CardioView QRS User Manual

Copyright Notice Copyright © 2004 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.

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 20th century and is stored 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 F

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 SENT BY MAIL OR COMMON CARRIER SHOULD BE INSURED AGAINST LOSS OR DAMAGES, AS THEY ARE NOT COVERED BY THIS WARRANTY.

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 [email protected]. 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 27th 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.

PRECAUTIONS Intended use CardioView is intended for use with an IEC 60950 compliant computer. The system includes the CardioView Software and a 6 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 power 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. If a 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. 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 Attention: Consult accompanying documents. Type BF defibrillator proof equipment.

TABLE OF CONTENTS CHAPTER 1 - INTRODUCTION……………………………………………………..1 WHAT IS CARDIOVIEW …………………………………………………………………...1 SYSTEM REQUIREMENTS…………………………………………………………………1 INSTALLATION…………………………………………………………………………….2 CHAPTER 2 - CARDIOVIEW………………………………………………………...5 ECG RECORDING………………………………………………………………………..6 CHAPTER 3 - SETTING UP CARDIOVIEW……………………...………...…...…8 CHAPTER 4 - WORKING WITH CARDIOVIEW………………………...……….12 DOWNLOADING AN ECG………………………………………………………………..12 PATIENTLIST………...………………………………………………………….………17 ECG LISTS……………………………………………………………………………..18 VIEWING AN ECG………………………………………………………………………19 PRINTING AN ECG………………………………………………………………….…..24 BATCH PROCESSING………………………………………………………………..….25 EXPORTING ECGS……………………………………………………………………..27 IMPORTING ECGS………………………………………………………………………28 CHAPTER 5 - REFERENCE………………………………………………………..29 MENU COMMANDS……………………………………………………………………...29 SETTING UP TRANSTELEPHONIC COMMUNICATIONS……………………………………32 RECEIVING AN ECG TRANSTELEPHONICALLY………………………………………….35 MANAGING RECEIVED ECGS…………………………………………………………….36 CHAPTER 6 - ECG ANALYSIS PROGRAM………………………………...…38 ANALYSIS & INTERPRETATION………………………………………………………….38 STATISTICAL PERFORMANCE OF THE ECG ANALYSIS PROGRAM………………………39 CHAPTER 7 - MAINTENANCE…………………………………………………….41 CHAPTER 8 - TROUBLESHOOTING……………………………………………..42 APPENDIX: SYSTEM SPECIFICATIONS``………………………………………46

1

CHAPTER 1 - Introduction

CHAPTER 1 - INTRODUCTION 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: Pentium II 400 MHz IBM compatible computer. 32MB RAM. SVGA display. One spare serial or USB port. PS/2 mouse or keyboard port (recommended) 1.44MB 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). Windows 98, 2000, or XP. Any pointing device supported by Windows. A Windows supported printer. A MAPI compliant electronic mail system must be installed on your computer (e.g. Outlook Express). Requirements for email support: A MAPI compliant electronic mail system must be installed on your computer.

2

CHAPTER 1 - Introduction

Installation Installing CardioView The program on the installation disk is used to install CardioView onto your computer. To install CardioView: 1. Start Microsoft Windows 2. Insert the CardioView installation CD into drive D (CD ROM drive). 3. Open the ‘Start’ menu and select ‘Run’. 4. Type D: and press ENTER (‘D:’ represents the allocated letter for the CD Rom drive and may vary between computers). 5. A window will open up showing 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.

3

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 ‘Data 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.

4

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.

3.

4.

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). Reconnect the Mouse or Keyboard plug into the in-line PS/2 power adapter plug. 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 that 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.

5

CHAPTER 2 - CardioView

CHAPTER 2 - CARDIOVIEW CardioView Main Screen

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 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.

6

CHAPTER 2 - CardioView

ECG Recording

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 patient 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 are 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 Identifiers found on the left hand side of the screen identify each of the 12 leads. If a lead is disconnected, a 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.

7

CHAPTER 2 - CardioView

The status 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.

8

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

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.

9

CHAPTER 3 - 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 box empty if you do not want a report title. Connection Settings

Device: The ECG device which connects to CardioView. CardioView offers two options for downloading ECG’s, the Universal ECG or Biolog 3000i connection.

10

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 3000i 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 3000i, 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 turn the QRS beep and the Audible ‘Leads Off’ indicator on 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

Directory: Selects the main database directory into which ECG files will be stored.

11

CHAPTER 3 - Setting up CardioView

Drive: Selects the drive that contains the data directory.

12

CHAPTER 4 - Working with CardioView

CHAPTER 4 - WORKING WITH CARDIOVIEW Downloading an ECG To download 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.

13

CHAPTER 4 - Working with CardioView

4. For an existing patient, select the patient from the list and click the OK button. 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