CardioView
Contents
1. fe wae UR H H Connors Ann 0011 C Joh 00010 Height 190 button Enter the patient details 7 wmo m x5 then click the OK button z Cancel New 14 CHAPTER 4 Working with CardioView 5 CardioView will then download and 58575 analyze the ECG from the Status Receiving data Biolog 3000i and display it on the device BIOLOG 684I Hw v2 5 SW v3 screen N Th C G ill b Connection 57600 bps ote le WI on y i e Speed 3927 bytes sec analyzed if the Analyze ECG option Progress 4096 of 5120 bytes is checked in the General Options 812 15 CHAPTER 4 Working with CardioView Patient List The Patient list is a list of all patients in the data directory and is displayed in the Select Patient dialog before downloading a new ECG or when assigning a patient to an ECG When you select a patient their full details are displayed to the right of the list The patient list contains the following columns The patients name 4 Number Patient number or ID 5 Select Patient OF Search T Sort by 0 semen fl First Name Joe LastName Bloggs Butler Len Carroll Jan 00012 Number 12345 Childs Daphne 00013 Chodora Kazimiera 00006 Sex Male Coleman Margaret 00014 Date of Birth 12 04 40 Connors Ann 00011 1 Connors John 00010 Height 130 cm Cooper Derek 00007 Weight 80 Crockett Stephen 00005 Deakin Bell Robert 00004 Dean2. Rules AS NZS3200 1 2 1995 and 601 1 2 1993 These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio telecommunications In addition radio frequency transmitters such as CB radios and wireless or cellular mobile phones may adversely affect this device There is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception or is itself affected by equipment off and on the user is encouraged to try to correct the interference by one or more of the following antenna e Reorient or relocate the receiving antenna e Increase the separation between the interfering devices Connect the equipment into an outlet on a circuit different from that to which the other equipment is connected Consult the dealer or an experienced radio TV technician for help gt APPENDIX SYSTEM SPECIFICATIONS Universal ECG Amplifier amp Controller Gain Sensitivity Input Range Acquisition Sample Rate Frequency Response Defibrillator protection Common Mode Rejection Safety Standards Leads Off Indicators Power Source Supply Voltage Supply Current 5 10 20mm m
3. Name The patients name Number Patient number or ID 4 Recorded Date and time the ECG was recorded Device Device and serial number of the ECG recorder Received Date and time the ECG was received by CardioView Filename Name of the ECG file Open ECG File OI x Search butler by Name Recorded Device Received Filename 12 Bloggs Joe 12345 5 12 97 15 51 00 BIOLOG 030293 9 12 97 14 16 27 t0000227 scp 14 Bloggs Joe 12345 1 12 97 8 54 00 BIOLOG 006795 16 12 97 18 26 20 0000246 12 Butler Len 00003 28 05 97 14 49 00 BIOLOG 036821 23 11 37 14 23 40 0000109 14 Carroll Jan 00012 7 05 97 10 46 00 BIOLOG 036821 23 01 98 14 20 42 0000032 12 Childs Daphne 00013 6 05 97 11 13 00 BIOLOG 036821 21 12 97 11 19 20 cO000024 scp 14 Chodora Kazimiera 00006 20 05 97 11 10 00 BIOLOG 036821 18 09 97 16 02 38 0000073 12 Coleman Margaret 00014 6 05 97 10 57 00 BIOLOG 036821 3 11 97 14 18 52 cOO00023scp 14 Connors Ann 00011 8 05 97 14 50 00 BIOLOG 036821 3 11 97 13 21 18 gt 0000035 14 Connors John 00010 8 05 97 14 57 00 BIOLOG 036821 3 12 97 14 20 22 cOO00036 scp 14 Cooper Derek 00007 15 05 97 8 46 00 BIOLOG 036821 16 11 97 16 22 06 0000059 12 Crockett Stephen 00005 2 06 97 9 58 00 BIOLOG 036821 23 01 98 14 25 58 0000116 14 Crockett Stephen 00005 20 05 97 16 57 00 BIOLOG 036821 5 08 97 15 15 56 cOO00076 scp 12 Deakin Bell Robert 00
4. 38 1 CHAPTER 1 Introduction CHAPTER 1 INTRODUCTION a What is CardioView CardioView is a Windows based application that allows the acquisition analysis review and printing of ECGs System Requirements Requirements for the CardioView software are 4 Pentium Il 400 MHz IBM compatible computer 32MB RAM SVGA display 4 One spare serial or USB port PS 2 mouse or keyboard port recommended 1 44 floppy disk drive CD Rom Drive At least 30MB of available hard disk space for the program plus additional space to store the ECG data approximately 90kBytes per 12 lead ECG 4 Windows 98 2000 ME XP or Windows NT 4 Any pointing device supported by Windows A Windows supported printer MAPI compliant electronic mail system must be installed on your computer e g Outlook Express Requirements for email support compliant electronic mail system must be installed on your computer 2 CHAPTER 1 Introduction mm m Installation Installing Cardio View The program on the installation disk is used to install CardioView onto your computer To install CardioView Start Microsoft Windows Insert the CardioView installation CD into drive D CD ROM drive Open the Start menu and select Run Type D and press ENTER 0 represents the allocated letter for the CD Rom drive and may vary between computers 5 A window will open up sh
5. 819 183 0 ol 13 1 Ist 0 5 0 73 3 94 ol 2 St 0j 75 0 88 526 16 1 gRs 105 0 324 76 167 0 00 15 4 VAM qas 171 0 1142 828 194 0 0 14 0 gfs 872 0 07 606 142 0 0 9 2 gRs 2 00 91 554 127 7 2 Jd A Interpretation If you have the Include Interpretation option enabled in the General Settings CardioView will generate an interpretation when an ECG is analyzed otherwise the interpretation field will be blank The interpretation is initially marked unconfirmed You can confirm the interpretation by selecting the Interpretation Unconfirmed checkbox From the Edit menu you can cut copy and paste text from and to the Windows clipboard Important ECG interpretation programs are not and can never be intended to replace sound medical reasoning by a trained professional Comments You can type any comments for the ECG The comments will be saved together with the ECG recording From the Edit menu you can cut copy and paste text from and to the Windows clipboard Measurements A summary of the measurements and a matrix of all measurements that are computed by CardioView are displayed if the ECG has been analyzed The measurements cannot be edited 22 CHAPTER 4 Working with CardioView Printing an ECG CardioView allows you to print a number of different ECG reports and select whether to include the interpretation comments and measurements and to select the scale
6. TN a true negative result and FP a false positive result Sensitivity TP TP FN Specificity TN TN FP Results Cardiac Disorder Left Ventricular Hypertrophy Right Ventricular Hypertrophy Biventricular Hypertrophy Anterior Myocardial Infarction Inferior Myocardial Infarction Combined Myocardial Infarction Combined Infarction and Hypertrophy Total Myocardial Infarction Includes Combined 547 76 8 87 2 Infarction and Hypertrophy Cardiac Disorder 00 71 52 31 CHAPTER 6 ECG Analysis Program Note 1 Modifications may be made to this interpretive program from time to time that could affect these results 2 Though false positive errors indicating features that do not exist will intentionally outnumber false negative errors missing features that do exist both will occur thus the necessity for over reading by a qualified physician of any computer interpreted ECG The computer interpretation indicates features of the ECG it does not produce a definitive diagnosis 3 ECG simulators should not be used to test the program s interpretation Simulators generally produce waveforms that emulate how certain ECG patterns look which do not represent the full information content of genuine ECGs A simulated ECG is not an adequate substitute for human ECG 32 CHAPTER 8 Troubleshooting CHAPTER 7 MAINTENANCE 1 Cleaning and Disinfection Universal ECG can be cleaned and disinfected very simply as follows
7. The Universal ECG is not suitable for use with flammable anaesthetics and offers no water ingress protection Inspect the Universal ECG electrocardiograph patient cable regularly for signs of mechanical damage particularly around patient leads To verify correct operation of the electrocardiograph connect all patient leads to a patient or an ECG simulator and check that there is a valid ECG signal on every lead by viewing the signal through CardioView Use during defibrillation or with large input signals The design of the Real Time monitor is such that the traces can cross in the presence of large signals This is to allow for the convenience of viewing all signals simultaneously while still allowing maximum input dynamic range It is recommended that a three lead view be selected for use during defibrillation to ensure that the signals are clearly separated following electrode polarization Symbols used on the Universal ECG N Attention Consult accompanying documents x BF defibrillator proof equipment TABLE OF CONTENTS CHAPTER 1 1 WHAT IS CARDIO VIEW utto Steaua taa tuti Mats oca DUDEN 1 SYSTEM REQUIREMENT Sc cc cesa ta dia ai rad Gba ein Per nd E Ges 1 INSTALLATION o clues piace ana Deere kent dete ei stile bas e dla Kona tons 2 CHAPTER 2 3 EGG FECORDING n
8. To clean the Universal ECG plastic case wipe the surfaces of the case with a clean cloth moiste ned with water only NOTE Do not wipe the case with alcohol Alcohol will damage plastic surfaces over time and may cause them to crack To disinfect the Universal ECG wipe the device with a hospital grade disinfectant NOTE Do not saturate the Universal ECG with any liquid because excess fluid could enter the case and damage the electronics 33 CHAPTER 8 Troubleshooting CHAPTER 8 TROUBLESHOOTING Symptom Likely Problem and Solution Please review the suggestions for troubleshooting some minor difficulties presented below If you cannot resolve the difficulty after following these procedures please contact your supplier or call QRS Diagnostic Cannot Connect to Device or Com Port 1 Ensure that the serial port number is set correctly for the port which you are using You may have a message such as Unable to Open Com Port ECG Capture Will Abort this means that you are using a COM number which doesn t exist or is being used for something else Check that your use of the COM port does not clash with the configuration of other serial port applications such as ActiveSync HotSync or fax and modem applications 2 If the message is Unable to Find Cable then the COM number is valid and free but may be for a different port or the cable may not be connected properly Consider plugging the cable into a differen
9. box empty if you do not want a report title Connection Settings General Connection Data Directory Device 12 lead cable eem Com Port Com 2 Y Baud Rate 115200 ECG Recording v Filter 50 60 Hz ECG Trace v Muscle Filter Green on Black v Beep on ORS C Black on White v Beep on Leads Off v Use MIDI sound Device The ECG device which connects to CardioView CardioView offers two options for downloading ECG s the Universal ECG or Biolog 3000i connection 8 CHAPTER 3 Setting up CardioView Com Port The communications port that the cable or the Biolog 3000i is connected to Baud Rate The maximum transmission speed between the Biolog 3000 and CardioView The default setting is 57600 You can try selecting a higher baud rate which may reduce the time to download ECGs However some computer systems may not be able to support higher baud rates If you have any communication errors or problems connecting to the Biolog 30001 you may have to set the baud rate to a lower value The baud rate for the Universal ECG is constant and cannot be changed ECG Recording The selection of filters to be used while recording an ECG from a 6 or 12 Lead Universal ECG A 50 or 60Hz mains filter and a muscle filter is available The frequency of the 50 60Hz filter is selected in the general section of these settings These can also be controlled in the main window and while recording the ECG You can also tur
10. with the snap or Biotab adapter Twist the adapter around the banana plug several times in both directions Replace the adapter and check the signal If the lead is still off contact QRS Diagnostic for new adapters Real Time ECG Display Doesn t Fit on the Screen CA 1 The resolution of display is not set to meet the minimum requirements of CardioView 2 Within the control panel change the display setting to a minimum of 800 x 600 pixels Excessive Noise on Traces 1 Noise on ECG traces is often caused by poor electrode contact Perform checks as described for Leads Off problems 2 Nearby equipment which electrically noisy can cause noise on the traces particularly if it is coupled to the patient or the patient leads Some laptop computer power supplies can introduce excessive noise and this may be improved by operating the laptop from its batteries The filters can also help note that if using the mains filter it needs to be set to 50 or 60 Hz under Options gt Settings gt General depending on the normal frequency of the mains supply in your country 35 CHAPTER 8 Troubleshooting Traces are Interrupted Periodically 1 Check that supplementary power is being delivered to the socket in the back of the 089 plug of the Universal ECG as described in Connecting the 6 or 12 Lead Universal ECG 2 Try shutting down all other applications which are running at the same time in o
11. you 12 leads of the averaged dominant complexes and a rhythm strip El John Ramsey 03 04 2000 09 56 00 25 mm s 10 mm mV Filters 0 05 150 Hz 20 CHAPTER 4 Working with CardioView ECG Strips This view shows up to 10 seconds of three leads 25mm s ld mm mV Filters 0 05 40 Hz Zoom This view shows a single lead strip or averaged complex Lead specific measurements can be displayed in the upper left corner of the Window The P PR QRS and QT intervals are also shown in the lead itself E John Ramsey 03 04 2000 09 56 00 of x 60 bpm 16 ms 68 pV 42 ms 384 28 ms 87 1 8 118 pV 39 250 25mm s ld mm mV Filters 0 05 40 Hz 21 CHAPTER 4 Working with CardioView Details The details view shows the interpretation comments and measurements of the ECG You can edit the interpretation and comments i John Ramsey 03 04 2000 09 56 00 Interpretation Unconfirmed Comments Normal sinus rhythm Widespread anterior infarction probably old j Measurements Data must be reviewed by a qualified physician DE SERES LE IR a ea a P P Q R S 5120 gs 55 0 68 384 57 0j 0 08 1 gRs 1460 170 1010 227 0 oj 171 aas 8210 1102 626 140 0 0 9 0 i 0 0 oj 18 697 16 0 12 2 q j 0 22 21 0 0 Rs 1201 0 136
12. 004 21 05 97 10 10 00 BIOLOG 036821 28 09 97 16 45 14 0000080 141 Deane June 00009 12 05 97 14 22 00 BIOLOG 036821 5 11 97 13 21 38 cOO00046 scp Cancel Batch Sorting the ECG list The ECG list is usually sorted in the order of the columns usually by patient name then the date that the ECG was recorded You can change the order of the columns with the Sort By button You can also sort the ECG list by a particular column by clicking that column s header click the column s header a second time to change the sort order from ascending to descending and vice versa By default dates are sorted in descending order so that the most recent ECGs are on top Selecting multiple ECGs To select multiple ECGs hold down the CTRL key and then click each ECG you want to select To select a group of ECGs that are next to each other click the first one then hold down the SHIFT key and click the last one in the group 17 CHAPTER 4 Working with CardioView Resizing the ECG list and columns You can resize the window containing the ECG list to display more items by using the mouse to drag a corner or side of the window You can also resize the width of each column by clicking and dragging the separator between each column header Searching To search for an ECG you can type the name of the patient or other details depending on the current column order in the search box The ECG list will automatically scroll to the desired p
13. 11 Connors John 00010 Height 190 cm Cooper Derek 00007 Weight 80 kg Crockett Stephen 00005 Deakin Bell Robert 00004 Deane June 00009 Cancel New For a new patient click the New button Enter the patient details and then click the OK button 5 Apply the ECG electrodes to the patient using correct lead placement Anatomical Positioning of the 6 or 12 lead Universal ECG Electrodes 12 CHAPTER 4 Working with CardioView The patient s ECG will appear on the screen After 10 seconds of ECG has been received the status bar will be filled This means that sufficient data has been received for CardioView to analyze 8 Press the Save button to transfer the most recent 10 seconds of ECG to CardioView This can be done multiple times 32 maximum with the number of saves appearing above the Save button The most recent 10 seconds will be displayed in CardioView i or Pine Press the PAUSE button to review up to 15 minutes of ECG 9 Use the scroll bar at the bottom of the 77 7 b bo bod screen to identity the 10 seconds of ECG wish to transfer to CardioView Ifa suitable ECG is not found you can return to the ECG recording by pressing lt i the RECORD button This will stata j jj 41 fresh recording Pressing es es ee button will transfer the selected 10 DOLUS seconds to CardioVi
14. 5 0 14 49 00 2 14 23 40 A Childs hne 12 Chodora Kazimiera 00006 20 05 97 11 10 00 18 09 97 16 02 38 BIOLOG 036821 cl 12 Coleman Margaret epar 10 ETA 00 CA 14 18 52 BIOLOG 036821 cl 3 G 036821 14 57 00 0797 14 20 22 BIOLOG 038821 cl Cooper Derek 00007 15 05 37 8 46 00 16 11 97 16 22 06 BIOLOG 036821 cl B Stephen 00005 2 06 37 9 58 00 23 01 98 14 25 58 BIOLOG 036821 Note You can import an ECG that you are viewing directly by selecting Import from the File menu if the ECG file is not located in the CardioView data directory The file will then be copied to the CardioView data directory 27 CHAPTER 5 Reference CHAPTER 5 REFERENCE Menu Commands File New F2 Open ECG Close Export Import Delete Patient details Import ECGs From Batch process Printer setup Print Send mail Exit F3 Ctrl F4 F5 Edit Initiates RT ECG or if the receiving device is set to Biolog 30001 it will download a stored ECG from the Biolog 3000i Opens an existing ECG stored in the database Closes the active ECG The active ECG is the one highlighted on the screen Copies the active ECG file to disk Copies the active ECG file to the database Removes the active ECG file from the database Displays patient details of the active ECG Copies ECGs from disk to the database Provides the ability to print
15. C 20 C 70 C 5 85 4 patient leads 10 patient leads 4mm Banana plug or Snap On adapters Abbreviations and colors to comply with either IEC or AAMI standards Dependent on PC supplied by user
16. CardioView User Manual Caution The computerized interpretation provided by CardioView is only valid when used in conjunction with clinical findings All computer generated tracings and interpretations must be confirmed by a qualified physician Copyright Notice Copyright 2003 by QRS Diagnostic LLC All rights reserved No part of the documentation may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopy recording or otherwise without the prior consent of QRS Diagnostic LLC Information in this manual is subject to change without notice and does not represent a commitment on the part of QRS Diagnostic LLC License Agreement The software described in this manual is supplied under a license agreement and may only be used in accordance with the terms of that agreement Trademarks All brands and product names are trademarks or registered trademarks of their respective holders and are hereby acknowledged trademarks European Representative Advena Ltd PO Box 30 Leominster Herefordshire HR6 OZQ UK CAUTION Federal law restricts this device to the sale by or on order of a physician YEAR 2000 This software is Year 2000 compliant provided it is run on a computer system that is itself Year 2000 compliant It is recommended that 4 digits be entered for all year values If a two digit year is entered it is assumed to be in the 20 century and is stored
17. G Language v Include interpretation v Suppress incomplete patient details warning ECG analysis Report title Amplitude units Sets the unit in which the amplitudes of the ECG are measured to microvolts or millimeters Power Filter Sets the frequency of the mains power filter This will vary depending on the country of use Measurement system Sets the measurement system for the patients height and weight to metric or imperial units 7 CHAPTER Setting up CardioView Action after receiving an ECG Analyze ECG If the Analyze ECG option is checked ECGs will automatically be analyzed after they are saved Language Sets the language to be used by CardioView Changing the language will not take affect until you click the OK button to accept the changes ECG analysis Include Interpretation If checked CardioView will generate an interpretation when an ECG is analyzed Suppress incomplete patient details warning If checked CardioView will not generate an incomplete patient details warning when an ECG is analyzed The patient s date of birth weight height and sex can affect the interpretation If you leave this option unchecked the interpretation will include a warning if any of these details have not been entered Report title The report title will appear on the top right of all printed reports You may wish to enter the name of your practice company name or leave this
18. Gs except in the zoom view Show Ctrl K If enabled averaged complexes will be displayed in the 12 or 6 lead view if the ECG Averaged has been analyzed Complexes 28 _ Show Toolbar Show Measurements Panel Show Control Panel Show Status Bar ECG Speed Sensitivity Details Remove Analysis Analyze Options General Window Cascade Displays or removes the toolbar from the top of the screen Displays or removes the measurements panel from the bottom of the screen Displays or removes the control panel from the right hand side of the screen Displays or removes the Status Bar from the bottom of the screen Selects the horizontal scale of the active ECG Selects the vertical scale of the active ECG Displays the date recorded date received the date last modified the device that recorded the ECG and file name Removes the computer analysis of the active 12 or 6 lead ECG Analyzes an active 12 or 6 lead ECG Defines general program settings Displays open ECGs overlapping each other from top left to bottom right of the screen Tile Horizontally Shift F4 Displays open ECGs horizontally across the screen Tile Vertically Shift F5 Displays open ECGs vertically across the screen Close All Closes all open ECGs Help About Displays general information about CardioView 29 CHAPTER 6 ECG Analysis Program CHAPTER 6 ECG ANALYSIS PROGRAM HEN Analysis amp Interpretation Ca
19. NT BY MAIL OR COMMON CARRIER SHOULD BE INSURED AGAINST LOSS OR DAMAGES AS THEY ARE NOT COVERED BY THIS WARRANTY i SERVICE For service please contact the QRS Diagnostic LLC Service Department at 763 559 8492 Service Representatives are available by phone Monday through Friday from 8 a m to 5 p m Central Standard Time You can also contact Technical Support by email at support QRSdiagnostic com In the event that your problem can not be fixed over the phone or via email you will be issued a Returned Merchandize Authorized number RMA Please have the serial number of your unit available Please re package your unit in the original packing materials if possible and ship it to QRS Diagnostic 14755 27 Ave N Plymouth MN 55447 This document contains proprietary information which is protected by copyright All rights are reserved No part of this document may be photocopied reproduced or translated to another language without the written consent of QRS Diagnostic LLC The information contained in this document is subject to change without notice mu PRECAUTIONS Intended use CardioView is intended for use with an IEC 60950 compliant computer The system includes the CardioView Software and a6 or 12 lead Universal ECG that combine to allow you to connect your patient directly to the computer to monitor their Electrocardiograph Warnings This equipment is not IEC60601 1 compliant unless it is supplied from a computer or p
20. V 6mV 500 Samples Second 0 05 to 175Hz 3dB Patient leads are isolated from system and operator with 4kV protection 80dB minimum Complies with AAMI EC11 IEC601 1 IEC601 1 1 IEC601 1 2 IEC601 2 25 Connection status for each lead is shown on Recording ECG screen Can be powered by the PC Serial port control lines in most cases depending on the PC being used Can draw extra power if necessary from a PC PS 2 port or an external mains adapter Note This equipment is not IEC60601 1 compliant unless it is supplied from a computer or power supply that complies with IEC60950 or equivalent 4 16V DC 18mA DC Physical Specifications Size 91 mm x 85 mm x 20 mm excluding cables Patient 1 meter Leads PC 3 meter Cable DB9 Male Connection Weight 280 380 grams depending on cable options Case ABS Plastic material Color Matt Black Filters Permanent High Pass Baseline Wander User Selectable Notch Filters Mains Power Noise Rejection Low pass Muscle Artifact Filter Report Capabilities Display Environmental Conditions Operating Temperature Storage Temperature Humidity 6 Lead Cable 12 Lead Cable Electrode Connections Electrode Labelling Display amp Operating Console 0 05Hz 1st order Baseline reset by adaptive zeroing algorithm 50 60Hz 35Hz User selectable Report formats Recommended minimum screen size Low High 0 C 40
21. ails and they will not be displayed in the patient list Assign Patient Assigns a patient to the selected ECGs You can select an existing patient or create a new one This enables you to correct a mistake if the ECG was allocated to the wrong patient or to select the patient for an ECG that has not been assigned to a patient Analyze Analyzes the selected 12 or 6 lead ECGs If the ECG has already been analyzed it will be re analyzed and if the nclude Interpretation option in the General Options is checked the current interpretation will be overwritten Export Copies the selected ECGs to disk Send Mail Sends the selected ECGs to another person as an attachment to an electronic mail message You must have a MAPI compatible e mail system installed to enable this command Open Opens and displays the selected ECGs CardioView will only open four ECGs at a time If you have selected more than four iin only the first four will be opened DU zI ol Saele Ls Te Qum LE oe LONE E ES Um Fer wt 25 CHAPTER 4 Working with CardioView Exporting ECGs You can copy or export ECG files to disk so you can transfer them to another CardioView system or to backup your data Each ECG file contains all ECG data and patient information There are several ways you can export ECGs You can export them from the Batch Process or Open ECG dialogs or if you are viewing an ECG you can exp
22. as a 4 digit year value Dates of birth occurring in the year 2000 or later are required to be entered with a 4 digit year 6000 4153 Rev C mm WARRANTY All instruments sold and supplied by QRS Diagnostic LLC are guaranteed to be free from defects in material and workmanship for a period of 3 years from date of purchase All supplies and accessories carry a 90 day limited warranty This includes oximetry fingertip sensors and ECG lead wires If in the judgement of QRS Diagnostic the instrument is proven to be defective during the warranty period it will be repaired or replaced with no charge for parts or labor An extended hardware warranty is available at additional cost This warranty does not cover any instrument that has been damaged by accident misuse abuse or has been altered or repaired by anyone other than an authorized QRS Diagnostic agent This warranty also does not cover any unit that has had a serial number removed defaced or rendered illegible This warranty is in lieu of all other warranties expressed or implied Including warranties of merchantability and fitness and is hereby limited to repair or replacement of instruments found defective during the warranty period ALL REPAIRS MUST BE MADE BY AN AUTHORIZED QRS DIAGNOSTIC AGENT THE INSTRUMENT MUST BE RETURNED FOR REPAIRS AT THE EXPENSE OF THE PURCHASER IN WARRANTY REPAIRED UNITS WILL BE RETURNED AT THE EXPENSE OF QRS DIAGNOSTIC OR ITS AUTHORIZED AGENT INSTRUMENTS SE
23. atient You can also use the scroll bar PAGE UP PAGE DOWN and ARROW keys to locate the ECG you want a Viewing an ECG CardioView can work with single lead six lead and twelve lead ECGs When you open an ECG CardioView will display it in a window with the patients name and the date of the ECG displayed in the title bar You can then switch between different views of the ECG zoom in make measurements etc You can also view enter and edit comments and an interpretation To review an ECG 1 Select Open ECG from the File menu or click the Open ECG button on the toolbar 2 Select the ECG you wish to view 3 Click the Open button 18 CHAPTER 4 Working with CardioView To compare multiple ECGs 1 Select Open ECG from the File menu 2 Hold down the CTRL key and then click each ECG you want to select Up to four ECGs may be viewed at a time 3 Click the Open button For all ECG views you can Select Zoom In from the View menu or click the Zoom In button on the toolbar to enlarge the ECG Select Zoom Out from the View menu or click the Zoom Out button on the toolbar to reduce the size of the ECG Click the Callipers button on the toolbar to select the callipers cursor then click and drag the mouse in any of the ECG views to make measurements Click the Zoom button on the toolbar to select the zoom cursor then click the mouse in any ECG view to zoom in on a section of ECG You can also click the rig
24. delete assign a patient analyze export or email multiple ECGs Allows you to select a printer and change its settings Displays printing options and prints the active ECG Sends the active ECG file as an attachment to an email Exits CardioView The Edit menu is only enabled when editing the comments or interpretation Undo Ctrl1 Z When editing the interpretation or comments it allows you to reverse the most recent editing operation s Cut Ctrl X Copies the selected text to the clipboard and removes it Copy Ctrl C Copies the selected text to the clipboard Paste Ctrl V Pastes text from the clipboard The text will be pasted at the current cursor position Delete Del Deletes the selected text Select All Ctrl A Automatically selects the entire interpretation or comment field View 12 Lead Selects the 12 lead view of the active ECG ECG Strips Selects the three lead strip view of the active ECG Zoom Selects the zoom view of the active ECG Details Selects the details view of the active ECG which shows interpretation measurements and comments Zoom In Ctrl Zoom in on the current view Zoom Out Ctrl Zoom out on the current view Next Lead PgDn Selects the next lead Previous Lead PgUp Selects the previous lead Show Ctrl M Displays or removes the measurements from all open ECGs Measurements Show Grids Ctrl G Displays or removes the grid lines from all open ECGs Grid lines are not shown for Single lead EC
25. e June 00009 v Cancel New Sorting the patient list The patient list is usually sorted by the patient s name You can change the order of the columns with the Sort By button You can also sort the ECG list by a particular column by clicking that column s header click the column s header a second time to change the sort order from descending to ascending and vice versa Resizing the patient list and columns You can resize the window containing the list of patients to display more items by using the mouse to drag a corner or side of the window You can also resize the width of each column by clicking and dragging the separator between each column header Searching To search for a patient you can type the name of the patient or number depending on the current column order in the search box The Patient list will automatically scroll to the desired patient You can also use the scroll bar PAGE UP PAGE DOWN and ARROW keys to locate the patient you want 16 CHAPTER 4 Working with CardioView ECG Lists There are several dialogs that display a list of ECGs The Open ECG and Batch Process dialog boxes show a list of all ECGs in the data directory The Received ECGs dialog displays a list of all ECGs in the receive directory The Import ECGs dialog displays a list of all ECGs in a directory you select Each list contains the following columns 3 amp el Type of ECG single lead 6 lead or 12 lead
26. ent is connected the ECG will be displayed on the screen in real time The Heart Rate box displays the active Heart Rate of the patient The Calibration pulse provides a visual indication of the combined sensitivity and speed The sensitivity of the ECG represents the number of millimeters that represent one millivolt This is represented by the width of the Calibration pulse The available options 5mm mV 10mm mV and 20mm mV The speed of ECG represents the number of millimeters that are passed in one second This is represented by the height of the Calibration pulse The available options are 12 5mm s 25mm s and 50mm s The lead display provides the user with the option to view 3 6 or 12 leads on the screen at any one time The ability to select between the Limb leads and the V leads is also available when viewing 3 or 6 leads at a time The view select arrows found at the top and bottom of the left hand side of the screen allow the user to scroll through the different sets of leads when you view the 3 or 6 lead sets The Lead ldentifiers found on the left hand side of the screen identify each of the 12 leads If a lead is disconnected red circle with a diagonal line through it is placed over the lead label The filter controls allow the user to turn the Muscle and the Mains 50 or 60Hz filters on and off The frequency of the mains filter is selected under the options menu of CardioView 5 CHAPTER 2 CardioView The s
27. ew D v 10 f you wish to print more than 10 seconds of the ECG press the Print button Selecting All will print the entire tore z recording selecting Pages allows you to identify D which pages you wish to print with page 1 ig p being from the start of the recording and tet selecting Selection will print the current te view 11 To exit and view the ECG press the button located in the to corner of the screen Note The ECG will only be analyzed if the Analyze ECG option is ch General Options 13 CHAPTER 4 Working with CardioView The following hot keys have been allocated for switching between the views Hot key View F2 Switches to 3 lead view F3 Switches to 6 lead view F Switches to 12 lead view p amp Toggle through the variations of each view gt To download an ECG from the Biolog 3000i In the options menu the device must be set to Biolog 30001 1 Connect the Biolog 3000i to the serial port on the PC using the direct download cable 2 Switch on the Biolog 3000i 3 From the File menu select New ECG or click the New ECG 1 button on the toolbar 4 For an existing patient select the NS patient from the list and click the OK FirstName Joe LastName Bloggs Butler L 3 b utton Carl Jan 00012 Number 12345 1 1 ilds Daphne 2 Hee For a new patient click the New
28. ht mouse button to zoom out 4 Select Scale or Sensitivity from the ECG menu to change the horizontal or vertical scale Select Show Grids from the View menu or click the Grids button on the toolbar to show or hide the grid lines Note For single lead ECGs grids are only displayed in the Zoom view Click the muscle button on to activate the muscle filter Click the 50 or 60 Hz mains filter e on to activate the mains filter For 12 lead and 6 lead ECG views you can Select Previous Lead or Next Lead from the View menu or click the Previous Lead Next Lead button on toolbar to show different leads Click in the caption of a single lead to display a zoomed view of the complex or lead Select the Show Measurements option in the View menu or click the Measurements button amp on the toolbar This will toggle the showing of markers and lead specific measurements in the zoomed view in the averaged complexes on or off Inthe 12 Lead or Zoom view click the Average On Off button on the toolbar to switch between showing the averaged complexes or 10 second lead strip For single lead ECG views you can a Click the Invert ECG button invert the polarity of the ECG 19 CHAPTER 4 Working with CardioView Click the Strips button 50 88 to change the number of ECG strips shown in the window Following are some of the views that are available for 12 lead ECGs 12 Lead This view shows
29. n the QRS beep and the Audible Leads indicator or off Some PC s may not function correctly using normal sound in which case the MIDI sound should be selected Two color schemes are available for the ECG recording Green trace on a black background and a black trace on a white background Data Directory Settings General Connection Data Directory Directory E ces Cancel gt cv3000 Directory Selects the main database directory into which ECG files will be stored 9 CHAPTER 3 Setting up CardioView Drive Selects the drive that contains the data directory 10 CHAPTER 4 Working with CardioView CHAPTER 4 WORKING WITH CARDIOVIEW E Downloading an ECG Todownload an ECG from the Universal ECG 1 Connect the Universal ECG to the serial port on the PC 2 Connect the power cable from the Cable to the PS 2 plug Note Once the cable is connected correctly a green light will blink slowly on the body of the cable 3 From the File menu select New ECG or click the New ECG button on the toolbar 11 CHAPTER 4 Working with CardioView 4 For an existing lli Select Patient el ES patient select the Search Y Sort by patient from the list and click the OK button i FirstName Joe Butler Len 1 LastName Bloggs Carroll Jan 00012 Number 12345 Childs Daphne 00013 Chodora Kazimiera 00006 Sex Male Coleman Margaret 00014 Date of Bith 12 04 40 Connors Ann 000
30. ort it by selecting Export from the File menu To export ECG that you are viewing 1 While viewing an ECG select Export from the File menu 2 Select the drive and directory you wish to export the ECG file to then click OK To export ECGs to disk 1 From the File menu select Batch Process 2 Select the ECGs you wish to export 3 Click the Export button Cancel 4 Select the drive and directory where you wish to export the ECGs to then click OK Drive 26 CHAPTER 4 Working with CardioView Importing ECGs You can import ECG files from disk or another directory into CardioView You may wish to import ECGs from another CardioView system or retrieve an ECG that you have archived to disk or another directory When you import an ECG file it will be copied into the CardioView data directory but will be given a different filename Each ECG file contains all ECG data and patient information import ECGs 1 From the File menu select Import ECGs From 2 Select the drive and directory where the ECGs are stored that 21297 you wish to import then click the OK button Import ECGs oy x 3 Select the ECGs you wish to Search Sort import then click the OK button Jp sm 12 Bloggs Joe 12345 5 12 97 15 51 00 9712 97 14 16 27 BIOLOG 030293 tC 14 Bloggs Joe 12345 1 12 97 8 54 00 16 12 97 18 26 20 BIOLOG 00679
31. ower supply that complies with IEC60950 or equivalent Note All CE marked devices will have been tested to this standard The following precautions need to be taken when a defibrillator is used on a patient Do not touch the patient during defibrillation Do not touch the defibrillator s paddle electrode surface when discharging the defibrillator Keep defibrillator electrodes well clear of other electrodes or metal parts in contact with the patient person is touching the patient bed or any conductive material in contact with the patient during defibrillation the delivered energy may be partially discharged through that person Make sure persons stand away from the patient bed and other conductive material before discharging the defibrillator CAUTION Conductive parts of electrodes and associated connectors including the neutral electrode should not contact other conductive parts including earth Ensure that the electrodes are connected only to the patient and not to any other conductive parts or equipment to prevent hazards to the patient from leakage currents The Universal ECG should be used with Ag AgCl ECG skin electrodes These should be used in accordance with manufacturers instructions There are no hazards associated with using this device with a pacemaker The Universal ECG is not intended to be sterilized or used in a sterile environment and therefore is not suitable for direct cardiac application
32. owing the files on the CD Double click the one whose name contains the word setup 6 Follow the setup instructions on the screen The setup program leads you through the installation process and prompts you to provide information and make several choices Networking CardioView CardioView can run on a stand alone computer or in a multi user network environment where ECG files are stored in a common location and accessed from multiple workstations The license for CardioView is for installation and use on a single computer only as described in the End User License Agreement Alternatively you can purchase a copy of CardioView Reader version that will allow you to view add comments and email ECG s on up to 25 computers Please contact your local distributor for pricing and availability 1 CHAPTER 1 Introduction CardioView workstation installation 1 Setup and configure the appropriate file and directory access permission s for each CardioView user and or workstation CardioView must have read and write access to a shared directory on the network where you wish to store all your ECG files See your Network administrator 2 On each workstation map a drive letter to the shared network drive or directory where you wish to store all your ECG files 3 For each workstation Install CardioView as described in the previous section Run CardioView From the Options menu select Settings then click the Da
33. rdioView provides analysis and interpretation of 12 lead ECGs The analysis and interpretation is based on algorithms developed by the Belgian company Cardionics S A which have been incorporated into the QRS Diagnostic CardioView software The ECG Analysis Interpretation Program uses 10 seconds of 12 simultaneously recorded leads The software produces accurate and consistent ECG measurements averaged beats and rhythm and morphology statements Why use an interpretive cardiograph While a computer interpreted ECG report is not a substitute for interpretation by a qualified physician computerized interpretation can improve physician and staff productivity The program s measurements and interpretation can help the physician save time when interpreting reports The ECG Analysis Program is highly effective at screening normal ECGs It makes quick and consistent measurements over the entire ECG providing more data for a more accurate interpretation The program s computerized interpretation can help the physician determine a final interpretation The program can help identify problem areas thereby saving time for the physician or editing technician who may only need to add delete or modify statements Those who read ECGs infrequently may find the interpreted reports to be a useful training tool What to expect from the analysis program The ECG Analysis Program provides an analysis of the amplitudes durations and morphologies of
34. sensitivity and type of minor grids To print an ECG that you are viewing 1 Select Print from the File menu or click the Print button on the toolbar 2 Select the reports and print options you want then click the OK button Note To print multiple ECGs refer to the section on Batch Processing m Print what C Reports C Zoomed view Reports to print Include Cael 3x4 Simultaneous v Measurements 3x4 Sequential IV Interpretation Averaged Complexes v Comments 6x1 Format 2 Page SEE 6x2 Format 1 Page Speed Emms Measurements table Sensitivity e Minor grid Lines Y Print what Reports Prints one or more of the selected reports in the Reports to print group Zoomed Prints the ECG as displayed in the zoom view of the active view ECG This option is enabled only if the active file is in the Zoom view Reports to print Allows you to select one or more report formats Include Allows you to select whether to include measurements interpretation and comments in the report s 23 CHAPTER 4 Working with CardioView Scale Allows you to select the speed 12 5 25 or 50mm s and sensitivity 5 10 or 20 mm mV of the ECG reports Minor grid You can select whether to print lines dots or no minor grid lines on the ECG If printing to a low resolution printer or fax you may need to select dots or no grid lines for a clear printou
35. t Batch Processing The Batch Processing command allows you to perform actions on more than one ECG You can print delete assign a patient analyze export or email multiple ECGs To process multiple ECGs 1 From the File menu select Batch Process The Batch Process dialog is displayed 2 Select the ECGs you wish to process 3 Click one of the buttons labelled Print Delete Assign Patient Analyze Export Send Mail or Open to perform the indicated action Note The Batch Process dialog will remain open until you click the close button This allows you to perform a series of actions on a group of selected ECGs ff Batch Process O xi Search Sort by Number Recorded Device Fa 12345 5 12 97 15 51 00 BIOLOG 030293 5 14 Bloggs Joe 1212297 8 54 00 BIOLOG 006795 12 Butler Len 28 05 97 14 49 00 BIOLOG 036821 14 Carroll Jan 7 05 97 10 46 00 BIOLOG 036821 14 Childs Daphne 00013 6205 97 11 13 00 BIOLOG 036821 12 Chodora Kazimiera 00006 20 05 97 11 10 00 BIOLOG 036821 14 Coleman Margaret 00014 6 05 97 10 57 00 BIOLOG 036821 12 Connors Ann 00011 BIOLOG 036821 lt 12 Connors John BIOLOG 036821 2 IAN Coo 00007 15 05 97 BIOLOG 036821 Print Prints the selected ECGs 24 CHAPTER 4 Working with CardioView Delete Deletes the selected ECGs You will be prompted before the ECGs are deleted Note that if you delete all the ECGs of a patient CardioView will not retain the patient s det
36. t port 3 Your operating system control panel has a System icon which gives access to Device Manager under the Hardware tab this varies slightly between versions of windows check your operating system instructions The Device Manager has a list of expandable icons The one marked Ports will show you the COM numbers available Many commonly available PCs do not have clear indications of which physical ports match the COM numbers so you may have to try each one or get assistance from someone with experience in PC support 4 If using the Universal ECG ensure that supplementary power is supplied to the socket at the back of the Universal ECG DB9 plug as described in Connecting the 6 or 12 Lead Universal ECG 34 CHAPTER 8 Troubleshooting Leads Off Indication Displayed During Monitoring The patient leads are not connecting to the patient Ensure that the electrodes are making contact with the patient skin and that all hair and surface grime has been removed If this fails please attempt the following 1 Identify which lead is off 2 Check that the electrode is connected properly 3 If the electrode is connected correctly remove the snap or Biotab adapter and swap it with an adapter from a lead that is working 4 Identify which lead is now off If the same lead is still off then there is a fault with the cable Contact QRS Diagnostic for repair If the new lead is now off then there is a problem
37. t the supplementary power adapter plug be used on all occasions This includes when being used with a USB adapter The PS 2 power adapter ensures that the power supplied to the Universal ECG is consistent Disruptions to the power supply may cause the Universal ECG to reset which may result in data loss 3 CHAPTER 2 CardioView CHAPTER 2 CARDIOVIEW CardioView Main Screen Active ECG_ Window E CardioView John Ramsey 03 04 2000 09 56 00 Menu Bar fie Edt View ECG Transtelephonic Options Window Help 8 Toolbar jee Sd es E e AIS e 34 is da i ECG Strips 200m Views Details by h g z IMa TV T EIS Lead Vertical aR st Selection ertica a Scale EI 5 Za F VE Y Horizontal E Scale x 1 E a eee ee oe ES NN Muscle Filter 2 10mm Fiter 0 05 40 H2 _ 80H 1 Control Measurement mue PR 1400 0 8 3Oms 358ms 353 s Panel Duration 120ms P Ws 65 ORS 64 T Aris Status Bar When you start CardioView it will initially display a blank workspace You can then open ECG files which are displayed in a window in the workspace The title bar of the active ECG window shows the patients name and date that the ECG was recorded You can customise the
38. ta Directory tab Select the shared network drive and directory then click OK Note CardioView does not support Universal Naming Convention UNC paths or long filenames To access a network drive you must first map a drive letter to the shared network drive or directory 2 CHAPTER 1 Introduction What is the Universal ECG QRS Diagnostic has developed the world s smallest ECG module This simple to use device collects ECG data and transmits it to a PC Laptop or Pocket PC to be displayed using either of QRS Diagnostic s software packages The Universal ECG is available in both a 6 lead and a 12 lead format Connecting the 6 or 12 Lead Universal ECG To use the CardioView software you need to connect the 6 or 12 Lead Universal ECG to the PC To install the Universal ECG 1 Connect the Universal ECG to the serial port of the PC If the PC has only USB ports you can use a QRS Diagnostic recommended USB serial adapter To install the USB adapter please follow the USB serial adapter set up instructions 2 Remove the Mouse or Keyboard plug from the PS 2 port at the rear of the PC and insert the in line PS 2 power adapter plug found on the power cable supplied MMI part 800 000 032 3 Reconnect the Mouse or Keyboard plug into the in line PS 2 power adapter plug 4 Insert the DC power plug found at the other end of the PS 2 power adapter cable into the socket found in the DB9 connector NOTE It is recommended tha
39. tatus bar represents whether 10 seconds of valid ECG data has been received When the status bar is full the save button is activated and data can now be recorded The pause button allows you to view the past fifteen minutes of ECG The user can then select the 10 seconds of ECG they wish to analyze and save by pressing the save button The record button is only available when in the pause mode and allows the user to continue recording the ECG The Print button allows you to print all or a selected portion of the paused ECG The save option allows the user to select whether they wish to save all 12 leads or the limb leads only 6 CHAPTER 3 Setting up CardioView CHAPTER 3 SETTING UP CARDIOVIEW The Settings dialog allows you to change general program settings select the desired input device setup the connection to the Universal ECG or Biolog 3000i and change the data directory where ECG files are stored To display the Program Settings 1 From the Options menu select Settings The Settings dialog is displayed 2 Click the General Connection or Data Directory tab Use the SHIFT and TAB keys to select a tab using the keyboard General Settings General Connection Data Directory m Amplitude units Power filter Measurement system i ance Microvolts yv 50 Hz Metric C Imperial Ib in C Milimeters mm C 60Hz L Action after receiving an ECG v Analyse EC
40. the ECG waveform The analysis is based upon standards of interpretation of these parameters as well as calculations of the electrical axis and relationship between leads The interpreted ECG is a tool to assist the physician in making a clinical diagnosis It is best used in conjunction with the physician s knowledge of the patient the patient s history the results of the physical examination the ECG tracing and other findings 30 CHAPTER 6 ECG Analysis Program Statistical Performance of the ECG Analysis Program The performance of the interpretation has been evaluated using two databases The ECG analysis program was tested using the CSE database which contains ECGs from 1220 adults The performance of the analysis software was assessed according to the clinical diagnosis derived from ECG independent evidence and it was compared with that of other ECG and VCG programs which had been evaluated on the same database The ECG analysis program was also tested using 1463 ECGs collected by Cardionics and interpreted by an ECG expert at a University Hospital Universit Catholique de Louvain This database includes pathologies that are different from those found in the CSE database The results from the ECG expert were compared with the program s interpretations The sensitivity and specificity were calculated according to the following standard formulas in which TP represents a true positive result FN a false negative result
41. ther windows In some cases computers are set up to perform background tasks such as looking for Internet updates for other applications and performing power saving tasks If the trace is being interrupted regularly check for such background tasks using the Scheduled Tasks icon in the Windows 2000 Control Panel or the Scheduled Tasks program in Windows 98 the method for this varies in different versions of Windows Check your operating system instructions for details CardioView Will Not Print If you are printing to a Networked printer it is recommended that you capture a printer port LPT 2 9 for use with the printer Please refer to Windows Help for directions on how to capture a printer port Incomplete Download From Biolog to CardioView 1 If you are attempting to download to CardioView from the Biolog and the download status bar reads less than 100 and fails you may need to change the batteries in the Biolog or turn off the backlight 2 This symptom can also occur when reaching the upper limit of the number of ECGs which can be stored in one directory by CardioView If there are more than 1000 ECGs move some of them to a different directory They can still be accessed by changing the directory under Options gt Settings gt Data Directory 36 APPENDIX ELECTROMAGNETIC COMPATIBILITY NOTICE This equipment has been tested and found to comply with the limits for a class B digital device pursuant to part 15 of the
42. us AAE d Puto ira m rane E el 4 CHAPTER SETTING UP 6 CHAPTER 4 WORKING WITH 10 DOWNLOADING AN EG OL uius c esed vn aa iion PAR e Medie Sarda dh cem a ca et as 10 PATENTS Ta ages ote seed sgh ase usa donet 16 P CHI TNI EE 17 Amer dcc TT M m 18 PRINTING AN EC Gis artist dex am exe canes abana tana c pa aee dads c ine on en 23 BATCH PROCESSING edades Vlog back Opa RC EAR NR A 24 EXPORTING EGG Siere nein dcc vetet lala na ucro thea eat ant cle Bi bte dada 26 IMPORTING EG ide esa t ft ka iocos dei es amer ca aestu dap Fl IR NES 27 CHAPTER 5 HEFEHENGE eduxi tinte e nnne tat 28 OMMANDS adde Diode feda tbid acida nnen rrr TQUE A INIM MAS 28 CHAPTER 6 ECG ANALYSIS 30 ANALYSIS NTERPRETA TION a 2 dawned va Ax Ec tb n OA 31 STATISTICAL PERFORMANCE OF THE ECG ANALYSIS 31 CHAPTER 7 33 CHAPTER 8 TROUBLESHOOTING eene nennen nnnm nnne nn 34 APPENDIX SYSTEM
43. workspace to show or hide the Toolbar Status Bar Control Panel or Measurements Panel and change the size and position of the ECG window The menu bar the horizontal list of menu names is at the top of CardioView Use the mouse or keyboard Alt underlined letter to choose an item from the menu Some menu commands have a shortcut key listed next to them on the menu Use the shortcut key method to choose the menu item directly Below the menu bar is the toolbar a row of command buttons that give you quick access to common CardioView commands You can position your mouse cursor over each toolbar button and hold it there for a couple of seconds to pop up an explanation of what the button is for The Measurements panel shows the general measurements of the active ECG file if it has been analyzed The Status Bar displays information about each toolbar button as they are highlighted with the mouse It also shows transtelephonic status information and other visual indicators 4 CHAPTER 2 CardioView ECG Recording i LT m Anh ave in ate teaa wb x S EMEN VS A T i nba tat E When you select new ECG from the main screen the Recording ECG screen will appear It will initially display a blank workspace however once a pati
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