommends the use of disposable electrodes at all times 9 Electrodes of dissimilar metals should not be used otherwise it may cause a high polarization voltage 10 disposable electrodes can only be used for one time 11 Do not touch the patient bed table or the equipment while using the ECG together with a defibrillator 12 Do not touch accessible parts of non medical electrical equipment and the patient simultaneously 13 The use of equipment that applies high frequency voltages to the patient including electrosurgical equipment and some respiration transducers is not supported and may produce undesired results Disconnect the patient data cable from the electrocardiograph or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment 14 attention on the examination to avoid missing important ECG waves 15 SHOCK HAZARD Don t connect non medical electrical equipment which has been supplied as a part of the system directly to the wall outlet when the non medical equipment is intended to be supplied by a multiple portable socket outlet with an isolation transformer SE 1010 PC ECG User Manual Safety Guidance WARNING 16 SHOCK HAZARD Don t connect electrical equipment which has not been supplied as a part of the system to the multiple portable socket outlet supplying the system 17 Do not connect any equipment o
72. ecord in the patient information list on the Data Manager screen and click on the Select button to display the Patient Information window Then click on the OK button the system will sample ECG data of the patient Patient Information 201002040000 Resting ECG Name LEN S S S Gender Age 35 0 Year C ECG Dept Room No 2 VCG TVCG SAECG Physician Risk Indicators Symptom Cigarette f Typical angina Diabetes C Non typical angina Congenital heart disease C angina Hypertension Asymptomatic Hyperlipemia Others Family medical history 111 SE 1010 PC ECG User Manual Processing Patient Records 8 5 Merging Examination Records Click on one or more examination records in the examination record list on the Data Manager screen and then click on the Merge Assign button to display the Patient Information window Input a patient ID and click on the OK button to assign the examination record selected to this patient 8 6 Comparing Two Examination Records Press the Ctrl button on the keyboard and select two examination records of resting ECG and then click on the Compare button to display the Compare window NOTE Please select two records to compare only in Resting ECG You can select the lead speed and gain to be compared from the lead pull down list Then the waves of the selected lead speed and gain of the two examination records wi
73. ectricity the patient should not wear loose clothing or clothing such as nylon that easily produces static electricity otop exercising immediately when the patient feels uncomfortable or something abnormal in the operation Press down the safety stop mushroom type or pull out the safety stop cord type to stop the treadmill immediately when an emergency happens SE 1010 PC ECG User Manual Safety Guidance 1 2 6 Contraindications for Exercise ECG Absolute Contraindications 1 pe oe q0 UE spes pu Acute MI within 2 days High risk unstable angina Hemodynamic compromise caused by uncontrolled cardiac arrhythmia oymptomatic severe aortic stenosis Heart failure with clinic episode uncontrolled Acute pulmonary embolus or pulmonary infarction Acute myocarditis or pericarditis The patient opposes the test Relative Contraindications A OO CO N O CO Left main coronary stenosis Moderate stenotic valvular heart disease Serum Electrolyte abnormalities Severe hypertension systolic blood pressure 200 mmHg or diastolic blood pressure 110 mmHg lachyarrhythmias or bradyarrhythmias Hypertrophic cardiomyopathy Patients can not cooperate because of mental impairment or physical disability High degree AV block SE 1010 PC ECG User Manual Safety Guidance 1 3 List of Symbols Equipment or part of CF type with defibrillator proof pA fe Consult Instructions for Use
74. el ECG waves are displayed in 2 groups of 6 and one rhythm lead on one screen 6 5 2 Specifying Lowpass Filter SUA LOQH z 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 1 higher than the set cutoff frequency will be attenuated 6 5 3 Specifying Gain 10mm mwv 5rmmiyrmwv 1 You can set the indicated 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 z5mmy s 5 rmrmn s You can set the paper speed to 5mm s 10mm s 12 5mm s 25mm s or 50mm 50 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 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 For details please refer Section 9 1 4 Specifying the Storage Path of the ECG Data Resting ECG 201002240000 Lily Green 36Year Resting ECG is sampling now v Sampling 106 kook 00 06 25mm s 10mm mV ave LA A Mee dee Me cae 100Hz Figure 6 6 Sampling Screen NOTE After you click on 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
75. er respectively Patient Information ID 201112200000 Resting ECG Name I IE Exercise ECG Medication Physician ponis Tl CDi Search Condition Examination Time iw Allergies Other Age range Department W Diagnosis SE 1010 PC ECG User Manual Configuring the System NOTE Click on the New Patient button on the main screen to open the Patient Information window as the above figure shows select Memory in Basic Information window the content of User Defined 1 in the Patient Information window will be saved For example when you enter None in the Allergies textbox of picture a and enter None in the Other textbox of picture b click OK and open the Patient Information window again you will find that None is in Allergies textbox and the Other textbox 1s empty If Memory is not selected the Allergies textbox and the Other textbox are all empty 9 1 2 Setting ID Mode set ID Create Type to Automatically Manually or Accumulatively When ID Create Type is set to Automatically the patient ID can be automatically generated according to the examination date When ID Create Type is set to Manually you should enter the patient ID manually in the Patient Information window When ID Create Type is set to Accumulatively the patient ID can be increased by one automatically You need to set the format and the starting number for ID 9 1 3 Setting Language You can set th
76. es 14679 i gt Diagnosis Save Glossary Other Result Rhythm and Arrhythmia QRS Deviation Ventricular Hypertrophy Atrioventricular Block Intraventricular Conduc Myocardial injury Myocardial Infarction gt Figure 6 11 Normal ECG Rhythm Wave Window You can set the gain the speed and the lead of the displayed ECG waves You can click on Previous Page or Next Page to display the waves of the previous or next page Click on one point on the wave and then drag the mouse to another point Then click on Print to print the selected wave field 6 6 1 5 Previewing Normal ECG Click on the Preview button to display the normal ECG preview screen l Page Zoomin Print Close is the toolbar on the normal ECG preview screen 1 Click on Previous Page Next Page to switch to the previous next preview page 2 Click on Zoom In Zoom Out to magnify minify the preview page 3 Click on Print to print the report 59 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 4 Click on Close to close the normal ECG preview screen and return to the previous screen EE 201002240000 Lily Green Normal Analysis Zoom in Print Close ECG Report lily Green Female 35 Year 1D 201002240000 Department Room 60 bpm 96 Rhythm 168 ms OOK Normal 86 ms 360 360 ms 50 43 49 de
77. f ALL and the 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 Vector Parameter Direction COW CAN o0 om eo oz o Los ee s T a 184 0 045 179 o oso ow or o Endv zems 172 o2 Directian Maw 7 ms 5 042 042 34 stv 3 005 6 06 i7 7 27 3 29 T cw T ORS Dur ms The position of the maximal amplitude of QRS P T loop mV a SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 8 font ring 0 01 amplitude The amplitude at 0 01s from QRS loop 0 01 angle The angle at 0 01s from QRS loop 0 02 amplitude The amplitude at 0 02s from QRS loop Start Vector start point of QRS loop The position of ST vector in vector loop Length Width The ratio of length to width T loop T R angle The degree between the Max vector of T loop and the Max vector of ORS loop degree F Click on 3D to display the 3D graph G Diagno
78. fer to Section 7 5 2 Viewing Other Information Edit the waveform For details please refer to Section 7 5 3 Editing the Waveform Click on the Print button to print the recovery report 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 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 screen The reason for termination will be displayed in the summary report Elease enter the reason for termination x Please enter the reasan far terminatian _ 98 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 7 9 About Analysis Screen 7 9 1 About Summary Screen l Click on Summary to open the Summary screen 201002240000 Lily Green Summary s f Summary ST analysis ALL View Trend ECG Strip Measure Preview Print Report Save Protocol Bruce Exit T 120 0 70 0 Total Time 4 49 min sec Br Bri 01 06 120 0 70 0 60 0 02 0 01 qoe Br EE 01 14 120 0 70 0 60 0 03 0 02 o ET Recovery 01 00 120 0 70 0 60 0 04 0 01 0 Max BP 120 70mmHg Recovery 01 2
79. fications 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 15 designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result in 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 Chapter I Satety Guidance E 1 nim e 1 1 2 Waimes and C OB IR 1 BP rt 1 1 2 2 Battery totu andate Nee Geen 4 1 2 3 Usu quls 5 1 24 Operation Wireless eve 5 1 2 5 Preparation and Operation Warnings for Exercise 2221 6 1 26 Contraindications To
80. 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 environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which SE 1010 PC ECG 1s used exceeds the applicable RF compliance level above SE 1010 PC ECG should be observed to verify normal operation If abnormal performance is 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 3 V m 160 SE 1010 PC ECG User Manual Information Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that 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 101
81. g L 110 0 562 mV Diagnosis Sinus Report Confirmed By 0 57 100 ACSO Exammahinn2012 03 23 10 19 201205801155 PC ECG2 11 SEMIP1 41 Figure 6 12 ECG Wave NOTE The report title is in one line by default you can also change the line to two lines Find the text named PCECG ini in the installation path modify LineofTitle 0 to LineofTitle 1 and then save the text to change the line to two lines Effect pictures of report title are as shown below 201002240000 Lily Green Normal Analysis XX Hospital ECG Report 35 Year ID 201002240000 Department Room No 360 360 ms 5043 49 deg 1 1 110 0 502 mV 0 57 00H 30 Enammation 30120323 10 19 Paixt 2013 05 30 1156 PC ECG2 11 1 1 61 Report Title in One Line 60 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG ECG Female 35 Y car D 20100 2240990 Department deg RVS SVI L11UD 562 mV Regort Confemed Ab wan eT TET TES Esmaea SS IP Prat Te Bd RERMZPDAL Report Title in Two Lines 6 6 2 Analyzing QT Dispersion Click on the QTD button to open the QT Dispersion screen 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 201002240000 Lily G
82. gs WARNING 1 Improper operation may cause the internal li ion battery hereinafter called battery to be hot ignited or exploded and it may lead to the decrease of the battery capacity It is necessary to read the user manual carefully and pay more attention to warning messages 2 Batteries of the same model and specification as manufacture configuration should be used 3 DANGER OF EXPLOSION Do not reverse the anode and the cathode when installing the battery 4 Do not heat or splash the battery or throw it into fire or water 5 Do not destroy the battery do not pierce battery with a sharp object such as a needle do not hit with a hammer step on or throw or drop to cause strong shock do not disassemble or modify the battery 6 When leakage or foul smell is found stop using the battery immediately If your skin or cloth comes into contact with the leakage liquid cleanse it with clean water at once If the leakage liquid splashes into your eyes do not wipe them Irrigate them with clean water first and go to see a doctor immediately 7 Properly dispose of or recycle the depleted battery according to local regulations 8 Remove the battery from the transmitter if the system won t be used for a long time SE 1010 PC ECG User Manual Safety Guidance 1 2 3 General Cautions CAUTION 1 Avoid liquid splash and excessive temperature The temperature must be kept between 5 and 40 during operation and it should
83. hat it 15 conductible 146 SE 1010 PC ECG User Manual Cleaning Care and Maintenance Do not drag or twist the patient cable with excessive stress while using it Hold connector plugs instead of the cable when connecting or disconnecting the patient 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 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 equipment 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 no
84. he PC if you set the BP monitor port to COMS3 you should connect the BP monitor to COM3 of the PC 9 3 4 Setting a Protocol Protocol Bruce Ellestad kattus Modified Bruce Naughtonth 2 0 Naughton N 3 0 Select a protocol from the Protocol pull down list also add a new protocol or modify a protocol You can 125 SE 1010 PC ECG User Manual Configuring the System 9 3 4 1 Creating a New Protocol Click on the New button in the Device window Figure 9 3 to enter the Edit the protocol window Edit the protocol Protocol Name Stage tim 12 lead ECG Report 12 lead ECG Report Hint 1 Right click the mouse to add or remove the stage 2 Double click the mouse to modify the stage information 3 12 lead ECG report First Repeat is the auto printing time of ECG report of each stage please don t set the time longer than the stage time 4 BP First Repeat is the auto measuring time of BP of each stage please don t set the time longer than the stage time 1 Enter the protocol name in the Protocol Name textbox Add stage Delete stage 2 Right click on the grid to display the menu click Add Stage and enter information in the grid 3 Set the auto printing time of 12 lead ECG reports in the 12 lead ECG Report First and 12 lead ECG Report Repeat columns 4 Setthe auto BP sampling time in the BP First or BP Repeat columns 5 After entering all the information click o
85. he amplitude 1s in the millivolt range and the frequency is 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 250Hz are invisible If these invisible high frequency components are abnormal it 1s 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 screen 201002240000 Lily Green HF ECG gt gt lt EN E Al Normal Analysis Measure Preview Print Report Save i0mm mVv 25mm s mm II Y SITES Limb lead 0 05 10 1 30mm mV L 300mm s 30mm mV Diagnosis 300mm s Other Result Rhythm and Arrhythmia QRS Deviation ventricular Hypertrophy ar Atrioventricular Block Intraventricular Conductio Myocardial injury Myocardial Infarction A ean Y Glossary lt Figure 6 19 HF ECG Analysis Screen 68 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG The ECG wave between the two green lines 1 the present one comm Click 7 to select another QRS wave Select the present lead in the pull down list Limb lead 30mm mV omm z You can choose the lead g
86. he name from the list Click on the Modify button enter a new name in textbox to modify the name and then click on the OK button Click on the OK button to confirm and exit the Edit window and then click on the Read White pull down list Edit you can select the doctor name you enter NOTE Take the same steps above for entering information of technician or Req physician 45 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 2 Enter information of department Click on the pull down list edit and then click on the Edit button to display the Edit Department window Enter the department name in the textbox and then click on the Add button The doctor name will be displayed in List Meanwhile you can also enter the department name in the textbox of Dept item and then click on the OK button in the Patient Information window Edit Department Add Cardiac Surgery List Cardiac Surgery Click on one department name in List and then you can delete or modify the name Click on the Delete button and then click the OK button to delete the department name from the list Click on the Modify button enter a new name in the textbox to modify the department name and then click on the OK button Click on the OK button to confirm and exit Edit window and then click on the 4 Cardiac Surgery pull down list Edit yo
87. he previous screen NE 201002240000 Lily Green CE Next Page Prey Page Two Page Zoom In Zoom Gut Close TVCG Report Lily Green Female 35Year 10 201002240000 Department Room HEET 4 I 1 4 34 i Esser El RE m 3 eb FEE AER a Z Y debe eb C S mmis 0 67 100Hz 50 Examination 2012 03 23 11 37 Print 2012 05 30 13 43 ECG2 11 5 61 Figure 6 28 Time Vector ECG Preview Screen 82 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 9 Analyzing Signal Averaged ECG SAECG is also called Ventricular Late Potential VLP Click on SAECG to open the SAECG analysis screen The SAECG analysis screen includes two tabs Time domain and Frequency domain 6 6 9 1 About the Time Domain Window Click on the Time domain tab to open the Time domain window NE 201002240000 Lily Green SAECG a Lj lt X E SAECG Measure Preview Print Report Save Exit Time domain Frequency domain rd Unfiltered 250mm s 100mrm m Standard QRS Total ORS Below 40uy x Lead IIR filter 40 250Hz
88. icator Color Flashing Frequency Duty Cycle 145 SE 1010 PC ECG User Manual Cleaning Care and Maintenance Chapter 11 Cleaning Care 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 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 failures 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 t
89. ick on Help H to see the help information Click on the Exit button on the main screen to exit the system If you use PC ECG software for the first time the following window will be displayed Initialization Please enter Hospital Name E Unit Set Print Set Height a d Mode 4 1 Weight Sequence sequential Date IrrY MK DD Orient dscape Output report when sampling stopped Please select the frequency of AC Frequency C 60Hz Please select the saving path of source data AWirless Figure 6 2 Initial Window 40 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG You can set the unit print frequency of AC and the saving path of source data based on your needs Click on the OK button after setup the system will enter the main screen automatically NOTE You should install the software to the saving path of source data after the uninstallation and reinstallation otherwise the software needs a new configuration 6 1 Viewing Lead Placement Information 1 Click on the Lead Placement button on the main screen to display the Lead Placement window Lead Placement Wilson lead system Frank lead system Exercise ECG lea a 2 Click on Wilson lead system Frank lead system or Exercise ECG lead system to view the lead placement information in the corresponding system 41 SE 1010 PC ECG User Manual Operat
90. 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 PC ECG software please refer to 5 1010 PC ECG Installation Guide 26 SE 1010 PC ECG User Manual Preparations Before Operation Chapter 5 Preparations Before Operation 5 1 Preparing the Patient 5 1 1 Instructing the Patient Before attaching the electrodes greet the patient and explain the procedure Explaining the procedure decreases the patient s anxiety Reassure the patient that the procedure 15 painless Privacy 1s 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 15 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 1s very important The skin 1s 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 1s natural resistance on the skin surface due to dry dead epidermal cells oils and dirt To prepare the skin 1 Shave hair from electrode sites 1f necessary Excessive hair prevents a good connection 2 Wash the area thoroughly with soap and water 3 Dry
91. int and T 15 the end point of T wave You can move these lines by dragging on the mouse and the mouse will turn to a hand pointer when it 15 put on these marks You can also use the arrows key on the keyboard to move these marks and the corresponding parameter values will change To Edit Diagnosis Result in the Average Template Window For details please refer to Section 6 6 1 1 Viewing the Waveform 3 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 1 3 About the Detail Information Window Click on the Detail information tab on the normal ECG analysis screen to open the Detail information window This window displays lead parameter values as Figure 6 10 shows 201002240000 Lily Green Normal Analysis Li a L3 4 _ Normal Analysis QTD FCG HF ECG Measure Preview Print Report Save Exit I a R avF 1 2 3 V4 V5 v6 Heart Rate b 76 Type Rs qRs qR Qr rS gR rs RS RS RS RS qRs P ms 116 Pa mV 0 072 0 156 0 100 0 104 0 027 0 127 0 066 0 050 0 076 0 075 0 073 0 055 PR ms 165 P a mv 0 000 0 000 0 000 0 000 0 000 0 000 0 052 0 000 0 000 0 000 0 000 0 000 QRS ms 88 E 0 576 1 030 0 780 0 327 0 289 0 868 0 231 0 929 0 881 1 897 1 960 1 101 QT QTc ms 358 402 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 P ORS T deg 67 95 33 Sa mV 0 494 0 214 0 000 0 000 0 547 0 000 0 454 1 9
92. iod None Last Backup Time Begin backup Figure 9 6 Data Maintenance Window 136 SE 1010 PC ECG User Manual Configuring the System 9 6 1 Database Rebuild You can rebuild the database to avoid losing data because of damaged data files Click on the Rebuild Database button in the Data Maintenance window and then you can select the path to rebuild database You cannot enter the path manually Database rebuild Setting Please select the path to rebuild database A Success to rebuild the database 9 6 2 Database Backup You can also make a backup for the data files to avoid your data files being damaged or missing Click on the Begin backup button in the Data Maintenance window and then you can select the path of data backup You should select the path of a disk with enough space Otherwise the system will prompt you to change the path If the Select Time in the Backup Setting window is selected the system will back up the data files from the start time to the finish time If the Select Time is not selected the system will back up all the data files 137 SE 1010 PC ECG User Manual Configuring the System Backup Setting Please select the path of data backup c SH Selecting Range for data backup 6 L Start Time 2000 01 01 Finish Time 2010 12 03 Click on the OK button in the Backup Setting window the system will begin backup You can
93. ion sampling Device 1s 1n sleep mode please 12 transmitter 1s in sleep mode press Power to wake it up The direct current offset voltage on an electrode Overload 15 too high MSDE 2000 or SQL Server 2005 Express 1 not Sorry Can not Connect to the Database started up Fail to create database The system fails to create database Fail to open the treadmill ergometer Fail to open the COM port which controls the port Please make sure the treadmill treadmill ergometer Reconnect ergometer has been connected to the treadmill ergometer to the PC and set the COM computer and the port setting 1s right port correctly Fail to open the BP monitor port Please Fail to open the COM port which controls the blood pressure Reconnect the BP monitor to the PC and set the COM port correctly make sure the BP monitor has been connected to the computer and the Port set 1s right 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 Systolic blood pressure exceeds the normal BP range range 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 Ind
94. ion Instructions for Exercise ECG ccce eee e eee e ee eee ee eee eee 88 7 1 Viewing Lead Placement 88 7 2 Selecting Patient Record to Start a New Test 89 TIPS OD ol 90 152 2 Settimo Normal Bb usse 90 752 5 DENNO NR 90 UU Morc up OSE Ne 90 152 3 mise qe 9 7 2 6 Setting BP Tripegetmo Mode RH uet ne Een a n ne exert edited 9 1 2 PEBU io o ER BO delle cusa Ui utu 9 7 5 Bntenne New Patent IHEODIGtlOE Hg eiie e biu ue RR 9 sampin o EC 92 T PV CUS SU PASC i ont E 93 7 5 1 Viewing the Heart Rate and the Blood Pressure 94 55 2 Mae Other Inrortmdilotr 95 95 Printing tbe Pretest ANC POLL ues VID UENIRE UNDE UT 977 TEKSE uta M uet 977 T RECOV Y PRASE e 98 98 1 9 ABOULAMAIYSIS SCEE 99 7 9 AA SUIMMALY STEE 99 1 92 POOUL ST 101 1 29 23 ADOULATLE VIEW REV IC WIS CLC IM cuo petatur
95. ion Instructions for Resting ECG 6 2 Selecting a Patient Record to Start a New Test Click on the Data Manager button on the main screen Figure 6 1 to open the Data Manager screen Figure 6 3 Data Manager Search Advanced Search Physician Examination The patinets with no examination Physician g 201002230001 James Smith Male 28Year 201002240000 Lily Green Female 36Year Modify Merge Assign lt gt Examination ID Examination Figure 6 3 Data Manager Screen Last day Last 1 week Last 1 month Last 3 months 1 Select a search item in the pull down list LLL on the Data Manager screen Then all the patient records which meet the search condition are listed in the patient information list Search Department 2 Or select a search item in the pull down list Diagnosis enter the corresponding information in the right textbox and then click on the Search button AII the patient records which meet the conditions will be displayed in the patient information list 42 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 3 Or click on Advanced Search to display the Search Condition window Enter the search 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 Mame Examination Time 2011 12 20
96. ions in the Auto diagnosis textbox and then click on the Save button 2 Or double click on the necessary results required to be added the Glossary textbox 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 in the Waveform Window 201002240000 Lily Green ve 2 V AQ 4 HRV HRT Measure Preview Print Report Save Exit Auto diagnosis result Waveform Next Page Figure 6 22 Waveform Window of HRV Br SE 1010 PC ECG User Manual Operation Instructions for Resting ECG waveform 1 displayed in the Waveform window Figure 6 22 1 You can drag the mouse in the window 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 6 6 5 3 Previewing HRV Click on the Preview button to open the HRV preview screen Page Frew Page Zoom In zeomBut Close is the toolbar on the HRV preview screen 1 Click on Print P to print the report Click on Next Page Prev Page to switch to the previous next preview page Click on Two Page to preview two pages on one screen simultaneously Click on Zoom In Zoom Out to magnify minify the preview page wem M uie Click on Close to close the preview screen and return to the previous
97. it should be no less than 15 seconds 3 he pretest phase report will be printed at the fourteenth second When the tracings are satisfying and you have specified the desired settings you can start the pretest 93 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG Exnrcaige ECG eron 1 tl C ad ca 4 t 3 L LII 1 FE Mq i Europ 0 100 2 Template Trend Compare 4157 Stage Supine Exercise Time Max STi mw yin STi mw Sys mmHg 00 07 00 00 0 00 1 0 00 I 6 O Total Speed mph Slope 1 20 70 EE 2 00 07 0 0 0 0 0 7 5 1 Viewing the Heart Rate and the Blood Pressure lt 15 l View the heart rate in the heart rate field 2 The middle number is the current heart rate and the right number 15 the target heart rate The symbol EN gt 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 HH has exceeded the target HH will appear on the sampling screen and the background colo
98. l not output files in SCP format when making diagnoses 9 5 4 Setting FDA XML select Output when sampling finishes the system will automatically output files in FDA XML format when sampling finishes Deselect Output when sampling finishes the system will not output files in FDA XML format when sampling finishes select Output when making diagnosis the system will automatically output files in FDA XML format when making diagnoses Deselect Output when making diagnosis the system will not output files in FDA XML format when making diagnoses 135 SE 1010 PC ECG User Manual Configuring the System 9 5 5 Setting DICOM Select Output when sampling finishes the system will automatically output files in DICOM format when sampling finishes Deselect Output when sampling finishes the system will not output files in DICOM format when sampling finishes Select Output when making diagnosis the system will automatically output files in DICOM format when making diagnoses Deselect Output when making diagnosis the system will not output files in DICOM format when making diagnoses 9 5 6 Specifying the Output Path Click on the button in the Output File window Figure 9 5 to assign the output path 9 6 Data Maintenance Setup System Setting Sample Setting Device Print Setting Output File Data Maintenance 4 gt Database Rebuild Rebuild Database Data Backup Reminded Backup Per
99. lectrical fast 2 kV for power Not applicable Mains power quality transient burst supply lines should be that of a typical IEC 61000 4 4 commercial hospital environment Surge 1 line to line Not applicable Mains power quality IEC 61000 4 5 2 kV line to groud should be that of a typical commercial hospital environment Power frequency Power frequency magnetic 50 7 60 7 fields should be at levels magnetic field characteristic of a typical location in typical IEC 61000 4 8 commercial hospital environment Voltage dips short lt 5 Not applicable Mains power quality interruptions gt 95 dip in should be that of a typical voltage variations commercial hospital for 0 5 cycle on power supply environment If the user of input lines SE 1010 PC ECG requires IEC 61000 4 11 continued operation during 60 dip 1n power mains interruptions for 5 cycles it is recommended 158 SE 1010 PC ECG User Manual Information 70 Ur 5 1010 PC ECG be 30 dip in Ur powered from an for 25 cycles uninterruptible power supply or a battery lt 5 295 dip in for 5 sec NOTE Uris the a c mains voltage prior to application of the test level Guidance and manufacture s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagneti
100. lectrode You can select Inquiring wil displayed for 10 Inquiring seconds to search DX12 receiver The address Address of 2 of DXI2 receiver will be displayed for 8 Match Device receiver seconds if a matching DX12 receiver is found No device found No device found Try again later will be Try again later displayed for 1 second if no matching DX12 receiver 15 found 10 You can see the related information such as screen Select Off to turn off the backlight of LCD Software version ID 0016a400035D Device Information manufacture and release time about the device EDAN 2010 04 20 software version ID address of DX12 receiver NOTE The device information is for reference only 20 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG Chapter 6 Operation Instructions for Resting ECG Double click on the shortcut icon 239 on the desktop to display the main screen the desktop icon for SE 1010 PC ECG NOTE Do not use other software when using PC ECG software PC ECG Tool F Help New Patient STAT ECG Data Manager System Setting Lead Placement Exit Figure 6 1 Toolbar of Main Screen 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 Cl
101. lick on 3D to display the 3D VCG graph 3D Three Dimensional Vector Loops This function allows you to observe the Vector ECG in three dimensions select Rotation and then you can rotate the whole picture to view all directions of the vector loops by clicking the mouse Select Axis to display the axes Select Plane to display the planes 90 lt SE 1010 PC ECG User Manual Operation Instructions for Resting ECG Click on Zoom In Zoom Out to magnify minify the picture Click on Reset to restore the magnified minified picture to original size Other functions Rotation Zoom in Axis Zoom out Plane Reset Preview Print Click on Preview to preview the 3D graph Click on Print to print the 3D graph Click on Save to save the graph on the current screen Click on Return to return to the ECG analysis screen 6 6 7 4 Previewing Vector ECG Click on the Preview button to open the VCG preview screen Two Page Zoomin ZoomGut Close the toolbar the preview screen 1 Click on Print P to print the report 2 Click on Next Page Prev Page to switch to the previous next preview page 3 Click on Two Page to preview two pages on one screen simultaneously 4 Click on Zoom In Zoom Out to magnify minify the preview page 5 Click on Close to close preview screen and return to previous screen 80 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG
102. ll be displayed in the window You can drag the scroll bar on the bottom to view all the waves of the selected lead Please select the compare lead TE 25mm s 10mm n Add II Heart P Duration ms PR Int ms QRS Dur ms QT QTc ms 362 396 P ORS T deg RV5 SVi1 mV RV54 Svi mv RV6 Sv2 mV Heart Rate B P Duration ms PR Int ms QRS Dur ms QT QTc ms P ORS T deg RV5 SV1 mV 54 28 66 1 244 0 561 1 805 1 012 0 000 73 99 155 82 364 401 55 29 66 1 33 0 553 1 883 1 0337 1 501 When Add is selected the waves of the two examination records will be displayed in the window The black wave is the original wave and the blue wave is the compared wave You can drag the scroll bar on the bottom to view all the waves of the two examination records 112 SE 1010 PC ECG User Manual Template When Template is selected the templates of the two examination records will be displayed in the window Compare Please select the compare lead 25mm s 10mm n
103. n the OK button 126 SE 1010 PC ECG User Manual Configuring the System 9 3 4 2 Modifying a Protocol l Select a protocol from the Protocol pull down list and then click on the Modify button to display the Edit Protocol window Edit the protocol Protocol Name Bruce Speed mph Slope 12 lead ECG Report 12 lead ECG Report 0 0 0 0 1 0 m Pretest Supine Pretest Sitting Pretest Standing Pretest Deep Breath Pretest Warm up Exercise Stagel Exercise Stage2 Exercise Stage3 Exercise Stage4 Exercise StageS Exercise Stage6 Exercise Stage Recovery 1 Recovery2 Recovery Recovery3 Hint 1 Right click the mouse to add or remove the stage 2 Double click the mouse to modify the stage information 3 12 lead ECG report First Repeat is the auto printing time of ECG report of each stage please don t set the time longer than the stage time 4 BP First Repeat is the auto measuring time of BP of each stage please don t set the time longer than the stage time Double click on an option 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 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 Right click on the grid to display the menu click on Add Stag
104. n the left midclavicular line C5 Left anterior axillary line at the horizontal level of C4 C6 Left midaxillary line at the horizontal level of C4 5 4 2 Frank Lead System 30 SE 1010 PC ECG User Manual Preparations Before Operation FRANK lead system 16 usually adopted when PC 1 used to produce VCG The conventional letter designations for the electrodes and their respective positions are E C2 at the front midline M C5 at the back midline at the right mid axillary line 4 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 L A and C are all located at the same transverse level approximately at the interspace between the fourth rib and the fifth rib 5 4 3 Attaching Electrodes to the Patient For Limb Electrodes Connecting to a Lead Wire Reed Clamp 1 Clean the electrode area which 1s a short distance above the ankle or the wrist with alcohol 2 Daub the electrode area on the limb with gel evenly 3 Placea 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 is placed on the electrode area above the ankle or the wrist 5 Attach all limb electrodes the same way For Chest Electrodes Suction Bulb Cup Connecting to a Lead Wire
105. nd Support Show Desktop Rename Search 27 Run Properties All Programs D 22 Log OFF Turn OFF Computer 3 Click on Device Manager on the Computer Management screen and then click on Human Interface Devices to view port information m Computer Management Im Action Window 90101 50 Compuber Jy 9 ommunic aic virus Le TST USB Human Interface Device Gig USE Human Interface Device LISE Human Interface Device IDE ATAJATAPI controllers Keyboards Mice and other pointing devices Other devices 7 Ports COM amp LPT Processors 8 Sound video and game controllers 2 System devices p Universal Serial Bus controllers 4 In the Barcode Setting window set Device to the port you view on the Computer Management screen and then click on the OK button to confirm 5 Restart the PC ECG software 130 SE 1010 PC ECG User Manual Configuring the System 9 4 Print Setup System Setting Patient information Diagnosis FirstMame LastMame Date of Birth Height Department 5 RVEHSVIBRVE SV2 Weight Pacemaker BP Auto Diagnosis Physician Average template Technician Position Mark Ref Physician Minnesota code Medication Room Rhythm lead set Ehythmi II Rhythmz vi
106. ne addresses For details please refer to Section 9 3 Device Setup 5 7 1 Keyboard Locking Unlocking If no operation 15 taken the keyboard will be locked automatically in 8 seconds If the previous screen 15 the menu screen it will return to the main screen after the keyboard is locked automatically When the keyboard 15 locked a prompt unlock will be displayed on the left bottom of the main screen and an icon will be displayed on the top right EDAN C3 C4 C5 C6 fe im QOO When the keyboard is locked press and then press __ in 1 2 seconds to unlock the keyboard _ OAS When the keyboard is unlocked press and then press in 1 2 seconds to lock keyboard manually _ 38 SE 1010 PC ECG User Manual Preparations Before Operation 5 7 2 Menu Settings wj Press 4 on the main screen to enter the menu screen Figure 5 2 Press on the menu p 4 AL screen to display an item in black and then press to enter the setting screen of this item Table 5 3 Menu EE CEN select On to turn on the backlight of LCD Back Light screen select On to display Sleeping on the screen Zu and make DXI2 transmitter be low power consumption mode after lead off for 5 minutes select Off to turn off auto sleep function English Language You can select English or Chinese Lead E
107. nfarction E E E E 55 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 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 the Glossary textbox the selected results will be displayed the Diagnosis textbox and then click on the Save button If the Integration function 1s activated the data can be uploaded to Smart ECG Net system after you click on the Save button 6 6 1 2 About the Average Template Window Click on the Average Template tab on the normal ECG analysis screen to open the Average Template window Figure 6 9 You can analyze average templates in this window 201002240000 Lily Green Normal Analysis gt a H Normal Analysis SmE FCG HF ECG Measure Preview Print Report Save Exit Waveform Average Template Detail information Rhythm wave Heart Rate b 60 P ms 96 QT QTc ms 360 360 P QRS T deg 50 43 49 5 5 1 1 110 0 562 Zen 14679 a Diagnosis Save Glossary Other Result Rhythm and Arrhythmia ORS Deviation Ventricular Hypertrophy Atrioventricular Block Intraventricular Conduc Myocardial injury Myocardial Infarction gt Figure 6 9 Normal Average Template Window 56 SE 1010 PC ECG User Man
108. ng button on the main screen Figure 6 1 to open the System Setting window There are eight tabs in the System Setting window Basic Information Sample Setting Device Print Setting Output File Data Maintenance GDT and Others After you modify some information in the System Setting window 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 in the System Setting window to display the Basic Information window System Setting Basic Information Hospital Name User Defined 1 Memory User Defined 2 ID Creation Type Automatically Manually t Accumulatively Language English Data Saving Path IC APC ECG data Figure 9 1 Basic Information Setup Window 118 SE 1010 PC ECG User Manual Configuring the System 9 1 1 Setting Basic Information Enter information in the Hospital Name User Defined 1 or User Defined 2 textbox in the Basic Information window Figure 9 1 When you fill in the User Defined 1 2 textbox the corresponding items in the Patient Information window will change into what 15 filled For example when you enter Allergies in the User Defined 1 textbox and enter Other the User Defined 2 textbox in the Basic Information window Figure 9 1 the corresponding items in the Patient Information window will be Allergies and Oth
109. ocardial infarction before they leave hospital and assess the effect of the treatment With SE 1010 ECG doctors workload can be reduced greatly NOTE 1 The exercise ECG function is optional It is available only if you purchased this function 2 pictures and windows in this manual are for reference only 2 1 SE 1010 PC ECG System SE 1010 PC ECG system includes the following equipment gt software gt ECG Sampling Box wired or wireless system Patient Cable Electrodes Sentinel USB Cable 10 SE 1010 ECG User Manual Introduction Wired System of SE 1010 PC ECG System Resting ECG of Wired System Patient Cable Resting PC Manually ECG Cable Configured DP12 ECG sampling Box USB Cable Printer Manually Configured 2 Exercise ECG of Wired System Treadmill or Ergometer Manually Configured Patient Cable Serial Cable Exercise BP Monitor Manually Exercise Configured ECG Cable PC Manually DP12 ECG sampling Box ECG Cable Configured USB Cable Printer Manually Configured 1 SE 1010 ECG User Manual Introduction Wireless System of SE 1010 PC ECG System Resting of Wireless System Patient Cable Resting DX12 PC Manually ECG Cable DXI 2 Configured Receiver USB Cable Transmitter Printer Manually Configured 2 Exercises ECG
110. ollowing features are only for the exercise test function of SE 1010 PC ECG Automatically controlling and adjusting the speed and the elevation of the treadmill Supporting many kinds of treadmills and ergometers 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 1s adjustable while sampling ECG Providing summaries ST analysis wave reviews and trends Providing specific statistic data of each lead in each stage Providing average waves of each lead in each stage for you to observe the changes of ST segments among different stages 20 SE 1010 PC ECG User Manual Assembling SE 1010 PC ECG System Chapter 3 Assembling SE 1010 PC ECG System 3 1 Assembling Wired System Patient Cable for Resting ECG Patient Cable for Exercise ECG 3 6 4 5 7 DP12 ECG Sampling Box Exercise ECG Cable Resting ECG Cable Assembly Drawing si SE 1010 PC ECG User Manual Assembling SE 1010 PC ECG System For Resting ECG of wired system zx X m xn Insert plug 1 of the patient cable into socket 3 of DP12 ECG sampling box Insert plug 8 of the cable into socket 4 of DP12 ECG sampling box Insert plug 9 of the cable into the USB socket of the PC Connect a printer to the PC Insert the Sentinel into the USB socket of the PC Make sure that the above parts are properly connected and then c
111. onment Emission test Compliance Electromagnetic environment guidance SE 1010 PC ECG uses RF energy only for its RF emissions CISPR 11 internal function Therefore its RF emissions Group are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class A SE 1010 PC ECG 1s suitable for use in all Harmonic emissions establishments other than domestic and those Not applicable 61000 3 2 directly connected to the public low voltage ower supply network that supplies buildings Voltage fluctuations p pp g flicker emissions Not applicable IEC 61000 3 3 used for domestic purposes 157 SE 1010 PC ECG User Manual Information Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity SE 1010 PC ECG 1s intended for use in the electromagnetic environment specified below The customer the user of SE 1010 PC ECG should assure that it is used such an environment Electromagnetic Immunity test IEC 60601 test level Compliance level environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD 8 kV air 8 kV air concrete or ceramic tile If IEC 61000 4 2 floor are covered with synthetic material the relative humidity should be at least 30 E
112. onnect the PC and the printer to the power supply For Exercise ECG of wired system d scm com AU X Insert plug 2 of the patient cable into socket 3 of DP12 ECG sampling box Insert plug 7 of the cable into socket 4 of DP12 ECG sampling box Insert plug 5 of the cable into the USB socket of the PC Connect plug 6 of the cable to the BP monitor Connect a treadmill or an ergometer to the PC Connect a printer to the PC Insert the Sentinel into the USB socket of the PC Make sure that the above parts are properly connected and then connect the PC treadmill ergometer and printer to the power supply WARNING Use a special grounded socket to get accurate voltage and current When using a laptop with a two prong plug please connect a grounded printer to avoid power interference Only stress BP monitors can be used 277 SE 1010 PC ECG User Manual Assembling SE 1010 PC ECG System 3 2 Assembling Wireless System Patient Cable DX12 Transmitter 5 N 4 DX12 Belt Resting ECG Cable 10 7 6 9 8 DX12 Receiver Exercise ECG Cable 205 SE 1010 PC ECG User Manual Assembling SE 1010 PC ECG System Burglar Lock Assembly Drawing For Resting ECG of wireless system 1 2 3 4 5 6 Insert plug 1 of the patient cable into socket 2 of DX12 transmitter Insert plug 4 of the cable into socket 6 of DX12 receiver Insert plug 5 of the cable into the USB socket of the PC Connect a printer to the PC
113. oolbar on the Frequency preview screen Click on Print P to print the report Click on Next Page Prev Page to switch to the previous next preview page Click on Two Page to preview two pages on one screen simultaneously Click on Zoom In Zoom Out to magnify minify the preview page n 2 Click on Close to close the preview screen and return to the previous screen 66 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 201002240000 Lily Green FCG BER Two Page Zoom In Zoom Gut FCG Report 35Year 10 201002240000 Department Room No Power Spectrum II 45 Power Spectrum Vv5 1 2 1 N 5 10 TU 36 1 2 1 M 5 10 TU 27 20 Phase Shift QXY Impulse Response PIH RV RD NW 20 nq Coherence RF Diagnosis Report Confirmed By 0 67 100Hz 50 Exarination 2012 03 23 10 19 Print 2012 05 30 13 39 PC ECG2 11 SEMIPI 61 Figure 6 17 Two lead Comparison Report EE 201002240000 Lily Green FCG Prev Page Two Zoom In Zoom Gut Close FCG Report Lily Green Female 35Y ear ID 201002240000 Department Room No Diagnosis Report Confirmed By D 67 100Hz 50 Exarination 201 2 03 23 10 19 Print 2012 05 30 13 39 2211 SEMIPI 61 Figure 6 18 12 lead Power Spectrum Report 26 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 4 Analyzing High Frequency ECG In a conventional electrocardiogram only these ECG signals of which t
114. r screen Figure 8 1 Data Manager Search Advanced Search Physician Examination The patinets with no examination Exercise ECG 201002230001 James Smith Male HRY 201002240000 Lily Green Female Resting ECG VCG TVCG SAECG Figure 8 1 Data Manager Screen Last day 28Year 36Year modiy x All records Examination ID Examination Import Click on a patient record 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 Last Last 1 week Last 1 manth Last 3 months 1 Select a search item in the pull down list on the Data Manager screen Then all the patient records which meet the search condition are listed in the patient information list 108 SE 1010 PC User Manual Processing Patient Records Search Department Fioiagnosis 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 click on Advanced Search to display the Search Condition window and then enter the search
115. r Exereise BCG ees reet tees 7 E E A 8 Chapter 2 Ith Ore OI 10 E TOIO PCS 10 2 2 12 ECG Sampling Box of Wired 13 2 3 DX12 ECG Sampling Boxes of Wireless 16 19 Chapter 3 Assembling SE 1010 PC ECG 5 1 1 1 21 2 ASsembhne Wired Sy Ste evo E 21 3 2 Assemblime Wireless 9 rta ot Fee eset cea esed eaae pede 23 Chapter 4 Installing SE 1010 PC ECG 5 rere eene 25 Ak System RUNNA Eni OMI MENG ne oH EE bag EUR EE ONE ahi 25 4 1 1 Requirements on the Hardware of the 25 4 1 2 Requirements on the Software of the 25 4 2 About Installation WIDOOW cic etae eene 26 Chapter 5 Preparations Before Operation eee Lecce eee ee e 27 Del Preparino ves cisco not Da d cuiu vag adbeast 27 Instr ctio the c E 27 S 1 2 27 5 2 Connecting Electrodes of Wired 28 23 9 Connecting the Elect
116. r accessories that are not approved by the manufacturer or that are not IEC EN 60601 1 1 approved to the system The operation or use of non approved equipment or accessories with the system is not tested or supported and system operation and safety are not guaranteed 18 Any non medical equipment such as the external printer is not allowed to be used within the patient vicinity 1 5 6 19 Do not exceed the maximum permitted load when using the multiple portable socket outlet s to supply the system 20 Multiple portable socket outlets shall not be placed on the floor 21 Do not use the additional multiple portable socket outlet or extension cord in the medical electrical system unless it s specified as part of the system by manufacturer And the multiple portable socket outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system 22 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 configurations 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 standar
117. r of the heart rate field will change from white to yellow Svys Dia mmHg 120 70 2 View the blood pressure in the BP field The left number 15 the systolic pressure and the right number 15 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 screen to open the following dialog box and then enter the blood pressure manually If you set the BP sampling mode to Manually Enter BP in the Exercise ECG Setting window clicking on the BP button can also open the following dialog box 94 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG Please enter BP value Sys Diat mmHg UN NOTE If the systolic pressure or the diastolic pressure exceeds the normal range the hint The systolic diastolic BP has exceeded the normal range will appear on the sampling screen and the background color of the BP field will change from white to yellow 7 5 2 Viewing Other Information 1 Ifa 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 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
118. re unavailable For details please refer to Section 9 1 1 Setting Basic Information NOTE In the Patient information window 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 7 V lt gt 2 Enter additional information such as BP height weight medication and race NOTE You can select the additional information items in the Print Setting window and these additional information items will be displayed in the Patient Information window after setting printer For details please refer to Section 9 4 1 Choosing Patient Information to be Printed 44 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 3 Enter information of doctor and department 1 Enter information of physician technician Req physician Click on the pull down list edit and then click on the Edit button to display the Edit window Enter the doctor name in the textbox and then click on the Add button The doctor name will be displayed in List Meanwhile you can also directly enter the doctor name in textbox of Physician item and then click on the OK button in the Patient Information window Add Read Write List Read White Click on one name in List and then you can delete or modify the name Click on the Delete button and then click the OK button to delete t
119. reen UI T d M a Normal Analysis Measure Preview Print 0 05 View SOmm s Rep 10mm mV Limb lead I 370 II 352 Ill 376 aVR 368 A s 344 avF 379 v1 357 v2 355 v3 344 M ss 260 v5 362 v6 363 QTd ms 35 Figure 6 13 QT Dispersion screen 61 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 2 1 Editing Waveform on the QT Dispersion Screen 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 represents position of wave 10mm mV Limb E You can set the speed and the gain of the displayed ECG waves The lead number and the lead type of the displayed ECG waves can also be chosen 6 6 2 2 About QT Value Lead 358 360 350 aVR 358 avL 358 360 v1 377 366 363 v4 355 Y5 354 353 27 QT values of 12 leads and QT dispersion QTd displayed as the left figure shows 62 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 2 3 Previewing QT Dispersion Click on the Preview button on the QT Dispersion screen to open the QT Dispersion preview screen Ner Fage Fage Two Fage Zoomin Close
120. rinter Recommend HP2035 2010 CANON 1 1980 Printer 17 TFT Resolution 1024x768 1280 1024 1366 768 or Display 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 SOL Server 2005 Express 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 be abnormal 25 SE 1010 PC ECG User Manual Installing SE 1010 PC ECG Software 4 2 About Installation Window Insert the installation CD into CD ROM double click Setup exe exe etup Microsoft to open the following installation window Figure 4 1 Installation Window 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 in the installation window Then the Environment Detection window pops up Check the installing status of all the components If the Environment Detection window shows that a certain component needs to be installed please install it manually NOTE During the installation of SQL Server 2005 Express in Windows 7 Vista only
121. rodes OL Wireless ORE C ees Pes E NR ue 29 5 4 Attaching Electrodes for Resting 2 000 4 11 0 000000000000000000000000000000 29 5 4 L Wilson Lead tede Uo be daa adn 30 9 4 2 Brank iones a etiaai aO Ue DM D M Ld 30 Attachime Electrodes to the Patient odore tx etat lv ipee 3l 5 5 Attaching Electrodes to the Patient for Exercise 33 3 0 InSpecuoB 35 5 7 Setting DX12 Transmitter for Wireless System iet ete eeu i ete 36 3d Keyboard rates ates uat 38 Def 2 MEDU SEES aote dud 39 Chapter 6 Operation Instructions for Resting ECG ccce ecce ee eee e eee eee 40 6 1 Viewing Lead Placement Information pes rn tee oto ata 4 6 2 Selecting Patient Record to Start a New 42 6 3 Entering New Patient Information nne enne eene nsns nenas 44 6 3 1 Entering New Patient Information Manually essen 44 6 3 2 Entering Patient Information by Using a Bar Code Reader 47 OA Endo 48 BC Causae 48 6 5 1 Specifying Display iecit i hee ab prat eta ta ae RN p uu ea
122. roup the gain and the speed of the waves displayed in the bottom part of the HF ECG analysis screen I II III avR avL avF V1 4 YS V6 Wiehe N 0 0 0 0 3 0 0 0 0 0 0 0 3 S 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 screen Newt Pane Erev Two Pase 2 Zemou Ces is the toolbar on the HF preview screen Click on Print P to print the report Click on Next Page Prev Page to switch to the previous next preview page Click on Two Page to preview two pages on one screen simultaneously Click on Zoom In Zoom Out to magnify minify the preview page 9420 Click on Close to close the preview screen and return to the previous screen 69 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 201002240000 Lily Green ECG Print P Next Page Zoom In Zoom Gut Close High Frequency ECG Report Lily Green Female 35Y ear 10 201002240000 Department TY 6 1 1 Eros ER m Es REESE REEL UR GRE
123. ructions for Exercise ECG The exercise ECG function is optional It is available only if you purchased this function 7 1 Viewing Lead Placement Information l Click on the Lead Placement button on the main screen to display the Lead Placement window Lead Placement Lead Placement Frank lead system Exercise ECG lead system 4 88 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 7 2 Selecting a Patient Record to Start a New Test 1 You can select a patient record from the database to start a new test The operation steps 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 the Patient Information window Resting Exercise ECG HRY ECG WOG TVCG SAECG 3 Click on OK the Patient Information window to open the Exercise Setting window After setting the parameters click on the OK button to open the pre sampling screen Exercise ECG Setting Target HR Max Predicted HR 220 Age Target HR Max Predicted HR 85 95 Mormal BP mmHg Max value 220 90 110 60 Please select protocol Please select Post J Bruce sampling made BP triggering mode BP Monitor enter once per stage Square Wave Auto print 89 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 7 2 1 Setting Target H
124. saved to the data path of the system and the other 15 saved to the output path the default of which 15 system disk SENData 9 3 5 2 Setting Barcode Click on the Barcode Setting tab to display the following window Advanced Setting Access Network Setting Barcode Setting Start Add End Add Item Start Add End Add MEOS LastName o 0 MenthofBrth i8 19 FirstName 0 X DayofBith 20 21 Gender fis 1 Female Code 2 Device Port coma Cancel NOTE You can make related settings only for two dimensional bar code readers in the Barcode Setting window Enter the start and end addresses the male and female codes and the device port and then click on the OK button confirm If the bar code reader cannot be automatically detected you can make related settings as the following procedures show 1 Connect the bar code reader to the PC 2 Click on start right click on My Computer and then select Manage in the pop up menu to display the Computer Management screen 129 SE 1010 PC ECG User Manual Configuring the System V Paint e Music Computer ECG Open Explore eA gt Control Panel S srt E Notepad Sek Program Access an Defaults bun Network Drive pe Windows Media Player M Printers and Faxes Disconnect Network Drive Help a
125. screen E 201002240000 Lily Green HEF Keport Departmen Sugary Room Tire Domain Parameter RR Histagram Histogran of RR Difference 769 ms 830 ms i 609 ms Heart Rate bpm 500 1000 1500 2000 240 80 80 240 400 amp 12 18 4 30 RR intereal ris RR difference Sampling time s Poincare plots Modified Poincare plots Spectral analysis i oa 07 124286 LAJ UJ UD 01 02 03 04 05 1001 400 800 1200 1600 2000 1000 600 2000 200 600 1000 Report Confirmed By 0 87 100 Exermnation 20111208 16 48 Port 2011 12 12 10 58 PC ECG2 11 SEMIPI 61 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG WE 201002240000 Lily Green Page Prev Page Two Page Zoom Zoom Gut Close HRV Report Lily Green Female 35Y ear ID 201002240000 Department Room No 3 H U T Hi i E n EE EET khi 1 LE HE HE leblegd iE BEHA REN MI iL E BEES aud d id LL E BE FE TL L3 LS EH LIT PEE SE T TEES LEE HE HE F
126. set the HR Analysis Lead to one of the 12 standard leads I II III aVR aVL aVF V2 V3 V4 V5 or V6 9 2 4 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 R ON T single PVC and Missed Beat 1s detected during the sampling course printing will be triggered automatically 9 2 5 Setting Background Grid Select Background Grid the grid on the background of the ECG sampling screen will be displayed Deselect Background Grid the grid on the background of the ECG sampling screen will not be displayed 9 2 6 Setting Anti aliasing Select Anti aliasing the system will automatically make the waveform smooth Deselect Anti aliasing the system will not make the waveform smooth 9 2 7 Selecting QRS Voice If you select QRS Voice there will be a beep when an wave 15 detected 9 2 8 Selecting Sequence Mode When Sampling When Sequence Mode When Sampling is selected groups of waves will be displayed in succession 123 SE 1010 PC ECG User Manual Configuring the System 9 3 Device Setup System Setting Basic Information Sample Setting Device Print Setting Output File Data 4 d Sampling Device Device Treadmill IDX12 Wireless Sampling Bax Device Made TMX425 Address Protocol Bruce Sampling Part
127. sis 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 the Auto Diagnosis textbox and then click on the Save button SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 7 2 Displaying Vector ECG with Frontal Plane and QRS Loop NE 201002240000 Lily Green L Q 3 WM amp TVCG SAECG Measure Preview Print Report Save Exit Frontal F Herizental H Sagittal S ALL Vector Loop C P loop C QRS Loop T Loop f ALL 20 27 Diagnosis Normal Glossary Other Result Rhythm and Arrhythmia QRS Deviation ventricular Hypertrophy and Atrioventricular Block Intraventricular Conduction B Myocardial injury Myocardial Infarction 3 REI REI REI RT RET RR RE Figure 6 25 Vector ECG Frontal amp QRS loop The percent values of 0 00 94 16 1 35 and 4 49 in the square represent the area percentages of QRS loop in every quadrant 20 mm mV indicates the magnified multiple gain The red curve is 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 QRS loop 6 6 7 3 Displaying 3D Vector ECG C
128. ss II Anti el ic shock man with defibrillation proof degree Degree of protection against harmful ingress of Ordinary equipment Sealed equipment without liquid proof water Disinfection sterilization Refer to the user manual for details method Degree of safety of application in the presence of flammable gas Patient Leakage Current lt 50 AC lt 50 DC Patient Auxiliary 1 AC lt 10 DC C t 5 50A lt 50uA DC A1 2 Environment DP12 ECG WI box 40 C 40 F 55 C 131 DX12 ECG box Comply with Equipment not suitable for use in the presence of flammable gas Temperature 5 41 F 40 104 F 20 C dee so 131 F 25 93 25 80 Non Condensing Non Condensing Atmospheric Pressure 700hPa 1060hPa 860hPa 1060hPa 153 Relative Humidity SE 1010 PC ECG User Manual Technical Specifications A1 3 Physical Specifications DPI2 ECG sampling box 148 mm L x100 mm W x 40 mm H 5 81nx3 9inx 1 611 Dimensions DX12 transmitter 63mm L x107mm W x23mm H 2 5inx4 2inx0 91in DX12 receiver 155mm L x100mm W x30mm H 6 11nx3 91nx 21n DP12 ECG sampling box Approx 210g Weight DX12 transmitter Approx 113g not including battery DX12 receiver Approx 173g 1 4 Power Supply Specifications Operating Voltage 110V 240V
129. sting ECG 6 6 5 1 Editing the HRV Data on the Analysis Screen NE 201002240000 Lily Green CN m T 4 2 HRY HRT Measure Preview Print Report Save Exit Auto diagnosis result Waveform mek Sampling tim Total Beat Heart Rate b Average RR i Max RR inter Min RR interv Max Min SDNN ms RMSSD ms lt RR Histogram Histogram of RR Difference HR trend Heart Rate bpm Diagnosis 0 500 1000 1500 2000 400 240 80 80 240 400 60 120 180 240 300 RR interval ms RR difference Sampling time s Poincare plots Modified Poincare plots Spectral analysis ke Glossary Other Result Rhythm and Arrhythmia QRS Deviation ventricular Hypertrophy ar Atrioventricular Block Intraventricular Conductior Myocardial injury Myocardial Infarction Figure 6 21 Analysis Screen of HRV Ratio of Maximum RR interval to Minimum RR interval Standard Deviation of Normal to Normal Intervals RMSSD Root Mean Square Successive Difference NN50 The number of duration difference that is more than 50ms the total beat number between the adjacent NN durations PNN50 unit per centum NNSO divide the total NN number SE 1010 PC ECG User Manual Operation Instructions for Resting ECG LF HF Ratio of low frequency to high frequency LF norm Standard LF power HF norm Standard HF power H Doctor Diagnosis Field 1 Enter your own opin
130. storme Medet oet et ee Rad 128 Advanced 128 9 3 5 21 Setine ACCESS INEDWOPK md EO aute fud cud 128 9 952 Setunp BAT COC 129 9A Proe LE 131 9 4 1 Choosing Patient Information to be 131 9 4 2 Choosing Diagnosis Information to be 132 o a 133 244 De tmmoe Printing e 133 QUEUE BIG cese debat 134 D 134 15 PDE JP tun 135 135 LLIN EM ER UM 135 136 9 5 6 Specifying the Output Path 136 90 6 Data e LU eoi ab eee tbe db DM eta 136 261 Database Ice DUTIO anu e tute 137 920 2 Database Bac lt 137 SI NER LEE 139 CRESCIT 140 Umi and C OLE sonet m eate tete Delta m Meet tu 141 2 5 2 etus Systetm PassWOEG teste etate titolo bud tuo 141 9 8 3 Setting Wave Width and Grid 141 MOGI iy the SI cR
131. sure NOTE When the current heart rate exceeds the target heart rate click on the Recovery button to enter the recovery phase and observe the waveforms View other information For details please refer to Section 7 5 2 Viewing Other Information Edit the waveform For details please refer to Section 7 5 3 Editing the Waveform Click on the Print button to print the exercise report 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 97 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG Click on the Keep button and the system enters the Keep state The hint Keep will be displayed in 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 1 pressed again 7 7 Recovery Phase l 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 15 over View the heart rate and BP of the patient For details please refer to Section 7 5 1 Viewing the Heart Rate and the Blood Pressure View other information For details please re
132. t 1s positive Otherwise 1t 1 minus 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 20 7 it is positive Otherwise it is minus If the main peak the middle upends the downward peak ao lt value is higher than the upward peak value it is positive Impulse Otherwise it 1s minus Response If there 1s a peak around the main peak higher than 60 of the main peak it is positive Otherwise it is minus RV If the main peak in the middle upends it is positive Otherwise it 15 minus Correlation EP If the main peak the middle deviates from the origin and Function the baseline it 1s positive Otherwise it 15 minus VXY 2 z 2 m The main peak is like the letter N 65 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 3 2 About 12 lead Power Spectrum Window The 12 lead power spectrum window displays the power spectrum of 12 lead ECG waves Eek 2 Ww b Report Save Exit EE 201002240000 Lily Green FCG A _ Normal Analysis QTD Measure Preview Two leads compare 12 lead power spectrum Figure 6 16 Frequency ECG 12 lead Power Spectrum Window 6 6 3 3 Previewing Frequency ECG Click on the Preview button to open the Frequency ECG preview screen Page Prev Page Page Zoomin in _ is the t
133. t rate between the two points will be displayed NOTE 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 54 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG The common parameters are displayed in the circle Figure 6 8 These parameters are as follows complex duration of the current lead QT QTc Q T interval of the current lead Normalized QT interval P ORS T Dominant direction of the average integrated ECG vectors The amplitude of R wave of V5 lead the amplitude of S 5 5 1 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 modifications To Edit Diagnosis Result in the Waveform Window Diagnosis Sinus Rhythm Right Axis Deviation Save Glossary Other Result Rhythm and Arrhythmia ORS Deviation Ventricular Hypertrophy a Atrioventricular Black Intraventricular Conductic Myocardial injury Myocardial I
134. t use chloric disinfectant such as chloride sodium hypochlorite etc 147 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 for Wired System Table 12 2 Standard Accessory List for Wireless System 148 SE 1010 PC ECG User Manual Accessories Table 12 3 Optional Accessory List sentinel USB 01 18 047229 Patient Cable for Exercise ECG 01 57 109850 only for Wired ECG System Resting ECG External USB Cable 01 13 036134 Disposable Frosting Film for Skin Preparation 01 57 107418 5 1212 Disposable Electrode 01 57 040171 Exercise ECG External USB Cable 01 13 036135 Computer 11 18 052208 Lenovo Qitian M6900 Snap Banana Socket Adapter 01 13 107449 only for Wired ECG System Bar Code Reader Z 31528R 0 01 18 052267 Bar Code Reader LAB 1000 11 23 068003 149 SE 1010 PC ECG User Manual Warranty amp Service Chapter 13 Warranty amp Service 13 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period The warranty is void in cases of a damage caused by mishandling during shipping b subsequent damage caused by improper use or maintenance
135. the Frequency domain window NE 201002240000 Lily Green SAECG gt a Lal 9 gt L L SAECG Measure Preview Print Report Save Exit Time domain Frequency domain Standard Unfiltered Title Data 250mm s 100 Standard QRS 118ms Total QRS 101ims Below 40uv 32ms Last 40ms 15 84uV Noise 0 34uVv Total beat 178 Initial Window 470ms 598ms Window Width 128ms Number of Steps 40 Step Increment 2 Current Lead X Window Type Blackman Harris gt Figure 6 30 Frequency Domain Window 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 84 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 6 6 9 3 Previewing Signal Averaged ECG Click on the Preview button to display the SAECG preview screen _ Zoomin _ Be is the toolbar on the SAECG preview screen oom Out 1 Click on Print P to print the report 2 Click on Next Page Prev Page to switch to the previous next preview page 3 Click on Two Page to preview two pages on one screen simultaneously 4 Click on Zoom In Zoom Out to magnify minify the preview page 5 Click on Close to close the preview screen and return to the previous screen 201002240000 Lily Green SAECG Pimp Page Prev Page TwoPage Zoomin
136. the skin to increase capillary blood flow and to remove the dead dry skin cells and oils 4 Use the disposable frosting film in the standard accessory list to get good ECG waveform NOTE Rub the skin with a gauze pad to increase capillary blood flow if you don t operate the steps above NU SE 1010 PC ECG User Manual Preparations Before Operation 5 2 Connecting the Electrodes of Wired System 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 colors and identifiers Connecting to ECG Sampling Box Lead Wires Main Cable Connecting to Electrodes Main Cable Lead Wires Screw Connecting to Electrodes DUX 4 Nee Connecting to the ECG Sampling Box Patient Cable for Exercise ECG l Connect the patient cable to DP12 ECG sampling box of wired system For details please refer to Section 3 1 Assembling Wired 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 28 SE 1010 PC ECG User Manual Preparations Before Operation 5 3 Connecting the Electrodes of Wireless System The patient cable includes main cable and lead wires which can be conne
137. tion lines on the wave and then the ST value will change Click on the OK button and then the Save button becomes available Click on Save to save the modifications Analysis ST 0 00m ST Slope 0 060175 Post 4 0ms Cancel 102 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 7 9 3 About View Review Screen 1 Click on the ALL View button to display the ALL View screen 201002240000 Lily Green ALL View A a _ Summar ST analysis ALL View Trend ECG Strip Measure Preview Print Report Save 1 Exit II 00 00 01 00 9 e 02 00 03 00 ROS P099 9 99 99 999 AAAA AAAA AAAA hl ll lh 05 00 06 00 07 00 08 00 09 00 some C zonn Previous page rose Figure 7 6 All View Screen The ALL View screen displays the ECG wave of one lead throughout the whole test and arrhythmia will be marked in red signs 2 Selecta lead from the lead pull down list to view the ECG wave of the lead Sri ry 3 Select a gain from the gain pull down list 10mm mv 103 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 4 Click on one point on the wave and drag the mouse to another point and then the selected range will be marked with two red lines 201002240000 Lily Green ALL View qum y w J 7 Summar ST analysis ALL View
138. to Ad or Letter set the Report Hint to Report confirmed by or Unconfirmed Report Set the Baseline Adjustment to OFF Horizontal or Auto Select Auto gain change and the gain will be changed automatically and Auto baseline will be changed to Horizontal automatically Select Color and the background grid of report will be printed in color Deselect Color and the background grid of report won t be printed in color NOTE If the printing color is set to color but a black and white printer is used the report printed will be illegible Select Background grid and the background grid will be printed in the report Deselect Background grid and the background grid won t be printed in the report 133 SE 1010 PC ECG User Manual Configuring the System 9 5 Output File Setup System Setting Basic Information Sample Setting Device Print Setting Output File Data Ma File Naming iw Modify File Naming File Name ExamTin ID SCP Setting PDF JPG Setting v Data Compression Output PDF when making diagnosis Output when sampling finishes Output JPG when making diagnosis Output when making diagnosis FDA XxML Setting DICOM Setting Output when sampling finishes Output when sampling finishes Output when making diagnosis Output when making diagnosis Output Path Figure 9 5 Output File Setup Window 9 5 1 File Naming 66 29 Th
139. to be Printed The diagnosis information 15 displayed on the preview screen and in the report printed out Position Mark should be selected together with Average template because the position mark 15 only used to mark the position of ECG waves in the average template Select Auto Diagnosis to display diagnosis results on the preview screen and in the report printed out Select Auto Measure to display values of parameters Select RV52SVI amp RV6 SV2 to display values of 5 5 1 6 5 2 Select Minnesota code to display Minnesota code 132 SE 1010 PC ECG User Manual Configuring the System 9 4 3 Setting Rhythm Lead The rhythm lead can be one of 12 standard leads I II III aVR aVL aVF V1 V2 V3 V4 V5 or V6 When the printing mode is set to 3x4 1 or 6x2 1 the rhythm lead selected the Rhythm list box will be printed out When the printing mode 15 set to 3x4 3 3 rhythm leads selected the Rhythm1 Rhythm2 and Rhythm3 list boxes will be printed out 9 4 4 Defining Printing Format dee xs The paper form can be set to landscape or portrait Set Sequence to sequential or synchronous When Sequence is set to sequential the lead group 15 printed one by one in a certain sequence The start time of a lead group 1 just the end time of the previous lead group When Sequence is set to synchronous all leads are printed simultaneously The start time of each group 15 the same set the paper size
140. ts 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 the selected results will be displayed 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 C Current Wave Select Summary Report or Current Wave Click on the OK button to open the preview screen 201002240000 Lily Green Summary Next Page Prey Page Two Page Zoom In Zoom But Close Summary Report ID 20100224 0000 e Frei are aa 7m ERES waver mas ue foo eem 23i ness Tu 204 193m ses 0221aam sos 22 2 7 Tonumation fox clmi 1962914 Confnusd Exam ten 2012 0303 1320 Prmo201205 50 14 27 11 7 141 Figure 7 3 Summary Report 100 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 201002240000 Lily Green Summary Report 35 ID 201002240000 De nem Room No rm EXE SERS eee Ieee ae 5 z iid il HERE HE IAE
141. u can select the doctor name you enter NOTE You can select Physician Technician or Req physician in the Print Setting window Before setting them these items in the Patient Information window are unavailable For details please refer to Section 9 4 1 Choosing Patient Information to be Printed 46 SE 1010 PC ECG User Manual Operation Instructions for Resting ECG 4 Confirm pacemaker information If you select Pacemaker in the Print Setting window Pacemaker appears in the Patient Information window Select Pacemaker to detect very small pacemaker pulses However when pacemaker pulse enhancer 1 on the system 1s very sensitive and should not be close to equipment emitting high frequency radiation High frequency radiation can interfere with pacemaker pulse detection and normal ECG acquisition NOTE Pacemaker is recommended to be deselected unless it is known that the majority of the electrocardiograph usage will be patients with pacemakers 5 Select risk indicators and symptoms for Exercise ECG such as cigarette diabetes congenital heart disease hypertension hyperlipemia and family medical history NOTE You can select risk indicators and symptoms only in Exercise ECG mode 6 3 2 Entering Patient Information by Using a Bar Code Reader Operation procedures are as follows 1 Configure the bar code For more detailed information about configuring the bar code please refer to Section 9 3 5 2 Setting B
142. ual Operation Instructions for Resting ECG To Edit Waveform on the Analysis Screen IL avL avr vi v2 93 v4 ve ALL You can press a lead button in to display magnified average templates of this lead When you press more than one lead button magnified average templates of these leads will be overlapped with the same central axis NE 201002240000 Lily Green Normal Analysis v v a af EN A _ Normal Analysis QTD FCG HF ECG Measure Preview Print Report Save Exit Waveform Average Template Detail information Rhythm wave Heart Rate b 60 P ms 96 PR ms 167 QRS ms 89 QT QTc ms 359 359 P QRS T deg 50 43 49 RV5 SViimv 1 110 0 562 DA C LCV1 v VIS d m EA a Diagnosis Sinus Rhythm Normal ECG Save Glossary Other Result Rhythm and Arrhythmia QRS Deviation ventricular Hypertrophy Atrioventricular Block Intraventricular Conduc Myocardial injury n Myocardial Infarction gt EL RET RTT RT RT RT E 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 You can drag marker lines of P1 P2 Q S and T on average templates 1s the start point of P wave P2 1 the end point of P wave marks the position of point S marks the position of S po
143. used for one time 2 05 SE 1010 PC ECG User Manual Preparations Before Operation 5 5 Attaching Electrodes 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 Table 5 2 Moreover the equivalent codes according to American requirements are given in Table 5 2 too Table 5 2 Electrodes and their identifiers and color codes European American Electrodes Color code Electrodes Color code SE 1010 PC ECG User Manual Preparations Before Operation The Precordial Electrodes Positions on Body Surface 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 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
144. uses Electrodes fall off the patient or the patient Lead off X cable falls off the sampling box It 1s pre sampling now please click on During the pre sampling course Start to begin recording Resting ECG 15 sampling now During the sampling course of Resting ECG Can t detect the Sentinel enter DEMO or nm l a The sentinel is not inserted not The Sentinel is not compatible enter ME The sentinel 1s 1ncorrect DEMO or not The USB cable is disconnected or the communication between the ECG sampling box and the serial port 1s interrupted Hint Please make sure the USB line has 1 Reconnect ECG sampling box to the been connected If possible please PC re connect it Click on the Device tab in the System Setting window of the PC ECG system and check whether the sampling device 1 set correctly Communication error Please check the The USB cable falls off the PC during the USB cable sampling process DX12 transmitter is connecting to DXI2 It is connecting now please wait receiver Can t find the corresponding Bluetooth sampling device please make sure the Fail to connect with DX12 receiver device 18 on Battery of sampling device is weak Battery of DX12 transmitter 1s low please change the battery after the test Battery 1s weak the sampling device 1 Battery of DX12 transmitter 1s low closing 144 SE 1010 ECG User Manual Hint Informat
145. ut Two lead Comparison Window 64 6 6 3 2 About 12 lead Power Spectrum 66 6 60 5 Previewing Preguenc y ER En 66 6 64 Analyzing High Frequency ECO 68 Kem 70 6 6 5 1 Editing the HRV Data on the Analysis 71 6 6 5 2 Editing HRV Waveform in the Waveform Window 72 0 06 55 PreVic WING 73 TV epe 74 66 Amalvzino Vector scia Pea ae aetate boi ped en dO nhu 76 6 6 7 1 Displaying Vector ECG with Plane and 76 6 6 7 2 Displaying Vector ECG with Frontal Plane and QRS Loop 79 6 0 5 9D Vector BC RU M Tie RU EQ 79 ne Vector ECO 90 Analy zine Time Vector EC GI ese exse o ar E UE e 81 6 0 9 Analyzing Stonal Averdged estote aedes 83 6 6 9 1 About the Time Domain Window 83 6 6 9 2 About the Frequency Domain 84 6 6 9 3 Previewing Signal Averaged 85 0 6 10 Printing BC GR CDOS oie uide E 86 6621 Savino RODOLNS 86 6T S TAT EC 87 Chapter 7 Operat
146. utes BP Monitor enter once 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 or QRS the Exercise ECG Setting window 7 2 7 Setting Auto Printing select Auto print to print ECG reports automatically 7 3 Entering New Patient Information If the patient is a new one 1 Click on the New Patient button M amp W Fatient the main screen Figure 6 1 to display the Patient Information window and 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 NOTE 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 91 SE 1010 PC ECG User Manual Operation Instructions for Exercise ECG 2 Select Exercise the Patient information window 3 Click on OK the Patient information window to open the Exercise Setting window After setting the parameters click on the OK button to open the pre sampling screen For details please refer to Section 7 2 Selecting a Patient Record to Start a New Test 7 4 Pre sampling ECG ire ZI TI beeen It is presampling now

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